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Full text of "ECDEU assessment manual for psychopharmacology"

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ASSESSMENT MANUAL 




U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE • Public Health Service 
Alcohol, Drug Abuse, and Mental Health Administration 



Digitized by the Internet Archive 

in 2010 with funding from 

Boston Library Consortium IVIember Libraries 



http://www.archive.org/details/ecdeuassessmentm1933guyw 



ECDEU 

ASSESSMENT 
MANUAL FOR 
PSYCHOPHARMACOLOGY 
Revised, 1976 

William Guy, Ph.D. 

Biometric Laboratory 

The George Washington University 

Kensington, Maryland 



U.S. DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

Public Health Service 

Alcohol, Drug Abuse, and Mental Health Administration 

National Institute of Mental Health 
Psychopharmacology Research Branch 
Division of Extramural Research Programs 
5600 Fishers Lane 
Rockville, Maryland 20852 



This publication was supported by NliVlH grant i\/lH-22019, 
from the Psychopharmacology Research Branch, 
Division of Extramural Research Programs. 

DHEW Publication No. (ADM) 76-338 
Printed 1976 



CONTENTS 

Acknowledgements 6 

I ntroduct ion 9 

Participation in ECDEU Program 11 

Description of ECDEU Battery 12 

Time Table for Using tine ECDEU Battery 1^ 

General Instructions 19 

The Identification (ID) Block 23 

Coding Duration of Study 25 

Research Plan Report (021-RPR) 27 

ECDEU Order Form (07^-EOF) ^9 

General Scoring Sheet (050-GSS) 53 

Encoding Non-Standard Data 59 

DEMOGRAPHIC PACKET 65 

Children's Personal Data Inventory (043-CPDl) 71 

Children's Symptom History (044-CSH) 87 

Adult Personal Data Inventory (041-APDl) 93 

Prior Medication Record (046-PMR) 109 

PSYCHIATRIST PACKETS 113 

PEDIATRIC SCALES 

Children's Psychiatric Rating Scale (027-CPRS) 123 

Children's Diagnostic Scale (030-CDS) 131 

Diagnostic Cr i ter ia-Ped iatr ic Psychopharmacology Conference 135 

Children's Diagnostic Classification (031-CDC) 1^1 

Instructions for CDC - Werry 1^3 

Diagnosis for Psychopharmacologica 1 Studies - Werry 1^7 

ADULT SCALES 

Brief Psychiatric Rating Scale (047-BPRS) 157 

Comments - Overall 166 

Depression Status Inventory (072-DSl) 171 

Comments - Zung 176 

Hamilton Depression Scale (049-HAMD) 179 

Comments - Hamilton 186 

Hamilton Anxiety Scale (048-HAMA) 193 

Anxiety Status Inventory (051-ASl) 199 

Comments - Zung 204 

Wittenborn Psychiatric Rating Scale (052-WITT) — 205 

Comments - Wittenborn 210 

UNIVERSAL SCALES 

Clinical Global Impressions (028-CGl) - - - -217 

Dosage Record and Treatment Emergent Symptoms Scale (029-DOTES) 223 

Patient Termination Record (032-PTR) 245 

NURSE PACKET 253 

Children's Behavior Inventory (034-CB I ) 257 

Nurses' Observation Scale for Inpatient Evaluation (039-NOSIE) 265 

Comments - Honigfeld 271 

Plutchik Geriatric Rating Scale (040-PLUT) 275 

Nurses' Global Impressions (042-NGl) 283 

INDEPENDENT PEDIATRIC SCALES 

Teacher Questionnaire (035-T(l) 287 

parent Questionnaire (036-PQ.) 293 

Parent-Teacher Questionnaire (037-PTQ) 299 

Rating Scales for Use with Children - Conners 303 



INDEPENDENT ADULT SCALES 

Self-Report Symptom Inventory (053-SCL-90) 313 

Comments - Derogatis, Lipman, and Covi 320 

Self-Rating Depression Scale (073-SDS) 333 

Self-Rating Anxiety Scale (05^-SAS) 337 

Comments - Zung 3^0 

INDEPENDENT ADVERSE REACTION SCALES 

TESS Write-In Scale (033-TWIS) - - --- 3^1 

Subject's Treatment Emergent Symptom Scale (O38-STESS) 3^7 

Laboratory Data (055-LAB) -- 351 

Clinical Laboratory Standards in Pediatric Psychopharmacology - Gershon 365 

Clinical Laboratory Test Standards for Schizophrenics - 

McGlashan and Cleary 379 

MEDICAL SCALES 

Physical and Neurological Examination for Soft Signs (O^l-PANESS) 383 

Manual for Scored Examination for Soft Signs - Abbott Lab. and Close 39^ 

PSYCHOLOGIST PACKET kOJ 

PEDIATRIC SCALES 411 

Wechsler I ntel 1 igence Sea le for Children (O6O-WISC) 4l5 

Wide Range Achievement Test (062-WRAT) k]7 

Porteus Mazes (06I-MAZE) - — - 4l8 

Goodenough-Harr is Figure Drawing Test (O63-GOOP) 422 

Bender Gestalt Test - Koppitz Scoring (064-BENDK) 423 

Psychological Examination Behavior Profile (O66-PEBP) 429 

Performance Tests for Children - Sprague 435 

ADULT SCALES - — - - 443 

Wechsler Adult I ntell igence Scale (O67-WAIS) 446 

Porteus Mazes (See Page 418) 

Bender Gestalt Test - Pascal -Suttel 1 Scoring (O68-BENDP) 448 

Wechsler Memory Scale (O69-WMEM) 449 

Friedhoff Task Behavior Scale (O7O-FTBS) 450 

Assembl ing Data for Shipment 451 

Alternative Types of Data Submission 454 

Data Shipment (07I-DS) 455 

DOCUMENTATION (THE DATA PACKAGE) 

The Processing System (BLIPS II) 468 

Contents of the Data Package 469 

Editing and Error Correction 472 

Raw and Computed Listings ■ 474 

Means and Standard Deviations 474 

Frequency Tables 474 

Cross-Tabulat ions 474 

Graphic Displays 480 

Data Inventory 483 

The Analytic Cohort 483 

Narrative Summary 483 

Comments on Statistical Procedures - Cleary and Yang 486 

Research Completion Report 497 



APPENDICES 

1. Occupation Categories 5)6 

2. DSM-11 and WHO Diagnostic Codes 521 

3. Formats for Non-Standard Instruments 528 

Profile of Mood States (056-POMS) 529 

Frostig Developmental Test of Visual Perception (O65-FROST) 532 

Abnormal Involuntary Movement Scale (II7-AIMS) 534 

Crichton Geriatric Rating Scale (201-CRICHT) 538 

Beck Depress ion Inventory (203-BECK) Sk] 

Guild Memory Test (205-GUILD) Shk 

Physician Questionnaire (208-PHYS) 546 

inpatient Multidimensional Persona I i ty Sea 1 e (210-IMPS) 5^9 

Physician's Outpatient Psychopathol ogy Scale (211-POPS) 559 

Memory for Designs Test (212-MF-D) 562 

Phillips Scale of Premorbid Adjustment in Schizophrenia (213-PHIL) 564 

Sandoz Clinical Assessment-Geriatric (238-SCAG) 568 

Clyde Mood Scale (239-CLYDE) 572 

Hopkins Symptom Checklist (240-HSCL) 575 

Self-Rat ing Symptom Scale (010-SRSS) 579 

Global Assessment Scale (241-GAS) 583 

Tartu Psychometric Battery (242-TARTU) 586 



ACKNOWLEDGEMENTS 

This revision of the 1970 ECDEU Assessment Manual represents the cooperative 
effort of many individuals whose comments and criticisms have served to sustain 
the ECDEU program as an evolving entity. The adult elements of the ECDEU Assess- 
ment Battery have been modified and expanded over the period of the last decade 
as a consequence of the interactions among those investigators employing the 
Battery in clinical drug trials, the pharmaceutical industry, the Psychopharmacol - 
ogy Research Branch of the National Institute of Mental Health and the Biometric 
Laboratory of The George Washington University. The size of this group makes it 
difficult to acknowledge every individual by name as I would wish, and, therefore, 
appreciation for their contributions is extended collectively but no less warmly. 

The newer pediatric section of the ECDEU Assessment Battery is the culmina- 
tion of several years of effort on the part of the Pediatric Psychopharmacol ogy 
Conference which was organized under the auspices of the Psychopharmacol ogy Research 
Branch. The contributions of this Conference have been summarized in a 1973 Special 
Issue of the Psychopharmacol ogy Bulletin, entitled "Pharmacotherapy of Children" and 
are happily acknowledged here. 

A number of individuals have been kind enough to provide special commentaries 
for sections of the Manual, A list of these contributing authors is given below. 
To them, and to the developers of all the assessment instruments cited in this Manual, 
deep appreciation is expressed. 

The emergence of the present Assessment Battery has been accompanied by the 
development of a data processing system called the Biometric Laboratory Information 
Processing System (BLIPS). To the entire staff of the Biometric Laboratory - and 
particularly to those cited below - I want to extend special thanks for the ingenu- 
ity and patience they have shown during the several years of almost continuous de- 
signing and redesigning of BLIPS. 

W.G. 



CONTRIBUTING AUTHORS 



Patricia A. Cleary, M.S. 

John H. Close, M.D. 

C. Keith Conners, Ph.D. 

Lino Covi , M.D. 

Leonard R. Derogatis, Ph.D. 

Barbara Fish, M.D. 

Samuel Gershon, M.D. 

Rachel G i ttelman-Klein, Ph.D. 

Max Rami Iton, M.D. 

Gilbert Honigfeld, Ph.D. 

Donald F. Klein, M.D. 

Ronald S. Lipman, Ph.D. 

Thomas McGlashan, M.D. 

John E. Overal 1 , Ph.D. 

Robert L. Sprague, Ph.D. 

John Werry, M.B . ,Dipl .Psychiat 

J. Richard Wittenborn, Ph.D. 

Kenneth Yang, B.A. 

Will iam W. K. Zung, M.D. 



Biometric Laboratory, The George Washington University 

Abbott Laboratories 

Western Psychiatric Institute & Clinic, Pittsburgh, Pa. 

Johns Hopkins University, Baltimore, Maryland 

Johns Hopkins University, Baltimore, Maryland 

University of California at Los Angeles 

New York University Medical Center 

Hillside Hospital, New York 

University of Leeds, Leeds, England 

Sandoz Pharmaceuticals 

Hillside Hospital, New York 

Psychopharmacology Research Branch 

Chestnut Lodge, Rockville, Maryland 

University of Texas Medical Branch, Galveston, Texas 

University of Illinois, Champaign, Illinois 

University of Auckland, New Zealand 

Rutgers University 

Biometric Laboratory, The George Washington University 

Veterans Administration Hospital, Durham, North Carolina 



PSYCHOPHARMACOLOGY RESEARCH BRANCH 

Jerome Levine, M.D. 
Wil 1 iam Petrie, M.D. 
Nina Schooler, Ph.D. 



BIOMETRIC LABORATORY, THE GEORGE WASHINGTON UNIVERSITY 



Luis Agu i lar 

Roland R. Bonato, Ph.D. 

Mary Cronin 

Mary-Alice Good ridge 

Barbara Holmes 

Nina Kit 



Robert McCarter, M.S. 
David Schaffer, M.S. 
Richard Schoenberg 
Richard W. Switalski, M.A. 
C la rise Wi 1 1 iams 
Robert L. Zimmermann, Ph.D. 



INTRODUCTION 



This revision of the 1970 assessment manual describes the redesigned and 
expanded ECDEU Assessment Battery. Developed under the auspices of the 
Psychopharmacology Research Branch of the National Institute of Mental Health, 
the original and present assessment batteries have been an integral part of 
their Early Clinical Drug Evaluation program (ECDEU) . The present product has 
evolved through a continuous interplay of interests among the participants in 
the ECDEU program - the investigators, the pharmaceutical industry, the Food 
and Drug Administrat ion, Psychopharmacology Research Branch and the Biometric 
Laboratory of The George Washington University. 

Intended for an audience with diverse interests, the general plan of the 
Manual mimics the usual order of events as they occur in a research study, i.e., 
from the planning phase to the analyses and interpretation of results. Indi- 
vidual instruments are presented in the order in which they are employed and 
are further categorized by purpose. Comments by their respective authors follow 
the description of the instruments. Being cognizant of the need for brevity, 
descriptions of the instruments, for the most part, have been kept to a minimum. 
For those who wish more detailed information about a particular scale and its 
psychometric properties, references have been provided and it is suggested that 
contact be made with the author/s. 

Def in i t i veness is not implied in the choice of scales included in the 
Battery. A large number of scales with demonstrated utility in psychopharma- 
cologica] assessment were discussed and evaluated by the ECDEU participants. The 
final selection was made by consensus. Thus, many scales of equal merit were 
omitted; but, through the versatility of the General Scoring Sheet, these scales 
may be processed and analyzed with almost equal facility. Several of the pediatric 
scales are frankly experimental. When the participants of the Pediatric Workshop 
felt that there were no completely satisfactory scales available for a particular 
assessment area, they set about to construct a new scale to serve the purpose. 
Necessarily, these new instruments have not yet undergone the degree of psycho- 
metric validation which characterizes the more venerable scales of the Battery. 
Recognizing the needs of the field, however, these new scales have been introduced 
with the understanding that psychometric analyses will be performed concurrently 
with their use. 

In conjunction with the dissemination of the standard assessment battery, the 
Biometric Laboratory has provided processing and analytical services to the partici- 
pants of the ECDEU program. The Biometric Laboratory Information Processing System 
(BLIPS) has been developed to generate standard documentation for the individual 
study. Consisting of a series of descriptive and statistical data displays as well 
as card output, the documentation provides the investigator with the fundamental 
analyses of his study based on an edited ("clean") data set. Given the uniqueness 
of a given study, standard documentation can not meet all specific needs. To the 
extent possible, however, requests for special analyses will be serviced. While 
the extent to which the investigator makes use of these services is at his discre- 
tion, both the Biometric Laboratory and Psychopharmacology Research Branch stand 
ready to provide assistance in the planning of the study; the selection and schedul- 
ing of assesg,ments , the training of personnel in the use of the Battery and the 
choice of statistical techniques. 



10 



PARTICIPATION IN ECDEU PROGRAM 

As originally conceived, the ECDEU program consisted primarily of grant- 
supported clinical investigators working in tine common area of psychotropic 
drug evaluation (both new and established compounds). One of the problems 
they encountered, and task they accomplished, was the development of a uniform 
battery of clinical assessment instruments known as the ECDEU Standard Report- 
ing System, first introduced for utilization in 1967. The rationale behind 
this effort was twofold. First, it was felt that such a system would enhance 
both the quality of early clinical drug research and allow greater general iza- 
bility of results across studies and investigating units. Second, data collected 
on common forms could be stored in a data bank for future study and research. 

Since the implementation of this Standard Reporting System and the Biometric 
Laboratory Information Processing System (BLIPS), the ECDEU program has evolved 
into more than an extramural grant support program for psychotropic drug research 
teams. In collaboration with The George Washington University Biometric Labora- 
tory, the ECDEU Standard Reporting System has been made available to any investi- 
gator interested in conducting clinical trials, whether federally grant supported 
or not. To utilize these services, the investigator is requested to: 

1. Submit a Research Plan Report (021-RPR) and agree to 
send the study data to the Biometric Laboratory. 

2. Collect sufficient information about the subjects in 
his study so that the data can be entered into the ECDEU 
data bank. This means, essentially, that a core of data 
must be collected for each patient. Such a core of data 
includes : 

a. Demographic information; e.g.. The 
Adult Personal Data Inventory. 

b. At least one major rating scale of 
efficacy or psychopathology; e.g., the 
Brief Psychiatric Rating Scale. 

c. Information on dosage and toxicity; e.g., 
the Dosage Record and Treatment Emergent 
Symptoms Scale. 

In return, he receives a sufficient number of assessment scales to conduct his 
research. Once the trial is completed, the forms are returned to the Biometric 
Laboratory for processing and data analyses, the results of which are sent to 
the investigator in the form of a standard data package. The rating scales and 
data processing services are provided at no charge - our sole "remuneration" be- 
ing the opportunity to add the investigator's data to the data bank. It should 
be stressed that an investigator's data and/or results are never published or 
disseminated to others without his permission. 



II 



Along with extending participation in the ECDEU program to a larger group 
of investigators, greater latitude in the types of studies which are considered 
appropriate for the services is now permitted. Originally, only studies -focussed 
on the investigation of drug effects were accepted. Now, studies in which the 
investigation of drug effects is peripheral may be submitted. This is particularly 
true in the pediatric area where the need for standardization data is great. 
Investigators who are uncertain about the appropriateness of their study are urged 
to contact the Biometric Laboratory or Psychopharmacology Research Branch. 

GENERAL DESCRIPTION OF THE BATTERY 

The most prominent feature of the new Battery - expansion aside - is the 
redesigned format of the scales. In the original Battery, the scales were self- 
contained with both items and their response positions preprinted on the form. 
While this format provided maximal rater legibility, the amount of data retrievable 
per page was low; and, since it was necessary to record identifying information on 
each page, the rater was faced with a great deal of redundant encoding. To offset 
these problems, items and response positions were separated. A universal answer 
sheet called the General Scoring Sheet was designed to serve as a means of encoding 
not only responses to the scales included in the Battery, but any type of data which 
an investigator might wish to encode. 

Coupled with the General Scoring Sheet, a number of assessment packets were 
developed. Each of these packets constructed of durable plastic contains the items 
of a set of related assessment instruments. Selecting the desired instruments from 
this set, a rater encodes responses on the General Scoring Sheet while retaining 
the packet for subsequent use. 

Figure 1 illustrates the manner in which the packets are used. Spiral bindings 
appear on 3 sides of the packet. Upon opening the cover, there are 3 sections each 
attached to one of the spiral binders. Along the top are "headers", i.e., sections 
which contain instructions and scalepoints for a specific scale. The 2 lower sections 
open up from the middle and contain items for specific scales. The instructional 
header and the appropriate item pages for a specific scale are color-coded for the 
convenience of the rater. When all of the headers and pages are open, the back 
cover of the packet can be seen, and it is here that a General Scoring Sheet is 
placed - fixed by a positioning tab. With the General Scoring Sheet in place, the 
rater flips to the desired header and page; finds the appropriate area of the 
General Scoring Sheet exposed and is ready to encode. There are presently 5 packets 
in the Battery: 

1. Demographic - containing 3 instruments for both pediatric 
and adult populations. 

2. Pediatric - containing 6 instruments for rating psychopathology , 
diagnosis, adverse reactions and termination status. 

3. Adult - containing 9 instruments - 3 of which are also contained 
in the Pediatric packet - for adult populations. 

k. Nurse - containing k pediatric and adult behavioral scales for 

rating by ward or para professional personnel. 
5. Psychologist - containing 9 pediatric and adult psychometric scales. 



12 



FIGURE I 
THE ASSESSMENT PACKET 



PACKET CLOSED 






Header 



PAGES AND HEADERS 
OPENED 



COVER OPENED 



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General Scoring Sheet 



13 



In addition to the 28 scales contained within 5 packets, there are 15 inde- 
pendent (self-contained) instruments. Table I catalogues all of the scales which 
comprise the standard ECDEU Assessment Battery and classifies them by applicabili- 
ty, format, content and rater. Applicability refers to the population (s) for 
which a scale is appropriate. Format indicates whether a scale is designed for 
opscan or not and whether it is contained within a packet or is independent. The 
content areas are: demographic (Dem) , efficacy (Ef f) , toxicity (Tox) , medical 
(Med), psychometric (Psy) and administrative (Adm) . Finally, the rater is designa- 
ted. Fourteen of the ^3 instruments are "universal" - reflecting the integration 
and compatibility of the Battery across diverse research populations. 

TIME TABLE FOR USING THE ECDEU BATTERY 

Table 2 depicts the usual order in which investigators employ various instru- 
ments in the ECDEU Assessment Battery during the 3 major phases of a research study ■ 
planning, data collection and analyses. 

Planning phase - Having developed an hypothesis and a research design to test 
it, the investigator decides to utilize the assessment instruments and services of 
the ECDEU program. Generally, he will have prepared his own written protocol from 
which he can extract the information required on the Research Plan Report (RPR). 

The RPR serves to notify the Biometric Laboratory and Psychopharmacology Re- 
search Branch that a study is contemplated and that it is expected to take a certain 
length of time for completion. Along with its intrinsic - and more important - 
value as a description of ongoing research, the RPR serves to alert the Laboratory 
to its future work load and, upon receipt of the data, to the nature of the study 
and the procedures employed. Along with the RPR, an ECDEU Order Form (EOF) request- 
ing the quantities of forms necessary to carry out his study is completed and 
mailed to the Biometric Laboratory. Should problems be encountered in completing 
the RPR or EOF, assistance can be obtained from the Biometric Laboratory. 

Data Collection Phase - With the availability of the General Scoring Sheet, 
the choice of assessment instruments is not limited to the standard ECDEU scales. 
The investigator may select those devices which he feels will best serve his needs - 
provided that he supplies the core of information required for ECDEU services, 
(p. .11). 

For new investigators unfamiliar with the instruments, the most frequent 
choice patterns of experienced ECDEU investigators working with adult populations 
may be helpful. The listing of these patterns should not be construed as obliga- 
tory but merely as a guide, 

1. Neuroleptic Studies with Schizophrenic Populations 

a. Brief Psychiatric Rating Scale (BPRS) 

b. Clinical Global Impressions (CGl) 

c. Nurses' Observation Scale (NOSIE) 



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16 



2. Antidepressant Studies 

a. Hamilton Depression Scale (HAMD) 

b. Clinical Global Impressions (CGl) 

c. Depression Status Inventory (DSl) 

d. Self Rating Depression Scale (SDS) 

3. Anxiolytic Studies 

a. Ham i 1 ton Anxiety Scale (HA^V\) 

b. Clinical Global Impressions (CGl) 

c. Anxiety Status Inventory (AS I ) 

d. Self Rating Anxiety Scale (SAS) 

e. Self Report Symptom Inventory (SCL-90) 

Along with appropriate demographic information, the assessment of side effects, 
and the recording of dosages through the use -of an instrument such as the Dosage 
Record and Treatment Emergent Symptom Scale (DOTES) should be considered. Finally, 
information concerning the disposition of subjects; e.g.. Patient Termination 
Record (PTR) , should be gathered. 

Analytic phase - Two administrative forms are completed at this phase. The 
new Data Shipment (071-DS) serves such a vital function in BLIPS II that process- 
ing of a study simply cannot proceed without an accompanying DS. The Research 
Completion Report (059-RCR) completes the transaction by documenting the investiga- 
tor's overall conclusions and future plans as based on the results of his study. 



17 



GENERAL 
INSTRUCTIONS 



For the rater, the substantive judgments he makes are of paramount importance - 
not the way in which he records those judgments on a sheet of paper. These 
instructions, unfortunately, are concerned with the unavoidable mechanics of encod- 
ing those judgments on op-scan sheets. It has been our experience that encoding 
errors are - by far - the prime reason for delays and misinterpretations during 
data processing. It is important, therefore, that raters become familiar with the 
"do's" and "don't's" of op-scan encoding. 

1. For those unfamiliar with it, the optical scan (op-scan) format can be 
frustrating, since it places strict constraints upon the rater. The op-scan reader 
is a sensitive machine which compulsively records intended as well as unintended 
marks. It should be remembered that an op-scan page is entirely covered with a 
field of response positions. Though not visible to the rater, these positions are 
"read" by the op-scan machine. With appropriate programming, many - but not all - 
of these extraneous positions can be suppressed. Consequently, some will be 
"triggered" by superfluous or incorrectly entered marks. Therefore, FOR ALL OP-SCAN 
SCALES, the following rules must be observed: 

A. USE ONLY A #2 PENCIL. Ink, ball point, felt markers, etc. 
will not be "read" at all or will be read haphazardly. 



DO NOT MAKE EXTRANEOUS MARKS ON THE GENERAL SCORING SHEET 
OR ANY OTHER FORM. Writing, when permissible, must be 
completely confined to the areas specified. Extra marks 
and/or writing in prohibited areas trigger multiple responses 
which will be rejected later during the editing process. 

Example - On the TESS Write-in Scale (TWIS), the rater wishes 
to record the presence of the symptom "giggling" as mild and 
possibly related to the drug. He encodes as follows: 



2. OTHER SYAAPTOM fConf.n 




(fiin ffiis block) 



y(l^L.^\\_j2' 



MOft 
MILD ERa/e SEVE 



Remole PoSMble P 



able Delir 
:3=: ---A 



In this example, both INTENSITY and RELATIONSHIP may be re- 
jected in the editing process because the lower part of the 
"'g'"s intrude into the "INTENSITY" and "REU\T I ONSH I P" areas 
and may be read by the op-scan reader as illegal multiple 
responses. The correct way to encode "giggling" is: 

4. OTHER SYMPTOM JConfme wnfmg w.(h,n th,s b/ocW 




INTENSITY 




MOD- 




RELATIONSHIP 




MILD 


ERATE 


SEVERE 


None Remote Possible Probable Delined 




— 


-.a- 


:*= 


rieii -.z\--z .«- ==3=: r:4ii 



Here the rater has confined his writing completely within the 
specified area and no illegal multiple responses are evoked. 



20 



CONFINE YOUR MARK WITHIN THE TWO PARALLEL LINES. Slashes 
or flourishes which extend beyond the parallels result in 
multiple responses; i.e., 2 response positions being "read" 
by the op-scan machine. Marks which do not fill in all of 
the space between the parallels, on the other hand, may not 
be "read" at all . 



Examples: 



Incorrect Correct 



D. DO NOT USE STAPLES OR PAPER CLIPS to affix forms or pages 
together. Similarly, DO NOT PUNCH HOLES in the forms. 

E. Please ERASE THOROUGHLY when changing a response. Failure 

to erase cleanly usually results in both the partially erased 
and corrected responses being "read". 

F. WHEN NUMERICAL VALUES ARE REQUIRED, ALL INDICATED DIGITS MUST 
BE MARKED including leading and following zeros. 

Example: Given a 3-digit field, the rater wishes to record ]k. 



•«■ ::*! ::*! ~»: ::*= -5:: ~frz =:fc ;:8:: "St: 

Correct ::ft: MM "*: "»: ii*: "-&- "fc: -*: -ft^ "*: 

::»: ::*: "»! ::>: m^ ..&-. z.tfz -fc ::fc ::St: 





i:ft: 


i:*: 


::»: 


Z-.X-- 


::*: 


::&: 


"*:: 


::*; 


"ft: 


"Sb: 


l.ncorrect 


3:ft: 


-*> 


::»: 


i:J:i 


::«:: 


::S: 


::ft: 


::fc 


lift: 


::Sb: 




=ft: 


"t: 


=*: 


ZZtLZ 


■^ 


zz&z 


::fci 


"3ti 


=8:: 


::fc 



NOTE - Numerical values of more than one digit are always encoded 
vertically on 2 or more rows. 



21 



2. Generally, the scales require the rater to assess effects which are 
directly observable either in word or deed. Inferences should be minimized. 
While this restricts the rater, variability related to rater experience and 
theoretical orientation is reduced. 

3. With some exceptions, the scales require a time-limited evaluation, 
i.e., the presence, absence and/or intensity of symptom at the time of the 
rating or within a specified time span prior to the rating. For example, on 
the Children's Psychiatric Rating Scale (CPRS) the subject reports feeling 
depressed "a couple of months ago, but not now". Since the time span for this 
item (35) is "now or within the past 7 days", the rater marks the item "Not 
Present". At the discretion of the principal investigator and with appropriate 
communication to the Biometric Laboratory, alternative time spans may be 
specified for a particular study objective. Suggested rating spans, where 
applicable, are given with each scale. 

k. Raters often exhibit a tendency to remain in the conservative center 
of a scale. When undecided about two alternatives, the rater should choose 
the response nearer the extreme end of the scale. For example, if undecided 
whether to rate "mild" or "moderate" on an item in which there has been a 
positive change from "severe", the rater should choose "mild" - the alternative 
nearer the positive end of the scale. Similarly, the rater should choose the 
alternative representing the higher degree of pathology when he is undecided 
about the severity of illness. In essence, raters should choose the more 
"radical" response in either the direction of improvement or deterioration. 

5. The style of interview is left to the discretion of the rater. Most 
raters quickly establish a method from which the material necessary for rating 
can be extracted. Generally, the method takes the form of a semi -structured 
interview in which target areas are explored in a more or less consistent 
sequential fashion. It is suggested, however, that raters not change interview- 
ing techniques during the course of a study. 

6. It is strongly urged that every effort be made to maintain the same 
rater for all assessments of a given subject on a given scale. 

7. The processing system has been programmed to expect a response for all 
items. Raters are, therefore, urged to complete all items on all forms they use. 
When this is not possible, the rater should utilize the "Not Ascertained" or "Not 
Assessed" response positions. "Not Ascertained" should be interpreted as not 
available, not applicable, no answer, or in those instances where the information 
is considered specious or improbable. "Not Assessed" indicates that the rater 
made no effort to elicit the information. 

8. While the investigator has complete freedom to employ any additional 
assessment techniques he wishes, the standard scales, their formats and items 
must not be modified or altered. It is imperative that data sent to the 
Biometric Laboratory be constituted under the contexts provided in this manual. 



22 



9. It is not possible to construct a manual which provides answers for 
all situations or contingencies. Should questions arise, feel free to contact 
either Biometric Laboratory or Psychopharmacology Research Branch by mail or 
telephone. 

ENCODING THE IDENTIFICATION BLOCK 

The identification (ID) block consists of 8 horizontal rows - 20 response 
positions (columns) to each row - and uniformly appears on all op-scan forms. 
The ID block provides response positions for the encoding of: 

1. Patient Initials 

2. Patient Number and Sex 

3. Rater Number 
'+. Sheet Number 

5. Period (Rating) Number 

THE IDENTIFICATION (ID) BLOCK 



PATIENT INITIALS 




















NUMBER 


MALES 001 


TO 


499: FEMALES 500 TO 998 








:A-: 


*: 


:^- 


:©:: 


.iz: 




:*:: 


Gzz 


:W: 


:(:- 


rrjr: 


:«:: : 


:lr: :5:: 


r* 


zzAz: :;&:: 


*" 


::7:: 


-"8-: 


:-9:: 


:*.--- 


:L:: 


-M-- 


:W: 


©: 


FIRST 
INITIAL 


::?:: 


zGpz 


;«:: 


::$:; 


::T:: 


«:: : 


-.1:: :5:: 


::3- 


..^.. PATIENT. .s.. 
"^"NUMBER-*- 


«;■- 


.:?:: 


■-«:: 


:r9:: 


:«:: 


^- 


-W' 


:;X:r 


::Y:: 




-zii 










:«:r : 


:!:: :5:: 


:=a-- 


:-4;: ::§:- 


«" 


"C" 


:«:: 


::9:: 


:-A:: 


-t-- 


:JX:: 






SECOND 


::p:: 


iyzz 

zxazz 




::(:: 
::$;: 


"T" 




;]:: r^:: 
:!:: ::?:: 




'"*' RATER '*" 
-.^.NUMBER -^. 




"7-- 

:.-7r: 


::8:: 


ZZ3-Z 












INITIAL 




























:«:: 


V: 


-W- 


::X:: 


::Y:: 




r^ 










:«:: : 


:]:: ::?:: 


:* 


PERIOD 


«:■- 


::^:: 


:«:- 


:-§-: 






































"tt: 


:3:: 


::2:: 


::3:: 


.:t: 


SHEET 


::S: 


: = 6: 


"^: 


::»; 


rift: 


H 


:!:: :2:: 




: 4;; ;:§:: 


« - 


::7;: 

inlhs 


:*: 


--:§ : 


"tt: 


-.3" 


:r2:: 


Z--A-. 


=;*,- 


NO. 


-.z5.z 


: = fe: 


"S: 


::&: 


iiS: 


z-Qz: z 




::?: 


^^ 




--4:: 







Complete and accurate encoding of the ID block is of paramount importance. In 
BLIPS, errors and/or omissions within this block are regarded as "catastrophic 
errors"; i.e., errors which half any further processing of the data. Delays can 
be lengthy since ID problems may bring the entire data set under suspicion and, 
consequently; require extensive verification. 

1. Patient Initials - First initial refers to given name; second to surname. 
Patient initials are utilized only during the editing phase; they never enter the 
data bank, thereby preserving patient anonymity. 

2. Patient Number and Sex - Patient number requires a 3-digit code. Numbers 
between 001 and 499 designate male; 500 to 999 female. The investigator is required 
to assign numbers to his research sample. Any 3 digit numbers, withinthe stricture 
on sex - may be used; although it is the usual practice of investigators to assign 
numbers sequentially as subjects enter the study. In double-blind studies, care 
should be taken that the assigned Patient Numbers do not form a pattern which might 
reveal treatment assignment. ALL 3 DIGITS MUST BE ENCODED including leading and 

fol 1 owi ng zeros . 



23 



3. Rater Number -A 2-digit code assigned by the investigator is required. 
Wherever possible, it is suggested that investigators maintain the same numbers 
for their "permanent" raters, i.e., those who rate in a series of studies. 
Sections of some of the scales; e.g., CPDI, PMR , etc. may be completed by 
different Individuals. In these cases, assign the number of that rater who has 
completed the greater portion of the scale. 

k. Sheet Number - A 2-digit code which identifies, for computer processing, 
the data which is encoded on a specific General Scoring Sheet. Sheet Numbers for 
the scales within the various rater packets are given with the instructions for 
each scale and must be adhered to by raters. For non-standard scales or data setS; 
the investigator may assign any number from 80-99. Unlike PERIOD NUMBER which 
corresponds to the time when a particular rating is performed, SHEET NUMBER FOR A 
SPECIFIC SCALE OR DATA SET REMAINS CONSTANT THROUGHOUT THE STUDY. Thus, if a 
rating scale; e.g.. Insipid Reaction Scale, is encoded on the GSS and assigned 
Sheet Number "80" at the initial rating; this number "80" must be assigned to all 
subsequent ratings of the Insipid Reaction Scale. 

5. Period Number - a 3~digit code encoded by the investigator is required. 
The code designates the time when a specific rating is made. Two digits are pro- 
vided for the numeric and one digit for the units of time - hours, days, weeks, 
months . 

Examples : 

1. To enter \k days; code as follows: 



-*- 


--^-- 


=:3=: 


PERIOD 


--^- 


::7:: 


;*: 


r;5:: 


i:2;: 


:*: 


"4* -:^-- 


i:©:-- 


:iT:: 


;*: 


Hours 




Days 


Weeks 




Months 





To enter 8 weeks;" code as follows: 



•^ 


ril:: 


zzSzz 


:*= 


PERIOD 


:*: 


zi7i: 


:*: 


III:: 


--:S-Z 


::*; 


zzAzz ::§:: 


zz^z 


zzr-z 




Hours 




Days 


Weeks 




Months 


--*: 


i:li: 




::2r: 


•*• 




:a;z= 



"-Note that the leading zero is encoded: 08 NOT blank 8. 
3. To enter the initial rating; code as follows: 



i:l:: r:2ri ::3:: 

Hours Days 



::S=: =«== --T-- -^- =*= 

Weeks Months 



Time units should be consistent on all scales throughout a study, whenever 
possible. Code Week 01, Week 02, Week Ok or Day 01, Day 14, Day 28, NOT Week 01; 
Day ]k. Month 01. While uniform use of any of the time units is acceptable, it 
is suggested that DAYS be used whenever possible. 



2k 



In most studies, assessments are planned at regular intervals (Week 00, 02, 
Ok, etc.) although the actual assessment may not be completed on the precise 
schedule. For uniformity, raters should encode PERIOD according to the study 
protocol. Example: Assessment is scheduled for Day 1^ but the rater is unable 
to accomplish it until Day 15. Encode Day 1^ - not 15 - as 15 would appear as 
an aberrant assessment in subsequent analyses and be deleted. Should a subject 
be prematurely terminated, however, and an assessment made at the time, encode 
the real time of the assessment even though it is "off schedule". 

CODING DURATION OF STUDY - In order to achieve uniformity within a given study 
and across different studies, duration of study should - in all cases - be coded 
in the following manner. The initial rating should be encoded "000". Duration 
in the study for any subject is counted from the initial rating to the final 
rating whether or not this time period corresponds to the actual period of drug 
(treatment) administration. This method of counting is necessary to encompass 
those studies in which more than one pretreatment (pre-drug) assessments are 
made. Similarly, the cessation of treatment may or may not coincide with the 
final rating. Many studies employ more than one follow-up rating after the treat- 
ment (drug) has been stopped. In this coding system, both pretreatment and follow- 
up phases are included in determining total duration of the study IF assessments 
are made which span these pretreatment and followup phases. 



Exampl es 
1 



The Investigator plans to have a 2-week drying out period following 
which the first ratings will be made. He then will administer his 
test drug for k weeks. He plans to make additional ratings 2 weeks 
and k weeks after the initiation of treatment. There will be no 
followup assessments. Duration of this study would be calculated 
and coded as follows: 



DRY-OUT PERIOD 



DURATION (DAY) 
RATING 



DRUG 
STARTS 



00 
1st 



14 

2nd 



DRUG 
ENDS 



28 
3rd 



The investigator plans a study exactly as before (1) but adds a 
rating at the beginning of the drying-out period and 2 weeks 
following the cessation of drug treatment. Duration in this study 
would now be calculated and coded as follows: 



DRY-OUT PERIOD 



DURATION (DAY) 00 
RATING 1st 



DRUG 
STARTS 



14 
2nd 



28 
3rd 



DRUG 
ENDS 



42 
4th 



56 
5th 



25 



3. A crossover study is planned in which the sequence, Drug A - PBO - 
Drug B, will be employed. Each treatment will be of 2-week duration 
with assessments every week. Duration would be calculated and coded 
as fol lows : 



CROSSOVER 

DURATION (DAY) 
RATINGS 



DRUG A- 



PBO- 



-DRUG B- 



1 



00 
1st 



07 
2nd 



14 
3rd 



21 28 
'tth 5th 



35 
6th 



7th 



SHADED AREAS - All independent scales; i.e., those with items printed 
directly upon them, will have one or more shaded areas in the identifi- 
cation block and possibly one or more within the text of the scale. 
The shaded areas with the ID are "prohibited areas" and NO MARKS OF ANY 
SORT are permitted. Similarly, shaded areas within the text of a scale 
are for coding only and writing should never be done here. This type 
of error has been so prevalent in the past that cautions are repeated 
throughout the Manual wherever there is the possibility of its occurrence, 



CARD FORMAT - IDENTIFICATION BLOCK - (513, 212, 51x, 11, 15, H, 13) 
This format for identification is universal for all ECDEU card outputs, 



1 tem 


Col. 


Unit No. 


1-3 


Study No. 


k-e 


Subject No. 


7-9 


Form No. 


10-12 



I tem 

Card No. 
Data Field 



Col . 

18-19 
20-75 



Treatment Assignment" 76-J 



Assessment Period 13-15 
Rater No. 16-17 



''Treatment Assignment - This code will designate the specific treatment assignment 
for each individual subject. The information is obtained from Data Shipment 
(071-DS), Item V, patient Identification. The coding is as follows: 



Factor 


1 Assignment 


- Col 


76 


Factor 


2 Assignment 


- Col 


77 


Factor 


3 Assignment 


- Col 


78 


Specia 


Ass Ignment 








Coding 


- Col 


79 



26 



021 RPR 
RESEARCH 
PLAN 
REPORT 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 


DO NOT WRITE IN THIS BOX 


PUBLIC HEALTH SERVICE 
HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 


UNIT NO. 


NATIONAL INSTITUTE OF MENTAL HEALTH 


STUDY NO. 


PSYCHOPHARMACOLOGY RESEARCH BRANCH 
RESEARCH PLAN REPORT 


RPR NO. 



GENERAL INSTRUCTIONS 

The Research Plan Report is designed to collect data concerning psychopharmacological research 
procedures in a format suitable for computer processing. The restrictions of such a format plus the 
great variety in research designs may create some difficulties in choosing a response. The investigator 
is asked, however, to make every effort to complete the form according to the instructions. If aspects 
of your study cannot be described appropriately under a given item or if the space provided is inade- 
quate for your response, please describe the details on page 11 or on a separate sheet and attach to 
the form. Submission of the investigator's complete protocol would also be appreciated so that errors 
of interpretation can be avoided. 

Specific instructions for this form (RPR) are given on pages 12-15 and should be read PRIOR TO 
COMPLETING THE FORM. This revision of the RPR, MH-9-21, Rev. 1 -73 (Blue) supersedes all 
other versions. Please discard all old forms, MH-9-13, Rev. 2-71 (Buff). 



I. IDENTIFICATION 



NAME OF INVESTIGATOR/S 



TITLE OF STUDY 



STARTING DATE 
Month 



ANTICIPATED COMPLETION DATE 

Month Year_ 



PURPOSE/S - Briefly state purpose/s and any specific hypotheses of the study 



If you concur, the Research Plan Report which you submit can be released to the scientific community 
in the form of a short narrative description of the study. Chemical formulae may be held confidential 
even if other information is released. 



Is this RPR a revision or modification of a previously submitted one? 



n Yes D No 



If YES, give Unit and Study numbers assigned to original RPR: 

May data on this form be given to the scientific community? CD Yes CH No 

Should chemical formulae be held confidential? □ Yes CD No 

Will ECDEU forms be used and data be sent to the Biometric Laboratory? CD Yes CD No 



Mail this completed form to: 



MH-9-21 
Rev. 1-73 



ECDEU Data Analyses 
Biometric Laboratory 
George Washington University 
11501 Huff Court 
Kensington, Maryland 20795 

28 



FORM APPROVED 
OMB NO. 68-R965 



ALL CARDS 
CODE: 
COL.: 



DO NOT WRITE HERE - FOR BIOMETRIC LAB USE ONLY 



2-4 



5-7 



REVISION 



21 



n. DESCRIPTION OF DRUG/S EMPLOYED 



TEST DRUGS 



DO NOT WRITE HERE 



CODE 



CARD 01 



b. Synonyms 



1. Test 
Drug 
No. 1: 



c. Manufacturer 



d. FDA (or appropriate regulatory agency) status 

1 . Approved for prescribing or sale and for the present indication or use 

2. Approved for prescribing or sale but jVOT" for the present indication or use 

3. Not approved for any use 



Single Drug D 1 

Combination Drug D 2 



INV NO. 1 



D 1 

D2 

D3 



b. Synonyms 



2. Test 
Drug 
No. 2: 



c. Manufacturer 



d. FDA (or appropriate regulatory agency) status 

1 . Approved for prescribing or sale and for the present indication or use 

2. Approved for prescribing or sale but A'OT' for the present indication or use 

3. Not approved for any use 



MAN NO. 2 



D 1 
D2 
03 



3. Presumed 
Clinical 
Action/s: 



01 




02 




03 




04 




05 




06 




99 





TEST DRUG 
NO. 1 

Neuroleptic 

A nx ioly tic/Sedative 

Antidepressant 

Stimulant 

Psychotomimetic 
Hypnotic 

Unknown 



01 




02 




03 




04 




05 




06 




99 





TEST DRUG 
NO. 2 

Neuroleptic 

A nxioly tic/Sedative 

Antidepressant 

Stimulant 

Psychotomimetic 
Hypnotic 

Unknown 



Other Action (Test Drug No. 1) 



Other Action (Test Drug No. 2) 



4. For Investigations of New Uses For Established Drugs 









NEW NO. 1 


Test Drug 


The generally accepted action is: 


45-48 




No. 1 








The action to be tested in this study is: 












NEW NO. 2 


Test Drug 


The generally accepted action is: 


49-52 




No. 2 








The action to be tested in this study is: 







MH-9-21 
Rev. 1-73 



29 



5. Chemical Cla»/ej (If known) 


UU NUT WRITE HERE 
COL. CODE 




TEST 
DRUC 
NO. 1 




TEST 
DRUG 
NO. 2 


CHEMICAL CLASSES 


TEST 
DRUG 
NO. 1 




TEST 
DRUC 
NO. 2 


CHEMICAL CLASSES 


53-68 


CLASS NO. 1 






101 




Phenothiazines 

Phenothiazine analogues & isosteres 

Lysergic acid derivatives 

Reserpine & derivatives 

Harmine & derivatives 

Other indole derivatives 

Cannabis derivatives 

Chromone derivatives 

Benzodiazepines 

Barbiturates 

Heterocyclic butyrophenones 

Other nitrogen heterocycles 

Benzodioxane derivatives 

Other non-nitrogen heterocycles 




401 




Phenylethylamine derivatives 

Phenylacetic acid derivatives 

Diphenylmethane derivatives 

Benzoic acid derivatives 

Other aromatic compounds 

Glycols 

Carbamates 

Carbinols 

Amides & hydrazides 

Amines & hydrazines 

Other aliphatic compounds 

Unknown 


59-64 


:lassno.2 






102 






402 










201 






403 












202 






404 










203 






405 










204 






501 










301 






502 










302 






503 










303 






504 










305 






505 










306 






506 










307 






999 










308 
















309 












6. For NEW DRUGS, draw chemical structure 




65 


FOi^MULAE 












66 


PUBLIC 




67 


SCALES 




68-71 


PURPOSE 













B. COMPARISON 


DRUG/S 










1. Does the study employ comparison drugs? 


D Yes If Yes, 
a No 


which? Standards D 1 
Active Placebo D 2 
Inert Placebo D 3 
Both Standard/s and Placebo/sD 4 


17-18 


CARD 02 




19 


COMPARE 


2. Comparison 


a. Name 




Single Drug D 1 
Combination Drug D 2 


20-24 


STD NO. 1 


Drug 
No. 1: 


b. Manufacturer 


25-27 


MAN NO. 1 


3. Comparison 
Drug 
No. 2: 


a. Name 




Single Drug D 1 
Combination Drue D 2 


28-32 


STD NO. 2 


b. Manufacturer 


33-35 


MAN NO. 2 


4. Placebo: 


a. Composition 


36-40 


PBO 


b. Manufacturer 


41-43 


MAN-PBO 





III. 


POPULATION 










1. Total number of subjects in study: 

2. Sex: Males Only D 1 

Females Only D 2 
Both Sexes D 3 

4. Aqe Ranoe: From To 


3. Maturity: 


ChUdien D 1 
Adolescents D 2 
Adults D 3 
Geriatric D 4 


44-46 


NO. 5 


DEMOGRAPHY: 


47 


SEX 




48 


MATUR 




49-50 


AGEFflOM 




51-52 


AGE TO 



MH-9-21 
Rev. 1-73 



PAGE 3 

30 



B. 

SUBJECT 
STATUS: 



1. (Check One) 



Inpatient 




1 


2. (Check One) 


Acute 




1 


Outpatient 




2 




Chronic 




2 


Both 




3 




Both 




3 


Not Applicable 




9 




Not Applicable 




9 



DO NOT WRITE HERE 



PRINCIPAL 

DIAGNOSTIC 

CATEGORIES: 



1. Adult Check all applicable (Omit if study involves childrerh only) 

Psychoneuroses-Anxiety States 
Psychoneuioses-Depressive States 
Personality Disorders 
Mental Deficiency 
Psychophysiological Disorders 
Vailed Psychiatric Disorders 
Non-Psychiatric Population 



Organic Brain Disorders 
Geriatric Disorders 
Alcoholism 

Manic-Depressive-Manic Phase 
Manic-Depressive-Depressive Phase 

Psychotic Depressions 
Schizophreiua 



Other Categories (WHO diagnoses may be gi 



13 
15 
17 

20 

22_ _ 

ven here) 



2. Children 

Childhood Schizophreiua 
Overanxious Reaction 
Unsocialized Aggressive Reaction 
Hyperactive Reaction 
Withdrawing Reaction 
Speech Disturbance* 
Learning Disturbance* 
^Special Symptom Disturbances 



71 
72 


Tic* 

Sleep Disorder* 




78 
79 


73 


Feeding Disturbance* 




81 


74 


Enuresis* 




82 


75 


Encopresis* 




83 


76 


Varied Psychiatric Disorders 




84 


77 


Non-Psychiatric Population 




85 



Other Categories (WHO diagnoses may be given here) 



D. 

BASIS FOR 
DIAGNOSIS: 



MH-9-21 
R«v. 1-73 



Check method/s for determining diagnoses of research sample: 



Psychiatric Case Record 
Investigator's Clinical Judgment 
Iiiflependent Clinical Judgment 



Clinical Target Symptoms 
Psychometric (CutofO Score, 



:/s* □ 



•// "Psychometric Score/s" checked, describe method: 



19-26 DX BASE 



Other Methods (Specify):,^ 



PAGE 4 
31 





Check all conditions which would lead 


you to exclude (or remove) an individual 






DO NOT WRITE HERE 




from the study: 


COL. 


CODE 




\cute or Chronic Brain Syndrome 
History of Convulsive Disorder 
History of CNS Disease 
Mental Deficiency 
Psychosuigery 




27 Electroconvulsive Therapy 

28 Alcoholism 

29 Drug Addiction 

30 Pregnancy 

31 Females of Childbearing Age 


— 


32 

33 
34 
35 
36 


27 


EXCLUDE 




28 






29 






30 






31 






32 






Allergic 37 Hepatic 39 Pulmonary 41 
Cardiac 38 Hematologic 40 Renal 42 


33 




E. 


34 




EXCLUSION 


35 




CRITERIA: 


Other Medical Illness or Condition (Specify 


): 


36 








37 








38 






Anv Other Exclusion Criteria (Specify): 


39 






40 








41 






42 












43-50 






1. For inpatient studies - During the study, the population will reside: 
(Check all applicable) 

1 D One RESEARCH ward sDOne Institution (hospital) 

20 More than one ' 4DMore than one institution (hospital) 

RESEARCH ward gQ y„ ^^^ administrative control of principal investigator 

eDA^of under administrative control of principal investigator 


51-53 


RES- la 




b. 

1 DOne CLINICAL ward sDOne Institution (hospital) 
2nMore than one 4DMore than one institution (hospital) 

CLINICAL ward gQ (/„jg^ administrative control of principal investigator 

eX3Not under administrative control of principal investigator 


54-56 


CLIN - lb 


F. 

RESEARCH 

SETTING: 


c. Describe, in detail, research settings which do not fit in the above categories: 


57-60 


SET - 1c 




2. For outpatient studies - During the study the population will be admitted: 

(Check all applicable) 
a. 
FROM- '*'-' ^"^ "'*■"'"* ^" ^_. SDOne SDCommunity mental health center 

2D More than one ' 4DMore than one eDOther psychiatric clinic 
catchment area ^QChjy ^^^^^^ „„t„ 

SDPsychiatric section (OPD) of a 

general hospital 
gDOffice of private practitioner 


61-67 


OUT - 2a 




b. Describe, in detail, research settings which do not fit the above categories: 


68-71 


SET - 2b 



MH-9-21 
Rev. 1-73 



PAGE 5 

32 



IV. PROTOCOL 


DO NOT WRITE HERE 


A. CLASS OF STUDY 


COL. 


CODE 




1. Clinical Pharmacology: Phase I (Activity, toxicity, dose tolerance) 

Early Phase II (Efficacy, dose range, small sample, non-blind) 


- 


1 
2 
3 
4 
5 
6 


17-18 


CARD 04 




2. Clinical Trial: Late Phase II (Blind, efficacy, comparative agent) 

Phase III (Definitive efficacy trial, large sample size) 


— 


19 


PHASE 




3. Special Drug Study: (EEC, metabolism, dose response, etc.) 








4. Special Non-Drug Focussed Study: (Demographic, methodological, etc.) 







EXPERIMENTAL DESIGN 





a. Drug alone or compared with another drug/s: Test Drug/s Only 




01 




TYPE-DES 




Test vs. Placebo 




02 








Test vs. Comparison Drug 




03 








Test vs. Comparison vs. Placebo 




04 
05 








b. Two ormore test conditions in the same drug: 2 or more Dose Levels 








2 or more "Brands" 




06 






1. Type: 


2 or more Dosage Forms 




07 
08 


20-21 






c. Drug in combination with or compared to Drug vs. Individual Psychotherapy 








non-drug treatment : Dnig vs. Behavior Modification 




09 








Drug vs. Group Psychotherapy 




10 








d. Other type (Specify): 






(Insert Number) 

LENGTH TIME 

OF PERIOD UNIT 




22-24 


DRY 




a "nrying-oiit" period? Fl Yet If Yf, length yuttl he: Days 
n No Weeks 


1 

2 










TYPE-DRY 




"Drying-out" period will employ: No Treatment 


n 1 


25 






Placebo 


n 2 








b. Drug administration period will be: 


Hours 


1 

2 




RX-ADM 


2. Duration: 


Days 






Weeks 


3 


26-28 








Months 


4 














c. Post treatment (follow-up) period will be: 




1 
2 




POST 




Davs 






Weeks 


3 


29-31 






Months 


4 








None 


D 000 








Describe duration and drug sequences to be employed. Duration should apply to the first 
sequence and will be adjusted for other sequences. Code drugs as follows: 




17-18 


CARD 05 




Test Drug No. 1 = Tl Comparison Drug No. 1 = CI Placebo = PBO 
Test Drug No. 2 = T2 Comparison Drug No. 2 = C2 

Duration coded in: id Hours 2[I]Days 3O Weeks 40 Months 








19 


CROSSOVER 
UNIT 




TREATMENT 


20-25 




3. For 


DURATION 


SEQUENCE 






No. 1 


No. 2 


No. 3 


No 


. 4 


26-31 




Designs 














32-37 




Only: 


























38-43 




















44-49 




















so-se 



















MH-0-21 
Rev. 



PAGE 6 
33 



C. DOSAGE ADMINISTRATION 


DO NOT WRITE HERE 






TEST DRUG 




COMPARISON DRUG 




PLACEBO 


1 
2 
3 
4 
5 
6 
7 
8 


COL. 


CODE 




17-18 






No. 1 


Tablet 

Capsule 

"Spansule" 

Liquid 

I.V. 

S.Q. 

LM. 

Depot 


No. 2 


No. 1 


Tablet 

Capsule 

"Spansule" 

Liquid 

I.V. 

S.Q. 

LM. 

Depot 


No. 2 


Tablet 

Capsule 

"Spansule" 

Liquid 

I.V. 

S.Q. 

I.M. 

Depot 


— 






1 






1 


1 






1 


32-41 


FORM 




2 






2 


2 






2 






3 






3 


3 






3 




1. Form: 


4 






4 


4 






4 






5 






5 


5 






5 






6 






6 


6 






6 






7 






7 


7 






7 






8 






8 


8 






8 








Other: 








Other: 






Other: 








a. Fixed/unchanging — dosage fixed in protocol prior to study at a single level, 
e.g., 5 mg/day for 10 days 


D 1 


42 


SCHED 


2. Dosage 


b. Fixed/changing - dosage fixed in protocol prior to study with increasing or de- 
creasing levels; e.g., 100 mg. for first week; 200 for second; 300 for third, etc. 


02 




Schedule: 


c. Flexible - dosage changed according to needs of subject 


03 






d. Fixed/flexible - dosage fixed in protocol for earlier dosages with option to 
"individualize" dosage according to needs of the subject later on 


04 






a. Record Dosage Schedules Below 

If flexible dosage schedule, give initial and maximum dosage. 

Enter TOTAL DAILY DOSE at each appropriate time period. 

For combination drugs, use Test No. 1 for component A and Test No. 2 for component B. 


T«t1 
Test 2 
Comp 1 
Comp 2 


CARD 06 
CARD 07 
CARD 08 
CARD 09 




DOSAGE LEVELS 




3. Dosage 


TEST DRUG 


COMPARISON DRUG 




Protocol: 


No. 1 


No. 2 


No. 1 


No. 2 






Time 
Period 


Dosage 


Time 
Period 


Dosage 


Time 
Period 


Dosage 


Time 
Period 


Dosage 


PERIOD/ 
DOSE 




1 














19-24 






i 














25-30 






















31-36 






















37-42 






















43-48 






















49-54 






















55-60 






















61-66 






b. Dosages are recorc 

Other (Specify):_ 


Jed in: (Oieck appropriate unit for dosage) "^'^S 

mg 
gm 
mg/kg 


J 1 
Zl 2 
O 3 
11 4 


67 


DOSE UNIT 










c. Time 
Other 


periods are recorded in: (Check appropriate unit for time) Hours 

Days 
Weeks 
Months 

(Specifv): 


O 1 
02 
O 3 
04 


68 


TIME UNIT 
























MH-9-21 
Rev. 1-73 



PAGE 7 

34 









1 


DO NOT WRITE HERE 


D. CONTROL PROCEDURE 


COL. 


CODE 


1. 


Procedure will be: Nonblind □ 1 

Double bUnd □ 2 


17-18 


CARD 10 




19 


BLIND 


2. 


Subjects will be assigned to treatment by: Strict Random Number 




1 
2 
3 

4 


20 


ASSIGN 




Se<]uential Assignment 








Matching 








StratiTied-random 
(Describe under "other") 








Other: 












3. 


Will other conconnitant non-drug therapies be permitted for the research population? 

1 — 1 Yes If Yes, which therapies? Individual Psychotherapy 




1 
2 
3 
4 
5 


21 


CON-THER 




f~l Nn Group Psychotherapy 








Behavior Modification 








Varied Psychological Therapies 








Other Therapies 








Specify Other: 












4. 


Will any other drug therapies be permitted? (Check all applicable) 


22-23 


ANCILL 




No other drug therapies for any reason 




1 
2 
3 
4 
5 
6 






Only remedial medications, i.e., medications for the amelioration of adverse reactions 








Antiparkinson medication will be given prophylactically to all subjects 








Medication/s for medical conditions prescribed for subject prior to study will be permitted 








Non-study psychotropic medication may be administered in emergency (crisis) situation 








No restriction of use of other drug therapies 








Describe, in detail, other procedures which do not fit the above categories: 









































E. ASSESSMENT INSTRUMENTS 


(Check all applicable instruments) 














Others: 




PDI 


r-i 


24 
25 


24 


DEMO 


1. 


CPDI 




25 




Demographic: 




































Others: 




CSH 


r-n 


26 
27 
28 


26 


DIAG 


2. 


CDC, 




27 




Diagnostic: 


CDS 




28 












29-30 


DEMO/ 





























MH-9-21 
Rev. 1-73 



E. ASSESSMENT INSTRUMENTS (Continued) | 


DO NOT WRITE HERE 




Adult Behavioral Rating Scales 

31 ncGi 

32 Dbprs 

33nNOSIE 

34 nHAM Depression 

35 Oh AM Anxiety 

36 DwiTT 

37 DPLUT 

nthPTs- 


38 QlMPS 

39 nzUNG Depression 

40 DSRSS 

41 nsCL-90 

42 DpOMS 
43nBECK 

44 DdRI 


COL. 


CODE 




31 


EFF-ADULT 




32 






33 






34 






35 






36 






37 






38 






39 




3. 


40 




Efficacy: 


41 






42 








43 






44 








45-*6 






Children's Behavioral Rating Scales 

47 nCGI 

48 DCPRS 

49 DcbI 
Others: 


50nPQ 

51 DtQ 

52 nPEBP 


47 


EFF-CHILD 




48 






49 






50 






51 








52 






53-54 












55 DWAIS/WISC 

56 DmAZE 

57 DbENDER 

58 DWRAT 
Others: 


59 nGOOD 

eoDRT 

61 nCFF 

62 LJContinuous Performance 


55 


PSYCHO 


4 


56 




Psychometric 
and 


57 




58 






59 






60 






61 












62 






63-64 










5. 


65 nDOTES 66 DtESS 67 DsTESS 
Others: 


65 


ADVERSE 






66 




Reaction: 


67 








68-69 






Hematology 

19 Dngb 

20 DhcI 

21 DrBC 
22nWBC 

Other: 


23 nDifferential 

24 Dsed. Rate 

25 nPlatelet 

26 □prothrombin Time 


17-18 


CARD 11 




19 


HEMAT 




20 






21 






22 






23 






24 








25 




6. 


26 




Laboratory 




27-28 




Tests: 


Serum Chemistry 

29 D Electrolytes 

30 LJ Liver function tests 

31 lJ Kidney function tests 

Other: 


32 CD Sugar Metabolism 

33 D Blood fats 

34 CD Thyroid function tests 


29 


SERUM 




30 






31 






32 






33 








34 






35-36 











MH-9-21 
Rev. 1-73 



PAGE 9 
36 





Urine 

nthcr- 


37 n Sp.Gr. 

SsDpH 

39 LJ Albumin 


40 n Sugar 

41 □ Microscopic 

42 O Electrolytes 


DO NOT WRITE HERE 


6 


COL. 


CODE 


Laboratory 
Tests 

(Continued) 


37 


URINE 


38 




39 








40 






41 








42 






43-44 






Tests on 

nthRf 


Other Biological Specimens 

45 n Saliva 46 D Feces 


47 D Cerebrospinal Fluid 


45 


BIOL ' 




46 






47 






48^9 










7. 


nthRr- 


50 CJ Physical Examination 

51 1 — 1 Neurological Examination 

52 D PANESS 


53 D EKG 

54 D EEG 

55 n SUt Lamp 


50 


MED 


51 






52 






53 








54 






55 










8. 




56-57 




Any 


58-60 


MISC 


Other 
Procedures: 







How many different individuals (e.g., psychiatrists/psychologists) 

will perform the major behavioral ratings? No. 

Will "multiple raters" be used, i.e., 2 or more individuals performing simultaneous 
or concurrent ratings of the same subject? (Check One) 



No Do 
YesDl 



ASSESSMENT SCHEDULE 



MH-9-21 
Rev. 1-73 



For Time Periods, check appropriate time units (days, weeks, etc.) and write in the assessmen 
to be employed. In the four other columns, mark (X) in all rows where ratings will be made. 
Circle the periods where drug treatment begins and ends. Designate initial (first) rating as "OC 


t periods 
". 

. Ol 
. 02 

] Months 




For adverse reaction only 

a. If symptoms are to be rated only if and when they occur; check here 


64 


TIME 
UNIT 


b. If symptoms are to be rated at each dosage change; check here 

c. If symptoms are to be rated on a fixed schedule, complete in manner described above. 


65-70 


INITIAL 
PERIOD 


Check whether time periods refer to: 1 D Hours 2 Days 3 Weeks 4C 


17-18 


CARD 12 




TIME 
PERIOD 


MAJOR 

BEHAVIORAL 

SCALE 


MAJOR 
PSYCHOMETRIC/ 
PERFORMANCE 


ADVERSE 
REACTION 


LABORATORY 
TESTS 




19-24 


2nd 




25-30 


3rd 


















31-36 


4th 


















37-42 


5th 


















43^48 


6th 


















49-54 


7th 


















55-60 


8th 


















61-64 


BEGIN-END 


















65 



















37 



H. TYPE OF DATA ANALYSIS 



DO NOT WRITE HERE 
COL. CODE 



1. Pre (Middle) Post — one way analyses of rating periods 



Di 



ANALYSIS 



2. Treatment (groups) Comparison — e.g., drugs x periods 



D: 



3. Factorial — more than 2 factors, e.g., drugs x periods x diagnosis 
Describe factorial design: 



03 



4. Crossover — two or more treatments in same subjects 



Da 



5. Other: 



REMARKS: 



MH-9-21 
Rev. 1-73 



PAGE 11 
38 



SPECIFIC INSTRUCTIONS 



II. DESCRIPTION OF DRUG/S EMPLOYED 

The term "Test Drug" refers to the investigational drug; 
while "Comparison Drug" refers to the control drug. As 
used here, these terms are not necessarily synonymous to 
the same ones used by FDA or other regulatory agencies. 
Space limitations allow a maximum of. four drugs to be 
encoded — two Test Drugs under A and two Comparison 
Drugs under B of this section. In some instances, these 
space limitations may force arbitrary assignment of drugs to 
Test or Comparison categories; e.g., one test vs. three 
control drugs. Space is provided to encode a PLACEBO in 
addition to the maximum of four drugs. 

The terms Test and Comparison may be used in various 
ways; not only as test versus control drugs but also to de- 
scribe any test versus control situation (different brands of 
the same drug, different populations or age groups, high 
versus low doses, liquid versus tablet, etc.). In such cases, 
record the usual or standard medication as Comparison and 
the new or unusual form as Test. 

A. TEST DRUGS 

la. Name — Give the generic name for the drug or, if 
none yet exists, give the code number. 

Single/Combination — "Single drug" means a drug 
consisting of one compound. "Combination drug" 
refers to two or more compounds given as a single 
treatment, even if the components are not enclosed 
within a single "capsule" or "tablet". The drug 
Triavil, for example, is a combination of amitrip- 
tyline (Elavil) plus perphenazine (Trilafon). To 
record this drug, write in ONE space the generic 
name of each component — amitriptyline and per- 
phenazine. Do NOT record the two components 
as Test Drug No. 1 and Test Drug No. 2. 

b. Synonyms — Give only the more frequently used 
synonyms, trade names and/or code numbers. 

c. FDA — Answer on the basis of the drug's FDA 
status for general use and for the use/indication 
being tested in the study. Example - A drug ap- 
proved for use in general adult populations is to be 
tested for use in children. It is not approved for 
such a population by the appropriate regulatory 
agency. Check 2 - "Yes, approved for prescribing 
or sale but not for the present indication or "use" 
in this case. 

3. Presumed Clinical Action — Two columns are pro- 
vided for studies which involve two test drugs. In 
these studies be sure to mark the action for each 
drug in the correct column. For example, if thio- 
thixene is Test Drug No. 1 and imipramine is Test 
Drug No. 2, check "neuroleptic" in column No. 1 
and "anti-depressant" in column No. 2. When 
Combination drugs are present, mark the action of 
each component of the combination in the column. 
For example, if the combination drug, Triavil (ami- 
triptyline -H perphenazine) is Test Drug No. 1 
check both "anti-depressant" and "neuroleptic" in 
column 1. 

MH-9-21 INSTRUCTIONS 

Rev. 1-73 



New Uses For Established Drugs - To be com- 
pleted when a drug has an established psychotropic 
action, e.g., neuroleptic; and is being studied for 
some other presumed action, e.g., anti-depressant; 
or when a non-psychotropic drug, e.g., an analgesic 
is tested for psychotropic action, e.g., anxiolytic. 



5. Chemical Classes — The classification is based on 
that of Usdin and Efron in their book "Psychotro- 
pic Drugs and Related Compounds". From the 
code numbers (101—506) choose the lowest num- 
ber which is applicable to your Test Drug. If the 
drug, for instance, is both a heterocycle (307) and 
a carbamate (502), check only (307). For those 
drugs where chemical class is as yet unknown 
check (999). For studies involving 2 Test Drugs 
and/or Combination drugs, follow the procedure 
described under A3, "Presumed Clinical Action". 

III. POPULATION 

C. PRINCIPAL DIAGNOSTIC CATEGORIES 

Complete either subsection 1 - Adult or 2 - Chil- 
dren. You may record a maximum of four 
categories. If the population is so heterogeneous 
that four of the categories can not account for the 
bulk of the sample, check "Varied Psychiatric Dis- 
orders". World Health Organization (WHO) 
diagnostic entities may be recorded under "Other 
Categories" if the investigator chooses. 

D. BASIS FOR DIAGNOSIS 

Psychiatric Case Record - refers to use of diagnosis 
contained in the subject's case (hospital) record as 
the determinant. 

Investigator's Clinical Judgment - refers to the 
determination of diagnosis by the principal inves- 
tigator or member of the research team. 
Independent Clinical Judgment - indicates deter- 
mination by an individual not directly involved in 
the study, e.g., a consultant - not a member of the 
research team - whose function is to ascertain or 
verify the appropriateness of the diagnosis. 
Clinical Target Symptoms - refers to the clinical 
judgment of the presence or absence of specific 
synptoms or characteristics; 

Psychometric Scores - refers to determination by 
the use of specific score/s on a psychometric assess- 
ment instrument/s; e.g., subjects rated below a 
specified severity (score) on a scale are ineligible 
(cutoff) for acceptance into the study sample. 

F. RESEARCH SETTING 

Research ward refers to a unit specifically organ- 
ized for research purposes. Residents on a research 
ward are selected primarily on the basis of research 
requirements. 



IV. PROTOCOL 

A. CLASS OF STUDY 

Check ONE of the six alternatives 



39 



B. EXPERIMENTAL DESIGN 



C. DOSAGE ADMINISTRATION 



Type - Check ONE of the ten alternatives listed 
under a, b, and c or write in a more appropriate 
description under d. 

Type of Drying-out — If a Placebo is used only during 
drying-out period and the design is not conceptualized 
as a crossover, DO NOT designate the study as Test 
versus Placebo. 

Duration — For each of the subheadings a, b and c, 
insert numerals on the line before the appropriate 
time unit to indicate the length of the period. For 
example, an investigator plans to have a 2-week, no 
treatment drying-out period followed by 6 weeks of 
drug administration and no follow-up, Item 2a, 2b 
and 2c would be completed as follows; 

M Yes 
D No 
Drying-out period will employ 



a. Drying-out period? 



Days 

JL Weeks , 

No Treatment W 
Placebo D 



b. Drug administration period M/ill be: 



Hours 

Days 

O Weeks 



Form — Check ONE of the dosage forms for each 
group in the study. For example, in a study con- 
sisting of 2 drug groups - Test and Comparison - 
in which both groups receive their medication in 
tablet form, check "tablet" under both Test and 
Comparison columns. "Spansule" refers to a sus- 
tained release form. Depot refers to a drug contained 
in a vehicle for I.M. injection which allows for slow 
release and long action. 

Dosage Schedule — Dose ranges rather than specific 
doses are often fixed in the protocol prior to the 
study and should be coded according to level; e.g., 
3 to 7 mg/day for 10 days would be coded as 
Fixed/unchanging; 75 to 125 mg/day for the first 
week, 172-225 mg/day for the second week, etc. 
would be coded as Fixed/changing. 

Dosage Protocol 

Example / — Test and comparison drugs with a Fixed/ 
changing schedule. The total daily dose for the test 
drug will be 50 mg. for 1 week; 100 mg. for 1 week; 
200 mg. for 1 week, etc. For the comparison drug, 
the total daily dose will be: 25 mg. for 1 week, 50 
mg. for 1 week, 75 mg. for 1 week, etc. 
Code as follows: 



c. Post treatment (follow-up) 
period will be: 



.Hours 
-Days 
-Weeks 
-Months 
None 



^ 



Crossover — Example: In a study involving a test drug, 
(T1) comparison drug (CI) and placebo (PBO), the 
investigator plans to vary the order in which the treat- 
ments are given. He plans to administer each of the 
drugs for 4 weeks and the placebo for 2 weeks. One 
half of the research sample will be placed on one 
sequence or the other. Coding is as follows: 



Duration is recorded in: 



DDays 



gweeks DMonths 



TREATMENT | 


Duration* 


Sequence No. 1 


Sequence No. 2 


2 


PBO 


CI 


4 


T1 


PBO 


2 


PBO 


T1 


4 


CI 


PBO 



•Duration applies to Sequence No. 1. It is assumed that the 
durations for Sequence No. 2 would be shifted along with the 
treatments, e.g., 4, 2, 4, 2. 

A Latin square design involving Test Drug No. 1, (T1), Comparison 
Drug No. 1 (CD, Comparison Drug No. 2 (C2) and Placebo (PBO) 
would be completed as follows: 



MH-9-21 
Rev. 1-73 



Treatment 
Duration 


Treatment Sequences | 


1 


2 


3 


4 


2 


T1 


CI 


C2 


PBO 


2 


CI 


C2 


PBO 


T1 


2 


C2 


PBO 


T1 


CI 


2 


PBO 


T1 


CI 


C2 



PAGE 13 
40 



Time 
Period 


Test 
Drug 
No. 1 


Time 
Period 


Comparison 
Drug 
No. 1 


1 


50 


1 


25 


1 


100 


1 


50 


1 


200 


1 


75 



b. Dosages are recorded in: 

llVmg 2D meg 

c. Time periods are recorded in: 

1 DHours 20 Days 



3Dgm 4Dmg/kg 

sEWeeks 4nMonths 



Example 2 — Test and comparison drugs with a flex- 
ible schedule. Over a 4 week period a range of 10— 
100 mg. of test drug is to be administered; 100-500 
mg. for the comparison drug. 
Code as follows: 



Time 
Period 


Test 
Drug 
No. 1 


Time 
Period 


Comparison 
Drug 
No. 1 


4 


10-100 


4 


100-500 



(Units of dosage and time omitted for brevity) 

Example 3 — Combination test drug and 2 compari- 
son drugs with a Fixed/changing schedule. Component 
A of combination is coded under Test No. 1 and 
Component B under Test No. 2. Dosage is changed 
as indicated. 



Time 
Period 


Test 
Drug 
No. 1 


Time 
Period 


Test 
Drug 
No. 2 


Time 
Period 


Com- 
parison 
Drug 
No. 1 


Time 
Period 


Com- 
parison 
Drug 
No. 2 


1 


50 


1 


5 


1 


50 


1 


5 


2 


100 


2 


10 


2 


100 


2 


10 


2 


150 


2 


15 


2 


150 


2 


15 



3. Dosage Protocol (Continued) 

Example 4 — Test drug in depot form and comparison 
drug in tablet form. Depot form (200 mg) is pre- 
sumed to be effective for 4 weeks. Initial dose of 
comparison drug is 50 mg and it increased 50 mg each 
week to maximum of 200 mg. 



Time 
Period 


Test 

Drug 
No. 1 


Time 
Period 


Comparison 
Drug 
No. 1 


4 


200 


1 


50 






1 


100 






1 


150 






1 


200 



Example 5 — Test and comparison drug with a fixed/ 
flexible schedule. Dosages for both test and compari- 
drugs are raised 100 mg each week for first 3 weeks of 
6— week study. Dosages can then be "individualized" 
according to needs of subject. (Write in "open" to 
indicate "individualizing"). 



Time 
Period 


Test 
Drug 
No. 1 


Time 
Period 


Comparison 
Drug 
No. 1 


1 


100 


1 


100 


1 


200 


1 


200 


1 


300 


1 


300 


3 


Open 


3 


Open 



D. CONTROL PROCEDURE 

1. Blindness — Single blind studies should be checked 
Nonblind. 

2. Treatment Assignment —Strict random number refers 
to the use of a table of random numbers for assign- 
ment of subjects. 

Matching refers to any attempt at specific matching 
of individuals. Sequential assignment refers to select- 
tion and/or assignment by order or sequence, i.e., 
alternating treatments to subjects as they are ad- 
mitted; choosing every nth subject, etc. Stratified 
random — a variant of "matching" in which groups 
rather than individuals are selected on basis of a set of 
characteristics, e.g., sex, age, etc. 

3. Concomitant Therapies — Refers to therapies which 
may be given to patients as part of their treatment 
but which are not a part of the research design. 



G. ASSESSMENT SCHEDULE 

Example 1 ■ Using the BPRS as his major behavioral 
rating scale, an investigator plans to make an assess- 
ment at pre-treatment, 2, 4, 6 and 8 weeks. Drug 
treatment will begin immediately following the initial 
rating and cease following the final rating. Ratings of 
adverse reactions and laboratory tests will be made at 
pre-treatment, 4 and 8 weeks. No psychometric/per- 
formance scales will be employed. 



Time 
Period 


Major 

Behavioral 

Scale 


Major 
Psychometric 
Performance 


Adverse 
Reaction 


Basic 
Laboratory 


® 


X 




X 


X 


02 


X 








04 


X 




X 


X 


06 


X 








(g) 


X 




X 


X 



Example 2 — On the major behavioral rating scale, the 
investigator plans to make assessments at the begin- 
ning and end of a 2 week drying-out period; the 1st, 
3rd and 5th weeks of drug administration and 2 weeks 
after cessation of treatment. (Psychometric/perform- 
ance tests, adverse reaction and laboratory tests are to 
be rated as marked). 
Code as follows; 

NOTE THAT THE TIME PERIODS ARE NUMBERED IN 
SEQUENCE REGARDLESS OF INITIATION/CESSATION 
OF DRUG ADMINISTRATION. 



Time 
Period 


Major 

Behavioral 

Scale 


Major 
Psychometric 
Performance 


Adverse 
Reaction 


Basic 
Laboratory 


00 


X 


X 






© 


X 


X 


X 


X 


03 


X 


X 






05 


X 


X 






© 


X 


X 


X 


X 


09 


X 


X 







MH-9-21 
Rev. 1-73 



PAGE 14 

41 



GLOSSARY OF ASSESSMENT INSTRUMENTS 



1. 


Demographic: 


PDI 


Patient Data Inventory 




CPDI 


Children's Patient Data Inventory 








CDS 


Children's Diagnostic Scale 




2. 


Diagnostic: 


CDC 
CSH 


Children's Diagnostic Classification 
Children's Symptom History 








Adult Behavioral Rating Scales 




Children's Behavioral Rating Scales 






CGI 


Clinical Global Impressions 


CGI 


Clinical Global Impressions 






BPRS 


Brief Psychiatric Rating Scale 


CPRS 


Children's Psychiatric Rating Scale 






NOSIE 


Nurses' Observation Scale for 


CBI 


Children's Behavior Inventory 








Inpatient Evaluation 


PQ 


Parents' Questionnaire 






HAM Depression Hamilton Depression Scale 


TO 


Teacher's Questionnaire 






HAM Anxiety 


Hamilton Anxiety Scale 


PEBP 


Psychological Examination Behavior Profile 






WITT 


Wittenborn Psychiatric Rating Scale 






3. 


Efficacy: 


PLUT 
IMPS 

ZUNG 

SRSS 

SCL-90 

POMS 

BECK 

DRI 


Plutchik Geriatric Rating Scale 
Inpatient Multidimensional 
Psychiatric Scale 

Zung Self-Rating Depression Scale 
Self-Rating Symptom Scale 
Symptom Check List 
Profile of Mood States 
Beck Depression Inventory 
Discharge Readiness Inventory 










WAIS 


Wechsler Adult Intelligence Scale 




4. 


Psychometric 


Wise 


Wechsler Intelligence Scale for Children 






and 


MAZE 


Porteus Mazes 






Performance 


BENDER 


Bender Gestalt Test 






Tests: 


WRAT 
GOOD 
RT 
CFF 


Wide Range Achievement Test 
Goodenougfi-Harris Draw-A-Man Test 
Reaction Time 
Critical Flicker Fusion 




5. 


Adverse 


DOTES 


Dosage Record and Treatment Emergent Symptoms 




Reaction: 


TESS 


Treatment Emergent Symptom Scale 








STESS 


Self-Rating Treatment Emergent Symptom Scale 






Hgb 


Hemoglobin 




6. 


Laboratory 


Hot 


Hematocrit 






Tests: 


RBC 
WBC 
Sp. Gr. 


Red Blood Count 
White Blood Count 
Specific Gravity 








PAN ESS 


Physical and Neurological Examination for Soft Signs 


7. 


Medical: 


EKG 
EEG 


Electrocardiogram 
E lectroencephalogram 





MH-9-21 
Rev. 1-73 



k2 



Developed within the ECDEU program, the Research Plan Report (RPR) is a 
43- item, self-contained scale for the recording of research procedures. The 
RPR is not formatted for optical scanning. It is, in essence, a summary proto- 
col in which the purposes of the study are recorded, the size and nature of the 
population delineated, the investigational and comparative agents described, the 
duration and dosage set forth, the experimental conditions to be observed and the 
assessment procedures recorded. The value of the instrument extends beyond its 
usefulness for describing the design of a given study. As a data file, it can 
serve to describe the current status of research activities among a large group 
of investigators as well as provide an historical record of past activities. At 
this writing, data on over 1000 research protocols are on file. 

APPLICABILITY - For all research populations 

UTILIZATION - Once per study. Completed prior to the initiation of the study. 

SPECIAL INSTRUCTIONS 

The investigator should be familiar with the instructions printed on the form 
itself as well as those contained below. Since no one form or the items contained 
therein can possibly cover all eventualities, investigators are asked to include a 
copy of their research protocol along with the RPR. An extensive coding system has 
been developed for the RPR which contains many more categories for each item than 
those printed on the RPR itself. With the investigator's personal protocol at hand, 
it has been possible to categorize almost all research procedures within the general 
framework of the RPR. 

Use of the RPR - Investigators may - and indeed are encouraged to - submit RPR's 
for their studies whether or not they intend to use ECDEU assessment instruments or 
Biometric Laboratory processing services. 

Unit and Study Numbers - These numbers are assigned by the Biometric Laboratory. 
When an RPR is received, a notice will be sent to the investigator acknowledging 
receipt and will give the unit and study number assigned to that RPR. This 6-digit 
identification number should be referred to in all subsequent correspondence regard- 
ing that particular study so that misinterpretations can be minimized. 

RPR Revision or Modification - If the investigator makes substantive changes 
in his study, a new RPR should be submitted. The original RPR can thus be "updated" 
in the ECDEU data bank. 

Confidentiality - Investigators may request that all or part of the information 
on an RPR be held confidential. For many reasons, new chemical formulae may need to 
be confidential and data pertaining to this area can be withheld while disseminating 
the other RPR information to the scientific community. 

ECDEU Forms - Indicates that ECDEU forms will be employed either wholly or in part. 



^3 



II. Drug/s Employed - This section focuses on a description of the agents or 
conditions to be studied. "Test drug" can refer to ANY TEST CONDITION; 
"Comparison drug" to ANY COMPARISON CONDITION. Examples: 

a. An atypical dosage of Drug A (test condition) vs. a typical dosage 
of Drug A (comparison condition) using the same drug in both 
instances. 

b. "Brand X" (Test) vs. "Standard Brand" (Comparison). 

c. Drug A given once a day (Test) vs. Drug A given 3 X a day (Comparison). 

d. Drug A given in "depot" form (Test) vs. Drug A given in tablet form 
(Comparison) . 

e. Drug A given with a smile (Test) vs. Drug A given without a smile 
(Comparison) . 

f. Withdrawal of Drug A with PBO substitution (Test) vs. Withdrawal of 
Drug A without PBO (Comparison). 

Space limitations allow recording of 2 "Tests", 2 "Comparisons" and a placebo. 
Which drugs or conditions are designated as "Test" or "Comparison" is left to 
the investigator and this decision may often be an arbitrary one. 

Combination Drugs - This phrase seems to cause confusion. The intent here is 
to describe the condition in which 2 or more drugs are given simultaneously as 
ONE treatment; i.e., the investigator presumes that the combination has a 
different effect than either of the components used singly. Combination treat- 
ments may also consist of drug and non-drug Components; e.g., Drug and ECT, 
Drug and Psychotherapy, Drug and Conditioning, etc. 

Manufacturer - Should be interpreted as the SUPPLIER of the drug/s employed in 
the study. The supplier is not necessarily the actual manufacturer of the drug/s. 

I I, A, 3. Presumed Clinical Action/s - The categories contained in this section 
are based on the classification, developed by the International Reference Center 
for information on Psychotropic Drugs. Table 3 describes this classification in 
detail . 

I I, A, 5. Chemical Class - Investigators may leave this section blank if they are 
uncertain of the classification of a drug. With very new drugs, a drawing of the 
chemical structure is most helpful in arriving at correct classification. When 
classifying a combination drug, check a class for each component - both in the 
appropriate column. 



kk 



TABLE 3 



PSYCHOTROPIC DRUG CLASSIFICATION - INTERNATIONAL REFERENCE CENTER NETWORK 


DRUG GROUPS 


SYNONYMS 


WORKING DEFINITION 


SUB-GROUPS EXAMPLES 


NEUROLEPTICS: 


Major Tranquilizers 

Neuroplegics 

Psychoplegics 

Psycholeptics 

Antipsychotics 


Non-hypnotic drugs 
with antipsychotic 
effects 


Phenothiazine Derivatives .... Chlorpromazine 
Thioridazine 
Fluphenazine 
Benzoquinolizine Derivatives . . . Tetrabenazine 
Thioxanthene Derivatives .... Chlorprothixene 
Butyrophenone Derivatives . . . Haloperidol 

■^auwolfia Alkaloids Reserpine 

Other: 


ANXIOLYTICS: 


Antianxiety Drugs 
Minor Tranquilizers 
Sedatives 


Non-hypnotic drugs 
with antianxiety 
effects but without 
antipsychotic effects 


Benzdiazepine Derivatives .... Chlordiazepoxide 

Oxazepam 
Glycol Derivatives Meprobamate 

Phenaglycodol 

Carbinols Phenprobamate 

Diphenylmethane Derivatives . . . Methaqualone 

Hydroxine 
Barbiturates Phenobarbital 

Amobarbital 
Other: 


ANTI- 
DEPRESSANTS: 


Thymoleptics 
Thymoanaleptics 
Psychoanaleptics 
Psychic Energizers 


Drugs which elevate 
mood and relieve 
depression 


MAO-lnhibitors Isocarboxazid 

Nialamide 
Phenelzine 
Tranylcypromine 


Desipramine 
Amitriptyline 
Protriptyline 
Other: 


STIMULANTS: 


Psychoanaleptics 
Psychotonics 
Analeptics 
Psychomotor Stim- 
ulants 


Drugs which accelerate 
psychomotor function 
and activity and improve 
performance under 
conditions of fatigue 


^henylethylamine Derivatives. . . Amphetamine 

Methamphetamine 

Other: Phenmetrazine 

Methylphenidate 
Pipradol 


PSYCHO- 
TOMIMETICS: 


Psycholytics 

Psychodysleptics 

Hallucinogenics 

Psychedelics 

Eidetics 


Drugs producing 
alteration in conscious- 
ness, characterized by 
perceptual and 
emotional changes with- 
out disorientation 


Phenylethylamine Derivatives . . . Mescaline 

Indole-alkaloids LSD 

Psilocybin 
Tryptamine Deriva- 
tives 

'iperidine Derivatives Ditran 

Phencyclldine 

Other: 


HYPNOTICS: 


Soporifics 
Somnifacients 


Psycholeptics with 
sleep-inducing and 
sleep-sustaining 
effects 


Sarbiturates Secobarbital 

Pentobarbital 

Mon-Barbiturates Glutethimide 

Ethchlorvynol 
Ethinamate 

Other: 



45 



Example 1 - Test Drug No, 1 Is a combination of ami tr Iptyl Ine (Class - 

Phenothiaz i ne analogue and isosteres) and perphenazine (Class - 
Pbenothiaz ines) . This combination of drugs will be administered 
as a single test condition. Code by checking both 101 and 102 
under the column "Test Drug No. 1". 



5. Chemical Class/es (If known) 





TEST 
DRUG 
NO. 1 




TEST 
DRUG 
NO. 2 


CHEMICAL CLASSES 


DK 
NO. 




X 


101 




Phenothiazines 

Phenothiazine analogues & isosteres 






X 


102 










201 




Lyserc'' -ivatives 













Example 2 - Test Drug No. 1 is a single drug, ami tr iptyl Ine, and Test Drug 

No. 2 Is a single drug, perphenazine. Each Is to be administered 
to one of two Independent groups. Code Test Drug No. 1 in its 
appropriate column; Te^t Drug No. 2 in its appropriate column. 



5. Chemical Class/es (If known) 





TEST 
DRUG 
NO. 1 




TEST 
DRUG 
NO. 2 


CHEMICAL CLASSES 


TF 
D 

r 






101 


X 


Phenothiazines 






X 


102 




Phenothiazine analogues & isosteres 



-•"• acid derivatives 

ll,B. Comparison Drug/s - Refers to any control or standard condition against 
which the test condition is to be compared. A frequent misinterpretation in 
completing the RPR occurs in studies where 2 drugs (conditions) are employed 
and, although the investigator is actually going to compare these conditions, 
he encodes both of them as "Test Drugs". For uniformity in the Data Bank, 
categorizing one drug as "Test" and one as "Comparison" Is preferred - even 
though this may be arbitrary from the investigator's point of view. 

III,A,1. Total Number of Subjects In Study - Give an estimate of the sample 
size you plan to achieve, even though it may be a tentative one. 

II1,C. Principal Diagnostic Categories - Up to 4 categories of diagnoses have 
been allotted In the coding system. Populations which exceed this limitation 
should be coded "Varied Psychiatric Disorders". The spaces labeled "Other 
Categories" may be used to record any additional diagnoses or to record the 
World Health Organization (WHO) diagnoses. 

III,D. Basis for Diagnosis -When the response "Psychometric (Cut-Off) Score/s" 
is checked, specify the nature of the "cutoff score". 

Examples : 

BPRS Total Score of 30 or more 

Hamilton Anxiety Scale Total Score of 25 or more 

BPRS Thought Disorder Factor Score of k or more 



46 



III.F. Research Setting - For Items F,l,a and F,i,b, 3 MARKS are required, 
Exampl e: 

The population will reside on one clinical ward in one hospital. 
The ward is not under the investigator's administrative control. 

....isuative contiol of principu. . 



b. 



I^fcne CLINICAL ward S^One Institution (hospital) 



CLINICAL ward 



4nMore than one institution (hospital) 

50Under administrative control of principal investigator 

^fSiVol under administrative control of principal investigator 



c. Describe, in detail, research settings which h^ 



For mixed inpat ient/outpatient studies, fill in both sections of this item. The 
distinction between a research and clinical ward may be confusing. A clinical 
ward is one organized for treatment purposes. Patients residing on such a ward 
may be selected as research subjects but the ward itself is not organized as a 
research ward. Catchment area refers to a geographical subdivision of a larger 
area (metropolitan area, ward, city, county, state, province, etc.) from which a 
given agency receives its clients. 

IV,B,2a. "Drying-out" period - In addition to checking the presence and length 
of a drying-out period, the investigator should indicate whether "no treatment" 
or PBO will be employed during this period. Should some other condition be main- 
tained during the drying-out period, describe the nature of the condition. 

IV,B,2c. Posttreatment (follow-up) period - Refers to the period immediately 
following the cessation of drug administration and during which assessment procedures 
will be conducted. 

IV, C, 2. Dosage Schedule - A single dose ("one-shot") would be coded as "Fixed- 
unchanging". When recording "Dosage Protocol" for a single dbse, give the time 
period over which the dose is presumed effective and the amount of the dose. Single 
dose is coded the same way as "Depot" although its length of action may be 
considerably shorter. 

E. Assessment instruments - When recording assessment instruments not printed on 
the RPR, give the FULL NAME of the instrument since there can be confusion in the 
interpretation of initials or partial titles. This is particularly important in 
describing laboratory tests or medical procedures. Citation of instruments here 
does NOT constitute an order for supplies. To obtain supplies, use the ECDEU Order 
Form (07^-EOF). (See pp. 50-52). 

IV, F Raters - Question 1 refers to the number of individuals performing the major 
behavioral ratings; e.g., the Children's Psychiatric Rating Scale and Clinical Global 
Impressions are selected by the Investigator as his major instruments and he and 2 
other colleagues will perform all of these ratings; enter "3" for the item. 



^7 



DOCUMENTATION 

Documentation for the RPR is both study-specific and general. For the 
study itself, the RPR provides the information for the "Description" paragraph 
contained in the Narrative Summary which accompanies each standard data analyses 
package and in the PRB Information Reporting and Retrieval System. For general 
documentation, the focus is on some selected subset of RPR's or RPR items con- 
tained in the ECDEU data bank, e.g., all studies reported in a given period of 
time; all Phase II studies; all double blind studies involving a given drug, etc, 
For the investigator, the PRB Information Reporting and Retrieval System is the 
primary source of general documentation of RPR information. A full description 
of this system and its use may be found in ECDEU Intercom, January, 1973i 
Vol. 2, No. 6. An offset of this Intercom issue may be obtained by writing to 
Program Head, ECDEU, Psychopharmacology Research Branch, NIMH, Room 9-101, 
5600 Fishers' Lane, Rockville, Maryland, 20852. 



48 



074 EOF 
ECDEU 
ORDER 
FORM 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

PUBLIC HEALTH SERVICE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 


FOR BIOMETRIC LABORATORY USE 


UNIT. NO. 


ECDEU ORDER FORM (EOF) 


RECEIVED 


SENT 



INSTRUCTIONS: Please use ECDEU Order Form (EOF) when requesting supplies. Be sure to give COMPLETE mailing 
address. See reverse side for description of scales contained within packets. A Research Plan Report 
(21 - RPR) MUST be completed describing the study for which supplies are requested. 

Has an RPR been completed? □ Yes ■ attached 

□ Yes - previously sent ECDEU Study No. 



MAIL TO: Biometric Laboratory 
ECDEU Data Analysis 
The George Washington University 
11501 Huff Court 
Kensington, Maryland 20795 







NAME OF PRINCIPAL INVESTIGATOR 


TO BE SENT TO: (Complete only if supplies to be sent to person 
other than principal investigator or to different address) 


SUPPLIES 
REQUESTED 


INSTITUTION/AGENCY 


NAME 


BY: 


Number and Street 


Number and Street 




City, State, Zip Code 


City, State, Zip Code 


Form 
No. 


ITEM 


No. 
Requested 


No. 
Sent 


Form 
No. 


ITEM 


No. 
Requested 


No. 
Sent 


807 


Assessment Manual 






38 


STESS 


Self Rating Treatment 
Emergent Symptom Scale 






801 


Blue 


Demographic Packet 






41 


PANESS 


Physical and Neurological 
Examination for Soft Signs 






802 


Green 


Psychiatrist Packet - Child 






46 


PMR 


Prior Medication Record 






b03 


Gold 


Psychiatrist Packet - Adult 






50 


GSS 


General Scoring Sheet 






804 


Orange 


Nurse Packet 






53 


SCL-90 


Symptom Checklist - 90 






805 


White 


Psychologist Packet 






54 


SAS 


Self Rating Anxiety Scale 






806 


Red 


Social Adjustment Packet 






55 


LAB 


Laboratory Data 






21 


RPR 


Research Plan Report 






59 


RCR 


Research Completion Report 






33 


TWIS 


Treatment Emergent Symptoms 
Write-in Scale 






71 


DS 


Data Shipment 






35 


TO 


Teacher Questionnaire 






73 


SDS 


Self Rating Depression Scale 






36 


PQ 


Parent Questionnaire 






74 


EOF 


ECDEU Order Form 






37 


PTQ 


Parent-Teacher Questionnaire 






117 


AIMS 


Abnormal Involuntary 
Movement Scale 















































MH-9-74 
Rev. 2-75 



50 



NOTES ON FORMS 



A full description of the ECDEU forms and their usage as well as the BLIPS processing system is given In 
the Assessment Manual. PACKETS refer to reusable, semipermanent binders which contain sets of scales 
organized by professional discipline and/or specific population. A separate answer sheet — General Scoring 
Sheet — must be used in conjunction with the packets. In requesting packets, base your needs on the num- 
ber of raters — NOT the number of subjects. Keep in mind that packets are reusable and need not be 
ordered anew for each study. 



The contents of the packets are: 
Demographic Packet (Blue) 

43 CPDI Children's Personal Data Inventory 

44 CSH Children's Symptom History 

45 APDI Adult Personal Data Inventory 

Psychiatrist Packet - Child (Green) 

27 CPRS Children's Psychiatric Rating Scale 

28 CGI Clinical Global Impressions 

29 DOTES Dosage Record and Treatment Emergent Symptoms 

30 CDS Children's Diagnostic Scale 

31 CDC Children's Diagnostic Classification 

32 PTR Patient Termination Record 

Psychiatrist Packet - Adult (Gold) 

47 BPRS Brief Psychiatric Rating Scale 
72 DSI Depression Status Inventory 
49 HAMD Hamilton Depression Scale 

48 HAMA Hamilton Anxiety Scale 

51 ASI Anxiety Status Inventory 

52 WITT Wittenborn Psychiatric Rating Scale 

28 CGI Clinical Global Impressions 

29 DOTES Dosage Record and Treatment 

Emergent Symptoms 

32 PTR Patient Termination Record 



Nurse Packet (Orange) 



34 


CBI 


39 


NOSIE 


40 


PLUT 


42 


NGI 



Children's Behavior Inventory 

Nurse's Observation Scale for Inpatient 

Observation 

Plutchik Geriatric Rating Scale 

Nurse's Global Impressions 



Psychologist Packet (White) 
Children 

60 Wise Wechsler Intelligence Scale for Children 

62 WRAT Wide Range Achievement Test 

61 MAZE Porteus Mazes 

63 GOOD Goodenough— Harris Figure Drawing Test 

64 BENDK Bender Gestalt Test - Koppitz Scoring 

66 PEBP Psychological Examination Behavior Profile 

Adult 

67 WAIS Wechsler Adult Intelligence Scale 
61 MAZE Porteus Mazes 

68 BENDP Bender Gestalt Test - Pascal-Suttell Scoring 

69 WMEM Wechsler Memory Scale 

70 FTBS Friedhoff Task Behavior Scale 

Social Adjustment Packet (Red) — In preparation, probable contents: 



58 
57 



DRI 
SADJ 



Discharge Readiness Inventory 
Social Adjustment Scale 



MH 9- 

21 RPR Research Plan Report Describes the clinical study. Af/4/VD/4 TO/?/ for all investigations 

33 TWIS Treatment Emergent Symptoms - 

Write-in Scale Necessary for recording side effects not printed on the Dosage Record 

and Treatment Emergent Symptoms 

37 PTQ Parent-Teacher Questionnaire . . Contains the ten items common to both the Teacher and Parent 

Questionnaires and usually employed in conjunction with them for 
repeated assessments 

50 GSS General Scoring Sheet Necessary answer sheet for all packets. Also employed for the encoding 

of non-standard data 

59 RCR Research Completion Report . . . Describe the investigator's conclusions of his study. Completed after 

data analysis 

71 DS Data Shipment Supplies necessary information for BLIPS processing. MANDATORY 

for all data submissions to the Biometric Laboratory 

54 SAS Self -Rating Anxiety Scale and 

73 SDS Self-Rating Depression Scale . . . Subject-rated versions of the clinician-rated Anxiety Status Inventory 

and Depression Status Inventory 

117 AIMS Abnormal Involuntary Movement 

Scale . Examination procedures and rating scale for dyskinetic movements 

MH 9-74 (Back) 

Rev. 2-75 C ] 



The ECDEU Order Form (EOF) is an administrative form for the distribution 
of ECDEU assessment material. It supersedes ECDEU Order Form (101-EOF). 

UTILIZATION - Whenever supplies are requested from ECDEU Data Analyses of the 
Biometric Laboratory. 

SPECIAL INSTRUCTIONS 

1. Materials will be sent only upon receipt of a completed Research Plan 
Report, describing the study for which the supplies are requested. If additional 
supplies are needed for a study for which an RPR was previously submitted, be 
sure to include the assigned ECDEU Study Number. 

2. Investigators are strongly urged to use the EOF when requesting supplies. 
Orders given by telephone or contained within letters primarily related to other 
matters are too easily misplaced - resulting in angry investigators and frustrated 
BLIPS bookkeepers. Emergencies do arise, however, and, under these circumstances, 
telephone orders will be accepted. 

3. Investigators should restrict the quantity of supplies requested to that 
required for immediate use. "Stockpiling" of supplies is discouraged. It is 
suggested that investigators request only those supplies necessary to fulfill the 
assessment needs of the study or studies "ready to go" in the immediate future. 

k. The new packets are expensive to produce and investigators should under- 
stand that they cannot be distributed with the largess'we might wish. Since they 
are sem i -permanent , packets should be serviceable for use in several studies or by 
several raters. Replacement of unserviceable packets will be made at reasonable 
intervals . 

5. Since facsimiles of the Battery are contained within this Manual, copies 
of the Manual rather than the actual packets and instruments should be requested 
for training and educational purposes. 

6.' This form may be duplicated when originals are not available. 

DOCUMENTATION 

Documentation for the EOF is basically an "inhouse" bookkeeping operation. 



52 



050 GSS 
GENERAL 
SCORING 
SHEET 



The General Scoring Sheet (GSS) is the basic ECDEU form for the encoding 

of data in op-scan format. It is the IBM Optical Scan Form No. 551 upon which 

the ECDEU identification block has been imprinted. The GSS replaces the 
General Purpose Scale (00-GP) . 

APPLICABILITY - All research populations and all types of numeric data. 

UTILIZATION - The GSS may be used in 2 ways : 

1. In conjunction with the various packets 

2. As a means for encoding non-standard data 
for BLIPS processing. 

DATA FIELD FORMAT - The data matrix of the GSS (Figure 2) is bounded by the 
coord i nates : 

Rows (Horizontal) 1 - 41 

Columns (Vertical) 1 - 20 

There are 820 response positions within this matrix. Not all 820 positions can 
be encoded at any single time, however. Note that there are four "quadrants" 
of response positions: Cols. 1 - 5; 6 - 10; 11-15 and 16 - 20. On any given 
row within a "quadrant", any 3 of the 5 response positions can legally be marked 
at the same time. 

Examples: 



1 -^ 


•ate 


•^^ 


-Sz-- 


"*: 


2-to 


-^ 


-ii 


.». 


:;*: 


3«te 


-i- 


::2:r 


;i3:r 


•ta 


Amam 


irjir 


.^ 


.». 


==*= 


5-*. 


i=3=: 


^. 


-tr 


m^ 


6-to. 


..i.. 


:=£= 


-^ 


^i 


7 --A-- 


-te 


-te 


-fc. 


-.--Apz 


9-zft-- 


«i- 


-»> 


:*: 


-«. 


9 =-et= 


•te 


;=2:r 


1^ 


-te 


10=*. 


-.-.Uz 


^m 


^. 


1 



Thus, a maximum of 492 response positions can be utilized - legally - at any 
given time. 

Four matrix coordinates are required to locate any data set: 

Rows R. to R 
I n 

Columns C. to C 
I n 



5h 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 













ECDEU 


GENERAL SCORING 


SHEET [50-GSS) 












^^ 


MTI»1T INITIALS 
















NUMBER 


MALES OOWO 4^9 NUMBER FEMALES 50C 


TO 


998 


— 


:«:: :*:: 
:■»■■- :V:: 


:!*: 
:»: 


:*: 
:«:: 
:«:: 


:«:: 

RRST 
:*: 

INITIAL 
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:*:: 
:J:: 


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:*: 


:*t: 
:«:: 


F 


:-J:: 

IGURE 


:*: 

2.*. 

:*: 


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::1:: :2:: 


:3:: :*-: :i: 

PATIENT 

:3:: :3»:: :i: 
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:*: 
:A: 
:*: 


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::&: 
::a: 
::&: 


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— 




b* 


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— 


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:«*: 
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IhllTIAL 


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:i:: 


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~~I0 EHLir.i-\.Miiur4 . Dio«^ih~ 


::6: 


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— 


:«:: :V:: 


:*: 
:*: 

:*: 


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PERIOD 
::(:: :«:: :3: :=»:: 

Hours , Days 


:*: 

:*: 
Weeks 
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Months 
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■■"*= SHEET 

:*: NO. 


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— 


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::t: 


:2:: :3:: -A-z 


:5:: 


::&: 


::7:: 


::&: 


:A: 


"" 


rr*: ::.:: 


2.: 


li: 


::*: 


:* 


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z.T-Z 


• 


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I 


2 :3:: :*: 


::5:: 


:*: 


::7:: 


:*: 


i:^ 


__^ 


4:*: ::!:: 


.2". 


:3:: 


Az. 


:*: 


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z.r-z 


:*: 


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:;t: 


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ii:: 


:i: 


:*: 


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:*: 


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:;t:: 


:2:: :*: :*: 


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:*: 


:*: 


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:*: 


::»: 6:*: 


::t:: 


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:*: 


:*: 


::7:: 


::a: 


::a: 


— 


;:«:: ::t:: 


:«:: 


:i: 


:*: 


:*: 


:*: 


::T:: 


::»: 


::»: 7*: 


::t:: 


:2:: :*: :*: 


:*: 


:*: 


::7:: 


::»: 


::a: 


— 


$:*: ::(:: 


:*: 


:.3:: 


:*: 


:*: 


:*: 


::T:: 


:*: 


:*: 8*: 


::(:: 


:2:: :*: :*: 


:*: 


:*: 


::7:: 


:&: 


::&: 


_ 


♦ :*: ::t:: 


:*: 


:*: 


A^z 


:*: 


:*: 


::7:: 


:*: 


::»: 9:*: 


::t:: 


:2:: :*: :*: 


:*: 


:*: 


::7:: 


::»: 


::»: 


~~ 


10:*: ::(:: 


:*: 


:*: 


:*: 


:*: 


:*: 


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:*: 


::»: 10:*: 


::(:: 


::2:: :.3:: :*: 


:*: 


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::7:: 


::&: 


::»: 


^ 


1|:«:: ::):: 


:*: 


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:*: 11 :0:: 


::►:: 


:2:: :3:: :=»:: 


:*: 


:&: 


::7:: 


:*: 


:*: 


~~ 


IJ:*: ::|:: 


:*: 


:*: 


:*: 


:*: 


:*: 


:i7^: 


::»: 


::*: 12=0 


::t:: 


:2:: :3:: -A-z 


:*: 


:&: 


::7:: 


:*: 


:*: 


^~ 


13:*: ::|:: 


:*: 


:*: 


::*: 


:*: 


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::7i: 


:«: 


::»: 13:*: 


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:*: 


:*: 


::7:: 


:*: 


::»: 


^~ 


H:*: ::|:: 


:*: 


:*: 


Azz 


:*: 


::&: 


:.7^: 


::&: 


::»: 14:*: 


::t:: 


:2:: :3:: :34:: 


:*: 


:*: 


::7:: 


:*: 


:*: 


~ 


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:*: 


:*: 


::*: 


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::»: 


::»: 15*: 


::(;: 


:2:: :3:: :*: 


:*: 


:*: 


::7:: 


::&: 


::»: 


~ 




U^*: ::!:: 


:*: 


:3:: 


:=*: 


::5:: 


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::e:: 


::&: IJ:*: 


::t:: 


.2.1 :3:: :*: 


zzSizz ::&: 


::7:: 


:*: 


::»: 


~" 




iT*: ::(:: 


:*: 


:*: 


:4:: 


:*: 


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::?:: 


:S: 


::9: 17:*: 


::(:: 




^7:: 


::&: 


~^ 


IZ 


!«:«:: --*--- 


:*: 


::5:: 


:^: 


::S: 


:«:: 


::?:: 


::e:: 


::»: 18:*: 


::|: 


:2:: :*: :*: 


:*: 


:*: 


::7:: 


:*: 


::»: 


""" 


If:*: ::t:: 


:*: 


:*: 


::*: 


::6:: 


:«: 


::?:: 


::8:: 


::9: 19:*: 


:C:: 


:2:: :3:: :*: 


:*: 


:*: 


::7:: 


::&: 


::*: 


_^ 


20:*: ::|:: 


:*: 


::*: 


::4:: 


:*: 


::e: 


::7i: 


::»: 


::»: 20:*: 


Q 


::2:: :*: :*: 


:*: 


:*: 


::7:: 


:*: 


::»: 


—" 




22:*: ::):: :*: :*: 




::5:: 
:*: 


:*: 
:*: 


::?;: 
::T:: 


:*: 
::»: 


:*: 21 :0:: 
::9: 22*: 


Mz 

:U: 


:2:: :3:: :*: 
:2:: :3:: :*: 


:i: 

:i:: 


zz&zz 
zz&zz 


. ::7:: 
::7:: 


zd&zz 
::&: 


:A: 
::a: 


^ 




23*: ::|:: 


:*: 


:*: 


:at: ::&:: 

■- HAL F-— 


::e:: 


::7^: 


::»: 


::»: 


23 * 

24:*: 
25:*: 


M 
:N 

::t:: 


:2:: :3:: :*: 
z2:z :*: ::»:: 
:2;: :*: -Azz 


:ic: 


::6: 
::&: 


::7:: 
::7:: 


::&: 
::8:: 


::a: 
::a: 


^ 




25*: ::|:: 


:*: 


::»: 




::6:: 


::e: 


::7^: 


::8:: 


::&: 


::&: 


::&: 


::7:: 


::a: 


::&: 


^ 


2t:*: ::|:: 


:*: 


::3:: 


:at: 


::5:: 


::e:: 


::7^: 


::e:: 


::&: 26:*: 


::t:: 


2^z :3:: ::«:: 


::&: 


:*: 


::7:: 


::&: 


::»: 


^_ 


27:*: ::(:: 


:*: 


:*: 


:at: 


::S:: 


::e:: 


::T:: 


::»: 


::»: 27 *: 


::(;: 


:2:: :*: ::4:: 


::&: 


:*: 


::7:: 


::&: 


::9: 


^~ 


21:*: ::):: 


:*: 


:-5:: 


::*: 


::S:: 


:*: 


::T:: 


::»: 


::»: 28*: 


::):: 


:2:: :3:: -Azz 


::&: 


:*: 


::7:: 


::&: 


::9: 


"" 


2»:*: ::|:: 


:*: 


::3:: 


::4:: 


::S:: 


::6:: 


::T:: 


::R: 


::»: 29:*: 


::(:: 


z2r.z :*: ::*: 


::&: 


::&: 


::7:: 


::»: 


::9: 


__ 


30* ::|:: 


:*: 


::S:: 


::*: 


:*: 


::e: 


::T:: 


::»: 


::»: 30:*: 


::(:: 


:*: ::3:: ::*: 


:*: 


::£: 


::7:: 


::&: 


::9: 


"^ 


31:*: ::j:: 


:*: 


::3:: 


:=*: 


:*: 


:«: 


zzT-Z 


::&: 


::»: 31 *: 


::t:: 


:2:: :3:: :^: 


:*: 


:*: 


::7:: 


zzSzz 


::9: 


^^ 


32:*: -■->--- 


:*: 


:*: 


13*:: 


:*: 


:*: 


::?:: 


::8:: 


::»: 32:*: 


::l:: 


2:: :*: :*: 


:*: 


:*: 


::7:: 


::»: 


::a: 


_ 


M:*: ::(:: 


:*: 


:*: 


::*: 


:*: 


::&: 


::T:: 


::&: 


::»: 33:*: 


::t:: 


:2:: :*: :*: 


:*: 


::&: 


::7:: 


::»: 


::9: 


~~ 


34:*: ::|:: 


:*: 


:-3:: 


::*: 


:*: 


::e:: 


::?:: 


::&: 


::ft: 34:*: 


::t:: 


:2:: :3:: :*: 


:i: 


::&: 


::7:: 


::a: 


::a: 


__ 


35:*: ::(:: 


:*: 


::*: 


::*: 


::&: 


::&: 


;:?:: 


::e:: 


::»: 35:*: 


::t:: 


:2:: ziizz .Azz 


::&: 


::&: 


::?:: 


::a; 


::9: 


__ 


3*:*: ::|:: 


:*: 


:*: 


::*: 


::&: 


::&: 


::7i: 


::&: 


::ft: 3*:*: 


::|:: 


:2:: :*: ::«:: 


::5:: 


::&: 


::^: 


::&: 


::9: 


^~ 


: 37*: ::|:: 


:*: 


::3:: 


::*: 


::5:: 


:*: 


::7:: 


::&: 


::9: 37:*: 


::(:: 


:*: :*: :*: 


::5:: 


:*: 


::7t: 


::&: 


::»- 


^~ 


5 3«:*: ::«:: 


:*: 


::3:: 


::*: 


::S: 


:«: 


::T:: 


::»: 


::»: 38:*: 


::):; 


:*: :3:: :*: 


::&: 


:*: 


::7:: 


::a: 


::»: 


~~ 


- 3»:*: ::|:: 


:*: 


::3:: 


:at:: 


::*: 


::e:: 


::7i: 


::»: 


::»: 39:*: 


::(:: 


::2:: :*: :*: 


::S: 


::e:: 


:7:: 


::a: 


::9: 




40*: ::):: 


:*: 


r:S:r 


::*: 


:*: 


::&: 


::?:: 


::&: 


::» 


::):: 


::2:: :3:: ::*: 


::&: 


::&: 


::7:: 


::a: 


::9: 




< 


:S^r t 


:*: 

3 


::3:: 
4 


::*: 
5 


::&: 

6 


::&: 

7 


::7:: 




::»: 

9 


^i1 




55 


::!:: 

Ui 


::£: 

13 


::i: :*: J 

74 J5 -^ 


k# 


::6: 
77 


::7:: 

'.8 


::a: 
79 


fo 





SPECIAL INSTRUCTIONS 

The GSS consists of an original and a carbon which are attached at the 
side of the set. Since only the original sheet can be processed by the op- 
scan reader, carbons should be retained by the investigator for his files and 
NEVER be sent to the Biometric Laboratory for processing. Care should be ex- 
ercised in detaching the carbon so that the original copy is not mutilated. 

When the GSS is used in conjunction with the packets, the rater should 
follow the printed instructions carefully. 

1. Encode ALL INFORMATION requested in the identification (ID) 
block for EACH GSS used. 

a. Patient Initials 

b. patient Number 

c. Rater Number 

d. Period Number and Time Unit 

e. Sheet Number 

2. Insert a new GSS when instructed to do so and again complete 
the ID block. 

3. Use the Sheet Number specified in the packet instructions. Sheet 
Number - unlike Period Number - remains constant; i.e., it is 
always the same for a given scale or set of scales. Even when 
the investigator plans to use only a portion of the scales within 
a packet, he must adhere to the specified Sheet Numbers. 

k. Follow the instructions for coding items carefully. Responses 
must be coded in precise locations or they will be rejected com- 
pletely or decoded incorrectly in subsequent processing. Raters 
should not become confused by the- numbers printed over each re- 
sponse position. Raters familiar with the NOSIE and its real 
scale points - l,2,3,^t5 - may be disturbed by the GSS response 
position numbers - 5,6,7f8,9. Through programming, the 5-9 
positions will be translated 1 - 5 in all output. The to 9 
labeling of GSS response positions is simply for rater orienta- 
tion. The "number" is not "read" by the opscan reader - just 
the position. 

5. If you wish to change a response, erase the incorrect response 
comp 1 e te 1 y . 

6. Finally, DO NOT FOLD, SPINDLE, STAPLE OR MUTILATE the GSS in any 
fashion. If, despite these prohibitions, you still feel an un- 
controllable urge to use paper clips, PLEASE affix them to the 
BOTTOM EDGE of the GSS. 



56 



TYPES OF ENCODING 

It might have been much less confusing for the rater if a single method 
of encoding a response had been adopted. To do this, however, the rater 
would have been faced with many more sheets of paper to complete - each with 
an identification block to fill. To avoid this, a variety of encoding tech- 
niques have been used to "paci<" data on the fewest sheets possible. The type 
chosen in any given situation has been based primarily on specific space 
requirements. The response positions required to encode an item can be assigned 
in several ways. 

Examples: 

1. One item along a single row (horizontal). This is the most common 
type of encoding. Scale points may vary from 2 to 10. 



DRUG 

Analgesic-narcotic 



YES 



CLASSROOM BEHAVIOR 

Fidgeting 



Prttty Very 
Much Much 



TENSION 



Physical and motor manifestations of tension "nervous- 
ness," and heightened activation level. Tension should 
be rated solely on the basis of physical signs and motor 
behavior and not on the basis of subjective experiences 
of tension reported by the patient 











MODES- 


EX- 


NOT 


VERY 


MILD 


MODER' 


ATEIY 


SEVERE TREMEIY 


PKESENT 


MILD 




ATE 


SEVERE 


SEVERE 



In a single column (vertical) 
are possible. 



For items where multiple responses 



13. SPECIAL SYMPTOMS 






Check presence of a symptom by mar 


king "0" on the proper row. 




If no special symptoms present mark 


'0" on row 21 . 




A. 


No symptoms 


21 


B. 


Speech disturbance 


22 


C. 


Specific learning disturbance . 


23 


D. 


Tic 


24 
25 


E. 


Other psychomotor disorder . 


F. 


Disorder of sleep 


26 


G. 


Feeding disturbance 


27 


H. 


Enuresis 


28 


1. 


Encopresis 


29 


J. 


Cephalalgia 


30 



22:*: 
24:*: 

25 a^ 

26:*: 

28:*: 
29:*: 
30*: 



57 



3. Two or more items in a single row - Used primarily on the demographic 
instruments where space is at a premium. 



Subject's Race is: 



Code both b and c on Row 4 

= Caucasoid 

1 = Negroid 

2 = Mongoloid 

3 = Other 



Has Subject's Residence Been: 

5 = Primarily urban 

6 = Primarily suburban 

7 = Primarily rural 



h. Several items having a common code and requiring several rows and columns, 



Has either parent or present surrogate been: 

Mark one response for = Neither parent 2 = Father 

each item using this code: ^ ^ ^^^^^^ 3 ^ g^,^ ^^^^^^^ 

Out of home (3 months or longer) due to physical or mental illness . 
Separated (3 months or longer) due to marital difficulties . . . . 

Cruel or abusive (to patient, spouse, siblings, etc.) 

Not a steady worker or competent housewife 





-&z 


>4b 


Hi: 


==»: 


"* 


22 


zftz 


z-izz 


•*• 


"»: 


;:* 


23 


•*• 


zzizz 


r:2:= 


--3:z 


--4: 


24 


:;&= 


"t; 


-=2:= 


-^ 


"*: 


25 













A single item requiring several rows - Used primarily for the 
encoding of numeric values of more than one digit. 



a^ r=2:i :3:: 

;rh: ::2:: :J:: 

III:: z-Szz iri: 

Sai -jaiz :d:: 



:Ar zzSr- -^-_ --:J-- ;;&! "ft: 

MAXIMUM 
lA: TOTAL :;5c: -^- --r_-_ "B: iifti 

DAILY 
:A: DOSE IN ::&; iife: =i7i: :r&: irft: 

MILUGRAMS 
a^m :iQ: iOBz IQ&O 



58 



ENCODING 

NONSTANDARD 

DATA 



The independent use of the GSS follows the procedures established for the now 
obsolete General Purpose Scale, Providing a larger data matrix, the GSS may be 
used for the encoding of a wide variety of numeric data in a format corresponding 
to the standard BLIPS identification and data fields. It enables investigators 
to submit non-standard assessment material in a format which will permit rapid 
processing and standard - as well as non-standard - analyses. 

UTILIZATION - Dependent upon type of data 

DATA FIELD MATRIX - The entire GSS matrix, or any part of it, may be used 
for non-standard data. 

LOCATING DATA ON THE GSS MATRIX 

A non-standard data set can be located within any portion of the GSS matrix. 
The choice of location depends on the size of the data set; i.e., the number of 
items, the number of scale points, the number of individual scales to be encoded, 
convenience in encoding and/or transcribing, etc. Generally, the investigator 
should try to "pack" data by encoding as much of his data set on one GSS as 
possible. Remember that more than one non-standard assessment instrument can 
be encoded on a single GSS provided that the data pertains to a single subject 
and a single rating period. 

Figures demonstrates some of the locations which might be used when encod- 
ing two non-standard scales. Scale A is a 10-item scale with 10 scale points; B 
is a scale with 10 items and 5 scale points. Note that only a few of the possible 
locations are illustrated. Also be aware that the numbers printed at each of the 
response positions are for the convenience of the rater and do not necessarily have 
to correspond to the actual scale points of given instrument. For example, Scale B!s 
actual scale points are 0, 1,2, 3. ^', but, the two extreme right locations of B 
utilize the response positions 5, 6, 6, 7, 9. This need not concern the investiga- 
tor since the response positions will be "normalized"; i.e., changed to actual scale 
points, through computer programming. 

ITEM FORMAT 

Item format can vary according to the needs of the investigator EXCEPT THAT 
ONLY ROW CODING CAN BE EMPLOYED. The investigator cannot employ column-wise coding - 
either totally or partially - since this would require extensive and individualized 
programming. Items can have different size fields; i.e., number of rows, or 
different scale points and both can be interspersed. All data within an item, 
however, must be uniform. If an item varies from 1 to 125, all data must be encoded 
in 3 rows, e.g., 001, 014, 122, NOT blank blank 1, blank 14, etc. 

SPECIAL INSTRUCTIONS 

1. Data encoded on a single GSS MUST PERTAIN to a SINGLE subject. Do not 
encode data from different subjects on the same sheet. 



60 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

ECDEU GENERAL SCORING SHEET (SO-GSS) 



PATIENT INITIALS 



:t:: 



HRST 
INITIAL 



NUMBER MALES 001 TO 499 

:0:: ::(:: -Zzz zzizz :*r 

F 
:©:: ::h: :2i: =3:: :*: 






SECOND 
INITIAL 



FIGURE 3 

tATER 

SAMPLE LOCATIONS FOR NON-STANDARD DATA "^ 



NUMBER FEMALES 500 TO 998 












SHEET 

NO. 



:-^: 



::7i: 



:3:: 

Days 



iT 

13: 
14: 
IS: 
16: 
17: 
1|: 
1»: 
20: 
21: 
22: 
23: 
24: 
25: 
26: 
27: 
21: 
2»: 
30 

31 = 

w 

n 

Kz 

16: 

17: 

»= 

10= 



:=(:: 
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*: :* 

*: =* 

*: :* 

*: :--» 






Row 



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B 



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31 :0:: 

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35:0:: 
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31 :0:: 
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61 



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15 



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2. Similarly, do not encode data from different assessment periods on 
the same GSS . 

3. Data pertaining to groups of subjects, e.g., summated data, means 
scores, may be encoded on the GSS. If you wish to compare these data with 
another group/s, the rules for the single subjects MUST be observed - only 
one group on one GSS: only one assessment period of the group on one GSS. 

k. When encoding the identification block, follow the instructions 
exactly as you would when using a standard ECDEU assessment instrument. 

5. SHEET NUMBERS from 80 to 99 MUST be used when encoding non-standard 
data. The Sheet Number - once assigned to a data set - must be used consis- 
tently throughout a given study. 

6. Should the data set from a single assessment period for a given sub- 
ject (group) be greater than the matrix of a single GSS, use another GSS and 
differentiate it from the first by assigning a different SHEET number to it; 
e.g., 80 for the first GSS; 81 for the second. 

7. When an item is missing at a given rating period, leave ENTIRE field 
blank; i.e., use a field of blanks as a missing data code. 

8. When a value for an item is recorded, there should be NO BLANKS with- 
in the field; e.g., encode 021, NOT blank 21. 

9. It is not necessary to encode decimal points; but the placement of 
the decimal MUST be consistent within a SINGLE field. For example, the rater 
wishes to encode these four scores - 1.65, 10.41, 106.8, .37. They should be 
encoded in a field large enough to encompass all of them. For these k scores, 
the necessary field is xxx.xx; and the scores are coded as follows: 

00165 
01041 
10680 
00037 

Note again that the decimal point is omitted in this example. It will appear 

in output when the proper format statement is inserted into programs; e.g., F6.2. 

10. I terns need not necessarily be encoded continuously, i.e., space may be 
left between items. The rater must, however, clearly indicate such "gaps". 

11. Scale points may differ from item to item. I terns may be continuous or 
discontinuous. The scale points may be given any name or designations. Examples 
of different scale possibilities are: 



62 



a) 


Not present 


Very mi 


Id 


Mi Id 


Moderate 


b) 


Never 


Rarely 




Occas iona 1 ly 




c) 


None 


Once 




Twice 




d) 


0-.9 


1.0-1.9 




2.0-2.9 


3.0-3.9 


e) 


Present 


Absent 








f) 


True 


False 








g) 


Yes 


No 








h) 


+ 


- 








i) 


A 


A + B 




A + B + C 




j) 


++ 


+ - 




- + 


— 



12. The investigator MUST send a copy of each scale or data set encoded on 
the GSS . In all instances, the investigator must identify clearly the positions 
in which he has encoded each item and, if it is not obvious from the actual scale, 
the scale points and/or range of scores of each item. For example: 

Rows Name of Item 

1-3 Variable 1 050 to 500 

k-5 Variable 2 01 to 20 

6 Variable 3 to 9 

7-8 Variable k 10.00 to 99-99 

9 Variable 5 True = 0; False = 1 

13. More often than not, data will be transcribed from the original forms 
to GSS. The investigator may, however, wish to use GSS for direct encoding of 
observations. This may be accomplished by means of a template; e.g., a fold of 
paper covering 1/2 of a side upon which the items to be rated are typed so that 
they are aligned with response positions on the other half of GSS. (Figured). 
This home-made template, like the rater packets, can thus be reused and the prob- 
lem of transcribing data eliminated. 

14. It is ESSENTIAL that the location of all non-standard data be described 
in Item 11 of Data Shipment (071-DS). Without this information, BLIPS processing 
cannot be accomplished. 



63 



FIGURE k 
TEMPLATES FOR ENCODING NON-STANDARD DATA 




Sk 



THE 
DEMOGRAPHIC 

PACKET 



The Demographic Packet contains three instruments - two for pediatric and one 
for adult populations. The demographic scales are: 

Chi Idren Adul t 

Children's Persona] Data Inventory Adult Personal Data Inventory 

Children's Symptom History 

Figures 5 to 7 present data matrices for each of the scales. These matrices 

indicate the encoding location of each scale item as well as the GSS sheet number 

upon which it appears. These locations are FIXED and MAY NOT BE ALTERED. To do 
so will render the data non-processable. 

Manipulating the sections of the packet and inserting the General Scoring 
Sheets may require some practice. The instructions on the back of the front cover 
of the packet should, however, provide the information needed to develop the 
necessary dexterity. It is important to state again, however, that the rater 
ALWAYS USE THE ASSIGNED SHEET NUMBERS for the scales - EACH AND EVERY TIME he 
uses them. Period Number changes, but Sheet Number never changes for a particular 
instrument . 

Raters are cautioned that encoding for the Children's Personal Data Inventory 
(CPDI) is rather complicated. Since the CPDI acquires a large amount of informa- 
tion, "packing" of the data was necessary in order to encode everything on one GSS 
sheet. This was accomplished by formatting more than one item on a single row, 
thereby . requi ri ng the rater to make multiple marks in specific response positions. 
The rater must be particularly alert to follow the instructions carefully. 

The Demographic Packet contains items which require varying degrees of 
professional "expertise" - from a clerical recording of a wel 1 -documented event 
to subtle judgments of development, motivation and veracity. A background in 
psychiatric social work would seem ideal for a rater of this packet, although such 
a background is not a requirement. What is paramount is the rater's ingenuity and 
persistence in acquiring complete and reliable information. The manner in which 
demographic 'data should be collected is succintly described by the following 
excerpt from "Soothe, H. H.; and Schooler, N. R.; Instruction Manual for Brief 
Social History for Studies in Schizophrenia, Psychopharmacology Bulletin, 8, 1, 
23-24, January, 1972. 

"Ideally the interviewer is so familiar with the content of the instrument 
that he can lead the discussion to each item in whatever way is most 
comfortable to the person interviewed, rather than by a rigid adherence 
to the word order of items in the form. He may not even want to have the 
form in sight, but may want to rely on his notes to complete the recording 
after the interview is finished. In any event it is good practice to check 
through the form before the informant leaves, to make sure that no items 
have been overlooked. 



66 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 















ECDEU GENERAL SCORING SHEET (50-GSS) 
















— 


PATIENT INITIALS 
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FIRST 

::R:: 
INITIAL 

::Z: 




NUMBER 

FIGURE 5 
MATRIX FOR 
CHILDREN'S PERSON) 
DATA INVENTORY 

::it: ::»: ::»: :*: 
::3!:: ::&: ::»: ::():: 


MALES 001 

-> -2:: 

a:: 


TO 499 
r^:: ::«:: 
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NUMBER 

::&: 
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FEMALES 500 TO 998 

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79 


201 





DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

ECDEU GENERAL SCORING SHEET (50-GSS] 



PATIENT INITIALS 

z-Jcz -.-.&-. "C: 

::t: -Mz 

-.z\tz .Mz 



iiK: 



FIRST 
INITIAL 



-K: "Ji: -*i 



NUMBER MALES 001 TO 499 



NUMBER FEMALES 500 TO 998 



=:|fc= 






rie= =:£>= ::£:- 

--*»: ;*t; ::Or 



FIGURE 6 

MATRIX FOR 

CHILDREN'S SYMPTOM HISTORY 



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12 13 * 













DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

ECDEU GENERAL SCORING SHEET (50-GSS) 



PATIENT INITIALS 
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The number and length of interviews needed to complete the form depend on 
a variety of factors, such as the personalities of the informants, their 
availability for interviews, the style of the interviewer, etc. Whenever 
possible, the interviewer should obtain a sufficient number of informants 
to cover the included items in the patient's life span adequately. For a 
married adult this ideally means a minimum of two people, a spouse and a 
parent. Available hospital records as well as additional knowledgeable 
informants are desirable. In fact, in dealing with schizophrenic patients 
who may be disconnected from any familial setting, an informant such as the 
landlady of the rooming-house, a neighbor, or such significant other person 
may be preferable as a source of reliable information about the patient's 
present circumstances to a relative who has had no real and recent contact 
with the patient. In each case, the objective is to acquire pertinent, 
reliable information, whatever the source. 

Some of the information requested concerns straightforward, factual matters, 
such as those specified by the first few items in the form. On the other 
hand, a much larger body of material is not strictly "factual" but is subject 
to interpretation, and the interviewer must often probe for additional 
illuminating information. For example, the discussion about the patient's 
past may lead the interviewer to suspect that the patient had been psych iatr ical ly 
sick before, despite the informant's earlier statement that the present illness 
was the first. By a skillful question, however, the interviewer may elicit 
information that confirms or eliminates his hunch. 

Every interviewer has to contend with the empirical fact that there is no "one 
truth" about a mental illness. To reconcile fragments of historical data and 
to arrive at an interpretation which most closely resembles the "objective truth" 
is one of the interviewer's most challenging tasks. It requires knowledge, 
ingenuity, skill and time. There are circumstances, however, which make it 
impossible to obtain reliable information. In these rare instances, the 
interviewer is asked to mark "not ascertained" rather than to provide answers 
which are mainly guesses." 

ERRATA - Raters should make the following corrections in their Demographic Packets: 

1. Children's Personal Data Inventory (O^S-CPDl) 

Page R-2 - Item 6b. Should read "Mark both 'b and c on Row kO" , NOT "Row 20". 

2. Children's Symptom History (044-CSH) 

Page L-4 - Item 2b. The word "stomach-aches" is misspelled. 

Page L-5 - I tern 7. Insert the letter "i" to the last question of 

this item "How do you deal with them?" 

Page L-5, Item 11a, Response No. 1 "Not at all" should read "Just a little". 

3. Adult Personal Data Inventory (045-APDl) 

a) Page L-9 - Item 8a. Insert "15" for Row Number. 

b) page L-9 - Item 8b. Text should read "Code diagnosis from those 
listed in ECDEU Manual using 4 digits for DSM 11 (Rows 16 - 19) 
or k digits for WHO (Rows 16 - 19)". 

c) Page R-3 - Item 12e. The Row Numbers for this item should read 
"7-9", NOT "5-9". 



70 



043 CPDI 
CHILDRENS 
PERSONAL DATA 
INVENTORY 



CHILDREN'S PERSONAL DATA INVENTORY 



INSTRUCTIONS: Insert General Scoring Sheet and Code 10 for Sheet Number. Code 000 for PERIOD. 

Raters are cautioned to be particularly careful in coding their responses since several items 
have sub parts which must be coded on the same row. Follow the coding instructions carefully. 
Complete once for each subject. Please answer all items. 

If information is not ascertained, mark a field of "9"s, e.g., 9, 99, 999 etc. 



Mark on right half of scoring sheet on row specified 



IDENTIFICATION (Note: Sex of subject is coded within Patient Number) 



Subject's Age: 


Marl^ time units - 1 = mo 


nths; 2 = years 




and give numeric (2 digits 


) on Rows 2 ■ 3 


Subject's Race 


s: Code both b and c 

= Caucasoid 

1 ■= Negroid 

2 = Mongoloid 

3 = Other 


on Row 4 



Has Subject's Residence Been: 

5= Primarily urban 

6 ^ Primarily suburban 

7 - Primarily rural 



Subject is the enter number (2 digits) child . 
of enter number (2 digits) ch i Id ren , . 
(Only child is coded "the 01 child of 01 childn 



Is Subject One of Twins, Triplets, etc.? 



0= No 

1 = Yes, homozygous 

2 = Yes, heterozygous 

3 = Yes, unknown zygosity 



The Subject's Present Fa 

(Mark all applicable o 

= Natural mother 

1 = Natural father 

2 = Step-parent 

3 = Adoptive parent/s 

4 = Paid foster parents 



lily Constellation Co 
' Row 10) 



sof: 



5 = Adult relative/s Igrandparen 



7 = Subject not living with family; 

non-psychiatric institution 

8 = Subject not living with family, 

psychiatric institution/unit 



PARENTS' DEfWOGRAPHY 

Is either NATURAL parent: Codeboth a and b on Row 11 
Dead? - No 2 = Yes, father 

1 - Yes, mother 3 = Yes, both 



5= No 

6 = Yes, mothe 



7 = Yes, father 
8= Yes, both 



Mother or mother surrogate presently in the home 
(2 digits) 00 = Not applicable 



Father or father surrogate presently in the hon 
(2 digits) 00 = Not applicable .... 



Continue marking on right half of scoring sheet on row specified 



PARENTS' EDUCATION 

Mother or Present Surrogate Code highest level attained for MOTHER 

Father or Present Surrogate Code highest level attained for FA THER 



0= Not applicable 

1 = Graduate professional training 

2 = College graduate 

3 = Some college or technical school 

4 = High school graduate 



5 = Some high school (10-11) 

6 = Junior high school (7,8,9) 

7 = Less than 7 years of school 
9 ^" Not ascertained 



PARENTS' OCCUPATION 

Mother's or Female Surrogate's Present Occupational Status is: 

Father or Male Surrogate's Present Occupational Status is: 

Use this code for g and h: = Not applicable 

1 = Full time gainful employment 

2 = Part time gainful employment 
3= Unemployed 

4 = Dependent spouse or student 

5 = Recipient of public or private 



Mother's or Female Surrogate's Highest Occupational Attainment is: 
Fathers or Mate Surrogate's Highest Occupational Attainment is: 

Use this code for i and j. See Manual for detailed list of occupations. 

1 = Higher executive, proprietor of large concern, major professional 

2 = Business manager of large concern, proprietor of medium-sized 

business, lesser professional 

3 = Administrative personnel, owner of small independent business, 

minor professional 

4 ^ Clerical or sales worker, Technician, ov/ner of little business 

5 = Skilled manual employee 

6 = Machine operator, semi-skilled employee 

7 - Unskilled employee 

8 = Never worked in paid employment 

9 = Not ascertained 



Has either parent or present surrogate been: 
Mark one response for = Neither parent 

each item using this code: i = m he- 

Out of home (3 months or longer) due to physical c 
Separated (3 months or longer) due to marital diff i 
Cruel or abusive (to patient, spouse, siblings, etc.) 
Not a steady worker or competent houiev/rfe 



2 = Father 

3 = Both parents 
r mental illness . 
ulties . . . . 



ROv7 



72 



CHILDREN'S PERSONAL DATA INVENTORY 



Continue marking on right half of scoring sheet on row specified 



FAMILY HISTORY OF PSYCHIATRIC ILLNESS 



Has there been a history of psychiatric illness in family member/s? 



Mark aft applicable = None of the members 

for each item using , _ m . ■ „ .u 

.. . , ^ 1 = Natural mother 

this code: 

2 = Natural father 

3 = Siblings 



Non-psychotic psychiatric disturbance 
Manic-depressive disturbance 
Other major affective disturbance . 

Schizophrenia 

Other psychotic disturbance 
Hospitalized for any psychiatric illness 

Mental deficiency 

Excessive use of alcohol .... 

Excessive use of drugs 

Imprisonment 



5 = Present mother 

surrogate 

6 = Present father 

surrogate 



SUBJECT'S HISTORY OF PSYCHIATRIC ILLNESS 



Code both a and b on Row 36 



1 = Not in any type of psychiatric treatment 

2 = In psychiatric treatment as an outpatient 

3 = In partial hospitalization, e.g., day or night 

hospital, halfway house, etc. 

4 = Hospitalized (24 hour) 



Prior to this episode^ 5 = Never had any type of psychiatric treatment 

' ' 6 = Received psychiatric outpatient treatment 

(Mark all applicable) ., „ -j^ . ^- ^-ii. -i- 

^^ ' 1 = Received treatment m partial hospitalization 

setting 

8 = Received treatment in 24-hour hospital 



"Psychiatric treatment" should be interpreted broadly to include all forms 
of therapy whose basic function is the alleviation of emotional, behavioral 
or mental disturbance. "Partial hospitalization" and 24-hour hospitaliza- 
tion include all forms of treatment environments in which the subject 
spends a substantial part of the day or, in the latter case, the full day. 



Age (years) when first received treatment for psychiatric illness (2 digits) 

00 = Never treated 



Estimate total duration of ALL outpatient psychiatric treatment - 
exclusive of present episode 



Give time units ( = days; 1 = weeks; 2 = months; 3 = 
duration (2 digits) 

EXAMPLE: Subject's total treatment amounts to 10 months. 
Code 210. 000 = No outpatient treatment 



/\4ark on left half of scoring sheet on row specified 



SUBJECTS HISTORY OF PSYCHIA TRIC ILLNESS - Continued 

Estimate total duration of ALL partial hospitalization - exclusive < 
present episode 

Give time units ( = days; 1 = weeks; 2 = months; 3 = years) 
and duration (2 digits) 000 = No partial hospitalization 



Estimate total duration of ALL hospitalizations (24 hour) exclusive 
of present episode 

Give time units ( = days; 1 = weeks; 2 = months; 3= years) 
and duration (2 digits) 

EXAMPLE: Subject's total hospitalization amounts to 4 years 
Code 304 000 = No hospitalizations 



Duration of present episode 

Mark whether coded in = days 1 = weeks 2 = months 3 = years 
and give duration (2 digits) 000 = Not applicable 



SUBJECT'S DEVELOPMENTAL HISTORY 

Code a, b and c on Row 10 

Pregnancy and Neonatal Course Were: 

= Normal 

1 = Suspected abnormalities 

2 = Definite abnormalities 

3 = Not ascertained 



Were there infant fei 

4 = YES 
5= NO 
6 = Not ascertained 



ding problems? 



Colic? 

7 = YES 
8= NO 
9 = Not ascertained 



For each of the following items d through V., record mor 
2 digits and judge rate of development on next row: 

Age (months) first ate solids - not pureed or strained food 

Considered = Slow; 1 = Normal 2 = Fast 



Age 


(months) first fed self with a 


spoon 




Considered = Slow 


1 = Normal, 2= Fast 


Age 


(months) sat unsupported 






Considered = Slow 


1 = Normal; 2= Fast 


Age 


(months) first walked by self without holding on 




Considered = Slow 


1 = Normal: 2= Fast 



Age (months) first words other than Mama and Dadda 

Considered = Slow; 1 = Normal, 2 = Fast 



73 



CHILDREN'S PERSONAL DATA INVENTORY 



ROW 
NO. 



Continue marking on left half of scoring sheet on row specified 



26-27 
28 



Age (months) of speaking 3-word sentences 

Considered = Slow; 1 = Normal; 2 = Fast 



29-30 
31 



32-33 
34 



j- 


Age 


(months) trained bladder during day 










Considered = Slow; 1 = Nornnal, 


2 = 


Fast 


k. 


Age 


(months) trained bowels 










Considered = Slow; 1 = Normal, 


2 = 


Fast 


1. 


Age 


(year) began menstruating (2 digits) 

00 = Not applicable 







Mark m. n and o all on Row 37 
Masturbates? 

0= NO 1 = YES 



2 = Not ascertained 



n. Does he/she dress in clothes or play with toys of opposite sex? 

3 = NO 4 = YES 5 = Not ascertained 

o. Does he/she express a desire to grow up to be a member of 

opposite sex? 

6 = NO 7 = YES 9 = Not ascertained 



SUBJECT'S SCHOOL HISTORY 

Current Grade Placement (2 digits) 
Number grades 01 — 12 

20 = Preschool 23 = Special or Ungraded 

21 = Nursery 24 = Not in school 

22 = Kindergarten 



Mark both b and c on Row 20 
Child's School History is Best Characterized by: 



= Not applicable 

1 = No significant problems 



Minor problems or 
occasional difficulties 



3 = Major problems seen 
only in current year 



■ Major problems throughout 
school history with periods 
of quiescence; "up and down' 

Major problems almost con- 
tinually since entrance into 
school 



In General Academic Achievement Has Been: 

6 = Above average 

7 = Average 

8 = Below average 



ATTITUDE TOWARD PRESENT TREATMENT 

At pretreatment, the attitudes of the child and his parent/s were: 

Make 2 marks (one for child, one for family) both on Row 41 



= Child positive 

1 = Child Indifferent 

2 = Child ambivalent 

3 = Child negative 

4 = Child's attitude 

not ascertained 



5 = Family positive 

6 = Family indifferent 

7 = Family ambivalent 

8 = Family negative 

9 = Family attitude 

not ascertained 



Ih 



The Children's Personal Data Inventory (CPDl) is a 55-item scale formatted 
for use with the General Scoring Sheet. Its purpose is to gather social and 
demographic data concerning the child and his family. The content of the CPDl 
was developed by members of the Pediatric Psychopharmacology Workshop. Wherever 
possible, items were made compatible with similar items contained in the Adult 
Personal Data Inventory (045-APDl). 

APPLICABILITY - Children to age 15. 

UTILIZATION - Once per subject 

CARD FORMAT - ITEMS 

CARD 01 = (19x, 211, 12, 211, 222, II, 13, 211, 212, 1011, 1012, 211, 12) 

Item Column Item Column 



Sex* 


20 


la 


21 - 23 


b 


Ik 


c 


25 


d 


26 - 29 


e 


30 


f 


31 - 33 


2a 


3^ 


b 


35 


c 


36 - 37 


d 


38 - 39 


e 


ho 


f 


k\ 


9 


kl 


h 


hi 


i 


kk 


J 


kS 



2k 


46 


1 


47 


m 


48 


n 


49 


3a 


50 - 51 


b 


52 - 53 


c 


54 - 55 


d 


56 - 57 


e 


58 - 59 


f 


60 - 61 


g 


62 - 63 


h 


64 - 65 


i 


66 - 67 


j 


68 - 69 


ka 


70 


b 


71 


c 


72 - 73 



* = This item is added to the card output. 

CARD 02 = (19x, 4l3, 311, 813, 12, 311, 12, 211, 12, 211, 12) 



Item 


Column 


4d 


20 - 22 


e 


23 - 25 


f 


26 - 28 


g 


29 - 31 


5a 


32 


b 


33 


c 


34 


d 


35 - 37 


e 


38 - 40 


f 


41 - 43 


g 


44 - 46 


h 


47 - 49 


i 


50 - 52 



tem 


Column 


5j 


53 - 55 


k 


56 - 58 


1 


59 - 60 


m 


61 


n 


62 


o 


63 


6a 


64 - 65 


b 


66 


c 


67 


7 


68 - 69 



Soc.Class M** 70 
'" •" F*>> 71 
Developmental 
Index-'nv 72-73 

**= These items are calculated and punched on the card via programming, 



75 



SPECIAL INSTRUCTIONS 

All of the items on the CPDI can be encoded on one General Scoring Sheet. 
As a result of this "packing of data", raters are cautioned that the encoding 
procedures are intricate and that close attention should be paid to the 
instructions printed on the scale and given below. 

I tern la. Age - Three marks are required for the encoding of this item: 

a designation of the time unit - month or year - in Row 1 
and the numeric for age in Rows 2 and 3. 

Examples: 

Subject is 6 years old. Encode 206. 

l:.ft= ~t: .^ ..*: :=*: ---&- ==fc: --r.- "ft: IfS:: .J I me Unit 

2>«> ::t: ---t-. z-.t-. -.-.4:z ----&-- ~fc: "3t: "ft: ::*:-• 

3::fti ---t-- ----t- ::»- ::*: --&- "^ "S: ::ft: ^^i: -* N Ume ra 1 

Subject is 72 months old. Encode 172. 

1 ::ft: -fc ~±: ::*: ::*: ::S:: ::fc: ::7:: ::8:: ::»::— J J me Unit 

2 ::ft: --t: ::4: ::*: ::*: ::5:: ::fc: avhi ::8:: :*: -1 

3::ft: -3. -ft. .=3:: =:*: ::&: ::fc: .r.- :*: :*: J Numeral 



Age encoded in years should be given to the nearest whole 
year; age in months to the nearest whole month. 

Item lb and Ic. Race and Residence - Both of these items are encoded on Row k. 
Subjects of mixed racial heritage should be encoded "Other". 

Example: Subject is negroid and her residence is 
primarily urban. Encode 1 and 5. 



A----0:-- -*• ::*: :=*= ==*- 



::fc: -.-.Jzz ::ft: ::*: 



Where there is difficulty in deciding primacy of residence, 
encode the most recent residence. 

Example: For approximately one-half of his life, a boy lived 

in an urban area. Since then, however, his residence 
has been suburban. Encode "Primarily suburban". 

4::a:: ::t: ::2:: ::3:: ::*: =:S:: mtm ::?:: :*: :*: 



76 



Item Id. Sibling sequence - Consider only maternal natural siblings. Encode 
the child's position in the sibling sequence in Rows 5-6 and the 
total number of siblings in Rows 7-8. 

Example: The child is the fourth of six children. Do not leave 
any blank rows and encode as follows: 



5-*. ::*: "i= -ztL- :=*= "i= "fr: =;*: ==ft 

6;=©:= rrt: :r2:z -J:; >^. -.&- r^fcz =:Z:i zzBi 



"Sb- 



""H Chi Id's pos it ion 

8;:0:= zzy.z ==2:= rrjrr 1:14:1 -&: >^ i^Jt: "8:= i:9:=J TOtB 1 Siblings 



7-ft» "li: "i: "J:: 1:4:: .z&: zztt: -zfzz =z8:; ::!: . 



I tern If. Present family constellation - The rater should mark all 

individuals living together as a family at the start of the 
study. All responses are encoded on Row 10. 

Examples: 

a. The child lives with his mother and stepfather. There 
are two natural siblings and one step-sibling living in 

the home along with a maiden aunt. Encode 0-2-5-6 on Row 10. 

10-^ .--i.-- -*. ;:3:: -4ZZ -*. -^ -r.- ,,6:: ==9:: 

Mother Stepfather Aunt Siblings 

b. The chi Id is a state ward. His family is unknown and he is 
currently residing at the state orphanage. Encode as follows: 

1 =*: --i--- --^-- --^-- :^: -^-- -^-- «l~ ==8== =*: 

t 

1 nst i tut ion 

To conserve space on card decks, a coding system has been 
developed which reduces the multiple entries of this item to a 
2-digit field. The codes are given in Table h. These codes 
should NOT be used by raters when recording (encoding) data. 
They are generated as output. 

Example: 

Output Code 33 = Response positions 0, 1 and 6; I.e., the rater 
coded mother, father and siblings as constituting the present 
family constellation. 



77 



TABLE k 
CODES FOR CPDI ITEM If - PRESENT FAMILY CONSTELLATION 



4-> — Q. 



Card 






















Response 


Code 





1 


2 


3 


k 


5 


6 


7 


8 


9 


Pos it ions 


00 




















X 


9 


0! 














X 








6 


02 












X 










5 


03 












X 


X 








5.6 


Ok 










X 












k 


05 










X 




X 








k.e 


06 










X 


X 










k,5 


07 










X 


X 


X 








4,5,6 


08 








X 














3 


09 








X 






X 








3.6 


10 








X 




X 










3.5 


11 








X 




X 


X 








3,5.6 


12 






X 
















2 


13 






X 








X 








2.6 


14 






X 






X 










2,5 


15 






X 






X 


X 








2.5,6 


16 




X 


















1 


17 




X 










X 








1,6 


18 




X 








X 










1.5 


19 




X 








X 


X 








1,5,6 


20 




X 


X 
















1 ,2 


21 




X 


X 








X 








1.2.6 


22 




X 


X 






X 










1,2,5 


23 




X 


X 






X 


X 








1.2,5.6 


2k 


X 























25 


X 












X 








0.6 


26 


X 










X 










0,5 


27 


X 










X 


X 








0.5.6 


28 


X 




X 
















0.2 


29 


X 




X 








X 








0,2,6 


30 


X 




X 






X 










0,2,5 


31 


X 




X 






X 


X 








0.2,5,6 


32 


X 


X 


















0,1 


33 


X 


X 










X 








0,1,6 


3k 


X 


X 








X 










0,1.5 


35 


X 


X 








X 


X 








0,1,5,6 


36 
















X 






7 


37 


















X 




8 


88 


Ml 


egal 


or 1 


mprc 


>babl 


e F£ 


imil^ 


f Cor 


iste 


lat 


on 



78 



Item 2. Parents' Demography - Items 2a and 2b refer to NATURAL PARENTS. 
Subsequent items (2c through 2n) refer to natural parents or 
their surrogates - whichever are PRESENTLY part of the family 
constellation, i.e., at the beginning of the study. 

Item 2a and 2b. These items are both encoded on Row 11. 

Example: Neither of the child's natural parents are dead or 
divorced. Encode - 5 on Row 11. 

1 1 ■•■ ::»:: =*- :*; ::4:: »*■ ;;t; ::*: "ft: ::St: 

Dead Divorced 

When information about the natural parents is not available, 
response position "k" may be used to indicate lack of informa- 
tion about death; position "9" to indicate lacl< of information 
about divorce. 

Items 2g through 2j . Parents' occupational status - The parents' 
present occupational status (items 2g and 2h) are encoded 
on l^ows 18 (mother) and 19 (father) using the 5 categories 
given. More than one response may be encoded. Multiple 
entries will be recoded on card decks using the following 
1-digit system. 

Rater should If he wishes 

Encode these Response/s Description 

S 2,5 Part-time employment and recipient of 

ass istance 

7 3,5 Unemployed and recipient of assistance 

8 4,5 Dependent student/spouse and recipient 

of assistance 

The parents' highest occupational status (Items i and j) are 
encoded on Rows 20 (mother) and 21 (father) using the 8 
categories given. A list of occupations adapted from 
Hollingshead are given in Appendix I and should be used in 
classifying specific occupations. 

Example: Fathe;r is a skilled machinist who is currently 
unemployed and receiving public assistance. 
Encode both "unemployed" (3) and "receiving 
public assistance" (5) .on Row 19. Encode "skilled 
machinist" (5) on Row 21. 



19::ft= ::fe ::£: mS^ 



Present Status 



2\zdtz =*: zzAz :Az zz4= mtm irfc: ::fc ~fc -sti Highest StatUS 



79 



COMPUTATION OF SOCIAL CLASS 

Social class for each parent is computed from their highest educational 
level and highest occupational level using the Hollingshead method. 
(Hoi 1 ingshead, A.B., Two Factor Index of Social Position, I965 Yale Station, 
New Haven, Connecticut, 195'/). 

The calculation of computed score for social class is as follows: 

Factor Weight 

Occupation Score (1-7) X 7 = Weighted score 

Education Score (1-7) X k = Weighted score 

Sum of weighted scores = Computed Score 

Social Class is assigned on basis of Computed Score as follows: 
Class Computed Score 



I 11-17 

II 18 - 27 

III 28-43 

IV Mf - 60 

V 61-77 



Example: A graduate of a college nursing program is currently 
employed as an OR (Operating Room) supervisor. Her 
social class is calculated as follows: 



Occupation = 2 x 7 = 1^+ 

Computed score = 22 Social Class = 2 
Education =2x4= 8 

22 



Social class for each parent is calculated via programming and documented in 
the output. 



80 



?^^ 



•'%)■ 



I terns 2k through 2n. Each of these k items requires a single response using 
the code provided: 

= I tern applies to neither parent. 

1 = Item applies to mother only. 

2 = Item applies to father only. 

3 = I tern applies to both parents. 



Example: The father, a sporadic worker, left the home 
6 months ago after assaulting his wife. The 
mother has been hospitalized for psychiatric 
illness for periods up to one year. She is 
considered a poor housekeeper but has never 
been abusive to the children. Encode as follows; 



22 "ft: :ii" "t- m^ -.Jt-. Qut of home 

22-A-. -i-.- w^m -..i=- --^- Marital 

24=:ft: "J" "^ -^- -^ Cruel 

25=:ft= ----i--- --^-- <^m z-n^-. Not steady 

Item 3. Family History of Psychiatric Illness - For each of the 10 items 
(a through j), one to five positions may be encoded depending on 
the number of family members exhibiting the condition. 

Example: While none of the members of this typical family are 

considered psychotic, the father has been hospitalized 
for alcoholism. The mother and youngest daughter are 
considered mentally retarded and an older brother is 
in prison for selling drugs to support his habit. Encode 
as fol lows: 



26 =.-6:: 


:it: 


::2.-- 


^fc 


z:A:: 


::&: 


::fc: 


::?:: 


::B:: 


rrSt: 


a 


27 «M 


i:t: 


::fc 


::»:: 


::*:: 


::&: 


::t:: 


:zJ:: 


r:ft: 


::9t: 


b 


28 ate 


zzi" 


"2:: 


r:!: 


::«:: 


::S: 


::t: 


::3t: 


::ft: 


"St: 


c 


29^ 


::fc: 


;;2:: 


::!: 


::<:: 


::&: 


::6:: 


::*: 


::&: 


::9ti 


d 


30 lite 


:it: 


riii 


::9t: 


::*:: 


::5:: 


::*:: 


::?:: 


::8:: 


::Sk: 


e 


31 -.-Az 


::tr 


>ite 


::!: 


::A: 


::ft: 


::fc: 


::3i:: 


::&: 


::9t: 


f 


32r:ft: 


-te 


::*: 


-te 


::*: 


::ft: 


::fc: 


::Jt: 


::&: 


::»:: 


g 


33::e:: 


zzUz 


-te 


:a:r 


:=«:: 


::&: 


::6:: 


::?:: 


::B:: 


::Sfcr 


h 


3A-.d6z. 


zzlii 


:±: 


-^ 


:=«:: 


::5:: 


::fc: 


::Jt: 


::ft: 


::9b: 


1 


35:*= 


"Ir: 


1:4:: 


i«. 


:3«:: 


::*:: 


::fc: 


::J:: 


::8:: 


::»:: 


J 



The multiple entries possible on this item have been reduced to a 2-digit 
coding system which will appear on all card decks. (Table 5). 



81 



TABLE 5 



CODES FOR CPDI ITEM 3a-3j - FAMILY PSYCHIATRIC ILLNESS 



^ ^ en 



J-J 4-1 c 



— u 



Card 
















Response 


Code 





1 


2 


3 


5 


6 


9 


Pos it ions 


GO 














X 


9 


01 












X 




6 


02 










X 






5 


03 










X 


X 




5,6 


Ok 








X 








3 


05 








X 




X 




3,6 


06 








X 


X 






3,5 


07 








X 


X 


X 




3,5,6 


08 






X 










2 


09 






X 






X 




2,6 


10 






X 




X 






2,5 


11 






X 




X 


X 




2,5,6 


12 






X 


X 








2,3 


13 






X 


X 




X 




2,3,6 


14 






X 


X 


X 






2,3,5 


15 






X 


X 


X 


X 




2,3,5,6 


16 




X 












1 


17 




X 








X 




1,6 


18 




X 






X 






1,5 


19 




X 






X 


X 




1,5,6 


20 




X 




X 








1,3 


21 




X 




X 




X 




1,3,6 


22 




X 




X 


X . 






1,3,5 


23 




X 




X 


X 


X 




1,3,5,6 


2k 




X 


X 










1 ,2 


25 




X 


X 






X 




1,2,6 


26 




X 


X 




X 






1,2,5 


27 




X 


X 




X 


X 




1 ,2,5,6 


28 




X 


X 


X 








I ,2,3 


29 




X 


X 


X 




X 




1,2,3.6 


30 




X 


X 


X 


X 






1,2,3.5 


31 




X 


X 


X 


X 


X 




1,2,3.5,6 


32 


X 


















82 



tern k. Subject's History of Psychiatric Illness - Item ka , Treatment 

Status, and I tern 4b, Prior History, are both encoded on Row 36. 
Only ONE Treatment Status may be marked; but as many marks as 
necessary (maximum of 3) may be used for Prior History. 

Example: The child - currently hospitalized (24-hour) - has 
had previous outpatient treatment and previous 
24-hour hospitalizations. Encode 4-6-8 on Row 36. 

36:A= --U- -.:3^. .^- ■^m -i:- mtm -r.- •^ ;;»: 

t t t 

Present Previous Previous 
Hosp. OP Hosp. 

As noted within the Demographic Packet, "psychiatric trfeatment" 
should be interpreted broadly to include all forms of generally 
accepted therapies; e.g., chemotherapy, individual and group 
psychotherap ies , behavior modification, counseling for behavioral or 
emotional problems, etc., provided by any of the professionally 
recognized disciplines; e.g., psychiatrist, pediatrician, 
physician, psychologist, social worker, supervised paraprofess ional s , 
etc . 

Since multiple entries are possible (maximum of 3) on 4b, a 1-digit 
coding system has been developed for card decks. 

Code Response Positions Description 

9 Not Ascertained 

1 8 24-hour hospitalization 

2 7 Partial hospitalization 

3 7,8 Partial , 24-hour 

4 6 Outpatient 

5 6,8 Outjsatient, 24-hour 

6 6,7 Outpatient, partial hospitalization 

7 6,7,8 Outpatient, partial, 24-hour 

8 5 Never had treatment 

Item 4c. First treated - Encode the age at which the subject first 
received any psychiatric treatment. To record the fact 
that the subject has never been "treated", the rater must 
encode "00" - leaving the item blank will be interpreted 
as missing data. The code "99" indicates Not Ascertained. 



83 



Items kd through kg. Duration of Treatments - Each of these k items 
requires a 3~digit entry: one digit indicating 
the time unit and 2 digits indicating the numeric 
for duration. Whichever time unit is employed, 
encode to the nearest whole unit. 

Examples: If time unit is weeks: 11 days is encoded as 2 weeks. 

If time unit is months: 11 weeks is encoded as 3 months. 
If time unit is years: 13 months is encoded as 1 year. 

"Outpatient psychiatric treatment" is to be interpreted broadly to include 
all forms of accepted therapy for behavioral or emotional disorders for which 
there are no " i n-res idence" requirements; e.g., outpatient hospital clinics, 
office visits to private practitioner, "the 50-minute hour", child guidance 
clinics, etc. "Partial hospitalization" refers to all therapies in which there 
is a "residency" requirement - either in terms of a certain portion of the day 
or in terms of a specific living situation; e.g., day hospitals, night hospitals 
half-way houses, etc. "2^ hour hospitalization" refers to therapies in which 
full time residency is a requirement; e.g., public or private psychiatric 
hospitals, psychiatric wards of general hospitals, schools for the emotionally 
disturbed, etc. 

I tern 5. Subject's Developmental History - I terns 5a, b and c are all 
encoded on Row 10. Note that response positions 3 and 6 as 
well as 9 serve as "Not Ascertained" for this 3~part encoding. 

Example: Pregnancy and neonatal course were considered 

normal, however, the child had feeding problems 
and colic. Encode O-k-J on Row 10. 

10i.«. -i.- -..%-. zr:== -*. -.-&-- z-M-.- ■*. .=6:= ==9:: 

Pregnancy Feeding Colic 

I terns 5d through 5k. Each of these items requires the recording of age 

in months and a judgment of developmental normality. 
If the information for one of the items is not 
available, CODE '999". 

The following table - supplied by Dr. Rachel G i ttelman-Kl e i n 
provides developmental norms for each of the 8 items. Other 
developmental inventories which may be of interest are: 

1. Frankenburg, W. K. and Dodds , J, B., The Denver Developmental 
Screening Test, J. Pediatrics, 71, 2, I8I-I9I, August, I967. 

2. Ireton, H. R. and Thwing, E. J., Minnesota Child Development 
Inventory, published by Interpretive Scoring Systems, kkO] 

W. 76th St., Minneapolis, Minnesota, 1972. 



84 













MONTHS 












1 tern 




Slow 


Normal 


Fast 




5d 


First 


ate sol ids 


13 


or 


more 


8-12 


7 


or 


less 


e 


First 


fed self 


2k 


or 


more 


12-23 


11 


or 


less 


f 


First 


sat alone 


8 


or 


more 


5-7 


k 


or 


less 


g 


First 


wa 1 ked 


]k 


or 


more 


11-13 


10 


or 


less 


h 


First 


words 


21 


or 


more 


12-20 


11 


or 


less 


i 


Speak 


ng sentences 


^3 


or 


more 


2it-U2 


23 


or 


less 


J 


Trained bladder 


29 


or 


more 


18-28 


17 


or 


less 


k 


Trained bowels 


25 


or 


more 


15-24 


14 


or 


less 



Developmental History Score - Items 5d through 5k are used to 
calculate a developmental score. Using the 3-point scale, the 
8 items are added together and the sum is divided by the number 
of items minus "Not Ascertained". Five of the 8 items must be 
present, however, for a score to be computed. Developmental 
scores below 1 reflect slower development; those above 1 reflect 
accelerated development. 

I tern 51. Age of Menstruation - This item requires the encoding of the 
YEAR of menarche.. The code, "00" - NOT 2 blanks - indicates 
"Not applicable"; The code "99" indicates "Not Ascertained". 
No judgment of developmental normality is required. 

Items 5m, These 3 items are all coded on Row 37. Response positions 2 
5n, and and 5 as well as 9 serve to indicate "Not Ascertained". 
5o. 

Example: A child who masturbates but does not crossdress 

or express a desire to be a member of the opposite 
sex should be encoded 1-3-6 on Row 37- 



37 ::&:: ata ::2=; ^m :^i 

Masturbates | 

Crossdress 



Oppos i te 
Sex 



85 



Item 6. Subject's School History 

6a, Current grade placement - give 2-cligit numeric code for grades 01 
through 12 or use the following special codes: 

20 - Preschool 

21 - Nursery 

22 - Kindergarten 

23 - Special or ungraded 
2k - Not in school 

99 - Not ascertained 

When child is in-between grades, e.g., has finished the fourth 
grade and is about to enter (promoted to) the fifth, encode the 
higher grade (05) • 

Item 6b Note that both of these items should be encoded on Row ^0 - NOT 
and 6c. Row 20 as indicated on the packet. Both require a "global 

judgment"; i.e., an overall characterization of the child's 

behavior and academic achievement. 

Example: The child has shown major problems only in the current 
year and his overall academic achievement is considered 
above average. Encode 3-6 on Row kO. 

40 zdOzz "Jir ==J" .^mm. -^zz "*: ■*» "Jt: "8:= --9:z 



/ 



Problems Achievement 



Item 7. Attitude toward Present Treatment - Judgments of both the child's 
and the family's attitudes are required and both are encoded on 
Row k] . Note that response position k as well as 9 are used to 
indicate "Not Ascertained". 

Example: Although the child feels positive toward treatment, 

her family is decidedly negative. Encode 0-8 on Row ^1 

41 -i- z-l.-- --:i-z =:3" --A---- "*= "«== --^- -•• -=*= 

Child Family 



Documentat ion 

a. Raw score printout 

b. Frequency Tables 

c. Cross-tabulations 



86 



044 CSH 
CHILDRENS 
SYMPTOM 
HISTORY 



CHILDREN'S SYMPTOM HISTORY 



INSTRUCTIONS: Insert New General Scoring Sheet and Code 11 for Sheet Number. Code 000 for PERIOD. 

Mark NO or YES tor ALL items in bold type. All items in light type (a., b., c, etc.) mark only 

NO YES 



EXAMPLE: 2b 



the YES responses. 

What time of day does he/she have stomach-aches? 



1 . Morning 

2. Day 

3. Evening 

4. Night 

5. Varies 



USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND 
DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 



Mark each item on right half of scoring sheet on row specif ied 
Mark NO or YES in columns 18 and 19 



Does he/she ever have severe headaches? . 

Is he/she sick with them? . . . . 
Does it affect his/her sight at all? . . 



Does he/she ever have stomach-aches? .... 

Does he/she vomit when he/she has stomach-aches? 
What time of dav does he/she have stomaches? 



1. Morning 

2. Day 

3. Evening 

4. Night 

5. Varies 
Are stomach-aches more on weekends than during the week? . 
Does he/she get stomach-aches during school holidays? 



Is he/she ever sick at his/her stomach (Nauseated) ? 

Does he/she vomit when he/she is nauseated? 

What time of day is he/she nauseated? .... 1. Morning 

2. Day 

3. Evening 

4. Night 

5. Varies 
Is he/she nauseated more on weekends? 



Does he/she ever wet his/her bed? 

How often does he/she wet the bed? 1. Occasionally 

2. Often 

3. Constantly 

Has he/she always wet the bed? 

When did he/she start? 1. 2-5 years old 

2. After 5 

3. After 10 
What is the longest period he/she has been dry? . . 1, Days 

2. Weeks 

3. Months 
Does he/she wet when away from home such as 

when with relatives or on holiday? 



Does he/she ever wet his/her pants? .... 

Does he/she wet his/her pants regularly? . 
Has he/she always wet his/her pants? . 
Did he/she start before he/she was 5 years old? 
What is the longest period he/she has been dry? 



Days 
Weeks 
Months 



Does he/she v 
with relatives 



when away from home such £ 
3n holiday? 



ill him/herself? . 



Columns 
12 13 



16 



19 



Continue marking NO or YES in columns 16 and 17 on row specified 



rRBWI 



Continued 

Does he/she soil him/herself regularly? 

Has he/she always soiled him/herself regularly? 

Did he/she start before he/she was 5 years old? . . . " . . 
What is the longest period he/she has been clean? 1. Days 

2. Weeks 

3. Months 



Does he/she ever have temper tantrumi? 

What are they like? Does he/she scream? , 

Does he/she lie on 4he floor? 

Does he/she break things? , 

How of ten? 1. Daily 

2. A few times per week 

3, A few times per month 

Do they last a long time? 

What seems to bring them on? . . . 1 . Spontaneous , . . , 

2. Frustration or stress 

3. Fatigue 

Does he/she have tantrums when at school? 

Does he/she have tantrums when with relatives or friends? . . . . 
How do you deal with them? 1. Ignore 

2. Restrain 

3. Punish 



Has he/she in the last year c 



ried or been tearful when going to school? . 



Has he/she ever refused to go to school? 



Has he/she ever truanted from school?. 

How often? 1. Once only 

2. Occasionally 

3. Often 
Did he/she go home when he/she should have been at school? 

Did other children truant with him/her? 



Does he/she gat on with his/her brothers/sisten? 

How much do they fight and squabble? .... 1. Not at all 

2. Quite a bit 

3. A lot 



12. Does he/she get along with you? 



13. Does he/she get along with your husband/wife? 



E he/she an affectionate child? 



15. Does he/she stutter or stammer? 



16. Has he/she any other difficulty with speech? 



17. Has he/she ever taken things that don't belong to him/her? 



CHILDREN'S SYMPTOM HISTORY 



Continue marking NO or YES in columns 14 and 15 on row specified 

17. Continued 

m. Does he/she take things frequently? 

b. Did he/she take things from home? 

c. Did he/she take things at school? 

d. Did he/she take things from shops? 

•. Was he/she with others when he/she took things? 

I. Any contact with police? 

18. Is there any difficulty now with eating? 

19. It ther* any difficulty now with sleeping? 

a. Does he/she have any difficulty getting off to sleeps 

b. Does he/she ever wake in the night? 

c. Does he/she scream? 

d. Does he/she conne to your bed? 

•. Does he/she ever have nightmares or wake up with bad dreams? . 

f. Does he/she ever walk in his/her sleep? 

g. Does he/she wake early? (More than normal for age) 

20. Is he/she a fidgety child? 

a. Are there times when he/she doesn't fidget at all? 

21. Is he/she a destructive child? 

a. Does he/she break up his/her own things? 

b. What about other people's things? 

c. Does he/she break things frequently 

22. Does he/she gel into things that don't concern him/her? 

23. Does he/she tend to get into a lot of fights? 

a. Are they "friendly" fights? 

b. Are they "real" fights? 

24. Does he/she get on poorly with other children? 

25. Has he/she got any particular friends? 

26. Does he/she see them frequently outside school? 

Z7. Does he/she get bullied or picked on at all? 

28. Do«she/she tend to pick on or bully other children? 

29. Is he/she a good mixer? 

30. Does he/she tend to do things on his/her own? 

31. Does he/she worry a lot about things? 

32. Does he/she get irritable or cross easily? 

33. Is he/she generally unhappy or miserable? 

34. Does he/she have any mannerisms or tics such as twitches of his/her face 
or shoulders? 

35. Does he/she suck his/her thumb? 

36. Does he/she suck anything else? 

37. Does he/she bite his/her nails? 

38. Does he/she bite pencils or anything else? 

39. Is he/she disobedient a lot? 



Continue marking NO or YES in columns 12 and 13 on row specified 

39. Continued 

a. Is he/she disobedient with other people? 

40. Is his/her concentration poor? 

41. Has he/she got anythirtg he/she's afraid of — like dogs or cats — or the dark? 

42. Does he/she tend to be over-fussy about things? 

a. Are there things he/she insists on doing only in a special way — like 
getting dressed or v^rashing? 

b. Has he/she got any silly habits or rituals? 



43. 



Does he/she tell lies? 

Does he/she now, or at any time in the past, show the following signs of 
an unusual amount of activity? 

Wears out crib, toys, faster than other children? 

Wears out bike, toys, faster than other children? 

Wears out shoes, clothes, faster than other children? 



45. Would you say he/she is very overactive or restless? 



89 



The Children's Symptom History (CSH) is a 104-item, 2-point scale formatted 
for the General Scoring Sheet. The CSH is an extension of the Children's Personal 
Data Inventory (CPDl) and is designed to record the occurrence of syrtiptoms during 
the child's life as reported by the CPDl informant/s. The CSH was adapted by the 
Pediatric Psychopharmacology Conference from a medical and social history 
questionnaire developed by Satterfield. 



APPLICABILITY 



Children to 15 



UTILIZATION 
TIME SPAN RATED 



Once for each subject 

No specific time span for many of the items; others 
have clearly delineated time spans. 



CARD FORMAT - ITEMS 
CARD 01 = (19x, 56ll) 
Item Column 



1 




20 - 22 


2 




23 - 31 


3 




32 - 39 


CARD 


02 = 


(19x, 5611) 


Item 




Column 


7f-7i 




20 - 27 


8 




28 


9 




29 


10 




30 - 35 


11 




36 - 39 


12 




ko 


13 




k] 


]k 




k2 


CARD 


03 = 


(19x, 2211) 


1 tern 




Column 


29 




20 


30 




21 


31 




2i 


32 




23 


33 




2k 


34 




25 


35 




26 


36 




27 


37 




28 



Item 



Item 

k 

5 

6 

7-7e 



Column 



Item 



Column 

kO - 51 
52 - 59 
60 - 67 
68 - 75 



I tern 



Column 



!5 


43 


22 


67 


16 


Mf 


23 


68 - 70 


17 


45 - 51 


24 


71 


18 


52 


25 


72 


19 


53 - 60 


26 


73 


20 


61 - 62 


27 


74 


21 


63 - 66 


28 


75 



Column 



38 




29 


39 




30 - 31 


40 




32 


41 




33 


42 




34 - 36 


^3 




37 


44 




38 - 40 


45 




41 


Total 


Score 


42-44 



90 



COMPUTATION OF TOTAL SCORE - Total score for the CSH is calculated so as to 
reflect the degree of pathology; i.e., the higher the score the greater the 
number of symptoms reported as present in the child's history. Items encoded 
YES are scored as "1"; those encoded NO are scored as "0". The exceptions to 
this rule are as follows: 

a. Items scored on a scale of 1 to 3 



ka - Constantly = 3, Often = 2, Occasionally = I 

kc - After 10 = 3, After 5 = 2, 2 - 5 years = I 

kd - Days = 3, Weeks = 2, Months = 1 

5d - Days = 3, Weeks = 2, Months = I 

6d - Days = 3, Weeks = 2, Months = 1 

yd - Daily = 3, Few Times-week = 2, Few Times-month = 1 

7f - Spontaneous = 3. Frustration = 2, Fatigue = 1 

10a - Often = 3, Occasionally = 2, Once = 1 

lla - A lot = 3, Quite a bit = 2, A little = 1 



b. Items reflected in scoring; 
i.e., NO = "1" 



Items not included 
in total score 



12 


25 


13 


26 


]k 


29 


20a 


30 


23a 





2b 7i 

2c I Ob 

2d lOc 

3b i7e 
3c 



Total Score = Sum of Items 
SPECIAL INSTRUCTIONS 



Range =0-115 



Time Span Rated - Note that the CSH contains some items which ask whether a 
symptom HAS EVER OCCURRED in the child's lifetime and others which ask whether 
a symptom occurs at a specific time or under specific conditions. Since most 
of the rating instruments in the Battery have a uniform, circumscribed time- 
span for all items, the rater is cautioned to be particularly alert to varying 
"time" conditions of the CSH items. 

Obtaining Symptom History - While it is not necessary to follow the sequence 
of items, the rater is urged to make every effort to elicit responses to all 
items. Should the respondent be uncertain or ambiguous about the presence of 
a symptom or the rater question the validity of the response, the item should 
be left blank. 

Encoding Dependent Items - The CSH has a quas i-Guttman quality to it in that 
series of items are dependent upon positive response/s to previous item/s. To 
reduce the encoding required of the rater, ONLY THE ITEMS IN BOLD TYPE MUST 
ALWAYS pE MARKED YES OR NO. These are the "numbered" items (1-45). The items 
in light type ("lettered" items) should be marked only when the response is 
positive, i.e., YES or present. 



91 



Example 1: A "NO" response to Item 5 automatically means that Items 

5a, 5b, 5c, 5d, and 5e should ALL be encoded "NO". Encode 
"N0"(7) in Row 33, Column 18 and leave Rows 3^ tnrough kO , 
Columns 18 and 19 blank. 









33 








34 


b. 


Has he/she always wet his/her pants? .... 




35 


c. 


Did he/she start before he/she was 5 years old? . 




36 


d. 


What is the longest period he/she has been dry? . 


. 1. Days 


37 






2. Weeks 


38 






3. Months 


39 


e. 


Does he/she wet when away from home such as 








with relatives or on holiday? 




40 



33 


^ 


--.^ 


5 


34 


:i7:: 


-zii 


5a 


35 


llil 


zzttz: 


b 


36 


==?:: 


z-8:: 


c 


37 


zzj-.-. 


-t: 


dl 


38 


z-:t.-. 


"t: 


d2 


39 


"Sr 


rrB:: 


d3 


40 


-.zjz.-. 


-z^ 


e 



Example 2: If the response to Item 5 is YES, then one or more positive 
responses to 5a, 5b, 5c, 5d, and 5e should be encoded, as in 
the fol lowing: 

The child does wet her pants and has always done 
so since the age of h. The longest dry period is 
estimated to be in weeks. She does not wet away 
from home. 



5. 






33 


a. 


Does he/she wet his/her pants regularly? . 




34 


b. 






35 
36 


c. 


Did he/she start before he/she was>5 years old? . 




d. 


What is the longest period he/she has been dry? . 


. 1. Days 


37 






2. Weeks 


38 






3. Months 


39 


e. 


Does he/she wet when away from home such as 








with relatives or on holiday? 


, 


40 



33 zzT-z -». 5 

34 -z^-z >^ 5 a 

35 z^T-z -*. b 

36 ---T- -^ c 

37 ==3ti ==8:r dl 

38 -ziz -*■ d2 

39 =::?== "8:: d3 

40 -*■ "8:= e 



Uses of the Scale - While the CSH is primarily for use as an adjunct to the CPDI 
at the initial assessment, it might also be considered for use as a criterion 
measure by making repeated ratings over the course of the study. There are haz- 
ards in employing the CSH in this manner. Since the CSH is primarily historical, 
symptoms may have been present in the "distant past" but not present immediately 
prior to the study. This may lead to distortions when attempting to use the 
instrument for the assessment of change. 



Item 1 la, page L-5 



Note that the first scale point should read 
"Just a little", NOT "Not at all". 



DOCUMENTATION 



a. Raw sdore printout 

b. Total score printout 

c. Variance analysis 



92 



045 APDI 
ADULT 

PERSONAL DATA 
INVENTORY 



ADULT PERSONAL DATA INVENTORY 



INSTRUCTIONS: Insert General Scoring Sheet and Code 12 for Sheet Number. 

Items 1 through 10 are required for BLIPS processing and MUST BE COMPLETED FOR EACH SUBJECT. 
PERIOD is coded as "000". Mark a field of 9's when data are "Not Ascertained". 



USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 



Mark on right half of scoring sheet on row specified 



SUBJECT'S AGE: {2 digits) 



SUBJECT'S SEX: 



1 = Male 

2 = Female 



SUBJECT'S RACE: (Mark one) 



= Caucasoid 

1 = Negroid 

2 = Mongoloid 

3 = Other 



= Never married 

1 = Presently married for first time 

2 = Presently married with previous marriage/s 

3 = Previously but not presently married (separated 

or divorced) 

4 = Previously but not presently married (widowed) 



SOCIOECONOMIC STATUS 

Occupation Use scale given below for 1 and 2. See Manual for 

detailed list of occupations 

1. Subject's highest occupational attainment is: 

2. Head of Household's highest occupational attainment is 

If subject is Head of Household, code "0" here (Row 7) 

1 = Higher executive, proprietor of large concern, major professiona 

2 = Business manager of large concern, proprietor of medium-sized 



, lesser professi 

3 = Administrative personnel, owner of smi 

minor professional 

4 = Clerical or sales worker, technician, ow 

5 = Skilled manual employee 

6 = Machine operator, semi-skilled employe 

7 = Unskilled employee 

8 = Never worked in paid employment 

9 = Not ascertained 



itl independent busini 
ler of little business 



Education 

1. Using scale provided, code highest level attained by the SUBJECT 

2. Code highest level attained by HEAD 6F HOUSEHOLD . . . 

If subject is Head of Household, code "0" here (Row 9} 

1 = Graduate or professional training (Individuals who have completed 

or who have attended one year of a recognized professional course) 

2 = College or university graduate (Individuals who have completed a 

four year college or university course leading to a recognized 
college or university degree) 

3 = Partial college training (Individuals who have completed at least one 

year but not a full college course; individuals who have attended at 
least one year of, or who have completed a recognized Junior 
college, technical school, nursing school, etc.) 

4 = High school graduate (Private preparatory, public, parochial or 

trade school) 

5 = Partial high school (Individuals who completed grades JO or 11 

but did not complete high school) 

6 = Junior high school (Individuals who completed grades 7, 8 and 9) 

7 = Less than seven years of school 
9 = Information not available 



Continue marking on right half of scoring sheet on row specified 



TREATMENT STATUS 

Subject is presently: (Mark one) 

1 = Not in any type of psychiatric treatment 

2 = In psychiatric treatment as an outpatient 

3 = In partial hospitalization, e.g., day or night hospital, halfway house, etc. 

4 = Hospitalized (24 hour) 

Prior to this episode, subject has: (Mark all applicable) 

V = Never had any type of psychiatric treatment 

2 = Received psychiatric outpatient treatment 

3 = Received treatment in partial hospitalization setting 

4 = Received treatment in 24— hour hospital 



"Psychiatric treatment" should be interpreted broadly to include all forms 
of therapy whose basic function is the alleviation of emotional, behavioral 
or mental disturbance. "Partial hospitalization" and "24— hour hospitali- 
zation" include all forms of treatment environments in which the subject 
spends a substantial part of the day or, in the latter case, the full day. 



DURATION OF PRESENT EPISODE 

Code whether in: = Days 1 = Weeks 2 = Months 3 = Years 
and give length (2 digits) 

EXAMPLES: Present episode = 1 1 Weeks Code 1 1 1 

Present episode = 3 Months Code 203 

Present episode = 4 Years Code 304 



PRIMARY PSYCHIATRIC DIAGNOSIS 

indicate nosological system used 1 = DSM II 



Code diagnosis from those listed in ECDEU Manual using 4 digits for 
DSM II (Rows 15-19) or 3 digits for WHO (Rows 16-18) 



Secondary psychiatric diagnosis Use same nosological system as 8a 

If no secondary diagnosis, code field 0000 



SIGNIFICANT CURRENT MEDICAL CONDITIONS? 
If NO, 9b and 9c may be left blank 



If YES, give ICD-8 code for illness (3 digits) 

See Manual for ICD-8 list of diseases. Maximum of 2 conditions 
may be entered at 9b and 9c 

Second medical condition (3 digits) Code 000 if no 2nd conditic 



10. ARE THE FOLLOWING ITEMS (11-15) 

TO BE COMPLETED FOR THIS SUBJECT? 

If YES, turn page and continue with item 71 on L— 10 



1 = YES 

2 = NO 



9^ 



ADULT PERSONAL DATA INVENTORY 



Continue marking on right half of scoring sheet on row specified 


ROW 
NO. 


11. CURRENT CONDITION (Present Episode) 

a. The current condition (present episode} is best characterized as: 

' 1 = Indistinguishable from the past; continuation of long-standing 
condition 

2 = Exacerbation of chronic condition 

3 = Recurrence of similar previous condition 

4 = Significantly different from any previous condition 

5 = First occurrence with no previous psychiatric illness 


32 


b. Onset of current condition was: 

1 = Sudden - less than 4 weeks 

2 = Gradual — one to several months 

3 = Very gradual - one to several years 


33 


c. Precipitating external stress viras: 

= Absent 

1 = Probably present 

2 = Definitely present 


34 


12. SUBJECT'S PSYCHIATRIC HISTORY 

a. Age when first received any treatment for psychiatric illness 12 digits) 
00 = Never treated 


3536 


b. Age when first hospitalized for psychiatric illness (2 digits) 

00 = Never hospitalized 


37-38 



ROW 
NO. 


Mark on left half of scoring sheet on row specified 1 




12. SUBJECTS PSYCHIATRIC HISTORY - Continued 




1.3 


c. Estimate total duration of ALL outpatient psychiatric treat 
exclusive of present episode 


mont- 




Give time units: = Days 1 = Weeks 2 = Months 3 


Years 




and duration (2 digits) 






EXAMPLE: Subject's total treatment amounts to 10 months 






C°<^^210 000 = No outpatient treatn 


lent 


4.6 


d. Estimate total duration of ALL partial hospitalization — excl 
of present episode 


.sive 




Give time units: = Days 1 = Weeks 2 = Months 3 


Years 




and duration (2 digits) „„„ ^, . ,. , ,. 
000 = No partial hospitahz 


Btion 


59 


e. Estimate total duration of ALL hospitalizations (24 hour) — 
exclusive of present episode 






Give time units: = Days 1 = Weeks 2 = Months 3 


= Years 




and duration (2 digits) 






EXAMPLE: Subject's total hospitalization amounts to 4 years | 




Code 304 ggg , ^^ hospitalizations 




10 


f. Number of hospitalizations 

0-None, 1,2,3,4,5,6,7, 8 = 8 or more 
9 = Not ascertained 






g. Does subject have a history of: 






0= No 2 = Yes, only within las 


year 




1 = Yes, but not within last year 3 - Yes, both in past an 


d 




last year 




11 


1. Excessive use of alcohol 




12 


2. Excessive use of Tobacco 




13 


3. Excessive use of Opiates 




14 


4. Excessive use of Marijuana 




IS 


5. ■ Excessive use of Sleeping pitis or Sedatives 




16 


6. Excessive use of Amphetamines/Stimulants 




17 


7. Excessive use of Hallucinogens 




18 


8. Excessive use of Other Drugs 




19 


9. Imprisonment 




20 


10. Sexual deviation 




21 


11. Suicidal attempts 




22 


12. Contributory physical illness or injury 





95 



ADULT PERSONAL DATA INVENTORY 



ROW 
NO. 


Continue marking on left lialf of scoring sheet on row specified 


ROW 
NO. 


Continue marldng on left half of scoring sheet on row specified 


23 
24 
25 
26 
27 
28 
29 
30 
31 
32 
33 


13. FAMILY PSYCHIATRIC HISTORY 

Among family members (lineal and conjugal), has there been a 
history of: (Mark all applicable on the appropriate rows! 

= No history in any lineal or conjugal family members 


36 


15. ROLE PERFORMANCE 

a. Subject's present occupational status is: 

0= Not applicable 

1 = Full time gainful employment 

2 - Part time gainful employment 
3= Unemployed 

4 = Dependent spouse or student 

5= Recipient of public or private assistance 

9 = Not ascertained 


LINEAL 


CONJUGAL 


1 = No history in parents or 

siblings 

2 = Mother 
3= Father 
4= Sibling/s 


5 = No history in spouse or 

children 

6 = Spouse 

7 = Children 

urbance 


37 


b. In the past 3 years, subject has been gainfully employed: 

1 = Briefly or not at all 

2 = Less than 1/2 of the time 

3 = Half of the time 

4 = Most of the time 

5 = Virtually all of the time 
9 = Not ascertained 


b. Manic-depressive disturbance 

c. Other major affective disturbance 

d. Schizophrenia 

a. Other psychotic disturbance 

f. Suicide 

g. Hospitalized for any psychiatric illness 
h. Mental deficiency 

i. Excessive use of alcohol 
j. Excessive use of drugs 
k. Imprisonment 


38 


c. His/her employment has been limited primarily by: 

= Not limited 

1 = Going to school 

2 = Household responsibilities 

3 = Job market 

4 = Retirement 

5 = Physical illness 

6 = Psychopathology 

7 = Institutionalization 
9 = Not ascertained 


34 


14. LIVING SITUATION 

a. In the 3 years preceding the present episode, the subject's 
residence has been: 

1 = Primarily urban 

2 = Primarily suburban 
3= Primarily rural 


39 


d. The subject's work performance (whether in job, in household or 
as student) during the past 3 years is best characterized as: 

= Not applicable 

1 = Marked decline in effectiveness 

2 = Some decline in effectiveness 

3 = Adequate with no change in effectiveness, static 

4 = Some increase in effectiveness 

5 = Variable, fluctuating in degree of effectiveness 


35 


b. Family type during this period has been: 

1 = Parental or lineal — Patient does not carry major responsibility 

for the home: it is either the home of his 
family of origin or of his children. Code 
foster home here. 

2 = Conjugal - The patient or his spouse carries major 

responsibility for the home; the household 
may include his parents and/or children. 

3 = Collateral - Home is not the responsibility of the 

patient, his parents or children, but of a 
sibling, aunt or some other non-linear 
relative 

4 = Alone - Patient maintains - wholly or in part - his 

own quarters. Home may be shared with 
others not related to the patient, or he may 
live in a rooming house, dormitory, etc. 


40 


e. The subject's social functioning during the past 3 years is best 
characterized ai: 

1 = Marked decline in competence 

2 = Some decline in competence 

3 = Adequate with no change in competence, static 

4 = Some increase in competence 

5 = Marked increase in competence 

6 = Variable, fluctuating in degree of competence 









96 



Developed within the ECDEU program, the Adult Personal Data Inventory (APDl) 
is a 55-item scale formatted for use with the General Scoring Sheet. Its purpose 
is to describe the social and demographic background of the subj-ect. Evolving 
from the now obsolete Patient Personal Data Inventory, the APDl has been designed 
to cover a greater diversity of subject types than its forbear. Most of the items 
from the original inventory have been retained, although the majority have been 
modified to increase their universality. Items numbered 1 through 10 constitute 
the basic minimum of necessary demographic information. I terns numbered 11 through 
15 are considered supplemental, although they represent the types of information 
most investigators commonly collect. 

APPLICABILITY -All adult populations 

UTILIZATION —Once per subject 

CARD FORMAT - ITEMS 

CARD 01 = (19x, 12, 911, 13, M, 2|4, II, 213, k\] 

I tern Column 



1 


20 - 21 


2 


22 


3 


23 


k 


2k 


5a 


25 - 26 


5b 


27 - 28 


6a 


29 


b 


30 


7 


31 - 33 


8a 


34 


b 


35 - 38 


c 


39 - k2 


9a 


43 


b 


hk - kS 


c 


kl - k3 



212, 313, 


911) 


Item 


Column 


10 


50 


11a 


51 


b 


52 


c 


53 


12a 


5k - 55 


b 


56 - 57 


c 


58 - 60 


d 


61 - 63 


e 


64 - 66 


f 


67 


12g-l 


68 


2 


69 


3 


70 


k 


71 


5 


72 


6 


73 


7 


74 


8 


75 



97 



12g-9 


20 


10 


21 


11 


22 


12 


23 


13a 


2k - 25 


b 


26 - 27 


c 


28 - 29 


d 


30 - 31 


e 


32 - 33 


f 


3k - 35 


g 


36 - 37 



CARD 02 = (19x, k\], 1112, k\] , I3, k\]) 

I tern Column I tern 

13h 38 - 39 

i kO - k\ 

j k2 - 43 

k kk - k5 

]ka ke 

b 47 

1 5a 48 

b 49 

c 50-52 
d 53 

e 54 

Social class-Subject" 55 
Head/Household-v 56 

" - These items are calculated and punched on the card via programming. 

SPECIAL INSTRUCTIONS 

All items of the APDI are coded on one General Scoring Sheet. ITEMS NUMBERED 
1 THROUGH 10 MUST BE COMPLETED. No data will be processed by the Biometric 
Laboratory without completion of these 10 items for each subject. While data will 
be processed without Items numbered 11 through 15, investigators are strongly 
urged to complete the entire set of APDI items. 

Item 1. Age - Encode the subject's age to the nearest whole year. 

Examples: 25 years, 7 months. Encode as 26 years. 

Exactly 25 years, 6 months. Encode as 25 years. 
25 years, 4 months. Encode as 25 years. 

Since "99" is employed as a "missing" or "not ascertained" code, no subject 
can be 99 years of age - or, for that matter, any older - in this system. 
Any bias introduced by halting time at 98, however, would appear acceptable, 

I tern 2. Race - Subjects whose racial heritage is melanesoid, australoid or 
mixed should be encoded as "Other"(3). In geographical areas where 
these racial types are prevalent rater may encode melanesoid as 4; 
australoid as 5 and mixed as 6. "Unknown" racial heritage should be 
encoded as 9. 

Item 4. Marital Status - The choice of categories is almost always straightforward. 
In the event that the subject could be classified as b oth "3" and "4", 
encode the most recent status, e.g., the subject's first marriage ended 
in divorce, the second in the death of the spouse. Encode as 4 (widowed). 
Code "5" may be used to designate common law relationships; i.e., living 
in a conjugal situation without legal status. 



98 



6;=e:= ---^ 


-- z-.Z-. 


-». 


7-*. ..^ 


-. "»: 


---X- 


8=:©:- ----i 


-. -.2^-. 


"*= 


9.^> ::] 


z zztzz 


----s^-- 



I terns Occupation and Education - Tliese 2 items require ratings of the 
5a and subject AND/OR the Head of Household. if the subject is also 
5b the Head of Household, only one actual rating is required - "0" 

being encoded for both Head of Household's occupation (5a2) and 

education (5b2) . 

Example: The subject, owner of a small business and a high- 
school graduate, is also the Head of Household. 
Encode as follows: 

"ir "fci z.Jzz ==8:r rr9:= QCC Upa t i On "S Ub j eC t 
;:&= =:6:= i:3!:: -=8:= "9:: QCCUpa t i On "Hea d 
::a:: "t: -.r.z "&= =:»:: Educa t i On "S ub j 60 t 

..4. ..^- „jL. -g.. -jK. Educat ion-Head 

The subject, a nuclear physicist prior to marriage, 
has a Ph.D. Her husband, the Head of Household, is 
a building contractor and has a 9th grade education. 

Occupat ion-Subject 
Occupation-Head 
Educat ion -Subject 
Educat ion-Head 



A list of occupations - adapted from Hollingshead - are given in 
Append ix I . 



COMPUTATION OF SOCIAL CLASS - (See page 8o) . 

I terns Treatment Status - While only one response may be encoded for 6a, 
6a 'and a maximum of 3 responses may be encoded for Item 6b. The terms ■ 
6b "psychiatric treatment", "Outpatient", "partial hospitalization". 

"24-hour hospitalization" - should be interpreted broadly. 

Definitions for these terms are given on p. 84. 

Example: The subject is presently in outpatient 

treatment. In the past, she has received 
treatment as an outpatient and in a day 
hospital. Encode 2 on Row 10; 2 and 3 on 
Row 1 1 . 






6 ::a:: 


-4- 


::2:: 


--Szz 


::*: 


-zSzz 


::«:: 


::7:: 


:*: 


-z9z 


7::et: 


::lr: 


m^ 


-Szz 


::4:: 


::S=: 


::6:: 


::7:: 


:*: 


:* 


8::a:: 


mim 


::2:: 


::3:: 


::4:: 


::&: 


::6:: 


zzlzz 


:*: 


z^- 


9:re:: 


::3:: 


::2:: 


zz3^z 


zzA^z 


.6. 


::&: 


::?:: 


:*: 


::»: 



z&z 


zzbiz 


::3!:: 


::&: 


::St: 


Present 


-iz 


::fc: 


::?!:: 


::ft: 


::9:: 


Prior 



99 



A coding system has been developed to reduce the possible multiple entries 
in I tern 6b to a 1-digit field for card decks. 

1 Card Code Response Position Description 

9 Not Ascertained 

1 4 24-hour hospitalization 

2 3 Partial hospitalization 

3 3,4 Partial and 24-hour 

4 2 Outpatient 

5 2,4 Outpatient and 24-hour 

6 2,3 Outpatient and partial 

7 2,3,4 Outpatient, partial and 24-hour 

8 1 Never had treatment 

item 1 . Duration of present episode - A 3-digit entry is required: one digit 
to indicate the time unit; 2 digits for the numeric for duration. 
Whichever time unit is employed, encode to the nearest whole unit. 

Examples: When time unit is months: 11 weeks and 2 days is encoded 

as 3 months . 
When time unit is years: 1 year and 1 month is encoded 

as 1 year. 

Item 8a. Nosological System - The rater may use one of two nosological systems, 
DSM II or ICD 8 (WHO), by the appropriate designation on Row 15. (Note 
that this Row Number has erroneously been omitted in the packet). Codes 
for both DSM II and WHO systems are listed in the Appendix 2, Certain 
5-digit codes used in the official DSM II have been changed - for uni- 
formity - to 4 digits. 

Item 8b. Primary psychiatric diagnosis - Rows 16 through 19 - NOT 15 - 19 as 
printed in the packet - are required for encoding a diagnosis under 
BOTH systems. Item 8b should read: 

Encode diagnosis from those 1 i.sted in Appendix 2 using 
4 digits for both DSM II and WHO on Rows 16 - 19. 

Examples: DSM II - Schizophrenia, chronic undifferentiated. 
Encode 2959. 

16-0:: --'.iz- 1.^ ^ ---iLZ 

17:.fl:: "i: ==i; irir "*i 

18"Q;= ::i= .z^z zzi: r;*l 

\^zz(Szz z:ir =:i; ^3s =i4:r "i: -=fc= -zlzz ::fti lafc 

WHO - Schizophrenia, paranoid type. Encode 2953. 

16:*: ---y-z ■«■ ::3:: ::4:: ::*:: :=*:: -zlzz ::8:: ::»:: 

1 7 ::&:: ::!:: -^z zzizz zzAzz ::*: -Ztaz ::3t: ::8:: ^^ 

1 8 -zfyzz ::J:: zz^z zz^z zzizz mtm --(az ::?:: ::&:: zz9z. 

1 9 zz&zz ::J:: zz3zz ^^m ::i:: ::S:: ::fc: -Zfzz ::8:: =*: 



-&: z-kz zzfzz r:8:: =:Sb: 
::5:: "fc: ::X: ::&: ute 
laA. ::fc: -*: ::&: ::*: 



100 



Item 8c. Secondary psychiatric diagnosis - This item MUST be encoded in the 
SAME NOSOLOGICAL SYSTEM as that used in I tern 8b. Leaving the field 
blank or encoding "0000" will indicate no secondary diagnosis. 

Item 9. Medical Conditions - If NO significant current medical conditions 

are present, Items 9b and 9c may be left blank. No error citations 
will occur since the "NO" response to I tern 9a is a programming sig- 
nal. A "YES" response to the item requires that the rater then MUST 
ENCODE RESPONSES FOR ITEMS 9a AND/OR 9b. 

Item 9b. Medical Condition Number 1 - The rater selects the 3-digit code 

appropriate to his diagnosis and encodes it in Rows 25 - 27. For 
the comprehensive listing of diseases (and synonyms), refer to: 
Eighth Revision, International Classification of Diseases, (lCD-8) 
Public Health Service Publication No. 1693, Vol. 1 and 2, U.S.G.P.O., 
Washington, D. C. The ICD-8 codes may also be found in the Diagnos- 
tic and Statistical Manual of Mental Disorders, American Psychiatric 
Association, 1968, 3rd Edition. 

Item 9c. Medical Condition Number 2 - Encoding a second significant current 

medical condition is at the option of the rater. Leaving Rows 28-30 
blank will be interpreted as the absence of a second medical condi- 
tion. 

Example: Subject has acute nasopharyngitis but no second 
medical condition is rated. Encode 460 in 
Rows 25 - 27 and leave Rows 28 - 30 blank. 

25::e:i "Jz: r:2:i :i3:: .Urn 

26-6:: =iaii z:2:= ;z3ti "<b= 

27-ite :rJ:: zzSiz .z3zz z:<fc: 

28r=e:r iiji: "ir zzir r:<t: 

29:ze:z :=a=z zziz zziz zzdiz 

SOzzttz zzJz: zziz zziz zztz 

Item 10. This is a MANDATORY ITEM. It is a programming signal as well as a 
statement of fact. In responding "YES", the rater commits himself 
to respond to ALL of the remaining items (11 - 15). 

Item 11a. Current condition - Only one response is permitted. Select the 
category which best describes the subject's current condition. 

1. Indistinguishable from the past - refers to those 
conditions which have exhibited little - if any - 
variation in intensity or floridity from the pre- 
vious status. 

2. Exacerbation of chronic condition - refers to an 
intensification (flare-up) of a previously stable 
(static) condition. 



zzft: zzfcz 


zzJrz 
zziz 


zzfcz 
zzfcz 


zzSbz -J 

zzstz -1st Condition 

zzStz _ 


zz&z zzfcz 


zz?:z 


zzfcz 


zziz zzfcz 


zzSz 


zzfcz 


zzStz — ■ 

--^- -2nd Condition 

zzStz _ 


zzftz zzfcz 
zzSrz zzfcz 


zzJzz 
zzjrz 


zzfcz 
zzfcz 



101 



3. Recurrence of similar previous condition - refers to 
recurrent episodes of illness. Differs from 2 in 
that there are symptom-free periods between episodes. 

k. Significantly different from previous condition - 
refers to a present condition which can be clearly 
distinguished from any in the subject's past. 

5. First occurrence - refers to the initial recognized 
episode of psychopathology. Differs from k in that 
there is no prior history of illness. 

I tern 12. Subject's Psychiatric History - The several parts of this item 

(12a - 12f) ask for the temporal aspects of some of the events in 
the subject's history. The information necessary to answer the 
items is not always complete or precise and the, rater is urged to 
make the best estimates possible. 

I terns These 2 items require a 2-digit code for age in years. Encode age 
I2a and in the nearest whole year. Encode "99" if the subject is known to 
12b. have been treated and/or hospitalized, but the age is "Not ascertained". 

I terns Each of these items requires a 3-digit code: one digit to indicate the 

12c- time unit and 2 digits to indicate the numeric for duration. To 

12e Indicate that the subject has not received one or more of the treatments 

the rater must encode "000". Do not leave blanks; rather encode "999" 

when data is "not ascertained". 

Example: The subject has received an aggregate of 2 years 
of outpatient treatment; has never received 
treatment in a partial hospitalization setting 
and has had a total of 10 months of 24-hour 
hospital ization. 



1 "ft: "i: :r3:: ■•* 
2i^ ::*: :=2:: =:*: 




::5:: 


::6:: ::?:: :=&: 
::&: =:3t: ::8:: 


::9:: 

::9:: 




Outpatient 


3 "ft: "*: ^ "*: 


::*: 


::5:: 


::fc: "Jt: =:8:: 


::»: 




i i ::*: -*: "*= 
5«*- ::*:: ::»: ::*: 
6^- "t: z-tz ::*: 


::*: 
zzt:z 


::&: 
::&: 
::&: 


::fc: ::7:: ::8:: 
::&: ::jt: ::8:: 
::&: ::?:: ::8:: 


::9:: 

::»: 

:r9:: — — 


Partial 


7::ft: ::!=: -*> "*: 
8::0:: -*■ ::*: --t^z 
9<i«a "t: ::*: "»=: 


1:4:: 


=:5:: 
::&: 
::5:: 


::fc: zzfiz ::8:: 
::«:: ::3t: ::8:r 
::t: ::3t: ::ft: 


::*: 

::9:: 

:=*: __ 




24-hour 



102 



Uem I2g Each of the items asks whether the event has been present in the 
subject's recent (within the last year) and/or past (beyond the 
last year) history. Do not leave blanks. Encode 9 for "Not 
Ascerta ined". 

I tern 13- Family Psychiatric History - This item gathers information on the 
presence of a variety of psychiatric illnesses within both the 
subject's lineal and conjugal families. For each of the items 
(133 through 13k), record the presence or absence of the charac- 
teristics among family members by marking ALL appropriate response 
positions. The code "0" indicates the ABSENCE of the characteris- 
tic in BOTH lineal and conjugal family members. The code "1" indi 
cates the absence of the characteristic among the subject's lineal 



family members ONLY, 
1 ings . The code "5" 
family members ONLY, 



the subject's parents and/or his sib- 
ndicates absence among the subject's conjugal 
.e., the subject's spouse and/or his children, 



Example: The subject's mother committed suicide following the 
imprisonment of her alcoholic husband (the subject's 
father). One of the subject's sisters is hospitalized 
for heroin addiction. The subject's spouse, presently 
hospitalized, has been diagnosed as schizophrenic. 
The subject is presently taking care of the 10 children 
one of whom has been diagnosed as mentally defective. 
Encode as follows: 



M F Sib 



Sp Ch 



23 ^P 


==»:r =*r 


1*1 


==4== 


==5=: 


-re: 


::f:r 


-.*-- 


=r». a 


24'-*r 


==»== ;*= 


I*: 


==*= 


==5== 


=*= 


-zT--. 


==»'= 


==»=b 


25i*r 


==»== :*: 


i*r 


==*= 


==*= 


==e:= 


zzT--. 


:rft: 


==»= c 


2*=*= 


>*« ==fc= 


:*r 


--*'- 


==S== 


'^ 


zzT-z 


==»= 


==»=d 


27a*K 


"trr ::r-z 


;:3;z 


==*= 


==s== 


==e:= 


"T:i 


"»= 


==»= e 


n-:0^z 


==»== M,^ 


==3== 


--^-. 


-*• 


=*= 


=:T:i 


==»= 


*. f 


2»=«:: 


==!=: r=t= 


i-J:: 


•*- 


:=S== 


«^ 


"T== 


==»= 


9 9 


30=*= 


:>*» ==«:= 


==5== 


==*= 


==*:= 


==«:= 


-»1 


==*= 


==»=h 


31=*^= 


"J;: -:*:: 


«•> 


=:*= 


a«> 


:*= 


z:3t: 


:*= 


==»= 1 


32=*= 


~J=: :*: 


:3=r 


^^ 


•*• 


==&= 


z^r-z 


==»= 


==»=j 


33=*= 


:=t=i :*: 


1*1 


==*= 


««E 


==e= 


zzT.z 


==»= 


==»=k 



103 



To conserve space on card decks, the possible multiple entries on items 13a 
through 13k have been reduced to a 2-digit coding system - the first digit 
referring to lineal history and the second to conjugal. 

Lineal History 

Card Code Response Positions Description 

1 k Siblings 

2 3 Father 

3 3,k Father, s ibl ings 
k 2 Mother 

5 2,k Mother, s ibl ings 

6 2,3 Mother, father 

7 2,3,4 Mother, father, siblings 

8 1 No 1 ineal history 

9 No 1 i neal/conj uga 1 

Conjugal History 
Card Code Response Positions Description 

1 7 Children 

2 6 Spouse 

3 6,7 Spouse, children 

k 5 No conjugal history 

9 No 1 i neal /conjuga 1 

Examples: 99 = No lineal or conjugal history 

62 = illness in mother, father, spouse 

83'= No lineal history, illness in spouse, children 

Item ]ka. Subject's residence - If the subject's residence has been split, 
approximately 50% between 2 of the categories, encode the most 
recent residence. Example: In the last 3 years, the subject 
lived on a farm for the first 18 months and in a large city 
thereafter. Encode the residence as "primarily urban" (1), 

I tern ]kb. Family type - In circumstances analogous to those cited in Item l4a, 
rncode the most recent family type. 

Item 15a. Present occupational status - One or more responses may be encoded 
up to a maximum of 2. 

Example: Subject is currently unemployed and receiving public 
assistance. Encode 3 and 5 on Row 36, 



Unemployed Assistance 



104 



Rater s 


hou 


Id 


If 


he wishes 


encode 






these responses 


6 








2,5 


7 








3,5 


8 








^,5 



A l-digit coding system has been developed for these multiple entries 
and is as fol lows : 



Descr ipt ion 

Part-time employment and recipient 
of ass istance 

Unemployed and recipient of 
ass istance 

Dependent student/spouse and 
recipient of assistance 

Items 15b While only one response is permitted for Item 15b; a maximum 
and 15c. of 2 may be encoded for Item 15c. 

Example: During the past 3 years, the subject has been 
gainfully employed for less than 1/2 the time. 
Her employment has been limited by attendance 
at school and household responsibilities. En- 
code 2 in Row 37; 1 and 2 in Row 38. 



37:*= ::l:: -*■ =:3:= zjUz riS: =:6:= "7:: :=8:= ::»:: AmOUnt Employed 

38 =A: -*.. -a- ::3:: --4^- ==&: --b:-- -zT- ==8:r --9,- Limited 



A 2-digit field is reserved for Item 15c on card decks. The codes are given 
in Table 6. 



105 



TABLE 6 
APDI (ITEM 15c - EMPLOYMENT LIMITATIONS) 



— — O -M 





_j 

■i-i 
o 


o 
o 

o 
to 


o 

o 


O 

—3 


E 

■I-I 


to 
u 

\n 
>- 

Q- 




o 
>- 


4-1 

3 

+-I 

4-1 
U1 

c 


0) 

o 

< 

o 

■z. 


Response 


Card Code 





1 


2 


3 


4 


5 


6 


7 


9 


Pos i tions 


00 


















X 


9 


01 
















X 




7 


02 














X 






6 


03 














X 


X 




6,7 


Ok 












X 








5 


05 












X 




X 




5.7 


06 












X 


X 






5,6 


07 










X 










k 


08 










X 






X 




k,l 


09 










X 




X 






k,G 


10 










X 


X 








k,5 


11 








X 












3 


12 








X 








X 




3,7 


13 








X 






X 






3,6 


14 








X 




X 








3,5 


15 








X 


X 










3,4 


16 






X 














2 


17 






X 










X 




2,7 


18 






X 








X 






2,6 


19 






X 






X 








2,5 


20 






X 




X 










l,k 


21 






X 


X 












2,3 


22 




X 
















1 


23 




X 












X 




1,7 


2k 




X 










X 






1,6 


25 




X 








X 








1,5 


26 




X 






X 










\,k 


27 




X 




X 












1,3 


28 




X 


X 














1,2 


29 


X 






















106 



Examples: 29 = Not limited 
11 = Job Market 

10 = Retirement, physical illness 
01 = Institutionalization 
00 = Not ascertained 

I terns 15d These items attempt to characterize the course of work performance 
and 15e. and social functioning during the past 3 years by a "global judgment", 
"Work performance" should be interpreted in a general way to include 
effectiveness as a housekeeper or student as well as effectiveness in 
gainful employment. For subjects who have been hospitalized for the 
3-year period, rate their performance in industrial therapy, ward 
assignments, etc. Similarly, the social functioning of inpatients 
should be rated in the context of the hospital setting. 

Example: The subject who has been hospitalized for the past 
10 years has been a steady (unvarying) worker on 
the ward. He has become markedly more isolated and 
uncommunicative in relation to others, however. 
Encode 3 on Row 39; 1 on Row kO . 



39 :*: 



z-.k-. -1.-- -.--&-. r:9:: -; ^o r k 

-.-Mz z.Jzz ::B:= :;9::-< S OC I a ! 



Documentat ion 



a. Raw score printout 

b. Frequency tables 

c. Cross-tabulations 



107 



046 PMR 

PRIOR 

MEDICATION 

RECORD 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

PRIOR MEDICATION RECORD 



PATIENT INITIALS 

:Jt: :A: ::&: ::B:: :£: :f:: 

FIRST 

:it: :±z: :M:: :it: :ft: :*:: 

INITIAL 
:dd:: ::V:: :«: :Jt: ::Y:: :i: 


::&: :it: ::!:: ::d:: 
:.-9:: :&: ::S:: ::T:r 


NUMBER MALES 001-499 FEMALES 500-998 

zSz: ::!:: z2zz :i: :*: zzi: ::&: zzT^z ::&: ::»: 

PATIENT 

:&: ::!:: :i: :i: :z4zz ::5z: z*: zzT^z ::&: ::*: 
:&: ::!:: ::2z: :i: :z*:: :z5zz zz&: ::^: zzft: ::&: 





:z4z: :&: ::€:: :A: :£:: :f:: 

SECOND 

:&: :i:: :«:: :*t: :«:: :dP:: 

INITIAL 

likz :?^:: :*: :dt: ::Y:: i: 


:«:: z:H:: ::!:: ::<):: 
:A: :i: :5zz zzTz: 


:Sz: ::!:: :2z: zi: :z4:: :z5z: 

RATER 
:&: z:l:: zZzz ::3:: :^4:: ::5:: 


:*: ::7^: ::&: ::*: 
:r6: ::^: ::ft: ::ft: 


~ 


■-' -^ 'zzhz' zzZz: ziz zzftz' ■ ' zzS:;' 

PERIOD 

•Ac zztzz :2zz ziz zztz . z.-fc 

Hourt Dayl Weeki 

^dic zzlzz z:2:: ' zzSzz 


zz6z ::7iz zzftz zzftz 

zz&z zzTzz zzftz zzftz 
- ," Montirt ■ - : ' 
■.'""' .zz4zz ■-■■',' 


— 


j -4« FORM 
[ NO. 


_^ 


^ 


PLEASE USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


— 


1. PRIOR PSYCHOTROPIC MEDICATION 

a. Record the name/s and maximum total daily dose/s of the drug/s which 
the subject received during the MONTH PRECEDING THE STUDY (prior 
to any drying-oul period). If no drugs received, write "none". DO NOT 
WRITE IN SHADED AREAS. 


2. OTHER TREATMENTS RECEIVED PRIOR TO STUDY 

Mark "YES" for all treatments which subject received in MONTH 
PRECEDING THE STUDY (prior to ar^y drying-out period). 
Mark NO for those not received. 


^ 


1 . Drug Name — Confine writing within this block 


a. DRUG 

Analgesic-narcotic 

Analgesic-non-narcotic 

Anesthesia-general 

Anesthesia-local 

Antiallergenic 

Anticoagulant 

Anticonvulsant 

Antifertility 

Antihypertensive 

Antimicrobial 

Antiporkinson 

Antitumor 

Blood tonic 

Bronchodilator 

Cardiac medication 

Cough and cold preparation 

Dermatological preparation 

Diabetic medication 

Diet medication 

Diuretic 

Gastrointestinal preparation 

Hormonal medication 

Muscle relaxant 

Sedative /hypnotic 

Stimulant 

Thyroid medication 

Vitamin 

b. NON-DRUG 

Behavior modification 
Electroconvulsive therapy 
Milieu therapy 
Physical therapy 
Psychothera py-g roup 
Psychotherapy-individual 
Rehabilitation/occupational therapy 
1 1 Remediol educational therapy 


NO YES 

zdObz zzlz: 
zz&z zzlzz 
zz&z zzlzz 
zdftz zzlzz 
zd&z zzlzz 
zd&z zzlzz 
zd&z zzlzz 
zi&z zzlzz 
zd&z zztzz 
zSzz zzlzz 
zfez zzlzz 
zJ&z zzlzz 
zflzz zzlzz 
zd&z zzlzz 
zftz zzlzz 
zfizz zzlzz 
z&z zzlzz 
zfizz zzlzz 
zd&z zzlzz 
zdft: zzlzz 
zfizz zztzz 
zflzz zztzz 
zd&: zztzz 
zfiz: zzlz: 
zfizz zztzz 
zCzz zztzz 
zfizz zzlzz 

NO YES 

zS:: zzlzz 
zS:: zzlzz 
zd&: zzlzz 
zd&z zzlzz 
zd&z zzlzz 
zd&z zzlz: 
:fe: zzlzz 
zfizz zztzz 


~~' 


zflzr zzlzz zizz zz3- zz4zr zzSzz 

z^. rrlr; --2zz zzSzr :-fc z^z 

DRUG 
zdBz: zzhz z£z-. zz3z: z*z zJSzz 

CODE 
=d9b= =J- z£ri zAr z*z zzStz 

z&z zzizz' zJlzz zziz r*= zzSrz 


zz&z :z7zz zzftz zAz 
zzSzz zz7:z zzBz zzft: 
zzfiri zz7:z zzft: zzSb 
zzfc z:7- rrfc zzSzz 
zz&z zzJzz zz&z zz&z 


^ 


:^: ::.:: ::^: z3z: .:4^,,,„,„.^: 
:ze:: ::):: :z2zz zz3zz zA: TOTAL :&; 

DAILY 

zAz zz):: :z2z: ::i: :z«z: DOSE IN ::&: 

MILUGRAMS 

:dt: flQt zflt: :J:: ::!:: :1Q: 


:A: ::7:: ::&: ::ft: 
zzfrz ::7:: ::&: ::»: 
:*: ::7:: ::ft: ::&: 

loa iQOfl 


1 


2. Drug Name — Confine wri(ing within this block 


I^ 


zOzz zrtrz zSzz :A: z^tzz =Sz: 

r&i ^rlzz rizz z3zz r*z ^*i 
DRUG 

zSzz ::tz: rizz r3:r -tr .rzSi; 
CODE 

ziSrz rrl- z£zz ziSzz :?i=z rdfc 

r& ^1= ^£zz zzS:: rztz :i: 


zz&z zJzz zdOzz -z9t= 
=&: =7zz zzft: zA: 
zz&z zr7=z zdfc =a= 
zz&z zzT:; =B:: z3b: 
CZ&: ,r£tr ziftz zzStz 


^ 


:ft: :z.zz zzEzz z3zz -*-^^^,^^,^^- 

:S:: ::!:: :5zz zz3zz zz4:: TOTAL -_J^, 

DAILY 
:fi:: ::l:: :i:: :i: :z4:: DOSE IN :z5z: 

MILUGRAMS 

:JL: iJQL zi31: :d:: r:lr: :1Q: 


::6: :z7zz zzft: ::ft: 
::&: ::7:: zzft: ::9: 
:.-&: ::7r: :&: zziz 

IQCt \QBQ 


^ 


b. Estimate length of time subject has been receiving psychotropic medica- 
tions. Mark appropriate time units and enter number. If "neveK' or "not 
ascertained", leove number area blank. 


E 


Neuroleptic "?'?^ 1'^^. 

:&: ::!:: :£:: ::3:: :4z: zzS; 
z&z ::!:: z2zz zi: :A: zA: 


Month Y«or Not Astortoinmi 

zA; ::7:z zzft: ::ft: 
zA: ::7:: :A: ::*: 


^ 


Antidepressant *.'!?[ **'A 

zfiz: zzlz: :2:: :3:: :.4:: zdSzz 
:fi:: ::tz: :2z: :3:: zAzz zdSz: 


Vonth Toor Not Auortoinxl 

zz&z ::7:: z*: :A; 
zz&z ::7:: :A: ::9:: 


— 


Anxiolytic _"-'-'?'. *•_•>_ 
zQzz zzL:: :£:: zz3z: zAz zzSzz 
:fl;z ::L:z z2zz z3zz :-4z: zirz 


■ooth Teoi Not Asiinoinail 

:&: ::7zz zz&z zAz 
zz&z zz7zz zzft: z:*: 




Other Psychotropic ."5.«?L J!nl 

:0:: :zlzz ziz ::3:: zAzz ::5zz 
z&: ::!:: :2z: zAz zz4zz zA: 


Monlh Tior Not AKsrtoiiiiil 

zz&z ::7zz zzft: zzftz 
zz&z z:7zz :A: :Az 





Developed with the ECDEU program, the Prior Medication Record (PMR) is a 
single-page, 8 item form designed to capture information concerning the subject's 
medication history prior to his entrance into the study. Responses are coded 
directly on the form and the General Scoring Sheet is not utilized. The PMR 
evolved from the now obsolete Drug Study Resume. 



APPLICABILITY 
UTILIZATION 
TIME SPAN RATED 



All research populations. 

Once for each subject. 

For I tern la, 11a and lib, one month prior to entrance 
into study. For I tern lb, time span is dependent on 
subject's psychotropic history. 



CARD FORMAT ITEMS 

CARD 01 = (I9x, 2(15, 1^) , ^13,2611) 

Item Column 

la - Drug Name No. I 20-24 

Dose No. 1 25 - 28 

Drug Name No. 2 29-33 

Dose No. 2 3^-37 

lb - Neuroleptic 38 - kO 

Antidepressant k] - 43 

Anxiolytic 44-46 

Other psychotropic 47 - 49 

2a - Other drug treatments (to Thyroid) 50 - 75 

CARD 02 = (I9x, 9i 1) 

2a - Other drug treatments (Vitamin) 20 

2b - Other non-drug treatments 21-28 

SPECIAL INSTRUCTIONS 

1. Do not write in the shaded areas of the ID block. Both Form Number and 
Period are pre-coded and need not be marked. (PERIOD for the PMR Is always 
des ignated "000") . 




ncorrect 





Correct 


\ 
















'.A. zAzz 

•A. zAzz 

Hours 

•A. zAzz 


z2zz 

■.-2zz 


z-3r.z 

Days 


PERIOD 
rA: r=fe: 

Weeks 




-Zu 


1 '■'''■" 


3*4- fORM 
NO. 


^ 


Montl^ 



111 



2. Item 1 - When writing in the names of drugs, the rater MUST CONFINE ALL 
WRITING WITHIN THE DESIGNATED AREAS. Failure to do so will result in processing 
difficulties. Needless to say, the writing should be legible. 



I ncorrect- 



Drug Name — Conine » 


riting v 


vilhin this block 








._ jy2P<i 


yU4 


^Uyi-<kJ^ 


5^ .:{.. 


--«- 


— - 



Correct 



Drug Name — Confine writing wilhln this block 



-t" ..izz -.-2r.-. 



3. Item la - Note that "month preceding study" means prior' to any drying-out 

period. Do not mark in the shaded area labeled DRUG CODE. Codes for drugs are 

assigned by the Biometric Laboratory. A list of the ECDEU drug codes may be ob- 
tained upon request from the Biometric Laboratory. 

h. See pages 230-232 for instructions on encoding dosage. Note that 
all dosages should be coded in miligrams. 

5. Item lb - This item is NOT limited in time to the month prior to the study 
but encompasses the subject's entire prior drug history. Estimate duration as an 
aggregate total in those instances where intake has been intermittent. To encode 
this ^-part item, the rater must designate the time unit and then encode in the 
numerics for duration. 

Example: Subject has received neuroleptics for h years; antidepressants 
only for 2 months; never received anxiolytics and received a 
stimulant for 3 weeks. These data should be encoded as follows: 



Neuroleptic 




Kner 


*^. 


Month 


Teor 


Not As(enoine<l 


^ ::li: :2:: 


liz 


z4zz 


:i6:: 


zdBiz 


:ir;: 


"ft: lift: 


ifi:: :zb: ri: 


zjbzz 


tA, 


:*: 


zzSzz 


ri7i: 


::&: ::&: 


Antidepressant 




Mtvir 


Week 


Month 


Teor 


Not AHOiloined 


A^ ::tii :£:i 


z3:: 


:4:: 


:5:: 


:*:: 


::?:: 


:A: 1:9:: 


zQzz ::br: .9. 


:3ir 


zAzz 


:5-.: 


:i6ci 


:i7i: 


:A: r:9:: 


Anxiolytic 




Nev«r 


WMk 


Month 


tent 


Not Ascertoined 


ifi:: ::l:: i£=: 


idi: 


:-»:: 


:5r-- 


rrfc: 


"7i: 


:A: :*: 


:fi:-_ ::l:: :£== 


=3:: 


:3»:r 


:5z: 


:*:: 


::7i: 


i:ft: :r9:: 


Other Psychotropic 




Never 


*e.k 


Month 


Teor 


Not Auertonied 


jdM. :;li: z2zz 


li: 


::t: 


r*: 


1*1 


:i7:: 


::&: ::ft„ 


!&: iitir z-2zz 


■Ok 


=4:: 


zJSnz 


:r&: 


::7:: 


:A: ::9:: 



6. I terns 2a and 2b - Contrary to the instructions printed on the form, raters 
may mark positive responses (YES) and LEAVE NEGATIVE ONES (NO) BLANK. 

DOCUMENTATION 

a. Raw score printout 

b. Frequency tables 



112 



THE 

PSYCHIATRIC 

PACKETS 



There are two Psychiatrist Packets - one for pediatric and one for adult 
populations. Each packet contains scales specific for the particular popula- 
tion and three common or universal scales. The compositions of the packets are: 

Children Adult 

Children's Psychiatric Rating Scale Brief Psychiatric Rating Scale 
Children's Diagnostic Scale Depression Status Inventory 

Children's Diagnostic Classification Hamilton Depression Scale 

Hamilton Anxiety Scale 
Anxiety Status Inventory 
Wittenborn Psychiatric Rating Scale 

Universal (Conmon to both packets) 

Clinical Global Impressions 

Dosage Record and Treatment Emergent Symptoms 

patient Termination Record 

Manipulating the sections of the packet and inserting the General Scoring 
Sheets may require some practice. The instructions on the back of the front 
cover of the packets should, however, provide the information needed to develop 
the necessary dexterity. It is important to state again, however, that the 
rater ALWAYS USE THE ASSIGNED SHEET NUMBERS for the scales - EACH AND EVERY TIME 
he uses them. Period Number changes, but Sheet Number never changes for a 
particular instrument. 

Although entitled "Psychiatrist Packets", these sets of scales may be rated 
by members of other professional disciplines as well; e.g., clinical psychologists, 
nonpsychiatric physicians, etc. The essential requirements for a rater are the 
appropriate clinical experience to make competent judgments and a thorough 
familiarity with these particular instruments and their uses. The selection of 
rating scales for a specific study is at the discretion of the investigator. 

Figures 8 to 12 present data matrices for each of the scales. These matrices 
indicate the encoding location of each scale as well as the GSS sheet number upon 
which it appears. These locations are FIXED and MAY NOT BE ALTERED. To do so will 
render the data non-processable. 

A maximum of 3 GSS is required at any given assessment with either packet. 
Figures 13 and 1^ describe the manner in which Sheet Number is assigned to General 
Scoring Sheets and show a typical usage of the scales. 



114 



ERRATA - Raters should make the following corrections in their packets. 

PSYCHIATRIST PACKET - CHILD (GREEN) 

1. On the cover, the word "PSYCHOPHARMACOLOGY" is misspelled. 

2. Dosage Record and Treatment Emergent Symptoms (29-DOTES) 

a) Page L-^, I tern 3. Should read "(No. through 6)", NOT 
"(No. 1 through 6)". Also on Adult (Gold) packet. 

b) Page R-5 - I tern 5. The word "Tachycardia" is misspelled. 

3. Clinical Global Impressions (28-CGl) - Page R-3. The word 
"GLOBAL" is misspelled. Also on Adult (Gold) packet. 

PSYCHIATRIST PACKET - ADULT (GOLD) 

1. Depression Status Inventory (072-DSl) 

a) All 20 items should be assessed using response positions 

1 through 4. The "Not Assessed" category should NOT be 
used as it would change the scoring structure. 

b) Page L-3- Item k. Under Interview Guide , the item should 
read: "Frequent and early AM wakings". 

c) Page L-3- Item 7. Under Interview Guide , the item should 
read: "Do you enjoy looking, talking or being with 
attractive men/women?" 

2. Hamilton Depression Scale (049-HAMD) 

I tern 9 - Agitation - This item should be rated on a 5-point scale 
as follows: 

= None 

1 = Fidgetiness 

2 = Playing with hands, hair, etc. 

3 = Moving about, can't sit still 

k = Hand wringing, nail biting, hair-pulling, 
b i t ing of 1 ips 

3. Anxiety Status Inventory (051-ASl) 

a) We regret that the author's name was inadvertently omitted 
from the AS! header page. 

b) The instructions given on the header page for the Depression 
Status Inventory should be applied to the Anxiety Status 
Inventory as follows: 

MH-9-51 ANXIETY STATUS INVENTORY (AS I ) 

Wm. W. K. Zung 

INSTRUCTIONS: Code 01 under Sheet Number on General Scoring Sheet 

The data upon which the judgments are based come from the interview with the patient. The items in the 
scale are to be quantified by using all the information available to the rater. This includes both clinical obser- 
vation and the material reported by the patient. 

Use of the Interview Guide below assures coverage of all the areas on which judgments are required. How- 
ever, the rater has the flexibility of modifying the questions or probing for details, which makes possible a 
smooth interview that does not sound like a question-answer examination. In rating the patient's current 
status, an arbitrary period of 1 week prior to the evalutaion is adopted in order to standardize the data. In 
order to reinforce this, the interviewer should occasionally precede questions with, "During the past week, 
have you 7" 



115 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

ECDEU GENERAL SCORING SHEET (50-GSS) 



PATIENT INITIALS 








NUMBER MALES 001 TO 499 NUMBER 


FEMALES 500 TO 


998 





::A: rrfi: i^C: "D: "fc: 


::F:: 


::«: ::H: --i"- 


::*: 


:*: ::l:: ::S:: rij:: ::4:: 


::£: 


::fc: 


::f:: 


::*: 


::fc: 





FIRST 








PATIENT 


r 










~~ 


rrlfc: "t: zztAz :*t: ::0: 


::P:: 


::Q: 




::3:: :=*:: 


::5:: 


::fc: 


::7:: 


::&: 


::»:: 


^^ 


INITIAL 
"tt: -zltz =A«: ::)t: i=Vi: 


::£: 




FIGUR 
MATRICE 


E 8 -_^, -^ 


::5:: 


::6:: 


::7:: 


::8:: 


::S:: 


— 








S FOR ^ . 












~~ 


:JC: "ft: ::£: ::£>= "&: 


::?:: 


::©: 




::3:: ::4:: 


::5:: 


::&:: 


::?:: 


::8:: 


::»:: 




SECOND 


CHILDREN'S PSYCHIATRIC RATER 












"^ 


i:K:r :rt: zMz :*t: :«: 


::P:: 


-^ ACCCCCMCkfT crAi CC -^" =^" 


::£: 


::&: 


::7:: 


::8:: 


::»:: 


~~ 


INITIAL 
.:tt: "U: :*»: ::X: "¥:: 


::£: 


Moo 




1 J ur-\ i_ u 

::3:: ::4:: 


::5:: 


::*:: 


::?:: 


::8:: 


::»:: 


— 




E] 


::3:: rri: ::9:: ::*: SHEET 


::S: 
::5: 


::fe: r:^: ::»: 

::&: ::S: ::&: 


::9: 
::a: 


PERIOD 
:*: ::}:: :*: :4:: ::*:: 

Hours Days 
::&: ::t: ::2:: 


::5:: 

/Veeks 
::a: 


::&: 


::?:: 

Months 
::a:: 


::8:: 


::?:: 


— 


::tt: 


^1::a:: ::3:: ::±: NO. 





Row 


'G6mpitis-lVe==3:= ==*= 


::S;: 


::fc:(42^; 


::ft: 


::9:: Ro 


' 1 :5tens4ton s: ----t- 


§■■■■■ 

::5:: 


::&:: 


::7:: 


::8:: 


::»:: 


— 




2H&t)itS 2:z ::3:: :=*: 


::&: 


::fc:(4*: 


::&: 


::*: 


2iJfeder-pr«duotivse Speeali 


r:6:: 


::f:: 


::8:: 


::»:i 


"~" 




3©fe=se*si^e --*- "*= 


::5:: 


::fc:(4^5 


::»: 


::ft: 


Sf'idgetSeSS ::*: 


::5:: 


::fc: 


::7:: 


::&: 


::»:: 


^_ 




4g&^li«ary ==3:: ::*: 


::S: 


::fc:(4*; 


::ft: 


::9:: 


4 ^p eta G=e-i vi^ y 


::5:: 


::6:: 


::7:: 


::8:: 


::*: 


^ 




5Pe«r In^teeraeti^n 


::S:: 


::fc:(4a:; 


::ft: 


::*: 


SilypO&Cfcivity ::*: 


::£: 


::6:: 


::J:: 


:rS:: 


::«:: 


^_ 




6gfeTig ==*= 3^ ==*= 


iiS:: 


::fc:(4:7:; 


::»: 


::*: 


6 =MsG*^ae=tiMlity 


::£: 


::&:: 


::7:: 


::8:: 


:*: 


^_ 




7Ft-gh«itig ==*= ==*= 


::5:: 


::fr:(4g:: 


::8:: 


::9:: 


7^nGtma-l Rs^latttonsh 


L:p:S 


::fc: 


::?:: 


:*: 


:*: 


^_ 




SBttlly ::2:: ::3:: ::*: 


::&: 


::«::( 4ft^ 


::»: 


::St: 


8 4fet t hiir a«a 1 ::*: 


::£: 


::fc: 


::?:: 


:*: 


:*: 


^ 




'ftemp^T 3^ ==*: ::*: 


::&: 


::fc:(5#^ 


::ft: 


::St: 


9 #vertForaf ii=^nt^=*= 


::5:: 


::6:: 


::7:: 


:*: 


:*: 


~ 




'"S^Fap^gcFat =*-■ ==*= 


::&: 


-^=(5*5 


::ft: 


::St: 


10 4»egalfeiV«^ ::3:: :z4z: 


:*: 


::6:: 


::7:: 


:*: 


:*: 


IZ 




'iL^ng ==2== ==3== ==*= 


::&: 


-t<52^^ 


::&: 


::»:: 


1 1 ^BlgrJf :*: :*: :^: 


::*: 


::6:: 


::?:: 


::8:: 


::»:: 


"■" 




i2Efepl«fit3tive ==*: 


::5:: 


::fc:(5:>) 


::ft: 


::St: 


12#ili^ :*: :=3:: :-t: 


::5:: 


::6:: 


::?:: 


::8:: 


::«:: 


"^ 




"3l*abiii=ty c& fail asieep =(5#) 


::&: 


::Sk: 


i3:@Gn£»3si:®n ^-- ^^ 


::S:: 


::fc: 


::7:: 


::»: 


::»:: 


~ 




"4S4«e^ di€fi^Hal=feies 


:i5c: 


-^<5#^ 


::ft: 


::9t: 


1 4 :M s o?ei ©«t afri oa - 


::5:: 


::6:: 


::?:: 


::»:: 


::»:: 


^ 




l5BfedW*ttitag 3:: ::*: 


ii5;: 


-fc<5#^ 


::ft: 


::9:: 


ISjSlingiag ::*: ::4:: 


i:S:: 


::6:: 


::?:: 


::8:: 


::»:: 


— 




l6Rfefe*ei«fe ::3:: :=*: 


:iS:: 


::*:(5:>) 


::&: 


::9t: 


i6^feisp©Tifeane»as :: 


::5:: 


::6:: 


::?:: 


::8:: 


::»:: 


_^ 




tJ'B^VSACVttSGTy .: ::*: 


::&: 


::fc:(5a^ 


::ft: 


::»:: 


17 :gbiSpici«US:a€SS 


::£: 


::6:: 


::?:: 


::&: 


::*: 


^ 




i8?lFinMng Difeor4ers 


::&: 


::fc:(5*^ 


::ft: 


::9:: 


l8:Bepi?fess*d ©emeanor 


::S: 


::6:: 


::?:: 


::8:: 


::9:: 


~ 




'9B<^lu#icFF*s ---^-- ==*= 


::5:: 


==fc<6^) 


::ft: 


::*: 


19:Munt-ed Affect 


::S: 


::6:: 


::?:: 


::«:: 


::8t: 


^ 




JOHfel Ittc tflatifens:*: 


::&: 


::fc:(6±) 


::ft: 


::*: 


20:liabitiey ---3== ==*= 


::S: 


::6:: 


::?:: 


::8:: 


::*: 


— 




MEteltaSl-ee a: ::*: 


::&: 


::fc:(6-l) 


::ft: 


::9:: 


21 -Sxes&urdiz cti spieech 


::S: 


::6:: 


::7:: 


::8:: 


::*: 


— 




Wtftck: of: insight: 


::&: 


::^:^6i^ 


::ft: 


::St: 
::*: 


22 ^ee-eh ^^ev^lopftent 

23 #feu£ifeertng ' ----^-- 


::5:: 
::5:: 


::6:: 
::6:: 


::?:: 
::?:: 


::8:: 

::8:: 


::»: 
::5t: 


— 


23:*: ::!:: ::2:: :*: ::4:: 


::&: 


^: ::^: 


::ftr 


^ 


24::ecr ::J:r rit: rii: rafcn 


::&; 


izflk ::7:: :ift: 


::9:: 


24:Lgw *?oi«e --s^-- ==*: 


::5:: 


::6:: 


::3i: 


::»:: 


::9:: 


^ 


25::e:: =i3" =:St= :ilr r:4:: 


::5:r 
::5:: 


:A:^ 

::£M? 


::ft: 


::9t: 


25:lA3ud -V&iCe : ::4:: 

26 ^Misp^eoitanGiation 


::S:: 
::»: 


:i6:: 
::6:: 


::7:: 
::7:i 


::8:: 
1=8:: 


::*: 
::*: 


~ 


26-6:: ::3" ::2:: zrl: rri:: 


::ft: 


::*:' 


.^ 


27::a:: ::tr rrii :n3c: z:i:n 


::&: 


::6:: ::3!:: iiBii 


1=9:: 


27 #peefeh =iev#anGfie 


::S:: 


::fr: 


::Ji: 


::»: 


::St: 


^ 


28 1:6:: i;ai: z:2:i ::3:: -"4:: 


:ift: 


::&: :i3t; "ft: 


::9:: 


28:^ytfenii=fe m^ioRS 


::*: 


zzlcz 


::JI:: 


::»:: 


::»:: 


~ 


29::ft: ::3r: n:2:r -i: :=<t: 


::&: 


:;&: ::i: :*: 


::S:: 


29 =laf e»ri<3*ity ==*= 


::*: 


zzifiz 


::?:: 


::»: 


::»:: 


""" 


30-8:: zit: iiti ==lr :=4:r 


::5:: 


::fc: nK: ::ft: 


::9:: 


30 =^an«i(ySit5f -^- 


::S:: 


::6:: 


::/:: 


::8:: 


::*: 


— 


31::a:= r:3rr "i: "i: "4:: 


::&: 


::6:: ..J-.z ::ft: 


::St: 


31 =Miys»tcffl cSinplaints 


::*: 


::6:: 


::3t: 


::&: 


::*: 


— 


32::a:: ==ii: nil iii: ii4:= 


::5:: 


lit: ::3I:: ::8:: 


::9t: 


32 :QbeSjLty -- :*: ::4:: 


::S: 


::6:: 


::^: 


::&: 


::*: 


^ 


33=16:: ::!:: ::2:: :3:: :3d:: 


::&: 


::6:: ::ft: ::ft: 


::»:: 


33:Batifeg proMeiBS 


::*: 


::&: 


::3t: 


::8:: 


::*: 


^ 


34:*: ::l:: :i: ::3:: :=*:: 


1=5:: 


::fc: ::J:: ::&: 


::9b: 


34:9epa»pafrion ansftety 


::S: 


::6:: 


::Jb: 


::&: 


::9:: 


*■" 


35:*:: ::!:: :i: zJ:: :34:: 


::&: 


::&: ::?:: ::ft: 


::9l:: 


35 :BepFesffiDn ■ --*^- 


::&: 


::*:: 


::3b: 


::8:: 


::9:: 


^ 


36 :A: ::5:: :i: ::3:: :d1:: 


Hi: 


1:6:: ii3t: :*: 


::*: 


36:guph*5ri» =*: =*= 


::S: 


::6:: 


::Jii 


::*: 


::9:: 


^~ 


37::eiz 


:ili: i:2:= ::3:: :d4:: 


::t: ::?:: 


:=8:: 


::St: 
::9;: 


37 :Sack :of enargy-: 
38-^Snxi*et7 to^lcst= 


::5:: 
::*: 


::6:: 
::&: 


::3t: 
::3tr 


::8:: 
::&: 


::»: 
::Sb: 


^ 




38:*: 


::!:: :i: :a:: SfevGrl 


t^ 


::«c:(i).: 


::ft: 


~ 




39:*: ::!:: ::2:: :*:Impr OVetnfitll 

40-*- -i- -±- ^flcacy Ii^c 


: (2:>: 


::ft: 


::9t: 


39 :&ep£»es s4ve top»ics 


::*: 
::S:: 


:i6:: 
::&: 


::3t: 
::3t: 


::8:: 
::»: 


=:»:: 
::»:: 






iX, 3 


::t: 


T!^ 






41:*i ::a~ =:2:: :*: :3l:: " 


::5:: 


-4: ::!:: ::t: 


.116 




:,&: 


lift:: 


::7:: 


::8:: 

79 


::*: 
20 




a 


ok: f 


"3 — 3 — 4 & 


T~ 


y g 




ols: 11 12 13 14 IS 


/6 


77 


18 





DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 













ECDEU GENERAL SCORING SHEET (50-GSS) 

















PATIENT INITIALS 


















NUMBER MALES 001 TO 499 NUMBER 


FEMALES 500 TO 


998 





z-Jkz 


=:ft: 
==J;= 
==V= 


:=e: 

=da= 
=a«= 


::D= 
==fct= 
==)t= 


==£:: 

FIRST 

==o= 

INITIAL 
==>fc= 


==p.= 

==P:= 
==Z:= 


==©= 

==Q= 


=:H= 


==4== ==*= zzOzz 

FIGURE 9 
MATRICES FOR 
:HILDREN'S DIAGN 
SCALES 


==l== ==2:= =:3== =^= = 

PATIENl 

--'-- -"»- ::3=: ==4== 

=:3== ==4== 


==4= 
==4= 
==4= 


==fc: 

==4= 
==4= 


==?== ==4= 

==f:= ==4= 
::3t: ==4= 


==4= 
==4= 
==4= 


— 




==ft: 
==1;: 


==e= 


=:B= 

==M= 


==£:= 

SECOND 

==o= 

INITIAL 


==fc= 
=:P:: 


=«= 


OSTIC '*'" '^" RATER 

==3== =^= 


==4= 

==i: 


==4= 
==4= 


==?:= ==4: 
==?== ==4= 


==4= 
==4= 



















.itl. 


:=\t: 


= 4W: 


-Xz 


==y:= 


= :£= 










==3== :=4== 

PERIOD 

:*: =:»=: ==2== ==3== ==*== 

Hours Days 
rift: :=4=: = = 2: = 


==4= 

==4= 
Heeki 
==3= 


==6== ::7:: ==4 = 

==4= ==f== ::4= 

Months 
==4=: 


==4= 
==4= 




EL 


=:3:: 

=:a== 


::2: = 


[3 


"*: SHEET 
==4:= NO. 


=:»= 
==5= 


==»= 

==&= 


=:5t: 
==i= 


==8= 

==a= 


==a= 
==a= 


^ 


Row 1 ;:0:: 


==t= 


==2:= 


==»= 


==*: 


==&= 


==&= 


==7:= 


==4= 


==4= Row 


1 Pgy<?hoCism 3:= ■>" 


T^T* 


=:6== 


==7== 


::4= 


==4= 





2::a- 


==t= 


==2:= 


==»: 


:=*: 


==&= 


==fc= 


==7:: 


==4= 


==Sb= 


2A-ftxi*ty reafeti^n 


==4= 


=:t= 


==?:= 


==4= 


==4= 


~ 


3=:ft: 


==t= 


==*= 


:=*: 


:=*= 


==a= 


==fc= 


==7:= 


==4= 


==*= 


sWitl^drawal ■::"==4== 


==4= 


==fc: 


==?== 


==4= 


==4= 





4r:D:: 


=:t= 


==2:= 


==}:= 


==*: 


==&= 


==fc= 


==K: 


==4= 


==Sk= 


4U*tsocializsd 3ggress:ion =6== 


::?:: 


==4= 


==4= 


— 


5::0:: 


==t= 


==2:: 


==»= 


==*= 


==&= 


==&= 


==K= 


==ft= 


==9:: 


5S€Jcialt*ed aggfessio^f- 


==6== 


= =7=; 


==4= 


==4= 


._ 


6::fti 


==J== 


==2:= 


:=J:= 


==*= 


==&= 


==6:: 


==7:= 


==4= 


==ft= 


6E^l«3st*e 3^ ---^-- 


==i= 


==4= 


==7=: 


==4= 


==«== 


— 


7z:ftr 


==J== 


==i= 


=:»= 


==*: 


:.&z 


==& = 


==3t= 


:=4= 


==4= 


7 Hyperac-feivi ty ==4== 


= =4: 


==4= 


==7=: 


==4= 


==»== 





8==©:: 


==J== 


==^= 


==*= 


==*= 


==&= 


==6:= 


==3t= 


==4= 


==4: 


8l«Bnatur=e ==3== ==4== 


==4: 


:=6=: 


==7:: 


==4= 


==4= 





9==e:r 


==J:= 


==^= 


==»:= 


==*= 


:=&: 


:=«:= 


zrS: 


::»= 


==4= 


9Qcg3?t-iG iTnpair«ent 


==4= 


==6== 


==?== 


==t= 


==4= 





10 ==8:: 


==J:: 


==2:= 


==J== 


==4== 


::&= 


==6:: 


~3i:r 


::a= 


==4= 


lOBeliriua =*= -^ 


==S=: 


==6== 


==7=: 


==4= 


==«== 





1 1 ==e:i 


==!== 

==J== 


==2:= 
==2:= 


==3== 
==*: 


==4== 
==4== 


==&= 
==&= 


==&= 

==&= 


==3!:= 
==7:= 


==4= 
==4= 


==4= 
==4= 


11 Mental retardation 


==s= 


==4= 


==7=: 


==4= 


==4= 





12=:e:= 


l2Bi=agiiosis =<'a) :^-= ♦^ 


==4= 


==fc:: 


==7: =:4= 


= =4: 


..^ 


13=*r 


==J== 


==2: 


=*= 


==4== 


==&= 


==6:= 


=;3i= 


==4= 


==4= 


13 ==4= ==H= ==2== =(%)==4== 


==4= 


==4= 


==7:: ==4= 


==4: 


"~ 


14r=et= 


:=3== 


==2:: 


=:3b: 


==*= 


:=&= 


==4= 


==3i= 


==ft= 


==ft= 


14==*== ==H= ==2:= =(-b) =^-^ 


==4= 


==4= 


==7= ==4= 


==4: 





15.:Q:: 


==J=: 


==2: = 


==&: 


==*= 


==5:= 


==4= 


==3!;= 


==4= 


==4= 


15 ==4= :=J*= ==2=: =(t))==4== 


==S= 


==4= 


==7i: ==4= 


==4: 





16==&: 


==t= 


==i= 


==3:= 


==*= 


==&= 


==4: 


==7:: 


==4= 


==4= 


16 ==4= ==S?= ==2== =(b) ==4== 12 


==S= 


==4= 


==7=: ==4= 


==4: 





17iitt= 


==i= 


==2:= 


==3:= 


==*= 


==&= 


=:fc: 


==7:= 


::4= 


:=»:= 


17 ==4= ==i5= ==2== =(Tg) -^= 


==4= 


==6:: 


:=7=: :=4= 


==4: 





18.-=&: 


=r±= 


::2:= 


==1: 


==*: 


==&= 


==4= 


==J:= 


==4= 


==4= 


18==e== ==5?= :=2== ={g) ==4=: 


==4= 


==4= 


zzr-z =4= 


==4: 


— 


19r:tt: 


==i= 


==2:= 


==3:: 


==*= 


==4= 


==4= 


==K= 


==4= 


==4= 


19 ==4= -=S== ==2:: =(e) ==4== 


==S= 


==4= 


==7== 4= 


==4: 





20i=&: 


==±= 
==±= 


==2:: 
::2:= 


==3: = 
==3:= 


==4= 
==*= 


==&= 
==&= 


==4= 
==4= 


==3!:= 
==*: 


==4= 

==4: 


==4= 
:=4= 


20 ==4= ==5J= ==2:= =(ig)==4==^J 


==4= 


==4= 


==7== ==4= 


==4: 





21 ==a= 


21 ==4= 


No special SymptoHfe 


i^) 




=4= 


==4= 





22z=fi= 


==±= 


==2:= 


==3:= 


==*= 


==&= 


==4= 


==31:= 


:=4= 


==4= 


22 ==4= 


&pee<?h <Jist-trbanc-e 


im 


==7:= 


:4= 


==4= 


■^ 


23=zfc= 


==J=: 


=:2=: 


==3== 


==4== 


==4= 


==4= 


==3!:= 


==4= 


==4= 


23 ==4: 


Learfting --Mz 


==4= 


4^) 


==7== 


:4= 


==4= 


^~ 


24==e:i 


==a== 


==2:= 


==»:= 


==4== 


==&= 


==4= 


==*= 


==4: 


:=4= 


24 ==4= 


Tic r=2== ==3== ==4== 


==S= 


m 


==7:= 


:4= 


==4= 





25==e:= 


==J:= 


==2:= 


==3== 


==4== 


==4= 


::4= 


==7:= 


==4= 


==4= 


25 ==4= 


VsychovaetoT- = 


==&= 


^£) 


==7:= 


:4= 


==4= 


^_ 


26r=a:. 


:=!== 


==2:= 


==9== 


==*= 


==5:= 


==4= 


==3t= 


==4= 


==4= 


26 ==4= 


Sleep :=3== ---^-- 


==S= 


i^) 


zzrz ^i= 


==4= 


^_ 


27 ==6:= 


==3== 


==2:= 


==9=: 


:=*:= 


==a= 


==4= 


==?:= 


==4= 


==4= 


27 ==4= 


F=eediag •== =*= 


==*= 


i^) 


==7:= 


=4= 


==4= 


^~ 


28 ..6:= 


==J== 


==2:= 


==3== 


==*= 


==&= 


==4= 


==3t= 


==4= 


==4= 


28 ==4= 


Bnurfrsi^ --^- 


==4= 


i^) 


==7:= 


=4= 


==4= 


"" 


29==e:= 


==3== 


==2:= 


==3b= 


==*:= 


==&= 


==4= 


==S= 


==4= 


==4= 


29 ==4= 


Encrdprscis = 


==4= 


i^) 


==7:= 


=4= 


==4= 


"^ 


30=:e:. 


::1== 
==t= 
==i= 


==2:= 
==2:= 
==2:= 


==i= 
==1= 
==9:= 


==*= 
==*= 
==*: 


==5:= 

==&= 

==4= 


==4= 
==4= 
==4= 


==J:= 
==?:= 
==i: 


==4= 
==4= 
==4= 


==4= 
==4= 
::4= 


30 ==4= 


(Sephalalgia 


==»= 


iiS:) 




=4= 


==4= 
==4= 


^ 


31 zzfti 


31 ==e== ==j== ==2== ==- CD£= 


==&= 


==4= 




■^ 


32:re:= 


32 ==4= ==J== ==2:= ==3== =^= 


==5:= 


==6:= 


zzr-z ==4= 


^~ 


33 3=6== 


==»== 


==2== 


==3== 


=:4== 


==5:= 


==4= 


==J:= 


==4= 


==4= 


33 ==4: ==J== ==2== ==3== ==4=: 


==4= 


=:6c= 


==7:: ==4= 


==4= 


^ 


SA-dBzz 


==!== 


==2== 


=J== 


==d== 


==i= 


==4= 


==?:= 


==4= 


==4= 


34 ==4= =:J== ==2== =*= :^= 


==*= 


::ec: 


==7:: ==4= 


==4= 


^ 


SS-ddzz 


==!== 


==2== 


==3== 


==*=: 


==&= 


==4= 


==J:= 


==4= 


==4= 


35 ==4= :=»:: ==2== ==3== ==4== 


==4= 


r:ec= 


==7:= ==4= 


==4= 


-" 


3b. Az 


==!== 


==2== 


==3== 


=d4== 


==5:= 


==4= 


==?:= 


==4= 


==4= 


36 ==4= :=»== ==2== ==3== ==4=: 


==4= 


==4= 


==7t= ==4= 


==4= 


■~" 


37=*= 


==!== 


==2== 


==3== 


==4== 


==5:= 


==4= 


==3t= 


==4= 


==4= 


37 ==4= zzUz =:2== =:3== =^= 


==4= 


==4= 


==7:= ==4= 


==4= 


^ 


38==e== 




==2== 


==3== 


==*== 


==5:= 


==4= 


==J:= 


=:4= 


==4= 


38 ==6== ==l== ==2== ==3== ==4== 


==4= 


==4= 


==7:r =4= 


==4= 


^~ 


39==&= 


==!== 


zz3zz 


:=3:: 


:d4:= 


==5:= 


==4= 


==7== 


==4= 


==4= 


39 ==4= ==!== ==2== =:3== ==4== 


==4= 


==4= 


==7:= ==4= 


==4= 




40==ft:= 




==2== 


==3== 


==*:: 


==5:= 


==4= 


==7:= 


==4= 


==' 


==»== ==2== ==3== =*= 


==*= 


==6:= 


==7:= ==4= 


==4= 




41==e== 


==J== 


==2== 


==3== 


==i== 


==4= 


==4: 


==i= 


==4= 


==' 11 


7 :=»:= ::2== =:3== =^=: 


==4= 


==4= 


==7t= ==4= 


==4= 




Cols: 1 


;> 


3 


4 


K 


6 


7 


S 


9 


7 




72 13 14 IS 


Tfi 


17 


18 




19 


20 





j 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

ECDEU GENERAL SCORING SHEET (50GSS) 



PATIENT INITIALS 


NUMBER MALES 001 TO 499 NUMBER FEMALES 500 TO 


998 


— 


::A; ::&: riC: "D: -fc: ::ft: r33: : 


[== zzSzz ==4:: ==£: zzbzz 


::7: = 


==8:= 


==9t= 





FIRST 


PATIENT 








■"■ 


"K: rrt: zzIAz :i>t: :«: ::P:: :«: i 


^ , ^ , ,r, r- 1 r, '" -^- -'■*-'- "5:: r:6:: 


==f: = 


==8:= 


==9:: 


^^ 


INITIAL 


FIGURE 10 








^ 


z.tlz :r!sf: zViz ::)t: :=V^= zzZ:= f^lA TR 1 C C TOR ^ '"^^ '"*'' '=*' "^' 


:=7=: 


::S: = 


==9== 





==*= ==^^ -e: .E.. ^=E. .^: .*: ADULT PSYCHIATRIC ^= -^-- =^== .^^ER ^=^= ^^'^^ 


==?== 


==8: = 


::9:: 


E 


zztr :.t= --A*. :*t: :«: .:ft: ::£>: z: ASSESSMENT SCALES iz ==3.: r:4r: ::5:. ..&: 


==7== 


= =8== 


==9== 


— 


INITIAL 
:;tt- :rVi :i«: ::X: ::1|^: ::£: 




:*: ::J:: :.^== ==3== =^== ==5== ==&= 


=:7:: 


==8:= 


=:9=: 


— 




Li. 


:=3== ==2:= irl: ==*: 


SHEET 


::f:- rrf." -:7= : = S = 


==5= 


PERIOD 

::©=: ==»=: ==2== ==3== =^=: ==5:= ==&== 

Hours Doys Weeks 
==ft= ==t= ==2= ::3= 


==?== 

Wonth 
=i;== 


==8== 


==f== 


— 


-tt: 


^1 =:2:= = = 3:: ==4: 


NO. 


=«= |==*=|^=l==a= 


^L - 


— 


Row 


' I>epresg^g<i =Meod 




ATlxi=GUS^=^= ==a= 


==9:= U 


" iS&maedc Gortfeera -5:: ::»:: 


::7= 


==8:: 


=:»:: 


— 




2 (klilt ::2:: :::»: i:*; 




F^ai^:' - ::S: ==&= 


==9t= 


2Aftxie=ty : =--3:= ==4== ==5:= ==6== 


==?= 


==8: = 


==9== 


— 




3 &lieide ::3:: ::*: 




P^ani^: ==s: =:ft: 


iSt: 


3Effiot=i«nal Wtthdrawal ^z ==6== 


==7= 


==8: = 


= =?== 


— 




4 Barly Inrsonffila 




D-isiii£egr=at;ion == | 


4Gffincaptaal fiisarganizatifin 


::7:: 


= =8:= 


==9== 


— 




5 Mddle insoainia 




A|iprflhen3S:iGja= 


==9t= 


sGtflila Faelistgs : ==5== ==6== 


= =7=: 


==8:= 


=*: 


— 




6 Late InsoiHTtia t; 




T^semorSzzT:: ==a:= 


==9:: 


6Xens-l-on- ==3:= ==4== ==5== ==6== 


= =7=: 


==8== 


==9=: 


— 




7 Work :=2:: ::?:: ::* = 




Aahe=a^Pai=ns,8:: 


::ft: 


jMenriftri^ss & Pasturing ..t. 


==7=: 


==8== 


==9== 


— 




8 Retardation =^*^ 




E«ti^ue==s= ==ft= 


==9:= 


8Gtandiosity ----^-- ==5== ==6== 


==7=: 


==8== 


==?== 


— 




9 Agitatien ^z*: -«:; 




Rustles see s=s 


==9b = 


9Bepres s=ive ==Moo4 -' - ==6== 
ioli®sti=li^ ==3== =^= *=!''**..== 


==7=: 


==8== 


==9== 


— 




10 iteX:; PaydChiC ::* = 


*l 


Balpkitation 


A 


.=7=: 


==8== 


==9== 


— 




11 A¥ix==jSoma=ti« :*; 




D=izz=inesB: ==&= 


S 


iiSaspicicftiSRass = "5== "fc= 


::7:= 


==8:: 


:=9== 


— 




12 Sytn^6omB= G=I ----^-- 


H 


EairttnesE ==&= 


« * = 


I2li«llueiaat03f=y ftehavior ==6== 


==7=: 


==8== 


==9:= 


— 




13 Symptoms Gane^ 


A 
M 


D^tspaea . ==&= 


==9t= 


l3Mffl£oH R&tard-ati=on ==5== ==4== 


==7== 


==8:= 


==9:= 


— 




14 Srjnnpitomi: G^:!!!:^ 


D 


Paraithestas ^ = 


==9: = 


i4U!ffiCQ0perativena:Ss ==5:= ==6== 


::7=: 


==8:= 


==9:= 


— 




15 i%yp<3teh0fe=dr#asdte 




Nausea ==3^-: ==&= 


==ft = 


isUmusiial Theaigh4 Gonteet ==6== 


==7=: 


==8:= 


==*:: 


^^ 




16 lit. Leas. - ill-a£ 




U#inary=:Fre(| 


==9:= 


UMunfied Aff-feCt :=5:= =:*== 


::7:: 


==8:: 


::9:= 


X 




I7 54t.- losi^A&txiss^ 


4I 


Swea=6ing ==&= 


==ft = 


i7E«ciaem©nt ----^-- -5== ==&== 


==?== 


==8:= 


==9:= 


— 




18 Insight : "Sb: ::*:; 

19 Mu^nal-^Pr^s ==*= 




E=Lusiied E-aez&z 
lasoBKiia ==&= 


==9t= 
==9t= 


isMsoBdea Cation -: ==5== ==*== 


==7^: 


==8:= 

==8:: 


zzfzz 

::9t: 


— 




I9liepre=ssed MeDd(l) 


:=5:= z-dzz 


:=jfc: 


— 




20 MurtiaL>-5e^ --iz 

21 BepeiESOfial. . -i: 




Nightaaarfes :,&= 


==9t= 


20&s=yiag ==2== ==»== =(2) 
2lBiurnal==2== ==3== =(3) 


-..Szz :=6:= 
"S: ==6:= 


:=Z:= 
::^= 


==8== 

==8:= 


=:St= 
==St= 


— 




TkrPritened ==&= 


4i; 


— 




22 Ba ratio i4 =:a= ==4: 




Eare±K3diBbg ==&= 


^2; 


22S:leep ==2:: ==3:= =(4) 


==5:= zzfsLz 


:=7== 


==8:= 


==9:= 


~ 




23:abS©SS/:£k3I^. ==4=: 


H 


Gi±il=t -=K= ==8:= 

Aaaxieiyiij:: ==8:: 




23Appe&ite ==3== =(5) 
24Wedgh;t isosa =(6) 


==£= ==6:= 
==5:= ==6:= 


==7== 
==7:: 


==8:= 
==8:= 


=:9t: 
==9:= 


— 




24 Aiixious Moiad (zlz) 


^^^^ 




25 5€nsion ==3=: (=2) 


A 
M 


At.tea£io& ^ 


^5) 


25ifibid© 3^ =*= :(?) 


::S:: :=fc= 


=:^= 


==8:: 


:=9t= 


^~ 




26 g«a=r-S r=2:= zri: (^S-) 


A 


S^rop-t-ems ^ 


m 


26G«nseipat;iofi =(6) 


=lS= ==6:: 


==7:: 


::8:= 


--9zz 


^~ 




27 ins£rmnia ::i= (-4) 






G3^gaBic"^= t 


if-) 


z^Tsch^a^dia =^9) 


::S= zzfszz 


..r-z 


==8:= 


==9:= 


^~ 




28 l¥lt«ile€tU*105) 






P3*obi€ J^r =:&= 


im 


28F«tigse==2== ==3== (49) 


^ D s 1 


zzT-z 


==8:= 


==St= 


"■■■ 




29 ®ep^-essfed (6) 






Gfaiseseive: ==&: 


i^) 


29A-gica£iQn =*= (=ii) 


==. . ..«:: 


==7:: 


==8:= 


:=St= 


ZI 




30 S©matie-Mu#c(=?) 


J 




G<5mpQ4si^e ---^- 


im 


30Rfetaa?dation - (15) 


:=S= ==fc= 


==Jt: 


==8:: 


==»:= 


^~ 




31 9omatic-5etts(8) 




l«de«isi^fe ==»= 


a^-) 


^leftnfU^ibff =*= (13) 


==S= .z«.= 


z=7:= 


==8:= 


:=9t= 


^ 




32 Sym^tomfr-CV (9) 




A'TOi^nee --^- 


(m 


32Eftpt3L¥iess =*= (14) 


==S= z-t^z 


==?:: 


==8:= 


==*= 


X 




33 S:yTi^£oi^-RE(10) 




Ra:tajrdatioita:= 


(i^) 


33H©peiessnes« (=15) 


:=S:= "6:: 


==7:= 


==8:: 


==9:: 


^~ 




34 Synif* t orafe- 6 1 ( 1 1 ) 




G:^?eraeti^-e ----^-- 


(i^) 


Ml^deeisdve. (16) 


=:S= r:6:= 


-7i: 


==8:= 


==9:= 


"^ 




35 gyTnptoraS:-GU(12) 




I»re:leva»t ==8== 


Ci^) 


}5I«ri=ftabdlity (d?) 


irS: ==6:= 


==7:= 


==8:= 


==9:: 


~~ 




36 SymptoiBe-AfI(13) 




Mis i¥iterpre*B( 1^)1 


j6Mssa=EiBfae^ (18) 


==&= ==6:: 


==7:: 


==8:= 


==9:: 


"~" 




37 ftehayiec (1=4=) 




Ii*fliaeiiei6f --^^-- 


Liii 


37BfevcEiBa«i-ofl (19) 
JBSadcidai ==3== (3^) 


::S:= ==6:= 
:=S:: "6:= 




::8:= 
::8:: 
::8:= 


:=8t: 
==9:= 
==9:: 


"^ 




38:A: iiJ:: ::ir ::3ri HA^fBTXty i<l)==I:-- 
39:A= =:hz :=2=: :=3 Jna^OVemeiLt ,l2).zJzz 


==8:= 


==9i:r 


^ 




::*: 


39 =*= ==}== =:a== ::3== ==4== 

•4— c ti 1 


iiS: ==6:= 






40:16:= ==j=: ==2== Mfisacy ladej&.o <."?:= -fc 
41 ==e== ==j== ==2== Eff iaacv ladexr ==?== ==8== 


* 1 


'" - I:: :=2== =:3== =*= ==»= ::6:= 


iijbi 


=:8:: 


==9:: 






-1 


118 j== =:2== =:3:= =:4=: :=*= iifci 


==7:= 

78 


1=8:: 

79 


20 




c 


o)S?T" 


2 5 4 5 






6 7 8 


9 


10 


2 13 14 IS 16 17 





DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

ECDEU GENERAL SCORING SHEET (50-GSS) 



PATIENT INITIALS 

::A: ::ft: riC: ::D: z-izz 

FIRST 
iiK: ::t: :**: -Mz :«r 

INITIAL 
::li; ::\t: zMz =iX: zzY.z 


::F:: 
::P:: 
:i£: 


:«: 


::H: ::4:: ::*: 

FIGUR 

MATRIX 

DOSAGE RE 

TREATMENT EMER 

SCAL 

::3t: ::&: ::2: | 


NUMBER MALES 001 TO 499 NUMBER 
::«:: ::l:: ::2:: ::3:: -yt-z zzSoz 

PATIENT 

: ::«:: ::5:: 
Ell . :^:: ::£: 


FEMALES 50( 

::t: ::7:: 
:rfc: ::?:: 
::&: :iS: 


) TO 

::8:: 
::*: 
::8:: 


998 
::»:: 
::9:: 
::9t: 


^_ 


iA= lift: r:e: "B: ::&= 

SECONC 
::lfc: ::t:: zMz :*t: :«: 


::fc: 

» 
::P:: 

::£: 


FOR . .^.. 

CORD AND "ATER 

::4:: 


::5:: 
::5:: 


::6:: 
::&: 


::7:: 


::8:: 
:*: 


::»:: 
::9:: 





r:tt: :=Xt; :Wr "X: ::1ri: 


rn . :^:: ::&: 

'^^ PERIOD 

: zzizz ::5:: 

Hours Doys Weeks 
::0:: ::t: ::2:: ::3: 


::6:: 
::fc: 


Months 
::4r: 


:*: 
:*: 


:r9:: 
:*: 


— 




P^ r.J:: ::2:: rzS:: ::*:: SHEET 


::»: 
::5: 


— 


::a: :H::| ^1::^: .4: 'W'. 


— 


Row 


'"Akafthisra"*= '*- 

2::a: ::t^' r:^: ::»: ::4:r 


::S: 
::5:: 


"t: 
::fc: 


"S: 
1- 


::fc: 
::8:: 


-^Ro, 

::ft: 


^ R€a3=*n ^=2^= ^ --*- 


::5:: 


::fc: 


::7:: 


::&: 


::9:: 







2D«il^= DE?se-(2a>^ 

3::ft: ::K: ::2:: ::<:2a>= 
4::a: ::^5: ::2:: ::<2a> 
5::ftr ::«: ::2:: ::<:2a>= 
6::e:i ::«= ::2:: -<2b>= 
7::e:r ::«-- i.i: =K2fe>= 
8::a:: ::«: ::2:: ::<:2b^ 
9::ft: ::H: ::J:: :.(:2bJ 

lOLcmg Aceing<:2e=>= 

11:*: ::J!: :*: -42e>: 
12:*: ::J?: :*: :-42g>: 


::S:: 
::S:-- 
ni: 
::5:: 
::5:: 
::5:: 
:*: 
:*: 
:*: 
:=S:: 
"S: 


-.:&: 
i:fc-. 
::fc: 
::6:: 
::6:: 
::&:: 
"6:: 
:*: 
::6:: 
1=6:1 
::6:: 


::f:: 
::?:: 
::7:: 
::7r: 
::7:: 
::?:: 
::?:: 
::7:: 
"Iir 
::?:= 
rr^:: 


::8:: 
::8:: 
:*: 
:*: 
:*: 
:*: 
:*: 
:*: 
:*: 
:=8:: 
::8:: 


::»:: 
:*: 
:*: 
:*: 
:*: 
:*: 
:*: 
z^.z 
I*: 
::»:: 
::»:: 







3=5ry Mouth *= "*- 

4;:0:t ::j:V :z2:r ;:J:: z:l»zz 


::S:: 
::S:: 


::6:: 


::R: 


::8:: 


H 


— 




|::K: 


::&: 


::9:: 







5:«asFsii &&ng«sC*on 

6::a: ::J:':' ::2:: rrj:: ::4:: 


::&: 
::S: 


::fc: 
::&: 


::f:: 


::&: 


d 







|::f:: 


::ft: 


::9:: 







8:8:: ::)-^ ::2:: ::3:: ::*: 


::&: 
::&: 


::&: 
::fc: 


::f:: 


::&: 


;| 







1- 


::&: 


::9:: 







9=€oiTatipati«n ^=*: 

10::e:: ::jJ:' ::2:: ::}:: ::*: 


::&: 
::&: 


::&: 
::4: 


::f:: 


::&: 


"^ 







l::K: 


::&: 


::9:: 







12-6:: ::):':' ::2:: :*: ::*: ::5:: 


::fc: 
::fc: 


::K: 


::&: 


H 







1- 


::ft: 


::9b: 







14::eb: ::JJJ ::2:: zzizz ::*: 


-a: 

i:5:: 


"6:: 
::fc: 


::K: 


::&: 


_d 


l3Pres:crip:tieEn(3) | 


::S: 


::fc: 


::?:: 


::»:: 


::»:: 


1 




1- 


::&: 


::9t: 


i4Ss^l3:tDmS P^«geft4:(4) 


::S: 


::&: 


::?:: 


::&: 




15 :$taij&ea/¥oiHitiT*g 

16::ft: ::JJ:' ::2:: ::3:: ::*: 


::&: 
::5:: 


::fc: 
::&: 


::J:: 


::&: 


H 


16::©:: ::3:: :*: :*: :^: ::&: 


2 <=5 

::fc: 


^:^: 


::8:: 


::9:: 




1- 


::&: 


::ft: 


'=- 


::8:: 


::9:: 




18 ::£>:: ::±':' ::2:: ::3:: ::*: 


::&: 
::&: 


::fc: 
::6:: 


::?:: 


::ft: 


::9bj 


i7SKcitemsnt/Agifeation ^ 

18::a:; ::J:: rli: r*: :.4:: ::S:: 


::fc: 
::t:: 


::?:: 


::»:: 


::»:: 


1 = 




1- 


::&: 


::Sb: 




::8:: 


::9:r 




I9:gypoten«:ioft ^ 

20::fl:: ::i^:' ::i: ::3;: ::*: 


::&: 
::&: 


::fc: 
::fc: 


::K: 


::ft: 


~n 


i9DBepr^essa:ve Affect 

20 ::a:: ::3:: ::!i: :*: ::*: 


::&: 
::&: 


::6:: 
::6:: 


::?:: 


::«:: 


::»:: 




1- 


::&: 


::Sb: 


::?:: 


::8:: 


::9:: 




21 rSyneope/DtazLiiess 

22::fi: "i:' ::i: ::3:: ::*: 


::&: 
::&: 


::fc: 
::&: 


::3t: 


rift: 


■q 


21 i*tereas«d J^otor Acti^i 

22::a:: ::J:: :^i: :--3:: ::*: ::*: 


ty : 

::6:: 


::?:: 


::8:: 


::»:: 




1- 


::ft: 


::9t: 


-= 


::*: 


::* 




23:¥acfeycardia -*- 

24::e:: "3?^ ::2:: ::3:: ::4:: 


::&: 
::&: 


::fc: 
::6:: 


;:ft: 


::ft: 


"^ 


23gecrfeas«d }«tetor Acti^^ 

24::e:: ::lr: :it: :*: ::*: ::*: 


ty - 

::6:: 


r:?:: 


::&: 


::9:: 




1- 


::&: 


::9:: 


::7:: 


::8:: 


::*: 




25:a:yp:©3?teftsi*n ==<t= 

26::e:: ::J::' ::2:: "3c: ::<t: 


::&: 
::&: 


-fc: 
::fc: 


"Kr 


::ft: 


::St:| 


25=ifis0tenia ^*= ==*= 

26 ::8:: ::!:: rc'i: :*: ::*: 


::&: 
::*: 


::fc: 
::6:: 


zzr-z 


::»:: 


::*:: 




|::7:: 


::ft: 


:r9t: 


::?:: 


::«:: 


::* 




27:BKG - ::2:: ::3b: ::4: 
28::e:: ::3?:' ::2:: ::3:: -*: 


::&: 
::£: 


::&: 
::fc: 


::3!:: 


::ft: 


-d 


27Bcowsdn*ss ==*: 

28:*: ::3:: :*: :*: ::*: 


::S: 
::5:: 


::6:: 
::6:: 


:=?:: 


::8:: 


::9:: 




1- 


::ft: 


rrfti 


h- 


::8:: 


::» 




29=Bemiatolog*e -*= 

30::e:: -a!^ ::2:: ::3:: ::*:: 


::5:: 

::£: 


::fc: 
::fc: 


::J:: 


:rft: 


"1 


29 AfenG tmai H^^ma t-e^l og i c=s:= 

)0 :=e:: ::}:: :*: ::3:: ::4r: ::&: 


::6:: 
::6:: 


::^: 


::8:: 


::St: 


3 




|::7:: 


::ft: 


:r9- 


--^- 


::»: 


::9:: 




32::a:: ::3iJ ::2:: ::&: ;:d:: 


::5:: 


::6:: 
::fc: 


::J:: 


::ft: 


2*J 


J2:*: ::»:: :S: ::3:: :U:: 


::&: 
::S: 


zztizz 
::6:: 


::^: 


::«:: 


::*: 


i 

li 
r 




1- 


::ft: 


::9t: 


::?:: 


::«:: 


::r 




33=Weight Los#^ =*== 

34: A: r:J»J ::2:: ::3:: :=4:: 


::5:: 
::&: 


::fc: 
::fc: 


::S: 


::ft: 


.-] 


"Abnormal U*ine - 

J4:*: ::5:: :*: :*: ::4:: 


::*: 
::&: 


::6:: 
::6:: 


::f:: 


::8:: 


::*: 




|::S: 


::fti 


::9t: 


::Jt: 


::8:: 


::9t 




35 Ano*exiA/Ddfcr-e*ased 

36::e:: ::HJ :i: ::3:: :=*" 


APP 

::5:: 


et-i 

::fc: 


te 


:=ft: 


"3 


36:*: ::l:: rSr: ::3r: ::4-: 


::S:: 
::&: 


::6:: 
::6:: 


::?:: 


::8:: 


::*: 




h- 


:=ft: 


"9-- 


::?!:: 


::8:: 


::9t: 




37 aea^acher- =^- =^- 

38:*: ::l': :i: ::3:: :::4:: 


::&: 
::£: 


::fc: 


-?:i 


rrft: 


"R 


J7 ifreHSsT =2== ^ =^= 

}8 :*: ::i:: ::¥:: ::3:: :=4:: 


::S:: 
::5:: 


zztnz 
::6:: 


::jt: 


::8:: 
::8:: 


::9t- 




1- 


lit: 


==9t: 




39 Tardive Dy#ki^esia 

40::e:: ::Jr: ::2:r ::3:: ::i4:r 


::£: 
::S:: 


::fc: 
::6:: 


::?:: 


::fti 


i=9t^ 


59©yseein±-e S^ptsm 

40:*: ::J:: :*: :4:: ::4:: 


::5:: 
::&: 


::&: 
::6:: 


::f:: 


::8:: 

::«:: 


::St: 




1- 


::ft: 


i:*: 


::St: 



4i:Sev€git-»^ 
, J j 



cSBTf 



Distress: 

b ' y a 



::t: ::*J 



119 



r2 13 



::3:: ::«" 

74 /5 



16 



::&: 

J7 



78 79 20I 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

ECDEU GENERAL SCORING SHEET (50-GSS) 



PATIENT INITIALS 

Z.A. Z--&. .-.C-. ---&- 

rilfc: ==t= zMz zMz 



-^z 



NUMBER MALES 001 TO 499 



NUMBER FEMALES 500 TO 998 

"5:: ::fc: zzjzz "ft: :i9=: 



:iU= zz\tz 



.Mz ==X= 



:ft= 



r^e: 



:=A: 

-Ifc: iiti -vAA: i*t: 

z.U. zz\tz zitiz ::>t: 



-z&z 



RATI 



FIGURE 12 
MATRIX FOR 
ENT TERMINATION 
RECORD 



PATIENT 



: ::3" 


=:4=: 




::&: 


"fc: 


==?:= 


:;8:: 


::9:: 


"■" 


-Z3-. 


=:4:: 




:=S:: 


"fci 


;:?:: 


=:ft: 


=:9=: 





i:3" 


==fc: 


RATER 


"i: 


::fc: 


==?:= 


:ift: 


::9:: 





=:3:: 


lit: 




:=5:= 


z:fci 


==S= 


:it: 


==9:= 


~~ 



|=L 

i-O- 



r:2:: 



SHEET 
I NO. 



:*: :4r: 

Days 
-z2:z 



PERIOD 



^reorasho dilate c<^b) 
3£ardiaC"i: (€ b^ 

SBermat; o i©g tea 
%labe€ie ^ 
7@tet ==*= 
85^ur-atiG 

9g:I .z^rz :r2:. 

iiMftBcle r«lax. 
1 2P fty ch« t E op te^i 
i3s«daGive ^i€b^ 
i^s^iiittilai* -^€5=)^ 
iSTfeyr-ddd = =r^:6 3=) 



(|6b:) 



1 7&&nf<*rmi.fcy < 7 a^) : 

18e«nt.:RX ::<7b.)-: 



i9Msp.- 



In|;t <8a=> 
0at-pt<6b=> 



22 "fiz :;± 

23 r A: =:a= 
24:rft: "3: 
25 "6:= -iz 
26rre:= :=J= 
27-6:: ::]= 
28::a:r iH: 
29=:e:: :Hr 

30 -zOiz ;:J: 

31 llftr 1=3: 



::2:: "3:: 



::2:: ::3:: 
::2:-_ ::i: 



::2:i iiil 
rri: ::i: 



32::ft: :it 



33 1*1 :: 


:: :i: 


::3:: 


::4:: 


34::fc: := 


:: :i: 


::3:: 


::*:: 


35 I A: :: 


:: :i: 


:*: 


::4:: 


36:*: 


-: ::2:: 


::3:: 


::«:: 


37:*: :: 


:: :±: 


:*: 


:d4:: 


38:*: :: 


:: ::2:: 


::3:: 


:d4:- 


39:*: :: 


:: :±: 


:*: 


::4: 


40:*: :: 


:: zziiz 


:*: 


::4: 


41:*: :: 


1:: :±: 


:*: 


::4: 


Cols: 1 2 3 


4 


5 



::»: 
::St: 
::S:: 
::»:: 
::Sb: 



:3t: 


::ft: 


::Sb: 


:J:: 


::ft: 


::9:: 


:?:: 


::ft: 


::i: 


:3t: 


::&: 


::9t: 


:i: 


::&: 


::S:: 


:3t: 


::&: 


::9:: 


-:*: 


::ft: 


::*: 


::£: 


::&: 


::9:: 


::i: 


:r8:: 


::9:: 


::K: 


::ft: 


::9t: 


::3I:: 


::8:= 


::»:: 


::i: 


::ft: 


::St: 


::£: 


::&: 


::St: 


::S: 


::ft: 


::9t: 



ft: 


::St: 


ft: 


::«:: 


ft: 


::9t: 


ft: 


::9t: 


ft: 


::9b 


ft: 


::9: 


:ft: 


::9S 



120 



8::a:: 
9:* 
10:* 

II :* 



i2StaratiGft -=*= <2a) 

I3::e DairS in ::3:: <:2^) 

14:*: &tLidy ::3:: <:^a) 

l5P3;ema;t.Term., <-'2b) 



iS^bjfect befere (la) 
2Eteta seat iflb4-lb) 

(=lc) 

He) 

ac) 
nc) 

tic) 
:3:Pa4:iea£ <ic) 

:,:: :*: ::3:: ^Ic) 

i-- =S^inb€r9(lc) 



3EeDE¥^ ==2:: ::£: 

4::6:: ::3:: ::2:: ::3:: 

5::ft:StUdy : ::*: 

6 ::ft: ::J:: ::J:: :*: 

7 ::et: ::ani2:= =*= 
::J:: ::2:: ::*: 



::5:: ::&: 

::5:: ::&: 

::£: ::&:: 

::S:: ::&: 

::5:: ::6:: 

::5:: ::6:: 

::5:: zztiz 



:*: 

:*r 



16^-nt ervai Mst < § ) 



i7lton-dTug RX 
l8Behav:ios Mod 
19B6T-'" '-^- "^- 

iOMilifeU ?:: :*: 

21 i>hysi<;ai =*; 



<4b) 
<4b) 
<^b) 
^frb) 



22 ifsyehotfeer=grp<=4b) 

23 i^syGirotfeer-ind (:4b) 
M S€hab=it*ta-e±on<=4b) 
25Sdueatio:na:l: K^b) 
26 family =*n -^er (=4c) 
' 7Sffigae-» =*- k#d) 



:S:: ::fc: 

:&: ::fc: 

:S:: ::6:: 

:5:: ::fc: 



t8 s^u^}:rLn^alc^= ^&) 



29 Anciitla*y =Brug (=6a) 
*o Analgesic 'ftare (=6b) 
>1 Anaiges^-noBttia3?e(6b) 
J2 Anestiie*iar-'gen<:6b) 
'3 Anestlie*ia-ioe<=6b) 
w -AntieFll£rgenie<=6b) 
'5 Afttieoa^ul-lml|=^ C-6b) 
'6 Anticonvulsant (6b) 
»7 Antifertility (6b) 
je Antihypertenl- (6b) 
»9 =Ant±toie*ob4«l- ^6b) 
to :iteiti^aE^in*on (6b) 

11 :totd.fe\JinC-r :4:: I ::4-< 6b ) 

oETTt 72 /3 74 15 



3= 



::S:: ::6:: 
::»: --(nz 



:Jb: ::8:: ::9t: 

:3t: ::&: ::St 

:^: ::ft: ::St: 

:S: ::8:: ::»: 

:Jt: ::&: ::»:: 



::&: ::fc: ::?:: ::ft: "»:: 

::S: ::6:: ::Jt: ::ft: ::9:: 

::&: ::fc:: ::7:: ::&: ::*: 

76 77 78 79 20' 



FIGURE 1 3 
CHILDREN'S PSYCHIATRIST PACKET 
Sequential Use of Scales and Assignment of 
GSS Sheet Nxombers 



INITIAL 
RATING 



INTERMEDIATE 
RATINGS 



FINAL 
RATING 



SHEET NO, 
01 



GPRS 
CGI 



I 



SHEET NO. 
02 



DOTES 



JZ. 



SHEET NO. 
03 



CDS 
CDC 



SHEET NO. 
01 



GPRS 
CGI 



SHEET NO. 
02 



DOTES 



SHEET NO. 
01 



GPRS 
CGI 



SHEET NO. 
02 



DOTES 




121 



FIGURE lU 
ADULT PSYCHIATRIST PACKET 
Sequential Use of Scales and Assignment of 
GSS Sheet Numbers 



INITIAL 
RATING 



SHEET NO 
01 



BPRS 

DSI 

HAMD 

HAMA 

AS I 

WITT 

CGI 



I 



SHEET NO, 
02 



DOTES 



INTERMEDIATE 
RATINGS 



SHEET NO. 
01 



BPRS 

DSI 

HAMD 

HAMA 

AS I 

WITT 

CGI 



SHEET NO, 
02 



DOTES 



FINAL 
RATING 



SHEET NO, 
01 



BPRS 

DSI 

HAMD 

HAMA 

AS I 

WITT 

CGI 



I 



SHEET NO, 
02 



DOTES 




122 



027 CPRS 
CHILDRENS 
PSYCHIATRIC 
RATING SCALE 





c 

MH.9-27 CHILDREN'S PSYCHIATRIC RATING SCALE p 

1-73 S 

INSTRUCTIONS: Insert General Scoring Sheet, Form 50, and Code 01 under Sheet Number. 

Rate the first 28 items exclusively on the basis of direct observation during the interview. 

Rate the last 34 items (29-63) on the basis of the child's verbal report of occurrence at the time 
of the interview or during the past seven days. Do not use any other data, but that obtained in 
the interview with the child. 

Mark ?ll rows consecutively — do not skip any rows. Each row is numbered on the scoring sheet 
and also on the page with the item to facilitate marking on the correct row. 

USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 






NOT MOOER. EX NOT MODER- B(- 

AS- NOT VE(^ MODER- AT^LY TREMELY AS- NOT VERY MODEH- ATtLY , ™BIELY 

SESSED PRESErn MILO MILO ATE SEVERE SEVERE SEVERE SESSED PRESEffT MILD MILD ATE SEVERE SEVERE SEVERE 






Mark on right half of scoring sheet on row specified 


RQIft/ 
NO. 


Continue marking on right half of scoring sheet on row specified 


ROW 
NO. 




1. TENSION (Do not include fidgetinessi 

Musculature appears taut, strained or tense. Fingers clothing, clenclnes jaws, 
grips arms of chair, hands tremulous. 


1 


12. SILLY AFFECT 

Clowning, inappropriately giddy, playful, silly behavior 


12 




13. CONFUSION 

Confused, bewildered, perplexed in behavior or verbal expression. 


13 




2. UNDERPRODUCTIVE SPEECH (Rate antount of speech only, not rate or 
relevance} 

Fails 10 answer questions, monosyliabic. has to be pushed to gel an answer, 
doesn't elaborate, blocked. 


2 




14. DISORIENTATION 

Child is unaware of identity of surroundings after being told where he is. 
Not aware of time discriminations. Doesn't know age or surname. 


14 




3. FIDGETINESS IDo not include tics) 

Wriggles, squirms, moves or shifts restlessly in chair. 


3 




15. CLINGING BEHAVIOR 

Clinging, in physical and verbal behavior with the examiner. Seeks physical 
contact, demands constant direction. 


15 




4, HYPERACTIVITY 

Has difficulty sitting in chair, gets up. moves fast, vigorously, impulsive 
bursts of locomotion. Exclude slow ambling even if constant In rating 
degree of overactivity, consider the ease with which the hyperactivity can 
be controlled. , 


4 




16. UNSPONTANEOUS RELATION TO EXAMINER 

Responds to examiner, but does not initiate social or verbal overtures, nor 
sustain conversation once begun. Lacks spontaneity. Restricted. 


16 




5. HYPOACTIVITY 

Few or no spontaneous movements. Sluggish. tVlovements are slowed, feeble 
or labored. Requires prompting for initiation of motor movements. Long 
latencies of appropriate motor behavior. 


5 


17. SUSPICIOUS AFFECT 

Expresses concern about the intent of the examination. Questions 
instructions and good will of interviewer. 


17 




18. DEPRESSED DEMEANOR 

Exhibits a dejection, depression in mood. Looks sad. Seems to be in 
a state of painful dejection. 


18 




6. DISTRACTIBILITY 

Distracted by usually minor, irrelevant stimuli. Shifts from one topic to 
another. Interrupts thought or action abruptly. 


6 




,19. BLUNTED AFFECT 

Restricted range and intensity of emotional expressions, blank or fixed 
facial expression, monotonous voice. 


19 




7. -ABNORMAL OBJECT RELATIONSHIPS 

Autistic use of objects with disregard for usual function. Stereotyped and 
repetitive sequences or fragments of play. Aimless behavior without 
organizing goal idea. 


7 




20. LABILITY OF AFFECT 

Can suddenly vary from calm or silly to sullen mood, to screaming, crying, 
loud complaining. 


20 




8. WITHDRAWAL 

Oblivious of examiner, preoccupied. Facial expression and behavior do not 
respond directly to examiner. Attention focus is oblique and vague in direc- 
tion, with avoidance of eye contact. Responses are very delayed and require 
forceful stimuli. (The fact that the child may have peculiar interest in 
examiner, such as obsessive interest in parts of body or clothing does not 
preclude a rating of withdrawal). 


8 




21. PRESSURE OF SPEECH 

Speech is hurried, accelerated, pushed, difficult to interrupt. 


21 




22. LEVEL OF SPEECH DEVELOPMENT (Do not include diction, rate of 
speech, or relevance of speech) 

From age appropriate (1) to severely retarded (71 o I ?k^' q™! 
speech development. Using your clinical judgment ^ '° ^^^ 
of verbal I.Q.. estimate the level of speech develop- 3 = 61 - 75% 
ment (in percent) in relation to verbal l.Q. 4 > 46 - 60% 

5 = 31- 45% 
6= 15-30% 
7= Less than 15% 


22 




9. OVERCOMPLIANT 

Goes along with whatever examiner says in a passive fashion, even contra- 
dicting self. Does not assert self in a reasonable manner. 


9 




10. NEGATIVE, UNCOOPERATIVE 

Active opposition and resistance to examiner's initiative (differs from with- 
drawal and oblique avoidance). Guarded, evasive replies, teasing, manipulative 
or hostile refusal to cooperate. Child may remain silent in passive-aggressive 
fashion. 


10 




23. STUTTERING 


23 




24. LOW VOICE 

Voice weak, mumbling, whispering, almost inaudible. 


24 




n. ANGRY AFFECT 

Irritable, touchy, erupts easily - shouts angrily, screams at examiner, overtly 
and directly hostile. 


11 

124 




25. LOUD VOICE 

Voice loud, boisterous, shouting. 


25 



CHILDREN'S PSYCHIATRIC RATING SCALE 



Continue marking on right half of scoring sheet on row specified 


ROW 
NO. 


26. MISPRONUNCIATIONS 


26 


Lisping, mispronounces letters such as r, s. 1, etc. Unclear speech. 




27. OTHER SPEECH DEVIANCE 


27 


Echolalia, question-like melody, neologisms; sentences fragmented, 
unusual syntax. 




28. RHYTHMIC MOTIONS (STEREOTYPE) 


28 


Rocking, whirling, head banging, rolling, repetitive jumping, 
hand movements, alhetoid. twiddling, arm flapping 




RA TE THE FOLLOWING 34 ITEMS ON THE BASIS OF THE CHILD'S 
VERBAL REPORT OF OCCURRENCE AT THE TIME OF THE INTERVIEW 
OR DURING THE PAST 7 DA VS. DO NOT USE ANY OTHER DA TA BUT 
THAT OBTAINED IN INTERVIEW WITH THE CHILD. 




29. EXPRESSED FEELINGS OF INFERIORITY 


29 


Describes feelings of inadequacy, inferiority, se!f<jeprecaling, self belillling 




30. EXPRESSED FEELINGS OF GRANDIOSITY 


30 


Exaggerates own value, boasting. Unduly pleased with own achievement. 
Says he is much better than others. Distorted sense of own capacity. 




31. PHYSICAL COMPLAINTS 


31 


Somatic complaints of headaches, stomach aches, dizziness, not feeling well, 
etc, {do not include fatigue). 




32. OBESITY 


32 


Judge from child's appearance from normal physical appearance to severe 
obesity. 




33. OTHER EATING PROBLEMS 


33 


Picky, fussy, many dislikes, extremely restricted diet, peculiar food tastes. 




34. SEPARATION ANXIETY 


34 


Ease with which child separates from mother or other significant people. 
Extent of observed or reported anxiety {by child) experienced by child 
when separated from mother or other significant people. 




35. DEPRESSION 


35 


Admits feeling sad. lonely, feels like crying, expresses a despondent or 
despairing attitude. Difficulty in anticipating success and enjoyment. 




36. EUPHORIA - ELATION 


36 


States he feels terrific, great; elevation of mood, hypomanic state. "This is 
the best of all possible worlds." Feels elated and wonderful. Nothing is 
impossible. 




37. LACK OF ENERGY 


37 


States he feels sluggish, fatigued. Everything is too much. Weary and feels 
unable to make slightest effort. (Do not infer from motor retardation or 
expressed indifferencei. 





When you have completed this page (item 41), turn all pages 
on this side and continue with text (item 42) on page Rl 



38. PREOCCUPATION WITH TOPICS OF ANXIETY 

Says he has nervous or scary feelings, concerns, apprehension, fears. Says 
he worries about failure or other mishaps, thinks about something happening 
to self or parents- illness, injury, death, loss or separation. 



39. PREOCCUPATION WITH DEPRESSIVE TOPICS 

Preoccupied with feelings of inadequacy and inferiority. Expresses feeling 
that nothing can turn out all right. Preoccupied with feelings of uselessness 
futility, and possibly guilt. Suicidal preoccupation. 

40. SUICIDAL ATTEMPTS 

= Not assessed 

1 = None 

2= Suicidal threat 

3 = One minor gesture without danger 

4 = A couple or several minor gestures without danger 

5 = Dangerous gesture 

6 = Infliction of life threatening damage to self 

7 = Several life threatening attempts 

41. FEARS AND PHOBIAS 

Irrational morbid fears of specific objects, person, or situations, which, if 
extreme, lead to avoidance behavior. Rate 6 or 7 only when fear is so 
severe it leads to phobic avoidance. 



125 



CHILDREN'S PSYCHIATRIC RATING SCALE 



ROW 
NO. 


Mark on left half of scoring sheet on row specified 


ROW 
NO. 


Continue marking on left half of scoring sheet on row specified 




1 


42. COMPULSIVE ACTS 

Acts or "habits" which are regarded as unreasonable by the child, 
such as, counting, checking, rituals, excessive orderliness, and 
cleanliness. 


13 


54. INABILITY TO FALL ASLEEP 

Child reports a long time to fall asleep after going to bed. 
1 = Not present 5 = 46 to 60 min. 
2=10to15min. 6 = 60 to 90 min. 
3= 16 to 30 min. 7 = Over 90 min. 
4 = 31 to 45 min. 




2 


43. NERVOUS HABITS AND MANNERISMS 

Stereotyped movements; rituals which are not perceived as 
irrational. Facial tics or mannerisms. Biting nails, fingers, cuticles. 
Sucking of objects or body parts (thumbs fingers^ hair, etc.); 
Picking on skin, scabs, nose, twisting hair. 




14 


55. OTHER SLEEP DIFFICULTIES 

Nightmares, early morning awakening, sleep walking, interrupted 
sleep. 




3 


44. OBSESSIVE THINKING 

Inability to "turn off" repetitive thought. Preoccupation, ruminations 
about abstract problems or personal matters. 


IB 


56. BEDWETTING 

Rating is for frequency of bedwelting for past 7 nights 

1 = None 4 = 3 times 7 = 6 to 7 times 

2 = One time 5 = 4 times 

3 = 2 times 6=5 times 




4 


45. SOLITARY INTERESTS 

Interested in activities which require little if any peer interaction, 
such as stamp collecting, movie going, reading, school work, 
solitary activities. 




16 


57. IDEAS OF REFERENCE 

People are looking at him, following him, staring, etc. 
Malevolent intent is not necessary but may occur. 




5 


46. LACK OF PEER INTERACTION 

Isolated from other children. Has no friends or cannot name current 
Close friend nor describe participation in play with peers. Lacks 
interest in peers. 




17 


58. PERSECUTORY 

Feels people have it in for him, try to hurt him. In the extreme 
rating, the thinking has a delusional quality in that the belief is 
impervious to change, rational arguments, or corrective experiences. 




6 


47. GANG ACTIVITY 

Joins in antisocial activities along with a group of children (fighting, 
trouble making, stealing) as a cooperating group against others. 




18 


59. OTHER THINKING DISORDERS 

Irrelevant speech; or incoherent speech; or loose associations. 




7 


48. FIGHTING miTH PEERS 

Says he frequently gets into fights - beats up other kids or gets 
beaten up. Says he has a bad temper. 




19 


60. DELUSIONS 

Delusional beliefs or convictions besides paranoia (58). i.e. 
believes has introjected persons or objects in his body, has 
a mission; is some other person or character, has unusual 
powers; is guilty of some event. 




8 


49. BULLY 

Says he's always the leader, winner; or says he teases, bullies 
children, pushes children around; threatens them. 




20 


61. HALLUCINATIONS 

The overall rating is a frequency rating reflecting the constancy 
of the experience: 

1 = Not present 5 = 4 to 5 times 

2 = Once 6 = 5 to 6 times 

3 = 2 times 7 = Daily recurrent phenomenon 

4 = 3 times 




9 


50. TEMPER OUTBURSTS 

Admits to feeling angry, irritable, touchy, admits he has a temper. 




10 


51 . SCAPEGOAT 

Says he's picked on. teased, left out or pushed around, and bullied 
by other children. May be called "sissy" or "baby". 




21 


62. PECULIAR FANTASIES 

Morbid or bizarre fantasies and preoccupations, peculiar body 
sensations, disturbances of body image experiences (not figure 
drawings); preoccupation with flying, supernatural influences, 
sadism, masochism. 




11 


52. LYING 

Contradicts self in ways indicative of effort to hide the truth. 
Reports telling tall stories, fibs, or admits he's accused of telling lies. 




12 


53. EXPLOITATIVE RELATIONSHIPS 

Interested in other people insofar as he can get something out of it. 
Callous and calculating in interpersonal activities. 




22 


B3. LACK OF INSIGHT 

Is convinced of the reality of hallucinations or fantasies. 





126 



The Children's Psychiatric Rating Scale (CPRS) is an original scale 
constructed by members of the Pediatric Psychopharmacology Workshop, It 
is a comprehensive scale which endeavors to assess the broad spectrum of 
psychopathology within this age group. As a consequence, items of the 
CPRS will have varying degrees of relevance when assessing a circumscribed 
diagnostic group. The CPRS is formatted for use with the General Scoring 
Sheet and contains 63 items. A 7-point scale derived from the Adult Brief 
Psychiatric Rating Scale is employed. The CPRS should be regarded as 
experimental. Standardization procedures will be undertaken as soon as 
sufficient data are accumulated. 



APPLICABILITY 
UTILIZATION 

TIME SPAN RATED 
CARD FORMAT - ITEMS 



For children to age 15. 

Once at pretreatment ; at least one pos tt reatment 
assessment. Additional ratings are at the 
discretion of the investigator. 

The first 28 items are rated on the basis of direct 
observation of behavior during the interview. The 
last 3^ items are rated on the basis of the child's 
report of occurrence during the interview or within 
the past week. 



CARD 01=(19x, k] II) 

I tern Column Item 



1 


20 


11 


30 


2 


21 


12 


31 


3 


22 


13 


32 


k 


23 


]k 


33 


5 


2k 


15 


34 


6 


25 


16 


35 


7 


26 


17 


36 


Bi 


27 


18 


37 


9 


28 


19 


38 


10 


29 


20 


39 



Col umn 



I tem 



Col umn 



21 


ko 


31 


50 


22 


41 


32 


51 


23 


42 


33 


52 


Zk 


43 


34 


53 


25 


kk 


35 


54 


26 


45 


36 


55 


27 


46 


37 


56 


28 


47 


38 


57 


29 


48 


39 


58 


30 


49 


40 


59 






41 


60 



CARD 02=(19x, 2211) 



tem 



Col umn 



Item 


Column 


Item 


Column 


1 tem 


Col umn 


1 tem 


Col umn 


42 


20 


47 


25 


52 


30 


57 


35 


43 


21 


48 


26 


53 


31 


58 


36 


44 


22 


49 


27 


54 


32 


59 


37 


45 


23 


50 


28 


55 


33 


60 


38 


46 


24 


51 


29 


56 


34 


61 
62 
63 


39 
40 
41 



127 



CARD FORMAT - CLUSTERS CARD 51 = (19x, 9F6.2) 

(Code "5" in Column 18 indicates a card containing factors, clusters or 
other grouped scores) . 



Cluster 

1 




Column 
20-25 


1 1 




26-31 


1 1 1 




32-37 


IV 




38-43 


V 




kk-kS 


:, 6F6.2, 


,f4.o) 




Cluster 




Column 


X 




20-25 


Xi 




26-31 


XI 1 




32-37 



uster 


Col umn 


VI 


50-55 


VI 1 


56-61 


VI 1 1 


62-67 


IX 


68-73 



Cluster 


Col umn 


XI 1 1 


38-43 


XIV 


kk-ks 


XV 


50-55 


Total Score 


56-59 



Cluster score = Sum of composite items cluster score range =1-7 

Number of composite items 

Total score = Sum of all items Total score range = 63 - 441 

CLUSTER COMPOSITION - As a means of data reduction, the clusters have been 
empirically derived for use in statistical analyses. It is planned to under- 
take psychometric analyses of the CPRS when sufficient data are accumulated. 

I . Psychotic IV. Anxiety 

2. Underproduct i ve speech 1. Tension 

7. Abnormal object relationships 15. Clinging behavior 

19. Blunted Affect 34. Separation anxiety 

27. Other speech deviance 38. Preoccupation - anxiety 

28. Rhythmic motions (stereotypic) 41. Fears and phobias 
57. Ideas of reference y_ Thought Disturbance 

II. Hostile-Uncooperative 58. Persecutory ideation 

10. Negative, uncooperative 59. Otherthinking disturbances 

11. Angry affect ^0- Delusions 

17. Suspicious affect ^2. Pecul ,ar _ fantas , es 

50. Temper outbursts ^3. Lack of ins ight 

III. Hyperactive VI. Neurotic 

3. Fidgetiness 31. Physical complaints 

4. Hyperactivity 42. Compulsive acts 
6. Distractibi 1 ity 43. Nervous habits 

20. Lability of affect 44. Obsessive thinking 



128 



CLUSTER COMPOSITION (cont'd.) 

Vll. Depression X. Antisocial 



VI I I 



IX, 



Dep 


ress ion 


5. 


Hypoact ivi ty 


18. 


Depressed demeanor 


Ik. 


Low voice 


29. 


Expressed feelings of 




infer ior i ty 


35. 


Depress ion 


37. 


Lack of energy 


39. 


Preoccupation with depressive 




top ics 


uo. 


Suicidal attempts 


Exc 


■ ted mood 


12. 


Silly affect 


21. 


Pressure of speech 


25. 


Loud voice 


30. 


Expressed feelings of 




grandios i ty 


36. 


Euphoria-elation 


Withdrawal 


8. 


Wi thdrawal 


9. 


Overcompl iant 


16. 


Unspontaneous relation to 




examiner 


45. 


Sol i tary interests 


i+6. 


Lack of peer interaction 


51. 


Scapegoat 



kl . Gang activity 

48. Fighting with peers 

kS. Bully 

52. Lying 

53. Exploitative relationships 

X I . Organic 

1 3. Confus ion 

\h. Disorientation 

XII. Speech disturbance 

22. Level of speech development 

23. Stuttering 
26. Mispronunciations 

XIII. Sleep disturbance 

54. Inability to fall asleep 

55. Other sleep difficulties 

XIV. Eating disturbance 

32. Obesity 

33. Other eating problem 

XV. Enuresis 

56. Bedwetting 

SPECIAL INSTRUCTIONS - Cues for rating as well as specific instructions for each 
item are printed on the scale. Strict adherence to these instructions is re- 
qui red of al 1 raters . 

Item 22 - Level of Speech Development - This item may be confusing. The rater 
is asked to judge whether the level of speech development is appro- 
priate to the child's verbal |Q. For example, response position k is 
read as level of speech development is only 46 - 60% of Verbal jQ; 
position 2 as level of speech development is 76 to 90% of Verbal IQ.. 

I tern 56 - Bedwetting and Item 61 - Hallucinations. Remember that these items 
(as with all items from 29 to 63) refer to the past 7 days. 

DOCUMENTATION 

a. Raw score printout 

b. Cluster score printout 

c. Means and standard deviations for cluster scores 

d. Cross tabulations 

e. Variance analyses 



030 CDS 
CHILDRENS 
DIAGNOSTIC 
SCALE 



CHILDREN'S DIAGNOSTIC SCALE 

INSTRUCTIONS: Insert New General Scoring Sheet and Code. 03 under Sheet Nun^ber. 

Responses should be based on overall psychiatric judgments utilizing all data sources integratively; 
e.g., school reports, mother's reports, interview data, etc. 

Rate current status only. Be sure to answer all items. 

Complete at pretreatment only. 



Mark each item on right half of scoring sheet on row specified 



PSYCHOTICISM Gross 
ronment.bizarfe inleracti. 
responses appear markedl' 
distinct thinking disorders 
irrelevant or tangential coi 
bizarre ideation; delusion 



illogical or contradictory < 



mpairment of relationship with people and envi- 
n, extrei-ne preoccupation with internal stinnuli; 
inappropriate to external stimuli and/or displays 
neologisms, echolalia. incoherence: confused, 
tent: or confused about reality or morbid or 
, hallucinations, or permeated by loosening of 



ANXIETY REACTION Expresses feelings of nervousness, anxiety, 
unrealistic fears or worries; concern with feelings of inadequacy: infe 
shyness, obsessions or compulsions. 



WITHDRAWAL REACTION 

detachment, inability to form 



lose r 



onships. 



UNSOCIALIZED AGGRESSIVE BEHAVIOR Overtly negative, defiant, 

hostile, and/or manipulative, evasive, guarded- Attempts to control others; 
aggressive, antisocial: overwhelmingly selfish. Denial of anxiety and personal 
responsibility for feelings and acts. Is in hostile conflict with the 
environments in a variety of social settings (family, school) which do not 
involve group expression of hostility. 



SOCIALIZED AGGRESSIVE BEHAVIOR 

conflict with the environment, primarily in j 
gang, rarely on own. 



EXPLOSIVE AGGRESSION Unable to control appropriately his 

responses towards peers and/or adults. Physically aggressive, impulsive, often 
reacts to others before understanding the meaning or motives of their words 
or actions. Gets into numerous fights. Physically disruprive particularly in 
classroom where he may hit out at others with little or no provocation. 



CHRONIC HYPERACTIVITY High and conspi 
activity in a variety of settings such as school, hon 



level of gri 



IMMATURE AND INADEQUATE BEHAVIOR Variable and poorly 

organized personality characteristics and coping techniques. 



PRESENCE OF GROSS ORGANIC IfVlPAIRMENT 

Don 



0= NO 

ude impression of minimal brain damage, but use all 
taminaiinnal riata Such as neurological tests, EEG. etc. 
refers to findings which lead to a strong 
■ganic diagnosis, e.g.. hemi- 



Gross organic impa 

paresis, cerebral palsy, epilepsy, etc 



If YES, specify PSYCHIATRIC diagnosis (DSM II) in item 12b and/or 
12c. Any neurologic diagnosis without associated psychopathology 

nd Neurological Examination form 



DELIRIUM Gross acute impairment of orientatio 

place or person) and/or memory, with clouding of sen 
Unlike Item 9, delirium should imply reversable organi 

If YES, specify PSYCHIATRIC diagnosis (DSM II) 

12c, Any neurologic diagnosis without associated psychopathology 

should be specified on the Physical and Neurological Examination form 



0= NO 
1 = YES 



12b and/or 



PRESENCE OF GROSS MENTAL RETARDATION 

Obvious to the examiner and/or found on psychometric tests. 
If YES, specify diagnosis in item 12b and/or 12c. 



0- NO 
1 = YES 



MOOER EX- 

ArtLY SEVERE TREMELY 
SEVERE SEVERE 



Continue marking on right half of scoring sheet on specified row 

12. DIAGNOSIS 

(a) Specify ONE of the following diagnoses on row 12 OR record any 
other DSM II diagnosis under lb) and/or (c) below. 

1 -Schizophrenia, childhood (295,8) 
2 -Overanxious reaction 1308,2) 

3 - Unsocialized aggressive reaction (308,4) 

4 - Hyperactive reaction (308,0) 
5 -Withdrawal reaction (308,1) 

6 - Diagnosis cannot be formulated but 

significant psychopathology is preser 

7 ■ No significant psychopathology (318,0) 

(b) Other diagnosis #1 Mark on 4 n 

(c) Other diagnosis #2 Marie on 4 n 

13. SPECIAL SYMPTOMS 

Check presence of a symptom by marking "0" on the proper row. 
If no special symptoms present mark "0" on row 21 , 

A, No symptoms 

B, Speech disturbance , . , , 

C, Specific learning disturbance . 

D, Tic 

E, Other psychomotor disorder . 

F, Disorder of sleep 

G, Feeding disturbance . 

H. Enuresis 

I. Encopresis 

J. Cephalalgia 



J 132 



13 16 
17-20 



The Children's Diagnostic Scale (CDS) is a 13-item scale formatted for 
use with the General Scoring Sheet. It is an original scale developed by 
members of the Pediatric Psychopharmacology Workshop to explore and clarify 
some of the nosological problems within this age group. The first 8 items 
consist of behavioral syndromes to be evaluated on a 7-point scale derived 
from the adult Brief Psychiatric Rating Scale (BPRS) . From the ratings ob- 
tained on the eight syndromes, construction of more precise typological 
entities may hopefully emerge. The remaining 5 items of the CDS are composed 
of specific diagnostic questions. 



REFERENCE 



- Diagnostic and Statistical Manual of Mental Disorders 
American Psych iatr ic Assoc iat ion , I968, 3rd Edition. 



APPLICABILITY 



Children to 15 



UTILIZATION 



Once at pretreatment . May be used at termination at the 
discretion of the investigator. 



TIME SPAN RATED - Current status only 
CARD FORMAT - ITEMS (I9x, 1211, 2\k, 101 1) 
I tem Col umn I tem 



Col umn 



1 
2 

3 

k 
5 
6 
7 
8 
9 
10 
11 



20 
21 
22 
23 
2k 
25 
26 
27 
28 

29 
30 



12a 
12b 
12c 
13A 
13B 
13c 
13D 
13E 
13F 
13G 
13H 
131 
13J 



31 

32-35 
36-39 

ko 

k] 

42 

43 
kk 

kS 
kS 
hi 
48 
49 



SPECIAL INSTRUCTIONS 

Items 1 - 8 - Descriptions of each of the syndromes are printed on 

the CDS. Raters should make their judgments within 

these contexts. 
I terns 9, 10, 1 1-These 3 items require a present (YES) or absent (NO) 

judgment. Appropriate diagnoses should be encoded 

under Items 12b and/or 12c. 



133 



Item 12a - The 7 most frequent diagnoses are printed on the CDS. Criteria 
for these diagnoses are given in Table 1 . To enc9de any one of 
them, the rater chooses the appropriate single-digit number and 
enters it on Row 12. 

Example: The rater has decided that the diagnosis is 

Childhood Schizophrenia. She does NOT encode 
the DSM-II code-295.8; rather she encodes 1 
i n Row 1 2 . 

1 2 :*: -«• rrt-- i:3r: --Al-- ::5:: "fc: ir?b: iiftir ri»:: 

items 12b- Diagnoses other than the 7 listed in item 12a are encoded here. 

and 12c Codes for these additional diagnoses (4 digits) should be ob- 
tained from Appendix 2. Some of the codes of the DSM-II have 
been modified so that all diagnoses may be entered with h digits, 
(The official DSM-II contains several 5 digit codes). Diagnoses 
associated with the presence of organic impairment, delirium or 
mental retardation (Items 9, 10, 11) should also be encoded here. 

Item 13 - One or more of these Special Symptorirs may be recorded as 
"Present" - regardless of the diagnosis - by encoding "0" 
in the appropriate row. The code "0" in Row 21 indicates 
that none of the 9 Special Symptoms are present. 

Example: The child has both a speech disturbance 
and enuresis. Encode as follows: 



No symptoms .... 
Speech disturbance • 
Specific learning disturbance 

Tic 

Other psychomotor disorder 
Disorder of sleep. 
Feeding disturbance . 

Enuresis 

Encopresis 

Cephalalgia 



21 
22 
23 
24 
25 
26 
27 
28 
29 
30 



21 

22 

23 

24 

25 

26 

27 

28. 

29 

30 



DOCUMENTATION 



a. Raw score printout 

b. Frequency tables 

c. Means and standard deviations 

d. Variance analyses 



13^ 



TABLE 7 
DIAGNOSTIC CRITERIA - FORMULATED BY THE PEDIATRIC PSYCHOPHARMACOLOGY WORKSHOP 
SCHIZOPHRENIA, CHILDHOOD TYPE 

A, Necessary and Sufficient Symptoms 

Autism - Gross impairment of relationships with people and the environment, 
cons ist i ng of: 

1. Avoidance of, or bizarre, human interaction 

2. Behavior reflects lack of comprehension of social 
or external situations, the ordinary meaning of 
words or even the uses of ordinary objects, 

and/or Thought Disorder 

Austic vocabulary, neologisms, stereotyped echolalia, 
incoherence, and/or disconnected, confused, irrelevant 
or tangential content, and/or permeated by bizarre 
fantasies which are ego-synotic, and/or lack of clear 
recognition of the unreality of bizarre or morbid pre- 
occupations (such as introjected bodies, hallucinations, 
somatic delusions, persecutory delusions, delusions of 
special reference or purpose. 

B. Symptoms Commonly Associated, but not sufficient for Diagnosis 

1. Extreme preoccupation with internal stimuli. 

2. Responses appear to be dictated by inner impulses 
and experiences, and appear inappropriate to ex- 
ternal st imul i . 

3. Treats other persons as interchangeable. 

k. Rejects approaches or minimal initiative by other 
persons; remains isolated in group setting. 

5. Excessively diminished responses to sensory stimuli 
or excessive responses to minor irrelevant stimuli. 

6. Affect severely underrespons ive, out of harmony with 
thought content, play or external context; exhibits 
inappropriate, acute and unmodulated shifts to un- 
differentiated excited, panicky or angry states, pre- 
cipated by minimal change in the environment or aris- 
ing without any apparent external stimulus. 

7. Mutisim 

8. Play is marked by one or more such features: stereotyped 
behavior; repetitive use of objects; fragmentary, dis- 
connected and illogical sequences. 

9. Motility usually dyskinetic; may show posturing, manneris- 
tic, choreo-athetot ic or tic-like movements, catatonic 
rigidity, inert flaccid postures, or bursts of darting, 
tiptoeing and whirling hyperactivity. 

10. Is seen as "different", "queer", "crazy" or "sick" by 
peers . 

1 1 . Scapegoated. 



135 



TABLE 7 (Continued) 



Disqua] if iers 



1. Organic psychosis 

2. Delirious or toxic states (such as acute drug reaction) 

3. Q.uest ionable or "borderline" psychotic features. 

OVERANXIOUS REACTION 

A. Necessary and Sufficient Symptoms 

Generally well patterned, well organized behavior marked by expressed 
preoccupation with one or more of the following feelings of subjective 
distress: anxiety, "nervousness", worries, unrealistic fears, tension. 

B. Symptoms Commonly Associated, but not Sufficient for Diagnosis 

1. Overconcern with performance. 

2. Compliant; attempt to conform to external demands or 
situations (including exam); dutiful, suggestible. 

3. Seeks approval, protection and help from adults (includ- 
ing examiner) and usually elicits sympathetic responses 
as "n ice ch i Id". 

4. Expresses feelings of unmet/unsatisfied needs for approv- 
al, being cared for, helped, (which he/she may or may not 
see as unrealistic). 

5. Expresses preoccupation with guilt for his/her own real 

or unreal demands on others, failures, misbehavior, imper- 
fections . 

6. Grossly self-conscious, lacking in self confidence, easily 
flustered, inhibited. 

7. Usually apprehensive in new situations; readily moved to 
tears, upset or worried by inconsequential or imagined 
failure, rejection, disappointment or loss of support by 
others . 

C. Disqual i f iers 

1. Psychosis - If shows generally well organized behavior and 
above preoccupation with anxiety, but language is so per- 
meated by thought disorder, as defined under schizophrenia, 
as to necessitate a diagnosis of psychosis, then classify 
as Childhood Schizophrenia. 

2, Denial of anxiety - Do not diagnose as overanxious, if 
anxiety is not openly expressed as a preoccupation by child 
on examination; e.g., if anxiety is only inferred from 
physiological signs (tremors, muscle tension, fidgeting, 
restlessness; sweating, vasomotor instability, irregular 
respiration); or if anxiety is only inferred from history 
of behavior which is interpreted as fearful by others (such 
as insomnia, feeding disorders, poor attention and perse- 
verance in school or other activities); or if anxiety and 
fearfulness are diffuse and not fully articulated; or if 
unrealistic fears, anxiety or tension do not dominate the 
picture (upon exam or history) but are present only briefly, 



136 



TABLE 7 (Continued) 



UNSOCIALIZED AGGRESSIVE REACTION 

A. Necessary and Sufficient Symptoms 

Generally well patterned, organized behavior marked by: 
overt hostile disobedience, quarrelsomeness, physical 
and/or verbal aggressiveness, vengeful ness and destruc- 
tiveness in a variety of interpersonal contexts. 

B. Symptoms Commonly Associated , but not Sufficient for Diagnosis 

1. Tantrums, solitary stealing, lying and hostile 
teasing of other children. Usually has no con- 
sistent parental acceptance or discipline. Fre- 
quently rationalizes and construes feelings and 
actions in terms of external provocation. Denies 
anxiety and personal responsibility for feelings 
and acts. 

2. Attempts to manipulate and control surroundings. 

3. Expresses resentment at being controlled or placed 
in an inferior position, or being exposed as in- 
adequate or helpless. 

4. Overtly negative, defiant, hostile, suspicious, 
even belligerent with outbursts of anger and shout- 
ing. 

5. Manipulative, obliquely negative and saucy; oppor- 
tunistically placating and ingratiating when faced 
with superior strength or authority; bland, con- 
trolled affective facade, with bravado and even 
euphoria if feels in control of situation, becom- 
ing guarded, calculated, evasive, suspicious only 
if pressed in areas of personal concern. 

6. Speech is guarded and calculated; capable of elabora- 
tion but content limited, noncommital and evasive 
about areas of personal concern. 

7. Preoccupied with feeling restricted and threatened 
by the control of others and with the need to assert 
his/her own autonomy. 

8. Denies feelings of needing support or approval from 
others . 

9. Denies personal responsibility for feelings and diffi- 
cul t ies . 

10. Domineering or exploitative with peers; aggressive if 
challenged; respected, feared or resented by peers as 
"tough" leader, "bossy" or "bully". 

11. Resentment at being controlled or placed in inferior 
position may lead to problems with authority figures 
and to antisocial behavior. 

12. Despite superficially confident facade, may refuse to 
engage in any activity where unable to function ade- 
quately or compete successfully, including learning 
situations or peer group activity. 



137 



TABLE 7 (Continued) 



D isqua 1 if iers 



1. Psychosis - If shows generally well organized behayior with 

denial of personal responsibility for feelings 
and acts with negativism, hostility, suspicious- 
ness and projection, as described above, but 
language is so jDermeated by thought disorder, as 
defined under childhood schizophrenia, as to 
necessitate a diagnosis of psychosis, then classi- 
fy as childhood schizophrenia. 

2. Expressed preoccupation with anxiety and sadness which is per- 
vasive, NOT transient. 

HYPERACTIVE REACTION 

A. Necessary and Sufficient Symptoms 

Hyperactivity - with a high and conspicuous level of gross motor activity 
(locomotion; or "rump" hyperactivity when seated, i.e., 
squirming, changing position and getting up and down fre- 
quently; but not finger-hand twisting, picking or other 
small muscle activity) occurring across environments in 
situations in which sedentary or quiet behavior is appro- 
priate for age; 

and Disorder of attention - with higher distractab i 1 i ty and shorter atten- 
tion span than appropriate for chronological age (not mental 
age), especially in school or group situations. 

B. Symptoms Commonly Associated but not Sufficient for Diagnosis 

1. Poorly integrated and labile behavior, which gives the impression 
of immaturity and of uneven but generally inadequate abilities. 

2. Extremely variable relation to adults (including examiner), with 
rapid fluctuation from attempts at compliance to silly clowning, 
boisterous, mischievous or impertinent behavior, clinging and 
demanding behavior and/or angry or sullen negativism. 

3. Labile affect. Reacts with excessive irritability to any situa- 
tion interpreted as rejecting, demanding or restricting, with 
angry, suspicious, anxious, unhappy and silly clowning responses, 
often associated with gross motor discharge, tantrums, destructive 
or aggressive behavior. 

k. Speech is often sparse and unelaborated with a tendency to evade 
emotionally charged material. 

5. Fantasy is usually expressed more clearly in play; concerned with 
movement and aggression, diffuse fears of retaliation and loss of 
love. 

6. Motility usually variable, impulsive and poorly coordinated. Move- 
ments are relatively undifferentiated for age; has difficulty 
suppressing gross body movement when attempting isolated, finely 
coordinated finger-hand or arm movements. Body manipulation 
relatively uninhibited for age, chewing, sucking, nose picking, 
masturbation. 



138 



TABLE 7 (Continued) 



Unable to conform to demands of a group situation witii peers; often 
becomes scapegoat and/or participates peripherally by provocative, 
wily, teasing, aggressive, quarrelsome behavior; usually considered 
"baby" and "pest" by peers. 

Adults usually consider him/her immature, demanding, difficult to 
manage. Has chronic and recurring difficulties in adapting to age- 
appropriate social and educational demands. 



Disqual if iers 



1. Psychosis - If so permeated by autistic preoccupations or thought 

disorder, as defined under schizophrenia, as to necessi- 
tate a diagnosis of psychosis, then classify as Child- 
hood Schizophrenia, 

2. Expressed preoccupation with anxiety and sadness which is pervasive, 

NOT transient. 

3. Unsocial ized Aggressive Reaction with organized behavior pattern. 

WITHDRAWAL REACTION 

A. Necessary and Sufficient Symptoms 

1. Generally well patterned, well organized behavior marked by shyness, 
seclus iveness , withdrawal, detachment, and general inability to 
form close interpersonal relationships. 

2. Solitary "loner" or participant in group activities without zest, 
reticent, aloof in a variety of settings. 

B. Symptoms Commonly Associated, but not Sufficient for Diagnosis 

1. Compliant; attempt to conform to external demands or situations 
(including exam); dutiful, suggestible. 

2. Expresses preoccupation with guilt for his/her own real or unreal 
demands on others, failures, misbehavior, imperfections. 

3. Grossly self-conscious, lacking in self-confidence, easily 
- flustered, 

k. Apprehensive in new situations; may be moved to tears, upset or 
worried by inconsequential or imagined faflure, rejection, dis- 
appointment or loss of support by others. 

C. Disqual if iers 

1. Psychosis - If shows generally wel 1 -organized behavior with above 

withdrawal but language is so permeated by thought 
disorder, as defined under schizophrenia so as to 
necessitate a diagnosis of psychosis, then classify 
as Childhood Schizophrenia. 

2. Hostile - negative interaction with examiner. 

3. Overtly expressed anxiety, worries and unrealistic fears. 

4. Hyperactive Reaction. 

5. Unsocial ized Aggressive Reaction. 



139 



031 CDC 
CHILDRENS 
DIAGNOSTIC 
CLASSIFICATION 



CHILDREN'S DIAGNOSTIC CLASSIFICATION 

INSTRUCTIONS: ONE RESPONSE and only ONE is permitted. Mark that response on ROW 31 in the column specified. 
Mark on General Scoring Sheet numbered 03. 

Rate current status only. Follow the items until you reach the most appropriate classification for the child. 
Mark that response and STOP. 
Complete at pretreatment only. 



MARK ON R0W31 ONLY 





Proceed through sequence of YES-NO choice points and cho 
Mark that response in specified RESPONSE POSITION. 


ose ONE. 


n 




1 31 


:=er: 


1. 


Is significant psychopathology present? 












YES - Go to 2 












Mark 









and STOP 




2 


Is delirium present? 








YES - Diagnose as ACUTE BRAIN SYNDROME . . . 
NO - Go to 3 


. Mark 
and STOP 


1 




3. 


Is autism and/or thought disorder present? 










YES - Diagnose as SCHIZOPHRENIA CHILDHOOD TYPE 
NO - Go to 4 


. Mark 
and STOP 


2 




4. 


Is subjective distress (anxiety, worries, etc.) expressed? 










YES - Diagnose as OVERANXIOUS REACTION . . . 
NO - Go to 5 


. Mark 
and STOP 


3 




5. 


Is there deliberate antisocial behavior and/or hostile conflict 
with environment (not simply explosive reaction to frustration)? 








YES - Diagnose as UNSOCIALIZED AGGRESSIVE 

REACTION . . . 

NO - Go to 6 


. Mark 
and STOP 


4 




6. 


Is antisocial behavior predominantly in peer group (gang) 
situation? 










YES Diagnose as DYSSOCIAL REACTION 


Mark 


5 




NO - Go to 7 


and STOP 




7. 


Is hyperactivity /attention disorder present? 










YES - Diagnose as HYPERACTIVE REACTION . . . 

NO - Go to 8 


Mark 
and STOP 


6 




8 


Is shyness-withdrawal the predominant behavior pattern? 










YES - Diagnoseas WITHDRAWING REACTION . . . 


. Mark 


7 








Mark 


8 











:J:: i*= ::3:: 



]kZ 



The Children's Diagnostic Classification (CDC) is an alternative method 
of arriving at a diagnosis. Developed by members of the Pediatric Psycho- 
pharmacology Workshop, the CDC differs from the Children's Diagnostic Scale 
in that it leads the rater through an ordered series of choice points until 
a d iagnos is is made. 

APPLICABILITY - Children to 15. 

UTILIZATION Once at pretreatment . May be used at 

termination at the discretion of the 
invest igator. 

TIME SPAN RATED Current status only 

CARD FORMAT (19x, II) 

CDC I tem Column 20 

SPECIAL INSTRUCTIONS 

Encoding the CDC is simple and direct. The rater proceeds through the 
sequence of YES-NO choice points until one of his choices results in the 
instruction to enter a number on the GSS. Having encoded this response on 
Row 31, the rater STOPS. No other method of rating is permitted. Detailed 
instructions for completing the CDC are given below. 

DOCUMENTATION 

The CDC item is displayed with the output of the Children's Diagnostic 
Scale (030-CDS) . 

a. Raw score 

b. Frequency table 

INSTRUCTIONS FOR THE CHILDREN'S DIAGNOSTIC CLASSIFICATION 

John S. Werry, M.B., Ch.B.J 
Department of Psychiatry 
The University of Auckland 

Like all diagnostic systems for children's psychiatric disorders, this one 
is a compromise and it has some unsatisfactory features. However, if it is to 
mean anything at all, it is important that the following rules be understood and 
adhered to strictly. It is also important to realize that the best prediction 
of drug action is likely to come from a multivariate analysis which includes 
measures additional to diagnosis such as neurological status, birth history, IQ. 
and so on. Thus, any shortcomings of the present classification should be 
evaluated with the knowledge that such multivariate analyses will be done. 

1 
Drs. B. Fish, R. G i ttelman-Klein and D. Klein assisted in the development of 
this classification. 



1^3 



It will be seen that a section of the DSM II Diagnostic classification of 
the American Psychiatric Association (Behavior Disorders of Childhood and Adoles- 
cence (308) and Schizophrenia, childhood type (295.8)) form the basis of the termi- 
nology and symptomatolog ica 1 descriptions used since these appear to form the most 
parsimonious and the best cross-validated categories as judged by a wide variety 
of clinical and emp i r ica 1 -stat ist ical studies. However, there are important differ- 
ences from the DSM II classification, notably the exclusion of etiology, severity 
and mental deficiency as irrelevant to classification. The reason for so doing is 
that these three variables are included in other parts of the evaluative battery 
and it was felt, a) that they are more properly used in the context of a multi- 
variate analysis, and b) that they are among the principal causes of obfuscation 
in present nosology, c) Their separation from clinical symptomatology is consis- 
tent with the proposed 9th revision of the International Classification of Diseases. 
It is important again to emphasize that the importance of these excluded variables 
is not denied in the present classification - it is simply felt that their contribu- 
tion is better assessed by subsequent multivariate analyses on large numbers of sub- 
jects. The number of categories is few (7) but it was felt that this number could 
not only classify all children but would result in interjudge reliability of classi- 
fication. Indeed it was also demonstrated in preliminary studies that assignment to 
these categories could be made reliably across investigators. 

The diagnostic process has been specified and is designed on a systems analysis 
or pyramiding basis with each classification arranged in series and linked to the 
previous one by a binary (yes/No) decision. While this injects a certain artificia- 
lity it is designed to force a diagnostic decision and ensure comparability across 
invest igators . 

Rules of Procedure 

1. Observe the stated data base from which to make the diagnosis. The format of the 
clinical examination should follow that of Rutter and Graham, the instructions for 
which are attached. Information not easily elicited in the examination and necessary 
for certain categories should be taken from the standard teacher and/or parent rating 
forms rather than based on each examiner's own rendering of these areas. This will en- 
sure the use of a standard data base. 

2. The diagnostic system must be purely symptomatolog ical . Parent and teacher reports 
must be used only to establish the presence or absence of behavioral symptoms, their 
severity and their persistence across different environments (notably the school and 
peer group). The diagnostician must answer only two questions in classifying a child: 
1) Is there clear evidence of abnormality? If so, 2) What is the symptomatolog ical 
picture? Severity appears as a separate dimension and like CNS status is not denied 

to be important but is more properly entered separately. 



]kk 



The following are to be specifically excluded from use in making the 
diagnosis, a) Brain damage whether established by neurological tests, or 
inferred from pre or perinatal history and/or psychological tests, b) Sever- 
ity (except to make the distinction of normal v. abnormal) and prognosis em- 
bodied in such distinctions as transient situational disturbance, behavior 
disorder, personality disorder or neurosis, c) Intellectual level (IQ.) or 
cognitive function and all psychological test data (learning disorder, per- 
ceptual handicap, etc.). Of course, IQ. or more properly, mental age is nec- 
essary for an accurate evaluation of the abnormality of behavior (such as 
activity level) within a developmental context. 

3. Symptoms must be seen by the examiner, explicitly reported by the patient 
or detailed on the rating scales. Minimal inference must be made - in parti- 
cular all psychodynamic formulations are specifically excluded. Extreme cau- 
tion must be exercised in formulating affective states and only clear verbali- 
zations and/or clear physiological evidence of such states may be used to make 
such inferences as "anxiety" or "depression". It will be seen that with the 
exception of overanxious-withdrawing disorder, all diagnoses are made on the 
basis of a necessary externally observable or reportable symptom complex. 

k. Symptomatology must be evaluated within a developmental and sociological 
context; in particular, the peer group norm with reference to antisocial be- 
havior. Thus, an appropriate question to ask is, what is the average child 
of his age in his neighborhood like? This will prevent classifying the average 
slum child as unsocial ized aggressive. 

5. The diagnostic "flow sheet" (Figure 15) must be used with each case to en- 
sure some minimal standardization across investigators. The diagnostician's 
job is primarily to establish the presence or absence of symptoms. Once this 
has been done the diagnostic flow sheet will make the diagnosis automatically. 

6. Interjudge reliability of diagnosticians should be established by proper 
independent evaluations. Diagnosticians need not be psychiatrists, particular- 
ly when checking interjudge reliability. The categories are clear enough to be 
made by anyone with some clinical experience who follows the instructions. 
While it obviously is preferable to have every child independently diagnosed 

by two judges, once the reliability of a diagnostician has been established he 
may proceed to make unilateral diagnoses. Periodic checks of reliability should, 
however, be made (say every 20th case). 

7. Use the Diagnostic Criteria of the Children's Diagnostic Scale (Table 7) for 
the interpretation of each diagnostic term. 



145 



FIGURE 15 
DIAGNOSTIC FLOW CHART 



BEGIN 



1. Is significant psychopathology present? 

(Q (no) 

2. Is delirium present? 
fNO) (fE^ 



3. Is autism and/or thought disorder present? 



NO) 

V 

k. Is subjective distress (anxiety, worries, etc.) 
expressed? 



5. Is there deliberate antisocial behavior and/or 
hostile conflict with environment (not simply 
explosive reaction to frustration? 



6. Is antisocial behavior predominantly in peer 
group (gang) situation? 



7. Is hyperact ivi ty/attent ion disorder present? 
fNO) (fE^ 



8. Is shyness-withdrawal the predominant 
behavior pattern? 



DIAGNOSE AS; 



-^ NORMAL 

-|> ACUTE BRAIN SYNDROME 



"O SCHIZOPHRENIA CHILDHOOD 
TYPE 



-O OVERANXIOUS REACTION 



-|> UNSOCIALIZED AGGRESSIVE 
REACTION 



-{> DYSSOCIAL REACTION 
-{> HYPERACTIVE REACTION 



-C> WITHDRAWING REACTION 
-[> UNDIAGNOSED 



146 



DIAGNOSIS FOR PSYCHOPHARMACOLOG I CAL STUDIES IN CHILDREN 

John S. Werry, M.B., D ipl . Psych iat . 
Dept. of Psychiatry, School of Medicine 
University of Auckland, New Zealand 

(Adapted from article appearing in Psychopharmacology Bulletin, Special Issue - 
Pharmacotherapy of Children, 89 - 96, 1973) 

In 1969 the Psychopharmacology Research Branch of the National Institute of 
Mental Health brought together a group of clinicians and investigators interested 
in children to develop a battery of measures for pediatric psychopharmacological 
studies similar to those in the adult ECDEU test battery. The author was a member 
of a subcommittee on psychiatric examination and diagnosis. This paper describes 
the results of this subcommittee's deliberations but also provides some of the 
background concepts and literature on diagnosis in child psychiatry as well as 
some pilot work on the measures proposed. 

Purposes of Diagnosis 

We may arbitrarily draw a distinction between assessment and diagnosis: The 
former is concerned principally with the idiographic or unique features of the 
child; while the latter is an attempt to describe how this child resembles every 
other child with a similar condition - in short, it is a nomothetic concept. Diag- 
nosis is a process in which a child is assigned to a nosological category in order 
to summarize statements about etiology, symptomatology, treatment, prognosis, and 
prevention. Unfortunately, because of the present state of knowledge in child 
psychiatry, this is likely to be less useful in dealing with the child as a patient 
than would be a detailed dissection of his inner and soc iofami 1 ia 1 world. 

However, as Dr. Fish (5) has argued, it is essential in psychopharmacological 
studies as opposed to patient needs that the type of child who is studied is clearly 
delineated so that others may interpret, replicate, and/or apply the findings In 
addition, there is also reason to believe from the history of medicine that improbable 
as it may seem at the moment, diagnosis may in the long run prove more heuristic than 
the idiographic approach (3). 

It may also be noted that diagnosis alone cannot adequately describe the sample 
studied and that other identifying characteristics such as age, sex, socioeconomic, 
and ethnic status are also necessary. 

Diagnosis takes two main forms, discontinuous and continuous. In the first, 
typical in medicine, the diagnostic condition (e.g., scarlet fever) is considered 
qualitatively distinct from health or some other disease. In the continuous concept, 
on the other hand, the condition is considered to be simply some arbitrary extreme 
point along a continuum, e.g., in obesity, two standard deviations from the age mean 
for triceps skin folds (9). There has been some debate in the mental health field 
whether the discontinuous or continuous position is more valid (17). As an example, 
some concepts of childhood psychosis, such as the Nine Points or Kanner's original 
description of autism, are discontinuous; while others, particularly psychoanalytic 

Drs. Barbara Fish, Rachel G i ttelman-Klein and Donald Klein participated in the 
subcommittee, but the author is responsible for the opinions expressed herein. 

1^7 



views, reflect only a severe degree of psychopathology rather than anything 
qualitatively different from other conditions (19). The epidemiological 
approach (21), as typified in the works of Lapouse and Monk (8) and Rutter 
and Graham (1^), which uses a statistical definition of abnormality but 
then treats the children so diagnosed as "sick", is nevertheless more dis- 
continuous than continuous. 

Allied but not identical to these two concepts of discontinuity and 
continuity of health and disease are those of nosological category and di- 
mension. The first is a kind of "pigeon hole" into which a patient is fitted 
along with other children with similar disorders. The dimensional approach, 
on the other hand, assumes N dimensions of behavior or personality which like 
physical dimensions, such as height, weight, hemoglobin level, and skin hue, 
can be measured in any child. From this multidimensional space, diagnostic 
categories can be developed by defining upper limits of normality on any num- 
ber (1 through N) of the dimensions; e.g., an albino could be described in 
terms of skin hue, while a dwarf could be described in terms of height and 
weight. These differences may appear pedantic but they tend to be associated 
with entirely different strategies in approaching a diagnosis. 

The nosologist tends to employ the log ical -intuit ive or a priori tech- 
nique - clinicians raise hypotheses which consider early infantile autism as 
a distinct disease entity and suggest symptoms which distinguish it. They 
then may or may not test the validity of their hypotheses. Depending on the 
prestige of the proponent and the degree of clinician concensus, these hypo- 
theses are likely to become incorporated untested into the lore of the pro- 
fession. The history of medicine and of psychiatry in particular shows that 
this technique may lead, as in nineteenth century European psychiatry, to a 
plethora of nonexistent syndromes. A modern day example is that of the sym- 
biotic child (18) or the Gilles de la Tourette syndrome which is only a severe 
case of tics, as there is good reason to believe. However, in general, this 
strategy despite its haphazard nature has served medicine well, certainly in 
the pre-Vernard-V i rchow era. 

The second strategy is the empirical-statistical or, as some might less 
charitably call it, the serendipitous. Here the diagnostician makes few as- 
sumptions about classification. He concerns himself with only the data domain 
from which he believes classification will emerge. He then collects measure- 
ments on large numbers of children after which he tries, usually by means of 
multivariate statistical techniques, to group the children on a post hoc basis. 
The works of Jenkins, Lessing, Dreger, Patterson, and Q.uay (12) are examples of 
this approach. As might be expected, with the notable exception of Jenkins, 
the empirical-statistical technique is more favored by psychologists than by 
psychiatrists who tend to favour the a priori approach. 

Diagnostic Examinations 

Before a diagnostic category can be assigned, it is necessary to elicit 
the data (or signs and symptoms) by which diagnosis is made. The first concept 
germane to examination is the data domain of data base. This refers to the type 
and amount of information available to the "diagnoser" for processing into a 
diagnos is . 



]kB 



Data domains may be implicit or explicit. In psychiatry, a considerable 
number of invalid assumptions are made about the implicit data domain from which 
the diagnoser is operating. Thus, it is assumed that a competent child psychia- 
trist will cover all necessary points in the child's history and examination to 
arrive at a diagnosis. Though sporadic attempts have been made to systematize 
history and examination (15), they have never really become popular. In sharp 
contrast, psychologists have been almost obsessed with explicating the precise 
details of how to elicit information and then how to score it, e.g., in the 
standard intelligence tests. While this may inject some rigidity into the 
diagnostic examination, child psychiatrists could well take a lesson from their 
psychologist colleagues in the respect, since there is little doubt that the 
unreliability of current diagnostic systems in child psychiatry stems at least 
in part from the differing data domains of individual diagnosticians. 

Diagnosis in child psychiatry is typically arrived at through a multifaceted 
data domain, including a history taken from the mother, buttressed by school psy- 
chometric reports, and confirmed by one or more psychiatric examinations of the 
child. Methods, except psychological tests, tend to be informal and verbal; but 
there is no good reason why they cannot be written, explicit (as in a questionnaire) 
and based on less inferential techniques of observation, such as time sampling of 
behavior (20) or measurement by electronic or other mechanical devices (16, 22). 
Obviously, the technique and the source of elicitation will affect the data domain 
sampled. It is also apparent that it will never be possible to sample the entire 
potential data domain but that accuracy will be improved by sampling across ob- 
servers (or informants), environments, and techniques, i.e., in the case of psycho- 
pharmalogica 1 studies, until the precise cellular or system locale of the drug 
action is known and can be measured. Even then its action is likely to be influenced 
by social and other variables. 

In summary, in order to understand the accuracy of a diagnosis, we really need 
to know the scope and content of the techniques which elicit the information previous 
to the diagnos is . 

Logical Processes in Formulating a Diagnosis 

Once information has been elicited, it must be processed to form a diagnosis. 
The logical process can be judgmental or inexorable. Thus, once a psychologist has 
administered the test items in a WISC, the actual |Q score is inexorably fixed. On 
the other hand, a child psychiatrist in reviewing the data available to him from 
many sources and of many types will have to exercise a considerable degree of judg- 
ment in coming to a diagnosis. This is partly because different evidence is likely 
to be conflicting (e.g., mother and teacher ratings) but principally because the 
rules for assigning a child to one particular diagnostic category have never been 
spelled out in unambiguous fashion. Even the "Nine Points" for diagnosing childhood 
psychosis do not indicate which signs are necessary and how many are sufficient for 
a diagnosis. Thus as a starter, someone has to specify these rules, however arbitrary, 
so that assigning a diagnosis may become similar across different diagnosticians. Not 
only is it necessary to specify what a condition is in terms of necessary and 



1^+9 



sufficient symptoms but also it must be indicated what it is not; in other words, 
d isqual i f iers must be determined. Thus, no two diagnostic categories should have 
the same set of necessary and sufficient signs or d isqua 1 if iers . There is only 
one way to decide whether a system is reliable. Construct a decision tree or flow 
chart, beloved of computer programmers, and then put the system to an-empirical 
test with actual cases. No popular diagnostic system in child psychiatry present- 
ly meets these criteria. Even if one did, it is not always easy to get psychia- 
trists to abide by the logical rules as Overall and Hoi lister (10) have found. 
Their solution was to use the unquestioning and obsessively logical computer to 
make the diagnosis from the history and examination data. 

Current Nosological Systems 

One of the main obfuscating features of most current systems of nomenclature 
is that they are conceptually impure being based on a mixture of severity, etiol- 
ogy, intelligence, and behavioral symptomatology. This would be satisfactory if, 
as with Fish and .Shapiro's (6) typology, it were a genuine multidimensional system 
where each cell or nomenclature is defined by its position along each dimension. 
Thus a true dimensional system would have the following possibilities: 1. Etio- 
logical - organic/nonorgan ic , 2. Intellectual - retarded/normal. 3- Severity - 
mild, moderate, and severe (replacing adjustment reaction, personality disorder, 
and psychosis). 4. Symptomatolog ical - psychotic, antisocial, hyperkinetic, 
anxious, withdrawing, and mixed. Thus a child would then be scored on each of 
these dimensions. A child now described as psychotic, if one of Goldfarb's (7) 
organic group, could be described as organic, retarded, severe, psychotic, and 
not simply as of the schizophrenic-childhood type. 

There are several popular systems available at the moment (12). The most wide- 
ly used in North America is the APA's DSM li- which differs from the ICD S-- version 
only by the interpolation in the section on Children's Behavior Disorders (308.0) of 
a number of subcategories (such as, hyperkinetic reaction and withdrawing reaction) 
which are actually derived from Jenkins' emp i r ical -stat ist ical system (12). The 
GAP"~'~'' system is rather similar to the above except that in addition it categorizes 
by "developmental level." Other systems are (a) by Rutter (13) which is part tradi- 
tional and part empi r ical -stat ist ical and (b) a series of conceptually pure (i.e., 
behavioral only) empirical, statistical (mostly factor analytically derived), 
dimensional systems of which the best worked out is certainly the four dimensional 
one by Quay (12). Q.uay's dimensions are conduct problem, neurotic, immaturity- 
inadequacy, and socialized (gang) delinquency. Unlike most other systems, Quay's 
has a considerable amount of data on norms, reliability, predictive validity (e.g., 
outcome in delinquency), and discriminative power (normals vs. child guidance 
populations). A weakness of Quay's system is that his original samples included 
few psychotic children so that psychosis does not emerge. Dimensional systems like 
Quay's are theoretically dimensional but not categorical. Yet, in practice it is 
customary, as Quay does, to make categories by extreme scores, e.g., conduct-problem 
type (equals unsocial ized aggressive reaction) for high scorers on that dimension, 

"American Psychiatric Association's Diagnostic and Statistical Manual of Mental 
Disorders-! I 
v-'^orld Health Organization's International Classification of Diseases-8 
*>WrGroup for the Advancement of Psychiatry 



150 



low scorers on the other three dimensions. 

We may note that the idea of an emp i r ica 1 -stat ist ica 1 classification as 
opposed to a logical intuitive one has won favor in the adult ECDEU battery 
in Overall's classification based on the Brief Psychiatric Rating Scale (BPRS) 
(11). What is remarkable about factor analytically derived systems is that 
many different investigators have derived virtually the same dimensions, certain- 
ly in so far as the more common ones are concerned (12), and it would, there- 
fore, only be a matter of agreeing on the method of eliciting the information, 
the cutoff scores, and combinations of dimensional scores for diagnostic entities 
to have a good nosological system (in the scientific sense). The children's 
ECDEU battery will include, in sections other than the psychiatric examination, 
empirical statistical instruments and Conner's Teacher and Parent Rating Scales 
(1) which could be used nosolog ica 1 1 y . This would perhaps make the psychiatric 
examination and diagnosis unnecessary. 

Characteristics of a Good System 

When the committee came to consider its task, it had to define the charac- 
teristics of a good system. The following characteristics appear to have emerged 
not a priori but like termites out of the woodwork. 

1. It should be acceptable to most investigators - simple, topical, compre- 
hensible, accurate, and useful. 

2. It should specify the data domain and the method of eliciting the data. 
This domain should be wide enough to cover all conditions, including uncommon ones 
1 ike psychos is . 

3. The decision flow from data to diagnosis should be explicated. 

k. Diagnoses should be mutually exclusive. This does not preclude making a 
secondary diagnosis. It just means that one set of data should lead to a clear 
terminal diagnostic point distinct from all others. 

5. Diagnosis should be reliable across investigators. 

6. Diagnosis should be valid in predicting drug responders and meaningful in 
terms of current concepts and theory and in describing samples of children studied. 

7- Diagnoses should be in a form suitable for statistical analysis, i.e., 
capable of being reduced to numbers or scales rather than a purely descriptive 
statement. 

How far the committee achieved these goals is a matter for future verification, 

The System of Examination 

The system consists of three parts: 1) A system of psychiatric examination, 
2) a rating scale to be completed by the psychiatrist, and 3) a diagnostic section. 



151 



1. Developed by Dr. Fish from Rutter and Graham's (15) method of examination, 
it describes the setting, conduct, and duration of the examination. While it is 
specified to a certain extent, it is only a semistructured examination and much is 
still assumed about the communal ity of operating assumptions, behavior, and the 
competence of child psychiatrists. This apparent weakness need not bother us at 
this time since reliability studies as well as other studies are planned. Further- 
more, the complete children's ECDEU battery includes a number of other measures, 
such as Conner's Parent and Teacher Scales (1) against which it can be validated. 
Discrepancies will be difficult to interpret. Nevertheless, Conner's psychometri- 
cally developed instruments together with their proven usefulness in drug studies 
{k, 23) suggest that, opposed to the traditional position, the psychiatric rating 
must be regarded as "not proven" rather than as a standard. This is particularly 
the case since it is mainly based on a shorter sampling of the child's behavior and 
one taken in a most unusual situation for the child in a one-to-one interview. In 
the end, however, the acid test will come when its predictive ability to discrim- 
inate between drug responders and nonresponders is tested rather than its descrip- 
tive ability, important as the latter may be. 

2. The Children's Psychiatric Rating Scale (CPRS) is a 63-item checklist to 

be completed by the psychiatrist from his own observations and the child's verbaliza- 
tions to him. Each symptom is defined in a manual and rated on a 7-point scale of 
severity. 

The reason for restricting it to interview material is so that it does not simply 
parrot mothers' or teachers' reports but offers something unique. There was a differ- 
ence of opinion in the committee as to how valid the result is likely to be. The 
author was among those who felt that the yield from this restriction is not likely 
to be high, but in the end the proof of the pudding is in the eating and the useful- 
ness of the checklist can be tested empirically by consumer reaction, data reduction, 
test construction, and other statistical analyses once sufficient numbers of observa- 
tions have been accumulated in the ECDEU data bank. 

Some initial work carried out by the author in the child psychiatry clinic of the 
Auckland Hospital shows that a number of the items are nonoccurr ing , and only 20 per- 
cent occurred with a frequency of 10 percent in the sample studied (N = 22). The 
reason may have been (as might be expected from Dr. Fish's participation) that the 
scale is overloaded with items reflecting severe psychopathology of the type found in 
psychosis. Also, items in which the child reports his own psychopathology were very 
infrequent, but this could reflect either the deficiencies of the Auckland examiners 
or the sample of children seen there (a preponderance of unsoc ial ized , aggress ive , and 
hyperkinetic reactions). If it should prove that many items are infrequent, a 
decision would have to be made as to their value in the occasional case - decide 
whether the instrument should remain wideranged or narrowed to a shortened version 
as Conner has done with his Parent and Teacher Scales. A more satisfactory alterna- 
tive in the author's opinion would be to use a "gating" system whereby one key question, 
if positive, leads into a subset of related items (e.g., around psychotic behavior). 

3. The diagnostic section consists of two scales - Children's Diagnostic Scale 
and Children's Diagnostic Classification. As might be expected the committee spent 
most of its time discussing this most contentious area. It was agreed that given the 
chaotic state of diagnosis in child psychiatry, some arbitrary decisions would have 



152 



to be made simply to achieve some standardization. Knowledge cannot progress 
until a common set of definitions and domains of study can be agreed upon. This 
does not mean that the definitions or their underlying assumptions are valid but 
that there can be no testing of their validity until this process has occurred. 
The system below is offered then - not as a definitive system - but as a starting 
point to be refined, extended, or even rejected - not a priori by armchair philoso- 
phers - but by systematic empirical study of its worth. Unlike the CPRS, this 
section is scored using information from al) sources and informants. It is sub- 
divided into four parts: (See Children's Diagnostic Scale) 

a. Symptomatic Dimension Ratings (Items 1 - 8) - This section is a symptoma- 
tological or personality profile which is developed, as are all other parts of 
this section, on the basis of all information available (except factor scores on 
Conner's Parent and Teacher Scales). This is partly to see if psychiatrists can 
validate the basic personality dimensions revealed by empirical statistical studies 
(12) as Overall (11) has done with adult scales. It was mainly done though to pro- 
vide a brief, readily comprehensible picture of the child's symptomatology or 
personality profile. The latter cannot be done either by the APA diagnosis, ignor- 
ing as it does all except the most prominent symptoms, nor by the 63-item Symptom 
Checklist which is too cumbersome for summary statements. It is important to 
realize that these are dimensions and not mutually exclusive diagnostic categories, 
and thus a child must be rated on all dimensions on a scale of severity from 1 (not 
present) through 7 (disabling). A preliminary test of the i nterexami ner reliability 
of both (23) showed that a satisfactory degree of reliability can be attained in 
both dimensional ratings and APA diagnoses. 

b. Neurological and Intellectual Status (Items 9 - 11) -As discussed earlier, 
the mixed etiological, intellectual status, severity, and symptomatolog ica 1 nature 
of most diagnostic systems, such as the DSM II, presents insuperaole difficulties. 
For this reason, the committee decided to separate out these areas, and all are 
scored separately except that severity is assumed to apply to behavioral psychopathol - 
ogy and scored there. There is provision elsewhere for rncluslon of the actual IQ. 

or estimate of severity of retardation. Only major neurological signs (not history, 
psychological tests, soft signs, etc.) permit a positive score for organic. Tnis 
hard line position was decided upon in view of the elasticity with which the term 
organic is often used, making it virtually worthless. 

c. Modified APA Diagnosis (Item 12) - It was decided that the Behavior Dis- 
order section in the DSM II was the most suitable because it is purely symp tomato logi- 
cal, is derived from empirical -statistical studies, and has oeen repeatedly validated 
in factor analytic (12) and clinical studies (b) . It was of course necessary to add 
schizophrenia, childhood type to cover psychosis even though it has not emerged as a 
symptom complex, no doubt oecause of its infrequency in the patient samples of Jenkins, 
Peterson, Conners, and others. Some of Jenkins' categories which appear in this 
section of the DSM II were, however, rejected on the grounds that they have not 
appeared in other than his studies (e.g., runaway reaction). Also included are normal 
and undiagnosable categories, the latter largely as a test of consumer acceptance. 



153 



d. Special Symptoms (item 13) - Provision is made for outstanding special 
symptoms, such as enuresis or learning disability, but these do not preclude mak- 
ing a modified APA diagnosis. Thus one could check enuresis and mark "normal" 
overanxious reaction or something else. Attention is drawn to the exclusion of 
juvenile delinquency of the gang-type which is considered to reflect social not 
individual pathology (12). Only the true psychopath (i.e., unsocial ized aggress- 
ive reaction) of the gang would be included and not because of his belonging to 
a gang or because of severe antisocial behavior in accord with the gang's rules; 
but because of such behavior as cheating on friends, general impulsivity (most 
gangs require high degrees of discipline), exploitative relationships, and 
ultimately nearly always rejection by the peer group. 

Conclus ions 

The above system is offered as a start to some degree of conformity in the 
areas of psychiatric examination and diagnosis for pediatric psychopharmacological 
studies. It is unlikely that it will become the definitive system, but it is 
hoped that changes will be based primarily on an empirical test of the reliability, 
validity, and predictive ability as far as the effects of medication are concerned. 
Only field testing of the instrument by many investigators making the results avail- 
able to NIMH's ECDEU will provide the necessary data for this empirical analysis. 
Reliability studies require two independent examiners and thus more effort by the 
investigators, but hopefully this will be done, too, and the children's ECDEU 
battery will be off to a worthy start unusual for child psychiatry. 

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Werry, J. (eds) , Psychopathological Disorders of Childhood. New York: Wiley, 
1972. 

13. Rutter, M. Classification and categorization in child psychiatry. J. Child 
Psychol. Psychiat., 6:71-83, 1965. 

]k. Rutter, M., and Graham, P. Psychiatric disorder in 10- and 11-year-old children. 
Proceedings of the Royal Society of Medicine, 59:382-387, I966. 

15. Rutter, M., and Graham, P. The reliability and validity of psychiatric assessment 
of the child, I, Interview with the child. Brit. J. Psychiat., 114:653-659, 
1968. 

16. Schwi tzgebel , R. Survey of electromechanical devices for behavior modification. 
Psychol. Bull., 70:444-459, 1968. 

17. Ullmann, L., and Krasner, L. A Psychological Approach to Abnormal Behavior. 
Englewood Cliffs, New Jersey: Prentice-Hall, I969, pp. 9-24. 

18. Werry, J. Childhood psychosis. In: Q.uay, H., and Werry, J. (eds), Psycho- 
pathological Disorders of Childhood. New York: Wiley, 1972a. 

19. Werry, J. Psychosomatic disorders. Ibid., 1972b. 

20. Werry J., and Quay, H. Observing the behavior of elementary school children. 
Except. Child., 35:461-472, I969. 

21. Werry, J., and Quay, H. The prevalence of behavior symptoms in younger 
elementary school children. Amer. J. Orthopsych iat . , 41:136-143, 1971. 

22. Werry, J., and Sprague, R. Hyperactivity. In: Costello, G. (ed.), Symptoms 
of Psychopathology. New York: Wiley, 1970, pp. 397-417. 

23. Werry, J., Sprague, R. et al. Methylphen idate in children - Effect of dosage. 
Submitted for publication, 1972. 



155 



047 BPRS 
BRIEF 

PSYCHIATRIC 
RATING SCALE 



MH-9-47 
6-73 



BRIEF PSYCHIATRIC RATING SCALE (Overall and Gorham) 



INSTRUCTIONS: Insert Genera/ Scoring Sheet and Code 01 Under Sheet Number. 

This form consists of 18 symptom constructs, each to be rated on a 7-point scale of 
severity ranging from "not present" to "extremely severe". If a specific symptom is 
not rated, mark "0" = Not Assessed. 

Mark the column headed by the term which best describes the patient's present condition. 
USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE 



Mark on right half of scoring sheet on row specified 



SOMATIC 
CONCERN 



EMOTIONAL 
WITHDRAWAL 



CONCEPTUAL 

DISORGANI 
ZATION 



GUILT 
FEELINGS 



MANNERISMS 

AND 
POSTURING 



GRANDIOSITY 



DEPRESSIVE 
MOOD 



Degree 
the pati 



concern over present bodily health. Rate the 
'vhich physical health is perceived as a problem by 
t, whether complaints have a realistic basis or not. 



Worry, fear, or over-concern for present or future 
solely on the basis of verbal report of patient's ov 
tive experiences. Do not infer anxiety from phys 
or from neurotic defense mechanisms. 



and t 



Deficiency in relating to the intt 
er situation. Rate only the degree to which the p. 
the impression of failing to be in emotional conta 
other people in the interview situation. 



he i 



Degree to which the thought processes are confused, dis- 
connected or disorganized. Rate on the basis of integratiot 
of the verbal products of the patient; do not rate on the 
basis of patient's subjective impression of his own level of 

functioning. 



Over-concern or remorse for past behavior. Rate on the 
basis of the patient's subjective experiences of guilt as 
evidenced by verbal report with appropriate affect; do not 
infer guilt feelings from depression, anxiety i 
defenses. 



and heightened activation level. Tension should be rated 
solely on the basis of physical signs and motor behavior ar 
not on the basis of subjective experiences of tension 
reported by the patient. 



Unusual and unnatural motor behavior, the type of motor 
behavior which causes certain mental patients to stand out 
in a crowd of normal people. Rate only abnormality of 
movements; do not rate simple heightened motor activity 
here. 



Exaggerated self-opinion, conviction of un 
powers. Rate only on the basis of patient' 



demeanor in the interview situation. 

Despondency in mood, sadness. Rate only degrt 
despondency; do not rate on the basis of inferei 
cerning depression based upon general retardatic 



al ability t 



mosity, contempt, belligeren 
jide the interview situation. 
verbal report of feelings and 



o ope rat IV: 



, disdain for other people 
)te solely on the basis of 
tionsof the patient towa 
neurotic defenses. 
Rale attitude toward 



SUSPICIOUS- 
NESS 



Belief {delusional or otherwise} that others have now, or 
e had in the past, malicious or discriminatory intent 
(ard the patient. On the basis of verbal report, rate oi 
se suspicions which are currently held whether they 
cern past or present circumstances. 



MODER- EX 

ATILY TREMELY 

SEVERE SEVERE SEVERE 



Continue marking on right half of scoring sheet on row specified 


ROW 
NO. 


12. HALLUCINA- 
TORY 
BEHAVIOR 


Perceptions without normal external stimulus corre- 
spondence. Rate only those experiences which are 
reported to have occurred within the last week and which 
are described as distinctly different from the thought and 
imagery processes of normal people. 


12 


13. MOTOR 

RETARDA- 
TION 


Reduction in energy level evidenced in slowed movements. 
Rate on the basis of observed behavior of the patient only; 
do not rate on basis of patient's subjective impression of 
own energy level 


13 


14. UNCO- 
OPE RATIVE- 
NESS 


Evidence of resistance, unfriendliness, resentment, and lack 
of readiness to cooperate with the interviewer. Rate only on 
the basis of the patient's attitude and responses to the 
interviewer and the interview situation; do not rate on basis 
of reported resentment or uncooperativeness outside the 
interview situation. 


14 


15. UNUSUAL 
THOUGHT 
CONTENT 


Unusual, odd, strange, or bizarre thought content. Rate 
here the degree of unusualness, not the degree of disorgan- 
ization of thought processes. 


15 


16. BLUNTED 
AFFECT 


Reduced emotional tone, apparent lack of normal feeling 


16 


17. EXCITEMENT 


Heightened emotional tone, agitation, increased reactivity. 


17 


18. DISORIENT- 
ATION 


Confusion or lack of proper associationfor person, place 


18 



158 



Developed by Overall and Gorham, the Brief Psychiatric Rating Scale (BPRS) 
is formatted for use with the General Scoring Sheet and consists of the l8-item 
version of the scale. Developed from the longer Lorr Multidimensional Scale for 
Rating Psychiatric Patients (MSRPP) and Lorr Inpatient Multidimensional Psychiatric 
Scale (imps), the BPRS provides a rapid and efficient evaluation of treatment 
response in both clinical drug trials and routine clinical settings. Its focus 
is primarily inpatient psychopathology . It has been employed in outpatient settings 
to assess levels of anxiety and depression and to distinguish neurotic from more 
severely disturbed patients; but the authors caution that the BPRS was not designed 
to represent the fine distinctions between types of neurotic patients. 

REFERENCES 

1. Overall, J. E. and Gorham, D. R., The Brief Psychiatric Rating Scale, 
Psychol. Rep., 10:799-812, 1962. 

2. Overall, J. E., The Brief Psychiatric Rating Scale in Psychopharmacology 
Research, Psychometric Laboratory Reports, No. 29, University of Texas, 
Galveston, June, 1972. 

APPLICABILITY Primarily for adult inpatient populations. 

UTILIZATION Once at pretreatment; at least one post-treatment 

assessment. The number and spacing of post-treatment 
assessments are at the discretion of the investigator. 

TIME SPAN RATED At a maximum, the interval since the last assessment. 
At pretreatment, a span of one week is suggested. 

CARD FORMAT - ITEMS CARD 01 = 19x, iSll) 

I tern Column I tem Column 

Hostility 29 

Suspiciousness 30 

Hallucinatory Behavior 31 

Motor Retardation 32 

Uncooperat i veness 33 

Unusual Thought Content 3^ 

Blunted Affect 35 

Excitement 36 

Disorientation 37 



1. 


Somatic Concern 


20 


10. 


2. 


Anxiety 


21 


11. 


3. 


Emotional Withdrawal 


22 


12. 


k. 


Conceptual Disorganization 


23 


13. 


5. 


Guilt Feel ings 


2k 


14. 


6. 


Tens ion 


25 


15. 


7. 


Mannerisms 


26 


16. 


8. 


Grandios i ty 


27 


17. 


9. 


Depress ive Mood 


28 


18. 



159 



CARD FORMAT - FACTORS 



CARD 51 = (19x, 5F6.2, F4.0) 

Code "5" in Column 18 indicates card contain- 
ing factor, cluster or derived scores. 



Factor 



Columns 



1 


20-25 


II 


26-31 


III 


32-37 


IV 


38-43 


V 


i+4-49 


Total Score 


50-53 



Factor score = Sum of composite items pactor score range = 1 
No. of composite items 



Total score = Sum of all items 



Total score range = 18 - 126 



FACTOR COMPOSITION This factor structure is based on a I974 

analysis of the pretreatment scores of 3596 

subjects with diagnoses of schizophrenia. (Table 8). 



I. Anxiety-Depression (ANDP) 

1 . Somat ic Concern 

2. Anxiety 

5. Guilt Feel ings 
9. Depressive Mood 

I I . Anergia (ANER) 

3. Emotional Withdrawal 
13. Motor Retardation 
16. Blunted Affect 

18. Disorientation 



IV. Activitation (ACTV) 

6. Tension 

7. Mannerisms & Posturing 
17. Excitement 



V. Hosti le-Suspiciousness (HOST) 

10. Hostility 

1 1 . Suspiciousness 

14. Uncooperat iveness 



Mi. Thought Disturbance (THOT) 

4. Conceptual Disorganization 

8. Grandiosity 

12. Hallucinatory Behavior 

15. Unusual Thought Content 



160 



TABLE 8 
5-FACTOR VARIMAX SOLUTION OF 18-ITEM BRIEF PSYCHIATRIC RATING SCALE 

Guy, W., Cleary, P. and Bonato, R. R., Methodological Implications of a Large 
Central Data System, published in Proceedings of IXth Congress, CINP, Excerpta 
Medica, Amsterdam, 1975. 



ITEM 

Somatic Concern 

Anxiety 

Emotional Withdrawal 

Conceptual Disorganization 

Gu i 1 1 Feel ings 

Tens ions 

Manner isms 

Grand ios i ty 

Depressive Mood 

Hosti 1 ity 

Susp ic iousness 

Hallucinatory Behavior 

Motor Retardation 

Uncooperat i veness 

Unusual Thought Content 

Blunted Affect 

Exci tement 

Disor ientat ion 

Contribution 

of factor (V ) 
P 

% Total Variance 

% Common Variance 



I I I 



IV 



-627 


066 


-164 


030 


-jkS 


115 


-073 


293 


156 


-808 


-139 


157 


019 


-344 


-640 


280 


-e^k 


014 


-055 


013 


-381 


-040 


-064 


732 


023 


-463 


.-216 


568 


004 


208 


-536 


-027 


-784 


-116 


099 


-008 


-208 


036 


-156 


195 


-346 


078 


-376 


-020 


-081 


-147 


-711 


156 


-337 


-635 


125 


-198 


078 


-451 


044 


301 


159 


-027 


-797 


049 


015 


-793 


-094 


-077 


-030 


172 


-210 


744 


227 


-475 


-330 


300 



2.58 

14.3 
22.8 



2.48 

13.8 
21.1 



2.30 

12.8 
20.3 



10.5 
16.7 



V 


Communal i t ies 


014 


425 


127 


677 


073 


726 


052 


610 


074 


491 


161 


712 


-082 


591 


441 


526 


124 


653 


778 


712 


650 


689 


003 


558 


039 


573 


641 


713 


286 


745 


■032 


645 


319 


729 


208 


519 


1.94 


11.29 


10.8 


62.7 



17. 



161 



SPECIAL INSTRUCTIONS 

Brief instructions for rating each item are printed on the scale itself. 
To increase the degree of communal ity in interpretation, the items are defined 
below in greater detail by Overall and Gorham, and the rater is urged to con- 
fine his responses within these contexts. 

A. Ratings Based Upon Observation of Patient 

3. Emotional Withdrawal - This construct is defined solely in terms of the 
ability of the patient to relate in the interpersonal interview situation. 
Thus, an attempt is made to distinguish between motor aspects of general retarda- 
tion, which are rated as "motor retardation" and the more menta 1 -emotional 
aspects of withdrawal, even though ratings in the two areas may be expected to 
covary to some extent. In the factor analyses of change in psychiatric ratings, 
a "general retardation" factor has emerged in several different analyses, and 
this general retardation factor has included both emotional and motor retarda- 
tion items. It js difficult to identify the basis for rating of "ability to 
relate"; however, initial work has indicated that raters achieve reasonably high 
agreement in rating this quality. Emotional withdrawal is represented by the 
feeling on the part of the rater that an invisible barrier exists between the 
patient and other persons in the interview situation. It is suspected that eyes, 
facial expression, voice quality and variability, and expressive movements all 
enter into the evaluation of this important, but nebulous, quality of the patients. 

6. Tension - It should be noted that the construct "tension" is restricted in the 
Brief Scale to physical and motor signs commonly associated with anxiety. Tension 
does not involve the subjective experience or mental state of the patient. Although 
research psychologists in an effort to attain a high degree of objectivity 
frequently define anxiety in terms of physical signs, in the Brief Scale observable 
physical signs of tension and subjective experiences of anxiety are rated separately. 
Although anxiety and tension tend to vary together, developmental resiearch with an 
earlier form of the Brief Scale indicated that the degree of pathology in the two 
areas may be quite different in specific patients. A patient, especially when under 
the influence of a drug, may report extreme apprehension but give no external evi- 
dence of tension whatsoever, or vice versa. |n rating the degree of tension, the 
rater should attend to the number and nature of signs of abnormally heightened activa- 
tion level such as nervousness, fidgeting, tremors, twitches, sweating, frequent 
changing of posture, hypertonic! ty of movements, and heightened muscle tone. 

7. Mannerisms and posturing - This symptom area includes the unusual and bizarre 
motor behavior by which a mentally ill person can often be identified in a crowd of 
normal persons. The severity of manner istic behavior depends both upon the nature 
and number of unusual motor responses. However, it is the "unusualness", and not 
simply the amount of movement, which is to be rated. Odd, indirect, repetitive 
movements, or movements lacking normal coordination and integration, are rated on 
this scale. Strained, distorted, abnormal postures which are maintained for ex- 
tended periods are rated. Grimaces and unusual movements of lips, tongue, or eyes 
are considered here also. Tics and twitches which are rated as signs of tension 
are not rated as manneristic behavior. 



162 



13. Motor retardation - Motor retardation Involves the general slowing down and 
weakening of voluntary motor responses. Symptomatology in this area is represented 
by behavior which might be attributed to the loss of energy and vigor necessary to 
perform voluntary acts in a normal manner. Voluntary acts which are especially 
affected by reduced energy level include those related to speech as well as gross 
muscular behavior. With increased "motor retardation" speech is slowed, weakened 
in volume, and reduced in amount. Voluntary movements are slowed, weakened, and 
less frequent. 

]k. Uncooperat i veness - This is the term adopted to represent signs of hostility 
and resistance to the interviewer and interview situation. It should be noted that 
"uncooperat i veness" is judged on the basis of response of the patient to the inter- 
view situation while "hostility" is rated on the basis of verbal reports of hostile 
feelings or behavior toward others outside the interview situation. It was found 
necessary to separate the two areas because of an occasional patient who refrained 
from any reference to hostile feelings and who even denies them, while evidencing 
strong hostility toward the Interviewer. 

B. Ratings Based Primarily Upon Verbal Report 

1. Somatic concern - The severity of physical complaints should be rated solely' 
on the number and nature of complaints of bodily illness or malfunction, or 
suspiciousness of same, alleged during the Interview period. The evaluation is of 
the degree to which the patient perceives or suspects physical ailments to play an 
important part In his total lack of well-being. No consideration of the probability 
of true organic basis for the complaints is required. Only the frequency and 
severity of complaints are rated. 

2. Anxiety - Anxiety Is a term restricted to the subjective experience of worry, 
overconcern, apprehension or fear. Rating of degree of anxiety should be based upon 
verbal responses reporting such subjective experiences on the part of the patient. 
Care should be taken to exclude from consideration In rating anxiety the physical 
signs which are included in the concept of tension, as defined In the scale. The 
sincerity of the report and the strength of the experience as indicated by the 
involvement of the patient may be important in evaluating degree of anxiety. 

k. Conceptual disorganization - Conceptual disorganization involves the disruption 
of normal thought processes and Is evidenced in confusion. Irrelevance, Inconsistency, 
disconnectedness, d Isjol ntedness , blocking, confabulation, autism, and unusual chain 
of associating. Ratings should be based upon the patient's spontaneous verbal 
products, especially those longer, spontaneous response sequences which are likely 
to be elicited during the initial, non-»d I rect I ve portion of the Interview. Attention 
to the facial expression of the patient during the verbal response may be helpful in 
evaluating the degree of confusion or blocking. 

5. Guilt feelings - The strength of guilt feelings should be judged from the 
frequency and intensity of reported experiences of remorse for past behavior. The 
strength of the guilt feelings must be judged in part from the involvement evidenced 
by the patient In reporting such experiences. Care should be exercised not to infer 
guilt feelings from signs of depression or generalized anxiety. Guilt feelings 
relate to specific past behavior which the patient now believes to have been wrong 
and the memory of which is a source of conscious concern. 



163 



8. Grandiosity - Grandiosity involves the reported feeling of unusual ability, 
power, wealth, importance, or superiority. The degree of pathology should be 
rated relative to the discrepancy between sel f-appra isa 1 • and reality. The 
verbal report of the patient and not his demeanor in the interview situation 
should provide the basis for evaluation of grandiosity. Care should be taken 
not to infer grandiosity from suspicions of persecution or other unfounded 
beliefs where no explicit reference to personal superiority as the basis for 
persecution has been elicited. Ratings should be based upon opinions currently 
held by the patient, even though the unfounded superiority may be claimed to 
have existed in the past. 

9. Depressive mood - Depressive mood includes only the affective component of 
depression. it should be rated on the basis of expressions of discouragement, 
pessimism, sadness, hopelessness, helplessness, and gloomy thema. Facial ex- 
pression, weeping, moaning and other modes of communicating mood should be con- 
sidered, but motor retardation, guilt, and somatic complaints, which are 
commonly associated with the psychiatric syndrome of depression, should not be 
considered in rating depressive mood. 

10. Hostility - Hostility is a term reserved for reported feelings of animosity, 
belligerence, contempt, or hatred toward other people outside the interview 
situation. The rater may attend to the sincerity and affect present in reporting 
of such experiences when he attempts to evaluate the severity of pathology in the 
symptom area. It should be noted that evidences of hostility toward the inter- 
viewer in the interview situation should be rated on the "Uncooperat iveness" item 
and should not be considered in rating hostility as defined here. 

11. Suspiciousness - Suspiciousness is a term which is used to designate a wide 
range of mental experience in which the patient believes himself to have been 
wronged by another person or believes that another person has, or has had, intent 
to wrong. Since no information is usually available as a basis for evaluating 
the objectivity of the more plausible suspicions, the term "accusations" might 

be a more appropriate characterization of this area. The rating should reflect 
the degree to which the patient tends to project blame and to accuse other people 
or forces of malicious or discriminatory intent. The pathology in this symptom 
area may range from mild suspiciousness through delusions of persecution or ideas 
of reference. 

12. Hallucinatory behavior - The evaluation of hallucinatory experiences frequent- 
ly requires judgment on the part of the rater as to whether the reported experience 
represents hallucination or merely vivid mental imagery. In general, unless the 
rater is quite convinced that the experiences reported represent true deviations 
from normal thought and imagery processes, hallucinatory behavior should be rated 
as "not present". 

15. Unusual thought content - This symptom area is concerned solely with the CONTENT 
of the patient's verbalization; the extent to which it is unusual, odd, strange, or 
bizarre. Notice that a delusional or paranoid patient may present bizarre or un- 
believable ideas in a perfectly straightforward, clear, and organized fashion. Rate 
only unusualness of content for this item, not degree of organization or disorganiza- 
tion. 

16. Blunted affect - This symptom area is recognized by reduced emotional tone and 
apparent lack of normal feeling or involvement. Emotional expressions are apt to 



164 



be absent or of marked indifference and apathy. Attempted expressions of feeling 
may appear to be mimetic and without sincerity. 

DOCUMENTATION: 

a. Raw score printout 

b. Factor score printout 

c. Means and standard deviations 

d. Cross tabulations 

e. Variance analyses 



165 



COMMENTS OF THE AUTHOR 

THE BRIEF PSYCHIATRIC RATING SCALE IN PSYCHOPHARMACOLOG I C RESEARCH 

John E. Overal 1 ^ Ph.D. 

The Brief Psychiatric Rating Scale (BPRS) was originally developed to provide 
an efficient and clinically valid means of assessing efficacy in psychopharmacolog ic 
research.' Later research demonstrated its utility for descriptive class i ficat ion of 
psychiatric patients according to profile pattern. ^'3 The BPRS consists of 18 
(originally 16) symptom constructs, each to be rated on a 7-point scale of severity. 
The ratings are coded 0-6-'- for the 7 categories of severity ranging from "not present" 
to "extremely severe". 

In most clinical research applications, the BPRS is completed immediately prior 
to the start of drug treatment and again after a fixed period of time, usually k to 
6 weeks. Ratings are based on information obtained in a clinical interview of about 
20 minutes duration. It is recommended that each patient be interviewed and rated 
independently by two professional observers to enhance the reliability of ratings, 
although the advantage gained from duplicate independent ratings is not now considered 
to be as great as it once was. A minimum of 35 to kO patients in each treatment group 
should be included in any study in which the BPRS is used with two independent raters, 
or approximately 45 to 50 patients per group if a single rater is used.^ These esti- 
mates of sample size do not appear restricted to the BPRS and can be readily calculated 
for any particular research setting. 5 

The BPRS pre-treatment ratings can be used to describe the patient sample and to 
classify patients into phenomenological homogeneous sub-types. Profile classification 
has been found useful in reducing wi th in-treatment variability and in the study of 
specific indications of psychotherapeutic drugs. Although earlier efforts at profile 
classification using the BPRS were attempts to provide more objective methods for 
assigning patients among standard diagnostic categories ,°»7, 8 more recent efforts have 
centered about the use of cluster analysis and related empirical methods to identify 
the most frequently occurring and thus most representative profile patterns .9, 1 jhe 
results of these studies have produced a classification system consisting of six types 
described as anxious depression, hostile depression, withdrawn-retarded depression, 
paranoid host i le-susp iciousness syndrome, withdrawn-disorganized thinking disturbance 
and florid thinking disorder.'' Most psychiatric patients can be recognized as hav- 
ing symptom patterns fitting closely one of these six types. The six BPRS prototype 
patterns, which depend upon only the original 16 items, are as follows. 

ANXIOUS DEPRESSION 
2.6 2.8 I.I 0.5 0.8 0.2 0.2 2.5 0.8 O.k 0.1 1.0 0.3 O.k 1.0 

HOSTILE DEPRESSION 
0.6 2.7 1.1 1.1 2.0 1.8 0.3 0.3 2.5 2.9 2.2 0.2 0.5 1.0 0.7 0.7 



The ECDEU version of the BPRS is coded 1 - 7 rather than 



166 



} 



WITHDRAWN-RETARDED DEPRESSION 
1.4 1.7 3.0 1.2 0.7 1.1 0.6 0.1 3.4 0.5 0.5 0.3 2.2 0.8 0.4 2.7 

PARANOID HOSTILE-SUSPICIOUSNESS SYNDROME 
1.4 1.5 1.0 1.4 0.4 1.4 0.4 1.0 0.5 3.4 2.6 0.1 0.4 1.6 1.2 0.7 

WITHDRAWN-DISORGANIZED THINKING DISTURBANCE 
0.7 0.8 3.1 3.4 0.1 1.1 1.3 0.2 0.5 0.4 1.0 1.5 1.8 1.2 2.2 3.6 

FLORID THINKING DISORDER 
0.7 1.3 2.4 3.9 0.2 2.0 1.5 1.4 0.8 1.4 3.0 3.5 0.7 1.6 4.2 2.6 

Patients can be classified among the six phenomenolog ical sub-groups by simply 
calculating the sum of squared differences between individual profile elements 
(scored 0-6 for single rater or average of two raters) and the corresponding proto- 
type values, with the patient then being assigned to the group for which the simple 
d^ is smallest. ^2 por studies involving only pre-screened clinically depressed 
patients, only the first three profile patterns need be considered. Several more 
complex profile analysis methods have been programmed for computer to classify 
patients among the six types and can be obtained from J. E. Overall (University of 
Texas Medical Branch, Galveston). Dr. Overall also has the facilities to process 
profiles sent to him in punched cards and has agreed to do so for any ECDEU 
invest igator . 

Several composite scores derived from the BPRS are frequently used in evaluat- 
ing treatment effects. Numerous factor analyses of BPRS ratings have consistently 
revealed the presence of four major higher order factors which have been described 
as thinking disturbance, wi thdrawa 1 -retardat ion , host i 1 e-susp ic iousness and anxious 
depress ion. ' 3 Factor scores are obtained by summing ratings on the three BPRS items 
most highly related to each factor. 

THINKING DISTURBANCE - Conceptual Disorganization, Hallucinatory Behavior 
and Unusual Thought Content. 

W I THDRAWAL - RETARDAT I ON - Emotional Withdrawal, Motor Retardation and Blunted 

Affect. 

HOSTILE - SUSPICIOUSNESS - Hostility, Suspiciousness and Uncooperat i veness . 

ANXIOUS DEPRESSION - Anxiety, Guilt Feelings, and Depressive Mood, 

In addition to the four higher order factor scores, a "total pathology" score is used 
to represent the total deviation from normality and to evaluate total change during 
treatment. The total pathology score is the sum of ratings on all 18 rating constructs, 
each scored on a 0-6 scale. Where patients have been grouped into distinctively 
different profile types, the total pathology score is recommended for evaluation of 
treatment outcome because specific symptom factors tend to be too highly related to 
prof i le group. 



167 



Considerable effort has gone into the identification of extrinsic factors 
which influence BPRS ratings. It is considered that these non-drug factors produce 
variability in symptom patterns and treatment responses which should be controlled 
experimentally or statistically jn order to improve the precision of clinical 
psychopharmacologic research. Differences in initial symptom patterns are significant- 
ly related to age, race, sex, age of onset, previous course of illness, marital status, 
education, work achievement and a variety of other less important factors. 1^> '5, 16 
Differences in treatment outcome have been found to depend significantly on pretreat- 
ment level and type of symptomatology, age of onset, previous hospitalizations and/or 
course of illness, marital status, presence of identifiable precipitating stress and 
race.''' '° Where several different raters are involved in a project, systematic 
rater differences are often very important. 

While work is continuing along these lines, it appears obvious that a variety 
of factors do influence BPRS evaluations of symptom pattern and treatment outcome, 
and the above appear to be among the potentially most important. It is recommended 
that these extrinsic factors be carefully recorded and that their effects then 
should be removed by using somewhat more complex statistical analyses than have 
been used in the past.''' Experimental control can be achieved by holding certain 
of the extrinsic factors constant, such as age or sex, but this tends to restrict 
the generality of conclusions that can be drawn. 

A completely adequate experimental design involving BPRS evaluations should take 
into account (a) pre-treatment profile type, (b) pre-treatment level of severity, 
(c) demographic and sociocul tura 1 background characteristics of the patient which 
may influence outcome independently of drugs, (d) experimentally introduced systematic 
effects such as hospital differences, rater differences and the like, and (e) drug 
treatments. Where patients are classified into distinct profile groups, the broad 
measure of change in total pathology is recommended for evaluation of outcome with 
differences in pre-treatment level of severity partial led out. In this brief summary, 
an attempt has been made to provide the investigator with essential information con- 
cerning sample size, scoring, patient classification and control variables that will 
enable him to use the BPRS in as effective a manner as current methodology permits. 

REFERENCES 

1. Overall, J. E. and Gorham, D. R. The brief psychiatric rating scale. Psychol. 
Rep., 1962, 10, 799-812, 

2. Overall, J. E. and Gorham, D. R. A pattern probability model for classification 
of psychiatric patients. Behavioral Science, 1963. 8, 108-116. 

3. Overall, J. E. and Hollister, L. E. Computer procedures for classification of 
psychiatric patients. J. Am. Med. Asso., 1963, I87, 583-588. 

k. Overall, J. E., Hollister, L. E. and Dalai, S. N. Psychiatric drug research: 
Sample size requirements for one vs. two raters. Arch. Gen. Psychiatry, 196?, 
16, I52-I6I. 

5. Overall, J. E. and Dalai, S, N. Empirical formulae for estimating appropriate 
sample sizes for analysis of variance designs. Perceptual Motor Skills, I968, 
27, 363-367. 



168 



6. Overall, J. E., Hollister, L. E., Meyer, F., Kimbell, I. Jr., and Shelton, 
J., Imipramine and thioridazine in depressed and schizophrenic patients. 
J. Am. Med. Asso., 1964, I89, 605-6IO. 

7. Overall, J. E. and Hollister, L. E. Studies of quantitative approaches to 
psychiatric classification. In the Role and Methodology of Classification 
in Psychiatry and Psychopathol ogy . U. S. Dept. of Health, Education and 
Welfare, PHS , U.S. Gov't. Printing Office. 

8. Hollister, L. E., Overall, J. E., Bennett, L., Kimbell, I. Jr. and Shelton, J. 
Triperidol in schizophrenia: Further evidence for specific patterns of action 
of antipsychotic drugs. J. New Drugs, 1965, 5, 3^-42. 

9. Overall, j. E., Hollister, L. E., Johnson, M. and Pennington V . Nosology of 
depression and differential response to drugs. J. Am. Med. Asso., 1 966 , 195, 
946-9^8. 

10. Overall, j. E., Hollister, L. E., Shelton, Jr., Kimbell, I., Jr., and 
Pennington, V. Broad-spectrum screening of psychotherapeutic drugs: Thiothixene 
as an anti-psychotic and antidepressant. Clin. Pharm. and Therapeutics, I969, 
10, 36-^+3. 

11. Overall, J. E. Personal communication. To appear in Multivariate Methods for 
Clinical Research by Overall and Klett. New York: McGraw-Hill, 1971. 

12. Cronbach, L. J. and Gleser, G. C. Assessing similarities between profiles. 
Psychol. Bull., 1953, 50, 456-473. 

13. Overall, j, E., Hollister, L. E. and Pichot, P. Major psychiatric diso'-ders: 
A four -dimensional model. Arch, of Gen. Psychiat., I967, 16, 146-151. 

14. Overall, J. E. and Hollister, L. E. Controlling for extrinsic variability 
associated with differences in background characteristics. Proceedings of 
the VI International Congress of the C.I.N. P., I968. Excerpta Medica Inter- 
national Congress Series, No. 180. 

15. Pokorny, A. D. and Overall, J. E. Relationships of psychopathol ogy to age, 
sex, ethnicity, education and marital status in state hospital patients. 

J. Psychiat. Research, I969, 7, (Dec. Issue) 

16. Overall, j. E. Historical and sociocul tural factors related to the phenomenology 
of schizophrenia. |n Schizophrenia: Current Concepts and Research. D. V. Siva 
Sankar (Ed.) PJD Publications LTD., Hicksville, New York, I968. 

17. Overall, J. E. and Tupin, J. P., Investigation of clinical outcome in a doctor's 
choice treatment setting. Dis. of Nerv. System, I969, 30, 305-313. 

18. Overall, j. E., Hollister, L. E., Kimbell, I. Jr., and Shelton, J. Extrinsic 
factors influencing responses to psychotherapeutic drugs. Arch, of Gen. Psychiat. 
1969, 21, 89-94. 



169 



072 DS I 
DEPRESSION 
STATUS 
INVENTORY 





MH-9-72 DEPRESSION STATUS INVENTORY (bSI) 

6-73 Wm.W.K.Zung 

INSTRUCTIONS: Code 01 under Sheet Number on General Scoring Sheet 

The data upon which the judgments are based come from theMnterview with the patient. The items in the 
scale are to be quantified by using all the information available to the rater. This includes both clinical obser- 
vation and the material reported by the patient. 

Use of the Interview Guide below assures coverage of all the areas on which judgments are required. How- 
ever, the rater has the flexibility of modifying the questions or probing for details, which makes possible a 
smooth interview that does not sound like a question-answer examination. In rating the patient's current 
status, an arbitrary period of 1 week prior to the evalutaion is adopted in order to standardize the data. In 
order to reinforce this, the interviewer should occasionally precede questions with, "During the past week, 
have you ?" 


Mark on right half of scoring sheet on row specified 


ROW 
NO. 


MODER- 
NONE MILD ATE SEVERE 
12 3 4 


SIGNS AND SYMPTOMS 
OF DEPRESSION 


INTERVIEW GUIDE 


1. Depressed Mood 


Do you ever feel sad or depressed? 


19 




2. Crying Spells 


Do you have crying spells or feel like it? 


20 


20 "3" "2:: rrS:: :Lt: 


3. Diurnal Variation: 

symptoms worse in a.m. 


Is there any part of the day when you 
feel worse? Best? 


21 


22 "3== ---2zz ::3:= ==4=-" 


4. Steep Disturbance 


Frequent and early AM wakings 


22 


24 i-J:: ==2:= :*: ==*= 


5. Decreased Appetite 


How is your appetite? 


23 


25 z-i- r=2:= ::3zr 4-" 

26 ==):: ==2:= i*r =:4== 


6. Weight Loss 


Have you lost any weight? 


24 


27 zzl.z zziz. r=3:: z-tzz 

28 "1:: ==2== :i3:: -zAzz 


7. Decreased Libido J^/^^ ^"J^^ 1 ook i ng . ta 1 k i ng or 
being with attractive men/women? 


25 


30 ::J:= "2=: ::3:: z-Azz 


8. Constipation 


Do you have trouble with constipation? 


26 


32 :i3" 1=2== ==3== 1=4== 


9. Tachycardia 


Have you had times when your heart 
was beating faster than usual? 


27 


34 ==}:= ==2== ==3=1 --J\zz 

35 ::i:= ==2== =*: ==4== 

36 ==i== r=2== ==3== =-^-: 


10. Fatigue 


How easily do you get tired? 


28 


11. Psychomotor Agitation 


Do you find yourself restless and 
can't sit still? 


29 


37 :=l== ::2:: ==3== =-4=: 

38 ==}=: ==2== ==3:= =i4== 

Cols: 12 13 14 15 


12. Psychomotor 
Retardation 


Do you feel slowed down in doing the 
the things you usually do? 


30 


13. Confusion 


Do you ever feel confused and have 
trouble thinking? 


31 




14. Emptiness 


Do you feel life is empty for you? 


32 




15. Hopelessness 


How hopeful do you feel about the future? 


33 




16. Indecisiveness 


How are you at making decisions? 


34 




17. Irritability 


How easily do you get irritated? 


35 




18. Dissatisfaction 


Do you still enjoy the things you used to? 


36 




19. Personal Devaluation 


Do you ever ffeel useless and not wanted? 


37 




20. Suicidal Ruminations 


Have you had thoughts about doing 
away with yourself? 


38 


172 



The Depression Status Inventory (DSl), developed by Zung, has been designed 
as the professionally-rated analogue of the patient-rated Zung Depression Scale 
(SDS) , With appropriate contextual changes, it consists of the same 20 items as 
the SDS; and, based on 209 cases, the author reports a Pearson product moment 
correlation of .87 between the 2 scales. The DSl provides a global measure of 
the intensity of depressive symptomatology. 

REFERENCE Zung, W. W. K., The Depression Status Inventory: An 

Adjunct to the Self-Rating Depression Scale, J, Clin. 
Psychol ., 28: 539-5^3, 1972. 

APPLICABILITY Adults with depressive symptoms 

UTILIZATION Once at pretreatment ; at least one posttreatment rating. 

Additional ratings are at the discretion of the investigator, 

TIME SPAN RATED Now or in the last week 

CARD 01 = (19x, 2011 , lOx, \k) 

Item Column 

11 30 

12 31 

13 32 
]k 33 

15 3^ 

16 35 

17 36 

18 37 

19 38 

20 39 
Z Score-'- 50-53 

"The Z score is derived by dividing the sum of the raw item scores by the 
maximum possible score (80) multiplied by 100. See Table 9 for the 
Conversion of Interviewer-Rated Raw Scores to the DSl Z Scores. Zung has 
provided the following mean DSl "Z" scores for various diagnostic groups: 

Diagnos is 

Depressive disorders 

Schizophrenia 

Anxiety disorder 

Personality disorders 

Transient situational disturbances 

= Significantly different from other diagnostic groups (p. <[ .01) 



CARD 


FORMAT - 


ITEMS CA 


Item 
1 




Column 
20 


2 




21 


3 




22 


k 




23 


5 




2k 


6 




25 


7 




26 


8 




27 


9 




28 


10 




29 





Mean 


N 


DSl Z 




Scores 


96 


6b'wV 


25 


kS 


22 


51 


54 


52 


12 


kk 



173 



TABLE 9 (from Zung) 
THE CONVERSION OF I NTERV lEWfR-RATED RAW SCORES TO THE DS I Z SCORES 





Raw 


DSl 


Raw 


DSl 


Raw 


DSl 


Score 


Z Scores 


Score 


Z Scores 


Score 


Z Scores 


20 


25 


40 


50 


60 


75 


21 


26 


41 


51 


61 


76 


22 


28 


42 


53 


62 


78 


23 


29 


^3 


54 


63 


79 


24 


30 


44 


55 


64 


80 


25 


31 


45 


56 


65 


81 


26 


33 


46 


58 


66 


83 


27 


34 


47 


59 


67 


84 


28 


35 


48 


60 


68 


85 


29 


36 


49 


61 


69 


86 


30 


38 


50 


63 


7b 


88 


31 


39 


51 


64 


71 


89 


32 


40 


52 


65 


72 


90 


33 


41 


53 


66 


73 


91 


34 


43 


54 


68 


74 


92 


35 


44 


55 


69 


75 


94 


36 


45 


56 


70 


76 


95 


37 


46 


57 


71 


77 


96 


38 


48 


58 


73 


78 


98 


39 


49 


59 


IM 


79 
80 


99 
100 



SPECIAL INSTRUCTIONS 

The following rules and guidelines should be used in rating the patient's 
psychopathology: 

A. Each item should be rated independently as a unit in order to eliminate 
the "halo" effect. 

B. Each score should be the average of the full range of responses 
observed or elicited, and not necessarily the extreme in severity. 



174 



C. The items are judged on a 4-point system that takes into account 
Severity in terms of: intensity, duration and frequency. These 
are defined as follows: 

1 = none or insignificant in intensity or duration, present 

none or a little of the time in frequency 

2 = mild in intensity or duration, present some of the time 

3 = of moderate severity, present a good part of the time 

k = severe in intensity or duration, present most or all of 
the time in frequency 

To help establish severity, the following questions may be necessary: 
Intensity: "How bad was it?", Duration: "How long did it last?", and 
frequency: "How much of the time did you feel that way?" 

D. An item is scored positive and present when (a) behavior is 
observed, (b) behavior was described by a patient as having 
occurred, and (c) patient admits that symptom is still a 
problem. 

E. An item is scored negative and not present when (a) symptom 
has not occurred and not a problem or present, (b) response 
is ambiguous even after suitable probing, or (c) patient 
gives no information relevant to an item. 



ERRATA 



Rating of the items - The "Not Assessed" (0) position printed in 

the packet should NOT be used. Use scale points 1 through h only. 

Item 4 - The printed instructions should read "Frequent and early 
AM wakings". 

Item 7 - The printed instructions should read "Do you enjoy looking, 
talking or being with attractive men/women?" 



DOCUMENTATION: 

a. Raw score printout 

b. Z score printout 

c. Z score means and standard deviations 

d. Variance analyses 



175 



10. Zung, W.W.K.: Depression in the normal adult population, Psychosom. 12: 
164-167, 1971. 

11. Zung, W.W.K.: The differentiation of anxiety and depressive disorders: 
A biometric approach, Psychosom. 12:380-384, 1971. 

12. Zung, W.W.K.: A cross-cultural survey of depressive symptomatology in 
normal adults, J. Cross-Cult. Psychol. 3:177-183, 1972. 

13. Zung, W.W.K.: How normal is depression? Psychosom. 13:174-178, 1972. 

14. Zung, W.W.K.: The Depression Status Inventory: An adjunct to the self- 
rating depression scale, J. Clin. Psychol. 28:339-543, 1972. 

15. Brown, G.L. & Zung, W.W.K.: Depression scales: Self- or physician-rating? 
Comp. Psychiat. 13:361-367, 1972. 

16. Zung, W.W.K.: From art to science: The diagnosis and treatment of depres- 
sion. Arch. Gen. Psychiat. 29:328-337, 1973. 

17. Zung, W.W.K. , van Praag, H.M., Dijkstra, P. and van Winzum, C: Cross- 
cultural survey of symptoms in depressed and normal adults, in Itil, T. (Editor) 
Transcul tural Psychopharmacology. 



178 



049 HAMD 
HAMILTON 
DEPRESSION 
SCALE 



MH-9-49 
6-73 



HAMILTON PSYCHIATRIC RATING SCALE FOR DEPRESSION 

INSTRUCTIONS: Code 01 under Sheet Number on GSS. 

For each item select the one "cue" which best characterizes the patient. 

Be sure to record your answers in the appropriate spaces (positions through 4), 
Columns 1 - 5, on the left half of the General Scoring Sheet. 

See Spec/a/ Instructiorts in Manual for Items 7, 16, 18, and 20. 



Row 1 -Q:- 


:=t: 


:=2:: 


::3:: 


==*: 


2:.ttr 


r:t: 


=:2:: 


==3:= 


==*= 


3:=ttr 


::t: 


r:2:: 


: t: 


==4== 


4:r0:r 


"ti 


z.Zz 


"3:: 


==*= 


5:=£t: 




r:2:: 


::3:r 


==*= 


6==0: = 




::2:: 


"3:: 


::*= 


7. .ft: 




;:2:: 


"*- 


==4:= 


8:re:: 


.Uz 


"2:: 


::3:: 


::*: 


9r:e:: 




::2:: 


::}:: 


==4== 


lOz.a:: 




::2:: 


:*: 


==4== 


1 1 =:&= 




::2:: 


"J:: 


==4:: 


n-.-e:- 




=i2:= 


:*: 


::4=: 


n-.-o:-. 




"2: 


zz3^z 


==4i= 


UzEbr 


:;3:: 


-St; 


"fc 


==*= 


ISrzEtz 


rrJ:: 


:ri: 


::2t-. 


==*= 


16;ifi:= 


rrJ" 


"3tr 


-ar 


::*: 


17.:a:: 


:H=i 


nil 


1=3:: 


==*= 


18.=a: 


zzizz 


iia: 


==3:1 


= :*= 


19==a= 


::i: 


::2: 


= = 3:= 


==*= 


20 -B:. 


"±= 


-i: 


::3:= 


==* = 


21 ::ft= 


=r±: 


:ra: 


::3:: 


==* = 


22 --.&-. 


r=±: 


=:3ti 


==3:: 


::*: 


23. A. 


::J;r 


Ii2:= 


==3== 


=a!:: 


Cols: 1 


2 


3 


4 


5 



ROW 
NO. 


Mark each item on left half of scoring sheet on row specified 
Use marking positions — 4, columns 1 — 5 


1 


1. DEPRESSED MOOD (Sadness, hopeless, helpless, worthless) 

= Absent 

1 - These feeling states indicated only on questioning 

2 = These feeling states spontaneously reported verbally 

3 = Communicates feeling states non-verbally - i.e., through facial 

expression, posture, voice, and tendency to weep 

4 = Patient reports VIRTUALLY ONLY these feeling states in hit 

spontaneous verbal and non-verbal communication 


2 


2. FEELINGS OF GUILT 

= Absent 

1 = Self reproach, feels he has let people down 

2 = Ideas of guilt or rumination over past errors or sinful deeds 

3 = Present illness is a punishment. Delusions of guilt 

4 = Hears accusatory or denunciatory voices and/or experiences 

threatening visual hallucinations 


3 


3. SUICIDE 

= Absent 

1 = Feels life is not worth living 

2 •" Wishes he were dead or any thoughts of possible death to self 

3 = Suicide ideas or gesture 

4 = Attempts at suicide (any serious attempt rates 4) 


4 


4. INSOMNIA EARLY 

= No difficulty falling asleep 

1 = Complains of occasional difficulty falling asleep — i.e., more than 

Vs hour 

2 = Complains of nightly difficulty falling asleep 


5 


5. INSOMNIA MIDDLE 

= No difficulty 

1 = Patient complains of being restless and disturbed during the night 

2 = Waking during the night — any getting out of bed rates 2 (except 

for purposes of voiding) 


6 


6. INSOMNIA LATE 

= No difficulty 

1 = Waking in early hours of the morning but goes back to sleep 

2 = Unable to fall asleep again if he gets out of bed 


7 


7. WORK AND ACTIVITIES 

= No difficulty 

1 = Thoughts and feelings of incapacity, fatigue or weakness related to 

activities; work or hobbies 

2 = Loss of interest in activity; hobbies or work — either directly 

reported by patient, or indirect in listlessness, indecision and 
vacillation (feels he has to push self to work or activities) 

3 = Decrease in actual time spent in activities or decrease in produc- 

tivity. In hospital, rate 3 if patient does not spend at least three 
hours a day in activities (hospital job or hobbies) exclusive of 
ward chores 

4 = Stopped working because of present illness. In hospital, rate 4 if 

patient engages in no activities except ward chores, or if patient 
fails to perform ward chores unassisted 



180 



HAMILTON PSYCHIATRIC RATING SCALE FOR DEPRESSION 



ROW 
NO. 


Continue marking on left half of scoring sheet on row specified 




8. 


RETARDATION (Slowness of thought and speech: impaired ability 

to concentrate: decreased motor activity) 
= Normal speech and thought 


8 




1 = Slight retardation at interview 

2 = Obvious retardation at interview 

3 = Interview difficult 

4 = Complete stupor 




9. 


AGITATION 







= None 




1 


= Fidgetiness 




2 


= Playing with hands, hair, etc. 




3 


= Moving about, can't sit still 




k 


= Hand wringing, nail biting, 
hair-pulling, biting of lips 




10. 


ANXIETY PSYCHIC 

0= No difficulty 


10 




1 = Subjective tension and irritability 

2 = Worrying about minor matters 

3 = Apprehensive attitude apparent in face or speech 

4 = Fears expressed without questioning 




11. 


ANXIETY SOMATIC 

= Absent Physiological concomitants of anxiety, such as: 

^ ~ l^'ld Gastro-intestinal — dry mouth, wind, indigestion. 


11 




2 = Moderate diarrhea, cramps, belching 

3 = Severe Cardio-vascular — palpitations, headaches 

4 = Incapacitating Respiratory - hyperventilation, sighing 

Urinary frequency 
Sweating 




12. 


SOMATIC SYMPTOMS GASTROINTESTINAL 
0= None 


12 




1 = Loss of appetite but eating without staff encouragement. Heavy 

feelings in abdomen 

2 = Difficulty eating without staff urging. Requests or requires laxa- 

tives or medication fpr bowels or medication for G.I. symptoms 




13. 


SOMATIC SYMPTOMS GENERAL 

0= None 






1 = Heaviness in limbs, back or head. Backaches, headache, muscle 

aches. Loss of energy and fatigability 

2 = Any clear-cut symptom rates 2 




14. 


GENITAL SYMPTOMS 


14 




= Absent Symptoms such as: Loss of libido 

1 = Mild Menstrual 

2 = Severe disturbances 




15. 


HYPOCHONDRIASIS 

= Not present 






1 = Self-absorption (bodily) 

2 = Preoccupation with health 

3 = Frequent complaints, requests for help, etc. 
4= Hypochondriacal delusions 



ROW 
NO. 


Continue marking on left half of scoring sheet on row specified 1 




16. 


LOSS OF WEIGHT Rate either A or B 




A 


When Rating By History: 


16 




= No weight loss 

1 = Probable vreight loss associated with present illness 

2 = Definite (according to patient) weight loss 

3 = Not assessed 




B. 


On Weekly Ratings By Ward Psychiatrist. When Actual Weight Changes 
Are Measured: 


17 




= Less than 1 lb. weight loss in week 




1 = Greater than 1 lb. weight loss in week 






2 = Greater than 2 lb. weight loss in week 






3 = Not assessed 




17. 


INSIGHT 

= Acknowledges being depressed and ill 


18 




1 = Acknowledges illness but attributes cause to bad food, climate, 

overwork, virus, need for rest, etc. 
2= Denies being ill at all 




18. 


DIURNAL VARIATION 




A 


Note whether symptoms are worse in morning or evening. If NO 


19 




diurnal variation, mark none 




= No variation 






1 = Worse in A.M. 






2 = Worse in P.M. 




B 


When present, mark the severity of the variation. Mark "None" if NO 
variation 


20 




= None 

1 = Mild 

2 = Severe 




19. 


DEPERSONALIZATION AND DEREALIZATION 

= Absent Such as: Feelings of unreality 


21 




1 = Mild Nihilistic ideas 




2 - Moderate 






3 = Severe 






4 = Incapacitating 




20. 


PARANOID SYMPTOMS 

0= None 


22 




1 = Suspicious 

2 = Ideas of reference 

3 = Delusions of reference and persecution 




21. 


OBSESSIONAL AND COMPULSIVE SYMPTOM? 


23 




= Absent 

1 = Mild 

2 = Severe 



181 



Hamilton's Depression Scale (HAMD) is a 23-item (including two 2-part items) 
scale formatted for use with tiie General Scoring Sheet. The scale points vary 
from 3 to 5. The HAMD is one of the most widely used instruments for the clinical 
assessment of depressive states. Unfortunately, the scale has been employed in a 
number of different versions - creating considerable difficulty when attempting 
to compare published findings. The present version is, we believe, the author's 
vers ion. 



REFERENCE 



APPLICABILITY 
UTILIZATION 



TIME SPAN RATED 


Now 


CARD FORMAT - ITEMS 


(i9x, ; 


i tern 


Col umn 


1 Depressed Mood 


20 


2 Guilt 


21 


3 Suicide 


22 


k Insomnia - early 


23 


5 Insomnia - middle 


2k 


6 Insomnia - late 


25 


7 Work 


26 


8 Retardation 


27 


9 Agitation 


28 


10 Anxiety-Psychic 


29 


1 1 Anxiety-Somat ic 


30 


12 Somatic-GI 


31 



Hamilton, M., Development of a Rating Scale for 
Primary Depressive Illness, Brit. J. Soc. Clin. 
Psychol ., 1967, 6, 278-296. 

Adults with depressive symptomatology 

Once at pretreatment ; at least one posttreatment 
rating. Additional ratings are at the discretion 
of the investigator. 

Now or within the last week 



I tem 



13 Somatic-General 

14 Genital Symptoms 

15 Hypochondriasis 
16A Weight-History 
16b Weight-Actual 
17 Insight 

Diurnal Variation-time 
Diurnal Variation-severity 
Depersonal ization 
Paranoid 
Obsess/Comp 



Col umn 

32 
33 
3^ 
35 
36 
37 
38 
39 
ko 
k] 
kl 



CARD FORMAT - FACTORS CARD 51 = (19x, 6f6.2, F4.0) 

Code "5" in Col. 18 indicates card which contains 
factor, cluster or derived scores. 



Factor 
1 

2 
3 
k 



Col umns 

20-25 

26-31 

32-37 

38-43 



Factor 


Columns 


5 


kh-kS 


6 


50-55 


Total Score 


56-59 



Factor score = Sum of composite items 
No. of composite items 
Total Score = Sum of a 1 1 items." Total Score Range 

in calculating Total Score, Only Item 18 



Factor Score Range = 

0-62. 
not I 8A - is included. 



182 



FACTOR COMPOSITION 

This factor structure based on a 1975 analysis of the pretreatment ratings 
of ^80 subjects with diagnoses of neurotic depression. (Table 10). 

Factor I - Anxiety/Somat izat ion Factor I V - Diurnal Variation 

10. Anxiety, Psychic 18A. Diurnal Variation (Time) 

11. Anxiety, Somatic B. Diurnal Variation (Severity) 

12. Somatic Symptoms, Gastro- Intestinal 

13. Somatic Symptoms, General Factor V - Retardation 
15. Hypochondriasis 

17. Insight 1. Depressed Mood 

7. Work and Activities 

Factor II -Weight 8. Retardation 

]k. Genital Symptoms 
16A. Loss of Weight (History) 

16b. Loss of Weight (Actual Factor VI - Sleep Disturbance 

Factor III - Cognitive Disturbance k. Insomnia, Early 

5. Insomnia, Middle 

2. Feelings of Guilt 6. Insomnia, Late 

3. Suicide 
9. Agitation 

19. Depersonalization and Derealization 

20. Paranoid Symptoms 

21. Obsessional and Compulsive Symptoms 

SPECIAL INSTRUCTIONS 

I tern 7' Work and Activities - Rater may seek information from relatives or 
ward personnel . 

I tern 9. Agitation - This item - printed in the packet as a 3-point scale - should 
be rated on a 5-point scale as follows: 

= None 

1 = Fidgetiness 

2 = Playing with hands, hair, etc. 

3 = Moving about, can't sit still 

k = Hand wringing, nail biting, hair pulling, biting of lips 

I tern 16. Loss of Weight - This is an "either/or" item requiring a response to only 
part of the item, i.e., I6A or 16b. Actual Weight Changes (16b) is the 
preferred choice - particularly during the course of a study. It is 
suggested that Weight by History (I6A) be used only at the pretreatment 
rating. 



183 



TABLE 10 
6 - FACTOR VARIMAX SOLUTION OF 23-ITEM HAMILTON DEPRESSION SCALE 



Cleary, P. and Guy, W., Factor Analyses of the Hamilton Depression Scale, 
at the International Symposium on the Evaluation of New Drugs in Clinical 
pharmacology, Pisa, September, 1975. 



presented 
Psycho- 



Depressed Mood 1 

Feel ings of Qui 1 1 2 

Suicide 3 

Insomnia (Early) k 

Insomnia (Middle) 5 

Insomnia (Late) 6 

Work & Act ivi t ies 7 

Retardation 8 

Agitation 9 

Anxiety Psychic 10 

Anxiety Somatic 11 

Somatic Symptoms G.I. 12 

Somatic Symptoms - General 13 

Genital Symptoms ]k 

Hypochondriasis 15 

Loss of Weight A 16 

Loss of Weight B 17 

Insight 18 

Diurnal A.M. 19 

D.iurnal P.M. 20 
Depersonalization & Dualization 21 

Paranoid 22 
Obsess ional -Compuls ive Symptoms 23 
Contribution 
of factor (V ) 

% of Total Variance 11.43 8.91 

% of Common Variance 20.06 15.63 



F3 

-213 

-678 

-429 

-065 

-194 

-102 

-167 

-065 

-465 

-393 

-158 

-139 

-211 

-117 

-070 

025 
-101 

054 
-121 
-082 
-556 
-678 



2.63 2.05 2.45 



Fl 


F2 


077 


052 


012 


006 


009 


237 


091 


367 


058 


109 


105 


084 


184 


103 


167 


000 


420 


144 


448 


233 


720 


155 


462 


293 


601 


002 


340 


083 


731 


076 


086 


746 


262 


8?8 


513 


-417 


■015 


109 


084 


064 


119 


235 


173 


-139 


162 


-022 



10.65 
18.68 



F4 
043 

-068 
163 
052 
104 
119 

-032 
074 

-196 
117 

-030 
048 
116 
325 
048 
167 
054 
094 
731 
814 
140 
229 
076 

1.56 

6.78 
11.89 



F5 
709 
152 
366 
105 
223 
244 
602 
645 
-021 
201 
156 
224 
338 

531 
167 
136 

-040 

-252 
229 

-030 
223 

-083 
205 



f6 

100 

090 

157 

585 

709 

708 

261 

222 

295 

030 

109 

326 

284 

004 

■097 
269 
174 
323 
078 
134 
146 
163 

-051 



2.33 2.09 



10.13 
17.77 



9.08 
15.94 



Communa 1 
it ies 

57 
50 
43 
50 
62 
60 
50 
50 
54 
46 
60 
48 
61 
52 
58 
68 
92 
62 
62 
70 
47 
59 
47 

13.11 
56.9 



184 



Item 18. Diurnal Variation - When no variation is present, encode "0" for 
Item A (Row 19) and leave 1 8b (Row 20) blank as follows: 

19.^ ..t.. -^-- :*: :^: ] 8A 
20:*: ::):: :*: :*: A^- 1 8B 

When diurnal variation is present, encode the time of day when the 
symptoms are worse in 1 8A and indicate the severity of variation; 
i.e., the degree or amount of variation, in 1 8b . "Mild" should be 
interpreted as doubtful or slight variation: "Severe" as clear or 
marked variation. 

Example: The patient's symptoms are clearly worse in the morning. 
Encode 1 in Row 19 and 2 in Row 20. 



19:0:: «^ ^^ 


:*: 


:*: 


ISA 


20:*:: ::(:: -•• 


:*r 


:*: 


18b 



DOCUMENTATION 



a. Raw score printout 

b. Factor score printout 

c. Means and standard deviations of factor scores 

d. Crosstabulat ions 

e. Variance analyses 



185 



COMMENTS OF THE AUTHOR - Adapted from "Development of a Rating Scale for Primary 
Depressive Illness"; Brit. J. of Soc. Clin. Psychol., 1967, 6, 278-296 

Max Hami 1 ton , M.D. 

The scale provides a simple way of assessing the severity of a patient's condi- 
tion quantitatively, and for showing changes in that condition. It should not be 
used as a diagnostic instrument. A set of items to be so used should include not 
only those which will show the presence of the symJDtoms that the patient has, but 
also those which the patient has not, for a diagnosis not only includes the patient 
within a certain category but also excludes him from others. It is possible that 
the scale may have other uses, e.g.: predicting outcome and selection of treatment, 
but these have not yet been worked out. 

Ratings can be done in a number of ways, depending on the purpose, but whatever 
this may be it must never be forgotten that the scores are merely a particular way 
of recording the rater's judgment. Other things being equal, the value of the 
ratings therefore depends entirely on the skill and experience of the rater and on 
how adequate is the information available to him. This scale was devised for 
recording the severity of symptoms of a patient C^part from minor and temporary 
fluctuations) and therefore questioning should be directed to his condition in the 
last few days or week. It is desirable to obtain additional information from rela- 
tives, friends, nurses etc. and this should always be done whenever there is doubt 
^bout the accuracy of the patient's answers. A question frequently asked concerns 
the length of time required to make a rating, i.e. for how long should the patient 
be interviewed in order to obtain sufficient information on which to base a judg- 
ment. This will obviously depend on the skill of the rater and the condition of 
the patient. Sick patients cannot think quickly and they should never be hurried. 
An adequate interview will surely be not less than half an hour, for that gives an 
average time of about two minutes per item, which is not really sufficient. 

The following points about interviewing will be obvious to the skilled inter- 
viewer, but it does no harm to emphasize them. The patient should not be pressed 
and should be allowed sufficient time to say what he wants to say; but he should 
not be allowed to wander too far from the point. The number of direct questions 
should be kept to a minimum and such questions should be asked in d if ferent ways and, 
in particular, both in positive and negative form, e.g. 'How badly do you sleep?' 
and 'How well do you sleep?' Questions should be asked in language which the 
patient understands and ordinary words should never be used in a technical sense. 
It must not be forgotten that patients sometimes misuse technical words. Patients 
should be helped and encouraged to admit to symptoms of which they are ashamed. 
Normal people do not talk freely about themselves to strangers, and this is true of 
patients; it is therefore helpful to delay a detailed assessment to a second intei-view. 

When ratings are repeated they should be made independently. The interviewer 
should not have previous ratings in front of him and should use a new fortti on each 
occasion; this may seem a trivial matter but experience has shown that it is important. 
As far as possible he should avoid asking questions relating to changes since the 
previous interview. In order to increase the reliability of ratings, it is advisable 
for two interviewers to be present, one of them conducting the interview and the 
other asking supplementary questions at the end. The two raters should record scores 
independently and then sum them after the interview to give the rating for the 
patient. Discussion can take place after this. A discrepancy of one point on any 



186 



item is of no consequence, but a difference of two JDoints requires careful con- 
sideration. Experience has shown that a preliminary training done on about a 
dozen patients should produce close agreement. A difference of k points on the 
total score is the maximum allowable, but in practice, the difference is rarely 
more than 2 points. There is a great practical gain from having two raters: 
occasionally one of them may not be available and then the other can do the 
rating (and double his scores). With increasing experience, a rater can learn 
to give half points, but summed scores from two raters should be converted into 
integers for each item. 

Symptoms are rated finely or coarsely; the former are on a five-point scale 
(0-U) where the numbers are equivalent to absent, doubtful or trivial, mild, 
moderate and severe. The latter are on a three-point scale (0-2) equivalent to 
absent, doubtful or mild, and obvious, distinct or severe. 

The Rating of Male Patients 

1. Depression (0-4) - Depressed mood is not easy to assess. One looks for a 
gloomy attitude, pessimism about the future, feelings of hopelessness and a 
tendency to weep. As a guide, occasional weeping could count as 2, frequent 
weeping as 3, and severe symptoms alloted k points. When patients are severely 
depressed they may 'go beyond weeping'. It is important to remember that 
patients interpret the word 'depression' in all sorts of strange ways. A use- 
ful common phrase is 'lowering of spirits'. 

2. Guilt (0-4) - This is fairly easy to assess but judgment is needed, for the 
rating is concerned with pathological guilt. From the patient's point of view, 
some action of his which precipitated a crisis may appear as a 'rational' basis 
for self-blame, which persists even after recovering from his illness. For 
example, he may have accepted a promotion, but the increased respons ibi 1 i ty 
precipitated his breakdown. When he 'blames' himself for this, he is ascribing 

a cause and not necessarily expressing pathological guilt. As a guide to rating, 
feelings of self-reproach count 1, ideas of guilt 2, belief that the illness might 
be a punishment 3, and delusions of guilt, with or without hallucinations, k points. 

3.' Suicide (0-4) - The scoring ranges from feeling that life is not worth living 1, 
wishing he were dead 2, suicidal ideas and half-hearted attempts 3. serious attempts 
4. Judgment must be used when the patient is considered to be concealing this 
symptom, or conversely, when he is using suicidal threats as a weapon, to intimidate 
others, obtain help and so on. 

4, 5, 6 Insomnia (initial, middle and delayed) (0-2) - Mild, trivial and infrequent 
symptoms are given 1 point, obvious and severe symptoms are rated 2 points; both 
severity and frequency should be taken into account. Middle insomnia (disturbed 
sleep during the night) is the most difficult to assess, possibly because it is an 
artifact of the system of rating. When insomnia is severe, it generally affects 
all phases. Delayed insomnia (early morning wakening) tends not to be relieved by 
hypnotic drugs and is not often present without other forms of insomnia. 

7. Work and Interests (0-4) - It could be argued that the patient's loss of interest 
in his work and activities should be rated separately from his decreased performance, 
but it has been found too difficult to do so in practice. Care should be taken not 
to include fat iguabi 1 i ty and lack of energy here; the rating is concerned with loss of 
efficiency and the extra effort required to do anything. When the patient has to be 



187 



admitted to hospital because his symptoms render him unable to carry on, this 
should be rated k points, but not if he has been admitted for investigation or 
observation. When the patient improves he will eventually return to work, but 
when he does so may depend on the nature of his work; judgment must be used here. 

8. Retardation (0-4) - Severe forms of this symptom are rare, and the mild forms 
are difficult to perceive. A slight flattening of affect and fixity of expression 
rate as 1 , a monotonous voice, a delay in answering questions, a tendency to s i t 
motionless count as 2. When retardation makes the interview extremely prolonged 
and almost impossible, it is rated 3, and h is given when an interview is impossible 
(and symptoms cannot be rated). Although some patients may say that their thinking 
is slowed or their emotional responsiveness has been diminished, questions about 
these manifestations usually produce misleading answers. 

9. Agitation (0-4) - Severe agitation is extremely rare. Fidgetiness at interview 
rates as 1, obvious restlessness with picking at hands and clothes should count as 
2. If the patient has to get up during the interview he is given 3. and k points 
are given when the interview has to be conducted 'on the run', with the patient 
pacing up and down, picking at his face and hair and tearing at his clothes. Although 
agitation and retardation may appear to be opposed forms of behavior, in mild form 
•they can co-exist. 

NOTE - The scale points printed on the original Adult packet are 0-2. Dr. Hamilton 
states that the original range (0-4) was abandoned when severer forms of agitation 
could not be found. He has since found that more severe cases of agitation do occur - 
particularly in countries other than Great Britain. The author prefers the 0-4 range, 
but the packet was printed before this instruction could be inserted. Subsequent 
editions of the Adult Packet will contain the 5-point scale and raters are urged to 
employ the 5-point scale for this item. 

10. Anxiety (psychic symptoms) (0-4) - Many symptoms are included here, such as 
tension and difficulty in relaxing, irritability, worrying over trivial matters, 
apprehension and feelings of panic, fears, difficulty in concentration and forgetful- 
ness, 'feeling jumpy'. The rating should be based on pathological changes that have 
occurred during the illness and an effort should be made to discount the features of 
a previous anxious disposition. 

11. Anxiety (somatic symptoms) (0-4) - These consist of the wel 1 -recogn ized effects 
of autonomic over-activity in the respiratory, cardiovascular, gas tro-intest ina 1 and 
urinary systems. Patients may also complain of attacks of giddiness, blurring of 
vision and tinnitus. 

12. Gastro-intestinal symptoms (0-2) - The characteristic symptom in depression is 
loss of appetite and this occurs very frequently. Constipation also occurs but is 
relatively uncommon. On rare occasions patients will complain of 'heavy feelings' in 
the abdomen. Symptoms of indigestion, wind and pain, etc. are rated under Anxiety. 

13. General somatic symptoms (0-2) - These fall into two groups: the first is 
fatiguabi 1 i ty , which may reach the point where the patients feel tired all the time. 
In addition, patients complain of 'loss of energy' which appears to be related to 



difficulty in starting up an activity. The other type of symptom consists of 
diffuse muscular achings, ill-defined and often difficult to locate, but 
frequently in the back and sometimes in the limbs; these may also feel 'heavy'. 

]k. Loss of libido (1-2) - This is a common and characteristic symptom of 
depression, but it is difficult to assess in older men and especially those, 
e.g. unmarried, whose sexual activity is usually at a low level. The assess- 
ment is based on a pathological change, i.e. a deterioration obviously related 
to the patient's illness. Inadequate or no information should be rated as zero. 

15. Hypochondriasis (0-4) - The severe states of this symptom, concerning 
delusions and hallucinations of rotting and blockages, etc., which are extremely 
uncommon in men, are rated as k. Strong convictions of the presence of some 
organic disease which accounts for the patient's condition are rated 3. Much 
preoccupation with physical symptoms and with thoughts of organic disease are 
rated 2. Excessive preoccupation with bodily functions is the essence of a 
hypochondriacal attitude and trivial or doubtful symptoms count as 1 point. 

16. Loss of insight (0-2) - This is not necessarily present when the patient 
denies that he is suffering from mental disorder. It may be that he is denying 
that he is insane and may willingly recognize that he has a 'nervous' illness. 
In case of doubt, enquiries should be directed to the patient's attitude to his 
symptoms of Guilt and Hypochondriasis. 

17. Loss of weight (0-2) - The simplest way to rate this would be to record the 
amount of loss, but many patients do not know their normal weight. For this 
reason, an obvious or severe loss is rated as 2 and a slight or doubtful loss as 
I point. 

18. Diurnal variation (0-2) - This symptom has been excluded from Hamilton's 
factors as it indicates the type of illness, rather than presenting an addition 
to the patient's disabilities. The commonest form consists of an increase of 
symptoms in the morning, but this is only slightly greater than worsening in the 
evening. A small number of patients insist that they feel worse in the afternoon. 
The clear presence of diurnal variation is rated as 2 and the doubtful presence 

is 1 point. 

The following three symptoms were excluded from Hamilton's factors because 
they occur with insufficient frequency, but they are of interest in research. 

19. Derealization and Depersonalization (0-4) - The patient who has this symptom 
quickly recognizes the questions asked of him; when he has difficulty in under- 
standing the questions it usually signifies that the symptom is absent. When the 
patient asserts that he has this symptom it is necessary to question him closely; 
feelings of 'distance' usually mean nothing more than that the patient lacks 
concentration or interest in his surroundings. It would appear that the severe 
forms of this symptom are extremely rare in patients diagnosed as depressive. 



189 



admitted to hospital because his symptoms render him unable to carry on, this 
should be rated k points, but not if he has been admitted for investigation or 
observation. When the patient improves he will eventually return to work, but 
when he does so may depend on the nature of his work; judgment must be used here. 

8. Retardation (0-4) - Severe forms of this symptom are rare, and the mild forms 
are difficult to perceive. A slight flattening of affect and fixity of expression 
rate as 1 , a monotonous voice, a delay in answering questions, a tendency to sit 
motionless count as 2. When retardation makes the interview extremely prolonged 
and almost impossible, it is rated 3> and h is given when an interview is impossible 
(and symptoms cannot be rated). Although some patients may say that their thinking 
is slowed or their emotional responsiveness has been diminished, questions about 
these manifestations usually produce misleading answers. 

9. Agitation (0-4) - Severe agitation is extremely rare. Fidgetiness at interview 
rates as 1, obvious restlessness with picking at hands and clothes should count as 
2. If the patient has to get up during the interview he is given 3, and k points 
are given when the interview has to be conducted 'on the run', with the patient 
pacing up and down, picking at his face and hair and tearing at his clothes. Although 
agitation and retardation may appear to be opposed forms of behavior, in mild form 
■they can co-exist. 

NOTE - The scale points printed on the original Adult packet are 0-2. Dr. Hamilton 
states that the original range (0-4) was abandoned when severer forms of agitation 
could not be found. He has since found that more severe cases of agitation do occur - 
particularly in countries other than Great Britain. The author prefers the 0-4 range, 
but the packet was printed before this instruction could be inserted. Subsequent 
editions of the Adult Packet will contain the 5-point scale and raters are urged to 
employ the 5-point scale for this item. 

10. Anxiety (psychic symptoms) (0-4) - Many symptoms are included here, such as 
tension and difficulty in relaxing, irritability, worrying over trivial matters, 
apprehension and feelings of panic, fears, difficulty in concentration and forgetful- 
ness , 'feeling jumpy'. The rating should be based on pathological changes that have 
occurred during the illness and an effort should be made to discount the features of 
a previous anxious disposition. 

11. Anxiety (somatic symptoms) (0-4) - These consist of the wel 1 -recognized effects 
of autonomic over-activity in the respiratory, cardiovascular, gas tro- intest ina 1 and 
urinary systems. Patients may also complain of attacks of giddiness, blurring of 

V is ion and t inn i tus . 

12. Gastro-intest inal symptoms (0-2) - The characteristic symptom in depression is 
loss of appetite and this occurs very frequently. Constipation also occurs but is 
relatively uncommon. On rare occasions patients will complain of 'heavy feelings' in 
the abdomen. Symptoms of indigestion, wind and pain, etc. are rated under Anxiety. 

13. General somatic symptoms (0-2) - These fall into two groups: the first is 
fatiguabi 1 i ty , which may reach the point where the patients feel tired all the time. 
In addition, patients complain of 'loss of energy' which appears to be related to 



difficulty in starting up an activity. The other type of symptom consists of 
diffuse muscular achings, ill-defined and often difficult to locate, but 
frequently in the back and sometimes in the limbs; these may also feel 'heavy'. 

]k. Loss of libido (1-2) - This is a common and characteristic symptom of 
depression, but it is difficult to assess in older men and especially those, 
e.g. unmarried, whose sexual activity is usually at a low level. The assess- 
ment is based on a pathological change, i.e. a deterioration obviously related 
to the patient's illness. Inadequate or no information should be rated as zero. 

15. Hypochondriasis (0-^) - The severe states of this symptom, concerning 
delusions and hallucinations of rotting and blockages, etc., which are extremely 
uncommon in men, are rated as k. Strong convictions of the presence of some 
organic disease which accounts for the patient's condition are rated 3. Much 
preoccupation with physical symptoms and with thoughts of organic disease are 
rated 2. Excessive preoccupation with bodily functions is the essence of a 
hypochondriacal attitude and trivial or doubtful symptoms count as 1 point. 

16. Loss of insight (0-2) - This is not necessarily present when the patient 
denies that he is suffering from mental disorder. It may be that he is denying 
that he is insane and may willingly recognize that he has a 'nervous' illness. 
In case of doubt, enquiries should be directed to the patient's attitude to his 
symptoms of Guilt and Hypochondriasis. 

17. Loss of weight (0-2) - The simplest way to rate this would be to record the 
amount of loss, but many patients do not know their normal weight. For this 
reason, an obvious or severe loss is rated as 2 and a slight or doubtful loss as 
1 point. 

18. Diurnal variation (0-2) - This symptom has been excluded from Hamilton's 
factors as it indicates the type of illness, rather than presenting an addition 
to the patient's disabilities. The commonest form consists of an increase of 
symptoms in the morning, but this is only slightly greater than worsening in the 
evening. A small number of patients insist that they feel worse in the afternoon. 
The clear presence of diurnal variation is rated as 2 and the doubtful presence 

is 1 point. 

The following three symptoms were excluded from Hamilton's factors because 
they occur with insufficient frequency, but they are of interest in research. 

19. Derealization and Depersonalization (0-4) - The patient who has this symptom 
quickly recognizes the questions asked of him; when he has difficulty in under- 
standing the questions it usually signifies that the symptom is absent. When the 
patient asserts that he has this symptom it is necessary to question him closely; 
feelings of 'distance' usually mean nothing more than that the patient lacks 
concentration or interest in his surroundings. It would appear that the severe 
forms of this symptom are extremely rare in patients diagnosed as depressive. 



189 



20. Paranoid symptoms (0-4) - These are uncommon, and affirmative answers should 
always be checked carefully. It is of no significance if the patient says that 
others talk about him, since this is usually true. What is important in the mild 
symptom is the patient's attitude of suspicion, and the malevolence imputed to 
others. Doubtful or trivial suspicion rates as 1, thoughts that others wish him 
harm rates as 2, delusions that others wish him harm or are trying to do so rates 
as 3, and hallucinations are given k points. Care should be taken not to confuse 
this symptom with that of guilt, e.g. 'people are saying that I am wicked'. 

21. Obsessional symptoms (0-2) - These should be differentiated from preoccupations 
with depressive thoughts, ideas of guilt, hypochondriacal preoccupations and 
paranoid thinking. Patients usually have to be encouraged to admit to these 
symptoms, but their statements should be checked carefully. True obsessional 
thoughts are recognized by the patient as comrng from his own mind, as being alien 
to his normal outlook and feelings, and as causing great anxiety; he always 
struggles against them. 

The Rating of Female Patients 

The same general principles apply to the rating of women as of men, but there 
are special problems which need to be considered in detail, 

I. Depression {0-k) - It is generally believed that women weep more readily 
than men, but there is little evidence that this is true in the case of depressive 
illness. There is no reason to believe, at the moment, that an assessment of the 
frequency of weeping could be misleading when rating the intensity of depression 
in women. 

7. Work and interests (0-4) - Most women are housewives and therefore their work 
can be varied, both in quantity and intensity, to suit themselves. Women do not 
often complain of work being an effort, byt they say they have to take things 
easily, or neglect some of their work. Other members of the family may have to in- 
crease the help they give. It is rare for a housewife to stop looking after her 
home completely. If she has an additional job outside the home she may have to 
change it to part-time, or reduce her hours of work or even give it up completely. 
Women engage in hobbies less frequently than men. Loss of interest, therefore, 
may not be as obvious. Patients may complain of inability to feel affection for 
their families. This could be rated here, but it could be rated under other 
symptoms, depending upon its meaning and setting. Care should be taken not to rate 
it in two places. It is a very valuable and important symptom if the patient 
mentions it spontaneously but could be very misleading as a reply to a question. 

II. Anxiety (somatic) (0-4) - These last three symptoms appear to be more common 
in women than in men. 

13. Somatic symptoms (general) (0-2) - It is not uncommon for women to complain of 
backache and to ascribe it to a pelvic disorder. This symptom requires careful 
quest ioning , 



190 



]k. Loss of libido (0-2) - In women whose sexual experience is satisfactory, 
this symptom will appear as increasing frigidity, progressing to active dislike 
of sexual intercourse. Women who are partially or completely frigid find that 
their customary toleration of sex also changes to active dislike. It is diffi- 
cult to rate this symptom in women who have had no sexual experience or, indeed, 
in widows since loss of libido in women tends to appear not so much as a loss 
of drive but as a loss of responsiveness. In the absence of adequate informa- 
tion of a pathological change a zero rating should be given. Disturbed menstrua- 
tion and amenorrhea have been described in women suffering from severe depression, 
but they are very rare. Despite the difficulties in rating, it has been found 
that the mean score for women is negligibly less than men. 

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Davison, K., et al. Genetic Polymorphism in Metabolism of Phenelzine. Brit. J. 
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191 



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Amitriptyl ine, Isocarboxazid, & Tranylcypromine in 0-P Depressive Illness. 
Brit. J. Psychiat. 110: 846-850, Nov. 1964 

Valentine, M., et al. A Comparison of Techniques in Electro-Convulsive 
Therapy, Brit. J. Psychiat. 114: 989-996, Aug. I968 

Lewis, A., and Hoghughi, M. An Evaluation of Depression as a Side Effect of 
Oral Contraceptives, Brit. J. Psychiat. 115: 697-70I , June I969 

Munro, A. Parental Deprivation in Depressive Patients, Brit. J. Psychiat. 
112: 443-457, May I966 

Hamilton, M., A Rating Scale for Depression, J. Neurol. Neurosurg. Psychiat., 
23, 56-62, i960 

Hamilton, M., Comparison of Factors by Ahmavaara's Method, Brit. J. Math. 
Stat. Psychol., 20, 1, IO7. May I967 

Hamilton, M. Standardized Assessment and Recording of Depressive Symptoms. 
Psychiat. Neurol. Neurochir., 72, 201-205, I969 



192 



048 HAM A 
HAMILTON 
ANXIETY 
SCALE 



MH-9-48 HAMILTON ANXIETY SCALE 

6-73 

INSTRUCTIONS: Code 01 under Sheet Number. 

Be sure to record your answers in the appropriate spaces (positions through 4), 
Columns 1—5, on the left half of the General Scoring Sheet. 

USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


12 3 4 




NOT MODER- VERY 
PRESENT MILD ATE SEVERE SEVERE 


ROW 
NO. 


Mark on left half of scoring sheet on row specified 

Mark in response positions — 4, columns 1—5. Follow 

rating scale on header template. 










24 


= o °* . 1 = Mild 2 = Moderate 3 = Severe 4 = ^^'^^ 
Present Severe 




24*1 r-azz ::2:= :*= ::4:: 
25z*r .:lz: :r2:: :=i= r:4c = 
26:*= :raz= ::2:: r*: ::4cr 
27 r*: rr3:: ::2:z :*r r:4c: 


ANXIOUS MOOD 

Worries, anticipation of the worst, fearful anticipation, irritability 




25 


TENSION 

Feelings of tension, fatigability, startle response, moved to tears easily, 
trembling, feelings of restlessness, inability to relax 




29:*r ::arz ::2:r :*. :,4:: 
30:*: ::a:r ::£: ::a:z ::4:: 


26 


FEARS 

Of dark, of strangers, of being left alone, of animals, of traffic, of crowds 




31 ::&: ::3:: ::2:: ::!: ::*: 
32:6:: ::a:: ::2:: ::!: =:i:r 
33:*: ::1:: :d2:: :3:: ::4r 


27 


INSOMNIA 

Difficulty in falling asleep, broken sleep, unsatisfying sleep and fatigue on 
waking, dreams, nightmares, night terrors 




34:*: ::J:: :^:: :J:: ::4:: 
35:*: ::l:: :d2:: :J:: :.*:: 
36:*: ::J:: :i: :*: =.4:: 
37:*: ::J:: ::2:: =*= =,4: 


28 


INTELLECTUAL 

Difficulty in concentration, poor memory 




29 
30 


DEPRESSED MOOD 

Loss of interest, lack of pleasure in hobbies, depression, early waking, 
diurnal swing 




Ct»#s: 12 3 4 5 


SOMATIC (Muscular) 

Pains and aches, twitchings, stiffness, myoclonic jerks, grinding of teeth, 
unsteady voice, increased muscular tone 






31 


SOMATIC (Sensory) 

Tinnitus, blurring of vision, hot and cold flushes, feelings of weakness, 
pricking sensation 






32 


CARDIOVASCULAR SYMPTOMS 

Tachycardia, palpitations, pain in chest, throbbing of vessels, fainting 
feelings, sighing, dyspnea 






33 


RESPIRATORY SYMPTOMS 

Pressure or constriction in chest, choking feelings, sighing, dyspnea 






34 


GASTROINTESTINAL SYMPTOMS 

Difficulty in swallowing, wind, abdominal pain, burning sensations, 
abdominal fullness, nausea, vomiting, borborygmi, looseness of bowels, 
loss of weight, constipation 






35 


GENITOURINARY SYMPTOMS 

Frequency of micturition, urgency of micturition, amenorrhea, 
menorrhagia, development of frigidity, premature ejaculation, loss of 
libido, impotence 






36 


AUTONOMIC SYMPTOMS 

Dry mouth, flushing, pallor, tendency to sweat, giddiness, tension headache, 
raising of hair 






37 


BEHAVIOR AT INTERVIEW 

Fidgeting, restlessness or pacing, tremor of hands, furrowed brow, strained 
face, sighing or rapid respiration, facial pallor, swallowing, etc. 





19^ 



The Hamilton Anxiety Scale (HAMA) is a 1^-item scale formatted for use with 
the General Scoring Sheet. The HAMA was designed by Hamilton and intended for 
use with patients already diagnosed as suffering from neurotic anxiety states - 
not for assessing anxiety in patients suffering from other disorders. Until the 
contrary is proved, it must be regarded as invalid for the rating of anxiety in 
any other setting. This limits the range of usefulness of the scale but, within 
these limits, patients can be compared meaningfully. The scale places great 
emphasis on the patient's subjective state. This follows from the medical bias 
of the author. In treatment, the patient's subjective state takes first place 
both as a criterion of illness, which brings the patient for treatment and as a 
criterion of improvement. 



REFERENCES 



APPLICABILITY 
UTILIZATION 

TIME SPAN RATED 
CARD FORMAT - ITEMS 



1. Hamilton, M., The Assessment of Anxiety States by 
Rating, Brit. J. Med. Psychol., 32, 50-55, 1959. 

2. Hamilton, M., Diagnosis and Rating of Anxiety, in: 
Studies of Anxiety, Lader, M. H., Brit. J. Psychiat. 
Spec. Pub. 3, 76-79, 1969 

Adults with diagnosis of anxiety neurosis 

Once at pretreatment ; at least one posttreatment assess- 
ment. Additional ratings are at the discretion of the 
investigator. 

Now or during the past week 

CARD 01 = (19x, l4ll) 



Item 
1 




Col. 
20 


2 




21 


3 




22 


k 




23 


5 




2k 


6 




25 


7 




26 


CARD FORMAT ■ 


■ FACTORS 


CA 



I tern 
8 
9 
10 
11 
12 
13 
]k 



Col . 
27 
28 
29 
30 
31 
32 
33 



CARD 51 = (I9x, 2F6.2, F4.0) 
(Code "5" in Column 18 indicates card containing factor, cluster or other 
derived scores) . 



FACTOR 



COLUMN 



I - Somat ic Anxiety 
I I - Psychic Anxiety 
Total Score 



20 - 25 
26-31 
32 - 35 



Factor Score = Sum of composite items 
No. of composite items 



Total Score = Sum of all items 



Factor score range =0-5 
Total score range =0-70 



195 



FACTOR COMPOSITION 

Hamilton has presented both centroid and orthogonal factor structures in 
his 1959 article. Since other ECDEU factors are orthogonal and unipolar, this 
structure - rather than the centroid one - will be employed for analyses. When 
a sufficient sample is accumulated, factor analysis will be performed on ECDEU 
data . 



1 . Somat ic Anxiety 

7 - Somatic, muscular 

8 - Somatic, sensory 

9 - Cardiovascular symptoms 

10 - Respiratory symptoms 

11 - Gastro-intest inal symptoms 

12 - Gen i to-urinary symptoms 

13 - Autonomic symptoms 



I I . Psychic Anxiety 

1 - Anxious mood 

2 - Tens ion 

3 - Fears 

k - insomnia 

5 - Intellectual 

6 - Depressed mood 

14 - Behavior at interview 



SPECIAL INSTRUCTIONS 

1. Assessments are made on a 5-point scale. In practice, however, the last scale 
point (very severe, grossly disabling) is very rarely used for out-patients and 
serves more as a marker, a method of delimiting the range, rather than as a grade 
of practical use. 

2. Each of the 14 items represents a set of symptoms grouped together according 
to their nature or where clinical experience indicates that they were associated. 
The symptom groups which serve as cues for the rater are: 



1 . Anxious mood 



3. Fears 



Worries 

Anticipation of the worst 

Apprehension (fearful 

ant icipat ion) 
I rri tabi 1 i ty 

2. Tension 

Feelings of tension 

Fat iguabi 1 i ty 

Inabi 1 ity to relax 

Startle response 

Moved to tears easily 

Trembl ing 

Feelings of restlessness 



Of Dark 

Strangers 

Being left alone 

Large animals , etc. 

Traffic 

Crowds 

Insomnia 

Difficulty in falling asleep 
Broken sleep 
Unsatisfying sleep and 

fatigue on waking 
Dreams 
Nightmares 
Night terrors 



196 



5. Intellectual (cognitive) 



11. Gastro-intestinal symptoms 



Difficulty in concentration 
Poor memory 

6. Depressed mood 

Loss of interest 

Lack of pleasure in hobbies 

Depress ion 

Early waking 

Diurnal swing 

7. General somatic (muscular) 

Muscular pains and aches 
Muscular stiffness 
Muscular twitchings 
Clonic jerks 
Grinding of teeth 
Unsteady voice 

8. General somatic (sensory) 

Tinnitus 

Blurring of vision 
Hot and cold flushes 
Feelings of weakness 
Pricking sensations 

9. Cardiovascular symptoms 

Tachycardia 
Pa 1 p i ta t i ons 
Pain in chest 
Throbbing of vessels 
Fa inting feel ings 
Missing beat 

10. Respiratory symptoms 

Pressure or constriction in 

chest 
Choking feel ings 
S ighings 
Dyspnoea 



Difficulty in swallowing 

Wind 

Dyspeps ia: 

pain before and after means 

burning sensations 

ful Iness 

waterbrash 

nausea 

vomi ting 

s inking feel ings 
'Working' in abdomen 
Borborygmi 
Looseness of bowels 
Loss of weight 
Constipation 

12. Gen i to-urinary symptoms 

Frequency of micturition 
Urgency of micturition 
Amenorrhea 
Menorrhagia 

Development of frigidity 
Ejaculatio praecox 
Loss of erection 
Impotence 

13. Autonomic symptoms 

Dry mouth 

Flushing 

Pallor 

Tendency to sweat 

G iddiness 

Tension headache 

Raising of hair 



197 



1^. Behavior at interview 

a. General b. Physiological 

Tense, not relaxed Swallowing 

Fidgeting: hands, Belching 

picking fingers. High resting pulse rate 

clenching, tics Respiration rate over 20/min. 

handkerchief Brisk tendon jerks 

Restlessness: pacing Tremor 

Tremor of hands Dilated pupils 

Furrowed brow Exophthalmos 

Strained face Sweating 

increased muscular tone Eye-1 id^ twitching 
Sighing respirations 
Facial pallor 



DOCUMENTATION 

a. Raw score printout 

b. Factor score printout 

c. Means and standard deviations of factor scores 

d. Variance analyses 



198 



051 AS I 
ANXIETY 
STATUS 
INVENTORY 



ANXIETY STATUS INVENTORY 

Wm.W.K.Zung 

INSTRUCTIONS: Code 01 under Sheet Number on General Scoring Sheet 

The data upon which the judgments are based come from the interview with the patient. The items in the 
scale are to be quantified by using all the information available to the rater. This includes both clinical obser- 
vation and the material reported by the patient. 

Use of the Interview Guide below assures coverage of all the areas on which judgments are required. How- 
ever, the rater has the flexibility of modifying the questions or probing for details, which makes possible a 
smooth interview that does not sound like a question-answer examination. In rating the patient's current 
status, an arbitrary period of 1 week prior to the evalutaion is adopted in order to standardize the data. In 
order to reinforce this, the interviewer should occasionally precede questions with, "During the past week, 
have you ?" 



Se«r<t)r of Observed 
or Reported Responses 



5 6 7 F" 

MODEIi 
NONg MUD ATE SEVERE 



Row 1 


iiSi 


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2 


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4 


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5 


=:5:: 


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6 


::5:= 


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7 


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8 


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9 


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10 


nil 


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nil 


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11 


"ir 


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12 


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13 


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14 


z&z 


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15 


-S:-- 


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16 


lft= 


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17 


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18 


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19 


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list: 


riftr 


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6 


7 


8 


9 



Mark each Item on left half of scoring sheet on row specified. 
Mark in response positions 5-8, columns 6 through 9. 
Observe severity rating scale on header template 


ROW 

NO. 


AFFECTIVE AND 

SOMATIC SYMPTOMS 

OF ANXIETY 


INTERVIEW GUIDE 

FOR 

ANXIETY STATUS INVENTORY lASI) 


1 


Anxiousnest 


Do you ever feel nervous and anxious? 


2 


Fear 


Have you ever felt afraid? 


3 


Panic 


How easily do you get upset? Ever have 
panic spells or feel like it? 


4 


Mental 
disintegration 


Do you ever feel like you re falling apart? 
Going to pieces? 


S 


Apprehension 


Have you ever felt uneasy? Or that some- 
thing terrible was going to happen? 


6 


Tremors 


Have you had times w^en you felt 
yourself trembling? Shaking? 


7 


Body aches 
and pains 


Do you have headaches? Neck or back 
pains? 


8 . 


Easy fatigability 
weakness 


How easily do you get tired? 
Ever have spells of weakness? 


9 


Hestlessness 


Do you find yourself restless and can't 
sit still? 


10 


Palpitation 


Have you ever felt that your heart was 
running away? 


11 


Dizziness 


Do you ever have dizzy spells? 


12 


Faintness 


Do you have fainting spells? Or feel like it? 


13 


Dyspnea 


Evei have trouble with your breathing? 


14 


Paresthesias 


Ever have feelings of numbness and tingling 
in your fingertips? Or around your mouth? 


15 


Nausea and vomiting 


Do you ever feel sick to your stoma* or 
feel like vomiting? 


16 


Urinary frequency 


How often do you need to empty your 
bladder? 


17 


Sweating 


Do you ever get wet, clammy hands? 


18 


Face flushing 


Do you ever feel your face getting hot 
and blushing? 


19 


Insomnia 


How have you been steeping? 


20 


Nightmares 


Do you have drean is that scare you? 



200 



Developed by Zung, the Anxiety Status Inventory (AS I ) is a 20-item scale 
formatted for use witli the General Scoring Sheet, Employing a 4-point scale, 
the AS I is the clinician-rated counterpart of the Self-Rating Anxiety Scale 
(SAS) . The ASI along with the SAS were designed specifically for the assess- 
ment of anxiety as a clinical disorder rather than as a trait or feeling state. 
Zung reports a product-moment correlation of .7^ between the ASI and SAS for 
patients with diagnoses of anxiety neurosis. (N = 22). 

REFERENCE Zung, Wm. W.K,, A Rating Instrument for Anxiety 

Disorders, Psychosomat ics , 12: 371-379, Nov. -Dec, 1971 

APPLICABILITY Adults with diagnoses of anxiety neurosis 

UTILIZATION Once at pretreatment ; at least one post-treatment rating. 

Additional ratings are at the discretion of the investigator, 

TIME SPAN RATED Now or in the week prior to evaluation 

CARD FORMAT - ITEMS CARD 01 = (19x, 2011, lOx, \k) 

Item Column 

1 20 

2 21 

3 22 
k 23 

5 2k 

6 25 

7 26 

8 27 

9 28 
10 29 

'A- The Z score for the ASI is derived by dividing the sum of the raw item scores 
by the maximum possible score (80) multiplied by 100. See Table 11 for the 
conversion of raw scores to AS I and SAS indices. Zung has provided the following 
mean Z scores and standard deviations for 5 diagnostic groups: 

Diagnosis N MN 

Anxiety Disorder 
Schizophrenia 
Depressive Disorder 
Personality Disorder 
Transient Situational 

Disturbances 12 42.0 8.1 

:-'■ Significantly different from other h groups (p = .05) 



1 tem 


Column 


11 


30 


12 


31 


13 


32 


14 


33 


15 


34 


16 


35 


17 


36 


18 


37 


19 


38 


20 


39 


Z Score * 


50-53 



22 


62.0 


13.8V.'* 


25 


49.4 


15.9 


96 


49.9 


12.5 


54 


52.6 


13.6 



201 



TABLE I 1 

THE CONVERSION OF RAW SCORES TO 
ASI AND SAS INDICES 



AS I ASI ASI 

& & & 

Raw SAS Raw SAS Raw SAS 

Score Index Score Index Score Index 

20 25 ^0 50 60 75 

21 26 k] 51 61 76 

22 28 42 53 62 78 

23 29 ^3 54 63 79 
2k 30 kk 55 64 80 

25 31 45 56 65 81 

26 33 46 58 66 83 

27 34 47 59 67 84 

28 35 48 60 68 85 

29 36 49 61 69 86 

30 38 50 63 70 88 

31 39 51 64 71 89 

32 40 52 65 72 90 

33 41 53 66 73 91 

34 43 54 68 74 92 

35 44 55 69 75 94 

36 45 56 70 76 95 

37 46 57 71 77 96 

38 48 58 73 78 98 

39 49 59 74 79 99 

80 100 



SPECIAL INSTRUCTIONS 

The Interview Guide is printed in the packet to assist the rater in eliciting 
the presence of a symptom. The items in the scale are to be quantified by using 
all of the information available to the rater. This includes both clinical observa- 
tions and the material reported by the patient. Use of the Interview Guide assures 
coverage of all of the areas in which judgments are required. However, the rater 
has the flexibility of interposing other questions or probing for details which allow 
for a smooth interview without sounding like a question and answer examination. 

In making judgments, the following rules should be observed: 

1. Each item should be independently rated as a unit 
by itself in order to eliminate any "halo" effect. 

2. Each score should be the average of the full range 

of responses observed or elicited, and not necessarily 
the extreme in severity. 



202 



3. The items are judged on a four-point system, taking 
into account Severity in terms of: intensity, dura- 
tion, and frequency. These are defined as follows: 

1 = none or insignificant in intensity or 

duration, present none or a little of 
the time in frequency 

2 = mild in intensity or duration, present 

some of the time in frequency 

3 = of moderate severity, present a good 

part of the time in frequency 

k = severe in intensity or duration, present 
most or all of the time in frequency 

To help establish severity, the following questions may be necessary: 
Intens i ty - "How bad was it?" Duration - "How long did it last?" Frequency - 
"How much of the time did you feel that way?" 

4. An item is scored positive and present when: 

a. Behavior is observed 

b. Behavior was described by the patient as having occurred 

c. patient admits that symptom is still a problem 

5. An item is scored negative and not present when: 

a. Symptom has not occurred and not a problem or present 

b. Patient gives no information relevant to an item 

c. Response is ambiguous even after suitable probing 



ERRATA 

The instructions printed on the "header" for the AS I should be identical to 
those printed on the "header" for the Depression Status Inventory. Raters are ad- 
vised to duplicate these DS I instructions and paste them on the AS I "header". 

Item 19 - Note that this item should be entitled "Insomnia-initial", NOT 
simply "Insomnia". 

DOCUMENTATION 

a. Raw score printout 

b. Index score printout 

c. Means and standard deviations of index scores 

d. Variance analyses 



203 



COMMENTS OF THE AUTHOR 

ANXIETY STATUS INVENTORY 

Will iam W. K. Zung, M. D, 



In the construction of the present rating instrument the symptoms of the 
illness were delineated by using the descriptive approach, since the basis of 
definition and classification in psychiatric nosology continues to be based 
upon presenting symptomatology. A review of the literature cited in the 
original publication describing the anxiety scale (1) will indicate that al- 
though anxiety as a disorder is discussed from several disparate frameworks 
of psychiatric orientation, the diagnostic criteria used by the various schools 
of thought are almost identical. 

Anxiety Status Inventory (AS I ) 

As with the Depression Status Inventory (DSl) described elsewhere in this 
manual, (p. 17^), the data upon which the judgments are based for the AS I come 
from the interview with the patients. Thus, the following discussion is 
applicable to both interviewer rated scales. 

The items in the scale are to be quantified by using all of the information 
available to the rater. This includes both clinical observations and the 
material reported by the patient. 

Use of the interview Guide assures coverage of all of the areas in which 
judgments are required. However, the rater has the flexibility of Interposing 
other questions or probing for details which allow for a smooth interview with- 
out sounding like a question-answer examination. In rating the patient's cur- 
rent status, an arbitrary period of one week prior to the evaluation is adopted 
in order to standardize the data. 

REFERENCES 

1. Zung, W.W.K. and Green, R. L., Jr.: Detection of affective disorders in 
the aged, in Eisdorfer, C. and Fann, W.E. (Editors): Psychopharmacology 
and Aging, Plenum Press, New York, 1973. 

2. Zung, W.W.K. : The differentiation of anxiety and depressive disorders: 
A psychopharmacological approach, Psychosom. 15, 197^. 

3. Zung, W.W.K.: The measurement of affects: Depression and anxiety, in 
Pichot, P. (Editor): Psychological Measurements in Psychopharmacology, 
Karger, Basel, 197^. 



204 



052 WITT 
WITTENBORN 
PSYCHIATRIC 
RATING SCALE 



MH-9-52 
6-73 



INSTRUCTIONS: 



WITTENBORN PSYCHIATRIC RATING SCALES (Short Survey) 

Code 01 under Sheet Number. 

1. The statements in the Rating Scales are arranged in steps from (no pathology) through 3 (extreme pathology). 

2. For each scale, select the one statement which best describes the most extreme manifestation during the past week. 

3. If the behavior is doubtful or variable, select the alternative which is nearer to 3. 

4. Rate every item, but base the rating on the specified period of observation only. 

5. Record your rating by marking the appropriate response position on the answer sheet. 

Be sure to record your answers in the appropriate spaces (positions 5 — 8), columns 6 — 9, on the 
left half of the General Scoring Sheet. 

USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 



21 


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22 


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23 


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24 


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zzjz 


25 


r=S:= 


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-^ 


26 


-S: 


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-7: 


27 


"5:= 


==6:= 


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28 


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29 


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30 


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31 


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32 


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33 


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34 


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35 


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36 


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37 


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6 


7 


8 



206 



ROW 
NO. 



Mark each Item on left half of scoring sheet on row specified. 
Mark in response positions 5 — 8, columns 6—9. 
See rating instructions on header template. 



I. ANXIETY 



Threatened 
by Task 



Sense of 
Foreboding 



Subjective 
Anxiety 



= Does not express any feeling of anxiety when confronted 
with a task, a test or a new situation 



1 = When confronted with a task, a test or a i 
the patient admits anxiety experiences 



'■ When confronted with a task, a test or a new situation, 
the patient admits anxiety experiences, and quality of 
performance is adversely affected 



3 = Feets threatened by a task, or new situation, and shows 
failure and blocking 



= Does not complain of premonitory experiences or any 
sense of foreboding 



1 = Has vague feelings of foreboding or misfortune 



2 = Has definite feeling that something bad is going to happen 
which will involve him or his family (but there is no 
evidence upon which to base a prediction) 



3 = Definite feelings of impending, inescapable, personal 
doom or catastrophe (but there is no apparent basis for 
this strong fear) 



= No evidence that patient considers himself to be particu 
larly unworthy or blameworthy 



1 = Patient tends to blame himself or refer to his 
unworthiness 



2 = Patient blames and criticizes self to an unrealistic and 
inappropriate degree 



3 = Patient appears to have a delusional belief that he is i 
extraordinarily evil, unworthy or guilty person 



= No complaint of subjectively experienced anxiety 



1 = Experiences at least minor feelings of anxiety 



2 = Experiences anxiety which is strong enough to make 
him express acutely uncomfortable feelings 



3 = Is desperately distressed by his anxiety and considers it 
to be intolerable 



II. SOMATIC-HYSTERICAL 



Attention 
Demanding 



= Does not appear to be attention-demanding 



1 = In conversation, usually brings attention of others to 
his own role 



2 = Engages insistently in description of own role or 
difficulties 



3 = Dramatically attention-demanding 



WITTENBORN PSYCHIATRIC RATING SCALES (Short Survey) 



BOW 
NO. 


Continue marking on left half of scoring sheet on row specified 1 


26 


Uses 
Symptoms 


= No discernible psychological use made of phyiical 
disease symptoms 


1 = Use is made of physical disease symptoms to gain 
attention or to dramatize self 


2 = Use is made of physical disease symptoms for evading 
responsibilities, justifying failures, etc. 


27 


Organic 
Involvement 


= Presents no complaint or symptoms of organic 
pathology or malfunctioning 


1 = Presents symptoms of organic pathology or malfunction- 
ing which was not caused by emotional factors 


2 = Presents organic pathology or malfunctioning which may 
be caused in part or greatly aggravated by emotional 
factors 


3 = Presents organic pathology or malfunctioning which 
probably was caused by emotional factors 


28 


III. OBSESSIVE-COMPULSIVEPHOBIC 


Phobic 


= No complaint of phobias or phobic reactions 
(i.e., specific isolated, inappropriate fears) 


1 = Patient experiences phobic reactions in certain situations 


2 = Phobic reactions have affected patient's current behavior 


3 = Patient's behavior is greatly disrupted or delimited by 
his phobias 


29 


Obsessive 


= No evidence for obsessional (repetitive, stereotyped} 
thinking 


1 = Obsessive thoughts recur but can be banished without 
difficulty 


2 = Patient is able to banish obsessive thoughts, but only 
with difficulty 


3 = Cannot banish or control obsessive thoughts 


30 


Compulsive 


= No evidence of compulsive (repetitive, nonadaptive, 
uneconomical) behavior 


1 = Acts judged to be compulsive are performed from time to 
time but not every day 


2 = Compulsive acts occur daily 


3 = Compulsive acts are practically continuous 


31 


IV. DEPRESSIVE RETARDATION 


Indecisive 


= No evidence of difficulty in making decisions 


1 = Reports uncertainty and postponement of decisions 


2 = Cannot make decisions without advice or pressure 


3 = Cannot make decisions 



ROW 
NO. 


Continue marl<ing on left half of scoring sheet on row specified | 


32 


Avoids 
People 


= No evidence of social withdrawal 


1 = Does not appear to seek out the company of other 
people 


2 = Avoids many people 


3 = Attempts to avoid almost all people 


33 


Motoric 
Retardation 


= No evidence of slowing of responses 


1 = Actions have a deliberate quality. No evidence of haste 


2 = Overt responses are slow and may appear to be delayed 


3 = All overt activity is at a minimum. Patient loath to move 
and all motions tend to be tediously slow 


34 


V. EXCITEMENT | 


Overactive 


= Is not particularly overactive 


1 = Moderately overactive, e.g., toys with objects, 
frequently changes his sitting position 


2 = Noticeably restless 


3 = In almost constant movement 


35 


Irrelevant 
Words 


= Does not use words in an obscure or irrelevant manner 


1 = Words not always clearly relevant to recognizable idea 


2 = Words used in such a manner that ideas seem unclear 
and confused 


3 = Words not relevant to any recognizable, logical idea 


36 


VI. PARANOIA 1 


Misinterprets 
Others 


= No evidence that he misconstrues the intentions of others 


1 = May exaggerate the intentions of others 


2 = May seriously misinterpret the intentions of others 


3 = Arbitrarily misinterprets the intentions of others, 
apparently to conform with his delusional beliefs 


37 


Ideas of 
Influence 


= No evidence that patient feels that others seek to spy 
upon or control his behavior or thought 


1 = Wonders if others have a particular interest in.or desire 
to know about his thoughts or behavior 


2 = Wonders if others attempt to influence his behavior in 
some unknown manner or attempt to control his thoughts 


3 = Believes that others influence his behavior in some 
strange manner or control his thoughts 



207 



Wittenborn's Psychiatric Rating Scale (WITT) is a ly-item scale formatted 
for use with the General Scoring Sheet. The present ECDEU version was developed 
from the longer 72-item Wittenborn scale in response to the need for a brief 
assessment procedure to ascertain the rate and nature of symptomatic change. 
With one exception, items are rated on a if-point scale. 

REFERENCE Wittenborn, J. R., Manual: Wittenborn Psychiatric 

Rating Scales, 1955, Psychological Corporation, 
New York. 

APPLICABILITY Inpatient and outpatient adult populations 

UTILIZATION Once at pretreatment ; at least one posttreatment 
rating. Additional ratings are at the discretion 
of the principal investigator. 

TIME SPAN RATED Now or during the past week 

CARD FORMAT - ITEMS CARD 01 (19x. 1711) 

Item Column Item Column 

1 20 10 29 

2 21 11 30 

3 22 12 31 
k 23 13 32 

5 2k ^k 33 

6 25 15 3^+ 

7 26 16 35 

8 27 17 36 

9 28 

CARD FORMAT - FACTORS CARD 51 (19x, 6f6.2, F^f.O) 

(Code "5" in Column 18 indicates card containing factor, cluster or derived score.) 

Factor Column Factor Column 



1 


20-25 


II 


26-31 


1 1 1 


32-37 


IV 


38-i+3 



V 


kk-ks 


VI 


50-55 


Total Score 


56-59 



Factor Score = Sum of composite items Factor score range = - k 
No. of composite items 

Total Score = Sum of a 1 1 items Total score range =0-68 



208 



FACTOR COMPOSITION: 



FACTOR I 



ANXIETY 



1. Threatened by task 

2. Sense of foreboding 

3. Guilt 

k. Subjective anxiety 

FACTOR II SOMATIC - HYSTERICAL 

5. Attention demanding 

6. Uses symptoms 

7. Organic involvement 



FACTOR I I I 

8. Phobic 

9. Obsessive 
10. Compulsive 



OBSESSIVE - COMPULSIVE - PHOBIC 



FACTOR IV DEPRESSIVE RETARDATION 
1 1 . Indecis ive 

12. Avoids people 

13. Motoric Retardation 



FACTOR V 



EXCITEMENT 



14. 
15. 



Overactive 

I rrelevant words 



FACTOR VI PARANOIA 

16. Misinterprets others 

17. Ideas of influence 



SPECIAL INSTRUCTIONS 

See "Comments of the Author" (pp. 210-2)6 ) for detailed instructions. 
DOCUMENTATION 

a. Raw score printout 

b. Factor score printout 

c. Means and standard deviations for factor scores 

d. Cross Tabulations 

e. Variance analyses 



209 



COMMENTS OF THE AUTHOR 

Manual for Wittenborn Psychiatric Rating Scales 
J. Richard Wittenborn, Ph.D., Rutgers University 

I. CHARACTERISTICS OF SYMPTOM RATING SCALES 

The development of research in psychiatry, clinical psychology, and clinical 
psychopharmacology has been accompanied by the appearance of several psychiatric 
symptom rating scales. Although these rating scales may all be used as criteria 
for therapeutic efficacy, they may differ in several fundamental respects. 

A. Content 

There are many different patient characteristics which may be sampled by 
rating scales. For example, it is possible for scales to reflect the strength 
of certain aspects of the patient's personality. It is possible also for rating 
scales to include aspects of the patient's clinical history. Some rating scales 
include only currently discernible symptoms of psychopathology, and such scales 
can be most sensitive to any change in the patient's status. Symptom rating 
scales can be restricted to represent only certain limited psychopathological 
deviations, such as depression, anxiety, or somatization, or they can attempt to 
sample a broad spectrum of psychopathology so that change in target symptoms may 
be seen in the context of a total symptom complex. 

The WPRS samples a broad spectrum of commonly encountered psychopathology 
and is restricted to currently discernible symptoms. It is not a diagnostic 
device in any fundamental sense. Instead, it is intended to be sensitive to 
change and to be sufficiently comprehensive to provide a common basis for compar- 
ing a wide diversity of patients. 

B. Referents 

Many rating scales provide distinctions between patients on the basis of the 
rater's general impression of the patient. Such scales do not refer directly to 
the observational or factual basis for the judgments. As a consequence, a rating 
based on such a judgmental scale may be as sensitive to rater characteristics as 
it is to patient characteristics. A few other scales refer explicitly to verifiable 
observations or other factual situations or events directly descriptive of the 
patient and in this way minimize evaluative and interpretive judgments of the 
rater. It is never possible to eliminate the influence of the rater's judgment 
or to correct completely for the selective nature of his observation. Rating scales 
do vary greatly, however, in the extent to which they involve the screening, 
evaluative, and judgmental characteristics of the individual rater. 

The WPRS emphasizes the use of verifiable observations as the basis for rating 
and attempts to minimize the rater's judgmental involvement. For this reason, the 
WPRS requires thorough and meticulous observation of the patient and does not rely 
upon the interpretive acumen of the rater. 



210 



C. observational basis 

The observational requirements for the proper use of a rating scale must be 
related to its content. If historical considerations or aspects of the premorbid 
personality are included in the ratings, the observational period cannot be rigidly 
defined. Despite their possible diagnostic interest, ratings based on enduring 
personal qualities or referring to indefinite time periods cannot be most sensitive 
to the changes which are pertinent to current therapeutic effects. 

Since the WPRS is designed to reveal changes, the obser-vat ional per iod on which 
the ratings are based must be carefully defined. This period can be of any duration, 
but it is necessary that firm limits be set so that old observations do not bias 
current ratings and so that comparisons may be made between definite periods or 
phases in the illness. Obviously, the selected rating period must be standard within 
any sample of data submitted to common analysis. 

For a sample of data submitted to common analysis, the observational setting 
should be specified also. For the Long Form, the diversity of content requires an 
in-patient setting. For the Short Form, however, the outpatient interview situation 
(including the substance of the patient's verbalization) can provide an adequate 
sett ing. 

The provocative qualities of the observational setting remain an uncontrolled 
factor in the ordinary use of rating scales. Certain settings, because of the 
personnel or because of the qualities of the interview situation, can admittedly 
be most provocative of psychopatholog ical reactions. For this reason, it is import-ant 
for comparative purposes that the setting for a given patient remain constant, other- 
wise the effect of any changes in the setting would be confounded with effects due to 
treatment. in order to keep the "error variance" as small as possible, it is desirable 
also that the settings be as uniform as possible among patients generating data for 
a common analysis. Nevertheless, it is not recommended that ratings be based on a 
standardized question and answer type of inquiry which is little more than a tour de 
force of the items comprising the rating scale. Instead, it is recommended that the 
observations and the interview be thorough and evocative with reasonable opportunity 
for the expression of thoughts, sentiments, and reactions which are pertinent to the 
patient's disorder and to the content of the rating scale. 

The rater may either restrict the ratings to his own observations or decide to 
incorporate the reports and observations of reliable informants , such as ward 
personnel, family associates, etc. If ratings are to include the reports of informants, 
it is obviously necessary that the informant be used in a consistent and standard 
manner throughout any set of ratings required by an investigation. In many out- 
patient §ituationSy particularly in work with juveniles and with character disorders, 
it may be most helpful for the rater to have recourse to reliable informants. 

The behavior of patients is ordinarily episodic and variable in its pathologic 
quality. Accordingly, the interview itself provides, at best, a meager and, at 
worst, a misleading sample of the patient's reactions. All other things equal. 



211 



the longer the observational period the greater the opportunities for pertinent 
observation. For example, if the assessment period for which the rating is to 
be descriptive is one week, the inadequate, untoward, or deviant behaviors during 
that week are probably much more pertinent to the quality of the patient's current 
functioning than are the qualities of behavior manifested during the period of one 
interview. The limitation inherent in ratings based on the interview apply to any 
rating scale, particularly any symptom rating scale which, by its nature, is con- 
cerned with current manifestations of psychopathol ogy and not merely with those 
qualities of behavior which may emerge in the course of one interview. Accordingly, 
in the outpatient situation, the rater is particularly dependent on sel f-reports 
and must rely on the patient's ability to recognize and willingness to describe 
difficulties and deviations which have occurred during the period covered by the 
assessment. This means, of course, that the rater must have excellent evocative 
rapport with his outpatients. 

In the evaluation of outpatient rating data based primarily on the intei — 
view, it is important to recognize the special vulnerabilities of such data and 
to remember that they are much more dependent upon both the rater's skill as an 
interviewer and his interpretive acumen than are data which have a broader observa- 
tional basis, e.g., data gathered in an inpatient situation. 

D . Sea 1 ing cont i nua 

The purpose of the rating scale is to record and systematize distinctions 
which may be observed in the behavior of patients and which may be used to distinguish 
between patients. These distinguishable qualities can be placed on continue to indi- 
cate increasing levels of pathology or severity of disorder. The arrangement of 
behavior qualities on such a continuum implies that a quality placed at any given 
level of severity is more pathologically significant in its deviance than a quality 
placed on the continuum at any lesser level of severity. The pertinence of such an 
arrangement or continuum of behavior rests upon the consensual acceptance of experts 
and is obviously dependent upon conventional concepts of pathological deviance. 
Some arrangements or gradients which reflect increasing severity of pathological 
deviation in our society may not be accepted as representing a gradient of deviation 
in all other societies. It is possible also that certain individuals within our 
society will challenge and perhaps reject an arrangement of items accepted by the 
majority as an indication of progressing deviance. 

Within any such a graded arrangement of behaviors, the distinctions between 
successive behavioral qualities or conditions represent no uniform quantity. Regard- 
less of their substance or format, behavior rating scales, like other measures of 
behavior, do not offer a standard, equal unit (and are not based on an absolute 
zero). Thus the increasing scores given to the successive rating scale positions 
represent only the direction of the difference and not successive magnitudes in 
any standard sense. 

In some instances, behavioral qualities have been conceived to range from one 
extreme through a point of indifference to some other extreme, e.g., from happiness 
through a point of indifference to sadness, extroversion to introversion, love to 
hate, honesty to dishonesty, etc. Unfortunately, human behavior seems not to 



212 



arrange itself according to the antonyms of the English language. In pathological 
states particularly, it is possible to observe extremes of happiness and sadness 
or love and hate concurrently, if not simultaneously, in the same individual. For 
this reason, in bipolar continua which range from one extreme to another, a given 
level of severity has no necessary implications for other levels of severity, i.e., 
a person might or might not be given an extreme position at both ends of the scale. 
As a consequence, most symptom rating scales are now restricted to a unipolar for- 
mat which begins with a point of indifference and proceeds in one direction through 
a series of graded observations or circumstances to some one pathological extreme. 

It must be acknowledged that rating scales which comprise an explicit arrange- 
ment of verifiable behavior qualities or events require specific information for 
their proper use. In addition, such scales place only minimal reliance on the rater's 
own judgment of the severity of the symptomatic quality in question. Accordingly, a 
set of rating scales, such as the WPRS, which relies on a graded series of verifiable 
behaviors, may not be preferred by raters who have no specific information about 
their patients. The use of the WPRS may be questioned also by raters who prefer to 
indicate their own estimates of the severity of the disorder and do not feel satisfied 
in expressing their evaluation in terms of a fixed series of graded qualities. For 
this reason, most professionals will appreciate an opportunity to supplement their 
standard objective ratings with a statement of their own estimate of the patient. 

E. The Model of Psychopathology 

Psychopathology can be assessed from the etiological, prognostic, dynamic, or 
descriptive standpoint. The WPRS is a strictly descriptive instrument. It 
represents no particular a priori dynamic or conceptual model. The separate scales 
comprising the set represent the symptomatic facets which occur commonly and are 
sensitive to the changing quality of psychopathology. These scales, each constructed 
to reflect increasing levels of severity, may be combined to provide cluster scores 
which represent the general severity of groups of interrelated symptoms. These 
groups of interrelated symptoms do not necessarily reflect a priori considerations. 
Instead, they indicate the natural symptom groupings which were found repeatedly by 
factor analyses of data from samples of patients in the northeastern portion of the 
United States. It is reassuring to find that these empirically determined groups of 
symptoms tend to reflect familiar syndromes and are reminiscent of the traditional 
descriptive concepts which have been in common usage since the days of Kraepelin. 

II. THE RATING SCALE FORMS 

The 1955 Form 

The form copyrighted by the Psychological Corporation in 1955 was generated in 
the course of a program of investigation initiated in 19^7. The symptom rating scales 
that this form comprises were based on interviews with New England psychiatrists, and 
the 52 items represent a consensual agreement concerning the tangible psychiatric 
symptoms which, at that time, were considered to be important in newly admitted mental 
hospital patients. This was a period prior to modern tranquilizers and one in which 
a primary emphasis was placed on the newly admitted patient. Accordingly, the 1955 
version includes florid symptomatic qualities which are not conspicuous in tranquil ized 
patients or in chronic patients. 



213 



The 196^ Form 

After 1955, patients appearing at psychiatric hospitals were usually to some 
degree tranqui 1 ized , and as a consequence florid unmodulated symptomatic manifesta- 
tions became unusual. In addition, the availability of tranquilizers generated a 
substantial research and therapeutic interest in chronic patients. (As a matter 
of fact, chronic patients appear to have been the subjects for most studies of the 
effects of tranquilizers.) In order to accomodate to this shift in interest, the 
original rating scales were extended and revised, and in 1964, a set of 72 symptom 
rating scales was made available. Many of these scales were included for the 
explicit purpose of revealing differences in and distinctions among chronic patients 
and other patients whose manifestations were somewhat subdued in consequence of 
tranqui 1 izat ion. In addition to the supplemental items, some of the original scales 
were deleted, and others were revised. The ]SGk form has been applied to several 
samples. Factor analyses of these data revealed distinctions in symptomatic patterns 
not apparent in the factor analyses of the untranqui 1 ized , newly admitted patients 
rated with the 1955 form. 

The 1964 form is more versatile than the 1955 form in the sense that, in addition 
to being descriptive of newly admitted patients, it reveals distinctions among chronic 
patients. It should be noted that the 1964 form attempts to place a minimal reliance 
on inferences of the rater. For example, there are no scales which rate the hallucina- 
tory experience per se, but there are several scales which rate observable response 
qualities that tend to accompany hallucinations. 

The short form provides scores for six major factors or symptom clusters: anxiety 
somatic-hysterical, obsessive-compulsive-phobic, depressive retardation, excitement, 
and paranoia. The scales which contribute to these respective cluster scores were 
selected on the basis of their appropriateness for outpatient use, their pertinence 
to the factor to which they contribute, and their proven sensitivity to changes 
accompanying treatment. 

III. DIRECTIONS FOR USE 

A. The Rating Procedure 

1. It is necessary that the observational period on which the 
ratings are based be scrupulously defined and that the 
limits of this observational period be recorded in the 
appropriate space on the face sheet. 

2. It is necessary that a rating be Indicated for ever y scale . 
If there is no information on which to base a rating, the 
initial or least severe level is the appropriate rating. 

3. The rating should always be the most pathological extreme 
observed during the rating period. Ratings should not be 
based on an average or general condition of the patient. 



214 



k. When informants are consulted as a basis for rating, the 
identity or the role of the informant should be recorded. 

5. Wherever possible, a diagnosis should be indicated in the 
appropriate space. Because of the episodic and variable 
nature of psychopathologica 1 manifestations, it is under- 
stood that the diagnosis of the patient and the symptoms 
which are rated as currently descriptive may not always be 
cons istent . 

B-. The Rater 

1. Familiarity with the rating scales is an important determiner 
of the speed and ease with which ratings may be made. The 
rater should anticipate that his initial experiences with the 
rating scales will seem tedious and time-consuming. 

2. Most professionally trained raters, particularly psychiatrists, 
psychologists, and social workers, will be able to use the 
rating scales without personal instruction. In a research team, 
where standardization can be critical, it is useful for beginners 
to review their initial ratings with other members of the group. 

3. Raters not professionally trained in psychopathology , e.g., 
occupational therapists, nursing personnel, or other ward 
personnel, should have at least their first six rating forms 
reviewed by a professionally trained person who shares their 
knowledge of the patient. Although the language of the scales 
is simple, it involves conceptual and terminological usages 
which may be unfamiliar to nonprofessional raters, or at best 
only partially understood by them. 

k. Almost any careful observer can be trained to make satisfactory 
ratings based on inpatient situations. Ordinarily, outpatient 
ratings should be provided only by professionally trained 
persons who are well acquainted with the patient. 

C. The Observational Setting 

Almost any standard observational setting can provide a useful basis for 
symptom ratings. For interpretive purposes, however, it is important that the 
observational setting be recorded on the face sheet of the form. 

The observational setting which provides the most useful ratings will depend 
upon the manner in which the setting is used and the purposes of the assessment. 
In general, the ratings of psychiatrists and psychologists show very slight 
average differences. The ratings of nurses tend to be consistently different from 
those of psychiatrists, particularly in the sense that nurses' ratings will con- 
tain fewer indications of affective or conceptual deviation, but will emphasize 
matters relevant to ward routine, particularly matters concerning the patient's 
cooperation and participation. 



215 



Ratings by different personnel will differ according to the observational 
basis for the rating. Thus, ratings of the same patient by two different raters 
should be expected to differ somewhat unless the two raters are observing at the 
same time. Accordingly, differences between raters describing the same patient 
have no necessary implications for either the validity or the reliability of the 
scales and may reflect differences in the behavior sample on which the ratings 
are based. 

Where a fully comprehensive description is imperative, independent ratings 
by the psychiatrist, the psychologist, and the nurse should be sought. Scale by 
scale the different ratings from these persons may then be reconciled and com- 
bined by selecting as most valid the one rating which shows the greatest pathologi- 
cal extreme. The appropriateness of this procedure is based on the assumption that 
the most pathological manifestation is the most pertinent basis for the rating and 
on the further assumption that an observation of an extreme pathological manifesta- 
tion is a valid basis for a descriptive rating regardless of whether the observa- 
tion was made by the nurse, the psychologist, or the psychiatrist. 



216 



028 CGI 
CLINICAL 
GLOBAL 
IMPRESSIONS 



CLINICAL GLOBAL IMPRESSIONS 

INSTRUCTIONS: Mark these items on General Scoring Sfieet coded 01. 

Complete Item 1 -severity of illness at the Initial and subsequent assessments. 
Items 2 and 3 may be omitted at the initial assessment by marking - "Not Assessed' 

Mark on the left half of the scoring sheet on rows 38-41. 



38: A: 


"1" 


zdizz 


:i: 


r:4:: 


39:A= 


::J" 


==2i: 


.-i3:: 


=:4i: 


40rAr 


::lr= 


:±: 


:J:: 


r:4r: 


41rrfcr 


z-Azz 


zziiz 


::3:r 


==«:: 


Cols: 1 


2 


3 


4 


5 



::^: 

z.Jzz :ra:r 
8 





ROW 
NO. 


CLINICAL GLOBAL IMPRESSIONS 








38 


1. SEVERITY OF ILLNESS 






B:: :: 
a:r " 


9:: 
9:i 
9ri 
9-- 




Considering your total clinical experience with this particular 
population, how mentally ill Is the patient at this time? 

= Not assessed 4 = Moderately ill 

1 = Normal, not at all ill 5 = Markedly ill 




9 70 




2 = Borderline mentally ill 6 = Severely ill 






_l 




3 = Mildly ill 7 " Among the most extremely 
ill patients 








THE NEXT TWO ITEMS MA Y BE OMITTED A T THE INITIAL 






ASSESSMENT BY MARKING "NOT ASSESSED" FOR BOTH ITEMS 






39 


2. GLOBAL IMPROVEMENT - Rate total improvement whether 
in your judgment. It is due entirely to drug treatment. 


or not. 








Compared to his condition at admission to the project, how much 
has he changed? 






= Not assessed 4 = No change 








1 = Very much improved 5 = Minimally worse 








2 = Much improved 6 = Much worse 








3 = Minimally improved 7 = Very much worse 








40 
& 


3. EFFICACY INDEX - Rate this item on the basis of DRUG EFFECT 
ONLY. 






41 


Select the terms which best describe the degrees of therapeutic 
effect and side effects and record the number in the box where 
the two items intersect. 








EXAMPLE: Therapeutic effect is rated as "Moderate" and side 
effects are judged "Do not significantly interfere with patient's 
functioning". Record 06 in rows 40 and 41 . 










SIDE EFFECTS 








= I 


c 
c 










THERAPEUTIC EFFECT 


o 

o 

Z 


1 ■$ 

— .CO 

0.2 c 

Lit 


e5.i S 


.1 & 

3i 






MARKED — Vast improvement. Complete 
or nearly complete remission of all 
symptoms 


01 


02 


03 


04 






MODERATE — Decided improvement. 
Partial remission of symptoms 


05 


06 


07 


08 






MINIMAL — Slight improvement which 
doesn't alter status of care of patient 


09 


10 


11 


12 






UNCHANGED OR WORSE 


13 


14 


15 


16 










Not Assessed = 00 













218 



Clinical Global Impressions (CGl), developed during the PRB collaborative 
schizophrenic stud ies , cons is ts of 3 global scales (items) formatted for use 
with the Genera] Scoring Sheet. Since the items are "universal", the CGI is 
included in both the Pediatric and Adult packets. Two of the items, Severity 
of Illness and Global Improvement, are rated on a 7-point scale; while the 
third. Efficacy Index, requires a rating of the interaction of therapeutic 
effectiveness and adverse reactions. 

APPLICABILITY For all research populations 

UTILIZATION For Severity of Illness: Once at pretreatment and 

at least one post-treatment assessment. Additional 
ratings are at the discretion of the investigator. 
For Global Improvement and Efficacy Index: No 
pretreatment (baseline) assessment is required. At 
least one post-treatment assessment should be made. 
Additional post-treatment ratings are at the discretion 
of the investigator. 

TIME SPAN RATED For Severity of Illness: Now or within the last week. 

For Global Improvement: Since admission to the study. 
For Efficacy Index: Now or within the last week. 

CARD FORMAT - ITEMS CARD 01 = (19x, 211, 12) 

I tern Col umn 

Severity of I 1 Iness 20 

Global Improvement 21 

Efficacy Index 22 - 23 

SPECIAL INSTRUCTIONS 

The contexts under which the 3 CGI items are to be rated have been modified to 
increase the reliability and precision of the items. Veteran ECDEU raters should be 
alert to these new contexts. 

I tern 1 - Severity of Illness - For this item, the modification for rating context is: 

OLD Considering your total clinical experience, 

how mentally ill is the patient at this time? 

Considering your total clinical experience with this particular 
NEW population, how mentally ill is the patient at this time? 

The old version asked the rater to judge the severity of illness of a given subject 
in the context of that rater's total experience with all types of patients; i.e., 
regardless of diagnosis, chronicity, age, etc. The present version restricts the 
judgment within the range of the specific population under study. Thus, an anxious 
neurotic subject is judged in the context of the rater's experience with anxious 



219 



neurotics - not, as was the case in the past - against a clinical background which 
may have included schizophrenics, brain damaged, and depressive subjects as well as 
anxious ones. 

J tern 2 - Global Improvement - The modification here involves the relationship between 
this item and Efficacy Index (item 3). In the past, no distinction between 
TOTAL clinical improvement and that portion of the TOTAL which, in the 
opinion of the rater, is the direct result of the drug administered. The 
present contexts are: 

Global Improvement 

GLOBAL IMPROVEMENT — Rate total improvement whether or not, 
in your judgment, it is due entirely to drufl treatment. 

Efficacy Index 

EFFICACY INDEX - Rate this Item on the basis of DRUG EFFECT 
ONLY. 

In many studies, of course, TOTAL improvement and improvement due to drug will be 
one and the same; nevertheless, the new contexts allow a distinction to be made 
when it is present. 

Raters are cautioned to observe the unique time span rated for Global Improvement, 
For most other ECDEU items, the time span to be rated is either a specified number of 
days or since the last rating. The time span for Global Improvement - at each and 
every rating - is "since admission to the project (study)" - NOT from the last rating 
period. 

Item 3 - Efficacy Index - In addition to the contextual modification mentioned above, 
the matrix of therapeutic vs. side effects has been changed as follows: 



THERAPEUTIC EFFECT 


SIDE EFFECTS 


m 
c 
O 
Z 


s .1 

o^ c 

III 


C 

"c 
o 

>-~ c 
■5= 5 3 

c « "^ 
a s M 

40 .5 Q 


8i 


MARKED — Vast improvement. Complete 
or nearly complete remission of all 
symptoms 


01 


02 


03 


04 


MODERATE - Decided improvement. 
Partial remission of symptoms 


05 


06 


07 


08 


MINIMAL — Slight improvement which 
doesn't alter status of care of patient 


09 


10 


11 


12 


UNCHANGED OR WORSE 


13 


14 


15 


16 


Not Assessed = 00 











220 



The new matrix has been made symmetrical (k x 4) by combining 2 therapeutic 
categories, "Unchanged" and "Worse" into one category. Category 4 of Side 
Effects has also been reworded. 

Efficacy Index is an attempt to relate therapeutic effects and side effects. 
Therapeutic effect is regarded as gross profit; side effects as cost. The Index, 
then, is analogous to net profit. The Index is derived by dividing therapeutic 
effect score by side effect score as follows: 

Side Effects 





Eff 


ect 














Therapeut ic 


None 

1 


No S ignif icant 
Interference 
2 


Significant 
Interference 
3 


Outweighs 
k 


k Marked 
3 Moderate 
2 Minimal 
1 Unchanged 


or 


Worse 


k . OOVr 
3.00 
2.00 
1.00 




2.00 
1.50 
1.00 

0.50 




1.33 
1.00 
0.67 
0.33 


1.00 
0.75 
0.50 
0.25 



Example: 



Therapeutic Score (4) 
Side Effect Score (1) 



= Efficacy Index (4.00) 



The transformation procedure for Efficacy Index (El) is; 
Number Encoded = Transformed Score = El 



01 
02 
03 
04 
05 
06 
07 
08 
09 
10 

11 

12 
13 
14 
15 
16 
00 



41 
42 
43 
44 

31 
32 
33 
34 
21 
22 
23 
24 

11 

12 
13 
14 
00 



4.00 
2.00 
1.33 
1.00 
3.00 
1.50 
1.00 
0.75 
2.00 
1 .00 
0.67 
0.50 
1 .00 
0.50 
0.33 
0.25 
0.00 



221 



Employing the cross tabulation scheme (page kjS) to interpret El, indices 
falling on the diagonal CB would indicate that the therapeutic and toxic effects 
of a treatment are equivalent. Those in the upper left quadrant would indicate 
some degree of "profit" - the profit increasing as pole A is approached. The 
converse is true of indices falling in the lower right quadrant and, in fact, 
in all of the last column. The treatment with the. greatest efficacy fills the 
cell at Pole A; the worst at Pole D. The cell at Pole C contains the "inert" 
treatment. Pole B represents a paradoxical and "theoretical" cell - not one 
likely to be encountered in the real world. 

DOCUMENTATION 

a. Raw score printout 

b. Means and standard deviations 

c. Frequencies and crosstabulat ions 

d. Variance analyses 



222 



029 DOTES 

DOSAGE RECORD AND 

TREATMENT EMERGENT 
SYMPTOM SCALE 



DOSAGE RECORD AND TREATMENT EMERGENT SYMPTOM SCALE 
I NSTR UCTIONS: Insert New General Scoring Sheet and Code 02 for Sheet Number 



Coding Dosage: Three rows are provided for the coding of the 
numeric value and one row for the multiplier 



Coding Symptom Judgments: The 3 judgments are coded 
on 2 rows as follows: 

INTENSITY RELATIONSHIP 



NUMERIC 
VALUE 



MULTIPLIER- 



■-O- "t" ■-■Z-- -^ 
«: ::«:: -.zZ.: ::S 



::S: 
"5: 



::e:: "T: 
r:S: ".T--- 
::e: --T.- 



None Remoie Possible Piobable Dcimeil 
:«: ::):: :*: -.:S:: ::*: INT-REL-J:: ::e: --T-: "ft: :■ 
::&: ::)- ::^: ::5:: ::4:: ACTION ::S: ::e:: ::T;: ::8: :: 



.001 



.1 



■ «•* 



The multiplier row designates the placement of the decimal point. 






INSTRUCTIONS 

TOTAL DAILY DOSE: To permit the coding of the widest range of 
dosages and, at the same time, minimize the number of "marks" required 
of the rater, the following 4— row schema has been constructed. 



Examples: 

2500 mg. = 250 X 10 

250mg. = 250x 1 

25mg. = 250x .1 

2.5mg. = 250x .01 

0.25 mg. = 250 x .001 



code 2505 
code 2504 
code 2503 
code 2502 
code 2501 



OR 



25 X 100 
25 x 10 
25 X 1 
25 X .1 
25 X .01 



code 0256 
code 0255 
code 0254 
code 0253 
code 0252 



CATALOGUE OF SYMPTOMS - For each symptom cited (present), three (3) 
judgments are required - intensity of the symptom, its relationship to the drug 
and the action undertaken as a consequence of its presence, 

1. INTENSITY - Generally, the levels of intensity are defined as follows: 

- Not Assessed - Mark this category when NO assessment (rating) of a 

specific symptom is made. Leave Relationship and Actions sections blank. 

1 - Not Present — Mark tjiis category if symptom is assessed and is found 

absent. 

2 ■ Mild - The symptom does not hinder the subject's normal functioning 

level, i.e., his level at pretreatment. An annoyance to the subject. 

3 " Moilerate — The symptom produces some degree of impairment to 

functioning but is not hazardous to health. Uncomfortable and/or 
embarrassing to the subject. 

4 - Severe - The symptom is a detmite hazard to well being. Significant 

impairment of functioning or incapacitation. 

b. RELATIONSHIP - A judgment of the degree of relationship between the 
occurrence of the symptom and the drug rated on a 5— point scale. 

5 " None - No relationship between symptom and drug 

6 -Remote - Less than a 10% probability that symptom occurrence is 
related to drug employed 

7 - Possible - Probability between 10% and 50% 

8 - Probable - Probability between 50% and 90% 

9 'Defined - Greater than 90% probability that symptom is related to 
drug employed 

c. ACTION TAKEN - Refers to action taken as a consequence of the symptom's 
appearance. Actions are arranged in order of increasing stringency. Only 
ONE action — the most stringent — should be recorded as it is assumed that 
less stringent actions may also be employed. 



ACTION CODE: ■= None 

1 = Increased Surveillance 

2 = Contraactive Rx 

3 " Change Dose 

224 



4 = Change Dose plus Contra- 
active Rx. 



5 = Suspend Rx 

6 = Discontinue Rx 



DOSAGE RECORD AND TREATMENT EMERGENT SYMPTOM SCALE 



Mark each item on right half of scoring sheet on row specified 



I AfiW 



REASON FOR COMPLETING SCALE On the DA Y recorded under 

PERIOD, dosage was: (Mark ONE only) 



0= Initialed (First Dose) 

1 = Changed per protocol 

2 = Changed due to ineffectiveness 

3 = Changed due to toxicity 

4 = Changed for titration (Test Dose) 

5 = Discontinued/suspended 

6 = Reinitiated following suspension 



7 = Changeover point of 

crossover design 

8 = Not changed but treatment 

emergent symptom/s 
occurred 

9 = Regular (fixed) TESS 

assessment 



2. TOTAL DAILY DOSE 

a. Component (Use lor all single component drugs) . 

b. Component (For combination drugs only) . 



FOR STUDIES IIV WHICH RECORDING "TOTAL DAILY DOSE" IS 
INAPPROPRIATE, E.G., LONG-ACTING DRUGS. DEPOT DRUGS. 
VERY SHORT-ACTING DRUGS. ETC, enter amount of drug in 2 a (b) 
and mark the length of time and time units over which the drug is pre 
sumed to be effective. (See Manual for instructions) 

Drug is presumed to be effective for (Code number) .... 

Time Unit: 1 = Hours 3 = Weeks (Code one) 

2 = Days 4 = Months 



PRESCRIPTION 



Dosage is 
to be given: 



Mark 2 responses — one for prescription 

(No. through 6) and one for proportions (No. 7 or 8) 



1 =qd 


2 = bid 


3 = tid 4 = qid 


6 = depot 


7 = equal 


8 = unequal proportions 



TREATMENT EMERGENT SYMPTOMS At the previous dosage level (or 
since the last assessment), were any significant physical signs, laboratory 
findings or symptoms present? (For initial assessment, record presence or 
absence at symptoms tor that day only) Mark one: 

= NO (II NO. and ALL SYMPTOMS WERE ASSESSED, no further 

responses necessary) 

1 = YES, printed symptoms present but no "write-ins" 

2 = YES, both printed and "write-in" symptoms present 

3 = YES, only "write-ins" present. (Do not forget to complete Item 6 

before proceeding to TWIS. TESS Write-In Scale) 



CATALOGUE OF SYMPTOMS 
Behavioral Toxicity: 



(See Instructions on page R — 4) 
Toxic confusional state . 
Excitement/agitation 
Depressive affect 
Increased motor activity 
Decreased motor activity 

Insomnia 

Drowsiness .... 

Abnormal Laboratory Findings: Abnormal hematologic . 
Abnormal liver 
Abnormal urine . 

Neurologic: Rigidity 

Tremor 

Dystonic symptoms . 



ROW 
NO 



5-6 
7-8 
9-10 
11-12 
13-14 
15-16 
17-18 
19-20 
21-22 
23-24 
25-26 
27-28 
29-30 
31-32 
33-34 
35-36 
37-38 
39-40 



Mark each item on left half of sheet on row specified 
5. CATALOGUE OF SYMPTOMS (Continued) 

Neurologic: Akathisia 

. Autonomic: Dry Mouth 

Nasal Congestion 

Blurred Vision 

Constipation 

Increased Salivation 

Sweating 

Nausea/Vomiting 

Diarrhea 

Cardiovascular: Hypotension 

Syncope/Dizziness 

Tachycardia 

Hypertension 

EKG Abnormality 

Other: Dermatologic 

Weight Gain 

Weight Loss 

Anorexia/Decreased Appetite 

Headache 

Tardive Dyskinesia 



GLOBAL JUDGMENTS (Omit at Pretreatment) 

u. Compared to other subjects in this study, how serious 

have his/her treatment emergent symptoms been? 

= Not at all 

1 = Minimal 

2 = Moderate 

3 = Marked 

4 = Not Ascertained 



Compared to other subjects in this study, how much 
distress has this subject expressed or attributed 
to his symptoms? 

5 = Not at all 
6= Minimal 

7 = Moderate 

8 = Marked 

9 = Not Ascertained 



225 



The Dosage Record and Treatment Emergent Symptom Scales (DOTES) is a 4l-item 
scale formatted for use with the General Scoring Sheet. Processing experience 
with the separate Dosage Record (DR) and Treatment Emergent Symptoms Scale (TESS) 
revealed that subsequent collation of the data was frequently fraught with errors. 
By combining the two scales, the rater is spared the tedium of redundant coding; 
and, more importantly, the emergent symptoms can be related to a specific dosage. 
Further, the combined scale is designed to capture judgments on the relationship 
of a symptom to the drug and the action undertaken as well as the intensity of 
that symptom. These three judgments - linked to a specific dosage - allow for a 
more precise documentation of the adverse event. DOTES supersedes both 02-DR 
Dosage Record and 03-TESS Treatment Emergent Symptom Scale. The scale is contained 
in both the Children's and Adults' Psychiatrist Packets. 



APPLICABILITY 
UTILIZATION 



Al 1 populat ions 

Completed for every dosage change. A pretreatment 
and terminal DOTES should always be completed. 



ITEM FORMAT 

CARD 01 (19x, II, 2\k, 13, 3H, 1313, 12) - Each symptom requires a 3-column 
field. 1st column - Intensity; 2nd column = Relationship; 
3rd column = Action. 



tem 



Column 



I tem 



Col umn 



1 


20 


2a 


21 - 2k 


2b 


25-28 


2c 


29 - 31 


3a 


32 


3b 


33 


k 


3k 


5 Toxic 


35 - 37 


Exc i te. 


38 - ko 


Depress . 


41 - 43 


1 nc. Motor 


44 - 46 


CARD 02 


(19x, 11, 1813, 11) 


Item 


Column 


Akath (Action) 20 


Mouth 


21 - 23 


Nasal 


24 - 26 


Bl.Vis. 


27 - 29 


Const ip . 


30 - 32 


Inc. Sal . 


33 - 35 


Sweating 


36 - 38 


Nausea 


39 - 41 



Dec .motor 
I nsom. 
Drows i , 
Abn.hemat , 
Abn .1 i ver 
Abn.ur ine 
Rigid 
Tremor 
Dyston, 



I tem 

Diarrhea 

Hypoten. 

Syncope 

Tachycard . 

Hyperten . 

EKG 

Dermat . 

Wt.GaIn 

Wt.Loss 

Anorexia 

Headache 

Tard ive ( I ntens i ty) 



47 
50 
53 
56 



49 
52 
55 
58 



59 - 61 
62 - 64 
65 - 67 
68 - 70 
71 - 73 



Akath. (Intens/Rel) 74 - 75 



Col umn 



42 
45 
48 
51 



44 
47 
50 
53 



54 - 56 
57 - 59 
60 - 62 
63 - 65 
66 - 68 
69 - 71 
72 - 74 
75 



226 



CARD 03 


(19x, 12, 211 


1 tern 


Col umn 


Tardive (Rel/Action) 


20 - 21 


6a Severity 


22 


6b Distress 


23 



FACTOR FORMAT - CARD 51 = (19x, 7F6.2, f4.0) 

Code "5" in Column 18 indicates factor, cluster or other derived scores. 

Factor 



I I 

I I I 

IV 



Col umn 
20 - 25 
26-31 
32 - 37 
38 - 43 



Factor 


Col 


umn 


V 


kk 


- kS 


VI 


50 


- 55 


VI 1 


56 


- 61 


Total Score 


62 


- 65 



Total Score = Sum of all symptoms (including TWIS) 

FACTOR COMPOSITION 

Six factors have been derived from a 197^ BLIPS analysis of 1963 pretreatment 
TESS records. (Table 12). A seventh "factor" - actually an empirical cluster - 
is composed of the 3 Abnormal Laboratory Findings. 



I. Anti-chol inergic (ANT) 
Drows i ness 
Nasal Congestion 
Dry Mouth 
Blurred Vision 

II. Central Nervous System (CNS) 
Rigidi ty 
Tremor 
Dys tonic 
Akathis ia 
Increased Salivation 

III. Neurotic (NEU) 

I nsomn ia 
Depress ion 
Const ipat ion 
Headache 
Weight Loss 

IV. Autonomic Nervous System (ANS) 
Hypotens ion 
Syncope/D i zz i ness* 
Tachycardia 
Nausea/Vomiting 
Diarrhea 



V, 



VI 



Mi seel laneous 
Derma to log ic 
Weight Gain 



(MIS) 



(DEL) 



Del i r ium 
Exc i tement 
Toxic Conf us ion 

VII. Abnormal Laboratory Findings (LAB) 
Abnormal Hematologic 
Abnormal Liver 
Abnormal Urine 

Symptoms not included in any factor 

Increased motor activity 
Decreased motor activity 
Sweat ing 
EKG Abnormal i ty 
Anorexia/Decreased Appetite 
Tardive Dyskinesia 



Dizziness now combined with syncope 



227 



TABLE 12 
6-FACTOR VARIMAX SOLUTION OF PRETREATMENT TESS 

SCORES OF 1963 SCHIZOPHRENIC SUBJECTS ( Guy and Cleary) 



tern 



I I 



I I I 



Insomn ia 


-on 


032 


-685 


Drows iness 


-482 


018 


-031 


Exc i tement 


-134 


045 


-040 


Depress ion 


007 


-040 


-733 


Toxic Confusion 


038 


059 


-107 


Rig id i ty 


-062 


660 


059 


Tremor 


-171 


574 


-121 


Dystonia 


162 


578 


073 


Akathis ia 


-019 


708 


-030 


Hypotens ion 


059 


187 


098 


Syncope 


-021 


005 


-029 


Tachycard ia 


-234 


005 


-220 


Nasal Congestion 


-713 


014 


083 


Dry Mouth 


-629 


196 


-251 


1 ncr . Sal ivat ion 


-217 


328 


128 


Blurred Vision 


-612 


089 


-105 


Nausea 


-261 


-102 


-095 


Diarrhea 


-129 


-059 


-145 


Constipation 


-307 


172 


-'?17 


Derma t it is 


-060 


-078 


047 


Headache 


-187 


-116 


-467 


Dizziness 


-282 


-022 


-454 


Wt. Gain 


065 


070 


-138 


Wt. Loss 


010 


-088 


-498 



1.99 l.i 



IV 

-094 

-025 

-100 

-201 

036 

143 

049 

-191 

-003 

-556 

-653 

-530 

-072 

-073 

-109 

-199 

-358 

-470 

060 

054 

-295 

-278 

035 

100 



V 

106 
-092 

-100 

073 
-007 
-039 
-075 

124 

-035 

-050 

-015 

-076 

081 

007 

182 

-012 

164 

■059 

090 

743 

178 

-018 

521 

-216 



VI 

242 

171 

528 

123 

612 

033 

118 

002 

-099 

-304 

041 

040 

055 

-123 

206 

-008 

092 

189 

-301 

-058 

327 

279 

-036 

-301 



2J9 '-73 1.05 1.35 



Percent Total Variance 
Percent Common Variance 



19.5 
8.3 



18.4 
7.8 



21.5 
9.1 



16.9 
7.2 



10.3 
4.4 



13.2 
5.6 



Communa 1 i t ies 

549 
272 
320 
600 
392 
466 
395 
418 
514 
452 
430 
391 
530 
517 
259 
434 
251 
301 
493 
570 
493 
442 
302 
402 

10.19 

42.5 



228 



SPECIAL INSTRUCTIONS 

DOTES is the most difficult form to encode since the data are not as "fixed in 
time" as are efficacy measures. The advent of side effects and the need for dosage 
manipulations are much more idiosyncratic and not readily scheduled in a pre-determined 
protocol. Raters should, therefore, pay particular attention to the following instruc- 
t ions . 

PERIOD - Whenever feasible, encode period in days since it will permit the more 
precise delineation of effects. 

I tern 1. Reason for completing scale - Preferably DOTES should be completed for 
each dosage change and/or occurrence of treatment emergent symptoms. 
The first 6 response positions are related directly to changes in dosage; 
while the last three (7, 8, 9) are to be employed for unique situations. 
Only one response is permitted for each DOTES. 

1. "Per protocol" refers to all planned dosage changes established 
prior to the study. The final (terminal) dose should be encoded 
under "Per Protocol" and Total Daily Dose encoded as "0000". 

2. Ineffectiveness - includes instances of increased psychopathology 
(worsening) as well as instances where psychopatholog ical condition 
is unchanged, unimproved or static. 

3. Toxicity - refers to changes which in the judgment of the clinician 
are the result of an untoward effect of the medication; i.e., to be 
distinguished from ineffectiveness (2). 

h. Titration - refers to changes which are made to enhance therapeutic 
response in the individual subject; i.e., "test doses". 

5. Discontinued/suspended - refers to unplanned interruptions in dosage 
schedule. Encode "5" here and "0000" for Total Daily Dose. 

6. Reinitiated - use this category when restarting medication following 
suspens ions . (5) 

7. "Changeover point" refers to planned switches of medication and is 
for use only in crossover designs. Encode the dosage of the new 
medication as usual. 

8. "Not changed but treatment emergent symptom/s occurred" - Although 
the dosage is unchanged from previous one, it should nevertheless be 
encoded again rather than left blank. 

9. "Regular TESS assessment" - Enter dosage whether or not the regular 
TESS assessment coincides with an actual dosage change. "Regular 
TESS assessment" refers to the use of the scale independent of dosage 
change, i.e., using the DOTES in the manner of the original TESS, e.g., 
fixed periods of assessment which are scheduled prior to the start of 
the study. 



229 



I tern II. Total Daily Dose - DOTES' time perspective requires the rater to be like 
Janus - looking simultaneously in two directions, forward for dosage; 
backward for symptoms. The dosage which he encodes is the dosage which 
he is going to give - not the dosage which has been given. Conversely, 
the symptoms which he cites have occurred under the previous dosage - not 
the one actually encoded on the form. 

Example: For the first 6 days of the study, the patient received a total 

daily dose of 100 mg. of drug. On Day 007 - on which the patient 
is still receiving 100 mg - the physician increases the dosage to 
150 mg and records this new dosage on DOTES. He then encodes 
nasal congestion and headache - two symptoms which have occurred 
under the old (100 mg) dosage. 

To permit the coding of the widest range of dosages and, at the same time, minimize 
the number of "marks" required of the rater, the following U-row schema has been con- 
structed. Three rows are provided for the coding of the numeric value and one row for 
the mul t ipl ier . 



NUMERIC 
VALUE 



MULTIPLIER- 



r:0:r --.y.-. -.^--. ::5:: --A^- -.-S^-. ::&= --T-- -R: -»: 

:«:: -.--t-- --Z-: :;5: "*: -S^- "6= -7^= "»= "-»- 

-..(f-. z-.i-.- zzZ--. -z^z -z^z "5: r;e= -7^: "B- --»- 

::0^: ril" :i2:: "Jr "4:: ;:5:: i.e: :;?; ::»: "S- 

.001 .01 .1 1 10 100 1000 

The multiplier row designates the placement of the decimal point 



1 = .001; 2 = .01; 3 = . 1 ; ^ = 1 ; 5 = 10; 6 = 100; 7 = 1000, 

Examples : 

1. To enter 1750 mg; translate as 175 x 10 
Encode 1 755 



zzOiz -*■ ..3zz :r3:i :=*: 

necr III:: zzizz zzSzz i:it: 

r:et: ::!:: ::2:: ::*:: ::4:: 

zzQzz ::!:: lit: ::3:: ::4:: 



zi: ::6:: ::7:: -Szz :*: 

zSzz ::&: -«■ :*: ==9:: 

■ft. ::6:: :i7:: :*: :*: 

.4. zifc: "7:: =*= =*= 



To enter 175 mg; translate as 175 x 1 
Encode 175^ 



:2:: ::3:: -zizz ::*: -zftzz z.r-z ::8:: zz-n 

z2:: zzSzz ::d:: zzSiz "fc: «*» "S:: ::* 

i2:: :*: ::4:: -^ ~fc: -?=: -8:: I* 

:2:: ::3:: "^ "*: ::6:= "?:: -*= "* 



3. To enter 17.5 mg; translate as 175 x .1 



Encode 1753 














■rt: -i^ lit: 


::3:: 


:i(ti 


::5:: 


lit: 


iiJ:i 


:i8:i ::! 


ifci ::!:: i:2:i 


::!: 


::d:: 


::5:i 


::t: 


«A> 


i:8:: ::! 


iiari III:: .z3zz 


::3:: 


iufci 


mim 


lit: 


i:3!:: 


::&: ::! 


iitti ::!:: ::2:: 


1,^ 


::*: 


::5:: 


i:fci 


::S: 


::&: ::! 



230 



To enter 1.75 mg; translate as 175 x .01 
Encode 1752 



-ft: m*^ iii: rri: ::*: 

■.dO-.z -.zUz -..3zz z-2zT zzA.z 

-.dOzz zzUz ;:2" :J:: r^i:; 

'.Az "1" .^b> rJ:: :^:: 



:5:= :rt: "f:: iifti ::*; 

:5:: ::&: — JU ::8t: ::»:: 

■te ;:t: r:S: "ft: ::ft:: 

:5:: ::fc: r:?:: ::&: ::»:: 



ALL FOUR ROWS MUST CONTAIN AN ENTRY. Blanks are not permitted and 
will he "read" by the computer as missing data. Therefore, all lead- 
ing and following zeros must be marked. For 1 mg . , code 0014, 
NOT \k; for 100 mg . , code 1004, NOT 1 4. 

For single drugs, i.e., drugs with one chemical component, com- 
plete I tern l|a only. For combination drugs, encode Component A in Ma 
and Component B in Mb. Even if the dosage for only one component of 
the combination is being changed, encode BOTH the "changed" and 
"unchanged" components. In a given study, always encode the components 
in a consistent fashion, i.e., A in l|a, B in Mb. 

Item lie. The sole purpose of this i.tem is to record dosage regimes which can not 

be adequately described by Total Daily Dose. In all other circumstances, 
it should be left blank. 

Examples: A depot drug is presumed to be effective for 2 weeks. 
The investigator plans to administer an initial dose 
of 50 mg . He encodes as follows: 

I. REASON FOR COMPLETING SCALE (0 = initiated) 

Row 1 ^M. ::J:: z:Sr.z ::3:: :=«:: zzSzz :*: zzT-z :*: :*: 



I I 



TOTAL DAILY DOSE 
a. Component 



(50 mg) 



J3*^ ==t 


:: ::fc: 


13:: 


:*: 


zzSzz 


:*: 


::?;: 


:*: 


::» 


y-:Ozz ::t 


:: :«:: 


:a:r 


:*: 


«i« 


:*: 


::7t: 


=*: 


==» 


A-^ =^i 


:: :4:: 


:i= 


:34:: 


:*-- 


::&: 


::?:: 


:*: 


::» 


5--^-- ----t 


:: :«:: 


:*: 


mtm 


l*= 


:*: 


::T:: 


:*: 


--9: 



b. Component Rows 6-9 omitted; i.e., left blank. 

c. Drug is presumed to be effective for: (2 weeks) 



10«*« = 


t-z :«:: 


:*= 


:34:: 


:*: 


r*: 


::7:: 


:* 


!!:«:: : 


t~ ««>. 


:*: 


:a):: 


:*: 


:*: 


zzT-z 


;* 



1 = hours; 2 = days; 3 = weeks; k = months 

]2:«:= ::(:: :*: mtm :*: :*: :*: ::7i: ::&: rrft: 



231 



At the end of 2 weeks, the investigator plans to administer another 50 mg 
dose. He encodes as follows: 

I. REASON (Marked as "1" - changed per protocol) 

Row 1:0:: »4-> :«:: "i: :*: ::*:: :&: "Tr: :*: --:S:-- 

I . TOTAL DAILY DOSE (50 mg) 

a. Component 

:5--: :*r ::7:: i:&-- :A: 

^4~ --:&. -iT--- zdB:-. -A. 

ri: ::&: :.7:: ::ft: ::9t: 

5:0:i .-:tr: :«:= *! -•• :i= ::&: "7:: ::a: ::9:: 

b. Component - Rows 6-9 omitted; i.e., left blank 

c. Drug is presumed to be effective: (2 weeks) 



2«e» ---.t 


-.-. zSr-. 


i3" 


r* 


3-iy-- ----t 


z: :2:: 


:3:: 


:* 


4>«« ----t 


:- zrZ--. 


:3-: 


=* 



10>«<^ :=l 


(II zztzz 


zzSzz 


ZTtzZ 


II&I 


II&I 


iiTii 


1*1 


lift 


11 :0" :=l 


t:: ^m 


zzSzz 


lAi 


-ii 


I*: 


:i7ii 


1*1 


:*: 



1 = hours; 2 = days; 3 = weeks; 4 = months 

12 lO:: lit:: iS" ■•» -Az- llfrl i*! ii7:i :*: iifti 

NOTE - For double-blind studies in which the rater is unaware of the actual dosage 
administered, the number of capsules or other units may be encoded rather than dosage, 
Later, when the data are processed, actual dosages can be calculated via computer. 

Example: In a double-blind trial, the rater does not know the actual 
dosage contained in identical capsules (one capsule contains 
100 mg of Investigational Drug; the other capsule contains 
10 mg of Control Drug). The rater changes dosage by adding 
or subtracting the number of capsules given per day. To en- 
code this information, he encodes the number of capsules in 
the 3~digit field for numeric value and encodes "8" in the 
multiplier. This will signal the computer that number of cap- 
sules - not dosage - has been encoded, 

III. Prescription - ERRATA: The phrase within the parentheses following the word 
"prescription" should read "(No. through 6)" NOT (No. 1 through 6). This 
item requires 2 responses - one for prescription (0-6) and one for proportions 
(7 and 8). 

Example: The total daily dose of 300 mg is to be given "tid" in 
equal proportions of 100 mg . each. Code as follows: 

13 ;:6ll iijil llji ^ =l4i: -&z II&I mJm iiftr nil 



232 



IV 



"Depot", which refers to a drug contained in a vehicle allowing for slow release 
and long action, should always be coded as equal proportions. Similarly, QD, HS 
and PRN are coded as equal proportions. 

Example: The drug is prescribed "Q,D". Encode "1"AND. "7" 

13 -.-.£t-. >^ z.i: -.-.a.-. ..*:. .&. -.-M-. .A. -.-.&z irSki 

Presence/absence of symptoms - Since symptoms other than those printed on the 
scale can occur and should be recorded, a separate "write-in" form has been 
provided (033-TWIS). on DOTES, three "YES" positions are necessary as signals 
to instruct the computer in its search for data. In the case where only write- 
in symptoms are present, encode response 3 - leave all the catalogue of symptoms 
blank (Item 5) - but be sure to answer Item 6, Global Judgments. 



Catalogue of Symptoms - Originally it was thought desirable to have raters encode 
some response for each and every symptom whether present or absent. Whatever the 
merits of insisting on positive responses, the notion has been troublesome for 
raters - as reflected in the high incidence of errors. Therefore, raters need 
ENCODE ONLY THOSE SYMPTOMS PRESENT OR NOT ASSESSED. Leave the rest of the cata- 
logue blank. Be extra careful, however, that you are encoding data on the 
appropriate rows. 

The rater should endeavor to make an assessment of all symptoms printed on 
the scale as well as an inquiry into the occurrence of any other "non-printed" 
symptoms. The extent to which symptoms may be monitored is - in part - dependent 
upon the setting of the study, the sources of observation and the capacity of the 
subject to report their occurrence. In making judgments, it is suggested that the 
rater make use of all available sources of information, (nurses' observations, 
family comments, subject's complaints, etc.) Whenever possible, objective verifica- 
tion of the symptom should be attempted. General questions such as "How have you 
been feeling physically?"; "How does the drug make you feel?" may be utilized to 
elicit the occurrence of symptoms which are not directly observable or which have 
not been brought to light from other sources. 

NOTE - Raters may find it helpful to duplicate the "Instructions - Catalogue 
of Symptoms" on page R-10 and paste copies on the backs of pages L-3 and 
R-ll where they will be more accessible during rating. 

For each symptom cited (present), three (3) judgments are required - 
intensity of the symptom, its relationship to the drug and the action under- 
taken as a consequence of its presence. The 3 judgments are coded on 2 rows 
as fol lows : 

Coding Symptom Judgments: The 3 judgments are coded 
on 2 rows as follows: 



RELATIONSHIP 



NOT ' 

AS NOT MODER- 

SESED PRESENT MILD ATE SEVERE NoiM Remote Possible Ptobabic Ocfiix 

■-:0:-. --i" :*: :*: ::4::INT-REL::S:: ::S: -Ji: :*: ::»: 

:*= "i.. ::2:r :i3:: i:*: ACTION r:*: ::«:: ::Jt: --»- -»- 



233 





Intens i ty 


35:©: 


::J" 2 >^ ::*= 


36:*: 


::J7= mOm. ..3o-. ..4:. 




Action Taken 



On the row labeled INT-REL, the rater makes a judgment of intensity - 
using response positions through <!+ and a judgment of relationship - 
using 5 through 9. On the row labeled ACTION, the rater records the 
action (if any) undertaken - using through 6. 

Example: The symptom "Rigidity" emerges and the rater judges 
it to be moderate in intensity and probably related 
to the drug employed. She prescribes an ant iparkinson 
drug. Encoding is as follows: 

Relationship 

::5:: "fc: "3:z mm^m. r^St: 
-zi-. -.-M-. -zj-.z ::8:: ;:»:: 



a. Intensity - Precise definition of the levels of intensity is complicated. 
Many symptoms are subjective; i.e., not directly observable; and, further, 
no established standards exist for rating intensity. (See NOTE below). 
Generally, however, the 3 levels may be defined as: 

2 = Mild the symptom does not hinder the subject's normal 

functioning level, i.e., his level at pretreatment . 
An annoyance to the subject. Evidence for the 
presence of the symptom may be equivocal or based 
entirely on subjective report. 

3 = Moderate - the symptom produces some degree of impairment to 

functioning but is not a hazard to life. Uncomfortable 
and/or embarrassing to the subject. Evidence for the 
presence of the symptom is clear-cut, i.e., directly 
observable and/or deduced from the subject's behavior. 
k = Severe Symptom is a definite hazard to well being. 

Significant impairment of functioning or incapacitation. 
Again, evidence is clearcut. 

Intensity should be rated independently without regard to its relationship 
to drug. Since there is a high degree of correlation between intensity 
and the action undertaken as a consequence of a symptom, however, raters 
may find that they differentiate intensity levels partially on the basis 
of act ion. 

b. Relationship - a judgment of the degree of relationship between the 
occurrence of the symptom and the drug rated on a 5-point scale. 

5 = None - no relationship. 

6 = Remote - less than a 10% probability that symptom 

occurrence is related tp drug employed. 

7 = Possible - probability between 10% and 50%. 

8 - Probable - probability between 50% and 90%. 

9 = Defined - greater than 90% probability that symptom 

occurrence is related to drug employed. 



23^ 



c. Action Taken - refers to action taken as a consequence of the 

symptom's appearance. Actions are arranged in order of increasing 
stringency. Only ONE action - the most stringent - should be 
recorded as it is assumed that less stringent actions may also 
be employed. 

= None - no action is taken; the symptom is simply cited 

as present by the investigator. 

1 = Increased surveillance . - Increased alertness over and 

above routine observation is required by the professional 
staff, the subject's relatives and/or the subject himself. 

2 = Contraactive Rx - Remedial medication or treatment is pre- 

scribed. Include all medications and treatments which, in 
the opinion of the physician, are administered in response 
to the presence of an adverse react ion/s. 

3 = Change dose - Any non-protocol change (increase or decrease) 

ordered as a consequence of adverse react ion/s. 

4 = Change plus Contraactive Rx - A combination of actions 2 and 

3 undertaken simultaneously. 

5 = Suspend Rx - Cessation of treatment for a period of time as 

a consequence of an adverse reaction. Be sure to encode 
response 6 (item 1) when reinitiating medication. 

6 = Discontinue Rx - A decision to stop medication completely 

as a consequence of adverse reaction/s. Do not rate the 
termination of treatment as planned in the protocol here. 
Such "planned" termination is considered "Per Protocol'.'. 

Item Vi. a. Global Severity. An overall judgment - similar to the widely used 

efficacy judgment - of the extent to which treatment emergent symptoms 

have affected the subject in comparison to all other subjects in the 
study. Omit the item at the pre-treatment rating. 

b. Degree of distress. An overall judgment of the subject's degree of 
distress attributed by him to "adverse reactions" in comparison to 
all other subjects in the study. The subject's degree of distress is 
judged here - not the accuracy of his attributions. Omit the item at 
pretreatment . 

NOTE ON DEFINING INTENSITY 

In the near future, it is planned to distribute a questionnaire among ECDEU 
participants in an attempt to derive objective standards for the rating of intensity 
levels of treatment emergent symptoms. This technique has been successful in the 
past in obtaining consensual definitions - the new DOTES itself being a prime example, 
In the interim, the following list of definitions is presented as guidelines for rat- 
ing the intensity of symptoms in adults. The sources for these definitions are: 

1. Vinai-, 0., Scale for Rating Side Effects during Psychiatric 
Psychopharmacology, Activ. Nerv. Super. 8, k, 411-412, I966. 

2. Schiele, B., Parkinson's Disease Rating Scale 

3. McGlashan, T., Personal Communication 



235 



CATALOGUE OF SYMPTOMS 

1. Toxic Confusional State (Vinar) 

Moderate - Transitory toxic confusion during night 
Severe - Toxic confusion lasting during daytime 

2. Excitement/Agitation (McGlashan) 

Mild - Expressed fear and anxiety 

Moderate - Expressed fear and anxiety and frequent - but not constant - 

agitated motor movements 
Severe - Expressed fear and anxiety with constant agitated motor 

movements; e.g., pacing, wringing of hands, etc. 

3. Depress ive Affect (McGlashan) 

Mild - Complains of depressed mood when questioned 

Moderate - Volunteers feelings of depression and hopelessness. Cries easily. 

Severe - Mimics full blown depressive episode with psychomotor retardation, etc. 

k. Increased Motor Activity (McGlashan) 

Mild - Increased - but not constant - activity which can be self controlled 
Moderate - Constant activity but no external controls needed 
Severe - Constant activity; external controls needed 

5. Insomnia (McGlashan) 

Mild - Loss of 2 hours from regular sleep pattern 
Moderate - Loss of 3 - 6 hours 
Severe - Loss of more than 6 hours 

6. Drowsiness (McGlashan) 

Mild - Dozing or sleeping the equivalent of 2 hours during daytime 

Moderate - The equivalent of 2 - 8 hours/day 

Severe - More than 8 hours; asleep most of the time but not comatose 

7. Liver Functions (Vinar) 

Moderate - Changes in the liver tests 
Severe - Jaundice 



236 



8. Rigidity (Schiele) 

Mild - Detectable rigidity in neck and shoulders. Activation phenomenon 

is present. One or both arms show mild, negative, resting rigidity, 

Moderate - Moderate rigidity in neck and shoulders. Resting rigidity is 
positive when patient not on medication. 

Severe - Severe rigidity in neck and shoulders. Resting rigidity cannot be 
reversed by medication. 

9a. Tremor (Schiele) 



Mild 

Moderate 
Severe 

9b. Tremor 



11 



- Less than one inch of peak-to-peak tremor movement observed in 
limbs or head at rest or in either hand while walking or during 
finger to nose testing. 

- Maximum tremor envelope f a.i 1 s to exceed k inches. Tremor is 
severe but not constant and patient retains some control of , hands . 

- Tremor envelope exceeds k inches. Tremor is constant and severe. 
Patient cannot get free of tremor while awake unless it is a pure 
cerebellar type. Writing and feeding himself are impossiible. 

(Vinar) 



Mild - A feeling of inner tremble or tremor, which is not objectively 

visible, unless a little when the arms are stretched in front 

of the body and the eyes are closed. 
Moderate - Clear, objectively visible tremor, not preventing the patient 

from work (not even a fine work or writing) 
Severe - Greater tremor, preventing the patient from precise manual work. 

Big tremor, the patient cannot even eat. 

10. Dystonic Symptoms (McGlashan) 

Mild - Rigidity without impaired mobility 

Moderate - Interferes with mobility but not incapacitating 

Severe - Incapacitated (motoric mobility) 

Akathisia (Vinar) 



Mild - Subjectively felt "inner agitation", lack of patience; the 
patient resists it. 

Moderate - Lack of patience makes the patient stand up during conversation; 
when working, he stands up now and then and walks a little. The 
conversation, however, is not interrupted and the work is finished 
in due time. 

Severe - The patient cannot keep sitting even when consulting the doctor, 

must walk along the room; his rate of work is substantially reduced, 
cannot read even one page of a book without break. Impatience and 
agitation prevent the. patient completely from any useful activity; 
he must be walking continuously, cannot master himself. 



237 



12. Dry Mouth (Vinar) 

Mild Mucuous membranes are dry; the patient complains of it. 
Modt.-ate or Mucuous membranes are so dry that it can be seen by the 
Severe observer clearly. 

13. Nasal Congestion (Vinar) 

Mild Feeling of stopped-up nose - or a very disagreeable feeling 

of completely dry membrane in the nose. 
Moderate or A stopped-up nose - it may be observed and proved (as the 
Severe patient speaks, etc.) 

]k. Blurred Vision (McGlashan) 

Mild Complaints of blurriness but little if any sensory impairment 

Moderate - Interferes with acuity 

Severe Interferes with acuity and motor movements, e.g., bumps into things 

15. Constipation (Vinar) 

Mild Constipation for more than 36 hours 
Moderate - Constipation for more than k days 
Severe The patient needs to be given clysma 

16. Increased Salivation (Vinar) 

Moderate - More saliva, the patient manages to swallow it. 
Severe - Sal iva flows out of the mouth. 

'7- Sweating (Vinar) 

Mild or He sweats more than usually or in fits 

Moderate 

Severe Facies oleosa 

18. Nausea/Vomiting (Vinar) 

Moderate - Nausea 
Severe - Vomiting 

19. Diarrhea (McG«1ashan) 

Mild Two loose bowel movements per day 
Moderate - 5 loose bowel movements/day 
Severe - Over 5/day 



238 



20. Hypotension (Vinar) 

Mild Blood pressure one tenth lower than before treatment 
Moderate - Blood pressure two tenths lower 
Severe - Blood pressure scarcely measurable 

Note: This evaluation does not refer to subjective troubles 
that may be in connection with hypotension. There is 
only the question of objectively measured values of 
blood pressure with mobile patients in sitting and 
immobile patients in lying. 

21 . Syncope/Dizz iness (McGlashan) 

Mild Transient feelings of dizziness either standing or sitting 

with no interference with equilibrium. 
Moderate - Dizziness with disequilibrium. No unconsciousness. 
Severe - Unconsciousness 

22. Tachycardia (Vinar) 

Mild The heart rate is between 90 and 100/min. in subjects where 

it was under 80/min. before treatment. 
Moderate - The heart rate is between 100 and 120/min. 
Severe - The heart rate is over 120/min. 

Note: The heart rate is recorded in the morning 
before the patient leaves his bed. 

23 . Hypertens ion McGlashan) 

Mild Blood pressure 1^+0/90 
Moderate - 160/100 
Severe - 200/120 

2k. Dermatologic (Vinar) 

Mild Photosensitivity (the patient complains and/or is more sunburnt 

than usual ) . 
Moderate - Itch, rash, transitory 
Severe - Dermatitis 

25. Weight Gain (McGlashan) 

Mild Gain of 5 pounds in one month 
Moderate - Gain of 6 - 10 pounds/month 
Severe - Over 10 pounds gain in one month 



239 



26. Weight Loss (McGlashan) 

Mild - Loss of 5 pounds in one month 
Moderate - Loss of 6 - 10 pounds /month 
Severe - Over 10 pounds/month 

27. Anorexia/Decreased Appet ite (McGlashan) 

Mild - Subject consumes the equivalent of 2 meals/day 
Moderate - The equivalent of 1 meal/day 
Severe - Does not eat 

28. Headache (McGlashan) 

Mild - Subjective complaint with no impairment 
Moderate - Sensory input painful but not incapacitating 
Severe - Incapacitating 

DOCUMENTATION 

Since DOTES is a crucial element in the documentation, the data displays pro- 
vided for it are extensive and, to a large extent, unique - requiring discussion 
in deta i 1 , 

a. Raw score printout - Follows the schema given in the Documentation 
section. (p. ^7^ ) . 

b. Cumulative factor scores - Factor scores along with total score are 
the variables employed in the quantitative analysis of DOTES. Unlike 
most efficacy measures, however, DOTES is not necessarily completed 
on a fixed schedule since differences in treatment response and/or 
the emergence of adverse reactions among subjects are to be expected. 
These individual differences produce variations in temporal order 
which make nomethetic analyses extremely difficult. By restructuring 
the DOTES data set, however, a temporal uniformity - necessary for 
analysis - can be achieved. The method chosen involves accumulating 
individual DOTES by time spans which correspond to those designated 

in the protocol for the major efficacy measure/s. Factor scores along 
with total score are first computed for each DOTES and then all DOTES 
within the specified time span are added together to produce cumulative 
scores. The display of these scores follows the schema for such data 
given in the Documentation section, (p.kyh). 

c. Individual summary - This display (Table 13) provides a detailed record 
of events on an idiographic level. Emergent symptoms and their attri- 
butes are linked directly to a given dosage level (total daily dose and 
cumulative dose) so that the investigator can follow the treatment course 
within the individual subject. 



240 



Dosage by groups - This display summarizes dosage events by group 
and is organized by uniform time spans (Table \k) . Treatment groups 
are juxtaposed so that the investigator can make direct comparisons. 
All symptoms by group - A group summary of symptom events by uniform 
t ime spans (Table 15) . 

Drug-related emergent symptoms - This group display enumerates ONLY 
those symptoms which meet the following criteria: 

1. The symptom is not present in a subject at pretreatment . 

2. Relationship is judged to be either "Probable" or "Defined". 

3. Some action - excluding "None" - is recorded. 
The display follows the schema given in Table 15. 

Variance analyses - The format for these displays follows the schema 
given in the Documentation section (p.if90). 



241 



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032 PTR 
PATIENT 
TERMINATION 
RECORD 



MH-9-32 
1-73 

PATIENT TERMINATION RECORD 

INSTRUCTIONS: Insert New General Scoring Sheet and Code 04 for Sheet Number P 
To be completed at the termination of the subject from the study. " 




Mark on right half of scoring sheet on row specified 


ROW 
NO. 


Continue marking on right half of scoring sheet on row specified 


ROW 
NO. 


1. REPEATER 

0= No 
a. Has the patient ever been . _ „ 
a research subject before? 

9 = Not Ascertained 


1 


4. NON-DRUG TREATMENT 

a. Did the subject receive any non-drug = No 
treatments during the course of the study? ^ ^ yes 

b. If YES, rate the effectiveness 

of all treatments received: Mark row in appropriate column 


17 


b. If YES, was the patient a subject 

in a study in which the data was = No 
sent to the Biometric Laboratory? 1 = Yes 

9 = Not Ascertained 


2 


T.ea.mem 


Efficacy 
Unknown 


Unsatis- 
factory 


Equivocal 


Satis- 
factory 


Behavior modification .... 





1 


2 


3 


18 
19 
20 
21 
22 
23 
24 
25 


Milieu therapy 










c. If YES, for the most recent 
previous study, give: 

1. ECDEU study number 

2, Patient's number in that study . 


3-8 
9-11 






















P ^chothera" individual 










Rehabilitation/occupational therapy 
Remedial educational therapy . 


















2. DURATION 


12-14 
15 


c. Did the subject's spouse/family receive therapy/coun- = No 
seling as part of the subject's overall treatment regime? i - v 


26 


b. Was patient prematurely terminated? (G/Ve major reason): 

= Not prematurely terminated 5 = Intercurrent illness 

1 = Did not return for treatment 6 - Found not to meet study 

or refused treatment criteria 

2 = Adverse reaction 7 = Dosage/Medication error or 

violation 

3 = Ineffectiveness or deterioration 

4 = Improvement 8 = Administrative 


d. If YES. rate the effectiveness of the therapy/counseling: 

= Efficacy unknown 2 ' Equivocal 

1 = Unsatisfactory 3 = Satisfactory 


27 


5. DRUG INTAKE 

How well did the patient follow his drug regime? 

= Not applicable, did not receive drugs 

1 = Took study medication as prescribed 

2 = Some irregularities but primarily took study medication as prescribed 

3 = Suspected significant irregularities 

4 = Confirmed significant irregularities 

5 = Took additional medication in violation 
9 = Not ascertained 


28 


3. INTERVAL HISTORY 

During the course of the study, were there any significant events or changes - 
external to treatment situation — in the subject's life situation? 

= No significani events or changes 

1 = Catastrophic event - fire, flood, financial disaster, accident, etc. 

2 = Death of significant other 

3 = Physical/mental illness of significant other 

4 = Difficulties in relationships with relatives or peers — spouse, 

children, family, lover.friends, fellow employees, etc. 

5 = Decrease in status and/or responsibility - layoff, dismissal, 

demotion or retirement from employment, school failure, loss of 
hospital privileges, rejection by or dissolution of family unit by 
divorce, separation or inability to perform household responsi- 
bilities 

6 = Improvement in relationships with relatives or peers 

7 = Increase in status and/or responsibility - promotion in school or 

employment, new employment, marriage or reuniting of family 
unit, increased hospital privileges 

8 = Pregnancy of subject (spouse or parents) and/or btrth of 

child/sibling 


16 


6. ANCILLARY HflEDICATION 

a. During the course of the study, did the subject receive = No 
any ancillary medication/s other than test/control drug/s? 1 = Yes 

b. If YES, rate the effectiveness of all ancillary medication received: 


29 


Ancillary fvledication 


Efficacy 
Unknown 


Unsatis- 
factory 


Equivocal 


Satis- 
factory 


Analgesic-narcotic 

Analgesic-non-narcotic .... 





1 


2 


3 


30 
31 
32 
33 
34 
35 
36 
37 
38 








































































39 












40 


Antitumor 



























246 



PATIENT TERMINATION RECORD 



ROW 
NO. 


B. ANCILLARY MEDICATION (Continued) 1 




Vark on left half of scoring 
fleet on row specified 


Efficacy 
Unknown 


Unsatis- 
factory 


Equivocal 


Satis- 
factory 


1 


Blood tonic 





1 


2 


3 


2 . 


Bronchodilator 










3 . 


Cardiac medication 










4 . 


Cough & cold preparation 










5 . 


Dermatological preparation 










6 . 


Diabetic medication 










7 . 


Diet medication 










8 . 


Diuretic 










9 . 


Gastrointestinal preparation 










10 . 


Hormonal medication 










11 . 


Muscle relaxant 










12 . 


Psychotropic medication 
(otfier ttan test or control 
drug) 










13 . 


Sedative/hypnotic 










14 . 


Stimulant 










15 . 


Thyroid medication 










16 . 


Vitamin 












7. GLOBAL ITEMS 




a. Compared to other subjects, how well did this subject 
conform to study requirements? 


17 


= Much below average 




1 = Below average 




2 = Average 




3 = Above average 




4 = Much above average 




b. Given the choice, would you continue this subject 
on his study medication? 




= Definitely no 


18 


1 = Inclined to say no 




2 = Undecided 




3- Inclined to say yes 




4 = Definitely yes 




B. DISPOSITION AT TERMINATION Answer either "a" or "b" 




a. Inpatients 




= Elopement or discharge against medical advice 


19 


1 = Remains hospitalized and has lost privileges and/or work 

assignments previously held, e.g., loss or decrease in passes, or 
freedom of movement within hospital, loss of or decrease in 
industrial therapy assignments, transfer to more closely 
supervised wards 




2 = Remains hospitalized and status is unchanged from pretreatment 




3 = Remains hospitalized and has earned greater privileges and/or 
work assignments, e.g., formal industrial therapy assignments, 
day or night passes, transfers to wards with less supervision 




Continue "Inpatients" on next page — R— 13 



ROW 
NO. 



19 
Cont. 



Continue marking on left half of scoring sheet on row specified 



Inpatients (continued) 

4 = Paroled or discharged to a supervised living situation in 

community, eg., foster home, halfway house, day hospital, 
community mental health clinic, etc. 

5 ^ Paroled or discharged to own custody or own family. Include 

patients discharged with recommendation to continue treatment 
with family physician; on OPD basis, etc. 

6 = Transferred or discharged for reasons unrelated to present 

treatment, e.g., intercurrent illness or accident, administrative 
reasons, etc. 



b. Outpatients 

= Discharged against medical advice, e.g., refused treatment, 

did not return for treatment, family uncooperative, etc. 

1 = Hospitalized (transferred to inpatient status) because of^ 

exacerbation or deterioration of psychiatric condition 

2 = Remains on outpatient status and treatment Is intensified 

because of exacerbation or deterioration of psychiatric 
condition, e.g., greater psychiatric supervision, partial 
hospitalization such as day or night hospital, etc. 

3 = Remains on outpatient status and status is unchanged from 

pretreatment 

4 = Remains on outpatient status and treatment is reduced 

because of improvement of psychiatric condition; e.g., less 
supervision, more widely spaced visits, etc. 

5 = Discharged to own custody or own family. Include patients 

discharged with recommendation to continue treatment with 
family physician or to seek treatment independently. 

6 = Transferred or discharged for reasons unrelated to present 

treatment, e.g., intercurrent illness or accident, administrative 
reasons, geographical relocation, etc. 



247 



Developed within the ECDEU program, the Patient Termination Record (PTR) 
consists of 8 items and is formatted for use with the General Scoring Sheet. 
The items of the PTR focus on the historical events of the study itself; e.g., 
the course and length of treatment, ancillary treatments, disposition of termlna* 
tion, etc. The information elicited by the PTR is essential for the complete 
documentation and evaluation of a study. The PTR evolved from and now replaces 
the Drug Study Resume (OU-DSR) . 



APPLICABILITY 
UTILIZATION 

TIME SPAN RATED 

CARD FORMAT - ITEMS 

Item Column 



la 
lb 
Ic 
2a 
2b 
3 



20 

21 
22 - 30 
31 - 33 

3U 
35 - 36 



All research populations 

Once per subject. Completed at the time of the 
subject's termination from the study. 

The length of the study; from entrance to termina- 
tion. 



CARD 01 = (19x, 211, 19, 13. M, 12, 3911) 



I tem 



Column 



ka 




37 


kh 


1 - 8 


38 - kS 


kc 




ke 


kd 




hi 


5 




kZ 


6a 




hS 


6b 


1 - 26 


50 - 75 



CARD 02 = (19x. 611) 

Item Column 

6b27 20 

6b28 21 

7a 22 

SPECIAL INSTRUCTIONS 



Item 

7b 
8a 
8b 



Column 

23 
24 
25 



Item 1. Repeater - This item has been included on the PTR for technical reasons 
rather than for its pertinence to termination status. (Translation - It didn't 
fit no place elsel) The item enables BLIPS to Identify all individuals who have 
been participants in more than one study and, further, to identify those who have 
multiple data sets in the ECDEU data bank. If the subject has participated in 
several previous studies, the rater should encode the identification data from 
the most recent study. Identification of a repeater requires 9-digit code as 
fol lows: 



XXX 


XXX 


XXX 


Unit # 


Study # 


Pat. # 


Rows 3-5 


6-8 


9-11 



If the subject has never been a repeater, leave items lb and Ic blank. If the 
subject has been a repeater but does not have data in the ECDEU bank, leave 
Item Ic blank. 

2i»8 



Item 2a. Duration - Duration is defined as the number of days from a subject's 
entrance Into a study to his termination. Entrance into a study is defined as 
the day of the initial assessment; termination as the day of the final assessment, 
Total number of days in the study may or may not coincide with total number of 
days under medication. Duration in studies in which a pretreatment drying-out 
period and/or a follow-up period are encompassed (bracketed) by assessments, for 
example, will exceed the actual duration of medication. (For detailed instruc- 
tions, sec "Coding Duration, p. 25). Notice that duration MUST BE CODED IN DAYS. 

Example: The subject was in the study for k weeks. Encode 
0, 2, 8 in Rows 12 - 14. Note that 28 days - NOT 
k weeks - is encoded and that the leading zero is 
included. 



12.*i 


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::Sb: 



Item 2b. Premature Termination - Only ONE reason should be given. Definitions for 
the categories are as follows: 

1 = Did not return for treatment or refused treatment - includes 

elopement; unauthorized leaves; rescinding of treatment per- 
mission by parents, relatives or legal guardian; sporadic or 
insufficient attendance of treatment appointments; refusal to 
cooperate with assessment and/or other research procedures. 

2 = Adverse reaction - Any reaction, side effect or treatment 

emergent symptom which, in the opinion of the investigator, 
requires termination of drug treatment. 

3 •= Ineffectiveness or deterioration - Refers to lack of change 

or exacerbation of psychiatric symptomatology which, in the 
opinion of the investigator, is ethically unacceptable and, 
therefore, requires termination. 

h = Improvement - Refers to a degree of positive change (improvement) 
in psychiatric symptomatology which, in the opinion of the 
investigator, ethically requires release from treatment situation, 
e.g., discharge or parole from hospital; discharge from clinic or 
other agency. 

5 = Intercurrent Illness - Refers to any non-treatment related illness 

or medical condition requiring termination of treatment. Pregnancy 
should be included here. 

6 = Found not to meet study criteria - Refers to subjects erroneously 

admitted to study, e.g., lacks required target symptoms; does not 
fit age group; has a history incompatible with inclusion criteria. 



249 



7 = Dosage/medication error or violation - Includes errors or 

violations by either the subject or the staff which necessi- 
tate termination, e.g., "over" or "under dosing" by subject 
himself or by his relatives; intake of medications prohibited 
by protocol; dispensing errors in dosage and/or medication. 

8 = Administrative - Includes transfers to other wards or hospi- 

tals; subject moving from area; drug withdrawn by company; 
personnel defections; protocol violations such as accidental 
revelation of treatment assignment codes, improper assessment 
procedures, introduction of services or activities prohibited 
by protocol . 

Item 3. Interval History - This item (and Item 8) is written in general terms so 
that it might serve as wide a population as possible. Rather than specifying the 
exact nature of the event, the rater is asked to judge the effect of the event 
upon the subject. An external event or change is considered significant if, in 
the opinion of the investigator, it has had a substantial effect on the course of 
treatment . 

I = Catastrophic event - refers to any natural disaster, economic 
event, "act of God", etc. 

k = Difficulties in relationship with relatives or peers - refers 
to detrimental events or changes in the subject's emotional or 
social interactions which do not appear to be primarily related 
to treatment. 

5 = Decrease In status and/or responsibility - includes any signifi- 

cant event or change which reflects a diminution in the subject's 
status or responsibility. 

6 = Improvement in relationships with relatives or peers - non- 

treatment related events or changes which reflect facilitation 
of relat ionsh ips . 

7 = Increase in status and/or responsibility - any events or changes 

which enhance the subject's status or reflect increased responsibil' 
i t ies . 

A MAXIMUM OF 2 ENTRIES may be made for this item. On card decks, the entries 
will be coded by a 2-digIt code. The legal codes are given in Table 16. 

Examples: 00 = No significant events 

10 = Difficulties in relationships 

31 = Catastrophic event and decrease in status 



250 



TABLE 16 
PTR - ITEM 3 INTERVAL HISTORY 



< -I 

LLl —I 
O — 



card 




















Response 


Code 





1 


2 


3 


4 


5 


6 


7 


8 


Pos it ions 


00 


X 





















01 


















X 


8 


02 
















X 




7 


03 
















X 


X 


7.8 


04 














X 






6 


05 














X 




X 


6,8 


06 














X 


X 




6,7 


07 












X 








5 


08 












X 






X 


5,8 


09 












X 


X 






5,6 


10 










X 










4 


11 










X 








X 


4,8 


12 










X 






X 




4,7 


13 










X 


X 








^,5 


14 








X 












3 


15 








X 










X 


3,8 


16 








X 








X 




3,7 


17 








X 






X 






3,6 


18 








X 




X 








3.5 


19 








X 


X 










3,4 


20 






X 














2 


21 






X 












X 


2,8 


22 






X 










X 




2,7 


23 






X 








X 






2,6 


24 






X 






X 








2,5 


25 






X 




X 










2,4 


26 






X 


X 












2.3 


27 




X 
















1 


28 




X 














X 


1,8 


29 




X 












X 




1,7 


30 




X 










X 






1,6 


31 




X 








X 








1,5 


32 




X 






X 










1.^ 


33 




X 




X 












1.3 


34 




X 


X 














1 .2 



ILLEGAL OR IMPROBABLE CODES 



251 



Item ^43 and kb . Non-drug Treatments - If the answer to I tern ka Is "NO", Item kb 
may be left blank. A "YES" response to ^a requires that EACH TREATMENT RECEIVED 
must be evaluated. 

Example: The subject did receive non-drug treatments. 
(Encode 1 in Row 17). Her response to physi- 
cal therapy was satisfactory (Encode 3 in 
Row 21) while her response to individual psycho- 
therapy was unknown. (Encode in Row 23). 
Leave the other non-drug treatments blank. 

17 -.0^ .Jii -Sz- ..3c. -.-.*,-. 

18 "ft: -t- "i. -.-.i:z ..*:-. 
\9~.&. -.-.iz "ir rriz r:*: 
20::a: r:i: ::i= ..Btz ..4zz 
21 rifti :iir "li «A. "*= 
22rrftr :=±r "ir zzStz z.4tz 
23 .rf- r=3:: :ifc: rJ=: "i" 
24i=a:r "3:: =:2:; rii: =al" 
25 "t: rilr= "t: ==&; ::4:i 

Note: Items 4c, kd, 6a and 6b are encoded in the same fashion. 

I tern 5. Drug Intake - Only one response is permitted. 

I tern 7a. This item requires a judgment of the behavior of the subject qua subject; 
i.e., how well did he follow the "rules" of the study; did he miss appointments; 
require surveillance; rebel against procedure; act as "guard -house lawyer"; etc. 

I tern 7b. In double blind studies, it is crucial that this item be completed prior 

to breaking the blind; i.e., revealing the exact nature of the treatment to the rater. 

Item 8. Disposition at termination - As in I tern 3. this item endeavors to be universa 
by stating the responses in general terms. The investigator must judge whether the 
subject's treatment regime - as it existed at the beginning of the study - has been re 
duced, intensified or altered substantially. 

DOCUMENTATION 

a. Raw score printout 

b. Frequency tables 



252 



THE 

NURSE 

PACKET 



Unlike the Psychiatrist packets which are focussed on specific populations, 
the Nurse packet is "discipline oriented"; i.e., it contains all of the scales 
which are rated by this profession. Spanning age from pediatric to geriatric, 
the scales are: 

Childrens Behavior Inventory (03^-CBl) - Pediatric 

Nurses Observation Scale for inpatient Evaluation (039-NOSIE) -Adult 

and Geriatric 
Plutchik Geriatric Rating Scale (040-PLUT) - Geriatric 
Nurses Global Impressions (042-NGl) - Universal 

Although entitled "Nurse Packet", this set of scales may be rated by ward 
personnel other than registered nurses (RN) ; e.g., licensed practical nurses (LPN) 
psychiatric aides, attendants, orderlies, etc. The essential requirements are 
that raters have appropriate clinical experience and that they be thoroughly 
familiar with the rating instructions for each scale. 

The selection of scales for any given study is at the discretion of the 
investigator. Depending on the population involved, the most frequent selection 
is one of the major scales - CBI, NOS I E or PLUT - in combination with the NG I . 

Figure 16 shows the data matrices for each of the scales. These matrices 
describe the encoding locations of the scales. Since all - or any combination - 
of scales may be encoded on one GSS, the raters ALWAYS encodes Sheet Number as 10 
each and every time he or she rates. Period number changes; but Sheet Number 
always remains the same. 

ERRATA - The authors' names were inadvertently omitted from the header for 
039-NOSIE. The authors are: 

Honigfeld, G., Gillis, R. D. and Klett, C. J. 



25^ 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 











ECDEU GENERAL SCORING SHEET ( 


50-GSS) 










— 


PATIENT INITIALS 




1 NUMBER MALES 001 TO 499 NUMBER FEMALES 500 TO 


998 


— 


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FIGURE 16 

MATRICES FOR 

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18 19 



034 CBI 
CHILDRENS 

BEHAVIOR 
INVENTORY 



CHILDREN'S BEHAVIOR INVENTORY 

Eugene I. Burdock and Anne S. Hardesty 



INSTRUCTIONS: Code 20 under sheet number on genera/ scoring sheet. 
This inventory is applicable to children from 1 to 15 
years of age. The items have been grouped according to 
the ages at which the corresponding behaviors first 
become significant of departure from developmental 
norms. The behavior recorded should have occurred 
during a specified interval of the observation day. 
Always start at the beginning of the inventory and 
proceed through the level corresponding to the child's 



last birthday. A STOP signal is given at the end of each 
age grouping. Mark "yes" when you reach the level 
corresponding to the child's last birthday; "no" if you 
are continuing to the next level. 



For each item record your judgment by marking "yes" or 
"no," All items within appropriate age groupings should 
be answered. 



USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 



Mark all items on this page in columns 11 & 12 

AGES ONE TO THREE: 

1. Responds to social stimulation (by talking, smiling, or reaching, etc.) 

2. Is slow in his movements 

3. Maintains a rigid posture when standing, sitting, lying or being held 

4. Grinds teeth . . . : 

5. Voice is flat and monotonous 

6. Ignores toys or other objects around him 

7. Repeatedly falls asleep 

8. Bangs head on wall or other hard surface 

9. Holds breath until face changes color 

10. Responds to physical contact with limpness 

11. Utters no sounds 

STOP (mark "yes" or "no") 

AGES THREE TO FIVE: 

12. Soils bed or clothing with excrement 

13. Acts apprehensive and afraid 

14. Engages in rhythmic motions I'swoy/V)^, /7eotfro///>i^, efc.^ 

15. Says that he had a bad dream 

16. Eats or drinks strange substance ^p/osfe/-, //Jit, e/c.^ 

17. Has attack of panic 

18. Remains in one place unless directed into some activity 

19. Has momentary lapse of consciousness 

20. Complains of aches and pains or of physical distress 

21. Picks at self (pulls out hair, picks at skin, face, buttocks, geriltals, etc.) . 

22. Talks and talks or babbles and babbles ^pressure o/'speec/)^ 

23. Refuses to eat 

24. Lisps 

25. Hbz \\c Of Xv4'\\ch (distorts face, turns neck, blinks, etc.) 

26. Gets angry or annoyed when addressed by adult 

27. Has recurrent spells of nausea or vomiting 

28. Appears listless and apathetic 

29. Responds to own antisocial act with no sign of sorrow or remorse . . 

30. Shows incongruous emotional response 

31. Smears self and surroundings with food or feces 

32. Acts perplexed or confused 

33. Repeatedly gets irritated 

34. Repeats some act over and over again as though driven 

35. Wets bed or clothing (incontinent) 

36. Is tense and anxious 

37. Has a fixed grin 

38. Speech is inarticulate 

STOP (mark "yes" or "no") 

AGES FIVE TO SEVEN: 

39. Clings to adult 

(Continue this age group on next page) 



Mark all items on this page in columns 13 & 14 



; FIVE TO SEVEN (Continued): 

I. Keeps drooling 

. Has temper tantrum 

:. Slurs his speech 

I. Uses baby talk 

1. Keeps feeling the contours of objects within reach . . . . 

i. Shifts attention in a restless manner 

i. Becomes anxious when he cannot make things neat and orderly . 

'. Has a dull expression 

\. Maltreats younger child with deliberate cruelty 

I. Complains of insomnia 

I. Gets angry when interrupted at play by adult 

, Displays excessive self-control and composure 

'. Cries or looks hurt when criticized 

I. Takes part in ongoing activity without being urged . . . . 

.. Does not play with other children 

t. Protests or resists directions of adult 

I. Keeps asking for help in whatever he is doing 

. Utterances consist of monosyllables or single words . . . . 

1. Says he is going to kill himself 

I, Shows understanding when given directions 

I. Sucks thumb 

. Acts nervous or agitated 

'. Uses no gestures 

:. Plays with genitals or masturbates 

. Has a tight-tipped expression 

I. Swears or uses bad language ' . 

\. Speaks in a faint voice . 



:lip 



- table 



Keeps slopping fodd c 

Twists mouth 

Has a mournful and downcast expressic 



Walks on tiptoe 

Stays by himself 

Speech is slow and full of pauses . 
Is hesitant and uncertain in making up his r 
Gives excuse for breaking the rules . 
Spills something or bumps into something 
Talks about death and killing .... 



258 



(Continue this age group c 



CHILDREN'S BEHAVIOR INVENTORY 



Mark all items on this page in columns 16 & 17 


ROW 
NO. 


Mark all items on this page in columns 18 & 19 


ROW 
NO. 


AGES FIVE TO SEVEN (Continued): 


1 
2 
3 


AGES NINE TO ELEVEN (Continusd): 

118. Giggles inappropriately 


1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 




119. Weeps under slight provocation 


STOP (mark "yes" or "no") . 


120. Keeps demanding to be the leader 


121. Says he feels sad . . . 


AGES SEVEN TO NINE: 


4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
16 
17 
18 
19 
20 
21 

22 
23 
24 
25 
26 
27 
28 
29 
30 
31 
32 
33 
34 
35 
36 
37 
38 
39 


122. Has a scornful expression 




123. Attention wanders .... 




124, Gets angry when something does not suit 

125. Hits or atiackj other child 


him 








126. Takes part in conversation 


86. Twists or turns hands 


127. Runs around or throws himself about in a 

128. Grimaces or gestures grotesquely 


wild and uncontrollable manner 




STOP (mark "yei" or "no") . 




AGES ELEVEN TO THIRTEEN: 

129. Bullies younger child .... 


13 
14 
15 
16 
17 
18 
19 




91 . Says that he is bad, that he is in the wrong, or that he is ashamed of himself 


130. Has a dirty appearance 


131. Speaks in a jerky, uneven fashion 




132. Acts friendly with another child . . 


94. Eyes keep shifting 

95. Acts as if he has a vision or talks about his vision 


133, Shows pleasure at being talked to 


134, Behaves in a sullen or argumentative man 


er 


STOP (mark "yes" or "no") . 


97. Talks to his voices or acts as if he hears voices 




AGES THIRTEEN TO FIFTEEN: 

135, Shows difficulty in concentrating 


20 
21 
22 
23 

24 


99. Is impatient (will not wait for something to be given to him or to be done 


136, Shows interest in the opposite sex (positii 

137, Expresses feelings of inferiority . 

138, Expresses a pessimistic outlook toward hi 

139, Complains that an adult wants to kill him 


e or negative feelings) 
future accomplishments 






102. Keeps eyes closed or averted or head bowed down 




104. Walks with a cautious tread Cos //sfepp/n^ on e^^s,^ 

105. Shows suspicion or complains of unfair treatment . 

106. Deliberately tears or breaks something 

107. Tries to kill himself 
















110. Curses or sneers at other child ... . . 




111. Attacks adult 




112. Sets a fire 








114. Keeps smiling 




STOP (mark "yes" or "no") . 




AGES NINE TO ELEVEN: 


40 
41 








(Continue this age group on next page) 





259 



Burdock and Hardesty's Children's Behavior Inventory (CBl) is a 139-item, 
2-point scale formatted for use with the General Scoring Sheet. The scale is 
a technique for recording maladaptive behavior of children. The absence of 
professional or technical jargon makes it possible for members of different pro- 
fessions to carry out and record the relevant observations after brief training. 
Experience with the method to date has demonstrated that with proper selection 
and adequate training the CBl is equally reliable in the hands of nurses, teachers, 
psychologists, psychiatrists and graduate students in psychology or special educa- 
tion. 

REFERENCES 1. Burdock, E. I. and Hardesty, A. S., A Children's Behavior 
Diagnostic Inventory, Ann. New York Academy of Sciences, 
105: 890-896, 1964. 
2. Burdock, E. I., and Hardesty, A. S., Contrasting Behavior 
Patterns of Mentally Retarded Children and Emotionally 
Disturbed Children, in Psychopathology of Mental Develop- 
ment, p. 370-386, Grune and Stratton, New York, I967. 



APPLICABILITY 



Chi Idren aged 1 to 15 



UTILIZATION 



TIME SPAN RATED 



Once at pretreatment, at least one posttreatment assessment. 
Additional ratings are at the discretion of the investigator. 

Restricted to the period of observation 



CARD FORMAT - ITEMS 

CARD 01 = (I9x, 5611) 
Item Column Item Column 



2 

3 
k 
5 
6 
7 
8 
9 
10 
11 



20 


11 


21 


12 


22 


13 


23 


\k 


Ik 


15 


25 


16 


26 


17 


27 


18 


28 


19 


29 


20 


30 


21 



■stop 31 

32 

33 
34 
35 
36 
37 
38 
39 
ko 
h\ 



CARD 02 = (19x, 5611) 



Item Column 

55 
56 
57 
58 
59 
60 
61 
62 
63 
(A 
65 



20 


66 


21 


67 


22 


68 


23 


69 


Ik 


70 


25 


71 


26 


72 


27 


73 


28 


Ik 


29 


75 


30 


76 



I tem 



Column 



Item Column 



22 
23 

Ik 

25 
26 

27 
28 
29 
30 
31 
32 



42 

43 
44 
45 
46 
47 
48 
49 
50 
51 
52 



Item Column 



31 


77 


42 


87 


53 


32 


78 


43 


88 


54 


33 


79 


44 


89 


55 


34 


80 


45 


90 


56 


35 


80- 


stop 46 


91 


57 


36 


81 


47 


92 


58 


37 


82 


48 


93 


59 


38 


83 


49 


94 


60 


39 


84 


50 


95 


61 


40 


85 


51 


96 


62 


41 


86 


52 


97 


63 



Item Column 



33 

34 

35 

36 

37 

38 

38-stop 

39 

40 

41 

42 



53 
54 
55 
56 
57 
58 
59 
60 
61 
62 
63 



Item Column 



I tem 

43 
44 
45 
46 
47 
48 
49 
50 
51 
52 
53 
54 

Item 

98 

99 
100 
101 
102 
103 
104 

105 
106 
107 
108 
109 



Column 

64 
65 
66 
67 
68 
69 
70 
71 
72 
73 
74 
75 

Column 

64 
65 
66 
67 
68 
69 
70 
71 
72 
73 
74 
75 



260 



CARD 03 = (I9x, 3311) 
Item Column Item Column Item Column 



no 


20 


111 


21 


112 


22 


113 


23 


]]k 


2k 


115 


25 


1 15-stop 


26 


116 


27 


117 


28 


118 


29 


119 


30 



120 


31 


121 


32 


122 


33 


123 


3U 


\2k 


35 


125 


36 


126 


37 


127 


38 


128 


39 


128-stop 


^40 


129 


'tl 



130 


k2 


131 


43 


132 


kk 


133 


45 


134 


46 


1 34-s top 


47 


135 


48 


136 


49 


137 


50 


138 


51 


139 


52 



Blanks on CBI cards indicate missing data only if they occur on items which are at or 
below the child's age. Blanks on items over the child's age should be interpreted as 
"not appl icable". 

CARD FORMAT - SUBTESTS CARD 51 = (19x, 9F5.2, F3.0) 

(Code "5" in column 18 indicates card containing factor, cluster or other grouped 
scores) . 



btest 


Column 


1 


20 - 24 


II 


25 - 29 


II 1 


30 - 34 


IV 


35 - 39 


V 


40 - 44 



Subtest 


Column 


VI 


45 - 49 


VII 


50 - 54 


VIM 


55 - 59 


IX 


60 - 64 


Total Score 


65 - 67 



Subtest Score - Sum of Composite Items 

Total Score = Sum of all Items Total Score Range = 0-139 

SUBTEST COMPOSITION 

1. Anger-Hostility - Contains items describing verbal behavior, 
attitudes and actions of an angry or hostile nature. 



26 


50 


90 


103 


120 


29 


55 


93 


106 


122 


33 


65 


96 


110 


124 


41 


76 


98 


111 


125 


48 


82 


99 


112 


129 
134 



261 



kl 


85 


hi 


87- 


h5 


117 


56 


123 


59,v 


131 


75 


135 



II. Conceptual Dysf unct ion Ing - Contains items reflecting 
disturbances of speech, memory, or orientation. 

11 
19 
22 
Ik 
32 
38 

" = I terns reflecting in scoring 

II. Fear and Worry - Contains items describing verbal behavior 
or actions reflecting fear and worry. 

13 52 

15 61 

17 79 

36 119 

^6 121 

IV. Incongruous Behavior. Indicates modes of behavior which are 
either inconsistent with one another or with age norms, or 
which are anomalous and unusual ways of doing things: head 
banging, incontinence, walking on tiptoes, etc. The more 
visual characteristics of psychological deviance are grouped 
here . 

k 35 69 104 

8 37 71 108 

9 39 72 109 
12 40 77 113 
14 44 81 114 
16^ 60 86 115 
21 63 89 116 
25 64 94 118 
31 67 100 127 
34 68 101 128 

130 

V. Incongruous Ideation - Contains items indicative of bizarre 
emotional and cognitive behaviors. 



30 


105 


78 


139 


88 





262 



bv 


28 


62 


2 


47 


66 


5 


51 


70 


6 


53* 


73 


7 


5k 


74 


18 


57 


83 



VI. Lethargy-Dejection - Is reflected in both physical and emotional 
behavior. A child may be reported to be slow in his movements, 
to fall asleep repeatedly, or to have a voice that is flat or 
monotonous; on the other hand, he may detach himself from his 
environment by staying by himself, or by ignoring toys or other 
objects around him. 

84.V 
102 
126^v 
132^v 

133--'- 
136-.V 

" = I terns reflected in scoring 

VII. Perceptual Dysfunct ion ing - I terns related to hallucinatory 
exper iences . 

95 97 

VIM, Physical Complaints - Is concerned with such indicators as refusal 
to eat, recurrent spells of vomiting, or responding to physical 
contact with limpness. 

3 27 

10 49 

20 92 
23 

IX. Self-Depreciation - is more dependent on verbal report than the 
other subareas. However, deliberately hurting himself and trying 
to kill himself are behavioral items included here in addition to 
expressions of feeling of inferiority. 

58 107 

80 137 

91 138 

SPECIAL INSTRUCTIONS 

1. Conduct of Observers - Whenever a study is. to be undertaken in a new setting 
the observer should arrange to let himself be seen in the situation and by the 
subjects before the beginning of the formal observations in order that his presence 
lose its novelty. It is best when the child who is the focus of interest does not 
perceive himself as such. The observer should give an impression of being interested 
in the activities of the whole group. If a child inquires about the observer's role 
or purpose, the observer may tell him, "I am watching because I am interested in 



263 



what children do here." There are two requirements which are essential if quantita- 
tive or even only qualitative use is to be made of the instrument: 

a. The observer must be able to maintain a friendly detachment from 
the situation so that he neither manipulates nor purposely evokes 
behavior that would not have occurred in his absence. 

b. The observer must be closely attentive to the appearance, verbaliza- 
tions, movements and gestures of the child. 

2. Recording Observations - The CB I has 139 dichotomous items. The observer should 
always start with the first item and proceed through all the items listed for the 
age group of the child under observation. When the child's age "overlaps" two age 
groupings, answer all items of the OLDER groupings and stop. (Example - if a child 
is 5, complete age group "Five to Seven". If child is 7. complete group "Seven to 
Nine".) The observer should mark "YES" when the child has displayed the behavior 
noted and "NO" if he has not seen the relevant behaviors. The observer must be able 
to set aside what he remembers or has heard from others about the child. His judg- 
ments must be based solely on what he sees or hears from the child during the observa- 
tion period. He must be sure to read every item carefully. Some items call for a 
judgment of the presence of a behavior; other items require judgment that a particular 
behavior is absent. Certain items describe behaviors which can be judged unequivocally 
from a single event; others describe complex qualities whose presence may only be in- 
ferred toward the end of the observational interval. 

3. Time Interval - The most effective use of the CBI is achieved when it is possible 
to observe an individual child in his normal activities over several behavioral sett- 
ings. When the observer can give his undivided attention to the actions and reactions 
of a single child, a period of two hours has been found to produce enough behavioral 
diversity to be of discriminative significance. On the other hand, should service 
obligations preclude such highly focussed observation, the behavior displayed over the 
usual working shift of approximately eight hours will offer a reliable basis for judg- 
ments provided observations are carried out consistently. 

DOCUMENTATION 

a. Raw score printout - item listings will end at each individual 
subject's appropriate age group. 

b. Subtest scores. 

c. Means and standard deviations for subtests. 

d. Crosstabulat ions of subtest scores. 

e. Variance analyses. 



26^ 



039 NOSIE 
NURSES 

OBSERVATION SCALE 
FOR INPATIENT 
EVALUATION 



MM 939 
1-73 



NURSES' OBSERVATION SCALE FOR INPATIENT EVALUATION 

Honigfeld, G., GMlis, R. D. and Klett, C. J. 



INSTRUCTIONS: Code 20 under sheet number on general scoring sheet 

For each of the 30 items below you are to rate this patient's behavior during the last THREE DAYS ONLY. 
Indicate your choice by marking one response position for each item. 



USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 



"^^ ?S!b' °"^ aTy ^"-"^^ 



Row 1 


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9 


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10 


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11 


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12 


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13 


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14 


iS: 


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15 


rS: 


rrfc: 


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16 


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r:3i: 


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17 


:&: 


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18 


li: 


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19 


li; 


"fc: 


i:K: 


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20 


zi. 


::fc: 


::?:r 


::ft: 


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21 


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"fc: 


"?:: 


::&: 


::*: 


22 


ri: 


r;6:: 


r:Jt: 


::&: 


::9b: 


23 


rS: 


:rfc: 


::?:: 


::fc: 


::9b: 


24 


-&z 


r:fc: 


::f:: 


::&: 


::St: 


25 


rSi 


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"^: 


;:ft: 


::9t: 


26 


:S: 


::fc: 


"St: 


::ft: 


::*: 


27 


iSr 


::6:= 


"ft: 


::&: 


::ftr 


28 


:i: 


::fc: 


"ft: 


::ft: 


::9t: 


29 


iS: 


z.biz 


::ft: 


::&: 


::9t: 


30 


iS: 


z.b:z 


::ft: 


::&: 


::*: 



ROW 
NO. 



A^arAr each item on row designated in columns 6—10 



Is sloppy 

Is impatient 

Cries 

Shows interest in activities around him 

Sits, unless directed into activity 

Gets angry or annoyed easily 

Hears things that are not there 

Keeps his clothes neat 

Tries to be friendly with others 

Becomes easily upset if something doesn't suit him 

Refuses to do the ordinary things expected of him 

Is irritable and grouchy 

Has trouble remembering 

Refuses to speak 

Laughs or smiles at funny comments or events 

Is messy in his eating habits 

Starts up a conversation with others 

Says he feels blue or depressed 

Talks about his interests 

Sees things that are not there 

Has to be reminded what to do 

Sleeps, unless directed into activity 

Says that he is no good 

Has to be told to follow hospital routine 

Has difficulty completing even simple tasks on his own 

Talks, mutters, or mumbles to himself 

Is slow moving and sluggish 

Giggles or smiles to himself without any apparent reason 

Quick to fly off the handle 

Keeps himself clean 



Cols 6 



10 



266 



Developed by Honigfeld, Gill is and Klett, the Nurses' Observation Scale (NOSIE) 
is a 30-item scale formatted for use with the Genera] Scoring Sheet. Designed for 
the assessment of ward behavior by nursing personnel, the NOSIE provides measures of 
the patients' strengths as well as pathology. Employing a 5-point scale, the items 
are written in simple language and ask for ratings based on the direct observation 
of behavior. Since its introduction in 1965, the scale has been widely used and has 
demonstrated its sensitivity to change. 



REFERENCES 



1. Honigfeld, G. and Klett, C, The Nurses' Observation 
Scale for Inpatient Evaluation (NOSIE): A New Scale 
for Measuring Improvement in Chronic Schizophrenia, 
J. Clin. Psychol., 1965, 21: 65-71. 



2. Honigfeld, G., NOSIE-30: History and Current Status 
of Its Use in Pharmacopsych iatr ic Research, published 
in Modern Problems in Pharmacopsychiatry: Psychological 
Measurement, P. Pichot (Ed), Karger, Basle, 1973. 

3. Guy, W. and Cleary, P., Factor Analyses of the NOSIE, 
to be publ ished. 

APPLICABILITY Adult and geriatric inpatients 

UTILIZATION Once at pretreatment ; at least one post -treatment assessment. 
Additional rating periods are at the discretion of the invest!' 
gator. 



TIME SPAN RATED 



The span has been established by the author as "the last three 
days only". 



CARD FORMAT - ITEMS CARD 01 = (19x, 3011) 



I tem 
1 
2 

3 

k 

5 

6 

7 

8 

9 
10 
11 
12 
13 
]k 
15 



Col umn 
20 
21 
22 
23 
2k 
25 
26 

27 
28 
29 
30 
31 
32 
33 
34 



I tem 
16 
17 
18 
19 
20 
21 
22 
23 
2k 
25 
26 
27 
28 
29 
30 



Column 
35 
36 
37 
38 
39 
ko 
k] 
k2 
kl 
kk 
k5 
kS 
kl 
48 
kS 



267 



CARD FORMAT - FACTORS CARD 51 = (19x, 8F^.0) 

(Code "5" in Column 18 indicates card containing factor, cluster or devised score.) 

Factor Column Factor Column 

I 20-23 
II 24-27 



V 


36 


- 39 


VI 


ko 


- 43 


VII 


kk 


- 47 


Total Assets 


48 


- 51 



III 28-31 
IV 32 - 35 

Factor Score = 2 X Sum of Composite Items 

Total assets = 150 + total POSITIVE (I, II, III) - total NEGATIVE factors (IV.V.VI ,VI I) . 

FACTOR COMPOSITION 

This factor structure is based on a I975 analyses of the pretreatment ratings of 
2415 subjects with diagnoses of schizophrenia. The factors derived are Identical with 
the original Honigfeld factors except for addition of Factor VII - Depression. (Table 17) 

POSITIVE FACTORS 

1. Social Competence 

"13 - Has trouble remembering 

"14 - Refuses to speak 

■*21 - Has to be reminded what to do 

''f24 - Has to be told to follow hospital routine 

*25 - Has difficulty completing even simple tasks on his own 

I I . Social Interest 

4 - Shows interest in activities around him 

9 - Tries to be friendly with others 
15 - Laughs or smiles at funny comments or events 
17 - Starts up conversation with others 
19 - Talks about his interests 

III. Personal Neatness 
*1 - Is sloppy 

8 - Keeps his clothes neat 
'-16 - Is messy in his eating habits 
30 - Keeps himself clean 

NEGATIVE FACTORS 

IV. Irritability 

2 - Is impatient 

6 - Gets angry or annoyed easily 

10 - Becomes easily upset if something doesn't suit him 

11 - Refuses to do ordinary things expected of him 

12 - Is irritable and grouchy 

29 - Quick to fly off the handle 



268 



v. Manifest Psychosis 

7 - Hears things that are not there 
20 - Sees things that are not there 

26 - Talks, mutters or mumbles to himself 

28 - Giggles or smiles to himself without any apparent reason 

Vl . Retardation 

5 - Sits, unless directed into activity 

22 - Sleeps, unless directed into activity 

27 - is slow moving and sluggish 

VII. Depress ion 

3 - Cries 
18 - Says he feels blue or depressed 

23 - Says he is no good 

* = I terns reflected in scoring 

SPECIAL INSTRUCTIONS 

Although most raters find it relatively easy to arrive at agreement on the 
meaning of the items, confusions and misinterpretations do occur. It would be 
prudent, therefore, to conduct training sessions for neophyte raters to reduce 
any confusion which may exist. 

DOCUMENTATION 

a. Raw score printout 

b. Factor score printout 

c. Means and standard deviations for factor scores 

d. Cross-tabulation of factor scores 

e. Variance Analyses 



269 



TABLE 17 
7-FACTOR VARIMAX SOLUTION OF THE NURSES' OBSERVATION SCALE FOR INPATIENT EVALUATION 



|tem 


1 


II 


Ul 


IV 


V 


VI 


VII 


Conmunal ities 


1 


-161 


190 


002 


802 


018 


188 


-257 


807 


2 


052 


780 


-032 


206 


-087 


140 


-089 


690 


3 


089 


167 


-059 


-043 


-612 


032 


-129 


433 


4 


6?? 


-116 


-217 


-273 


-028 


-160 


160 


616 


5 


-383 


043 


?7? 


024 


-047 


-005 


-255 


547 


6 


-062 


90? 


-045 


076 


-053 


124 


-096 


858 


7 


-247 


163 


-150 


135 


-027 


768 


-155 


743 


8 


230 


-148 


-023 


-864 


-024 


-101 


143 


853 


9 


82^ 

oo4 


-115 


-689 


-116 


-032 


-087 


137 


739 


10 


89? 


-029 


081 


-120 


091 


-085 


835 


11 


-087 


567 


128 


226 


-032 


127 


-441 


608 


12 


-083 


829 


027 


130 


-090 


124 


-142 


756 


13 


-106 


024 


M5 


259 


008 


251 


-686 


627 


]k 


-312 


167 


oh 


029 


olo 


035 


-^36 


532 


15 


7^? 


-025 


261 


-131 


-037 


110 


189 


660 


16 


-032 


119 


114 


567 


029 


263 


-324 


525 


17 


84? 


047 


-094 


-075 


-078 


-107 


149 


777 


18 


154 


067 


147 


-070 


-797 


-087 


062 


70I 


19 


704 
-234 


032 


-175 


-140 


-222 


-123 


049 


614 


20 


192 


- 59 


116 


-042 


725 


-223 


708 


21 


-195 


256 


85 


400 


Oil 


192 


-660 


770 


22 


-014 


024 


862 


076 


-037 


-027 


020 


752 


23 


032 


036 


08lf 


050 


-804 


025 


068 


663 


2k 


-141 


342 


153 


^81 


010 


161 


-^17 


712 


25 


-205 


241 


060 


366 


-028 


235 


-65^ 


721 


26 


-076 


263 


t014 


238 


-013 


760 


-111 
-324 


722 


27 


-107.. 


-141 


?62 


092 


-174 


-158 


516 


28 


1?6 


093 


093 


131 


081 


787 


-094 


685 


29 


-042 


882 


-Oil 


058 


-025 


155 


-098 


817 


30 


2^5 


-173 


-073 


-816 


-025 


-138 


196 


819 


Contribution 


















of factor (V ) 


3.57 


4.61 


1.73 


3.27 


1.79 


2.83 


2.99 


20.80 


% Total Variance 


11.9 


15.4 


5.8 


10.9 


6.0 


9.4 


9.9 


69.3 


% Comnon Variance 


17.1 


22.2 


8.3 


15.7 


8.6 


13.6 


14.3 





270 



COMMENTS OF THE AUTHOR 

The Nurses' Observation Scale for Inpatient Evaluation 
Gilbert Honigfeld , Ph.D. 

As a result of continued research with the NOSIE over the past several years 
we have developed a revised scoring system based on a subset of 30 items from the 
original 80-item scale. Our analyses show that this new version, the NOSIE-30, is 
as reliable and valid as the parent scale and will be considered the definitive 
scoring system in our future work. This research was based on an expanded norma- 
tive sample of over 600 chronic schizophrenic patients aged 26 to 7k. 

Five of the original 7 factors held up well under repeated factor analyses of 
both pre-treatment and change score data. One factor, Cooperation, became obscured 
because of its strong relationship with Social Competence and has since been dropped 
as a separate factor. 

Although potentially useful for describing patient status in a small number of 
chronic schizophrenic men and of some usefulness in describing changes in behavior 
over long time spans. Paranoid Depression has been dropped from the general scoring 
system since it is of relatively little use in measuring patient change over custom- 
ary experimental time spans. However, a new factor. Retardation, has been added 
which is related to observable aspects of Depression, and which is quite sensitive 
to changes over short time periods. Depression can still be scored using the NOSIE- 
30, but for general purposes its use is not encouraged. 

In addition a composite or overall score, Total Patient Assets, has been added 
for the use of investigators who want a global estimate of patient status or change. 
This score is simply the algebraic sum of the positive factors minus the negative 
factors, with the addition of a constant to adjust the scale to a true zero-point. 

A further addition to the scoring system involves the conversion of raw scores 
to normalized T-scores. Similar to the MMPI a conversion table will be used to pro- 
vide a rapid way of profiling patient scores, as well as giving immediate normative 
comparisons. T-scores involve the conversion of raw scores to an adjusted mean of 
50 and standard deviation of 10. Thus a patient's normalized T-score can be easily 
interpreted as a centile rank by reference to a normal-curve t-able. 

Regarding the validity of the scale, favorable evidence has been reported inde- 
pendently by Lentz et al., (1971). Although based on a sample significantly younger 
than the original norm group these authors reported (p. 75), "when compared to Honig- 
feld's older, chronic geriatric group, the current sample was essentially at the mean 
for Total Assets (T score=52) , and for all subscales (T score=49 or 50) except Social 
Interest. On the latter subscale females were significantly higher than males in the 
norm groups (T score=56) , and males in the current sample (T score (T score=5I)). For 
frr itabi 1 ity, the other subscale on which sex differences were found, males were slight- 
ly below the norm group (T=47) and females were slightly above (T=52) ." 



271 



In comparing the NOSIE with other scales, Ludwig and Marx (1969) reported a 
correlation of +.90 between NOSIE Total Assets and a ward behavior form. Kish 
(1970) reported that patients high on "sensation-seeking" (a measure of "Interest 
in seeking stimulating activities") exhibited on the NOSIE-30 significantly less 
retardation than patients low on "sensation-seeking". 

p ve-^borg and Willenson (I969) compared NOSIE-30 scores for mentally retarded 
Jb weil at mentally ill patients of both sexes. Very comparable scores obtained 
across both diagnostic groups and both sexes with one major discrepancy - mentally 
ill males scored significantly lower than all other groups on Social Interest. A 
specific relationship was found between high scores on the irritability factor and 
clinical categorizations of "hyperactive" classification. 

Concerning the reliability of these scores, the report by Lentz et al, (1971). 
showed high inter-rater reliabilities, as follows: 

Factor Inter-rater Reliability 

Total Assets (TOT) .95 

Social Competence (COM) .86 

Social Interest (INT) .95 

Personal Neatness (NEA) .95 

Irritability (IRR) .83 

Manifest Psychosis (PSY) .82 

Retardation (RET) .83 

REFERENCES 

1. Crumbaugh, J. C, Salzberg, H. C. and Agee, F. L., The Effects of Pool Therapy 
on Aggression. Journal of Clinical Psychology, I969, 22, 235-237- 

2. Hargreaves, W. A., Systematic Nursing Observation of Psychopathology. Archives 
of General Psychiatry, I968, 18, 518-531. 

3. Honigfeld, G. and Gill is, R. D., The Role of Institutionalization in the Natural 
History of Schizophrenia. Diseases of the Nervous System, I967. 28, 66O-663. 

k. Honigfeld, G., Gill is, R. D. and Klett, C. J., NOSIE-30: A Treatment-Sensitive 
Ward Behavior Scale. Psychological Faports, I966, 19, 180-182. 

5. Honigfeld, G., Rosenblum, M. P., Blumenthal, I. J., Lambert, H. L. and 
Roberts, A. J., Behavioral Improvement in the Older Schizophrenic Patient: Drug 
and Social Therapies. Journal of the American Geriatrics Society, 13, 57-72. 

6. Lentz, R. J., Paul, G. L. and Calhoun, J. F., Reliability and Validity of Three 
Measures of Functioning with "Hard-core" Chronic Mental Patients, J. Abn. Psychol., 
78, 69-76, 1971. 

7. Marshall, G., Beer and Geriatrics, An Objective Study. Washington Brewers 
Institute, Seattle, Washington, I965 (unpublished manuscript). 



272 



8. Ravensborg, M. R. and Willenson, D., Use of the NOSIE-30 Behavioral Rating 
Scale in Hospitals for the Mentally ill and Retarded, J. Clin. Psychol., 
25: 453-^54, 1969. 

9. Sugerman, A. A., Stolberg, H. and Herrman, J., A Pilot Study of P-46578 in 
Chronic Schizophrenics. Current Therapeutic Research, 1965, 7, 310-314. 

10. Taulbee, E. S., Overt Sexual Responses in Personal i ty Assessment and 
Alcoholism. Veterans Administration Newsletter for Research in Psychology, 
1968, 10, 22-23. 

11. Wolpert, A., Sheppard, C. and Merlis, S., Method for Evaluation of Behavioral 
Changes in Aged Hospital Patients During Anabol ic Steroid Therapy. Journal 
of the American Geriatrics Society, 196?, 15, ^70-^3. 

12. Wright, G. H. and Hambacher, W. D., Psycho-Social Problems of Shelter Occupancy, 
Report No. 75111-F, HRB-Singer Inc., State College, Pennsylvania. I965. 



273 



040 PLUT 
PLUTCHIK 
GERIATRIC 
RATING SCALE 



MH 9-40 
1-73 



PLUTCHIK GERIATRIC RATING SCALE 



INSTRUCTIONS: Code 20 under sheet number on general scoring sheet 

Choose one response for each item and record in the appropriate spaces. 



Row 1 :-(t- 


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Cols: 1 



ROW 
NO. 


yWar^ eac/» /fe/rj on row designated in columns 1—3 




1. When eating, the patient requires: 

= No assistance (feeds himself) 




1 = A little assistance (needs encouragement) 

2 = Considerable assistance (spoon feeding, etc.) 




2. The patient is incontinent: 


2 


= Never 


1 = Sometimes (once or twice per week) 




2 = Often (three times per week or more) 




3. When bathing or dressing, the patient needs: 


3 


= No assistance 


1 = Some assistance 




2 = Maximum assistance 




4. The patient will fall from his bed or chair unless protected by 
side rail: 


4 


= Never 




1 = Sometimes 




2 = Often 




5. With regard to walking the patient: 


5 


= Has no difficulty 


1 = Needs assistance in walking 




2 = Does not walk 




6. The patient's vision, with or without glasses, is: 




= Apparently normal 




1 = Somewhat impaired 




2 = Extremely poor 




7. The patient's hearing is: 


7 


= Apparently normal 


1 = Somewhat impaired 




2 = Extremely poor 




8. With regard to sleep, the patient: 


8 


= Sleeps most of the night 


1 = Is sometimes awake 




2 = Is often awake 




9. During the day, the patient sleeps: 


9 


= Sometimes 


1 = Often 




2 = Most of the day 




10. With regard to restless behavior at night, the patient is: 


10 


= Seldom restless 


1 = Sometimes restless 




2 = Often restless 




11. The patient's behavior is worse at night than in the daytime: 




= Never 




1 = Sometimes 




2 = Often 



276 



PLUTCHIK GERIATRIC RATING SCALE 



ROW 
NO. 


Mark each item on row designated in columns 1 — 3 




12. When not helped by other people, the patient's appearanc 


) is: 


12 


= Almost never sloppy 

1 = Sometimes sloppy 

2 = Almost always sloppy 






13. The patient masturbates or exposes himself publicly: 




13 


= Never 

1 = Sometimes 

2 = Often 






14. The patient is confused (unable to find his way around the ward, 
loses his possessions, etc.): 


14 


= Almost never 

1 = Sometimes 

2 = Often 






15. The patient knows the names of : 




15 


= More than one member of the staff 

1 = Only one member of the staff 

2 = None of the staff 






16. The patient communicates in any manner (by speaking, writing, or 
gestering) well enough to make himself easily understood: 


16 


= Almost always 

1 = Sometimes 

2 = Almost newer 






17. The patient resets to his own name: 




17 


= Almost always 

1 = Sometimes 

2 = Almost never 






18. The patient plays games, has hobbies, etc.: 




18 


= Often 

1 = Sometimes 

2 = Almost never 






19. The patient reads books or magazines on the ward : 




19 


= Often 

1 = Sometimes 

2 = Almost never 






20. The patient will bagin conversations with others: 




20 


= Often 

1 = Sometimes 

2 = Almost never 






21. The patient is willing to do things asked of him: 




■21 


= Often 

1 = Sometimes 

2 = Almost never 






22. The patient helps with chores on the ward: 




22 


= Often 

1 = Sometimes 











Mark each item on row designated in columns 1 — 3 



23. Without being asked, the patient physically helps other patients: 

= Often 

1 = Sometimes 

2 = Almost never 



24. With regard to friends on the ward, the patient: 

= Has several friends 

1 = Has just one friend 

2 = Has no friends 



25. The patient talks with other people on the ward: 

= Often 

1 = Sometimes 

2 = Almost never 



26. The patient has a regular work assignment: 

= Away from the ward 

1 = On the ward 

2 = No regular assignment 



27. The patient is destructive of materials around him (breaks furniture, 
tears up magazines, etc.) 

= Never 

1 = Sometimes 

2 = Often 



28. The patient disturbs other patients or staff by shouting or yelling: 

= Never 

1 = Sometimes 

2 = Often 



29. The patient steals from other patients or staff members: 

= Never 

1 = Sometimes 

2 = Often 

30. The patient verbally threatens to harm other patients or staff: 

= Hever 

1 = Sometimes 

2 = Often 

31. The patient physically tries to harm other patients or staff: 

= Never 

1 = Sometimes 

2 = Often 



277 



Developed by Plutchik, Conte, Lieverman, Bakur, Grossman and Lehrman, the 
Plutchik Geriatric Rating Scale (PLUT) is a 31-item scale formatted for use with 
the General Scoring Sheet. The scale was designed to measure the degree to which 
geriatric patients are able to function, both physically and socially, in an in- 
tact, integrated manner. The items are rated on a 3-point scale and the ratings 
are based on the direct observation of the patient's behavior. 



REFERENCE 



APPLICABILITY 
UTILIZATION 

TIME SPAN RATED 

CARD FORMAT - ITEMS 
I tern 

1 

2 

3 

k 

5 

6 

7 

8 

9 
10 
11 
12 
13 
14 
15 
16 



1. Plutchik, R., Conte, H., Lieverman, M., Bakur, M., 
Grossman, J., and Lehrman, N., Reliability and 
Validity of a Scale for the Assessing of Functioning 
of Geriatric Patients, J. Amer. Geriat. Soc, 18, 

6, 491-500, June, 1970. 

2. Guy, W. and Cleary, P., Factor Analysis of the 
Plutchik Geriatric Rating Scale, to be published. 

Geriatric inpatients 

Once at pretreatment; at least one post-treatment assess- 
ment. Additional ratings are at the discretion of the 
investigator. 

None specified by authors; but it is suggested that the 
time span be limited to now or within past week. 



CARD 01 = (19x, 31 M) 

Col umn 

20 
21 
22 
23 
2k 
25 
26 
27 
28 
29 
30 
31 
32 
33 
34 
35 



I tem 

17 
18 
19 
20 
21 
22 
23 
24 
25 
26 
27 
28 
29 
30 
31 



Col umn 

36 
37 
38 
39 
40 
41 
42 
43 
44 
45 
46 
47 
48 
49 
50 



278 



CARD FORMAT - FACTORS CARD 51 = (19x, 7F6.2, F4.0) 

(Code "5" in Column 18 indicates card containing factor, cluster or derived score.) 
Column Factor Column 



Factor 

I 

I I 

I I I 

IV 



20-25 
26-31 
32-37 
38-43 



V 
VI 
VI I 
Total Score 



50-55 
56-61 
62-65 



Factor Score = Sum of Composite I terns 
No. of Composite Items 



Factor Score Range =0-2 



Total Score = Sum of all items 



Total Score Range =0-62 



FACTOR COMPOSITION 



I. Overall Dysfunction 

1 - Eating 

2 - Incontinent 

3 - Bathing and dressing 
12 - Appearance 

1 k - Confus ion 

16 - Communicates easily 

17 - Reacts to name 

21 - Willing to do things 

II. Aggressive Behavior 

27 - Destructive 

28 - Disturbs others 

29 - Steals 

30 - Verbally threatens 

31 - Physically tries to harm 

III. Sleep Disturbance 

8 - Sleeps at night 

10 - Restless at night 

11 - Behavior worse at night 

IV. Social Isolation 

20 - Begins conversations 

2k - Friends 

25 - Talks with others 



This factor structure Is based on a 1975 
analysis of pretreatment scores from 260 
geriatric subjects. (Table 18). 

V. Sensory Impairment 

6 - V is ion 

7 - Hearing 

VI. Work and Activities 

18 - Games and hobbies 

22 - Helps with chores 

23 - Helps other patients 

26 - Regular work assignment 

VII. Motor Impairment 
k - Falls 
5 - Wal king 

Items not included in any factor 
9 - Sleep during day 
13 - Masturbates 
15 - Knows names of staff 

19 - Reads 



279 



TABLE 18 

7-FACTOR VARIMAX SOLUTION OF PLUTCHIK GERIATRIC RATING SCALE 

Items I II J II )V V VI 

1 58i -069 -024 -151 -076 -163 

2 6^2 103 -077 -166 -051 -264 

3 682 071 -026 -103 026 -294 
if 269 -007 -008 -038 -144 -199 

5 305 -049 054 004 -150 -237 

6 -051 -026 -041 110 -547 -097 

7 -022 -031 023 -109 ^7^8 018 

8 -103 010 -815 035 Oil 013 

9 249 -010 -013 -044 -394 318 

10 -064 154 -809 091 031 -068 

11 082 073 -770 003 -054 062 

12 206 130 -097 -140 134 -033 

13 033 289 -142 -371 -074 026 

14 202 -Oil 045 -042 -088 -320 

15 234 033 -039 -301 -268 -413 

16 6^0 -023 105 -269 -054 -103 

17 |o5 -061 187 -245 029 -114 

18 260 058 014 -244 -127 -482 

19 273 044 042 -223 -108 -403 

20 331 -086 143 -719 014 -218 

21 460 044 085 ^328 098 -416 

22 295 -021 -043 -153 085 -686 



23 170 -079 057 -477 047 

24 225 025 -053 -653 -052 -219 

25 242 -048 186 -790 049 -202 

26 222 044 -014 "=055^ 073 -590 

27 187 555 086 -182 273 143 

28 137 5JL2. 194 -141 -037 -031 

29 144 502 -072 088 193 092 

30 -144 280 -096 079 -086 -109 

31 -116 255 022 066 -048 -119 
Contr ibut ion of 
factor (Vp) 4.28 2.19 2.14 2.59 1.39 2.54 

% Total Variance 13.8 7.1 6.9 8.4 4.5 8.2 

7o Common Variance 25.7 13.1 12.8 15.5 8.3 15.2 9-3 



VII 


Communal ities 


-333 


518 


-246 


655 


-245 


631 


-640 


544 


-6?4 


604 


-245 


387 


-008 


605 


014 


677 


-025 


321 


090 


705 


-073 


618 


-133 


581 


-104 


260 


006 


607 


246 


451 


066 


578 


-068 


482 


-032 


380 


-064 


306 


-042 


703 


-169 


540 


-269 


663 


-181 


570 


135 


549 


-056 


767 


-174 


439 


-196 


517 


-174 


372 


158 


358 


054 


667 


126 


621 


1.55 


16.67 


5.0 


53,8 



280 



SPECIAL NOTE Plutchik et al have also provided percentile scores for 
geriatric subjects. The following table "provides a 
frame of reference against which future patients may be 
evaluated for purposes of placement, selection, treat- 
ment, and research". 



PERCENTILE 


DISTRIBUTION 


OF 


INDIVIDUAL 


PLUTCHIK 


SCORES 


OF 


GERIATRIC PATIENTS 


Score 


Percent! le 


Score 




Percent i le 



0-4 1 25 55 

5-6 2 26 59 

7 3 27 62 

8 5 28 65 

9 8 29 68 

10 10 30 71 

11 12 31 73 

12 15 32 76 

13 19 33 80 
\k 22 3^ 83 

15 25 35 86 

16 27 36 88 

17 30 37 91 

18 32 38 93 

19 34 39 95 

20 38 ho 96 

21 k\ k] 97 

22 k5 42-43 98 

23 48 44-48 99 

24 52 49-51 100 



DOCUMENTATION: 

a. Raw score printout 

b. Factor score printout 

c. Means and standard deviations of factor scores 

d. Variance Analyses 



281 



042 NGI 
NURSES 
GLOBAL 
IMPRESSIONS 



MHB-43 
1-73 



NURSES' GLOBAL IMPRESSIONS 



INSTRUCTIONS: Code 20 under sheet number on general scoring sheet. 
Choose one response for each item. 



USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE 



40::0:: 



41 :A. 


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-.-.&-. 


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zzJzz 


Cols: 1 


2 


3 


4 


5 


6 


7 


8 



ROW 
NO. 



Mark each item on row designated in columns 1 — 8 



1. SEVERITY OF ILLNESS 



Considering your total clinical experience with this particulir 
population, how mentally III is the patient at this time? 



>° Not assessed 

1 ■= Normal, not at all 

2 = Borderline mentally ill 
3-= Mildly ill 

4 = Moderately ill 

5 •= Markedly ill 

6 == Severely ill 

7 = Among the most extremely ill patients 



2. GLOBAL IMPROVEMENT 

Compared to his condition at admission to the study, 
how much has he changed? 

(this item may be omitted at r/ie initial evaluation by marking 
"0" - Not assessed) 

= Not assessed 

1 = Very much improved 

2 = Much improved 

3 = Minimally improved 

4 " No change 

5 = Minimally worse 

6 " Much worse 

7 = Very much worse 



284 



The Nurses' Global Impressions (NGl) was developed during the PRB collabora- 
tive schizophrenia studies and is a 2-item scale for the assessment of global 
clinical judgments and is formatted for use with the Genera] Scoring Sheet. These 
two items correspond to the first 2 items of the Clinical Global Impressions. They 
were previously attached as I terns 31 and 32 to the NOSIE but have now been formatted 
independently so that they may be used with any combination of scales in the Nurses' 
Packet. 



APPLICABILITY 
UTILIZATION 



TIME SPAN RATED 
CARD FORMAT - ITEMS 



SPECIAL INSTRUCTIONS 



Al 1 populations 

Generally rated simultaneously with other Nurses' 
scales. If used alone, the NGl should be rated 
once at pretreatment and at least once at post- 
treatment. Additional ratings of the NGl are at 
the discretion of the investigator. 

Now or within the past week 

CARD 01 = (19x, 211) 

Severity of Illness Column 20 

Global Improvement Column 21 



Severity of Illness - It should be noted that this item is rated in the context 
of the particular population under study, e.g., in a study involving schizo- 
phrenic subjects, the degree of illness should be assessed against the rater's 
clinical experience with this type of subject. This represents a contextual 
change from the original item in which the rater was asked to judge severity in 
the context of total clinical experience with ALL populations. (See page 219). 

Global Improvement - Change at any given rating should be compared to the sub- 
ject's condition at pretreatment - NOT to his condition at the preceding rating. 
This item should be rated in the same context as CGI Global Improvement; i.e., 
"Rate total improvement whether or not, in your judgment, it is due entirely to 
drug treatment. " 

DOCUMENTATION 

a. Raw score printout 

b. Means and standard deviations 

c. Frequencies 

d. Crosstabulation 

e. Variance analysis 



285 



035 TQ 

TEACHER 

QUESTIONNAIRE 



MH-9-33 
1-73 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE-PUBIIC HEALTH SERVICE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

CONNERS TEACHER QUESTIONNAIRE 



PATIENT INITIALS 












NUMBER MAl£S 001 TO 499; FEMALES 


500 TO 998 






— 




:;A:: :*: :<:: :ft: :*:: 

HRST 
:«:: :t:: :<*: :*: :*- 

INITIAL 
:«:: ::V:: :*: :«:: -rT- 


:*:: 
:*:: 
:-Jt: 


:ftr 
:ft: 


:*t: 
:*: 


::|:: 
:*: 


::T:: 




ft: ::J:: :*: :i: :*: 
ft: ::!:: ::fc: :i: :*: 
ft: ::»:: :*:: :i: :.-*: 


PATIENT 

:i: 
::&: 


:*: 
:*: 
::&: 


::!:: 
::J:: 
::3t: 


-.-.&-. 
-.--&-. 
"&-- 


::»: 
::»: 
::»: 


— 




:*: :»: :«:: :ft: :«:: 

SECOND 
:«:: :t:: :*»:: :«:: :«:: 

INITIAL 
:»:: .it--- :1»: -*-- -■^-- 


:*:: 
:*: 
:i:: 


:ft: 
:*: 


:«: 
:*: 


::!:: 
:*: 


::*: 
::T:: 




ft: ::»:: ::fc: :i: :*: 
ft: ::»:: :i:: :*: ::*: 


RATER 


::S: 


::&: 
::ft: 


::Jt: 
::?i: 


::ft: 

::«: 


::»: 
::»: 


^ 






ft: ::»:: ::£:: :*: ::*: 

ft: ::»:: :*: :.5:: :=4:: 

Hours Days 
ft: ::»:: ::t: 


PERIOD 


WMk> 
:--*: 


::a: 
::&: 


::?:: 

::J:: 

AAonthi 
:*: 


::a: 
::»: 


::S: 


__ 


n 


illll^^ 


!S9i 


N 


N 


H 


H 


^ 


PLEASE USE A NO. 2 LEAD PENOL BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


— 


Listed below ore descriptive terms of behavior. AAork in th 


e column whi 


ch best describes this child. ANSWER ALL ITEA^S. 












^ 


1. 
2. 


CLASSROOM BEHAVIOR 

Fidgeting 

Hums and makes other odd noises 




Not 
•t 
iUI 

:ft: 
:ft: 


Jnl 
UtHi 


frelty 
Much 

:2:: 

:*: 


V.ry 
Mu(h 

:*: 

:i: 


22. 


GROUP PARTICIPATION 

Isolates himself from other 
children 




Not 
ct 
All 

:ft: 


Just 

• 

imit 


Ftitty 
Huih 

:2:: 


Very 
Hucb 

:3:: 




— 


3'. 


Demands must be met immediately; 
gets frustrated 




:ft: 




:*:: 


:*: 


23. 


Appears to be unaccepted 
by group 




:ft: 


::!:: 


:2:: 


=3:: 




^ 


4. 


Coordination poor 




:ft: 


::»:: 


:*: 


:i: 


24. 


Appears to be easily led 




:ft: 


::t:: 


:2z: 


:*: 







5. 


Restless (overactive) 




:ft: 


::»:: 


I*: 


:3:: 


25. 


No sense of fair play 




:ft: 


::»:: 


:£:: 


:a:: 







6. 


Excitable, impulsive 




:ft: 




:*: 


:*: 


26. 


Appears to lack leadership 




:ft: 


::»:: 


:£:: 


:i: 







7. 
8. 

9. 
10. 
11. 


Inattentive, distractobie 

Fails to finish things he starts 
(short attention span) 

Sensitive to criticism 

Serious or sad 

Daydreams 




:*: 

:ft: 

:ft: 
:ft: 
:ft: 




:*: 

::fc: 
I*: 
:*: 
:*: 


:*: 

:*: 
:*:. 
:*: 
:3:: 


27. 

28. 
29. 


Does not get along with 
opposite sex 

Does not get along with 

same sex 

Teases other children or 

interferes with tfieir 

activities 




:ft: 
:ft: 
:ft: 


::t:: 
::t:: 
::»:: 


:£:: 
:2:: 
:i: 


:±: 
:±: 
:±: 




^ 


12. 


Sullen or sulky 




:ft: 


::t:: 


:*: 


:*: 


















.^ 


















.^ 


13. 


Cries 




:ft: 


::»::• 


:«:: 


:*: 




ATTITUDE TOWARD AUTHORITY 















14. 


Disturbs other children 




:ft: 




:*:: 


:3:: 


30. 


Submissive 




:ft: 


::t:: 


r2;: 


:3:: 







15. 


Quarrelsome 




:ft: 


::t:: 


:2:: 


:3:: 


31. 


Defiant 




-.&-. 


::!:: 


:a:: 


r±: 







16. 


AAood changes quickly 




:ft: 




-.£=-- 


:3:: 


32. 


Impudent 




.&-- 


::L:: 


:2:: 


ri: 







17. 


Acts "smart" 




:ft: 


::»:: 


:2;: 


:*: 


33. 


Shy 




:ft-: 


::t:: 


-2^ 


:±: 







18. 


Destructive 




:ft: 




:i: 


:3:: 


34. 


Fearful 




:ft: 


::L:: 


:2:: 


:i: 







19. 
20. 


Steals 
Ues 




:ft: 
:ft: 




:*: 
:*: 


:3:: 
:*: 


35. 


^ Excessive demands for 
teachers attention 




rft: 


-.-.U-. 


:i: 


zi: 




^ 


21. 


Temper outbursts (explosive ond 
unpredictable behavior) 




:ft: 


::J.:: 


:*: 


:*: 


36. 
37. 
38. 
39. 


Stubborn 
Anxious to please 
Uncooperative 
Attendance problem 




:ft: 
:ft: 
:ft: 
:ft: 


z-A-.-. 

::»:: 
::»:; 


:*: 
:*: 
::2:: 
:*: 


:ft: 
:i: 
:i: 
:i: 




3! 


40. 


Considering your total teaching experience with child 
problem is th« child at this time? 


ren of this age, how mu 


chof 


a 




Nmi 

:ft: 


HiU 
::!:: 


Hod- 
•rcti 
:*:: 


Sovira 
:*: 




= 
















Academic Achievement 




Hwh 
mprovw 


IJM. 


No 
Clwngt 
:i: 


•iir 
:=*: 


HiKh 
Won* 
:ft: 


— 


41. 


What changes have you observed in this child 
(Omit this Htm at the initial rating) 


since the start of the 


Study? 


Overall Behavior 
Group Participation 




=»:: 


:*: 


:±: 
:*: 


:*: 


:*: 


— 
















Attitude Toward Authority 




::,:: 


:*: 


:*: 


:*: 


z*: 


= 



288 



Developed by Conners, the Teacher Questionnaire (TQ.) is a single-page, 41- 
item scale to be completed by the child's home-room teacher. It is an independent 
form in that responses are coded directly on the form and the General Scoring 
Sheet is not utilized. The first 39 4-point items are divided into 3 large groups: 
classroom behavior, group participation, attitude toward authority. Item kO is a 
4-point global judgment of the severity of the child's problem. Item k] consists 
of four 5-point global judgments of improvement in the following areas: academic 
achievement, overall behavior, group participation, attitude toward authority. 
The TQ. was designed to tap the teacher's evaluations of the child's ability to 
cope with his peers and with the demands of the school curriculum. 



REFERENCE 



Conners, C. K., A teacher rating scale for use in drug 
studies with children. American Journal of Psychiatry, 
1969, 126, 152-156. 



APPLICABILITY Children to 15 years of age 

UTILIZATION Once at pretrea tment . The 4l-item TQ. may be used for 

repeated assessments; but frequently the 10-item Parent- 
Teacher Questionnaire (PTQ) is substituted for ratings 
subsequent to the initial rating. The number of assess- 
ments is at the discretion of the investigator. 

TIME SPAN RATED Now or within the past month. 

CARD FORMAT - ITEMS CARD 01 = (19x, kk\\) 



tem Column 



1 


20 


2 


21 


3 


22 


k 


23 


5 


2k 


6 


25 


7 


26 


8 


27 


9 


28 


10 


29 


11 


30 



Item Column 



CARD FORMAT - FACTORS 



12 


31 


23 


13 


32 


2k 


]k 


33 


25 


15 


34 


26 


16 


35 


27 


17 


36 


28 


18 


37 


29 


19 


38 


30 


20 


39 


31 


21 


ko 


32 


22 


k] 


33 


TORS 


CARD 5 


1 = ( 



I tem Col umn 



k2 
k3 
kk 
k5 
kS 
kl 
k8 
kS 
50 
51 
52 



I tem 



Col umn 



3^ 


53 


35 


5k 


36 


55 


37 


56 


38 


57 


39 


58 


Sever i ty 


59 


Improvement 




Academic 


60 


Overal 1 


61 


Participation 


62 


Attitude 


63 



19x, 5F6.2, F2.0, F^.O, 4F2.0) 



(Code "5" in column ]i 
scores) . 

Factor 



IV 
V 



indicates card containing factor, cluster or other grouped 



Col umns 
20 - 25 
26-31 
32 - 37 
38 - k3 
kk - ks 



Item Columns 

Severity 5'0 - 51 

Total Score 52 - 55 

Improvement, Academic 56 - 57 

" Overal 1 58 ~ 59 

" Part ic ipat ion 60 " 61 

" Att i tude 6? - 63 



289 



Factor score = Sum of composite items 
No. of composite items 

Total Score = Sum of a 1 1 items 



Factor Score Range =0-3 
Total Score Range =0-117 



FACTOR COMPOSITION 



Conduct Problem 


12 - 


Sul len or sulky 


]k - 


Disturbs other children 


15 - 


Quarrelsome 


17 - 


Acts "smart" 


18 - 


Destructive 


19 - 


Steals 


20 - 


Lies 


21 - 


Temper outbursts 


25 - 


No sense of fair play 


29 - 


Teases other children 


no - 


Submiss ive 


31 - 


Defiant 


32 - 


Impudent 


36 - 


Stubborn 



38 - Uncooperative 

Inattentive -Pass ive 
h - Coordination poor 

7 - Inattentive 

8 - Fails to finish things 
1 1 - Daydreams 

2k - Appears to be easily led 
26 - Appears to lack leadership 



Tens ion-Anxiety 
9 - Sens i t i ve 
10 - Serious or sad 
30 - Submiss ive 

33 - Shy 

34 - Fearful 

37 - Anxious to please 
''39 - Attendance problem 

Hyperactivity 

1 - Fidgeting 

2 - Hums and makes other odd noises 

5 - Restless 

6 - Excitable 

14 - Disturbs other children 

29 - Teases other children 

35 - Excessive demands 
37 ~ Anxious to please 

Social Abi 1 ity 

22 - Isolates himself 

23 - Unaccepted by group 

27 - Does not get along with opposite 

sex 

28 - Does not get along with same sex 



Items not included in any factor: 3. 12, 16, 

•'- = I terns subtracted from factor score 

This factor analysis of the TQ. (Conners, I969) was based on a slightly reworded 
version of the scale. The sample consisted of 82 boys and 21 girls (Mean age - 
117.5 months; SD - 21.5 months) characterized by behavior disorders, hyperactivity 
and poor attention spans associated with learning disorders. Only children for 
whom drug therapy seemed specifically indicated were included. Factor 1 accounts 
for 39 percent of the variance; Factor II for 16 percent; Factor III for 12 per- 
cent; Factor IV for 19.6 percent and Factor V for 13-7 percent. The factors have 
some degree of intercorrelat ion, especially between Factors I and IV. 

SPECIAL INSTRUCTIONS 

1. The investigator should make certain that teachers fully understand how to com- 
plete the scale - particularly how to properly mark their responses. In checking 
the completed scale, make sure that the encoded initials are the patient's, NOT the 
teacher's. If the investigator wishes, teachers may complete the ID block. To do 
so, however, they must be given patient numbers, their rating number and thorough 
grounding in the encoding of PERIOD. 



290 



2. Do not write in the shaded area of the ID block. Form Number has been preceded. 



f •*• FORM 

Incorrect — ^ i NO. :*■ 35" 



Correct — ^ I ■ 



DOCUMENTATION 



a. Raw score printout 

b. Factor score printout - including global items 

c. Means and standard deviations for factor scores and global items. Ten- 
item totals, in lieu of factor scores, will be displayed when the PTQ. 
is substituted for repeated assessments. 

d. Crosstabulat ion of factor scores - Displayed only when TQ. is used for 

repeated assessments. 
e. Variance analyses. 



291 



036 PQ 

PARENT 

QUESTIONNAIRE 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 



CONNERS PARENT QUESTIONNAIRE 



INSTRUCTIONS: Listed below are items concerning children's behavior or the problems 
they sometimes have. Read each item carefully and decide how much 
you think your child has been bothered by this problem during the 
last month: NOT AT ALL, JUST A LIHLE, PRETTY MUCH, or VERY MUCH. 



Indicate your choice by filling in the space | 
column to the right of each item. 



) in the appropriate 



OBSERVATION 




PROBLEMS OF EATING: 


















PROBLEMS OF SLEEP: 






















FEAR AND WORRIES: 






















MUSCULAR TENSION: 










1 4 Shokes 








SPEECH PROBLEMS: 




• 










WEHING: 














BOWEL PROBLEMS: 


19 Soiling self 












COMPLAINS OF FOLLOWING 
SYMPTOMS EVEN THOUGH 
DOCTOR CAN FIND 
NOTHING WRONG: 




, 








. 














PROBLEMS OF SUCKING, 
CHEWING or PICKING: 














29, Picks at things such as hair, clothing, etc 




CHILDISH OR lAAMATURE: 






31 Cries 




32. Wants help doing things he should do alone 




34 Baby talk 








TROUBLE WITH FEELINGS: 






36. Lets himself get pushed around by other children. 

37. Unhappy 

38. Carries a chip on his shoulder 





Pretty Very 
much much 



294 



MH-9-36 
1-73 










DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

CONNERS PARENT QUESTIONNAIRE 




FORM APPROVED 
0MB NO. 48R96 


1 


PATIENT 


INITIALS 

. :S:: 
: -.t:: 
: .itzz 


rC: 




HRST 

zQzz :fi" 

INITIAL 


:fi:: -H.z z±-Z :Ji: 
za.z :H:: :S:i :I:: 


NUMBER MALES 001 TO 499; FEMALES 500 

:D:: ::L;i :£:: :3:: :4-: :*:: 

PATIENT 
:0=: zdtzz :«:: :3:: :4:: =5" 

:fi:: ::t:: :£:: :3:: r4:: :5:: 


TO 998 

:&: ::7" =ft: 
ifci ::7- idBci 
:d6c: ::7" :dBb; 


:A: 1 
zA: 
-A 1 


:4: 






:0" 
-X-z 


=E:: :i=" 
SECOND 

INITIAL 


:fir: :«" ::l:: :J:: 
ifl" :«:: :S:: "Tr: 












:4:: :3:: 

RATER 
:.4:: :*:: 


:&: -7" -Ai 
i&= ::7:: :A: 


:A: 




:0:: 
:0:: 


M 




:£:: 

F 
:£:: 


:3:r 
:3:: 


, 


:0" ::l:; :£:: :3.: 


:.4:: r3=. 

PERIOD 
:4r= liri 

Weeks 
r3:: 


:&: ::7:: :Ar 

:&: ::7r: :*r 

Months 
:4r= 




1 


RS 


|Rffi 


i 


P 


^W^ 


1. 


:0:: 
:0:: 


Hours 
zizz 




:£r: 


r3:: 
Days 
:2;: 





OBSERVATION 




OVER-ASSERTS 
HIMSELF: 


















PROBLEMS MAKING 
FRIENDS; 


42. Shy 












45. Has no friends 




PROBLEMS WITH 
BROTHERS AND 
SISTERS: 






47 Mean 




48 Fights 








PROBLEMS KEEPING 
FRIENDS: 


















RESTLESS: 










54. Falls to finish things he starts fshort afienlion span 




TEMPER: 


55. Temper outbursts, explosive and unpredictable 




















SEX: 


















PROBLEMS IN 
SCHOOL: 






























LYING: 


















STEALING: 






72. At school 












FIRE-SEniNG: 


74. Sets fires 








TROUBLE WITH POLICE: 











OBSERVATION 1 




76. Everything must be 


PERFECTIONISM: 


77. Things must be 
done same way 
every time 




78. Sets goals too high 




79. Inattentive, easily 
distracted 








81 . Cannot be left alone. 




82. Climbing; gets into 




83. A very early riser . 




84. Will run around 
between mouthfuls 




85. Demands must be 
met immediately 
— easily f rustroted 


ADDITIONAL 
PROBLEMS: 


86. Cannot stand too 
much excitement . . 




87. Laces and zippers 




88. Cries 




89. Unable to stop a 
repetitive activity . 




90. Acts as if driven 
by a motor 




91. Mood changes 




92. Poorly aware of 
surroundings or 
time of day 










..-Ul._ A^ »»., think 



295 



94. How serious a problem do you think 
your child has at this time? . 



The Parent Questionnaire (PQ.) , developed by Conners, is a 93-item check list 
of symptoms most commonly associated with behavior disorders of childhood. The 
9^th item is a global judgment of the severity of the child's problem. Symptoms 
are rated on a 4-point scale by either or both parents of the child. The PQ. is an 
independent form and does not require a General Scoring Sheet. 



REFERENCE 



Conners, C. K. Symptom patterns in hyperkinetic, 

neurotic and normal children, Child 
Development, 1970, ^1, 667-682. 



APPLICABILITY 
UTILIZATION 



Children to 15 years of age 

Once at pretreatment . The 9^-item PQ may be used for 
repeated assessments; but frequently the 10-item 
Parent-Teacher Questionnaire (PTQ) is substituted for 
ratings subsequent to the initial rating. The number 
of assessments is at the discretion of the principal 
invest igator . 



TIME SPAN RATED 



Now or within the last week. 



CARD FORMAT - ITEMS 



CARD 01 - (19x, 5611) 



Item 


Col umn 


Item 


Col umn 


1 tem 


Column 


1 tem 


Col umn 


1 


20 


15 


3k 


29 


48 


43 


62 


2 


21 


16 


35 


30 


49 


44 


63 


3 


22 


17 


36 


31 


50 


45 


64 


k 


23 


18 


37 


32 


51 


46 


65 


5 


2k 


19 


38 


33 


52 


47 


66 


6 


25 


20 


39 


34 


53 


48 


67 


7 


26 


21 


40 


35 


54 


49 


68 


8 


27 


22 


41 


36 


55 


50 


69 


9 


28 


23 


42 


37 


56 


51 


70 


10 


29 


2k 


43 


38 


57 


52 


71 


It 


30 


25 


44 


39 


58 


53 


72 


12 


31 


26 


45 


40 


59 


54 


73 


13 


32 


27 


46 


41 


60 


55 


74 


]k 


33 


28 


47 
CARD 


42 
2 - (19x, 


61 
3811) 


56 


75 


Item 


Column 


Item 


Column 


Item 


Column 


1 tem 


Column 


57 


20 


66 


29 


75 


38 


84 


47 


58 


21 


67 


30 


76 


39 


85 


48 


59 


22 


68 


31 


77 


40 


86 


49 


60 


23 


69 


32 


78 


41 


87 


50 


61 


2k 


70 


33 


79 


42 


88 


51 


62 


25 


71 


34 


80 


43 


89 


52 


63 


26 


72 


35 


81 


44 


90 


53 


64 


27 


73 


36 


82 


45 


91 


54 


65 


28 


7k 


37 


83 


46 

c 


92 

93 

ever i ty 


55 
56 
57 



296 



CARD FORMAT - FACTORS 



CARD 51 = 19x, 8f6.2, F2.0, F4.0) 



(Code "5" in Column 18 indicates card containing factor, cluster or other derived 
scores .) 



Factor 




Column 




Factor 


Col umn 


1 




20 - 25 




VI 


50 - 55 


II 




26 - 31 




VI 1 


56 - 61 


1 1 1 




32 - 37 




VI II 


62 - 67 


IV 




38 - 43 




Severity 


68 - 69 


V 




kk - kS 




Total Score 


70 - 73 


re - Sum 


of 


compos i te 


items 


Factor Score 


Ranqe = - 



Factor score 

No. of composite items 



Total Score - Sum of 93 items 



Total Score Range = - 279 



FACTOR COMPOSITION 



I . Conduct Problem 
39 - Bui lying 

kO - Bragging and boasting 
41 - Sassy to grown-ups 
k7 - Mean 

k8 - Fights constantly 
51 - Picks on other children 
69 - Blames others for his mistakes 

11. Anxiety 

8 - Afraid of new situations 

9 - Afra id of people 

10 - Afraid of being alone 

11 - Worries about illness and death 
k2 - Shy 

43 - Afraid they (children) do not like 
64 - Is afraid to go to school 

III. Impulsive-Hyperactive 



IV. 



79 - Inattentive, easily distracted 

80 - Constantly fidgeting 

81 - Cannot be left alone 

82 - Always climbing 

83 - A very early riser 

84 - Will run around between mouthfuls 

89 - Unable to stop a repetitive activity 

90 - Acts as if driven by a motor 

Learning Problem 
45 - Has no friends 

62 - Is not learning 

63 - Does not like to go to school 
67 - Will not obey school rules 



V. Psychosomatic 

6 - Awakens at night 

21 - Headaches 

22 - Stomach aches 

23 - Vomiting 

24 - Aches and pains 

VI . Perfectionism 

76 - Everything must be just so 

77 ~ Things must be done same way 

78 - Sets goals too high 

VII. Antisocial 

71 - (Stealing) from parents 

72 - (Stealing) at school 
him 73 - (Stealing) from stores 

75 - Gets into trouble with police 

VIM. Muscular Tension 

12 - Gets stiff and rigid 

13 - Twitches, jerks, etc. 

14 - Shakes 
36 - Lets himself get pushed 

around 



Only 42 items are subsumed under the 
8 factors; the other 52 items are not 
utilized in the factor scoring. 



297 



This factor analysis is based on a sample of clinic outpatients and normal children 
(N=683) and has been shown to give relatively stable factor structure across ages 
and a wide social class range (Conners, 1970). These factor scores will be relative- 
ly independent since items were selected so as to have minimal overlap in loadings 
on other factors. However, some correlation among scales can be expected since only 
factor scores derived by using actual loadings will be orthogonal to other factors. 
Although similar patterns of symptomatology appear in normals and outpatients, the 
severity of symptomatology is higher among the patient groups. 

SPECIAL INSTRUCTIONS 

1. For any scales which are filled out by "lay raters" (patient, parent, etc.) an 
observer should be present, whenever possible, to make sure that the instructions 
are understood and that the rater knows how to properly mark his/her responses. 
Following completion of the scale, check to make certain that all items are completed 
and that only one answer is given to each item. With the PQ., make certain that the 
rater realizes that there are additional Items under the first fly leaf. If the 
parent fills in the initials, check to see that they are the patient's initials, NOT 
the parent's. The rest of the ID block is best completed by the observer. 

2. Coding Rater - Code 1 1 (M) when mother or mother surrogate completes the scale; 
code 22(F) when father or father surrogate completes the scale. Use any other 2 
digits for other rater. 

3. Do not write in the shaded area of the ID block. Form Number has been precoded. 



ncorrect — » \ /L 

' «/ Co NO. 



I: ■ -*• FORM 

Correct— * p ;,--■ i^_ 



DOCUMENTATION 



a. Raw score printout 

b. Factor score printout - including global item 

c. Means and standard deviations for factor scores and severity. Ten item 
totals, in lieu of factor scores, will be displayed when the PTQ. is 
employed for repeated assessments. 

d. Crosstabulat ion of factor scores - Displayed only when PQ. is used for 
repeated assessments. 

e. Variance analyses - When the PTQ is employed for ratings subsequent to 
the initial one, the 10 comparable items extracted from the PQ •■■"' ^''■ 
used as for the initial rating. 



298 



037 PTQ 

PARENT-TEACHER 

QUESTIONNAIRE 



DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

CONNERS PARENT-TEACHER QUESTIONNAIRE 



PATIENT 
:A: 
-H: 
:U: 


INITIALS 
:8:: 
:t:: 

. :«:: 


:C:: 
:M:: 

:*:: 


:0:: 
:«:: 
:X:: 


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RRST 
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INITIAL 
:W:: r2:r 


ifl:: 
ifl:: 


:H:: ::t:: 


:5J:: 
:I:: 


NUMBER 
:0:: 
:0:: 
:0:: 


MALES 001 TO 
::L:: :2:: :3:: 
r:t:: :2:: :3:: 
::L:: :«:: :3:: 


499; FEMALES 500 
:*:: :*: 

PATIENT 

:*: :3:: 
:<:: :3:: 


TO 
:* 
:* 
:* 


998 
::T:: 
::T:: 
::T:: 


-*: 

:*:' 
:*: 


:*: 
:*: 
:*: 


— 


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SECOND 
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INITIAL 
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F 
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RATER 

:*: :*: 


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:*: 
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^ 


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Houri 
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PERIOD 

:<:: :*: 

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Monthl 
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:*: 
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, 






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"" 


PLEASE USE A NO. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


— 



INSTRUCTIONS: Listed below are items concerning children's behavior or the problems they sometimes have. 
Read each item carefully and decide how much you think this child has been bothered by 
this problem of this time: NOT AT ALL, JUST A LIHLE, PRETTY MUCH, or VERY MUCH. 
Indicate your choice by filling in the space (>••) in the appropriate column to the right 
of each item. 
ANSWER ALL ITEMS 



Not Just 
•I • 

Ml tittli 



htttr Vtry 
Hsch Much 



1 . Restless (overactive) 

2. Excitable, impulsive 

3. Disturbs other children 

4. Foils to finish things he starts (short attention span) 

5. Fidgeting 

6. Inattentive, distractable 

7. Demands must be met immediately; frustrated 

8. Cries 

9. Mood changes quickly 

10. Temper outbursts (explosive and unpredictable behavior) 



zfic: ::t:: :4:: i*: 



:«:: irLi: :i:: 



:S:: ::»:: :2:: :i: 



:fi:: ::!:: :£:: :i: 



:fit: ::t:: :«:: :3:: 



riS:: "»:: =*:: :3:; 



rfic: ::t:: :«:: :*: 



:«:: ::»:: :*: ;*: 



:«:: ::(:: :*:: :*: 



:«:: ::J:: :*:: :*= 



How serious a problem do you think this child has at this time? 



:*: 



300 



The Conners Parent-Teacher Q,uest ionna i re (PTQ.) is an independently formatted 
scale containing II items common to both the Parent (Questionnaire and Teacher 
(Questionnaire. The PT(i per se is not so much an independent scale as it is a 
device which reduces - by abbreviation - the burden of repeated assessments for 
teachers and parents. The correspondence of items across the 3 scales is as 
f o 1 1 ows : 

PT(i Pd Td 

1 52 5 

2 53 6 

3 kS ]k 
k 54 8 

5 80 1 

6 79 7 

7 85 3 

8 88 13 

9 91 16 
10 55 21 

Severity (11) Sk kO 

APPLICABILITY Children to 15 years of age 

UTILIZATION The PT(i must be used in conjunction with either the 

Parent (Questionnaire or Teacher (Questionnaire. 

TIME SPAN RATED Now or within the last week. 

CARD FORMAT - ITEMS CARD 01 = (19x, 101 1, 12, ll) 

I tern Column Item Column 

1 20 

2 21 

3 22 
k 23 

5 2k 

6 25 

Total Score = Sum of Items 1 through 10. Total Score Range =0-30 

SPECIAL INSTRUCTIONS 

Either the full P(i or full T(i must be used for the initial assessment, even though 
the investigator plans to use the abbreviated PT(i for subsequent ratings. This is 
strongly recommended since a more detailed description of the subject prior to 
treatment can be obtained by use of these longer scales. Although the brevity of 
the PT(1 is a decided advantage for repeated ratings, it yields only a total score. 



7 


26 


8 


27 


9 


28 


10 


29 


Total Score 


30 - 31 


Severity 


32 



301 



Both the PQ and TQ provide factors which may permit scrutiny of specific drug 
effects within circumscribed behavior areas. For investigators who wish a 
more detailed measure of drug effect, it is suggested that the full PQ or full 
TQ be used for all ratings. 

Encoding Rater - Encode 11 (M) if mother completes the PTQ.; encode 22 (F) for 
father. Use any other number for teacher; but, of course, use the same number 
for a given rater throughout the study. 



Shaded Area - Do not write in the shaded area of the ID block, 
pre-coded . 



Form Number is 



incorrect- 



Correct- 



Monitoring - As with all forms used by lay raters, be sure that the rater fully 
understands the instructions and how to properly mark his/her responses. When- 
ever possible, the completed scale should be reviewed immediately for omissions 
or multiple entries (more than one mark for an item). The ID block should also 
be checked for accuracy if the lay rater has completed it. Make sure that the 
patient's (child's) initials - NOT the rater's - are encoded. 

DOCUMENTATION 

a. Raw score printout 

b. Total score means and standard deviations. 

c. Variance analyses - When the longer PQ and TQ are used at the initial 
rating, the 10 PTQ. items will be extracted from them for use in the 
variance model . 



302 



RATING SCALES FOR USE IN DRUG STUDIES WITH CHILDREN* 
C. Keith Conners, Ph.D. 

The purpose of this report is to describe some rating scales for use in 
children's drug studies. It seems eminently clear that no single choice of 
scales is likely to meet the needs for the variety of populations, designs, 
facilities and purposes of various research problems, and though I have chosen 
to recommend certain scales for consideration, I have also presented alterna- 
tives that may enrich the discussion and possibly be of use to investigators 
unfamiliar with these alternatives. 

A number of good sources are available regarding the technology of scale 
construction and methodologic issues (1, 2, 3), 3nd reviews of rating scales in 
psychiatric settings are available (4, 5). While there is indeed an elaborate 
technology for producing "pure" psychometric instruments, most evidence seems 
to indicate that the practical gains from elabora-te and sophisticated scaling 
procedures is minimal (1), and I do not propose to deal with the many methodologic 
issues raised in the use and construction of rating scales. Certain basic attri- 
butes of reliability and validity need, of course, to be considered, and for the 
most part I have not included a number of scales that look interesting but which 
have no published reliability or validity data. 

The choice of children's rating scales needs to be based on certain criteria 
and working assumptions which will eliminate some scales from further consideration. 

First, there is the source of the rating data. If the source of data is the 
parent or teacher, then the scale must be non-technical, brief and easily filled 
out. A clinician or trained observer on the other hand, may use much more detailed 
and theoretically-oriented instruments. Since parent, teacher, and clinician have 
different (though overlapping) behavior samples, the scales for different observers 
almost certainly need to be different in content, though an overlap in some areas 
would be des i rable. 

Secondly, there is the question of level of observation. This can be very 
molecular--where specific behavioral acts or sequences can be observed and time- 
sampled--or the categories can be quite global, abstract or inferential. Most 
people are agreed that ratings which require a great deal of inference about under- 
lying processes tend to be unreliable; but descriptive global ratings that use 
"middle level" inferences are often the most reliable. Unless the observer is high- 
ly trained there is likely to be a loss of reliability for rating of molecular events, 
We have, therefore, tended to assume that some middle level of abstraction, requiring 
a minimum of inference, is preferable unless highly trained observers are available. 



'-This material was written by Dr. Conners for presentation to the Pediatric 
Psychopharmacology Workshop. It reflects the processes by wh'i'ch assessment 
instruments were chosen for the ECDEU Pediatric Battery. 

303 



A related issue is whether one is interested in rating current behaviors, 
symptoms or states; or whether the intent is to describe basic traits, disposi- 
tions, or personality characteristics. While not mutually exclusive, these 
approaches lead to somewhat different types of scales. I have assumed that a 
symptom focus is most appropriate for our purposes, though the difference be- 
tween a symptom and a trait is probably more a question of values as to 
whether the behavior in question is normative or undesirable. 

Whether one uses state or trait methods depends to some extent on the pur- 
pose of using the ratings in the first place. A use for prediction might well 
require more trait-disposition items, while symptoms would seem to be more appro- 
priate for measuring change. Both types of items are appropriate for questions 
of taxonomic classification. It is coneivable to me that all three purposes — 
prediction, measurement of change, and class if icat ion--might be meaningfully 
applied in drug studies. In general, I have recommended the use of behavior 
items that are susceptible to short term change, but which can also be used in 
conjunction with statistical techniques for prediction and classification. 

The population under study clearly makes a difference in the type of scale 
to be employed. It has seemed reasonable that separate instruments should be 
employed for severe psychiatric disturbances (psychosis, retardation, autism, 
etc.) as contrasted with the more frequent and typical patients found in out- 
patient settings. Institutionalized children are usually more severely affected 
by their illness, and many of their symptoms are of low frequency in outpatients 
(e.g., hallucinations, autistic aloofness). 

Finally, the format of the scale needs consideration. For most purposes a 
scale with specific anchor points describing the behavior in question is most 
likely to be reliable and valid. But such scales are also more cumbersome and 
time-consuming to use. If the range of behavior to be sampled is broad, (as it 
is likely to be in the screening phase of a study) then the items should be brief 
and the rating procedure as simple as possible. This consideration has led me to 
recommend the "chec-k-1 ist" type of scale, especially for parent ratings. 

Teacher Rating Scales 

1. Cattel 1 and Coan (6) administered a 38-item trait list of bipolar items 
to teachers of 198 first and second grade pupils. This list was compiled to in- 
clude the major "markers" from other personality research, as well as "useful 
indicators of personality disturbance." Many of the items are probably irrelevant 
for symptom-oriented studies (e.g., "aesthetically sensitive, aesthetically fastid- 
ious, vs. lacking in artistic feeling"), but for those investigators interested in 
predicting drug effect from personality traits, this might be a useful scale. They 
identified some 15 factors by Cattel I's methods (oblique rotations), but the reliabil 
ity of factor scores is not given, and the non- independence of the factors probably 
makes them of little use as independent predictors in regression equations. 

2. Peterson (7) used the referral problems of 427 cases at a guidance clinic 

to select the 58 most common symptoms. The list was given to teachers of 831 kinder- 
garten through sixth grade pupils for ratings. Two major factors (conduct problem 
and personality problem) emerged with considerable consistency across the whole age 
range. Interrater reliabilities (for the Kg sample) were .77 and .75 for factor 



304 



scores for the two factors. Quite similar factors have emerged in a number of 
studies by Quay and associates (8) for various populations, from sources as dis- 
parate as case history ratings, questionnaires, standard ratings, and by a vari- 
ety of factor extraction methods. 

However, several questions can be raised about these results. The presence 
of only two (sometimes three) factors suggests that either the repertoire of items 
is so restricted as to guarantee a small number of independent factors or the meth- 
od of analysis produces few factors. Secondly, the two factors appear to subsume 
some very disparate behaviors which intuitively seem distinct. Thirdly, many of 
the items, particularly conduct problem items, are essentially synonyms, guarantee- 
ing that a strong factor will emerge. Some of the items are symptomatic (e.g. 
fighting), while some are essentially trait names (e.g. nervousness, aloofness). 
Nevertheless, similar factors emerge in some form or other in many other studies, 
and it is probably safe fo assume that there are at least two important dimensions, 
or causally independent factors, that could be extremely useful in basic classifi- 
cation, prediction, and possibly measurement of change in drug studies. 

3. A comprehensive classroom behavior and personality instrument has been 
developed by Shaeffer and colleagues at the Laboratory of Psychology of NIMH. The 
items were selected from a theoretical model of child behavior, have been extensive- 
ly analyzed for factor structure and reliability, and tested in the U.S. and 
Scandinavia. Specific classroom behaviors are organized into traits, and the traits 
are organized into factors and arranged in a "circumplex" model. Figure 17 shows 
the conceptualization of the item-trait-factor derivation, and Figure 18 is an 
example of the ordering of traits on a circumplex. 1 The major difficulty with this 
instrument seems to be its length. The 320 items in the scale seem prohibitively 
time-consuming for volunteer reporting by teachers. However, the excellent pool 

of items, and the extensive analytic work on sub-scales might be useful in some 
sett ings . 

4. The Devereux Elementary School Behavior Rating Scale (9) is a ^y-item 
anchored scale for teachers, with items easily grouped into 11 behavior factors. 
Normative data is available on 809 normal children in kindergarten through 6th 
grades. Test-retest factor scale reliabilities range from .71 to .91. with small 
standard errors of measurement, and median reliability of .87. The factor structure 
is quite similar across grade levels. In general the scale meets most of the require- 
ments for an instrument in drug studies, though I know of no demonstration that it is 
"drug-sensitive". This scale has a high priority for use as a standardized data- 
gathering instrument. 

5. A 39-item Teacher Symptom Checkl ist ,or iginal ly developed by Eisenberg and 
colleagues has been used in several drug studies and recently factor analyzed by 
Conners (10). The five factors are highly reliable on test-retest, and appear to 

be quite sensitive to changes due to drug, with relatively little placebo influence. 
Test-retest reliabilities over a one-month period ranged from .72 to .91. The five 



These data are from an unpublished manuscript by Shaeffer, Droppelman, and 
Kalverboer. Unfortunately, at the time of this preparation I did not have 
available Dr. Shaeffer's more recent extensive work. 



305 



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307 



factors were labeled "aggressive conduct", "day-dreaming-inattent i ve" , "anxious- 
fearful", "hyperactivity", "sociable-cooperative". (A newer, slightly modified 
form has been developed which contains 10 items that overlap with the symptom 
checklist for parents, described below. This allows one to compare ratings from 
both sources on a common core of items.) 

6. Two excellent teacher scales should be mentioned. Both are more appro- 
priate for identification of learning disorders and children with developmental 
deviations than for measuring change, but in view of the likelihood of increased 
interest in drug studies of learning disorders, the scales are important to keep 
in mind where large scale screening may be needed to identify potential candidates 
for drug studies. The first is a 24-item anchored scale by Myklebust (11). The 
items are grouped into five areas: auditory comprehension and learning, spoken 
language, orientation (time, space, relationship), behavior, and motor. The scale 
was used to identify children with minimal cerebral dysfunction in a sample of 
2767 third and fourth graders. Excellent discriminative power and validity were 
shown with the scale, though reliabilities are not reported. 

The Classroom Screening Inventory developed by the Rocky Mountain Educational 
Laboratory (12) is an 80-item scale that is divided into 14 sub-scales focused on 
classroom learning and behavior. A very thorough item analysis, factor analysis, 
reliability and validity studies are reported. The instrument was used in a study 
of a stratified random sample of 2400 children in the Rocky Mountain area. jnter- 
rater reliability was .85. A validity study showed that the screening produced no 
false positives and very few false negatives. This instrument though still being 
developed is the best of its kind known to this writer. 

In summary, the Devereux Elementary School Behavior Rating Scale appears to 
meet most of the requisites for a brief, reliable scale for children's drug studies. 
As an alternative, the Conners scale is probably easier to use and less likely to 
be resisted by the busy teacher because of its checklist format. However, the more 
extensive published research on the Devereux Scale makes it appear as the best bet 
at this time. 

Parent Rating Scales 

A number of studies of the dimensions of symptom behavior in young children 
have been made during the past several years. Jenkins and Hewitt (13) described 
three clusters of traits identified from case records of 500 children rated on 90 
symptoms. More recently, Jenkins (14) identified 5 clusters which he labelled 
"shy-seclus ive", "overanxious-neurotic", "hyperactivity with poor concentration", 
"undomesticated", and "socialized delinquent". These clusters fell into two broad 
categories of inhibited and aggressive children. Peterson (15) identified two 
dimensions from parent and teacher ratings which he labelled "conduct disorder" 
and "personality disorder". These patterns have emerged in several other studies 
by Quay (16), Dreger, et al. (I7), and Borgatta and Fanshel (18). The latter study 
produced 12 factors: defiance, unsoc ia] ized, tension-anxiety, lack of affection, 
infantilism, overcleanl iness , sex precoc iousness , sex inhibition, learning diffi- 
culty, (a and b) , likeability, responsibility. A second-order factor analysis 



308 



produced six factors including an "acting-out" factor, developmental immaturity, 
inhibited behavior, learning disorder, and sociable-responsible. Reliabilities 
of factor scales are not given, but individual item reliability ranges from .60 
to .77, suggesting that factor scales are likely to be highly reliable. These 
studies and others mentioned below provide a substantia] base of knowledge for 
purposes of prediction and classification. 

An anchored rating scale for nonprofessionals was developed by Spivack and 
Spotts (19) at the Devereux Foundation. Good norms are available for the 17 sub- 
scales of the 97~item scale. Like the teacher's version, this scale is thorough- 
ly researched, easy to use and score, and covers a bro^d range of psychopathology . 

The Missouri Children's Behavior Checklist (20) is a similar 70-item yes-no 
checklist of symptoms. The factors of aggression, inhibition, activity level, 
sleep disturbance, somatization and sociability have odd-even reliabilities rang- 
ing from .67 to .86. Inter-parent agreement on individual items ranged from 53% 
to 9k%. Validity studies of clinic versus controls showed significant discrimina- 
tion of all factors except somatization and sleep disturbance. 

Conners (21) has described a 93-item parent symptom checklist that was factor- 
analyzed on 316 clinic patients between the ages of 6 and \k, and 367 normal con- 
trols of the same age. Twenty-four categories of symptoms (sleep, learning, socia- 
bility, etc.) were factor analyzed. Six factors were identified by principal com- 
ponents analysis and labelled aggressive conduct disorder, anxious-inhibited, anti- 
social, enures is-encopres is , psychosomatic, and anxious-immature. Discriminant 
function analysis showed that 83% of controls and 70% of clinic patients could be 
correctly classified from factor scores. Neurotic and hyperkinetic children were 
also correctly identified in 77% and 7^% of the cases, respectively. Mother-father 
agreement averaged .85 on total scores, but factor scale agreement is not reported 
as yet. The first two factors (conduct disorder and anxious-inhibited) have been 
used in drug studies and show significant drug-placebo interactions. A recently 
modified version employs a 10-item scale to overlap with teacher ratings for repeated 
measures in drug studies. 

A factor analysis was also completed on individual items for the total sample 
of 683 subjects (previous analyses had shown close similarity in factor structure 
for different social classes, different age ranges, and for the sexes). Factor load- 
ings on each of the seven factors are very similar to the factors reported bv 
Achenbach, Borgatta and Fanshel (18), and several others. 

One drawback of the scales described here is that none includes symptoms of 
severe psychopathology such as psychotic manifestations. A rather extensive study 
on children's psychiatric symptoms by Achenbach (22) includes more of such symptoms. 
The large, first principal component factor appeared to be a bipolar "internalizing 
vs. externalizing" factor, and the second large component was identified as a uni- 
polar "diffuse psychopathology" factor. Eight rotated factors were identified as: 
somatic complaints, delinquent behavior, obsessions, compulsions and phobias; sexual 
problems; schizoid thinking; unsocial ized aggression; hyperactivity; and one minor 
factor. The main problem with this scale is that it is designed for professionals 



309 



or semi-professionals, so that various items would be difficult for parents to 
use (such as diplopia, compulsions, etc.). This is an excellent list, however, 
for rating of case records or other symptom rating in a clinical context. 

In summary, both the Conners and Devereux scales appear to be feasible in 
drug studies, with the latter scale being more thoroughly standardized. 

Cl inician's Ratings 

1. Very few standardized child-psychiatry rating scales are available. The 
brief standardized rating procedure described by Rutter and Graham (23) appears 
to have both good inter-examiner reliability and validity. A somewhat more com- 
prehensive rating scale for psychiatrists has been provided by Drs. Klein from 
the Hillside Hospital but standardization procedures are not available at this 

t ime. 

2. A valuable source of observation, particularly for measuring change in 
drug studies, is a behavior rating by the psychologist on the basis of observa- 
tions made during psychological testing. I am unaware of any standardized forms 
for this purpose, but the rating scale used by the NINDS Collaborative Perinatal 
project appears to be excellent for most purposes. 

Inpatients and Retarded 

The Children's Behavior Inventory by Burdock and Hardesty (24) is a 139-item 
yes-no scale with items grouped by age-appropriateness. Extensive reliability and 
validity studies have been done, and the results indicate sufficient discriminative 
power and stability to warrant using the inventory in settings where a moderate 
amount of training of observers is possible. The items are rationally grouped into 
categories of vegetative function, appearance and mannerisms, speech and voice, 
emotional display, socialization and thought processes. Drug studies have not yet 
been reported with this instrument. 

A much briefer scale has been reported by Davis, Sprague and Werry (25) for 
time-sampling measurement of stereotyped behavior in retardates. Interjudge relia- 
bilities ranged from .61 to .88 for the 7 categories. The scale showed sensitivity 
to drug treatment, and would appear to be an excellent measure for this relatively 
restricted (but common) set of behaviors in retardates or other severely disturbed 
inpatients . 

REFERENCES 

1. Chronbach, L. J. Essentials of Psychological Testing. Harper, I960 (New York), 
2nd Ed. 

2. Lyerly, S. B. and Abbott, P. S., Handbook of Psychiatric Rating Scales (1959- 
1964). USPHS Publication # 1495. 

3. Guilford, J. P., Psychometric Methods, McGraw Hill, 1954 (New York), 2nd Ed. 



310 



k. Norton, W. A., Review of Psychiatric Rating Scales, Canad. Psychiatric 
Assoc. Journal. I967, 12 (6), 563-7^. 

5. Doty, D., Rating scales used in children's drug research: a review of 
the literature. In Survey of research on psychopharmacology of children, 
by R. Sprague and J. Werry and Students (Children's Research Center, 

U. of 111 inois) . 

6. Cattell, R., and Coan, R. W., Child personality structure as revealed by 
teachers' behavior ratings. J. Clin. Psychol., 1957, 13, 315-327. 

7. Peterson, D. R., Behavior problems in middle childhood, J. Consult. 
Psychol., 1961, 25, 205-209. 

8. Quay, H. C. Personality dimensions in delinquent males as inferred from 
the factor analysis of behavior ratings. J. Research in Crime and 
Delinquency, 1964, 1, 33-37. 

9. Spivack, G. and Swift, M. The Devereux Elementary School Behavior Rating 
Scale. Devereux Foundation, Devon, Pennsylvania. 

Spivack and Levine, M. The Devereux Child Behavior Rating Scales: a study 
of symptom behavior in latency age atypical children. Amer. J. Ment. Def., 
1964, 68, 700-717. 

10. Conners, C. K. A teacher rating scale for use in drug studies with 
children. Amer. J. Psychiatry, I969, 126, 884-888. 

11. Myklebust, H., Minimal Brain Damage in Children. Final report to USPHS 
Contract #108-65-142, 

12. Rocky Mountain Educational Laboratory Classroom Screening instrument. 
RMEL, 1620 Reservoir R., Greeley, Colo. 8O63I. 

13. Jenkins, R. L., and Hewitt, L., Types of personality encountered in child 
guidance clinics. Amer. J. Orthopsychiatry, 1944, 14, 84-94. 

14. Jenkins, R., Psychiatric syndromes in children and their relation to 
family background. Amer. J. Orthopsychiatry, 1966, 36, 450-457- 

15. Peterson, D. R., op. cit. 

16. Quay, H. C, op. cit. 

17. Dreger, R. M., et al. Behavioral classification project. J. Consult. 
Psychol., 1964, 28, 1-1 3. 



311 



18. Borgatta, E. F. and Fanshel , D. Behavioral characteristics of children 
known to psychiatric outpatient clinics. Child Welfare League of America, | 
1965, (Library of Congress, 65-197^6). ' 

19. Spivack, G. and Spotts, The Devereux Child Behavior Rating Scale. 
Devereux Foundation, Devon, Pa. 

20. Sines, J. 0., Pauker, J. D., Sines, L. K. and Owen, D. R., Identification 
of clinically relevant dimensions of children's behavior, J. Consult. & 
Clin. Psychol., I969, 33, 728-73^. 

21. Conners, C. K., Symptom patterns in hyperkinetic Neurotic and Normal 
Children. Child Devel . (in press). 

22. Achenbach, T. M. The classification of children's psychiatric symptoms: 
a factor analytic study. Psychological Monographs, I966, 80, No. 6. 

23. Rutter, M. and Graham, P. The reliability and validity of a psychiatric 
interview for children. Brit. J. Psychiat. ,' I968, 114, 563-579- 

2k. Burdock, E. L., and Hardesty, Anne S., A children's behavior diagnostic 
inventory. Ann. N. Y. Acad. Sci., 1964, 105, 89O-896. 

25. Davis, K. v., Sprague, R. and Werry, J. Stereotyped behavior and 
activity level in severe retardates: the effect of drugs. Amer. J. Ment. 
Def., 1969, 73, 721-727. 

26. Alderton, H. R. & Hoddinot, B. A., A controlled study of the use of 
thioridazine in the treatment of hyperactive and aggressive children in 
a children's psychiatric hospital. Canad. Psychiat. Assoc. J., 1964, 
9, 120-130. 

27. Pritchard, M. Observation of children in a psychiatric inpatient unit: 
design of a behavioral rating scale for nursing staff. Brit. J. Psychiat., 
1963, 109. 572-578. 



312 



053 SCL-90 
SELF-REPORT 
SYMPTOM 
INVENTORY 



SCL-90 

Below is a list of problems and complaints that people sometimes have. Please read each 
one carefully. After you have done so, please fill in one of the numbered spaces to the 
right that best describes HOW MUCH THAT PROBLEM HAS BOTHERED OR DIS- 
TRESSED YOU DURING THE PAST WEEK INCLUDING TODAY. Mark only one 
numbered space for each problem and do not skip any items. Make your marks care- 
fully using a No. 2 pencil. DO NOT USE A BALLPOINT PEN. If you change your mind, 
erase your first mark carefully. Please do not make any extra marks on the sheet. Please 
read the example below before beginning. 



HOW MUCH WERE YOU 
BOTHERED BY: 



1. Backaches 



HOW MUCH WERE YOU BOTHERED BY; 

1. Headaches 

2. Nervousness or shakiness mside 

3. Unwanted thoughts, words, or ideas that won't leave your mir 

4. Faintness or dizziness 

5. Loss of sexual interest or pleasure 

6. Feeling critical of others 

7- The idea that someone else can control your thoughts .... 

8. Feeling others are to blame for most of your troubles .... 

9. Trouble remembering things 

10. Worried about sloppiness or carelessness 

11. Feeling easily annoyed or irritated 

12. Pains in heart or chest 

13. Feeling afraid in open spaces or on the streets 

14. Feeling low in energy or slowed down 

15. Thoughts of ending your life 

16. Hearing voices that other people do not hear 

17. Trembling 

18. Feeling that most people cannot be trusted 

19. Poor appetite , 

20. Crying easily 

21. Feeling shy or uneasy with the opposite sex 

22. Feeling of being trapped or caught 

23. Suddenly scared for no reason 

24. Temper outbursts that you could not control 

25. Feeling afraid to go out of your house alone , 

26. Blaming yourself for things 

27. Pains in lower back 

28. Feeling blocked in getting things done 

29. Feeling lonely , 

30. Feeling blue 

31. Worrying too much about things 

32. Feeling no interest in things , . . . 

33. Feeling fearful 

34. Your feelings being easily hurt 

35. Other people being aware of your private thoughts 

36. Feeling others do not understand you or are unsympathetic. , 

37. Feeling that people are unfriendly or dislike you 

38. Having to do things very slowly to insure correctness 



314 



MH 9-53 
5-73 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
NATIONAL INSTITUTE OF MENTAL HEALTH 

SCL - 90 



PATIENT INITIALS 



FIRST 
INITIAL 



NUMBER MALES 001 to 499; FEMALES 500 to 998 

6 



PATIENT 



SECOND 
INITIAL 



Day 
1 



HOW MUCH WERE YOU BOTHERED BY: 



Heart pounding or racing 

Nausea or upset stomach 

Feeling inferior to others 

Soreness of your muscles 

Feeling that you are watched or Talked about by others 

Trouble falling asleep 

Having to check and double-check what you do ... . 

Difficulty making decisions 

Feeling afraid to travel on buses, subways, or trains . . 

Trouble getting your breath 

Hot or cold spells 



Having to avoid certain things, places, or activities 
because they frighten you 



Your mind going blank 

Numbness or tingling in parts of your body 

A lump in your throat 

Feeling hopeless about the future 

Trouble concentrating 

Feeling weak in parts of your body . . . . 

Feeling tense or keyed up 

Heavy feelings in your arms or legs 

Thoughts of death or dying 

Overeating 



Feeling uneasy when people are watching or talking 
about you 



Having thoughts that are not your own .... 
Having urges to beat, injure, or harm someone 
Awakening in the early morning , 



Having to repeat the same actions such as touching, 
counting, washing 



Sleep that is restless or disturbed 

Having urges to break or smash things 

Having ideas or beliefs that others do not share 

Feeling very self-conscious with others 

Feeling uneasy in crowds, such as shopping or at a movie 

Feeling everything is an effort 

Spells of terror or panic 

Feeling uncomfortable about eating or drinking in public 



AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE 





HOW MUCH WERE YOU 




BOTHERED BY: 


74. 


Getting into frequent arguments 


75. 


Feeling nervous when you 


76. 


Others not giving you proper 
credit for your achievements . 


77. 


Feeling lonely even when 

you are with people 


78. 
79. 


Feeling so restless you couldn't 
sit still 


Feelings of worthlessness . . . 


80. 


Feeling that familiar things 
are strange or unreal 


81. 


Shouting or throwing things . . 


82. 


Feeling afraid you will 


83. 


Feeling that people will take 
advantage of you if you let therr 


84. 


Having thoughts about sex 
that bother you a lot 


85. 


The idea that you should be 
punished for your sins 


86. 


Feeling pushed to get things 


87. 


The idea that something 
serious is wrong with your body 


88. 


Never feeling close to 

another person 


89. 


Feelings of guilt 


90. 


The idea that something is 
wrong with your mind 



315 



Developed by Derogatis, Lipman and Cov i , the Self-Report Symptom Inventory 
(SCL-90) is an independently formatted form and does not require a General Scor- 
ing Sheet. The SCL-90 is composed of 90 items - each rated on a 5-point scale 
of distress. Evolving from the earlier Hopkins Symptom Checklist, the SCL-90 
was designed primarily as a general measure of psychiatric outpatient symptoma- 
tology in both clinical and research situations. 



APPLICABILITY 



Adults in psych iatr ic, and nonpsychiatr ic 
outpatient settings. 



UTILIZATION 



Once at pretreatment ; at least one post- 
treatment rating. Additional ratings are 
at the discretion of the investigator. 



TIME SPAN RATED 



Now or in the last week. 



CARD FORMAT - ITEMS CARD 01 = (19x, 56ll) 
Item Column Item Column 



I tern 



Column 



1 


20 


2 


21 


3 


22 


4 


23 


5 


2k 


6 


25 


7 


26 


8 


27 


9 


28 


10 


29 


11 


30 


12 


31 


13 


32 


]k 


33 


15 


34 


16 


35 


17 


36 


18 


37 


19 


38 



20 


39 


21 


ko 


22 


k] 


23 


k2 


2k 


k3 


25 


kk 


26 


k5 


27 


ke 


28 


kl 


29 


48 


30 


49 


31 


50 


32 


51 


33 


52 


3k 


53 


35 


54 


36 


55 


37 


56 


38 


57 



39 


58 


40 


59 


41 


60 


42 


61 


43 


62 


44 


63 


45 


64 


46 


65 


47 


66 


48 


67 


49 


68 


50 


69 


51 


70 


52 


71 


53 


72 


54 


73 


55 


74 


56 


75 



CARD 02 = (19x, 34ll) 



I tern 



Column 



I tern 



Column 



I tem 



Column 



I tem 



Column 



57 
58 

59 
60 
61 
62 
63 
64 
65 



20 
21 
22 
23 
24 
25 
26 
27 
28 



66 
67 
68 
69 
70 
71 
72 
73 
74 



29 
30 
31 
32 
33 
34 
35 
36 
37 



75 
76 
77 
78 
79 
80 
81 
82 
83 



38 
39 
40 
41 
42 
43 
44 
45 
46 



84 
85 
86 
87 
88 
89 
90 



47 
48 
49 
50 
51 
52 
53 



316 



CARD FORMAT ■ 


- DIMENSIONS 


CARD 


51-"- 


= (19x, 9F6.2) 






D imens 


on 


Column 






D imens ion 


Col 


umn 


1 




20 - 25 






VI 


50 


- 55 


II 




26-31 






VI 1 


56 


- 61 


1 1 1 




32 - 37 






VI 1 1 


62 


- 67 


IV 




38 - k3 






IX 


68 


- 73 


V 




kk - ks 













CARD 52-.'- = (19x, 3F6.2) 

Global Scores Column 

GSI 20 - 25 

PS! 26-31 

PSD! 32 - 37 

General Symptomatic Index (GS I ) = Sum of all Items 

No. of I terns 

Positive Symptom Total (PSI) = No. of items rated positively; i.e., rated 

1 , 2, 3 or 4. 

Positive Symptom Distress Index (PSDl) = Sum of a 11 items 

PST 

" Code "5" in Column 18 indicates card containing factor, cluster or derived scores 

DIMENSION COMPOSITION - Dimensions I - V have been validated on samples involving 
over 2500 patients. Dimensions VI - IX are presently 
assigned provisional status since validation studies for 
them are still in progress. 

I. Somatization Ml. Interpersonal Sensitivity 



Somat 


zat ion 


1 


48 


k 


49 


12 


52 


27 


53 


40 


56 


k2 


58 



IV. 



II. Obsessive-Compulsive 



3 


45 


9 


46 


10 


51 


28 


55 


38 


65 



6 


41 


21 


61 


34 


69 


36 


73 


37 




Depress ion 




5 


30 


14 


31 


15 


32 


20 


54 


22 


71 


26 


79 


29 





317 



v. Anxiety 



VIM. Paranoid Ideation 



VI 



2 57 

17 72 

23 78 

33 80 

39 86 

Anger-Host i 1 i ty 



11 67 
2k Ih 
63 81 

VII. Phobic Anxiety 



13 


70 


25 


75 


hi 


82 


50 





8 68 

18 76 
43 83 

IX. Psychoticism 

7 84 

16 85 

35 8? 

62 88 

77 90 

I terns Not Included in any Factor 

19 64 
kk 66 
59 ?9 
60 



SPECIAL INSTRUCTIONS 

The SCL-90 is normally completed by the patient, with administration and 
monitoring being performed by a technician familiar with the procedure. Usually 
about 15 minutes of patient time and about 5 minutes of technician time are re- 
quired. In instances where someone other thap the patient is doing the rating, 
(e.g., doctor, nurse, etc.) the technician's primary involvement is in verifying 
the accuracy for identifying information. The SCL-90 may be introduced to the 
patient as part of the facility's attempt to understand the problems of the pa- 
tient, or it may be explained directly as part of a research project for which 
the patient's assistance is requested. Both methods have proven quite success- 
ful. Stress completion of ALL items as quickly as possible. The patient should 
also work independently without discussing the items with spouse, family members, 
etc. The instructions should be read and carefully explained to the patient by 
the technician/administrator, with particular attention being given to an explana- 
tion of the Example printed on the form and the definitions of the scale points 
given below. 

Definition of Scale Points - To be explained to the subject and to be used by 
raters other than the subject. 

- Not At All Patient reports no distress associated with the 

particular symptom. 

1 - A Little Bit = Patient is aware of some distress associated with the 

symptom, but it is infrequent and of low intensity. 

2 - Moderately = Patient experiences distress associated with the symptom 

in a somewhat regular manner and it is of mild or 
moderate intensity. 



318 



3 - Quite A Bit = Patient experiences distress associated witii the symptom 
with regularity, and it is of moderate to high intensity. 

k - Extremely = Patient experiences extreme distress associated with the 
symptom, due to frequency, intensity, or a combination of 
both. 

RATER CODE - The code "00" is reserved for the subject; i.e., it indicates that the 
scale has been self-rated. Any other number may be used to designate a rater other 
than the subject. 

FORM NUMBER - The SCL-90 has the Form Number preprinted and it is not necessary - 
in fact it is prohibited - to encode this number. 

Example: Writing in the form number may trigger multiple opscan punches. 



Incorrect- 



^ I 



Correct 



DOCUMENTATION 



a. Raw score printout 

b. Dimension printout 

c. Means and standard deviations of dimensions and global scores 

d. Cross-tabulation of dimensions 

e. Variance analyses 



319 



COMMENTS OF THE AUTHORS 

SCL-90: /* -) Outpatient Psychiatric Rating Scale: Preliminary Report 
Leonard R. Derogatis, Ph.D. J Ronald S. Lipman, Ph.D.,^ and 
Lino Covi , M.D. ' 

The •" ; 90 ■ a self-report clinical rating scale oriented toward the symptoma- 
tic behavior of psychiatric outpatients. It is comprised of 90 items which reflect 
9 primary symptom dimensions believed to underly the large majority of symptom behav- 
iors observed in this class of patients. A number of additional scales are included 
outside the principal dimensional framework to assess disturbances in appetite and 
sleep. The primary symptom dimensions are: 

I. Somatization Vi. Hostility 

II. Obsessive-Compulsive VII. Phobic Anxiety 

III. Interpersonal Sensitivity VIM. Paranoid Ideation 

IV. Depression IX. Psychoticism 

V. Anxiety 

Dimensions I -V have been empirically established and validated in the context of 
the Hopkins Symptom Checklist on samples involving over 2,500 patients. Major studies 
in this series are listed in the Bibliography. Assessments of the various forms of 
reliability, validity and factorial invariance of these dimensions have been presented 
in Derogatis et al. (1) (2^). Dimensions VI-IX represent "new" dimensions that have 
been integrated with the five previous measures to provide a more complete representa- 
tion of the outpatient symptomatic domain. 

A brief description of the symptom constructs defined by these dimensions and, in 
several cases, a short synopsis of the development and rationale basic to each follow 
below. This is given so that the user may gain a better appreciation of the range and 
meaning of the SCL-90 clinical profile. 

I. Somatization - Reflects distress arising from perceptions of bodily dysfunc- 
tion. Complaints focused on cardiovascular, gastro-intestinal , respiratory, 
and other systems with strong autonomic mediation are included. Headaches, 
backaches, and pain and discomfort localized in the gross musculature are 
also components, as are other somatic equivalents of anxiety. 

II. Obsessive-Compulsive - Reflects ehaviors that are closely identified with 
the clinical syndrome of the same name. The focus of this measure is on 
thoughts, impulses and actions that are experienced as unremitting and 
irresistible by the individual but are of an ego-alien or unwanted nature. 
Behaviors indicative of a more general cognitive difficulty (e.g., "mind 
going blank", "trouble remembering") also load on this dimension. 

III. Interpersonal Sensitivity - Focuses on feelings of personal inadequacy and 
inferiority, particularly in comparison with other individuals. Self- 
deprecation, feelings of uneasiness, and marked discomfort during inter- 
personal Interactions are characteristic of persons showing high levels of 



1. School of Medicine, Johns Hopkins University 

2. Psychopharmacology Research Branch, NIMH 



320 



I.S. Feelings of sel f-consciousness and negative expectancies regarding 
interpersonal communications are also typical sources of distress. 

IV. Depression - Reflects a broad range of the concomitants of the clinical 

depressive syndrome. Symptoms of dysphoric affect and mood are represented, 
as are signs of withdrawal of interest in life events, lack of motivation, 
and loss of vital energy. The dimension mirrors feelings of hopelessness 
and futility as well as other cognitive and somatic correlates of depres- 
sion. Several items are included concerning thoughts of death and suicidal 
ideation. 

v. Anxiety - Subsumes a set of symptoms and experiences usually associated 

clinically with high manifest anxiety. General indicators such as restless- 
ness, nervousness, and tension are included here as are additional somatic 
signs (e.g. "trembling"). Scales measuring free floating anxiety and panic 
attacks are an integral aspect of this dimension, and an item on feelings of 
dissociation is included. The SCL-90 Anxiety dimension has been augmented 
beyond the item set used with the previous HSCL. 

VI. Hostility - The consistent observation that the presence of anger and hostile 
behavior function as important determinants in a variety of clinical decisions 
with psychiatric outpatients (e.g. diagnosis, treatment assignment, disposi- 
tion, etc.) has led to the development of a formal Hostility dimension. This 
dimension is organized around three categories of hostile behavior: thoughts, 
feelings, and actions. Items range from feelings of annoyance and urges to 
break things, through arguments and uncontrollable temper outbursts. 

Vll. Phobic Anxiety - Reflects symptoms that have been observed with high inci- 
dence in conditions termed phobic anxiety state or agoraphobia (Marks 2,3). 
Fears of a phobic nature oriented towards travel away from home, open spaces, 
crowds, or public places and conveyances are represented by this measure. 
In addition, several scales representing social phobic behavior have been 
included . 

/III. Paranoid Ideation - Derives from the notion that paranoid behavior is best 
considered from a syndromal point of view. The authors have adopted the 
position put forth by Swanson, Bohnert, & Smith (k) that paranoid phenomena 
are most effectively conceived as a mode of thinking. Accordingly, scales 
have been developed around the primary characteristics of paranoid thought. 
Swanson, et al. (k) list projective thinking, hostility, suspiciousness, 
central ity, delusions, loss of autonomy, and grandiosity as cardinal para- 
noid characteristics. Within the limitations imposed by a self-report format, 
scales were designed to reflect these manifestations. 

IX. Psychoticism - Since psychotic behaviors are observed in the out-patient 

setting, and play a critical role in administrative and treatment decisions 
when manifest, a psychoticism dimension was integrated into the SCL-90. 
The approach taken in building this scale involved sampling from the full 



321 



continuum of psychotic behaviors. Thus, florid, acute symptomatology, 
as well as behaviors typically viewed as more oblique, less definitive, 
indicators of psychotic process are represented. Four items reflect 
Schneiderian first-rank symptoms of schizophrenia: auditory hallucina- 
tions, thought broadcasting, external thought control, and external 
thought insertion (Schneider, (5); Mellor, (6); Taylor, (7) ). In 
addition secondary signs of psychotic behavior, as well as indications 
of a schizoid life style, are also represented. This combination 
approach is believed to have the greatest potential validity within 
the self-report format of the instrument. 

Areas of Utilization - Due to the ease of administration and broad range of symptoms 
reviewed in the SCL-90, it should find ideal utilization as a clinical screening 
instrument in numerous outpatient psychiatric settings. Outpatient departments, 
emergency services, acute treatment centers, and like facilities are potential pri- 
mary users. The graphic presentation of the SCL-90 Symptomatic Profile, coupled 
with the 9 dimensional symptom scores and the three global indices, provides a con- 
cise, relevant statement of the patient's immediate symptom status (Figures 19 and 
IQ) . A brief clinical narrative may also be appended to the SCL-90 Symptomatic 
Profile to provide a verbal description of the symptom picture in greater depth. 
Clinical utilization may be found particularly effective in situations where the 
patient/professional staff ratio is high and para-medical staff are employed in a 
screening role. 

The SCL-90 should also find effective utilization as an efficient means of ob- 
taining symptomatic information in non-psychiatric settings: Counseling centers, 
student health facilities and medical clinics with a primary orientation toward 
psychosomatic conditions should find the scales highly relevant. In addition, general 
medical and surgical facilities are increasingly incorporating information on the 
psychological status and psychiatric symptomatology of their patients to aid in mak- 
ing decisions about adequate treatment regimens and case dispositions. The scale 
provides a ready means of evaluating the interactive potential that the psychological 
status of the individual may have on both primary physical conditions, and on the 
outcome of procedures designed to alleviate or treat those conditions. 

Although designed primarily for use with outpatients, the SCL-90 may also be 
found valid and useful in certain specified inpatient settings. Raskin et al. (8) 
found a modified version of the HSCL to be a sensitive indicator in the NIMH-PRB 
inpatient studies of depression. Validation studies with inpatients are presently 
examining its feasibility in this regard. Modified administrative formats (e.g. 
interview presentation) are being assessed concomitantly. 

In research contexts, the SCL-90 is an excellent instrument for inclusion in 
protocols where the major criterion of interest involves assessment of an outpatient 
symptomatic configuration. Relative brevity and ease of administration allow the 
SCL-90 to be efficiently utilized in treatment studies which involve repeated assess- 
ments of the symptom picture across time. The high test-retest and inter-rater 
reliabilities of Dimensions I -V (1), {2k) are expected to extend to the new dimen- 
sions, thereby providing the clinical investigator with a consistent basis for 
evaluating treatment differences. 



322 



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324 



More specifically, the SCL-90 is expected to be particularly valid as a 
criterion measure in clinical drug trials where the principal focus is on the 
relative efficacy of psychoactive agents. Dimensions I -V have been repeatedly 
shown to be sensitive indicators of treatment effects with a wide range of 
psychoactive drugs (1), (Ik). The refinements in these scales, coupled with 
the supplementation provided by Dimensions VI-IX, results in a marked extension 
of the instrument's sensitivity to drug effects. Beyond the validity revealed 
for this specific utilization. Dimensions I -V have been shown to be sensitive 
to a wide variety of non-pharmacolog ic factors in the treatment setting (1), 
(24). It is expected that the methodological revisions and substantive extensions 
incorporated into the SCL-90 will function to enhance this sensitivity to drug- 
extrinsic influences as well. 

Scale Characteristics - The SCL-90 is comprised of 90 distinct items each of 
which is rated on a 5-point scale of distress ranging from "not-at-all" to 
"extremely". Under conditions of typical administration, the patient is instructed 
by the technician as to how to fill out the form. Questions concerning procedure 
or interpretation are resolved by the technician; however, the technician in no 
way interferes with the self-rating characteristics of the procedure. 

In those instances when the rater is other than the patient, (e.g. 
doctor, social worker, psychiatric nurse, etc.) ratings should be made in terms of 
manifest behaviors and/or complaints. Inferences about symptoms or distress, 
where there is no explicit behavioral or verbal referent on the part of the patient, 
should be minimized. 

The SCL-90 has been provided with a flexible time context so that different 
temporal limits may be utilized with the instrument. This feature also greatly 
facilitates research on the effects of different temporal referents on the nature 
of the symptomatic picture. Normally, however, the time context used with the 
SCL-90 is 7 days. Numerous other rating scales use the one-week rating period as 
standard, and a more extensive rationale for selection of this period is given by 
Hamilton (9). 

In developing the items, care was taken to use very fundamental phrasing; an 
attempt was made to select the most basic word levels possible that would still be 
consistent with the meaning of the item. Toward this end, the Thornd i ke-Lorge 
Word Book of 30,000 Words (10) was employed to equate the vocabulary levels of the 
9 dimensions and the overall verba] level of the instrument. Even with this con- 
sideration, some patients' literacy levels will be insufficient to allow them to 
validly complete the SCL-90. In cases of marginal literacy, care must be taken in 
making interpretations; profiles developed under such conditions are probably best 
assigned a tentative status. 

The selection of 5-point rating scales for each symptom reflect the well- 
documented observation - from both psychometric theory (11) and information theory 
(12) - that the reliability of rating scales tends to be proportional to the number 
of scale points provided (within certain limits). Also, the minimum number of 
items subsumed under any one of the primary dimensions is six, in keeping with 
recent observations about the relationship between factorial invariance and the 
number of items per factor (13). 



325 



Developmental History - The immediate precursor to the SCL-90 was a rating scale 
termed the Hopi<ins Symptom Checklist (HSCL) . This rating scale is comprised of 
58 items which tend to focus on conventional neurotic symptoms, and are rated on 
a 4-point scale of distress. A series of factor-analytic studies of both psychia- 
trist's ratings (14) and patient self-ratings (15) on the HSCL isolated five 
primary symptom dimensions underlying the scale. Construct validity has been demon- 
strated for these dimensions (I6), and factorial invariance has been shown for 
this dimensional set regarding patient social status, doctor rating versus patient 
rating, and diagnostic class (see Bibliography). 

The SCL was developed principally as a criterion measure in psychoactive drug 
trials. It has been shown to have high sensitivity and predictive validity in 
this regard (17, 18, 19). In addition, numerous "extrinsic" factors (e.g. doctor 
medication attitude, patient perception of doctor warmth, etc.) have been reflected 
by scores on the primary HSCL dimensions (see Bibliography). A consistent typology 
of "anxious neurotic" patients (20) has also been developed in terms of the HSCL 
symptom scales . 

Slight variations in the number and content of the scales have resulted in 
several similar versions of the HSCL (8, 21). These scales have very similar for- 
mats and tend to be highly compatible regarding the underlying dimensions they re- 
flect. Also, there is a brief version (35-item) of the HSCL that has been utilized 
primarily by investigators in the Early Clinical Drug Evaluation Units (ECDEU) spon- 
sored by Psychopharmacology Research Branch of NIMH. Most of these alternate 
versions may be traced back to a prototype "Discomfort Scale" developed by Parloff 
(22), and further elaborated by Frank (23). The Discomfort Scale was based to an 
appreciable extent on symptoms taken from the Cornell Medical Index, and has been 
used as a criterion measure in studies of psychotherapy. 

A bibliography documenting much of the recent research done with the Hopkins 
Symptom Checklist (HSCL) has been appended. In addition several thorough reviews 
of this work have recently become available (1), (2^+) . 

REFERENCES 

1. Derogatis, L. R., Lipman, R. S., Rickels, K., The Hopkins Symptom Checklist 
(HSCL): A Measure of Primary Symptom Dimensions in Psychological Measurement: 
Modern Problems in Pharmacopsychiatry. P. Pichot (Ed.) Karger, Basle, 
Switzerland; 1973- 

2. Marks, I. M. Fears & Phobias, Academic Press, New York, I969. 

3. Marks, I. M. The classification of phobic disorders. Brit. J. Psychiat., 
116:377-386, 1970. 

4. Swanson, D. W., Bohnert, P. J., and Smith, J. A., The Paranoid, Little, Brown 
and Company, Boston, 1970. 

5. Schneider, K. Clinical Psychopathology , M. W. Hamilton (trans.), Grune & 
Stratton, Inc., New York, 1959. 



326 



6. Mellor, C. S. First rank symptoms of schizophrenia. Brit. J. Psychiat.,' 
117:15-23, 1970. 

7. Taylor, M. A. Schne ider ian first-rank symptoms and clinical prognostic 
features in schizophrenia. Arch. Gen. Psychiat., 26:6U-67, 1972. 

8. Raskin, A., Schul terbrandt , J. G., Reatig, N. & McKeon, J. J. Differential 
response to chlorpromaz i ne, imipramine and placebo. Arch. Gen. Psychiat., 
23:16^-173, 1970. 

9. Hamilton, M. The Hamilton Depression Scale, In: Guy, W., & Bonato, R., 
ECDEU Assessment Manual, NIMH, Md . , O8-7, 1970. 

10. Thorndike, E. L., and Lorge, I. The Teacher's Word Book of 30,000 Words. 
Bureau of Publications, New York, 19^^. 

11. Guilford, J. P. Psychometric Methods. McGraw-Hill, New York, 195^. 

12. Garner, W. R. Rating scales, d iscr imi nab i 1 i ty , and information transmission. 
Psychol. Rev., 67:3^3-352, I96O. 

13. Gorsuch, R. L. A comparison of biquartimin maxplane, promax, & varimax. 
Educa. & Psychol. Meas . , 30:861-872, 1970. 

l^t. Lipman, R. S., Rickels, K., Covi, L., et al. Factors of symptoms distress: 

Doctor ratings of anxious neurotic patients. Arch. Gen. Psychiat., 21, I969. 

15. Derogatis, L. R., Lipman, R. S., Covi, L., et al. Neurotic symptom dimensions 
as perceived by psychiatrists and patients of various social classes. Arch. 
Gen. Psychiat. , 2k, 1971 . 

16. Derogatis, L. R., Lipman, R. S., Covi, L., et al. Dimensions of outpatient 
neurotic pathology: Comparison of a clinical vs. an empirical assessment. 
J. Consult. & Clin. Psychol., 3^, 1970. 

17. Uhlenhuth', E. H., Rickels, K., Fisher, S., et al. Drug, doctor's verbal 
attitude and clinical setting in the symptomatic response to pharmacotherapy. 
Psychopharmacolog ia (Berl.), 9, 1966. 

18. Lipman, R. S., Park, L. C. & Rickels, K. Paradoxical influence of a thera- 
peutic side-effect interpretation. Arch. Gen. Psychiat., 15, 1966. 

19. Rickels, K., Lipman, R. S., Park, L. C, et al. Drug, doctor warmth £- clinic 
setting in the symptomatic response to minor tranquilizers. Psychopharmacolog ia 
(Ber.), 20, 1971. 

20. Derogatis, L. R., Lipman, R. S. & Covi, L. A typology of anxious neurotics, 
paper presented at the Eastern Psychological Associat ion Annual Meeting, 
Boston, 1972. 



327 



21. Rickels, K., Lipman, R. S., Garcia, C. R., et al. Evaluating clinical 
improvement in anxious outpatients: A comparison of normal and treated 
neurotic patients. Amer. J. Psychiat., 128, 1972. 

22. Parloff, M, B., Kelman, H. C. & Frank, J. D. Comfort, effectiveness and 
self-awareness as criteria of improvement in psychotherapy. Amer. J. 
Psychiat., 111:3^3-351, 195^. 

23. Frank, J. D., Gliedman, L. H., Imber, S. D., Nash, E. H. and Stone, A. R. 
Why patients leave psychotherapy. A.M.A. Arch. Neur. & Psychiat., 77: 
283-299, 1957. 

2k. Derogatis, L. R., Lipman, R. S., Rickels, K., Uhlenhuth, E. H. & Covi, L. 
The Hopkins Symptom Checklist (HSCL) : A Self-R«Dort Symptom Inventory. 
Behav, Sci. (In press - March, 197^). 

BIBLIOGRAPHY 

A. SCALE EVOLUTION 

1. Derogatis, L. R., Lipman, R. S., Covi, L., et al: Neurotic symptom 
dimensions as perceived by psychiatrists and patients of various social 
classes. Arch. Gen. Psychiat., 2k, 1971. 

2. Derogatis, L. R., Lipman, R. S., Covi, L., et al: Dimensions of out- 
patient neurotic pathology: Comparison of a clinical vs. an empirical 
assessment. J. Consult. & Clin. Psychol., 34:2, 1970. 

3. Lipman, R. S., Rickels, K., Covi, L., et al: Factors of symptom distress: 
Doctor ratings of anxious neurotic outpatients. Arch. Gen. Psychiat., 

21, 1969. 

k. Lipman, R. S., Covi, L., Rickels, K., et al: Selected measures of change 
in outpatient drug evaluation. Psychopharmacology: A Review of Progress 
1957-1967. PHS Pub. No. I836, U. S. Gov't, Printing Office, Washington, 
D. C, 1968. 

5. Williams, H. V., Lipman, R. S., Rickels, K., et al: Replication of symptom 
distress factors in anxious neurotic outpatients. Multivar. Behav. Research, 
3. 1968. 

6. Mattsson, N. B., Williams, H. V., Rickels, K., et al: Dimensions of symptom 
distress in anxious neurotic outpatients. Psychopharm. Bull. 5 (Jan.), I969. 

B. DRUG SENSITIVITY 

1. Rickels, K., Lipman, R. S., Park, L. C. , et al: Drug, doctor warmth and 
clinic setting in the symptomatic response to minor tranquilizers. 
Psychopharmacologia (Berl), 20, 1971. 



328 



2, Lipman, R. S., Park, L. C, & Rickels, K.: Paradoxical influence of a 
therapeutic side-effect interpretation. Arch. Gen. Psychiat., 15, I966. 

3. Uhlenhuth, E. H., Rickels, K., Fisher, S., et al: Drug, Doctor's verbal 
attitude and clinic setting on the symptomatic response to pharmacotherapy. 
Psychopharmacologia (Berl.), 9, 1966. 

k. Covi, L., Lipman, R. S., Pattison, J. H., et al: Length of treatment with 
chlord iazepoxide and response to its sudden withdrawal. (in press, 
Psychopharmacologia) . 

5. Hesbacher, P. T., Rickels, K., Hutchison, J., et al: Setting, patient, and 
doctor effects on drug response in neurotic patients: II. Differential 
improvement. Psychopharmacologia (Berl.), 18, 1970. 

6. Covi, L., Park, L. C, Lipman, R. S., et al: Withdrawal of meprobamate and 
chlord iazepoxide in anxious outpatients. In Cole, J. 0. 5- Wittenborn, 

J. R., (Eds.), Drug Abuse: Social and Psychopharmacolog ical Aspects. 
C. C. Thomas, Springfield, 111., I969. 

7. Rickels, K.: Drugs in the treatment of neurotic anxiety and tension: 
Controlled studies. Psychiatric Drugs, Grune and Stratton, Inc., U.S.A., 
1966. 

C. SENSITIVITY TO EXTRINSIC FACTORS (NON-DRUG) 

1. Derogatis, L. R., Covi, L., Lipman, R. S., et al: Social Class and race 
as mediator variables in neurotic symptomatology. Arch. Gen. Psychiat., 
25, 1971. 

2. Hesbacher, P. T., Rickels, K., £• Goldberg, D.: Neurotic symptoms in 
general practice: Clarification of the relationships of sex, race, and 
social class. In press. 

3. Hesbacher, P. T., Rickels, K., Hutchinson, J., et al: Setting, patient, 
and doctor effects on drug response in neurotic patients: II. Differential 
improvement, Psychopharmacologia (Berl.), 18, 1970. 

k. Lipman, R. S., Uhlenhuth, E. H., Rickels, K., et al: Medication attitudes 
and drugs response. Dis. Nerv. Sys., 30, 1969. 

5. Uhlenhuth, E. H., & Covi, L.: Subjective change with initial interview. 
Amer. J. Psychother., 23:3, 1969. 

6. McNair, D. M., Kahn, R. J., & Droppleman, L. F.: Patient acquiescence and 
drug effects. In Rickels, K. (Ed.), Non-Specific Factors in Drug Therapy. 
C. C. Thomas, Springfield, 111., I968. 

7. Rickels, K., & Anderson, F. L.: Attrited and completed lower socioeconomic 
class clinic patients in psychiatric drug therapy. Comp. Psychiat., 8:2, 
1967. 



329 



8. Lipman, R. S., Rickels, K., Uhlenhuth, E. H., et al: Neurotics who fail 
to take their drugs. Brit. J. Psychiat., Ill, 1965. 

9. Rickels, K.: Some comments on non-drug factors in psychiatric drug-therapy, 
Psychosomat ics , 6, 1965- 

10. Uhlenhuth, E. H., Park, L. C, Lipman, R. S., et al: Dosage deviation and 
drug effects in drug trials. J. Nerv. & Ment. Dis., I4l:l, 1965. 

11. Fisher, S., Cole, J. 0., Rickels, K., et al: Drug-set interaction: The 
effect of expectations on drug response in outpatients. Neuropsychopharm. 
3, 196it. 

D. CONTENT VALIDITY 

1. Derogatis, L. R., Lipman, R. S., Covi, L., et al: Dimensions of outpatient 
neurotic pathology: Comparison of a clinical vs. an empirical assessment. 
J. Consult. & Clin. Psychol., 3^:2, 1970. 

E. CONSTRUCT VALIDITY 

1. Rickels, K., Lipman, R. S., Garcia, C. R., et al: Evaluating clinical 
improvement in anxious outpatients: A comparison of normal and treated 
neurotic patients. Amer. J. Psychiat., 128:8, 1972. 

2. Rickels, K-, Garcia, C. R., & Fisher, E.: A measure of emotional distress 
in private gynecologic practice. Ob-Gyn., 38:1, 197'. 

3. Derogatis, L. R., Lipman, R. S., Covi, L., et al: Dimensions of out- 
patient neurotic pathology: Comparison of a clinical vs. an empirical 
assessment. J. Consult. & Clin. Psychol., 3^:2, 1970. 

k. Park, L. C, Uhlenhuth, E. H., Lipman, R. S., et al: A comparison of 
doctor and patient improvement ratings in a drug (meprobamate) trial. 
Brit. J. Psychiat., ill, I965. 

F. RELIABILITY 

1. Derogatis, L. R., Lipman, R. S., Rickels, K., Uhlenhuth, E. H. & Covi, L.: 
The Hopkins Symptom Checklist (HSCL): A measure of primary symptom 
dimensions. In P. Pichot (Ed.). Psychological Measurement: Modern 
Problems in Pharmacopsychiatry. S. Karger, Basel, Switzerland, 1973. 

G. FACTORIAL INVARIANCE 

1. Derogatis, L. R., Lipman, R. S., Covi, L., et al: Factorial in\/ariance 
of neurotic symptom dimensions in anxious and depressive neuroses. 
Arch. Gen. Psychiat. 155, 1972. 

2. Derogatis, L. R., Lipman, R. S., Covi, L., et al: Neurotic symptom 
dimensions as perceived by psychiatrists and patients of various social 
classes. Arch. Gen. Psychiat., 2k, 1971. 



330 



H. ADDITIONAL STUDIES 

1. Derogatis, L. R., Lipman, R. S. & Covi, L.: A typology of anxious 
neurotics. Paper read at the 43rd Annual Meeting of the Eastern 
Psychological Association, Boston, April 27-29, 1972. 

2. Yevzeroff, H., Derogatis, L. R., Lipman, R. S. & Covi, L.: Constancy 
of neurotic symptom dimensions among psychiatric outpatients. Paper 
read at the 44th Annual Meeting of the Eastern Psychological Associa- 
tion, Washington, D. C. May 5, 1973. 



331 



073 SDS 

SELF-RATING 

DEPRESSION 

SCALE 



MH t73 
6-73 










DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
PUBLIC HEALTH SERVICE 

NATIONAL INSTITUTE OF MENTAL HEALTH 
ZUNG SDS 


FO«M APPROVED 
OM6 NO MII953 


PATIENT INITIALS 

:A:: -&■- 
:«:: :±;: 
:U:: :W:: 






:£: :H:: 

FIRST 

:0: :!?:: 

INITIAL 




-.Hz ::»: 


rj:: 
:fr:: 


NUMBER MALES 001 to 499; FEMALES SCO to 998 

rO:: ::t:: .:Z:z z-3:z ::4:^ =5" -&z if?:: :«:: :*: 

PATIENT 

:0:: ::t:: -^- :3:: :^: :5" rfi:: if?:: :«:: :S:: 
:0:: ::t:: =2:: 3:: ::*: =5:: :«: :i7;: ;»:: :«: 








; J4 : 


SECOND 
INITIAL 


:&.. 
-.&-. 


zhtz :rl: 




Sfc*- :;..- -:i\-- ,.' ' : RATER 




:i J 


0:: -:t-z .3z. -3zz lat: :5i: :«: 

PERIOD 
O:: ::t:: :2:: :3:: :^: :S== :«: 

Houn Days Weeks 


::7t: rft: i®: 


I 


■"•«■ 


FORM 
NO. 








::?:: :«: :«= 

AAonthi 


PLEA";.'- Mr. 


-: !\ HO 


. 2 LEAD PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 



INSTRUCTIONS 
Listed below are 20 statements. Please read each one carefully and decide how much of the statement describes how you have 
been feeling during the past week. Decide whether the statement applies to you for NONE OR A LITTLE OF THE TIME, SOME 
OF THE TIME, A GOOD PART OF THE TIME, OR MOST OR ALL OF THE TIME. Mark the appropriate column for each statement. 



EXAMPLE 1 


NONE 01 
« LinLE 

STATEMENT "{jf' 


SOME 
OF THE 
TIHE 


AEOOD 
tAII OF 
THE TINE 


MOST 
01 Alt 
OF THE 

TIME 


1 feel nervous -'^'-'- 


--2^z 


•*• 


ijjrr 


If the statement "1 feel nervous" describes the way you have felt 








"A GOOD PART OF THE TIME", you would mark column 3 








"A GOOD PART OF THE TIME" as shown. 









STATEMENT 



HONE 01 

A LiniE 

OF THE 

TIME 


SOME 
OF THE 
TIME 


A eooD 

PAIT OF 
THE TIME 


MOST 
01 All 
OF THE 

TIME 


"J:: 


z2^z 


.■3iz 


:lJ:: 


III" 


-Z^z 


z-3:z 


lit: 


III" 


rSi 


--3:z 


:ltr 


III" 


=2:-- 


z-3:z 


:4:: 


zzl" 


=2:: 


z-3zz 


:A: 


izlii 


z-2^z 


Z-3ZZ 


:A: 


r:t;: 


--2zz 


z-3zz 


-Az 


irli; 


=2:: 


Z-3ZZ 


:2t: 


lit" 


-S^z 


=3:: 


:4:= 


=;t" 


-S^z 


:3:r 


:2j:= 


Z^II 


=«:: 


:3:: 


:3t:: 


izlii 


=2:: 


:3c: 


:l4:: 


zAzz 


z-2zz 


:a:: 


:3t: 


"t=: 


=2:: 


:-3:: 


:Jt: 


zitii 


-S^z 


:3:: 


:4:: 


r4:: 


-Sr- 


:3:: 


.-21;: 


zzXzz 


-S^z 


:3:: 


:4:: 


:rjri 


-S;z 


:3:: 


;2l:: 


i:t" 


-S^z 


:3:= 


:*: 


"J" 


13:: 


:*: 


:2);: 



1 . I feel downhearted and blue 

2. Morning is when I feel the best 

3. I have crying spells or feel like it 

4. J have trouble sleeping at night 

5. I ea*. as much as I used to 

6. I still enjoy sex 

7. I notice that I am losing weight 

8. I have trouble with constipation 

9. My heort beats faster than usual 

1 0. I get tired for no reason 

1 1 . My mind is as clear as It used to be 

12. I find it easy to do the things I used to do 

13. I am restless and can't keep still 

14. I feel hopeful about the future 

15. I am more Irritable than usual 

16. I find it easy to make decisions 

17. I feel that I am useful and needed 

18. My life is pretty full 

19. I feel that others would be better off if I were dead 

20. I still enjoy the things I used to do 



334 



Zung's Self-Rating Depression Scale (SDS) is a 20-item independently 
formatted scale in which the subject rates his symptomatology on a ^t-point scale 
of severity. This version of the SDS replaces the original Zung Depression Scale 
(Form 09). The identification block has been changed and the wording of 2 of 
the scale points has been altered in the present version. The SDS is the patient- 
rated version of the Depression Status Inventory. 

REFERENCE Zung, W. W. K., A Self-Rating Depression Scale, Arch. Gen. 

Psychiat,, 12, 63-7O, 1965 

Zung, W. W. K., Factors Influencing the Self-Rating 
Depression Scale, Arch. Gen. Psychiat., 16, 5^3-5^7, I967. 

APPLICABILITY Adults with depressive symptoms 

UTILIZATION Once at pretreatment ; at least one post-treatment rating. 

Additional ratings are at the discretion of the investigator. 

TIME SPAN RATED Now or within the past week 

CARD FORMAT - ITEMS CARD 01 = (19x, 2011, lOx, l4) 

Item Column Item Column 

1 20 11 -A- 30 

2* 21 12-.V 31 

3 22 13 32 

k 23 14-A- 33 

5* 2k 15 34 

6^^ 25 16-A- 35 

7 26 17-A- 36 

8 27 18-.V 37 

9 28 19 38 
10 29 20-'- 39 

Index Score 50 - 53 

^v Items reflected in scoring. 

Table 9 gives the conversion of SDS raw scores into Index scores, (p. ]yk )'. 
The following table from Zung presents mean index scores for 5 diagnostic groups: 

Mean 
Diagnosis N SDS 

I ndex 

Depressive disorders 96 65" 

Schizophrenia 25 51 

Anxiety disorder 22 53 

Personality disorders 5^ 56 

Transient situational disturbances 12 48 

" Significantly different from other 4 groups (p <^ .01). 



335 



SPECIAL INSTRUCTIONS 

The rater should make certain that the subject fully understands the task 
and the correct method of recording his responses. When the subject finishes, 
the rater should check all items for omissions or multiple marks. Unless 
clinically inadvisable, the rater should urge subject to complete all items. 
The rater should also encode patient and period numbers within the identifica- 
tion block. Rater number is precoded and need not be filled in. The patient's 
initials may be encoded by either the subject or rater. 

Both Form and Rater Numbers are precoded and no entries are required - or 
indeed permitted - in these shaded areas. 

Example: Writing in Form and/or Rater Number is incorrect and 
may trigger multiple opscan punches. 





lis/:: 


rfrt: 

:W: 


vt: 


:^:t i-^z 




:0- 


:rt:: 


zisr-z -3zz 


:4: :5:: 


:«:: 


::?:: =8=: 


-l»z 




zEtz 
--tiz 
:3t: 


:£:: :H:: 

SECOND 

:©:: :P:: 

INITIAL 

zifzi :*: 


:e:: -Hz ::l:: :d:: 
:ar -Szz :S:: ::T:: 


. .0.C 


:.^:r 


zSr^z3= 


RATER 








' :t±c 


:0" 

:0== 
:0:: 


Hours . 


:« :3:: 

/Sr-z :3:: 

r Day* 

:2r: 


:*: rS-: 

PERIOD 

::*: -^z 

Weeks 
:3^: 


:«:: 


::?tr :«:: 

::7t: :«:: 

Months 
zzUzz 


-r&^z 


' 




t'^' 


'>«> 


FORM 
NO. 




::©:: 



\ 



This is incorrect, 



DOCUMENTATION: 



a. Raw score printout 

b. Index score printout 

c. Means and standard deviations for index scores 

d. Variance analyses 



336 



054 SAS 
SELF-RATING 

ANXIETY 

SCALE 



DEPARTMENT OF HEALTH. EDUCATION, AND WELFARE 
NATIONAL INSTITUTE OF MENTAL HEALTH 

S A S 

William W.K.Zung.M.D. 



PATIENT 


INITIALS 


















NUMBER MALES 001 TO 499 




NUMBER FEMALES 500 TO 998 





A 


B 


■x> 


-D 


E 


FIRST 


:*:: 


:«: 


:-H 


::(:: 


::J:: 


:»: 


::1:: 


::2:: 


-3 


:* 


:*: 


:*: 


.7:. 


::a: 


::9 



































fATIENT 








(} 




K 


t 


■■*A 


n 


ti 




:»>:: 


:Q: 


:«; 


:«:: 


.^.. 


:«: 


::J:: 


::?: 


:.S 


4 




::6: 


::J:: 


» 














INITIAL 
































^~ 


\f 


V 


■W 


-.JC-: 


:y: 




:rZ: 










^ 


::!:: 


::2: 


::3: 


:« 


:*: 


::6: 


::?^: 


::a: 


::9: 


^~ 


:A:: 


:fl:: 


:£: 


:&: 


-£: 


SECOND 


:f:: 


:S: 


:±t: 


-i:: 


:J:: 


, = •- 


-II-.- 


,^' 


"»: 


:♦: 


RATER 


:*; 


:*-. 


>A: 


-.-A: 


^ 


:«: 


:*,: 


-.M: 


:il»: 


:.0 


INITIAL 


:f:: 


rQ 


::R: 


:*: 


::T- 


= •■ 


"J.-= 


:«. 


,-■=*.:,.■ 


:*-• 


M.^S;:*'. 


-*: 


„„_^;., 


^: 


:«: 


^~ 


:«;- 


:V: 


vt 


X 


Y 


:Z. 










:*: 


::J:: 


"2:: 


::$: 


4 


::6:: 


::B: 


::?: 


::8: 


:;9 


— 


































PERIOD 














































FORM 


-^ 










::&: 


Hours 


.2.. 


:r3 

Days 


:4: 


Weeks 


-S^- 


::7:: 
Months 


::8: 


: 9: 


-_ 
























::&: 


r:^: 




r 




:3:: 




:* 






^ 



INSTRUCTIONS: Ljsted below are 20 statements. Please read each one carefully and decide how much of the statement 
describes how you have been feeling during the past week. Decide whether the statement applies to you 
NONE OR A LITTLE OF THE TIME, SOME OF THE TIME, A GOOD PART OF THE TIME, OR MOST 
OR ALL OF THE TIME. Mark the appropriate column for each statement. 

PLEASE USE A N0.2 PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 



None 

or 

a little of 

the time 

1 . I feel more nervous and anxious than usual ::j:: 

2. I feel afraid for no reason at all "1;: 

3. I get upset easily or feel panicky ::1:: 

4. I feel like I'm falling apart and going to pieces r:l:: 

5. I feel that everything is all right and nothing bad w/ill happen ::1:; 

6. My arms and legs shake and tremble ---.%-.: 

7. I am bothered by headaches, neck and back pains ::!:: 

8. I feel weak and get tired easily "1:: 

9. I feel calm and can sit still easily :;1:: 

10. I can feel my heart beating fast -.-.r--. 

11. I am bothered by dizzy spells z-.t.-. 

12. I have fainting spells or feel like it z:y.: 

13. I can breathe in and out easily ::]:: 

14. I get feelings of numbness and tingling in my fingers, toes z.^- 

15. I am bothered by stomachaches or indigestion "1:: 

16. i have to empty my bladder often -l- 

17. My hands are usually dry and warm z.y.z 

18. My face gets hot and blushes zzy.z 

19. I fall asleep easily and get a good night's rest -I:: 

20. I have nightmares ..y.z 



Some 
of the 
time 

::2:: 


A good 
part of 
the time 


Most 

or 

ALL of 

the time 


::2:: 


-3:: 


::*: 


::2:: 


:*: 


:^r 


::?:: 


::»: 


::*: 


::2: 


-^ 


:34:: 


::2: 


-^ 


::*: 


::2: 


-^ 


--4:- 


::2: 


-:» 


:i4;: 


i:2:: 


-^ 


::*: 


"2: 


r- 


::*: 


::2:: 


.<sr- 


=4:: 


::2: 


-^--. 


::*: 


::2:: 


:3:: 


:=*: 


::2:: 


-^ 


--A:- 


::2: 


-^■ 


--^z 


-2:: 


^ 


:^i 


.:2: 


:3=r 


::4:: 


;:2:: 


:3:: 


:^: 


::2: 


:3:r 


-^. 


::2: 


--»: 


:at: 



338 



Zung's Self-Rating Anxiety Scale (SAS) is a 20-item scale in which the 
subject rates his symptomatology on a 4-point scale of severity. The SAS is 
self-contained and does not utilize the General Scoring Sheet. The comparable 
clinician-rated version (AS I ) is described on pages 

REFERENCE Zung , Wm . W. K., A Rating Instrument for Anxiety 

Disorders, Psychosomat ics , 12, 371-379, Nov ./Dec , 1971 . 

APPLICABILITY Adults with symptoms of anxiety 

UTILIZATION Once at pretreatment ; at least one post-treatment assess- 
ment. Additional ratings are at the discretion of the 
i nvest i gator . 

TIME SPAN RATED One week prior to rating 

CARD FORMAT - ITEMS CARD 01 = (19x, 2011, llx, \k) . 

I tern Column I tern Column 

1 20 11 30 

2- 21 12 31 

3 22 13" 32 

k 23 ]k 33 

5-'- 2k 15 3h 

6 25 16 35 

7 26 17--'^ 36 

8 27 18 37 
9-'-- 28 19" 38 

10 29 20 39 

I ndex Score 50 - 53 

" = Scores on these items are reflected when computing total raw score. 

Table 11 gives the conversion of SAS raw scores into Index scores, (p. 202) 
The following table from Zung presents mean index scores and standard deviations 
for 5 diagnostic groups: 

SAS Index 
Diagnosis N Mean S.D. 

Anxiety Disorder 
Sch izophren ia 
Depressive Disorder 
Personality Disorder 
Transient Situational 

D isturbances 
Controls (Normals) 

" = Significantly different from other 4 diagnostic groups (p = .05) 
''"" = Significantly different from all diagnostic groups (p = .01) 



22 


58.7 


13.5--< 


25 


46.4 


12.9 


96 


50.7 


13.4 


54 


51.2 


13.2 


12 


45.8 


11.9 


00 


33.8 


5.9--' 



339 



SPECIAL INSTRUCTIONS: 

The rater should make certain that the subject fully understands the task 
and the correct method of recording his responses. When the subject finishes, 
the rater should check all items for omissions or multiple marks. Unless clin- 
ically inadvisable, the rater should urge subject to complete all items. The 
rater should also encode patient and period numbers within the identification 
block. Rater number is precoded and need not be filled in. The patient's 
initials may be encoded by either the subject or rater. 

Both Form and Rater Numbers are precoded and no entries are required - or 
indeed permitted - in these shaded areas. (See page 336 ). 

DOCUMENTATION: 

a. Raw score printout 

b. Index score printout 

c. Means and standard deviations for Index scores 

d. Variance analyses 

COMMENTS OF THE AUTHOR 

Wi 1 1 iam W. K. Zung, M.D. 

The SAS is based on the same 20 diagnostic criteria as the observer rated 
Anxiety Status Inventory. So that the patient is less able to discern a trend 
in his answers, the scale was devised so that of the 20 items used, some of the 
items were worded symptomat ical 1 y positive, and others symptomat ical ly negative, 
depending upon their suitability and usage. In addition, an even-number of 
columns were used to eliminate the possibility of a patient checking middle and 
extreme columns. 

Cumulative data on the SAS from several completed studies of psychiatric and 
normal subjects indicate that a morbidity cut-off score on this scale would be at 
kS. Thus, patients with scores of k5 and above on the SAS would be considered by 
most clinicians to have anxiety symptoms of significant severity. Complete corre- 
lation with clinical global impressions and the SAS indices and other anxiety 
scales will ^^° available at a later date. 



340 



033 TWIS 
TESS 

WRITE-IN 
SCALE 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

TREATMENT EMERGENT SYMPTOMS SCALE— WRITE-IN 



PATIENT 


INITIALS 

-v---- 


--U:-- 




RRST 
INITIAL 






z-J-.-. 


NUMBER MALES 001 
rO:: riL:: i£=: 
:Oi: =:L:: =£.-: 
:Oi: ::l;r :fcr 


TO 
i3i= 


499; FEMALES 500 

.^- PATIENT ... 
'" NUMBER 


TO 998 
r&= ::7:= 
r&.- "7=r 
:&: r:7:r 


:*= 
=:&= 


:A= 

':A= 
=d9:= 


:*:- 
:«:: 






-M---- 

-x--- 


SECOND 

-.0-.-. :*--: 

INIHAL 


:«;: 
:«:: 


-it-- ".i-.- 

-a---- zs--- 






r:Lr: 
"L:i 






^^^ RATER ;±: 
. NUMBER 




::7:= 


=dB:= 
==&= 


:A= 
==&: 


-.It-.-. 




:iL:= 

Noun 
iiLii 




:3ir 

I*: 

Oayi 


PERIOD 

Wnki 


=:&= 
=&= 


==7" 
zzTzz 
=*r' 


==&= 
==ft= 


==ft: 
==»: 


m 






H 


M 


H 




Pt£ASE USE A NO. 2 LEAD PENQL BE SURE TO MAKE MARKS HEAVY AND DARK. 


ERASE COMPLETaY ANY MARKS YOU WISH TO CHANGE. 







INSTRUCTIONS: This scale MUST be used in conjunction with the DOTES. Be sure that the PERIOD designation matches the 
proper DOTES. Make three judgnoents for each symptom and confine all writing wUhin the box provided. 
DO NOT MARK IN SHADED AREAS 



1. OTHER SYMPTOM (Conhntwriling within Iha block) 



MOO- 

==t== =4=: 



RELATIONSHIP 






ACTION 


NoM iMHti FKiibh hokobh MimI 


TAKEN: 


=«:i =:»== =*= :*: :a*= 





2. OTHER SYMPTOM (ConHn« wrHing within thii bhck) 



HIU ^^ SE«Bf 
=:»:z :i:: ==Sr 



3. OTHER SYAAPTOM (Conhnt writing within thii blocki 



HOO- 
"""l BAH 



SEVBE 

==3:= 



RELATIONSHIP 



N«M laintt rtsaM* htlnlil« Mmi 
;«:= ==J== =fcr =i: =*: 



4. OTHER SYMPTOM (ConKnt writing within thit block) 



WID 
=:t=: 



HOO- 

HATt ««K 

:4=r :*: 



RELATIONSHIP 



NoM laiwti r«aU< Pnbtfi MmJ 
:«:: ::»:= :«:= ==3== :*: 



5. OTHER SYMPTOM (Confin* writing within this block) 



MOO- 

wiii j„„ stvai 

==t=: =S=; ==3:: 



RELATIONSHIP 



NoM iMwta PesaU* rrobibh MmJ 
=«:: ==J" =*= zzi: =*= 



6. OTHER SYMPTOM (Confint writing within this block) 



MOD- 

Eun 



SEVBt 
==5:: 



RELATIONSHIP 



N«M Imnti Possflih PrekobI* MUmJ 

::©:= ==J:= ==fc= :=»= ==*= 




RELATIONSHIP 






ACTION 


NoM Innati PosiiUt Prekabb DtfiMd 


TAKEN: 


=*: 1=1" :S;= =i= ==•:= 





ACTION 
TAKEN: 



• ^A /yt^VX 



=fi:= ==Ji= =£== =3c= =*: ==5== :=&= 



^ 



^/ /•^^/t^ 






Developed within the ECDEU program, the TESS Write-In Scale (TWIS) is an 
independently formatted 6-item scale to be used in conjunction with the Dosage 
Record and Treatment Emergent Symptoms (DOTES). Since writing of any sort is 
absolutely prohibited on the General Scoring Sheet, a separate scale had to be 
designed to allow the rater to record the presence of any treatment emergent 
symptoms whose names were not printed on DOTES. 



APPLICABILITY 



UTILIZATION 



For all research populations 

Used in conjunction with DOTES whenever it is 
necessary to record the presence of a symptom 
not printed on DOTES 



TIME SPAN RATED Same as the referent DOTES 

CARD FORMAT - ITEMS CARD 01 = (19x, 6(13, 311) ) 



Symptom 



Col umns 

20 - 25 
26 - 31 
32 - 37 



Symptom 

k 
5 
6 



Col umns 

38 - k3 
kk - i+9 
50 - 55 



The length of the data field will vary with the number of "write-ins". The field 
for each "write-in" is |6 and is coded as follows: 



Symptom code 
I ntens i ty 
Relat ionship 
Act ion 



First 3 columns 
'4th column 
5th column 
6th column 



SPECIAL INSTRUCTIONS 

Identification Block (ID) - It is essential that the ENTIRE ID BLOCK coded on TWIS 
MATCH EXACTLY the ID block of the corresponding DOTES. Example - While rating the 
DOTES at Day 2k, the rater observes that - in addition to tremor and increased sali- 
vation (printed symptoms) - the subject is grinding his teeth. On Item k of DOTES, 
he codes "2 = yes, both printed and write-ins present" and then proceeds to code his 
judgments of "tremor" and "increased salivation". He next fills out the TWIS by com- 
pleting the ID block exactly as it appears on DOTES. Finally, he writes in "grinding 
teeth" and makes his 3 judgments of the symptom. 



- -t:: :«:: :a.- :«:: ::l:: :J:: 

SECOND 

:X:: :t:: :*»:: -H"- -O-- :«:: :«:: -Ji-- -S- ::T:: 


.«. -A'- 2- :3:: A- RATER ^ *^- ^ 

NUMBER 

:fl:: .rii. :2:: :3:: .A. :i: :*: ::7:: 


::a: 
::&: 


::»: 


:«:: :V:: -ift- ^X-- V ■•» 


:fl:: ::!:: «^ :3:: -A- :i: -A- ::7:: 

PERIOD 
:fl:: ::t:: :2:: -2- .4- :*: :*: ::7:: 

Hours Days Weelts Months 
:fl:: ::t:: ^^ :i: :*: 


::&: 
::a: 


::*: 
::*: 


>*- FORM 

,«. NO. 


PLEASE USE A NO. 7 LEAD PENCIL BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


INSTRUCTIONS: This scale MUST be used in conjunction with the DOTES. Be sure that the PERIOD designation matches the 
proper DOTES. Make three judgments for each symptom and confine o// writing within the box provided. 
DO NOT MARK IN SHADED AREAS 


1. OTHER SYMPTOM (Confine wri/ing w.lhin (/..s Wocic) 


:©:: ::t:: :£:: :3:: -A- :3:: :&: ::7:: 
:fl:: ::t:: :2:: :3:: :^r: :i:: :*: ::7:: 
:fl:: ::t:: :2:: :3i: -A.-- li:: :*: ::7:- 




:A: 
:Al 



3^3 



Notice in the above example that NO marks have been made in the shaded areas of 
either the ID block or text of the scale. The code for "grinding teeth" will 
be inserted by BLIPS editors. 

Form Number - This number is preprinted on the form and need not - indeed must 
not - be encoded again. (See page 336). 

Items 1 - 6. Other Symptom - When writing in a symptom, the rater must make 
judgments of intensity, relationship and action undertaken exactly as he does 
for DOTES. He must also confine his writing ENTIRELY within the blocks pro- 
vided. Failure to do so may cause the optical reader to misinterpret signals 
and cause processing delays, 

Exampl es : 



OTHER SYMPTOM (Conlir 



'iting within this block) 







None (emote foiMf/tiobMt Defined 



ACTIO 
TAKEN 



INCORRECT - May cause multiple codes in Intensity and/or Relationship, 



OTHER SYMPTOM (Confine writing within this block) 




•*""■ SEVERE 



None Remote Possible Probable Defined 
r:©:: ^.4» :i:r :ii lA: 



INCORRECT - Requires erasure before symptom code can be inserted, 



OTHER SYMPTOM (Confine writing within this block) 






RELATIONSHIP 



None Remote Possible Probable Defined 
=«:r :■!> :5:i -zS^z z=«:i 



ACTION 
TAKEN: 



CORRECT - No opscan problems, 



3^+4 



Symptom Code - A 3-digit numeric code for the "write-in" permits documentation 
of "write-ins" by name. A list of these treatment emergent symptom codes will 
be provided upon request to the Biometric Laboratory. 

Intensity, Relationship, Action - These 3 judgments are rated in the same manner 
as described in DOTES. 

DOCUMENTATION 

a. Raw score printout 

b. "Write-ins" will be incorporated within the documentation provided 
for DOTES. 



345 



038 STESS 
SUBJECTS 

TREATMENT EMERGENT 
SYMPTOM SCALE 



MH-9-38 
1-73 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

STESS 



PATIENT INITIALS 












NUMBER MALES 001 TO 499; FEMALES 500 TO 998 


~ 




zC-.-. :«:: 


HRST 
INITIAL 


:«;: -S-z 


zziz 




:0:: ::►:: :*:: 
:0:: "t" :4:: 
:Or: Z.U-. :4=: 




:*: :*; :*: :;Ti: =*: :*: 

PATIENT 
I*: :*; :*: :=T:r =*: rAr 

I*: I*: :*: zzTzz i*: r*: 


^ 




:C:: :«r: 

--M:-. --n-.z 


SECOND 
INITIAL 




zziz 






:0:: 
S 


M 




F 


:3" 


:*: :*i :*: ::Ti: i*: :*: 

RATER 

-.*: r*r r*: riT:= i*: ;*r 


^ 


:«" :V" 


=0--: t:L:: :*:: 


Doyi 


:*: :*r r*- ==T:: :*: :*-" 

PERIOD 

:*: :*r :*: idT: :*: ::*: 

WhIci «Aon«ht 


— 




WM 


^^^Hi 




m "^ ffi '^" 


~ 


PIEASE USE A NO. 2 LEAD PENQL BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


— 


INSTRUCTIONS: 


Since the 
you been 
filling out 
mark "Dor 


ast time here, hove you been bothered with or had trouble with any of the items listed below? If this is your first visit, have 
>othered by any of these items in the last week? Mark the number which best tells how much you were bothered. When 
form for the child, mark on the basis of what you have seen or what the child has complained about. If you are unsure, 
't know". 


^ 






EXAMPLE 


Cram 


Ncl Just ^ 
et . '""" 
All Unh ""■'" 

pS? :«:: i;t:r i«. 


Vtry 
Hgcb 


Don't 
Kiww 




— 


Hova you hoc 


trouble with: ITEM 
1 . Eating? 






«ii imi. "«'' 

:«:= :rj=-. z±:z 


Vtry 
Much 


Don't 
Know 


^ 




2. 


Drinking? 






:«:: "»" l*r 


:*; 


=*= 


— 




3. 


Dry mouth and lips? 






r*; r:J" t:^: 


:*: 


t*: 


— 




4. 


Wetness in mouth? 






:«:: =:»:: I*: 


=*: 


=*: 


— 




5. 


Fewer bowel movements (constipation)? 




:«:: =:):: i*: 


"-*: 


---^z 


— 




6. 


AAore bowel movements (diarrhea)? 




!«:= =.-»=: I*: 


=*: 


-z^z 


— 




7. 


Stomach aches? 






=«:: :rj=: =*i 


I*: 


=*- 


— 




8. 


AAuscle cramps? 






:«:: "J:r =*r 


1*: 


r:*: 


— 




9. 


Being sick to your stomach? 






I*: =:»:: -ztzz 


I*: 


i^i 







10. 


Wetting the bed? 






=«:: i:t" =*r 


z*: 


=*= 







11. 


Urinating? 






iS:: ::>:: :*: 


zzizz 


!=<;= 







12. 


hchy or scratchy skin? 






=«:: :=»=: =*: 


z*r 


=*: 


~ 




13. 


Rashes? 






=«:: "t" z:ar-- 


r3--= 


1=411 







14. 


Colds or sniffles? 






!«:: "t" :*: 


=*: 


i=4;r 


— 




15. 


Headache? 






z&i r:J:: ii: 


:*: 


=*= 


— 




16. 


Dizziness? 






zrBiz =rhi ;£:. 


;i= 


I*: 







17. 


Playing sports? 






=St; :rl:: z:2zz 


:i: 


=*: 


— 




18. 


Shokiness? 






rfi:: r:l=: ri: 


;i: 


=*: 


— 




19. 


Pronouncing words? 






=flc: =i»=r zir 


l*r 


=*: 


— 




20. 


Doing things vnth your hands? 




ifti "1:: :i: 


:*: 


I*: 


— 




21. 


Sitting still? 






ifi:: :ij=: li: 


:i: 


-v*- 







22. 


Tiredness? 






ifit: ."Ir: z:2zz 


:*: 


:*; 


— 




23. 


Feeling sleepy? 






=«:: :r»:: :*:: 


r3c: 


r*r 







24. 


Trouble getting or staying as 


leep? 




:£t: :iJ:: :i: 


=ii: 


:i4:i 







25. 


Bad dreams? 






idSt: ::l" ii: 


:i= 


:A: 







26. 


Getting olong with parents? 






:dBt: ;rl:: :ii 


III; 


iztr 


— 




27. 


Getting along with other kids? 




idBk: ::!:: .2zz 


iii: 


rrt: 







28. 


Crying? 






lAr irh: =i: 


"ir 


:A: 







29. 


Getting mad? 






:A: "1" i=fc: 


:i: 


:A: 


— 




30. 


Not being happy? 






:Ar rrhz ri:: 


li: 


:*: 






31. 


Being sad? 






:fib: ::!:: =i: 


;ii 


-=4:= 






32. 


Paying attention? 






348 . 


lA: "J:: :i:: 


;*: 


;:«:: !>. H»>.> 





The Subject's Treatment Emergent Symptom Scale (STESS) was developed within 
the ECDEU program and is an independently formatted 32-item scale designed to 
elicit information on the presence and degree of physical complaints. It may be 
completed by the child, parent or other knowledgeable adult. Although focussed 
on possible treatment emergent symptoms, STESS does not ask the rater to judge 
the relationship of his "symptoms" to the drug he is taking. A ^t-point scale of 
severity is used with an additional response position for "Don't Know". 



APPLICABILITY 
UTILIZATION 

TIME SPAN RATED 
CARD FORMAT - ITEMS 
Item Column Item 



20 
21 
22 
23 
2k 
25 
26 
27 



Children to the age of 15 

Once at pretreatment ; at least one post-treatment 
assessment. Additional ratings are at the discre- 
tion of the investigator. 



Now or within the past week. 
CARD 01 = (19x, 3211 , 12) 

Column I tern Column Item 



9 
10 
11 
12 
13 
14 
15 
16 



28 
29 
30 
31 
32 
33 
34 
35 



17 
18 
19 
20 
21 
22 
23 
24 



36 
37 
38 
39 
40 
41 
42 
43 



25 
26 
27 
28 
29 
30 
31 
32 



Col umn 

44 
45 
46 
^7 
48 
^9 
50 
51 



Total Score-'- 52-53 



* Total Score = Sum of all items, 
SPECIAL INSTRUCTIONS 



Total Score Range =0-96 



1. Coding Rater - When the child completes STESS, Code 00 (S) ; for mother or 
mother surrogate, encode 11; for father or father surrogate, encode 22. Use 
any other numbers for other adult raters. Do not intermix raters for a given 
subject; e.g., mother at one rating; father at the next; self at the next. Use 
the same rater throughout the study; e.g., self at every rating; mother at every 
rating, etc. Concurrent ratings may, of course, be used; e.g., self ratings 
along with mother and/or father. 

2. Do not write in the shaded area of the ID block. Form Num.ber has been preceded, 



Incorrect 



FOKM 



"<S r:-:^'S^: 1 



Cprrect- 



349 



3. STESS may be used as an independent scale for the periodic evaluation of 
treatment emergent symptoms (physical complaints) as: 

a. perceived by the subject 

b. observed by one or both parents or parent surrogates 

c. observed by other raters, e.g., nurses, counselors, aides, etc. 

Along with its use as an independent measure, the completed scale may also be 
referred to by the physician as a screening device in his assessments of treat- 
ment emergent symptoms. 

k. As with all scales filled in by lay raters (patient, parent, etc.) be certain 
that the rater understands the instructions and knows how to marl< his responses. 
Immediate monitoring of the completed form is suggested whenever possible to 
check that each item has been marked properly and that there are no multiple 
answers . 

DOCUMENTATION 

a. Raw score printout including total score 

b. Total score means and standard deviations by period and rater where 
appl icable. 

c. Symptom frequencies by period and rater where applicable 

d. Variance analyses - Rater may be included as a factor if the 
investigator chooses. When sufficient sample is available, 
factor analysis will be performed on the STESS. 



350 



055 LAB 
LABORATORY 

DATA 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALYH 

PSYCHOPHARMACOLOGY RESEARCH BRANCH 



LABORATORY DATA 



INSTRUCTIONS 



LABORATORY STANDARDS - If Laboratory Standards {normal limits) are not 
already established for your unit, i.e., in the ECDEU 
Data File or if you wish to employ different 
standards for analyses, please include such Standards 
with data. 



PERIOD - Laboratory tests MUST be encoded PERIOD BY PERIOD, i.e., do not encode laboratory data 
from different assessment periods on the same General Scoring Sheet (GSS). 

Record PERIOD in DAYS from initial (first) rating regardless of initiation of medication. 
For example, if ratings are made at the start and end of a 2-week drying out period; every week 
during a 4-week course of medication and finally 2 weeks after the cess^^tion of medication, 
PERIOD would be recorded as follows: 



Rating 


1 


2 


3 


4 


5 


6 


7 


Day 


00 


14 


21 


28 


35 


42 


56 



Dry 



Drug 



Followup 



While a set of laboratory tests may actually be collected in 2 days, code the entire set under one 
PERIOD if they were meant to constitute a single assessment. When a test requires verification, 
i.e., repeated to check result, ONLY THE VERIFIED VALUE should be encoded. 

For each laboratory test encoded, the rater must make 4 entries: 

1 . The numeric value 

2. A clinical judgment of abnormality 

3. A clinical judgment of relationship to drug 

4. The action undertaken as a consequence of the finding 



VALUE — Refers to the numeric value obtained from the test. 



For the preprinted tests, the number of "x's" indicates the number of digits required. Raters must 
fill in ALL required rows - including leading and following zeros. 

EXAMPLE - Obtained White Blood Count (WBC) was JfiOO/mirfl. 

Correct coding ~ 



«*• :il:: =2i: .^-. z^: 

WBC ^ ^ 

:0= zA--- :»- :*: =4- :«== =*■ 



xx.x thousandt/mm3 



zfl" 



r2ri :*: 



«=- =9" 

r«:: r:7" =«- =*: 



:0:: ::»" =8" =*= --^^ 

; xx.x th 

lAi "t: -az: -.i^z z*zr. 

=«:: ::t: ra^: :*= ==«:: 



:i7" ::»: =9" 
:*: :«ir «■» r«~ =«" 
i^i :«:: z:?:: =«:i rfl:: 



MH 9-55 
6-73 



352 



FORM APPROVED 
OMB NO. 68-R955 



CLINICAL 

JUDGMENTS — For each laboratory test, 3 clinical judgments are made: abnormality (ABN), relationship (RED 
and ACTION. 

a. ABNORMAL Abnormal refers to a clinical judgment of abnormality - regardless of 

numerical value. 

N = No, Not abnormal 

7 = Questionably abnormal 

Y = Yes, Clinically abnormal 

A = Alert, an extreme abnormality 

b. RELATIONSHIP - a judgment of the degree of relationship between the test abnormality 

and the drug rated on a 5-point scale. 

N = None, - no relationship 

R = Remote, - less than a 10% probability that symptom 

occurrence is related to drug employed. 
PC = Possible, - probability between 10% and 50%. 
PR = Probable, - probability between 50% and 90%. 
D = Defined, - greater than 90% probability that symptom 

occurrence is related to drug employed. 

c. ACTION TAKEN - refers to action taken as a consequence of the symptom's appearance. 

Actions are arranged in order of increasing stringency. Only ONE action 
- the most stringent - should be recorded as it is assumed that less 
stringent actions may also be employed. 



ACTION CODE: 






NO = None 


CH+ = 


= Change plus 


SR = Increased Surveillance 




Contraactive Rx 


CO = Contraactive Rx 


SU = 


= Suspend Rx 


CH = Change Dose 


Dl 


= Discontinue Rx 



EXAMPLE: A BUN value of 42mg/100 ml is obtained on a young schizophrenic male. The investigator considers 
the result abnormal; feels it is probably due to drug and suspends medication. Coding is as follows: 



:*:: 


:*- 


==»: 


XX mg/100 rnl 


:«ii 


:^:-- 


-9- 


:*: 


-ttz- 


::?r: 


^f^ 


.ZfifZ 




-n- 


:ff- 






























:*---- 


^^ 


-s^-- 


-A-.z -.S-.Z 


r*= 


i3:i 


:«:: 


=:»: 


«& 


SSi 


CO: 


Gtt: 


ei** 


Wt0 


Gtz- 



Unlisted tests may be encoded on pages 3 and 4 - either in conjunction with listed tests or by themselves by using 
Page 4 as an "independent scale." See Manual for Instructions. 

If you obtain data from a laboratory test using units other than those preprinted on the form, do not encode the 
data in the preprinted section. Record the data in one of the sections under "Additional Laboratory Tests." 

IMPORTANT - PLEASE READ CAREFULLY BEFORE MARKING THIS FORM. 

INSTRUCTIONS FOR COMPLETION OF MULTIPLE PAGE FORMS 

1. Complete page 1. 

2. Following completion of page 1 carefully tear out and remove the pink protective sheet lying between the carbon 
and your copy of page 2. Follow this procedure for each subsequent page. You must do this to obtain a copy of 
the data for your files. 



CAUTION: 



DO NOT REMOVE PINK PROTECTIVE SHEETS OTHER THAN THE ONE LYING BETWEEN 
CARBON AND COPY OF THE PAGE YOU ARE ABOUT TO COMPLETE, 



When you have completed all pages of the form, carefully tear out and remove carbon papers and your copy 
pages. The machine scannable pages should be left In booklet form for shipment to the Biometric Laboratory 
in packages prepared according to instructions received from the Biometric Laboratory. 



353 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 
NATIONAL INSTITUTE OF MENTAL HEALTH 

LABORATORY DATA 



PATIENT INITIALS 


















NUMBER MALES 001 TO 499 




NUMBER FEMALES 500 TO 998 


— 


---J<-- 


:*: 


z:C:-. 


:©:: 


:*: 


FIRST 


zzfzz 


:«: 


:»= 


:.,:: 


i-.Jzr 


--^- 


:;1" 


:«:: 


:*- 


;>*: 


PATIEN1 


--^-- 


--«:: 


:i7:: 


:«: 


-:&z 





:«:: 


"t:: 


-tit-. 


--*t- 


=o 


INITIAL 


:*--: 


-O: 


:*: 


:*: 


::T== 


:©: 


::1z: 


-:2:: 


--:»-- 


zA:z 




--:&-- 


:©= 


:=7:; 


:«: 


::&: 





:«:: 


::V:; 


-vt-- 


=*-- 


::V: 




:i:: 










-«:: 


:i1:r 


zz^z 


-.^-- 


-Jt:-- 




!:&: 


:«:: 


::?:: 


:«: 


::»: 




-A-- 


:*- 


r«zr 


:*- 


=* 


SECOND 


zzfzz 


:«: 


:«: 


::t:: 


"Jz: 


:©: 


::1:: 


--:&-- 


--^-- 


z-Az: 


RATER 


--:&-- 


=*= 


r:7:i 


=«:: 


;:»: 


— 


:*: 


-^---- 


-Mf- 


--*»:-- 


:©: 




:*: 


:0: 


:*: 


--^-- 


"T:; 


--:&-- 


::1r: 


z:S^z 


--:»-- 


:=*: 




--^- 


-? 


:r7:: 


=«: 


::»: 


— 












INITIAL 


































:#= 


:dV:: 


--W-- 


:*: 


zif: 




r:Zr: 










--:&-- 


==1" 


=:g:= 


--^-- 


::4:; 


PERIOD 


:«:: 


r«:: 


zzT-z 


::&: 


::&-- 





























^£^ 










FORM 


ifiii 










--:&-- 


:r1:: 


r^r 


=:»= 


---^z 




-^- 


=«: 


::?:: 


zz&z 


::»: 




























Hours 




Days 




Weeks 




Months 






^~ 












NO. 


^^j 










:©: 


::1:: 




:*: 






--:»- 




:^r 






__ 



PLEASE USE A NO. 2 PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. — 



HGB " 


;:1:: 
-.:1" 


rig:: 
rrg:; 




-zAz rig:: 
xx.x gm/lOD ml 


= «:: 


"Ti: 

zzfzz 






=©: 


::1r: 


=:g:r 


zz^z 


--4= i©= 


= «:= 


=:7:: 


:«:= 


zrSz 



33a 



WBC 

:«:.- :r1:= rrg: 



=r1" ::2:r 
:r1: 
z«:: ::1i: =:S:= 



::3:: ::4:: =©:: 

xx.x thousand/mm 3 

1:3:: :-4: ::§:: 



:©:r :;^: iig:: 

NA + 

!«:: ==1" =:g:i 



::3:: :4: :«:= 

XXX mvg/L 
::3:: :!*= -meq ::§:: 



«:; 


iiTii 


-^ 


«:= 


iiTti 


=«: 


©: 


r:7:= 


:«^ 



*IO rSS: «©: 



;:Ar 

:€» Gtt* 






*& :P«: 



-«e= 


= r1r: 


zzS-z 


^- 


z-A^z 




::»: 


=«:: 


zzT-z 


-»- 


:«:= 


=«= 


:r9i: 


::V:; 


:A:: 




=*t: 


:*: 


*©: 


=P«: 


=©:: 


HCT 










XX % 
































:©: 


::1:: 


zz^.z 


-:»-- 


---■4:-- 




r®: 


:©: 


:=7ii 


--»: 


:«:: 


-NO^ 


:S«: 


<» 


:«* 


G»* 


=S0: 


:01: 








».;.*' 


::1ri 


zz^.z 


-^-- 


:4: 




::&" 


:©: 


=:7^: 


i«:i 


:«:: 


-tt-- 


:=?:: 


iitii 


=5ft:: 




=«: 


:*= 


*& 


:{«: 


=©= 


RBC 








X.X IT 


illions/ 


mm'J 






























-^- 


::1:: 


i:g:i 


^ 


=4= 




zz^iz 


:©= 


iiT^z 


=«= 


=«: 


«© 


:SR: 


«3: 


aC*t 


C»* 


=so= 


=«: 









zjzz 


-^- 


:«:: 


=*»:: 


:r?:: 


:i»i= 


z-J^z 




;*t: 


:*: 


*& 


:T-- 


:«:= 


= «:: 


*IO 


-SR: 


<» 


^ett 


a** 


i$0= 


lOl: 




zfzz 


=*: 


:«:: 



















::©: :=1:: 


::S:: 


:*= 


zz4:z 




:*: 


:«:i 


zzT-z 


:«: 


=«:= 


=*t; 


::?:: 


ziYii 


:;*: 




:*):: 


:*: 


*& 


:Pt= 


:*: 


Neutrophiles 








XX% 
































:©: :=1:r 


::g:= 


=:»: 


z-AiZ 




=:&= 


r«:r 


z:^: 


:«:= 


=«:= 


*to 


=SK: 


=£© 


zCh: 


ew* 


:SU: 


;01: 








. =:&= :i1zz 


::2:: 


=:»= 


:=*= 




--^-- 


:«:: 


:;7t= 


;«:= 


:«:i 


:*tz 


::?:: 


ii>i: 


z-J^z 




=*»:: 


I*: 


*& 


:Pg= 


:«:= 


Lymphocytes 








xx% 
































r©: zzlzr 


:*i 


--^-- 


:=*: 




:*: 


=«:: 


zzT-z 


:«:: 


:«:= 


*IO 


=S«= 


3C© 


zCHt 


cw* 


lSU= 


:01: 








:©: ijl:: 


=S: 


--:»-- 


::*: 




:S= 


:©= 


1=7:: 


:«: 


-:&z 


:*t: 


rr?:i 


==>t= 


zzAzz 




:«: 


:*: 


*& 


=H»: 


zzStz 


Eosinophiles 








xx% 
































:<t: r:1:: 


=«:: 


--:»-- 


::*: 




=:fef: 


-^- 


i:7i: 


=©: 


=«:: 


*»o 


=S8: 


ac© 


:C» 


c»* 


=SU: 


:01: 








©: ilrz 


=:g:= 


-:»-- 


z-A^z 




:©: 


--:&-- 


::7t; 


:*= 


r:©:: 


:«: 


:;?:: 


"¥:: 


zzPiZ 




:*J:r 


:*: 


*& 


-mz 


-:&z 


Monocytes 








xx% 
































raS:: -"1=: 


rig: 


-:»- 


zzAzz 




:©: 


-:&-- 


==7^= 


:*: 


:«:: 


«o 


:SR: 


«ec 


aCtt 


Cttt 


zSO: 


:01: 








:«:= ;=1== 


::2:: 


::»= 


-A^- 




ir&r. 


--:&- 


"7t= 


--:&- 


:«:: 


-zUz 


-:?:: 


-y^i 


=;*:: 




=*t: 


=*: 


*0: 


-f*- 


-^-- 


Bosophiies 








x.x% 
































:«:: "Irr 


::g:r 


.:»z 


Z-4-. 




=*f= 


-^- 


::7i: 


-^ 


:«:= 


*to 


=SR: 


<» 


=ew 


CM* 


iSU: 


rOJ: 








:©: ::1r: 


rigrr 


-^- 


--A-- 




:*i:: 


--zQzz 


=:7i: 


-^ 


= «:= 


:*):: 


I!*: 


:dyi: 


=A: 




:*t: 


:*= 


*& 


:«»= 


:«= 


Sedimentation Rate 




XX mm/h 
































:«:i r=1:: 


::g:z 


-^- 


=4= 




:©: 


--:&-- 


r:7i= 


-^- 


:«:: 


*t© 


:S8: 


<» 


=0* 


cw* 


=S0= 


=01= 









::3:i :4= ::§:: 

X.X meq/L 
::3:r ::*: iig:: 



irTt: 
z=7t= 



«3: iCW G»* 



CL- 

r«:i " 


:: zzS.z 
rz ::S: 


:^r 
=:*= 


XXX 

-Ai-- 


meq/L 


:«:: 
=«:= 




r«:: 




=«:r r= 


z: =:g:z 


=:»: 


---■A- 


i«:r 


:«:: 


rrT:: 


:«:: 


=S: 



«0 :SR: <» ^O* G»* 



n*t= =:|t: *& =«t 
rSO: :«: 



=«:: 




=*= 


::»= 


13*: 


=«:= 


:©: 


::?:: 


:«:: 


:«:: 


=«:: 


::»:: 


::>r:: 


:;*: 




=W= 


"R:= 


*©: 


:«t 


:©: 


CA + + 








XX 


mg/100 ml 






























:<r= 




=«: 


-.:»-- 


:a*:: 


:*= 


:«:: 


::7:r 


:«- 


:«:: 


«IO 


=SR= 


<» 


=€» 


GK» 


=S0= 


:0»: 








:«:: 


::1" 


:«: 


■-:»-- 


:=*: 


-:&= 


:«:: 


::jt: 


=«: 


:«:: 


:«: 


::*: 


:^: 


:;A:: 




=W= 


==lt: 


*& 


:PR: 


:«:l 


P04 = 








X.X 


mg/100 ml 






























:©: 




=*: 


--^-- 


:=*: 


=^= 


=«:-- 


::7:: 


:«= 


-^- 


*to 


:SR: 


3SO: 


aC» 


GW* 


=S0= 


:OJ: 








=«:: 


:;5:= 


-rS^- 


--:»-- 


zAz 


:©= 


:«:: 


zzT-z 


:«:: 


-z&z 


:«:: 


::?:: 


::y^: 


:Vt: 




=*):: 


:*= 


*©: 


:Wt 


:©: 


MC++ 








X.X meq/L 






























■■:&■-- 


::!:; 


=*: 


1:3:= 


::*: 


::&= 


:«:: 


::7tr 


:*: 


-zSzz 


*l© 


:S«: 


«& 


=€» 


e»* 


=SOt 


:01: 








-:&-- 


"1" 


:*: 


=:3:: 


::*: 


::&: 


:«:: 


::?:: 


:«: 


:«:: 


:«: 


::*: 


:iVi- 


---Af-- 




:*t= 


:*: 


*©: 


:|* 


=©= 


Li + 








X.X meq/L 






























:©: 


:r1:: 


:*: 


:*: 


::*: 


=:&: 


--:&-- 


::?:: 


:«:: 


:*: 


*to 


:S«: 


«& 


«*: 


G»« 


=S0= 


:«: 









:©- ::1:: ::2:r 

SGOT 

:©: ::1:: :3:: 



::&: :=*: ::&: : 

XX Kormen U./100 ml 
::3:: ::*: ::§:: : 



■.zT-z :«: 
::?:: r*: 



354 



«© :SR: 3»3: :€«: Gtt* 



:«:: :*: *& :P«: 
:S0= =OJ: 



















LABORATORY DATA 












PAGE 2 




— 






















NUMBER MALES 001 


to 499 




NUMBER FEMALES 500 to 998 


— 






















:«:: 


zzy.z 


:S:: 


:*: 


:--*: 


:«^: 


:«: 


::?:: 


:«: 


:«:: 





BE SURE TO AAARK IN PATIENT, RATER AND PERIOD NUMBERS 


:©: 


z.y.z 


::2:: 


:S3:: 


PATIENT 
::*: ::&: 


:©: 


zzT-Z 


:«: 


::»: 





















































:©: 


z.y-z 


:*: 


::3:: 


::*: 


:©: 


:©: 


::7t: 


:«: 


::St: 







:©: 


::1:: 


::§:: 


::3:= 


::*: 


=:&: 


:«:: 


::?:: 


:«: 


::&: 



































«ATER 
































:«:: 


::1:: 


:«:= 


:S3:= 


::*: 


;*= 


:«:: 


::7i: 


:«:: 


:i*: 







:©: 


zzy.z 


::2:: 


:S3:: 


:=*: 


::&: 


:*: 


::7t: 


:«: 


::©: 


zz 










































■rtn 










•«■ 










zzQzz 


::J:: 

Hours 
::1:: 


:S:: 


:i3:: 

Days 

::2:: 


::*: 


Weeks 


:*:: 


::?-.: 

Months 

:3t: 


zz&z 


::a: 


^ 


:&-- A- 


:^: 


^z 


::*: 




:ri:: 


:«:: 


::?:: 


:®: 


:«:: 


:«:: 


::?:: 


::y:: 


:A: 




:W: 


:*: 


*0: 


:PS: 


:«:: 


— 


SGPT 






XX units/10( 


ml 
































:©: -U- 


:S:: 


^z 


::*: 




:«:: 


:©: 


zzT-z 


:«:: 


::&: 


«& 


:SR: 


3sec 


aa* 


c«« 


:SU: 


rO»: 








— 


:©: -zV.-. 


:^.: 


=3:: 


:4: 




::-i:: 


=©= 


zzT-z 


:«:: 


:«:: 


:*t: 


:A: 


:::r:: 


:A: 




:«: 


:*: 


*CC 


:PS: 


:»: 


— 


LDH 






XXX 


units/ 100 ml 






























_ 


:©i r:1ri 


:S:: 


=3:: 


::*: 




::Sf: 


:«: 


zzr-z 


:«: 


:«:: 


ttet 


:S«: 


«et 


aa* 


Cttt 


:SU: 


ziiiz 








— 


-.:&-. ::1:: 


r:2:: 


=3:: 


::*: 




:«:: 


:«:: 


::7t: 


:©: 


-:»z 






















^ 


:©: ::1:r 


11?:= 


:3:: 


:vt: 




::»: 


:«:: 


::7i: 


=«= 


:®: 


:*t: 


::?:: 


::Y:: 


:^: 




:«: 


::R:r 


*Cc 


:PS: 


:»: 


— 


Amylase 




XXX Somogyi units/100 


ml 




























_ 


:©:: ::1=: 


iriti 


:3:: 


"-*: 




:«:: 


:©:: 


r:^: 


:«:: 


::&: 


«© 


:S«: 


a^ec 


zatz 


cw* 


:S0-- 


ziiiz 








— 


:©: "1=: 


::2:: 


^z 


::*: 




:«:: 


:©: 


::T-: 


:«:: 


:«;: 






















~ 


.:»-. -V- 


::?:: 


:a:: 


::*: 




zzSfz 


:©: 


zzT-z 


::«:: 


::&: 


:«: 


::?:: 


riT:: 


::a^: 




:«: 


"R:: 


*Gc 


:P«: 


:«: 


— 


Alkaline P'tase 




xx.x K 


ng-Armstrong 


units/ 100 ml 




























... 


:«:: ::1:-- 


:S!:: 


::3:: 


::*: 




:«:: 


:©: 


zzr-z 


:«: 


:«:: 


WO 


:SR: 


ze& 


aa* 


GWt 


:SW: 


:«4: 








— 


:©i "1:: 


::2:: 


:«:; 


::4:: 




:«:: 


:©= 


-zT-z 


:«:: 


:®: 

























:©: "1:: 


::Pzz 


:^: 


::*: 




::«:: 


:©: 


zzr-z 


:«:: 


:«:: 


:3a:: 


::?:: 


zttzz 


::«i: 




:W: 


:*: 


*©: 


:P8: 


:©: 


— 


BUN 






XX 


mg/100 


ml 

































raSti ::1:: 


lit: 


:®: 


:^: 




::&: 


-ezz 


zzr-z 


:«:: 


:«:: 


«© 


:SR: 


ZGO: 


aa* 


CW-t 


z%A3-- 


:Ut: 








— 


= ©= ::1: = 


::?:i 


::3:: 


::*: 




=«:: 


:®: 


zzT-z 


:«:: 


:«:: 


:«:: 


irS:: 


:^:: 


:A: 




:«: 


iiRi: 


*Cc 


:Pe: 


:©: 


— 


Creatinine 






X.X 


mg/lOO 


ml 

































--:&-. :r1:: 


::2:: 


::3:: 


::>*: 




::&: 


:«:= 


z-r-z 


:«:: 


:*: 


«© 


:SR: 


«©: 


3E» 


CtHit 


:$«: 


:«!: 








— 


:©: =:1--: 


:5t: 


-zSzz 


::*: 




::S:= 


:«:: 


zzT-z 


:«: 


:«;: 


:**: 


::?:: 


:fr:: 


::A^: 




:«:: 


::R:: 


«5: 


:PS: 


:ft: 


— 


Uric Acid 






X X 


mg/lOO 


ml 

































=«t: =r1" 


rrSt: 


::3:: 


::*: 




::§:: 


=«:-- 


z-r-z 


:«:: 


:«:: 


*t© 


:S8: 


:£©: 


3E« 


c»* 


:SO: 


:«): 











:«:: ii1=: 


::5ti 


:<§:: 


::*: 




:*: 


:«:: 


zzT-z 


:«:: 


:«:: 


:«: 


:A: 


::Y:: 


:A:: 




:**: 


::g:: 


*& 


:PS: 


:©: 


— 


Total Bilirubin 






X.X 


mg/100 ml 

































i«:r :r5:i 


izgir 


=<§:= 


::*: 




::&:: 


:«:: 


z-r-z 


=«: 


::©:: 


W& 


:SR: 


:£©: 


ze»z 


C«t 


=S«: 


:Ui: 








— 


:©: :=1:: 


::?:z 


::3:= 


::*: 




:«: 


:«:: 


-zT-z 


=«= 


-:»z 


=*!:- 


::9:: 


:^:: 


:=*:: 




:«: 


:*: 


*0: 


:P8: 


:*: 


— 


Direct Bilirubin 






X XX 


mg/lOQ 


ml 






























^^ 


:«:: ::1:: 


=S:: 


:<g:: 


::*: 




::§:: 


=«:: 


zzr-z 


--«:: 


:*: 


*t© 


rSS: 


3EO: 


33* 


C«t 


:S«: 


:U4: 








— 


=©: :=1r: 


r^:: 


:::3:: 


:3t: 




r®: 


:©= 


-zT-z 


:«:: 


:«:: 






















__ 


:«:: -1=: 


=^= 


::§:: 


::*: 




zz^izz 


:«:=- 


z:7i: 


:«: 


=«:: 


:«: 


::?:: 


:^: 


:A:: 




:«:: 


:*: 


*CC 


:PS: 


:«:: 


— 


Total Protein 






X.X 


gm/100 


ml 

































--:&:-. -y- 


::S:= 


::3:: 


::*: 




:*j:: 


=«:: 


zzr-z 


=«: 


:«:: 


W© 


:S8= 


:«©: 


33* 


GW* 


:S»: 


:«l: 








.^ 


:©: .--V- 


=:?t= 


:*: 


=4: 




::&:: 


:©:: 


zzr-z 


zzQiz 


::&: 


:»: 


::?:: 


::Y:: 


::A:: 




:«: 


::?:: 


*Gc 


:PS: • 


:*:: 


— 


Blood Albumin 






X X 


gm/100 


ml 

































;53:; rrl:: 


r:2:: 


::§:: 


:--*: 




::&:: 


:®: 


z-r-z 


:«:-- 


:«:: 


W© 


:SR= 


3KC 


«* 


G«* 


:SO: 


= 131: 








— 


:«:= -=1rr 


==?^= 


::§:: 


:=*: 




::&: 


:®: 


-zT-z 


:«:: 


:*: 


:*t: 


::?:: 


::Y:: 


:^: 




:«:: 


"R:: 


*Gc 


:P8: 


:«:: 


— 


PBS 






XXX 


mg/100 


ml 

































rJ3:: i:1:: 


:5(:r 


::§:: 


i^r 




::»:: 


:«:: 


zzr-z 


-«:: 


::©:: 


*t© 


:Sfi: 


X.& 


3S* 


G«« 


:S«: 


:Ui: 








— 


=«:; "1r: 


::2:: 


::3:: 


::*: 




::&: 


:«:: 


zzr-z 


:«:: 


--:&: 






















_ 


;«:= :=1:= 


::5tr 


::3l: 


r=ti 




z^z 


:«:: 


zzT-z 


:*: 


:«:: 


:*t: 


::?:: 


:^:: 


:at: 




:«: 


:*: 


*Cc 


:P8: 


:*: 


— 


Cholesterol 






XXX 


mg/100 


ml 

































--:&-- :i1r: 


;S:= 


::§:: 


:^: 




::&:: 


:«:: 


zzr-z 


:«:: 


::&: 


«© 


:S«: 


:£©: 


«* 


G»« 


:S«: 


:«*: 








— 


:«:: r:1r: 


r:2:= 


::g:: 


:=*: 




::§:: 


:©: 


zzT-z 


:«:: 


:*: 






















""" 


:«:= ---y- 


::$^: 


:^: 


::*: 




:«:: 


:«:: 


r:7i: 


:«:: 


:«:: 


:«: 


::?:: 


::y:: 


::*;: 




:«:: 


:*: 


*©: 


:P8: 


:*: 


— 


PBI 






X.X 


meg/ IOC 


ml 

































:©: ==1:: 


=:2:i 


::3:: 


:^: 




:*>:: 


:«:: 


zzr-z 


r:©:: 


:«:: 


«© 


:SS: 


ze& 


ati* 


G*** 


:S«: 


:«1: 








__ 


r©: z-y- 


irftr 


::3:: 


r^: 




:«:: 


:«:: 


::7i: 


:*: 


::©:: 


:*t:: 


::?:: 


::y:: 


:;4^: 




:«: 


:*: 


*ec 


:PS: 


:«:: 


— 


Triglycerides 






XXX 


mg/100 ml 

































:©r ==1:= 


=5f= 


::3:r 


:^: 




::!=(:: 


:«:: 


::^: 


:«:: 


::9:: 


«© 


:SR: 


«& 


as* 


GH:« 


:S«: 


=431: 






::::: 


— 


:©::: -zy.z 


=:g:: 


::§:: 


::*: 




::§:: 


:«:: 


:r7i: 


=«:= 


::©:: 






















~~ 


Specific Gravit] 


::2:i 


=:§:: 


:4: 




:«:: 


:«:: 


-7:: 


:*: 


;:©:: 


:«: 


irfcz 


:3r^: 


::A:: 




:*(:: 


:*:: 


*» 


:PS: 


:*: 


— 


f (Urine) 




l.xxx 



































:«:: i:1r: 


1:2:: 


:=§:: 


::*: 




=:fe:= 


:«:: 


zzr-z 


:©: 


:S:: 


«© 


:SR: 


«© 


=3* 


GH:* 


:SU: 


:«): 








— 


:©: ;:1r; 


zz^.z 


::§:: 


::*: 




::&: 


r©: 


-zT-z 


:«:: 


zzQiz 


355 




















^ 











LABORATORY DATA 












PAGES 




— 














NUMBER MALES 001 


to 4-»9 




FEMALES 500 to 998 






— 














:©: 


zzizz 


zazz 


zO:: 


zz4zz 


zr&z 


:«:: 


zzTzz 


:«:: 


z«:z 


— 


BESURETOAAARKINPAT 
ON THIS PAGE EXACTLY 


lENT, RATER AND PER 
AS YOU DID ON PAGE 


ODNL 


MBER 


S 




zzizz 

zzizz 


zS:-- 
zzg:: 




PATIENT 

z^z z^zz 
Z-Azz zigzz 


=«:: 
:«:: 


zz7:z 
zzT^z 




z«:z 
zzS:: 











^~ 






zzizz 
zzizz 


z:g:z 
z^z 


::3:: 


:z4:z 
z^z 


RATER 


:«:: 
:«:: 


zzTiz 
zzTiz 




z«:z 


^ 






zzizz 

zziz: 

Hours 

z^zz 


z:g:z 

::2:z 


Days 
z:2:z 


ZZ4ZZ zrgzz 

PERIOD 

zAzz zSzz 

Weeks 


z«:z 


zzT^z 

zzTz: 

Month 

zz4z 


:«:: 

:«:: 


z«:z 

zdt 


__ 


■Ac 


•^ 










^ 


Albumin (Urine) 


(None 
or trace 


zzizz 


z^zz 


(4 
-<Szz 


or 4+) 
z-Azz 


zitz 


zz?zz 
zSRz 


zzYz: 

£0: 


zzfcz 

zO* 


CH* 


:*t= 


zzRzz 
zO»: 


*Cc 


:PS: 


rtcz 


^ 


Sugar (Urine) 


(None 

or trace 

-r&z 


zzizz 


zzgzz 


(4 
=0:: 


or 4+) 

zz^zz 


z*tz' 

wet 


zz?zz 

zSRz 


ziYzz 
«0: 


z=ft:z 

zCHz 


CH* 


=S«= 


zO): 


*0: 


zP«: 


=*: 


^ 


:«:: -z^.z i^:: =0== 

RBC (Urine) 

:«:: ::,:: i^:: =3:: 


zAzz zig:: 

xx/HPF 
:^: z:gzz 


z«:z 


zzT^z 
zzTiz 


z«:z 


:S:z 


z«:z 


zzfzz 
zSSz 


zet'zz 


zz4zz 

zCHz 


CW* 




==R=: 
zt5»z 


*©: 


=PR: 


:©: 


^ 


:©: III" ::2:: :3:: 

WBC (Urine) 

:©: :r1:: zzg:: r:3:: 


zz*: :®: 
xxx/HPF 


:«:; 
:«:: 


zzT^z 
zzTzz 


z«:: 
z«:z 


zSzz 


z«:z 


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iSR: 


zzVz: 

zOSz 


zAz 

aa* 


C«:* 


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:0»= 


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:©:: 


^ 


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:z4zz z:§:: 


^z 


zzT^z 


z«:z 


:*: 






















__ 


ADDITIONAL LABORATORY TESTS 






























_^ 


Spaces are provided below for the encoding and rating of laboratory tests not printed 
above. Write in the name of test in the space provided (PLEASE CONFINE WRITING 
TO THAT SPACE) and then code in value and make the clinical judgments as usual. 
As they serve as essential processing signals, ALWAYS BE SURE TO ANSWER THE 
FOLLOWING TWO QUESTIONS: 








~ 


















NO 




YES 












— 


Have you encoded non 


-listed tests on 


page 


3? 




















zz 


















NO 




YES 












.^ 


Have yc 


u encoded non 


-listed tests on 


page 


4? 




















^ 


Name of Test and Units 












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-4- 


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=:3^ 


z-Azz 


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zzTiz 






~ 


:©: irl;: =-5:; 1:3:: 


z=<1zz z^z 
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z«:z 


zzTtz 
zzTtz 


zzgz 
z«:z 


-zQzz 

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=©:: 1:1=1 :-2:: i^:: 


=«:- 


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3i)b ^ 


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MH't'SS 












DEPARTMENT OF HEALTH, EDUCATION, 


AND WELFARE 






FORM APPROVED 


















NATIONAL INSTITUTE OF MENTAL HEALTH 








OMB NO 68'R9SS 


— 




















LABORATORY DATA 












PAGE 4 




— 


PATIENT INITIALS 


















NUMBER MALES 001 to 499 




NUMBER FEAAALES SOO to 996 


— 


:-Jf-. 


-*: 


.-«:: 


=©: 


=* 


FIRST 


zzf-.-. 


:«: 


=*= 


-«- 


::*: 


:«:: 


r:1i: 


:«: 


=:»: 


rat: 


PATIENT 


--«:-- 


r=7:r 


:«: 


:4t: 


— 


:*; 


::t:: 


i*fti 


:*t: 


:0 


INITIAL 


--*---- 


--^-- 


:*: 


:*: 


::T=: 


:«: 


::1:: 


:*: 


:*: 


:=*: 


:*- 


;*t: 


:-.?:: 


:«:: 


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— 


r*t: 


zitt.- 


:««: 


:«: 


riV: 




:*: 










:«: 


::1:: 


:*= 


=*= 


r:*: 


z:^-. 


:«:: 


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, 


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:* 


SECOND 


zzf-.z 


:«= 


--*-- 


i:t" 


"*= 


=«= 


==1" 


:«: 


:*: 


:=*: 


RATER 


=«:: 


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:«: 


::»= 


— 


:*: 


"t" 


:Mr 


-M- 


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INITIAL 


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:«: 


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PERIOD 
















































-i- 


/ 










"1:-. 

Hour* 


:*= 


Days 


rat: 


Weeks 


:*: 


Months 


«: 


-«;i 






If the laboratory dota you wish to encode consist ONLY OF TESTS NOT PRINT- 
ED ON PAGES 1-3, this poge (4) may be used independently, i.e., by itself. 
Fill in patient's initials, patient, rater and period numbers and AAARK HERE 



Discorc 


pages 


1-3. 






































Name 


of Test and Unit* 
















z:0= 


z4- 


:*r 


^: 


zat: 


zz^- 


-^^ 


ziTtz 


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I*: 




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VALUE 






zzTiz 
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z*z 


z-^z 


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z*: 


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zS«z 


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zCHz 


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zSOz 


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Name 


of Te*t 


and Unit* 
















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rSiz 


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zatz 


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z*z 

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zz?:z 


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z*z 


z*: 
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Nam* of Teit and Unit* 
















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zS«z 


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ZOI: 








Nam* of T*sl and Unit* 
















:«r 


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ran 


=»: 


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=&^ 


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zS«z 


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NOTE THAT 4 ROWS ARE PROVIDED FOR VALUE IN THE NEXT 2 BLOCKS. 


Nam* of Test and Unit* 
















,:.,-^ 


=*=, 


=a= 


=»= 


:=4= 


=«= 


:«= 


zzT= 


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z«zz 




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zz4:z 
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VALUE 


z«:z 




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z*z 






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*to 


zz?zz 


zfr:z 


z:Az 


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-z»z 


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:«=. 


:*: 






















Nam* of T*st and Units 
















=*: 


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r*: 


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=4= 


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z^z: 
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z«:z 
z«:z 
z«:z 




zzTtz 
ziTiz 


r*z 
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z«z 
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zztzz 

za«z 


ZI^Z 


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Ot* 


zttz 


zztC: 

zOtz 


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:«: 


=1zz 


r*r 


:*: 


lat: 




:«:: 


=«= 


ziTiz 


:*- 


:«: 


357 





















Developed within tine ECDEU program, Laboratory Data (LAB) is an independently 
formatted 52-item form for the recording of results from clinical laboratory tests, 
It is in op-scan format and replaces the earlier l<ey-punch versions of Laboratory 
Data (05-LD Regular, 05-LD Special), 

APPLICABILITY All populations 

UTILIZATION Once at pretreatment ; at least once at postt reatment . 

Additional assessments are at the discretion of the 
i nvest i gator . 

TIME SPAN RATED By their nature, laboratory tests are "point in time" 

assessments . 

CARD FORMAT - ITEMS 

CARD 01 = (19x, 16, 215, l6, 6l5 , 13, M) 

Item Col . I tem Col . 



Hgb^v 


20-25 


Hot 


26-30 


RBC 


31-35 


WBC 


36-41 


Neut 


42-46 



Na (Act) 


20 


Na (Rel) 


21 


K 


22-26 


CI 


27-32 


Ca 


33-37 


P04 


38-42 



Lymph 


47-51 


Eos in 


52-56 


Mono 


57-61 


Baso 


62-66 


Sed.Rate 


67-71 


Na (Value) 


72-74 


Na (Abn) 


75 



"The format for each "printed" test is: 

Value = up to 3 columns 
Abnormal = 1 column 
Action = 1 column 
Relation = 1 column 

CARD 02 = (19x, 12, 715) 

I tem Col . I tem Col 



Mg 


43-47 


Li 


48-52 


SCOT 


53-57 



358 



CARD 03=(19x, 15, 316, 4l5, I6, 15, 12) 

I tern Col . 

SGPT 20-2^ 

LDH 25-30 

Amal 31-36 

Alk.Phosp. 37-'^2 

BUN 43-^7 

Creat 48-52 

Uric 53-57 

CARD Ok = (19x, 13, 216, 15, 216) 



1 tern 



Col 



Bl .Album. (Abn.) 20 

81 .Album. (Act.) 21 

81 .Album. (Rel .) 22 

FBS 23-28 

CARD 05 = (19x, 2l4, 15, 16,12, 319, 18) 

1 tem Col . 



Alb. (Urine) 


20-23 


Sugar (Urine) 


2i+-27 


RBC (Urine) 


2a-32 


W8C (Urine) 


33-38 



CARD 06 = (19x, 11) 

1 tem Col . 

Write-in 4(Rel) 20 

CARD 07 = (19x, II , k\3, 110, 19) 



1 tem 



Col 



Page k (Used) 


20 


Write-in 5 


21-29 


Write-in 6 


30-38 


Write-in 7 


39-47 



CARD 08 = (19x, 1 1) 

1 tem Col , 

Write-in lO(Rel) 20 



Item 

Tot.Bi 1 i 

Dir.Bil i 

Tot.Prot. 

Bl .Alb. (Value) 



I tem 



Choi 
PBl 
Tri . 
S.G. 



(Urine) 



tem 



I tem 



Col . 

58-62 
63-68 
69-73 
74-75 



Col . 

23-34 
35-39 
40-45 
46-51 



Col 



Page 3 Used 


39-40 


Write-in 1 


41-49 


Write-in 2 


50-58 


Write-in 3 


59-67 


Write-in 4 


68-75 



Col 



Wr i te-i n 8 


48-56 


Write-in 9 


'57-66 


Write-in 10 


67-75 



359 



"Write-in" tests have the following format: 

Test Code No.- 3 columns 

Value 3 columns (4 for No. k and 5, p.^) 

Abnorm 1 column 

Action 1 column 

Relation 1 column 

"Three-digit codes for "write-in" LAB tests are assigned by the Biometric 
Laboratory. A list of LAB codes will be provided upon request. 

SPECIAL INSTRUCTIONS 

Detailed instructions are printed directly upon the form and should be read 
carefully by the rater. 

1. STANDARDS refer to the limits of normality set by the investigator 
for his laboratory data. These standards MUST be sent to the 
Biometric Laboratory - otherwise processing cannot proceed. In 
subsequent BLIPS processing, each investigator's standards will be 
used as the basis of analyses for his data. Investigators may 
utilize more than one set of standards if they desire. For a given 
study, however, the investigator must specify which set of standards 
is to be used in the analyses. 

2. The new LAB form differs from the older key-punch version in one 
major way. ONLY DATA FROM A SINGLE PERIOD CAN BE ENCODED ON A SINGLE 
FORM. The older version permitted the encoding of data from several 
periods (assessments) on a single form. While this feature was popular 
among investigators, it created significant processing problems. Error 
rates for both the investigator and BLIPS staff were excessive and, 
consequently, much valuable data were lost. 

3. In assigning PERIOD to a set of LAB tests, ALWAYS encode the day on 
which the set of tests was actually obtained - not the day the report 
of results was obtained. Since the LAB usually requires transcription 
from hospital laboratory slips, this post-dating should not be any 
great problem. 

k. When a given test value requires verification (repeating the test), 

ENCODE THE "VERIFIED" VALUE ONLY: i.e., the value the investigator con- 
siders correct. 

5. If one of the LAB tests printed on the form employs UNITS OTHER THAN 
THOSE INDICATED, the test must be encoded as a write-in and the units 
indicated; e.g., SGOT values are obtained in Frankel units - not Karmen 
units. The investigator codes SGOT in one of the "write-in" blocks - 
not in the SGOT block printed on the form. 



360 



6. In instances where the obtained value of a test exceeds the number 
of rows provided for that test, use one of the "write-in" blocks; 
e.g., a BUN value of 100 is obtained and, as this exceeds the 2 
rows provided, the investigator uses one of the "write-in" blocKS. 

ENCODING TESTS NOT LISTED ON THE SCALE 

1. Encoding non-listed tests in conjunction with listed tests - When 
the investigator wishes to encode both listed and unlisted tests 
at a given assessment period, he MUST so indicate by answering the 

2 questions on page 3- He then may encode a maximum of 10 addition- 
al tests on pages 3 and k. 

2. Encoding non-listed tests only - When the investigator's data consist 
ONLY of unlisted tests, he MUST use page k - NOT page 3 - and so indi- 
cate by marking the specified location on page k. In this case, Page k 
becomes an "independent scale" - the first 3 pages can be discarded. 
When using Page k as an independent scale, the investigator MUST COMPLETE 
THE ENTIRE IDENTIFICATION BLOCK ON PAGE k. 

3. Note that the last 2 sections of Page h contain k rows of digits under 
VALUE rather than 3 rows. This provides for the encoding of test values 
which may require the extra digit. 

DOCUMENTATION 

a. Standards printout - it is the investigator's prerogative as to the 
set of standards employed. 

b. I ntra-subject display of test values and judgments. (Figure 21). 

c. Group summaries by test. (Figure 22), 

d. Cross-tabulation of tests/actions, ^Figure 23). 

e. Variance analyses 

For each subject, the events occurring throughout the study are described 
test by test. The daily and cumulative dosages, the actual value and its 
position in regard to limits and judgments of abnormality and drug related- 
ness are given. Similar data are summarized by treatment group. Finally, 
a cross-tabulation of actions undertaken by test are displayed for each 
treatment group. 



361 



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362 



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363 



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364 



CLINICAL LABORATORY STANDARDS IN PEDIATRIC PSYCHOPHARMACOLOGY--- 
Samuel Gershon, M.D., NYU Medical Center 



Clinical laboratory data at baseline and changes with treatment are an integral 
part of the assessment of the effects of new drugs. Former speakers have presented 
certain piroblems in this area in regard to studies in adults and to the applicability 
of textbook normative data for psychiatric populations (3) • 

Whatever the magnitude of the problem with adults, the situation in regard to 
children is far worse. First, the same problems, as mentioned above, will certainly 
arise, i.e., in the applicability of medical textbook norms to a population of mentally 
ill children. Second, they will arise also in regard to the vagueness of some of the 
child norms, i.e., when an adult normative figure is given and is followed by the state- 
ment: "higher in children" or "lower in children" without additional qualifications (1). 
Third, another problem which arises with children is the distinction between child and 
adult. This distinction is in itself somewhat arbitrary and still inadequate. More 
particulate divisions ought to be made in grouping children by age, e.g., norms for 
three years may not be applicable to norms for six years. In addition to such age sub- 
divisions, another parameter of maturat ional , physical, and mental levels may cut across 
such age levels. This issue of physical and mental levels of maturation may be even 
more marked in child psychiatric populations. Fourth, there is the problem of the ef- 
fect of manifest or covert intercurrent infection or physical disease on the clinical 
chemistry data. Admittedly, such situations can and do occur in studies with adult psy- 
chiatric populations, but they are more frequent and prevalent in institutions housing 
child psychiatric populations. The influence of such a variable may be of much greater 
magnitude than the possible effect of the drug under investigation. Fifth, laboratory 
measurements may indeed be the greatest source of error under adverse conditions. 

In this discussion, we will present some of the norms currently available in the 
literature, a brief analysis of some of the laboratory data obtained from the child psy- 
chiatric studies at New York University, and then conclude with a review of this material 
and proposals for consideration by this group. 

NORMS FROM REFERENCE SOURCES 

It can readily be seen that most of the information available is on hematology and 
that the normative data show variance at the different age levels. Also, there are 
differences in these values from one source to another. Other areas are not that well 
covered, e.g., liver function tests. 



" Presented at the Pediatric Psychopharmacology Conference, November 13-1^, 1969. 
Wash,ington, D. C. Sponsored by the Psychopharmacology Research Branch, Division 
of Extramural Research Programs, National Institute of Mental Health. 

'<■ Reprinted from Psychopharmacology Bulletin, Special Issue, Pharmacotherapy 
of Children, 1973- 



365 



DISCUSSION 

This review of laboratory findings was undertaken to explore the possibility 
that such data might show variation from recognized normal values derived from a 
nonpsychiatr ic population. Recognition of this problem in adult psychiatric popula- 
tions has resulted in exploratory studies which have tended to confirm the diver- 
gence of findings from textbook norms in this special population. 

The report by Gonzales et al. (3), Table 22, on hemogram studies in a psychiatric 
population showed that in the case of white blood cell (WBC) counts and if an upper 
normal limit of 7>000/cu mm is used as proposed by some reference sources, then 50.2 
percent of the values fell above 7,000 and ]k percent above 8,500. In regard to hemo- 
globin values in males, ]k percent fell below the norma] range of 14-18 grams. 

The findings for hematocrit were: 26.2 percent of determinations fell below and 
11.0 percent above the normal range of 42 to 50. When broken down by sex, 44.1 per- 
cent of hematocrit determinations in males fell outside these limits and for females 
42 percent were abnormal. 

Sedimentation rate determinations for. males showed that 77-2 percent were above 
the normal range of to 9. 

These findings would strongly suggest that it may be necessary to redefine limits 
of normal values for specialized patient groups. 

Hoi lister et al. (5) have commented on this same problem in adult psychiatric 
populations. These workers reported that 97 of 475 patients prior to treatment ex- 
hibited counts greater than 10,000/cu mm. There were 19 instances of serum glutamate 
oxalecetate transaminase (SCOT) estimations over 40 units in 154 patients in the same 
study. A study by Holden et al. (4) in a similar population produced similar findings 
and corroborated the previous reports that clinical laboratory data in adult chronic 
psychiatric populations exceed established textbook standards. Here again the great- 
est discrepancies were: 31 percent of erythrocyte sedimentation rate (ESR) in males 
and 70 percent in females were beyond the normal range, almost 30 percent of WBC were 
beyond the normal range and 15 percent of the differential counts. 

To date we do not have any such studies to compare results in a child psychiatric 
population with textbook norms. 

Looking at the very limited data obtained to date at New York University (2) on 
Dr. Fish'S" nursery children (to six years), it is exceedingly likely that a similar 
discrepancy will result as has been observed in the adult psychiatric population. 

The laboratories themselves may contribute markedly to errors. Variation in the 
methods or the time of day for the collection of blood can account for differences in 
results greater than those produced by standard laboratory methods. There are also 
variations which can be attributed to laboratory personnel. Clinical laboratory estima- 
tions of hemoglobin by two observers differed by more than 10 percent in 17 percent of 
measurements using the same laboratory facilities and methods. In a special study (10) 
of errors i/i measurement of serum electrolytes, it was found that for the same sample 
of blood the serum sodium, potassium, and chloride values varied widely among four 

*Now at: Department of Psychiatry, University of California (UCLA), Los Angeles, 
Cal ifornia. 

366 



hospital laboratories. The standard deviations of the results in three of the 
laboratories are approximately twice those obtained by the authors. The hospital 
results on normal sera were frequently outside the quoted normal ranges. This 
occurred for k8 percent of the sodium results from one laboratory and 55 percent 
of the chloride results from another. 

Thus, there is enough evidence to suggest that new normative clinical chemistry 
data will need to be obtained for a child psychiatric population. This issue is 
further compounded when the investigation of an experimental pharmacological com- 
pound is addecj. The question then becomes: How much deviation from normal labora- 
tory norms is allowed before attributing the "abnormal" findings to the experimental 
med i cat ion? 

PROPOSALS 

1. It will be necessary to establish new norms for laboratory data in this popu- 
lation and ranges for each age level. In few of the evaluations of new psychotropic 
compounds have parallel clinical and laboratory studies in control populations living 
under similar environmental conditions been reported. Reliance is most often placed 
on published standards of normality. It is most fortunate that the Biometric Labora- 
tory of the George Washington University, Kensington, Maryland, now has procedures 
available for the collection of such data and the provision of such norms. This should 
provide the sorely needed normative lab data for this special population and enable the 
better interpretation of drug effects in regard to clinical chemistry. 

2. Special care will be required in regard to quality control in each laboratory 

to avoid the possibility that laboratory errors alone may obliterate drug-induced changes, 

REFERENCES 

1. Cecil-Loeb Textbook of Medicine, P. B. Beeson and W. McDermott (eds.), Vol. 1 and 
II. Philadelphia: W. B. Saunders Company, 1963. 

2. Fish, B. Personal Communication. New York University, New York, New York. 

3. Gonzales, R. G., Bishop, M. P., and Gallant, D. M. Hemogram abnormalities in 
chronic schizophrenics used as placebo controls. Psychopharm. Serv. Cent. Bull., 
3:29. 1965. 

k. Holden, J. M. C, Itil, T., Simeon, J., and Fink, M. Clinical laboratory test 
standards in new drug trials. J. Clin. Pharmacol., 7:1, 1967- 

5. Hollister, L. E., Caffey, E., and Klett, C. J. Abnormal symptoms, signs, and 
laboratory tests during treatment with phenoth iazine derivatives. Clin. Pharmacol. 
Ther., l:28if, I96O. 

6. Nelson, W. E., VaUghan, V. C, III, and McKay, R. J. Textbook of Pediatrics. 
Philadelphia: W. B. Saunders Company, I969. 

7. O'Brien, D., Ibbott, F. A., and Rodgerson, D. 0. Laboratory Manual of Pediatric 
Micro-Biochemical Techniques, 4th Ed. New York: Harper and Row, I968. 

8. Slobody, L. B. and Wasserman, E. Survey of Clinical Pediatrics. New York: 
McGraw-Hill, I968. 

9. Smith, C. H. Blood Diseases of Infancy and Childhood. St. Louis: The C. V. 
Mosby Co. , 1966. 

10. Thompson, Gi S. and Jones, E. S. Errors in the measurement of serum electrolytes. 
J. Clin. Path., 18:443, 1965. 

11. Wintrobe, M. M. Clinical Hematology. Philadelphia: Lea and Febiger, I967. 



367 



Hemogic 


^^ (7) 


5 yrs. 




8-13 yrs. 




RBC 3,800,000-5.400,000 


Hematocrit 


A. 


(11) 


4 yrs. 


- 33-37 


6 " 


- 34-38 


8 " 


- 35-39 


12 " 


- 35-40 


B. 


(7) 



4-10 yrs. - 37% ±6% 
WBC Count (11) 



4 


yrs. - 5,500-15,500 


6 


- 5,000-14,500 


8 


- 4,500-13,500 


10 


" - 4,500-13,500 


12 


- 4,500-13,500 



Table 19 

Childrens 
Laboratory Norms 



(Aver. 9,100) 
8,500 
8,300 
8,100 
8,000 



WBC Differential (11) 

Ago Segmented Neut. 



12 1/2-15 gms. (Aver. 13 1/2) 
13-15 1/2 gms. (Aver. 14) 



Lymphos 



4 yrs. 


29-49% 


1-5% 


35-65% 


5% 


(Av.) 


2.8% (Av.) 


.6% (Aver.) 


6 " 


38-58% 


1-5% 


28-57% 


4.7% 


" 


2.7% " 


.6% " 


8 " 


40-60% 


1-5% 


24-54% 


4.2% 


" 


2.4% " 


.6% " 


10 " 


36-66% 


1-5% 


28-48% 


4.3% 


" 


2.4% " 


.5% " 


12 " 


37-67% 


1-5% 


28-48% 


4.4% 


" 


2.5% " 


.5% " 



Tr' i 20* 













Differential 




Hgb' 


Hct' 


RBC" 


WBC* 


Neutroi 


Lymphos 


Monos 


Eoi 


Bo SOI 


Plate lat> 


1 yr. 

2 yrs. 

3 yrs. 


10-12.5 


36% 
40% 


4.6 mil 


1 2,000 


30% 


60% 


5' 


^ 


2- 


3% 


0. 


5% 


250, 
350, 


000 
000 


4 yrs. 








8,000- 


40% 


50% 


















5 yrs. 


13-13.5 






10,000 






















6 yrs. 








7,500 


55- 

60% 


40% 


^ 


' 


1 


' 


1 


T 


^ 


r 



•Relevont data extracted from text (9). 

Hemoglobin. 

Hematocrit. 
' Red Blood Celli. 
* White Blood Cells. 



368 



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OO 00 ■* <o 



p>«>ooooooo-*r-h»o>>0 

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15 15 15 ^ 'c 

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369 



Table 22 Summary pf Laboratory Findings for 65 Chronic Schizophrenics on Placebo (3) 

Percent Percent Total 
Number of below above Percent 

Test Normal limits* Determination Mean S.D. normal normal "abnormal" 

Red blood count 4.2-5.5 mill. 244 4.6 mill. 0.3 mill. 6.4 1.6 8.0 

White blood count 5,000-10,000 342 7,090 1,200 2.0 1.8 3.8 

Hemoglobin : 

(Males) 14-18 grams 178 14.9 1.6 14.0 0.0 14.0 

(Females) 12-16 grams 134 13.9 1.5 1.5 2.2 3.7 

Hematocrit** 42-50 345 45.8 5.2 26.2 11.0 37.2 

(Males) 47±7% 195 47.0 4.1 26.7 17.4 44.1 

(Females) 42±:5% 150 43.8 4.5 10.7 31.3 42.0 

Sed. Rate (Wintrobe) : 

(Males) 0-9 145 12.3 7.6 — 77.2 77.2 

(Females) " 0-20 134 21.4 7.7 — 49.2 49.2 

• From Sunderman, F. W. and Boerner, F. Normal Values in Clinical Medicine. Philadelphia : W. B. Satinders 
Co., 1949. 

• Normal limits of 42-50 for hematocrit from reference above. Additional separate norms for males and females 
from Merck Manual of Diagnosis and Therapy, 10th Edition, 1961. 



370 



NORMAL BLOOD VALUES 

TABLE 23 Chemical Constituents of Blood 



ACID-BASE CONSTITUENTS 



Total fixed cations (Na + K + Ca + Mg) (serum) 150-155 mEq./liter 

By methods of Hald and Sunderman, normal 

values tend to be lower 143-150 mEq./liter 

Sodium* (serum) ...136-143 mEq./liter 

Potassium* (serum) 4.1-5 6 mEq./liter 

Calcium* (serum) 10-12 mg./lOO ml. 

5-6 mEq./hter 

Calcium,* diffusible (ionized Ca) (serum) 5-5.5 mg./lOO ml. 

Magnesium* (serum) 2-3 mg./lOO ml. 

In the newborn a value as low as 1.3 mEq./liter 1.65-2.5 mEq./liter 

would be considered normal 
Chlorides* (CD (serum) 98-106 mEq./liter 

At birth and during early infancy the plasma 

(serum) chloride is 6-10 m.Eq. /liter higher than 

that of older infants and children 585-620 mg./lOO ml. 

Phosphorus, inorganic, as P (serum) 4.0-6.5 mg./lOO ml. 

Slightly higher in the newborn (in infants,-up 

to 8 mg./lOO ml. considered normal) : 1.29-2.1 mM./liter 

HPO4— /H^POr (average valence 1.8 at pH 7.4) 2.3-3.8 mEq./liter 

Serum protein cation-binding power (serum) 15.5-18.0 mEq./liter 

Bicarbonate cation-binding power (serum) 19-30 mEq./liter 

The above two constitute a major portion of the 

buffer base (Hastings and Singer) of serum 

Standard bicarbonate (Astrup)t (plasma) 21-25 mEq./liter 

Buffer base.(BBlb (blood) 46-52 mEq./liter 

Base excess [BEJh (blood) -2.3 to -1-2.3 mEq./liter 

Sulfates, inorganic, as SOj"" (serum) 0.5-1.0 mEq./liter 

2.5-5.0 mg./lOO ml. 

Sulfates, ethereal (serum) 0.1-1.0 mg./lOO ml. 

Sulfur, neutral (serum) 1.7-3.5 mg./lOO ml. 

Lactic acid (serum) 10-20 mg./lOO ml. 

pHat38°C. (blood, plasma or 

serum) 7.3-7.45 

The sample must be protected against loss of 

CO2 and determination made as soon as pos- 
sible. Arterial blood in a resting person is about 

0.03 pH unit higher than venous blood. 

pH at 38° C. (serum from arterial 

blood) 
(Data from Cassels and Morse) 

1.5- 3.4 years 7.30-7.40 

3.5- 5.4 years 7.35-7.43 

5.5-12.4 years 7.37-7.43 

12.5-17.4 years , 7.35-7.41 

• In human red blood cells an average concentration of sodium would be about 21 ipEq./liter of red blood cells; of potassium about 
86 mEq./liter. 

The level of calcium in serum is influenced by the concentration of serum protein because part of the calcium is associated with or 
bound to the protein. Practically all the calcium in blood is in the plasma. 

The chloride concentration of whole blood depends largely on the cell volume, since the erythrocyte contains approximately half 
as much chloride as serum. 

t Concentration of bicarbonate in plasma which is separated from the cells with the hemoglobin completely oxygenated, at a 
pCO, = 40 mm. Hg and at a temperature of 38° C. 



371 



TABLE 23 I Continued/ 



ACID BASE CONSTITUENTS 



Carbon dioxide content (serum from venous 

blood I 45-70 vol. per cent 

20.3-31.5 mM /liter 
The CO-, content is lower at birth and rises 
slightly during the first 4 days of life 
Carbon dioxide content (whole venous blood) 40-60 vol. per cent 

18-27 mM. /liter 
Carbon dioxide content (arterial blood) 

(Data from Cassels and Morse) 

1.5- 3.4 years 15.5-20 5 mM. /liter 

3.5- 6.4 years 18.7-21.2 mM. /liter 

6.5-11.4 years 19.3-21.6 mM./liler 

11 5-14 4 years 19.9-22.2 mM./liler 

14.5-17 4 years 20.4-22.4 mM./liter 

Carbon dioxide tension (arterial blood) 

(Data from Cassels and Morse) 

15- 6 4 years 33.5-41.1 mm. Hg 

6.5-12.4 years 35.4-40.6 mm. Hg 

12.5-17.4 years 38.3-44.4 mm. Hg 

Oxygen tension P„. (arterial blood) 85-100 mm. Hg 

Oxygen capacity* (whole blood) 19-22 vol. percent 

Oxygen saturation (whole venous blood) 60-85 per cent 

Blood of newborn 30-80 per cent 

Hemoglobin 

At birth (whole blood) 17-20 gm./lOO ml. 

3 months 10.5-12 gm./lOO ml. 

1 year 11-12.5 gm./lOO ml. 

5 years-.. 12-13 gm./lOO ml. 

10 years 13-14 gm/100 ml. 

Above 1 years 14-16 gm. /1 00 ml. 

Methemoglobin (whole blood) 0.0-0.3 gm./lOO ml. 

Premature infants at higher level (0 4) 

Carbon monoxide hemoglobin (whole blood) up to 5'"/( of total hemoglobin 

Haptoglobin (serum) 40-170 mg. ""/i as hemoglobin-binding capacity 

Water (whole blood) 79-81 gm./lOO ml 

(serum) 91-92 gm./lOO ml. 

(red blood cells) 64-65 gm/100 ml 

The oxygen capacity and iron content of blood are directly related to the hemoglobin content of the blood 1 1 335 ml. O./gm of 
hemoglobin). 



CARBOHYDRATES, LIPIDS AND PIGMENTS 

Sugar, fasting 

(Somogyi-Nelson) (blood) 60-90 mg./lOO ml. 

Under fasting conditions capillary or arterial 

blood and venous blood are nearly the same 

Sugar, fasting arterial (Folin-Wu) (blood) 80-120 mg./lOO ml. 

fasting venous (Folin-Wu) (blood) 70-100 mg./lOO ml. 

Lactic acid. See Acid-Base Constituents 

Pyruvic acid, fasting (blood) 0.7-1.2 mg./lOO ml. 

Citric acid (blood) 1.3-2.3 mg./lOO ml. 

Citric acid (plasma) 1.6-2.7 mg./lOO ml. 

a-Ketoglutaric acid (blood) 8-10 mg./lOO ml. 

Acetone bodies (as acetone) (serum) 1-6 mg./lOO ml. 

Total cholesterol (over 6 yr.) (serum) 150-250 mg./lOO ml. 

Infants 70-125 mg./lOO ml. 

Newborn 50-100 mg./lOO ml. 

Cholesterol esters 125-180 mg./lOO ml. 

17-Hydroxycorticosteroids (plasma) 10-13.5 microgm./lOO ml. 

Total lipids 

(Rafsted) 2-14 years (serum) 490-1000 mg./lOO ml. 

3 days-1 year...., 240-800 mg./lOO ml. 



372 



TABIE 23 (Continued) 



CARBOHYDRATES, LIPIDS AND PIGMENTS 



3 days-10 days 430-760 mg./lOO ml. 

Newborn 170-450 mg./lOO ml. 

Free fatty acids (serum) 230-380 microgm./ml 

More variable in young children 
Phosphatides (lipid P x 25) (plasma) 

Children 180-295 mg./lOO ml. 

Up to 1 year 100-275 mg./lOO ml. 

Newborn 75-170 mg/100 ml. 

Bilirubin (total) (serum) 0.2-0.8 mg./lOO ml. 

Higher in newborn 1.0 or more 

Conjugated bilirubin (direct) 0-0.3 mg./lOO ml. 

Icterus index 4-6 units 



Total protein (from nitrogen determination) (serum) 6.5-7.5 gm./lOO ml. 

At birth the protein is slightly lower 
Albumin* [globulins precipitated by Nai.SOj-Nai,SO.i 

mixture (20.8'X Na.,SO< + 7.0'2 Na.SO.i)] (serum) 3.9-4.5 gm./lOO ml. 

Globulins (by difference) 2.3-3.5 gm./lOO ml. 

A/G ratio 1.2-1.9 gm./lOO ml. 

Protein values vary slightly with age. The follow- 
ing values for plasma are adapted from the 

paper of Metcoff and Stare (New England J. 

Med.. 1947) 
Total protein (plasma) 

Premature infant 4.55 ±0.59 gm./lOO ml. 

Full-term infant 5.11-5.70 gm./lOO ml. 

Birth to 1 year 6.10 ± 0.29 gm./lOO ml. 

1-4 years 6.94 ± 0.47 gm./lOO ml. 

5-12 years 7.30 i: 0.59 gm./lOO ml. 

12 years and above 7.16 gm./lOO ml. 

Albumin (plasma) (globulin precipitation by 22*;^ Na^SO^; Howe) 

Premature infant 3.55 ± 0.65 gm./lOO ml. 

Full-term infant 3.76-3.79 gm./lOO ml. 

Birth tol year 4.97 ± 0.73 gm./lOO ml. 

1-4 years 4.59-4.83 gm./lOO ml. 

5-12 years 5.0 ± 0.78 gm./lOO ml. 

12-15 years 4.72 gm./lOO ml. 

Globulin (plasma) 

Premature infant 1.01 ± 0.45 gm./lOO ml. 

Full-term infant 1.34-1.66 gm./lOO ml. 

Birth to 1 year 1.38 ± 0.68 gm./lOO ml. 

1-4 years 2.03 ±0.34 gm./lOO ml. 

5-12 years 2.4 ± 0.74 gm./lOO ml. 

12-15 years 2.49 gm./lOO ml. 

Fibrinogen (plasma) 0.2-0.4 gm./lOO ml. 

Gamma globulin 10-15?t of total protein 

0.7-1.2 gm./lOO ml. 

At birth values approximate adult levels, owing to passive transfer from the mother; during the ensuing weeks 

there is a decrease, the "low point" being reached between the second and fourth months. After this there is a 

gradual increase to the "adult level" by about the second year of life. 

Ceruloplasmin (serum) 16-33 mg./lOO ml. 

Mucoprotein (serum) 45-105 mg./lOO ml. 

Mucoprotein tyrosine (serum) 2-4.5 mg./lOO ml. 

Serum protein partition by paper electrophoresis (Durnim) 

5f of total protein 

Albumin 50-60% 

a, -globulin 5-89t 

a,-globulin 8-13% 

/3-globulin 11-17% 

y-globulin 15-25% 

•When the globulin is precipitated with the Na.SO^-Na.SOj mixture, the albumin values agree with those obtained by 
electrophoresis. 



373 



TABLE 23 Continued) 



NITROGEN CONSTITUENTS 



Nonprotein nitrogen (whole blood) 25-40 mg./lOO ml. 

(Tungstic acid filtrate; zinc hydroxide filtrates 

give lower values because more small molecule 

nitrogenous compounds are precipitated) (plasma) 18-30 mg./lOO ml. 

Urea nitrogen (whole blood) 7-15 mg./lOO ml. 

(plasma).. 10-17 mg./lOO ml. 

Creatinine (serum) 0.4-1.2 mg./lOO ml. 

Absorption by Lloyd's reagent (whole blood) 0.5-2.0 mg./lOO ml. 

Creatine + creatinine (whole blood) 5-8 mg./lOO ml. 

Concentration of creatine is low in plasma 

Uric acid (serum).. 2-6 mg./lOO ml. 

At birth the uric acid concentration of the blood 

of the infant is identical with that of the 

mother 

Ammonia (whole blood) 0.1-0.3 mg./lOO ml. 

Amino acid nitrogen (plasma) 3.5-5.5 mg./lOO ml. 

Serum gives slightly lower value than plasma 

Phenylalanine (serum) 0.7-4.0 mg./lOO ml. 

Proline (fasting) (plasma) 13.8-32.5 microgm./liter 

Glutamine (plasma) 6-12 mg./lOO ml. 

Citrulline (plasma) 0.3-1 mg./lOO ml. 



Amylase (plasma or serum) 70-200 Somogyi units 

6-33 Close-Street units 
Aldolase (serum) 0.15-0.8 units (micromoles of fructose diphos- 

phate split/per ml, serum/hour) 

Alkaline phosphatase 

Infants (serum) 5-10 Bodansky units 

Children (2-15 years) 3-13 Bodansky units 

The values by the Shinowara Jones and Rein- 
hardt method are about V3 higher, owing to 
incubation at pH 9.3 instead of 8.6 

Infants 4-14 Bessey-Lowry-Brock units (substrate p- 

nitrophenol-phosphate) (Sigma units) 

Children 3.4-9 B.L.B. units 

Children 10-20 King-Armstrong units (Substrate di- 

sodium phenyl-phosphate) 

Infants 3.8-11 Klein-Babson-Reed units 

Children 2-15 (Substrate buffered sodium phenolph- 

thalein phosphate); 1 unit of activity liber- 
ates 1.0 mg. phenolphthalein in 30 minutes 
at37°C. 

Phosphatase, acid (serum) 1-5 King- Armstrong units 

Creatine phosphokinase (CPK) (serum) to -0.72 milliuniU (Bergmeyer) 

Lactic acid dehydrogenase (serum). 30-120 units 

(Snodgrass method) 

Copper oxidase (Ravin method) (ceruloplasmin) (serum) 0.14-0.57 O.D. units 

Lipase (serum) < 1 unit/ml. Sigma-Tietz unit (ml. of 0.05 N 

NaOH to neutralize free fatty acid during 
6-hr. incubation period) 
Transaminase (children) (serum-glutamate- 

oxalacetate) 

SCO, spectrophotometric method 4-40 units (higher in infante) 

Serum glutamate pyruvate 1-45 unite 

MISCELLANEOUS 

Ascorbic acid (serum) 0.4-1.5 mg./lOO ml. 

Vitamin A (seruni) 15-60 microgm./lOO ml 

Carotenoids (serum) 40-400 microgm./lOO ml. 

Iron 0.04-0.18 mg./lOO ml. 



37^ 



TABLE 23 (Continued) 



MISCELLANEOUS 



Iron-binding capacity (serum) 0.187-0.65 mg./lOO ml. 

Transferrin (serum) 0.2-0.3 gm./lOO ml. 

Copper (serum) 0.08-0.235 mg./lOO ml. 

Lead (serum) 0.001-0.003 mg/100 ml. 

Lead (blood) 0.01-0 06 mg/100 ml. 

Bromine (serum) 0.7-1 microgm./lOO ml. 

Iodine, protein-bound (serum) 0.003-0 008 mg./lOO ml. 

Iodine, butanol extractable 0.003-0.0065 mg./lOO ml. 

Potassium (erythrocytes) 86-104 mEq. /liter of red blood cells 

Thiamine (blood) 5.5-9.5 microgm./lOO ml. 

Tocopherols (serum) 0.6-1.2 mg./lOO ml. 

Lower in the newborn 



PHYSICAL MEASUREMENTS 

Specific gravity (whole blood) 1.048-1.05 

Newborn infants: falls rapidly during first 2 1.06—1.085 

weeks and continues to decrease until second 

or third year (plasma) 1.025-1.03 

Prothrombin time (Quick) (plasma) 12-15 seconds 

This determination should always be con- 
trolled by a determination on a normal blood, 
since the activity of the thromboplastin prep- 
arations may vary greatly 

Bleeding time 1-3 minutes 

Coagulation time (test tube method) , 3-9 minutes 

Cephalin flocculation (serum) 0-1+ units 

During first 6 months of life this test may be 
negative in the presence of liver disease 

Thymol turbidity (serum) 0-4 Maclagan units 

Zinc sulfate turbidity (serum) 2-8 Maclagan units 

Viscosity, compared to water as unity (whole blood) 4.5-5.5 

(serum) 1.7-2.1 

Corrected erythrocyte sedimentation rate 

(Rourke-Ernstene) 0.1-0.35 mm./min. 

Cutler method 2-10 mm./hr. 

The rate is slower in the neonatal period 

Freezing point depression (serum) —0.535°-(— 0.555°) C. 

Osmolality (plasma) 270-285 milliosmoles/liter plasma water 

Refractive index, 20° C 1.3485-1.3505 



375 



NORMAL CEREBROSPINAL FLUID VALUES 

TABLE 2k 

Amount in the newborn Up to 5 ml. 

Increases with age to adult (igure 100-150 ml. 

Initial pressure 70-200 mm. H.O 

Cell count 

Under 1 year Up to 10 cells/mm.' 

1-4 years Up to 8 cells/mm." 

5 years to puberty 0-5 cells/mm,' 

Specific gravity 1.005-1.009 

Freezing point depression — 0.56-(-0.60)''C. 

Rerractive index at 20°C 1.33554 

pH 38°C. (protected against loss of CO.) 7.33-7.42 

Fluid exposed to air becomes alkaline 

Carbon dioxide-combining power.. 40-70 vol. per cent 

18-31 m.Eq./Iiter 

Chloride 

7 days-3 months 108.8-122.5 mEq./liter 

4-12 months 112.7-128.5 mEq./liter 

13 months-12 years 116.8-130.5 mEq./liter 

Cholesterol ^ Trace-0.22 mg./lOO ml. 

Glucose, 6 months-10 years 71-90 mg./lOO ml. 

over 10 years 50-80 mg./lOO ml. 

The glucose level is less than, and varies proportionally with, the rise and 

fall or the plasma glucose level 
ToUl fixed cations About 155 mEq./liter 

Sodium 130-165 mEq./liter 

Potassium 2.8-4.1 mEq./liter 

Calcium 4.5-5.5 mg./lOO ml. 

Magnesium 2.8-3.3 mg./lOO ml. 

Phosphorus, inorganic 1.5-3.0 mg./lOO ml. 

3 mg. first day of life 
Lactic acid Trace 

Fluid on standing may increase in concentration with disappearance 
of glucose 
Protein 15-40 mg./lOO ml. 

The ventricular fluid contains much less protein than does lumbar fluid. 

Fluid from the cistema magna contains more protein than that from the 

ventricle and less than that from lumbar region. The range is greater in 

the newborn and during the first month of life (20-120 mg./lOO ml.) 

Albumin 809 of toUl protein 

Globulin 209 of total protein 

Fibrinogen None 

Pandy reaction'. No precipitate 

Urea nitrogen 7-15 mg./lOO ml. 

Nonprotein nitrogen 8.5-20 mg./lOO ml. 

Creatinine _. ..i... 0.45-1.9 mg./lOO ml. 

Uric acid 0.3-1.5 mg./lOO ml. 

Amino acid nitrogen 1.5-3 mg./lOO ml. 

Ammonia nitrogen 0-0.015 mg./lOO ml. 

Bilirubin None 

Iodine Trace 

Transaminase (GOT) 2-20 units (about Vi the 

value of SGOTi 
Co(,loidal gold number (Wuth and Faupel) 0000000000 

Dilutions l-IO to 1-5120 with 0.49 NaCI solution 



376 



TABLE 25 

Hormal laboratory Ooto 

Blood: 

F4onprot«;n nitrogefl 25-40 mg/100 ml 

Ureo nitrogen 10-1 J mg/lOO ml 

Uric odd 2-3 mg/lOO ml 

Oeotin;n« 1-2 mg/100 ml 

Oeoline 5-7 mg/1 00 ml 

Glucoie 60-120 mg/100 ml 

Cholnterol 120-250 mg/100 ml 

EiJen 100-150 mg/100 ml 

Fre« 50-100 mg/lOO ml 

Bilirubin 0.2-1.0 mg/100 ml 

lct«rvi indox 3—5 ikmIi 

Qtlondes (exprexied as NoClh 

Wbola blood 450-500 mg/100 ml (70-85 mEq/liter) 

Sorum 585-420 mg/100 ml (I0O-106 mEq/nier) 

Sodium — MTum 310-330 mg/100 ml (133-143 mEq/ntar) 

Potoxsium — terum 1 6-22 mg/1 00 ml (4.0-5.5 mEq/Dlm-) 

Phosphonn — >«rum 3.5-5.0 mg/l 00 ml (2.0-3.0 mEq/litar) 

Coldum — i»rum 9-1 2 mg/1 00 ml (4.5-6 mEq/Clar) 

COi eontanl — »er«m 45-70 vol % (20.3-31.5 mEq/lilw) 

Servm albumin 4.5-5.5 gm/100 ml 

S«mim globuPm 1.8-2.7 gm/100 ml 

Sedimentation rate; 

Micro 4-10 mm/hr 

Weitergren 5-20 mm/hr 

Coagulotton time; 

Copillary 3—4 min 

VetMMn 4-10 min 

Bleeding time 1—3 min 

Frogirity test ^ 0.46-0.30% Kinna 

Prothrombin time (Ouidc test): 

Plasma 12-15 sec 

Urine: 

Albumin Negative (trace is often of no signiRcance) 

Sugar Negative 

Acetone bodies. Negative 

Speoflc gravity 1.005-1.030 

Urobilinogen Positive in dilution 1:20 

BHirubin.... Negative 

Red blood celb Absent (centrifuged) 

White blood celb ,. 0-2 HPF* (centrifuged) 

Cosh. ............................. Absent (few hyaline costs are often not 

signiRcantl 
Spinal fluid:t 

Pressure 70-200 mm water 

Cell count. 0-10 (chiefly lymphocytes) 

Protein 20-40 mg/100 ml 

Sugar. 50-90 mg/100 ml 

Chlorides (expressed os NoQ) 650-750 mg/100 ml (1 1 1-128 mEq/nter) 

* HPF: high-power field. 

I Amount in newborn infonts ranges from 30 to 60 ml; in a child of 10 yr, there may be up to 200 nU 



377 



TABLE 26 A, 



Blood Cell Voluet during Infancy ond Childhood* 



Cell! 


Binh 


2 days 


2 weeks 


3 montht 


I yeor 


5 yeor. 


10 yean 


Red blood cellj, million, per cu mm 


4.9-5.5 


5.3-6.5 


4,5-5.5 


3.9-4.8 


4.5-5.0 


4.7-5.3 


4.8-5.5 


Hemoglobin, gm per 100 ml 


16-20 


18-22 


14-17 


10.5-11.5 


12-13 


12.5-13.5 


12.5-14.5 


Rellculocylei, % 


3-5 


1-5 


1-2 


0.2-1.0 


0.1-1.5 


0.1-1.5 


0.1-1.5 


Nucleated red blood celli, per 100 
















while celli 


2-10 


0-5 


0-2 














White blood celli, Ihoujondi per cu mm 


10-20 


12-22 


8-12 


5-9 


6-10 


6-10 


6-10 


Neutrophil,, % 


45-55 


50-65 


30-45 


30-40 


35-45 


40-50 


45-55 


Lymphocytei, % 


45-30 


40-20 


55-45 


65-50 


60-50 


55-45 


50-45 


Others, % — monocytei, eojinophili. 


10-15 


10-15 


15-10 


5-10 


5 


5 


5 


boiophllj 


Occaiionol myelocyte! 














Plateleti, Ihouiondi per cu mm 


350 


450 


350 


200-300 


250-350 


250-350 


250-350 



• Dete 
In dehyd 

hond. 



hile 



ell 



otion of the 


peripheral 


jn, for exo 


nple, when t 


lasmo and 


ed blood ce 


er the blee 


ding has slov 


hange in si 


e of the circ 


ted by the 


peripheral n 


3ted for about 2 weeks. 



ed cell count or hemoglobin reflects the true size of the circulcsling red blood cell mass only when the blood volume is normal. 
"le plasma volume is greatly reduced, perlpherol measurements give falsely high values. In brisk hemorrhoge, on the otfier 
I volumes ore being proportionately reduced, peripheral measurements early do not reflect the true reduction of total red blood 
ved or stopped and plasma volume has been restored from the extrovascular fluids, red cell and hemoglobin concentrations 
flatlng red blood cell moss. In chronic anemia, the total blood volume is usually unchanged; thff total circulating red blood cell 
'alues. Several hours after birth, the total erythrocyte, plasma, and blood volume incroaies by as much as 20 per cent ond 



TABLE 27 N'oiniiil bloinl viiliici sigiiili(;iiil in diiignosis ol Hnenii^s 
in iiihiiicy iiiul tliiklliood* 



ll.nu.Klol.in 
First day 
2 weeks 

Kirst and second years 
:! lo ."> years 
.'> to 10 years 
10 years 

Red blood cells 
Ursl day 
Second week 
Older infant and child 



20 gm. (18 10 22 gm.) 

17 gm. 

II gm. (10 to 12.5 gm.) 

12..') to 13 gm. 

i:t 10 1S.5 gm. 

1-1.5 gm. 



5.500,000 (5 to C million) 
5,000,000 

4,000,000 per cubic milliiiieicr 
lower limit of normal 
.Nmlialcd red cells 

-Average— 3 to 10 per 100 while cells (birth to 4 days of life) 

Rclirnlocylcs 

0.5 lo 1.5% (6% upper limit of normal— fioiii birth to 4 days of life) 

(Iklow 0.5% in aplastic and hypoplastic anemia; increased in hemolytic anemia: 

in deficiency anemia rise from low to high levels with tiealment) 

\ ohniie of packed red cells (hematocrit) 
Infants 1 month to 2 years 
Childien 2 years to 12 years 
Older children 



34% 
36% 
40% 



Serum bilirubin 

Newborn full-leriu infants 2 lo 8 mg.% 

Newborn picmalure infants I to 15 mg.% 

(Values given for both full term and premanue newborn infants are the low vahie.s 

at birth rising to maximum during liisi week of life) 

Normal infants and children l.'nder 1 mg.% 

(Hemolytic anemias-elevalcd total bilirubin |)ii(loniinantly indirect fraction) 

I'ragility lest 

Normal range 0.425 to 0.325% sodium chlo- 

ride 
(Increased fragility in hereditary spherocytosis and in some cases of acute hemo- 
lytic anemia; decreased fragility in sickle cell anemia, thalassemia [major and 
minor], and in iron-deficiency anemia) 

•lioni Smith, C. H.: Anemias in infancy and childhood; diagnostic and therapeutic considerations 
null. New York Acad. Med. 30:155, 1954. 



378 



CLINICAL LABORATORY TEST STANDARDS FOR SCHIZOPHRENIC RESEARCH SUBJECTS 
T. H. McGlashan, M.D. and P. deary, M.S. 



Standards for 15 clinical laboratory tests have been developed from data 
obtained from pretreatment blood samples of subjects who were participants in 
22 clinical psychotropic drug trials conducted in collaboration with the ECDEU 
Program at nine different research centers in the United States and Canada be- 
tween 1969 and 1972. A final sample of 325 research subjects was selected on 
the cr i ter ia : 

a) Diagnosis of schizophrenia (regardless of subtype) 

b) Adult (18 years or more) 

c) No significant concurrent medical conditions 

d) Non-repeating research subject (i.e., if a patient participated 
in more than one research project in which laboratory values 

were recorded, only his first test results were included in the 
f inal sample) . 

e) Complete data on age, sex, and race (i.e., if any of this demo- 
graphic information was missing, the subject was excluded). 

Demographic characteristics of the sample are given in Table 28. Both 
parametric means and ranges (mean + 2 standard deviations) and non-parametric 
medians and percentile ranges (2.5 and 97.5 percentiles) are reported in 
Tables 29 and30. The results generally confirm the finding of increased 
variability in schizophrenic laboratory test data noted in the past. This, 
and implications of the method, are discussed more fully in a paper entitled 
"Clinical Laboratory Test Standards for a Sample of Schizophrenics", Psycho- 
pharmacologia, kk, 281-285, 1975. 



37.9 



TABLE 28 
POPULATION DEMOGRAPHIC CHARACTERISTICS 
N=325-'-' 

CHARACTERISTIC 



Sex 




Male 




Fema le 


Race 




White 




Black 




Other 




Marital 


Status 


Ever married 


Never 


marr ied 



Previous Treatment for Mental Illness (total time) 
None 

Less than two years 
More than two years 

Duration of Present Hospitalization 
Outpat ient 
Less than one month 
One month to two years 
More than two years 

Sch izoid L i f e Style 

Definitely characteristic 
Somewhat characteristic 
Not characteristic 

Occupational - Role Adjustment 
Adequate 
Marg ina 1 
I nadequate 



FREQUENCY 


PERCENT 


170 
155 


52 
48 


271 

^7 

7 


83 

14 

3 


138 
185 


43 
57 


28 

72 

212 


9 
23 
68 


45 
113 

33 
143 


14 
32 
10 

44 


128 

112 

51 


44 
38 
18 


134 
136 


14 
43 
43 



MEAN 
Present Age 40 

Age First Hospitalization 25 



S.D. 


RANGE 


11 


18 - 77 


8 


11-56 



"Missing data existed for many of the demographic characteristics other than age, 
sex and race. Therefore, the N's listed under Frequency do not always sum to 325. 



380 



TABLE 29 
PARAMETRIC NORMAL RANGE ESTIMATES 
FOR 15 CLINICAL LABORATORY TESTS: 
SCHIZOPHRENIC SAMPLE AND TEXTBOOK NORMALS-^ 



TEST 






SCHIZOPHRENICS 


TEXTBOOK NORMAL RANGE 




Sample 


N 


Mean 


Range (Mean ± 2 SD) 




Hemoglobin 


male 


149 


15.2 


12.8 - 17.6 


14 - 18 


gm/lOO ml 


female 


153 


13.8 


11.6 - 16.0 


12 - 16 


Hematocrit 


male 


166 


46 


40 - 52 


40 - 54 


% 


f ema 1 e 


150 


41 


35 - 47 


37 - 47 


Red Blood Count 


male 


51 


5.0 


4.0 - 6.0 


4.6 - 6.2 


mill ions/cumm 


female 


56 


4.5 


3.7 - 5.3 


4.2 - 5.4 


Sedimentation Rate 


male 


22 


17 


1 - 33 


0-20 


mm/hr 


female 


31 


28 


0-60 


0-30 


White Blood Count 


total 


320 


8.4 


3.2 - 13.6 


5 - 10 


thousands/cumm 












Differential Count 


total 


268 








% neutrophi les 






61 


41 - 81 




% lymphocytes 






33 


13 - 53 




% eos inophi les 






3 


- 9 




% monocytes 






4 


- 8 




% basophi les 






0.4 


- 1.8 




Blood Urea Nitrogen 


total 


274 


12 


2-22 


8-20 


mg/lOO ml 












Sodi urn 


total 


65 


139 


131 - 147 


136 - 142 


meq/1 iter 












Potass ium 


total 


64 


4.3 


3.1 - 5.5 


4.0 - 4.8 


meq/1 i ter 












Creat inine 


total 


53 


1.0 


0.6 - 1.4 


0.5 - 1.2 


mg/100 ml 












Di rect Bill rub in 


total 


124 


0.2 


- 0.4 


- 0.4 


mg/100 ml 












Total Bill rub in 


total 


196 


0.6 


- 1.2 


0.5 - 1.4 


mg/100 ml 












Total Protein 


total 


58 


7.5 


6.5 - 8.5 


6.0 - 7.8 


gm/ 1 00 












Blood Albumin 


total 


49 


4.8 


3.8 - 5.8 


3.2 - 4.5 


gm/100 ml 












Fasting Blood Sugar 


total 


103 


98 


62-134 


60-100 


mg/100 ml 












Chplesterol 


total 


131 


207 


113 - 301 


150 - 250 


mq/100 ml 













*Taken from: Clinical Diagnosis By Laboratory Methods 
Davidsohn and Henry, I969 
l4th Edition, W. B. Saunders Co. 



381 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

PHYSICAL AND NEUROLOGICAL EXAMINATION FOR SOFT SIGNS 

The Physical and Neurological Examination for Soft Signs (MH-9-41 PANESS) is a 4-page form for the 
assessment of physical status (pages 1 and 2) and soft neurological signs (pages 3 and 4) in pediatric popu- 
lations. BEFORE ATTEMPTING TO COMPLETE THE FORMS, RATERS SHOULD BE FAMILIAR WITH THE 
INSTRUCTIONS GIVEN IN THE ECDEU ASSESSMENT MANUAL. THIS IS PARTICULARLY CRUCIAL FOR 
THE EXAMINATION OF SOFT NEUROLOGICAL SIGNS. 

The neurological examination for soft signs has been developed and copyrighted by Abbott Laboratories 
and their permission to use it is gratefully acknowledged. 

IMPORTANT - PLEASE READ CAREFULLY BEFORE MARKING THIS FORM. 

INSTRUCTIONS FOR COMPLETION OF MULTIPLE PAGE FORMS 

1. Complete page 1. 

2. Following completion of page 1 carefully tear out and remove the pink protective sheet lying between the carbon and 
your copy of page 2. Follow this procedure for each subsequent page. You must do this to obtain a copy of the data 
for your files. 

CAUTION: DO NOT REMOVE PINK PROTECTIVE SHEETS OTHER THAN THE ONE LYING BETWEEN 
CARBON AND COPY OF THE PAGE YOU ARE ABOUT TO COMPLETE. 

3. When you have completed all pages of the form, carefully tear out and remove carbon papers and your copy pages. The 
machine scannable pages should be left in booklet form for shipment to the Biometric Laboratory in packages prepared 
according to instructions received from the Biometric Laboratory. 



MARKING INSTRUCTIONS 

Read each item and its numbered responses. When you have decided which response is 
correct, blacken the corresponding space on the page with a No. 2 pencil. Do not use 
a ball point pen. Make your mark as long as the pair of lines, and completely fill the area 
between the pair of lines. If you change your mind, erase your first mark COMPLETELY. 

EXAMPLE: The child is 56 months old. Code as follows: 



1. AGE Coded in: Months 

:©: ::1:r z:g:= z:^: zA: 
i©= zzi-.z :^.z .:^z zj^z 



:«:: 



Years ::::: 
zll-z =:§: = 



Mark a field of 9's if an item is unanswered or Not Ascertained. 
EXAMPLE: Blood pressure was not taken; the rater codes as follows: 



6. •BLOOD PRESSURE 










zS^z :=1 = : 
= ©:: A-Z 


5:: 


-<^z 
-i^z 


SVSTOLIC 


= €:: 

-^z 




z^z 




-Qzz =^== 


=5== 


:3:: 


:=1.-: :5:= 


-^z 


rr7=r 


z^z 


•^ 


zQzz i\z 


zQzz 


:3-: 


A^z ,5:: 


=€=: 
=«:= 


z:7=: 






--&: =^:: 


:5=: 


0== 


-A^z =5: = 


^z 


::7:: 


:*: 


■«- 



MH-9-41 (1-73) 



38it 



NATIONAL INSTITUTE OF MENTAL HEALTH 



PHYSICAL AND NEUROLOGIC EXAMINATION FOR SOFT SIGNS 



"ATIENT INITIALS 




















NUMBER MALES 001- 


499 




FEMALES SOO-998 






-A- 


■e 


:0: 


--&■■ 


:g:: 




r^E:: 


:©: 


-n- 


::(:: 


-.-4-.Z 




:#: ::1:: 


-zS-.z 


:*: 


::4:: 




::5:: 


:*: 


::7:: 


:*: 


:*: 


llCi- 


:4::: 


■m- 


■H: 


:©: 


INITIAL 


r:P:: 


:©: 


:}^: 


:«:: 


::T:: 




:*: ::1:: 


:5:: 


:*: 


::4:: 


PATIENT 


:*: 


:*: 


::7:: 


:*: 


:*: 


-iii: 


-.it-. 


--W- 


:*: 


:fr:: 




-.-.Izz 












:*: ::J:: 


zzS-.z 


:*: 


::4:: 




:*: 


:*" 


::7:: 


:*: 


:*: 


--A-- 


:&-. 


r©: 


:&: 


:g:: 




::p::: 


:&: 


:«:: 


::(:: 


:^:: 




zzQzz ::1:: 


:z3-: 


:*: 


::4:: 




:*: 


:*: 


::7:: 


:*: 


:*: 


rX:: 


-.if. 


-W- 




:©: 


SECOND 
INITIAL 


::P:: 


:0: 


:«:: 


:«:: 


::T:: 




::©:: ::}:: 


::2:: 


:*: 


z-Jtzz 


RATER 


:*: 


--^- 


::7:: 


:*: 


:*: 


•-1?: 




:«:: ::1:: 
zzQzz ::1:: 


ZZ2-.Z 
::2:: 


::*: 
:*: 


zzAzz 

:--4;: 


PERIOD 


:*: 
::§:: 


:*: 


::7:: 
::7:: 


:*: 
:*: 


:*: 
:*: 


,^m 








-^ 


FORM 














=^ 








NUMBER 














Hours 
zOzz :rt:: 




Days 
:2:: 






Weeks 
:3:: 




Monlhs 
:=»:: 






PLEASE USE A NO 2 PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


1. AGE 






Coded in 


Months 






Years 






7 


-VISUAL ACUITY 


Code 


numerator only 












-^- 


-.-.U-. 


-:S-.-. 


;*: 


::4:: 




::5--: 


:*: 


1:7:1 


:*: 


:*: 




:*: ::1:: 


:*: 


:*: 


::4:: 




:*: 


:«:: 


::7:: 


:*: 


:*: 


--^-- 


-.-.i-.-. 


zti.. 


:=*: 


;:4:: 




:=5-" 


:*: 


::;:: 


:*: 


:*: 




:«:: ::J:: 
:#: ::1:: 


::2:: 
:*: 


:*: 
:--*: 


::*: 
::4:: 


RIGHT 


:*: 
::&:: 


:*: 


::7:: 
::7:: 


:*: 
:*: 


ZZSZZ 

:*: 






:«:: ::!:: 


::2:: 


:*: 


::*: 




:*: 


::6:: 


::7:: 


:*: 


:*: 
























2. -HEIGHT 






Coded in 


Inches 




Cer 


limeters 








:«:: ::1:: 


::S:: 


:*: 


::4:: 


LEFT 


::&:: 


:*: 


::7:: 


:*: 


:*: 




:zU-. 


.^z 




::4:: 

zzAzz 
zzAzz 




1=5:: 

-.-.Szz 
:-§:: 


:«:: 

:*: 

:*: 


::7:: 
::7:: 

-.r.z 


:*: 
:*: 

:*: 


:*: 

:*: 
:*: 




::©:: ::!:: 


zzS-z 


:*: 


Z-.4ZZ 




::§:: 


:«:: 


::7:: 


:*: 


:*: 


::!:: 




S 


-OPHTHALMOSCOPIC 






Normal 
:*: 




Abnormal 
::!:: 




NA 
:*: 


3. -WEIGHT 






Coded in: 


Lbs 






Kg 






9 


-AUDIOGRAM 








Normal 
:«:: 




Abnormal 
::1:: 




NA 
:*: 


:*: 


::J" 


.-:2" 


"3:= 


-.-J(iz 




:*: 


:«:: 


::7:: 


:*: 


:*: 
































Right 




Lett 




Mixed 




NA 


:«:: 


"1:: 


zz^zz 


-^ 


z-J;zz 




"§:: 


:«:: 


::7:: 


:*: 


:*: 




•HANDEDNESS 




::!:: 




:*: 




:*: 




:*: 


:*: 


::li: 


::3:: 


--^- 


::4:: 




:*: 


:*: 


::7:: 


:*: 


:*: 


























'Specify abnormalities under Item 


r4 










4. -HEAD CIRCUMFERENCE 




Inches 






Cm 






11 


PHYSICAL EXAMINATION 

under Item 14 


— Spec//y any abnormal Imdmgs 






--*= 


.rl" 


zzSzz 


= *: 


::4=: 




::§:: 


:«:: 


::7:: 


:*: 


:*: 














Normal 




Abnormal 




NA 


:#: 


::1:: 


::2:: 


;*: 


riO^: 




::§:: 


::§:: 


::7:: 


:*: 


:*: 


A 
B 


HEENT 
NECK 










:*: 




::l:z 
i;t:: 




























S. 'PULSE 






Code 


Per 


minute' 












C 


CARDIOVASCULAR 








=*= 




-Jiz 




z*z 


--^-- 


"1" 


::2" 


^- 


::j)i: 




::§:: 


:*: 


::7:: 


:*: 


:*: 


D 


PULMONARY 










:#: 




-.zi-.-. 




:*: 


:=S== 


=:):: 


=:2=r 


3^ 


rup: 




::5:: 


::§:: 


::7:: 


-^-- 


-^-- 


E, 


LIVER 










=«:= 




zzUz 




=--9:: 


--^- 


zU. 


zz^.z 


-^ 


z-Ji^z 




::§:: 


:*: 


::7:: 


:*: 


:*: 


F 


KIDNEY 










lie:; 




::1:; 




:*: 








Regular 


--^-- 


Irregular 


::1:; 








G 


SPLEEN 










=:&= 




ziliz 




:*: 
























H 


OTHER ABDOMINAL 






:*: 




::!:: 




=*: 
























6. -BLOOD PRESSURE 


















1 


MUSCULOSKELETAL 






=*= 




zilzz 




:*: 


--^- 


..,.. 


= ^== 


==*= 


::4== 




==§:: 


:*: 


::7:: 


:*: 


:*: 


J. 


GROSS NEUROLOGIC 






:*: 




::3:: 




=*: 


;#: 




:*= 


--^- 


=:4== 


SYSTOLIC 


::§:: 


:*: 


::?:: 


:*: 


:*: 


K 


SKIN 










=*= 




zzjzz 




=*: 


:*: 




::gri 


-^-- 


:i4=r 




==5:: 


:*: 


::?:: 


:*: 


:*: 


L. 
M 


LYMPHATICS 
GU 










:*: 




zzjzz 
::J:: 




:*: 




-.-.i.z 


-zS-z 
-zSzz 






DIASTOLIC 


==5:= 

I*: 
1:5:: 


:*: 
:*: 

::«:: 


::?:: 
::?:: 
::?:: 


:*: 
:*: 

:*: 


:*: 
:*: 
:*: 


"1" 


12 


. Was the neurological examination for soft signs conducted 
and coded on pages 3 and 4 of this form? 






































NO 




YES 








































:*: 




::t:z 







385 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

HEALTH SERVICES AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 

PHYSICAL AND NEUROLOGICAL EXAMINATION FOR SOFT SIGNS 

The Physical and Neurological Examination for Soft Signs (MH-9-41 PANESS) is a 4-page form for the 
assessment of physical status (pages 1 and 2) and soft neurological signs (pages 3 and 4) in pediatric popu- 
lations. BEFORE ATTEMPTING TO COMPLETE THE FORMS, RATERS SHOULD BE FAMILIAR WITH THE 
INSTRUCTIONS GIVEN IN THE ECDEU ASSESSMENT MANUAL. THIS IS PARTICULARLY CRUCIAL FOR 
THE EXAMINATION OF SOFT NEUROLOGICAL SIGNS. 

The neurological examination for soft signs has been developed and copyrighted by Abbott Laboratories 
and their permission to use it is gratefully acknowledged. 

IMPORTANT - PLEASE READ CAREFULLY BEFORE MARKING THIS FORM. 

INSTRUCTIONS FOR COMPLETION OF MULTIPLE PAGE FORMS 

1. Complete page 1. 



Following completion of page 1 carefully tear out and remove the pink protective sheet lying between the carbon and 
your copy of page 2. Follow this procedure for each subsequent page. You must do this to obtain a copy of the data 
for your files. 



CAUTION: 



DO NOT REMOVE PINK PROTECTIVE SHEETS OTHER THAN THE ONE LYING BETWEEN 
CARBON AND COPY OF THE PAGE YOU ARE ABOUT TO COMPLETE. 



When you have completed all pages of the form, carefully tear out and remove carbon papers and your copy pages. The 
machine scannable pages should be left in booklet form for shipment to the Biometric Laboratory in packages prepared 
according to instructions received from the Biometric Laboratory. 



MARKING INSTRUCTIONS 

Read each item and its numbered responses. When you have decided which response is 
correct, blacken the corresponding space on the page with a No. 2 pencil. Do not use 
a ball point pen. Make your. mark as long as the pair of lines, and completely fill the area 
between the pair of lines. If you change your mind, erase your first mark COMPLETELY. 



EXAMPLE: The child is 56 months old 


Code as follows: 










1. AGE Coded in: 


Months m^ 


Years 








:#= ==1=: .:^.. Z^^. 


-.4-. -*- --^-- 


--J.Z 


:«:r 


--^-- 




.:&. .:1:: .dSr-. ::&: 


-..4^-. =5:: -^ 


zzj.z 


= # = 


--^- 



Mark a field of 9's if an item is unanswered or Not Ascertained. 
EXAMPLE: Blood pressure was not taken; the rater codes as follows: 



6. •BLOOD PRESSURE 










zQzz :^:: 


ZZ2ZZ 




:4^: :5:: 

SYSTOLIC 

4^: =5^: 


-^-- 
--^-- 


rr7:r 


--^- 
--^-- 


•^ 
-^^• 


r©:r zz^rz 


:5--: 


=0== 


-A^z :5: = 


--^-- 


rr7=: 


:€:: 


•«- 




z2zz 




DI/SSTOLIC 


r©:: 
-^-- 


:7:: 
=7: 


--^-- 
S = 




:0:: :^:: 


zit-z 


.0== 


:4^= :5:: 


=€--: 


::7r: 


-^- 


^- 



MH-9-41 (1-73) 



384 



NATIONAL INSTITUTE OF MENTAL HEALTH 

PHYSICAL AND NEUROLOGIC EXAMINATION FOR SOFT SIGNS 



J NO 6B-Re55 



PATIENT INITIALS 




















NUMBER MALES 001-499 




FEMALES SOO-998 






--i^-- 


:t:: 




"X" 


:©: 
::V:: 


FIRST 
INITIAL 


:4r:: 


:0: 


■n- 

:ft: 


=«:= 


::T:: 


zzOzz zzUz 


rij:: 

-za-z 


-zSzz 


::4:: 
r;4=: 
::4;: 


PATIENT 


::6:: 
:--5:: 




z.r-z 
z-r.z 

=:7:i 






■A- 


rV:: 


-W- 




:©: 

z.Y:: 


SECOND 
INITIAL 














-:3-Z 
zzSzz 




zu^zz 


RATER 


-z^z 


-*- 


"7" 






^<*= 




::2:: 
::2:: 


zzSzz 

Days 
::3:: 


zzAzz 
::4:: 


PERIOD 


::5:: 

:*: 

Weeks 
r3:: 




::7:: 

Months 
:4- 






■*- 


ui- 






"*• 


FORM 
NUMBER 












PLEASE USE A NO. 2 PENCIL. BE SURE TO MAKE MARKS HEAVY AND DARK. ERASE COMPLETELY ANY MARKS YOU WISH TO CHANGE. 


1. AGE 






Coded in 


Months 






Years 






7. -VISUAL ACUITY 


Code 


numerator only 












=*= 


::J:: 


:i2:: 


-^- 


::4:: 




::5--: 


zz^z 


:;7:: 


--^- 


:*: 


i:©:-. ::J:: 


=*: 


*: 


zzJ^z 




-5--: 


:*: 


::7" 


:*: 


:*: 


:*: 


"'" 


i:2:: 


z-S^-. 


::4:: 




:*: 


--^-- 


::7:: 


-^ 


:*: 




-:2" 

-zS-z 


-zSzz 


zzAzz 


RIGHT 


zzSzz 
::5:: 




::7" 








= *: :=lz: 


=:g:: 


:*: 


zzAzz 




zz.^zz 


-*= 


:i7:: 


:*: 


:*: 
























2. -HEIGHT 






Coded in 


Inches 




Ce 


limeters 






:#: i:l; = 


=*: 


---3^-- 


ZZl^iZZ 


LEFT 


::&:: 


--^-- 


zzr-z 


:*= 


:*: 




::J:-. 


.:2:: 

::2:: 
::2" 




1:4:: 
::4:: 








::7:: 
r:7:: 
"7:: 






::©:: iilri 


-z2-z 


"*: 


zzAzz 




::§:: 


^-- 


::7i: 


=*: 


= *: 


::!:: 




8. -OPHTHALMOSCOPIC 






Normal 




Abnormal 




NA 


3 •WEIGHT 






Coded in 


Lbs 






Kg 






9. -AUDIOGRAM 








Normal 




Abnormal 
rrl" 




NA 




"1: = 


.12:: 


"3:= 

==3=: 


::4:: 

:=4:: 






zz^z 


:;7" 
:i7" 


























-HANDEDNESS 




Right 




Left 




Mixed 




NA 


-^ 


i:l;: 


= :2:: 


-^ 


1:4:: 




I*: 


:*: 


::7:: 


:*: 


=*: 






















'Specify abnormalities under Item 


14 










A. -HEAD CIRCUMFERENCE 

r:©:: "1" -rS-- ::3:: 
r:©:: "1=; --^---- :*: 


r:4;: 


Inches 




::g:: 


Cm 

:i7:: 

-7:: 






11. PHYSICAL EXAMINATION 

under Item 14 

A HEENT 


— Specify any abnormal lindmgs 

Normal Abnormal 
::©:: -zUz 




NA 
























B NECK 










:#= 




==t== 




:*= 
























S. 'PULSE 






Code 


Per 


minute ■ 












C CARDIOVASCULAR 








=#= 




==li= 




=*: 


=«:= 


rrj:= 


=:3ir 


=^3:- 


zzAzz 




!=§:: 


=*: 


=:7:: 


--^-- 


:*: 


D PULMONARY 










:*: 




::}:: 




:*: 


-^-- 


=:Ji= 


zzSzz 


"3== 


zztizz 




=15:= 


=*: 


::7r: 


=*= 


=*= 


E LIVER 










==©:= 




==J=: 




:=»= 


--^-- 


;:J:: 


zz^z 


^ 


:i4:: 




:*= 


=*; 


::7:: 


:*: 


:*= 


F KIDNEY 










:*: 




=il;i 




--^- 








Regular 


-^z 


Irregular 


i:1:: 








G SPLEEN 










--^-- 




=zl== 




--^-- 
























H OTHER ABDOMINAL 
1 MUSCULOSKELETAL 














ZZ^LZ 


6. -BLOOD PRESSURE 




























-^-- 




zzizz 


:=3:-- 


zzAzz 




1=5:: 


:*: 


::T:: 


:*: 


:*: 


J. GROSS NEUROLOGIC 






=*: 




;:1:: 




:*: 


-«:= 




■■*: 


--^-- 


lut: 


SYSTOLIC 


::§:: 


:*: 


==7:: 


=*: 


=*= 


K SKIN 










=*= 




=zjz= 




Z.-9:: 


=*= 




::2:: 


:*: 


::*: 




:*: 


:*: 


r:7:= 


-zSzz 


=*: 


L. LYMPHATICS 
M GU 














zzjr: 














::4:: 


DIASTOLIC 


::5:: 
:i5:: 


=*: 


=:7:: 
::7" 
==7:= 




=*: 




12. Was the neurological examination for soft signs conducted 
and coded on pages 3 and 4 of this form? 




































NO 




YES 







385 



PHYSICAL AND NEUROLOGIC EXAMINATION FOR SOFT SIGNS (PANESS) 





NUMBER MALES 001 


499 




FEMALES 500-998 










:a3:: :: 


1;: ::?:; 


:*: 


:iit: 




::5:: 


:*: 


::?:: 


:*: 


:*: 


BE SURE TO MARK IN PATIENT, RATER AND PERIOD 
NUMBERS ON THIS PAGE EXACTLY AS YOU DID ON 




1" r:f:: 
1:: ::?:: 


::3:: 
"-3:: 


:-^: 
:l4i: 


PATIENT 


::5:: 
r:5:: 




::7r: 
:;7:: 






P'^'^E 1 fci 




1:: ::g.: 
1:: ::?:-- 




:l4=: 
::4;r 


RATER 






::7" 


■-*: 










):: ::2:: 
):: ::2:i 


::3:: 

:*: 

Days 
r:2:: 


:l4:: 


PERIOD 


::5:: 

z-S^z 

Weeks 
3:: 


:*: 
:«:: 


r:7:r 

:--7" 

Months 


:*: 


::S:: 

:*: 


■*" "^^ FORM 
i„,|, NUMBER 


13 PAST MEDICAL HISTORY - Desciibe only CONTRIBUTORY 
illness accidenls operations, elc 




i:: :5:: 
1" ::2:: 




---4;: 
::4-" 




;:5:: 
:-5:: 


:«:: 
:«:: 


::T:: 

::7:: 




zzSzz 




::&: =: 


1:: :5:: 


:--3-: 


:-^: 




:=5-: 


■«" 


;:7:: 


:*: 


:* = 




::©:: -" 


Jr: ::2;: 


::3=: 


::4." 




--rS:: 


:* = 


:;7:: 


:*: 


= *r 




r:©:; :: 


1r: r:2r: 


:* = 


::4:: 




ri&r 


::«:: 


-7:: 


:*: 


I*: 




:^-. '.-. 


1:: :3:; 


;3:: 


:L4:r 




:* = 


= *" 


::7" 


:*: 


= *= 




-.:^z -.-. 


In :i2:i 


:=3=: 


::4=: 




:*: 


:«=: 


::7== 


:«=: 


::r-i 




-.:Qii -.-. 


i;: ::2;- 


:*: 


r:4=: 




:*: 


:«:: 


::7r: 


^z 


1*: 




:#= r: 


):: :;2:: 


r-^: 


;r4;i 




:=§-: 


;*-= 


"7" 


-^- 


:*: 




::Q=: r: 


" ::2zr 


:-3-r 


r:4:i 




-5:: 


:*: 


r:7ri 


--*: 


= *: 




-i^r. :: 


:; :5:: 


--*r 


zz4zz 




= * = 


=*-- 


:;7:- 


*: 


::t:: 




:*: i: 


:: ::2r: 


::*: 


zzizz 




1:6:: 


:*: 


1:7--: 


■*: 


:*: 




:«:: :: 


:: ::2:: 


::3::' 


::4--: 


DO 


-z^- 


:*: 


::?:: 


r*: 


:*: 




::8:: :: 


:: ::2:: 


:*: 


;:4rr 




z-^z 


:«=: 


::7:: 


=*; 


:*: 


14, ABNORMAL PHYSICAL FINDINGS - Specify all abnormalities 
noted on physical ana GROSS neurologic examination (Item 11) 
(Soft signs are coded on page 3 and 4 j 


I*: :: 


:: .z2zz 
:: z:2:l 


::3:: 


"4;: 
::4;: 


NOT 




--*: 
= * = 


i:7:. 








:*: " 


:: r^r: 


-*: 


r:4: = 




::5:: 


:*: 


::7:r 


*: 


r*: 




::©:: =r 


:: .:2=: 


::3=- 


:at: 




::6:: 


:*: 


-7" 


:*; 


;*: 




:*i ;: 


rr ::2:: 


:*: 


:iit: 


MARK 


r*: 


:*: 


:i7:.- 


:*: 


:*: 




:*: r: 


:: :2:: 


:*: 


r:4;: 




::*: 


:*: 


:;?:: 


:*: 


I*: 






:: ;:2:: 
:i :i2=: 


"-3:: 


:-Jt: 
r:4-" 


OR 


:i5:: 

:i5:: 




::7:: 








::e=: == 


r: r:2_-_ 


:=3=: 


r=4;: 




= :&:: 


:«=: 


:i7:: 


:*: 


:* = 




:#: --: 


r: =5r: 


::*: 


r:4;: 


WRITE 


:*: 


:«:= 


=r7" 


= *- 


:*= 




:«:: " 


=: r:2=- 


= *: 


r:4; = 




=*i 


:*: 


::7:: 


:*: 


= *: 




:«:: :: 


:: :5:: 


::3:: 


:3tr 




: 5:- 


-*: 


zzjzz 


:*: 


:*: 




::©:: :: 


.. r:2" 


:*: 


:Kt: 


IN 


r:5:: 


:*: 


::7i: 


:*: 


:*: 




= «:-- =r 


r. :;2_-: 


r*: 


"4;: 




:i5=: 


:*: 


:i7- 


^- 


:*: 


15. DIAGNOSIS - Soecily all physical and neurological diagnoses here 
Please use ICD-8 classifications 




;; .z2zz 

:: :3r: 




::4=: 
::4:: 


THIS 


:*r 




=r7== 
"7: = 








=:©:: ^ 


=: =:2r= 


:*- 


i:4:= 




rifri 


:*: 


::7rr 


:*: 


:*: 




-.:&:-- -.-. 


:: ;:2:: 


:.3:: 


::4r= 


AREA 


rrg:: 


:*: 


r:7=: 


:*: 


:*: 




1:8:1 r: 


:: zzSzz 


r=3=: 


::4;: 




:*= 


::«== 


==7=: 


:*: 


1*- 




:*: r:l 


" :3:-- 


-■Sz- 


::4;; 




:* = 


:«-- 


:n7:r 


=*r 


:*: 




■.:&:-. Z-. 


i: ::2:: 


:*: 


::4:: 




:*: 


= *: 


::7:: 


= *: 


I*: 




z:Qiz :i 


=: rigr: 


:*: 


Z-4ZZ 




= :&;: 


:*:: 


-7=: 


:*: 


:*: 




zzQzz z: 


:r ::2=r 


:*r 


::4:: 




:*= 


:*: 


:i7=: 


:*= 


:*: 




zzQzz ;:J 


:: ::2- 


:*: 


i:4;= 




:*i 


:«:: 


"7r: 


:*: 


:*: 




--:©:: ril 


- _-z2" 


zz3zz 


"4:: 




:*r 


:*: 


r:7:: 


:*: 


:*: 




r:©:: ==1 


=1 r^:: 


:*- 


zr4:: 




;*: 


:«=: 


rr7:r 


:*: 


:*: 


386 


;*; :i) 


:= ;:2:: 


r*: 


:=4:r 




"-6:: 


:*: 


::7r.- 


:*: 


:*: 



PHYSICAL AND NEUROLOGIC EXAMINATION FOR SOFT SIGNS (PANESS) 





NUMBER MALES 001-499 FEMALES 500-998 










zzQzz ::J:: ::2:: ::3;; ^4:: 


::5:: 


:«--: 


::7:: 


:*: 


:*: 


BE SURE TO MARK IN PATIENT, RATER AND PERIOD 
NUMBERS ON THIS PAGE EXACTLY AS YOU DID ON 


::©:: ::!:: ::2:: zz^z :l4:: PATIENT 
zzHz: ::l:i :4:: :*: :=4=: 


::§:: 
::§:: 




::7:: 
::7:: 










zzQzz ::!:: ::g:: ::3:: zzAzz 

RATER 
::©:: ::!:: zzS-Z i:^:: zjHiz 


::5:: 
z-Szz 




::T:: 








zzQzz ::!:: ::2:: ::3:: ^4:: 

PERIOD 
;:©:: ::!:: iig:: llS:- zzAzz 

zzQzz :?l":? .^X 


::§:: 

::§:: 

Weeks 

3:: 




::7- 
zzj.z 
zAz!^ 




:*: 


i t^m m^ FORM 
' NUMBER 


USE THIS CODE FOR ITEMS 1-20 • SEE INSTRUCTIONS IN ASSESSMENT MANUAL FOR DETAILS 












1 - Performed correctly 

2 — Performed but not well 

3 — Performed poorly or only after repeated instruction and demonstration 


4 — Unsuccessful even after repeated demonstration 
9 — Not done or not ascertained 








1. Touch your finger to your nose ::1:; zzSzz ::3:: ::4:: ::9:-- 


5, Touch one heel to your other leg 


::!:: 


::2r: 


zzSzz 


::*:: 


:*: 


2. Touch your other linger to your nose ;;J:: ::2:: :;3:i :l4i: :r9:: 


6, Do the same with your other heel 


::!:: 


::2" 


zz^zz 


::4;: 


:*: 


3. Close your eyes and touch your ;:J:: iijr: ::3:: ::4r: irg:: 

finger to your nose 


7. Close your eyes and do it again 


::!:: 


::2" 


-^-- 


::4:: 


:*: 


4 Close your eyes and touch your ::J:: zzSzz :-^: ::4;: irg:: 

other finger to your nose 


8. Now the other heel 


::J:: 


ZZS.ZZ 


■^- 


::4r: 


:*: 


Child writes name at the top of separate sheet of paper. Trace a "6" in each palm and identify it for the child. Figure 
In palm as child would see it. "Close your eyes and 1 will draw a mark on your hand. Now open your eyes and draw it 


is drawn 
on paper." 






9. n Right Hand nj- .zS.z i:*: :i4^: ::t:: 


13. X Right Hand 


::!:: 


zz^zz 


:*: 


114;: 


:* = 


10. X Left Hand -I:; zS.z ::3:: "-4=: =*: 


14. 3 Left Hand 


::1:: 


::2:: 


:*: 


:liI:: 


::9:: 


11 O Right Hand -]:: ::2:: ::3:: :ii)i: zz^zz 


15, O Right Hand 


::!:: 


::§:: 


:*: 


::4;: 


::§:: 


12 D Lett Hand -l- ::2:: zzSiz :=4:: =*: 


16. 3 Left Hand 


::!:: 


=:2=: 


==3=: 


1:4:: 


::&: 


"Close your eyes and tell me what I'm putting in your hand." [ 


17. Com Right Hand ::!:: zzS-z ::3:: zziizz ::§:: 


19, Safety Pin Right Hand 


::1:: 


::2:: 


:*: 


::4=: 


:*: 


18, Ring Left Hand ::!:: :5ri ::3:: ii4;: .-:§:: 


20. Key Left Hand 


::J:: 


zzi-z 


:*: 


::4;: 


:*: 


SCORING: Count number of errors (more than 3 scored as three). An error is 


definite deviation from the line or steps incorrectly done 








21. Walk the line to the end on your toes zzQzz ::j:: .zS.z :=3:i :=g:: 


24, Now hop back on the other foot 


:#: 


::J:: 


:* 


-=3:: 


:*: 


22. Walk back on your heels ::©:: :ij:: .zSzz ::3:: ir§:: 
















25. Walk to the end this way (show tandem) 


:*= 


::1:: 


= =2:: 


:^: 


:*: 


23. Hop on one foot to the end of the line zzQiz :r1r: ::g:: zzSzz ::9:: 


26 Now walk backwards the same 
way (6 steps) 


:*= 


III:: 


zzSr-Z 


:=»: 


:*: 


27. FACE — HAND Brush face and/or hand gently with equal stroke (patients eye 


s closed) 


--^-- 


::1:: 


zz2zz 


-^-■ 


::*: 


28. FACE— NOISE Brush face and/or click toy cricket ipsilateral ear (patients eys 


>s closed) 


:*= 


iij:: 


:*: 


zzSzz 


:*: 


29. Two point discrimination. 1 cm. separation, dorsum of digiti minimi. 




zzQzz 


::J:: 


::2:: 


z^-- 


:*: 


PERSISTENCE MEASUREMENTS - Period of uninterrupted success (stopwatch) 


SECONDS 

20 15-19 10-14 0-9 

30. Stick out your tongue until 1 

tell you to stop ::1;; ::g=: rig:: 1:4;: r:^:: 

31. Raise your arms out in front of 

you until 1 tell you to stop ::!:: ::2:r 1:3:: zzAzz ::§:: 


35. Close your eyes and stand still 
until 1 tell you to stop 

Tendency to fall'' 


20 

::!:: 


SECONDS 

15-19 10-14 0-9 

zz^zz ::3:: 1.4:: 
NO YES 
::©:: ::1" 




32. Close your eyes until 1 tell you ::1:r ::2:: zzSzz zzJizz rrg:: 

to open them 

33. Stand on one foot until 1 tell you to stop ::1:: ;:grr zz^z zzAzz ::9:: 


36. Now do it again like this 
(Demonstrate tandem) 

Tendency to fall' 


::!:: 


-zi-z 

NO 


:*: 


::4_-r 
YES 
::1:: 


zzSzz 


34. Now stand on the other ..i.z ::2:: zz^z ::4:: iig:: 


387 













PHYSICAL AND NEUROLOGIC EXAMINATION FOR SOFT SIGNS (PANESS) 





NUMBER MALES 001 


-499 




FEMALES 500-998 










:*: 




z:3.z 


:*: 


zzAzz 




"-5:: 


:*: 


z-r-z 


:*: 


:*: 


BE SURE TO MARK IN PATIENT. RATER AND PERIOD 
NUMBERS ON THIS PAGE EXACTLY AS YOU DID ON 






zzSzz 


:--3:: 


zzHii 
::4:: 


PATIENT 


::5-: 




::7:: 
zzr-z 












--J-- 


::2r: 
-:S-z 




::4;: 
::4:: 


RATER 


r:5:= 




z-r-z 

-zj-z 








--^■- 
zt)zz 


Hours 


::a:: 


Days 


rut: 
::4:: 


PERIOD 


::5:: 

rig:: 

Weeks 
3:: 


:«:: ::7" 

:*: ::T:: 

Months 
:24r: 






"^ *"*" FORM 
^ NUMBER 


USE THIS CODE FOR THE QUALITY SECTION OF ITEMS 37-42 • SEE INSTRUCTIONS IN ASSESSMENT MANUAL FOR DETAILS 








1 — Performed correctly 

2 — Performed but not well 

3 — Performed poorly or only after repeated instruction and demonstration 


4 - 
9 - 


Unsuccessful even after 
Not done or not ascerta 


repeated demonstration 
ned 




SCORING: These are 5 second tests Always dennonstrate with a 4/second beat 


Three 


scores are 


recorded for each test. 








TEST 


NUMBER OF TAPS 


NUMBER OF MOVEMENTS 

(II greater ttian 4. mark 4 ) 


QUALITY 1 




20 15-19 10-14 0-9 


























37 Tap this fast witti your finger Left 


::!:: zzS.-. :*r ::4:: -z^zz 


"1=: 


1*: 


zzSzz 


::4;: 


--*: 






irlri 


-:2:: 


z^-- 


r:*: 


:*: 


38 Rigtit 


zzUz :5=: :*: -zAzz :*: 


::!:: 


-:i-z 


:*: 


:-.4:: 


:*: 






::J:: 


-3" 


:*: 


::4:: 


:*: 


39 Tap this fast with your foot Left 


zzUz -:2zz :*: ::4:: :*: 


:zj:: 


r*r 


:*: 


:^-: 


::9:: 






::lr: 


r:2=i 


--^-- 


n*: 


=*: 


40 Right 


::!:: zz2zz :*= :^: ::9:: 


::1" 


-ri-z 


:*: 


Z.AZZ 


-zSzz 






::1:: 


:a:: 


:*: 


:i4:: 


:*: 


41 Tap with your finger and fool Left 


"1:: i3=: =*: ::4:: =* = 


::1=: 


:a:: 


--^- 


zzAiz 


-*: 






:-.1:: 


-rS-z 


:*: 


::4:: 


=*: 


42 Right 


::!:: r^" :*: :^: =*: 


::1:: 


:a:: 


:*: 


zzAzz 


:*: 






::1=: 


zzSzz 


:*: 


r:4;: 


:*: 


43 STRING TEST 

ti/larl< the number of times child successfully 

followed the five motions To the righ 


"1" 






zzAzz 

Z.AZZ 


:=fr: 
".5:: 


No 


zzUz 

Present 
::1:: 


NYSTAGIWUS 

zzS-z I*: 

Right LeII 
zzSzz -zSiz 




44 GLOBAL IMPROVEMENT Rate degree of improvement since ad 


mission to the study 


















Mini- Mini- 
Uuch many No mally Much 
Improved Improved Change Worse Worse 


11 

sessed 






















(At initial rating, mark "Not Assessed") zzUz rij:: :*: :*= =*: 


;*: 






















45 The conditions of the examination were: Satisfacfc 


)ry ::li: 


Unsatisfactory 


::2:: 















388 



The Physical and Neurological Examination for Soft Signs (PANESS) is a 
multipage form which is independently formatted and does not require the use 
of a General Scoring Sheet. The first 2 pages contain the section relating 
to the physical examination; while the last 2 pages contain the scored neuro- 
logical examination for soft signs. Investigators may employ one or both 
sections of PANESS in their studies. The content of the physical examination 
section - though new to the ECDEU battery - should be very familiar to 
physicians. The neurological section, on the other hand, attempts to "quantify' 
a number of standard clinical procedures and may require additional training. 
The physical examination section has been developed within the ECDEU program; 
while the neurological section has been developed by Abbott Laboratories and 
Dr. Close. 



APPLICABILITY 
UTILIZATION 



Chi Idren to Age 15 

Once at pretreatment ; at least one post- 
treatment assessment. Additional ratings 
are at the discretion of the investigator. 



TIME SPAN RATED 



Present status 



CARD FORMAT 



ITEMS 



CARD 01 = (I9x, 13, 2|4, 13, |4, 4i3, 171I) 
I tem Col umn I tern 



Col umn 



Age 




20 - 22 


Height 




23 - 26 


Weight 




27 - 30 


C i rcumference 




31 - 33 


Pulse 




3^ - 37 


Systo) ic BP 




38 - 40 


Diastol ic BP 




41 - 43 


Visual acuity- 


■R 


44 - 46 


Visual acuity- 


•L 


47 - 49 


Opthal 




50 


Aud iogram 




51 


Handedness 




52 


HEENT 




53 


CARD 02 - Oper 


i-en( 


ded. Depi 



Neck 


54 


Card iovascular 


55 


Pulmonary 


56 


L iver 


57 


Kidney 


58 


Spleen 


59 


Other Abdom. 


60 


Musculoskeletal 


61 


Gross Neur. 


62 


Skin 


63 


Lymphat ic 


64 


6U 


65 


Neuro. Exam 


66 



Dependent upon number of "write-ins" under I terns 13, 1^ 
and 15. Using 3-digit ICD-8 codes, "write-ins" will be 
encoded by the Biometric Laboratory as follows: 



13. Past Medical History 

14. Abnormal Findings 

15. Diagnoses 



Columns 20 - 31 
Columns 32 - 43 
Columns 44 - 55 



389 



CARD 03 = (19x, 3811) 

I tern Column I tern Column 



I tem 



Column 



1 


20 


13 


32 


24 




43 


2 


21 


\k 


33 


25 




kk 


3 


22 


15 


34 


26 




hS 


k 


23 


16 


35 


27 




46 


5 


2k 


17 


36 


28 




47 


6 


25 


18 


37 


29 




48 


7 


26 


19 


38 


30 




49 


8 


27 


20 


39 


31 




50 


9 


28 


21 


ko 


32 




51 


10 


29 


22 


k\ 


33 




52 


11 


30 


23 


k2 


34 




53 


12 


31 






35 
35 
36 
36 


(Sec) 
(Fall) 
(Sec) 
(Fall) 


54 
55 
56 
57 



CARD 04 = (19x, 613, 212, 211) 



I tem 



Column 



I tem 



Column 



37 (Tap) 


20 


43 Left String 


38 - 39 


37 (Move) 


21 


43 Right String 


40 - 41 


37 (aual) 


22 


44 G 1 ob . 1 mp . 


42 


38 


23 - 25 


45 Exam 


43 


39 


26 - 28 






40 


29 - 31 






41 


32 - 34 






42 


35 - 37 







CARD FORMAT - CLUSTERS CARD 51 = (19x, 1512, 13) 

Code "5" in Column 18 indicates card with factor, cluster or other derived score 



Cluster 

1 

2 
3 
4 
5 
6 
7 
8 



Column 



Cluster 



Column 



20 
22 
24 
26 
28 
30 



21 
23 
25 
27 
29 
31 



32 - 33 
34 - 35 



9 


36 - 37 


lb 


38 - 39 


11 


40 - 41 


12 


42 - 43 


13 


44 - 45 


14 


46 - 47 


15 


48 - 49 


Total Score 


50 - 52 



390 



CLUSTER COMPOSITION 



CLUSTER 


ITEMS 


1 - Synergy 


1-8 


2 - Graphesthes ia (Right) 


9,11,13,15 


3 - Graphesthes ia (Left) 


10,12,14,16 


k - Graphesthes ia (Both 


9 - 16 


5 - Stereognosis (Right) 


17,19 


6 - Stereognosis (Left) 


18,20 


7 - Stereognosis (Both 


17-20 


8 - Gait 


21 - 26 


9 - Topognos is 


27 - 29 


10 - Persistence 


30 - 36 


11 - Rapid Movements (Left) 


37,39,41 


12 - Rapid Movements (Right) 


38,40,42 


13 - Rapid Movements (Both) 


37 - 42 


14 - String (Left) 


43a 


15 - String (Right) 


43b 


Total Score 


All 



CLUSTER SCORE RANGE 

8-32 

4-16 

4 - 16 

8-32 

2-8 

2 - 8 

4-16 

0-18 

- 9 

7 - 30* 

9-36 

9-36 

18-72 

2 - 5** 

2 - 5^-^^ 



-'cScore = Sum of Items 30 - 36 + 35b + 36b 
-'-"Score = No. of Movements + (Absence (1) or Presence (2,3) of Nystagmus) 

SPECIAL INSTRUCTIONS 

Identification block (ID) - Patient, rater and period numbers MUST be encoded 

on ALL pages used. Form and Page Numbers are preceded and no marks are required - 

indeed none are permitted - in these shaded areas. 

Multipage forms - The pink sheets inserted after the carbons of pages 2, 3 and 4 
prevent fnarks from passing through to the sheets below. Each pink sheet must be 
removed before you compilete the page before it; e.g., remove the pink sheet between 
white page 2 and yellow page 2 BEFORE filling in page 2. Exercise care in tearing 
but pink sheets so as not to mutilate white sheets. 

Physical Examination - This section of PANESS comprises pages 1 and 2. It may be 
used independently or in conjunction with the neurological examination for soft 
signs. All items should be "filled in" - whether or not all items (examinations), 
were conducted. For those examinations not done, code a field of "9's". (See ex- 
ample on face sheet of PANESS). 

NOTE - Although the physical examination section was designed specifically 
for children, the items - with the exception of Item 4, perhaps, are 
applicable for all populations. Investigators with adult populations 
may use this section of PANESS to submit medical data for BLIPS 
process Ing. 

Item 12 - This item MUST BE COMPLETED. It is a necessary signal - the absence of 
which will produce "severe persever i t is" in the computer; i.e., the computer will 
search endlessly for further data. 



391 



Page 2 - ONLY the left side of this page is for "write-ins"; the right side for 
encoding of "write-ins". 

EXAMPLE 



NCORRECT 



13. PAST MEDICAL HISTORY - Describe only CONTRIBUTORY 
illness, accidents, operations, etc 



Qi c^uX^ l\f aAJ2?^iAji^^.y^^ iZit' 



CORRECT 



CiCiX:^ N^^-^O^c^-r^-y^C^ 






Page 2 should always contain written entries if any abnormalities are cited on 
page 1. If the physical examination is completely "normal" and there are no 
"write-ins" to enter, page 2 may be omitted. The omission of page 2 under these 
circumstances may occur whether or not the neurological examination (pages 3 and 
h) is completed. 

Items 13, 1^ and 15 - Write-ins must be legible. Use ICD-8 terminology whenever 
possible to describe illness. The ICD-8 List of Major Disease Categories is given 
in the Diagnostic and Statistical Manual of Mental Disorders, American Psychiatric 
Association, 1968, 3rd Edition. Raters may write in the appropriate 3-digit codes 
in lieu of the written words. 

Pages 3 and k - Neurological Examination for Soft Signs - EXAMINERS MUST BE THOROUGH- 
LY FAMILIAR WITH THE PROCEDURES FOR CONDUCTING THIS EXAMINATION GIVEN IN THE SECTION 
"SCORED NEUROLOGICAL EXAMINATION". DO NOT ALTER OR MODIFY THE MANNER IN WHICH THE 
TESTS ARE TO BE GIVEN. 

I tern 17 - The child need not name the correct denomination of the coin - merely 
recognize it as a coin. 

I tern 18 - The response "circle" is acceptable for "ring". 

Items 27 and 28 - These tests are performed only ips i latera 1 ly . 

I terns 30 and 34 - The scale points for these items are in time intervals rather 
than quality of performance. No second chances are given with these items. 

Item 32 - Use clinical judgment as to whether eyes are closed tightly. 

Items 35 - 36 - These 2 items require judgments on the subject's tendency to fall 
in addition to recording time intervals. No second chances are given with these 
i tems . 



392 



I terns 37 - hi - Each of these items requires 3 judgments: number of taps, 
number of adventitious movements and quality of performance. 

Example - Subject taps 12 times; makes 2 adventitious movements and 
the quality is judged as poor. Code as follows: 



SCORING: These are 5 second tests Always demonstrate with a 4/second beat. Three scores are recorded for each test. 



TEST 



37 Tap this fast wilti your finger 



NUMBER OF TAPS 



20 15-19 10-14 0-9 
::li: i^:: <*• --Az-- :*: 



NUIV1BER OF rviOVEfVIENTS 

tit greater than 4. mark 4 } 



QUALITY 



Item 39 - Do not downgrade scores if amplitudes are increasing. 

Item ^3 - This 2-part item (left and right) requires 2 judgments: one for 
quality of performance and one for presence and direction of nystagmus. 

Example - Subject is able to follow the target to the left 

2 out of 5 times and exhibits nystagmus with a fast 
component to the right. Code as follows: 



43 STRING TEST 



fulark tlie number of times child successfully 
followed the five motions 



NYSTAGfVIUS 

flighl Leit 



DOCUMENTATION 



;& . Raw score printout 

b. Cluster score printout 

c. Frequency tables 

d. Means and standard deviations of cluster scores 

e. Variance analyses 



393 



MANUAL FOR THE NEUROLOGICAL EXAMINATION FOR SOFT SIGNS 
Abbott Laboratories and John H^ Close, M.D. 



I ntroduct ion 

This scored neurological examination is designed to assist the observer 
in determining whether neurological soft signs are present in a child. 
Because this is not a test of learning, it is important that the patient 
fully understand what is expected of him. The examiner (who need not 
necessarily be a physician) should demonstrate every task to be performed 
while giving the verbal instructions in the test description. Prefacing 
instructions should be used in an identical manner from one child to the 
next, utilizing a set routine of presentation. The time usually required 
to perform this test is 15 to 20 minutes. 

At the beginning of testing, the ch i Td ' s attention should be obtained 
by making the statement, "Pay attention and watch what I do because you 
will have to do it after me." Since many items require stopwatch timing, 
the caution must be given, "Don't start until I say NOW, Okay?" immediately 
after the description and demonstration of each task. Proper instruction 
and clear demonstration are important contributors to the effectiveness 
of this scored examination. 

A positive atmosphere should be maintained throughout the examination, 
accompanied by verbal praise and reinforcement. Incentive, such as the 
promise of a choice of a toy upon completion of testing from a box of in- 
expensive toys, may also be used. 

Materials and Equipment 

The room used for the test should be adequately lit, have a minimum 
noise level and be as free as possible for extraneous materials. One wall 
should be darkened by a black felt cloth or blackboard to provide a black 
background for the test of opt icoki nes ia . Other needed items include the 
examiner's chair (facing away from the dark wall), a chair for the patient 
which faces a table or desk, and a convenient drawer for examining materi- 
als. Adhe.sive tape, 1 1/2 inches in width should be used to make a six- 
foot long, straight line on the floor, away from any nearby obstructions. 

The following materials are needed: 

a. A standard-lined 8 1/2 inch by 11 inch writing tablet. On the 
cardboard back, clearly ink geometrically attractive figures of 
a square, a six, a circle, a three, and an X, approximately one 
' i nch h igh . 



a603X 



39^ 



Three or four sharp, soft lead pencils. 

A ba 1 1 point pen. 

A toy cricket or other hand-held device for making clicking noises. 

A stop watch (expensive models are unnecessary). 

A two-point discriminator with one-centimeter separation. 

A ring (simple wedding band type). 

A car key. 

A coi n (n ickel ) . 

A standard two-inch safety pin. 

Box of small, cheap toys. 



III. Administration and Scoring 

Rapport should be established by a few minutes of conversation. Acclim- 
atization to test circumstances may then be phased in by one or two simple 
unscored tasks, such as, "Can you show me your right foot? Goodl Now point 
to your left ear." (Gentle correction is used with an incorrect gesture, 
and then the gesture repeated). Above all, a completely encouraging, non- 
punitive atmosphere is required. In all the directions that follow, quota- 
tion marks indicate verbal instructions; parentheses enclose a physical des- 
cription of the demonstration. Right or left handedness should be recorded 
before the test begins. (item 10, PANESS - Page 1). 

NOTE - WHEN THE CHILD SIMPLY DOES NOT DO A TEST, MARK "9" = NOT ASCERTAINED. 

A. Tests 1 - 20 

1 . F i nger to Nose 

"I want you to touch a finger to (Extend the arm laterally 
your nose. Begin with your arm with the hand in a loose 
out here." fist, index finger extended 

as pointer.) 

"Now do like this." (Make a wide sweep medially 

to touch the nose.) 

Score: 1 - Smoothly and accurately performed. 

2 - Slowly, jerkily, and missing the target, then 

correcting. (if 10 seconds pass with no attempt, 
instruct and demonstrate again.) 

3 - Same as 2; but done only after encouragement or a 

repeat instruction and demonstration. 
k - Same as 3: but without correcting target error. 



395 



2. Contralateral Finger to Nose 

"Now do the other hand." (Demonstrate again.) 

Score as in Test No. 1 

3. Finger to Nose, Eyes Closed 

"Now close your eyes and do that (No demonstration necessary.) 

aga in." 

Score as in Test No. 1 

k. Contralateral Finger to Nose, with Eyes Closed 

"Close your eyes again and do it (No demonstration necessary.) 

with the other hand." 

Score as in Test No. 1. 

5. Heel to Shin 

"Touch your heel against the front (Demonstrate the heel touch- 
of your other leg, up high like ing just beneath the patella.) 

this." 

Score as in Test No. 1. Either foot may be used acceptably. 

6. Contralateral Heel to Shin 

"Now do it with the other heel." (Demonstrate again.) 

Score as in Test No. 1 

7. 'Heel to Shin, Eyes Closed 

"Now close your eyes and do that (No demonstration necessary.) 

last one again." 

Score as in Test No. 1 

8. Contralateral Heel to Shin, Eyes Closed 

"Now close your eyes and try it (No demonstration necessary.) 

wi th the other heel ." 

Score as in Test No. I 

For questions 9 - 16, the child is told to turn to the table, where a 
sheet of paper is taken from the pad and placed in front of the child and 
the date written in the upper right-hand margin. Tape or thumbtacks may be 



396 



used to fix the page in front of the child securely. The child is then 
given a pencil and told to write or print his name at the upper left. 
No matter how poorly this is performed, the child should be told that 
it is we 1 I done . 

For drawing on the child's hand, one should try to imagine a frame 
that consists of a line bordering one-half inch within the proximal, 
distal, and lateral margins of the hand. All numbers and figures should 
be drawn in the palm in the same aspect that the child would look at it 
when reading. All figures should be drawn with the nonwriting end of the 
ball point pen. On all graphes thes ia and stereognost ic samples, the child 
should be told, "Now turn your face up toward the ceiling and close your 
eyes." One must be certain that the demonstration cannot be visualized. 
Having been told this, take the palm of the child's hand in your hand and 
slowly (about three seconds) and smoothly draw a number or figure, the 
base of which should be at the thenar and hypothenar portions of the palm. 
The child should then be told, "Open your eyes and draw the figure on the 
paper." Practice one or more times with each hand until the child under- 
stands the procedure. The actual examinations are then initiated. 

The child is told, "Draw on the paper each of the things I draw in 
your hands while your eyes are closed. I may draw another number, or I 
may draw figures, like a circle or square." 

9. - 16. Graphesthes ia 

"Now turn your face up and 9- Draw a square - right hand 

close your eyes while I 10. Draw an x - left hand 

draw. There. Now open 11. Draw a circle - right hand 

your eyes and see if you 12. Draw a square - left hand 

can draw it." 13. Draw an x - right hand 

These verbal instructions ]k. Draw a 3 - left hand 

are used prior to each of 15. Draw a circle - right hand 

the tasks listed to the right. 16. Draw a 3 - left hand 

If the child is unsuccessful after the first tracing, make the remark, 
"That's fine, close your eyes and let me do it again." If after the 
second time the child is still unable to draw the figure, raise the pad 
off the table so that the figures drawn on the back are visible. "Can 
you pick out the one I drew? Fine, draw it." The child is allowed to 
draw the figure while still visualizing the example on the back of the 
pad. 

Scoring: "I" is marked if the child does the figure correctly after 
the f i rst trial. 

"2" is marked if the child does it successfully after the 
second example. 

"3" is marked if the child picks it from those drawn on the 
pad. 

"4" is marked if the child is still unsuccessful after two 
examples and the visualization of the figure on the pad. 



397 



Questions 17-20 involve stereognos is . Different objects are placed 
in the hands without bilateral repetition of the same object. The method 
of testing and of scoring here is similar to that in the preceding descrip- 
tion. The child's face should be directed toward the ceiling with eyes 
closed at all times when the objects might be in sight. The box of objects 
is kept beneath the table out of sight. Each object is placed in the child's 
hand in the order described on the examination form for a period of approximate- 
ly five seconds, and then the child is told, "Now give it back. Without look- 
ing, tell me what it is." If at that point the child is unable to identify the 
object, it is replaced in the hand with the remark, "Feel it and think what it 
could be," After five seconds, it is removed and replaced in the box with the 
other objects. If the child is still unable to identify it, the box is 
brought into sight with the question, "Can you pick it out of here?" 

Scoring: "1" is marked if the child names the object successfully 
on the f i rst trial. 

"2" is marked if the child names the object after the 
second placement in the hand. 

"3" is marked if the child is successful only after see- 
ing the object. 

"k" is marked if the child is unable to pick the object 
out of the box. 

B. Questions 21 - 29 

Here, the straight line taped on the floor is used for testing. As long 
as the patient's foot is touching the tape in any way, it is not considered a 
miss . 

21 . Walking Tiptoe 

"Walk this line to the end up (Demonstrate while up on the 
on your toes." balls of the feet; arms hang- 

ing naturally, carefully walk 
the 1 i ne .) 

"Be sure you stay on the line." 

The examiner should wait at the end of the line. This serves two 
purposes; first, he remains close to the child to protect against 
falling; and secondly, he will be positioned for the next demonstra- 
tion, the return trip. An error count is made for each time the 
child misses the line or puts a foot down flatfooted. This actual 
count, 0, 1,2, or 3, is scored. If a greater number of misses occurs, 
score as "3". 



398 



22. Heel Walking 

"Now go back on your heels like (Arms at side, walk on 
this." heels on the line.) 

Score: The same method as in Test No. 21 is used. 

23. Hopping on One Foot 

"Can you hop all the way (Demonstrate a hop on the 

without missing the line? line.) 

Be sure not to put the 
other foot down." 

The examiner should again remain at the end of the line. 

Scoring: An error occurs if the child misses the line 
or if the elevated foot is allowed to touch 
the floor. 

2k. Hopping on the Other Foot 

"Now hop back on the other foot." (Demonstrate accordingly.) 

Score as in Test No. 23 

25. Tandem Walking Forward 

"Now be sure you put your heel (Demonstrate heel -toe walking 
against your toe and walk to on line and remain at the end.) 
the end staying on the line." 

Score: An error consists of not placing the heel to toe 
or missing the line completely. 

26. Tandem Wal king Backward 

"Now do the same thing backwards." (Demonstrate accordingly.) 

Score as in Test No. 25 

In test Nos . 27, 28, and 29 the child is seated at the side of the 
table with hands on knees. Three (3) clear examples are given in 
each case before actual counting begins. The examples should always 
be given exactly the same way. The test should be performed on the 
dominant side; in a right-handed child the right cheek and right 
hand should be employed. Again, the child's face is directed upward 
with the eyes tightly closed. 

27. Face-Hand Test 

"I am going to brush your hand (with a light fluff of cotton in 
and face at the same time." each hand, the dorsum of the hand 

and the cheek beneath the malar 
eminence should be brushed simul- 
taneously and softly with as near- 
ly equal pressure as is possible.) 



399 



27. Face-Hand Test (Continued) 

"Did you feel it?" 

"Now I'm going to brush only 
your face." (This is then performed.) 

"Did you feel it?" 

On the third example, the hand only is brushed, and again with 
the forewarning: 

"Now I'm going to brush only 
your hand," (This is then performed.) 

Begin actual test - 

"Now I'm going to do this some (First, hand only; 
more and I want you to tell me Second, face only; 
what I do each time." Third, face-hand combin- 

ation; each time asking 
the child: "There, what 
did I do?") 

Scoring: If the child misses none of these, "0" is marked; 
if he misses one, "1" is marked; and so on, up to 
a total of missing all three. 

28. Face-Noise Test 

This test is similar, except that the face is brushed at the same 
time a cricket toy is clicked in the ipsilateral ear. Again, three 
variations are performed as examples. First, the cricket only is 
clicked; second, the cricket is clicked and the face is brushed; 
third, the cricket is clicked without brushing the face. Note that 
the cricket is clicked in every example. 

Begin actual test -- 

(First, the cricket is clicked "Can you tell me what 
and face simultaneously brushed; I did?" 

Second, the cricket is clicked "Can you tell me what 
without brushing; I did?" 

Third, the cricket is clicked "Can you tell me what 
and face brushed again.) I did?" 

Scoring: As in the case of Test No. 27, the number of errors is 
counted; if the child misses none of the trials, "0" is 
marked; if 1 of the examples is missed, "I" is marked; 
if two are missed, "2" is marked; and if all three are 
missed, "3" is marked. 



ifOO 



29. Two-Point Discrimination 

Again, three examples are given utilizing the one-centimeter separation, 
two-point discriminator on the dorsum of the digiti minimi. 

"You see, I have only touched you (Only one point is touched.) 
wi th one point ." 

"I used two points on you that (Both points are used.) 
time, could you tell it?" 



'Now only one point again.' 



(One point only is again used.) 



Begin actual test '-- 

"What did I do that time?" 

"What did I do that time?" 

"What did I do that time?" 



(Us i ng two poi nts .) 
(Using one point.) 
(Us i ng two poi nts .) 



Scoring: Same as in Tests 27 and 28, appropriate number is 
marked for through 3 errors. 

C. Questions 30 - 36 

These tests require the use of a stopwatch and accurate timing of the 
child's performance. It is necessary that the child know clearly when the 
test starts, and that he is told to keep doing the task until the examiner 
tells him to stop. For scoring purposes, if the child persists in the task 
for 20 seconds or more "1" is marked; 15 to 19 seconds, "2" is marked; 10 
to 14 seconds, "3" is marked; and to 9 seconds, "4" is marked. At the 
outset of these tests the child is told, "Now I am going to tell you some 
things to do; be sure that you don't stirt doing each one of them until I 
say 'begin'. Do you understand? Also, be sure you continue doing them 
until I tell you to stop." 



30. Tongue Extrusion 
"Watch me now." 



"Did you see that I did? Al 1 
right, now when I tell you to 
start do it a long time until 
I tell you to stop. Ready - 
beginl" 



(The examiner should stick out 
his tongue for a period of 
three to four seconds.) 



401 



31 . Arms Extended 

"Hold your arms in front of 
you like this until I tell 
you to stop." 

"Could you see how I did that? 
Are you ready to start? All 
right - beginl" 

Presence of drift does not alter 
task. 



(The arms shoujd be extended 
directly in front of the 
examiner, palms down.) 



the timed nature of scoring in this 



32. Eyes Closed 

"Watch how tightly I can close 
my eyes . 



(Close the eyes very tightly.) 



Now you do it when I tell you 
to. Ready - beginl" 

33. Stand on One Foot 

"Now I'm going to stand on one 
foot without moving it." 

"It doesn't matter which foot 
you stand on. Did you see how 
I did that? Are you ready? 
Beg in'." 

3k. Stand on the Other Foot 

"Now do the same thing when I 
tell you to start, standing on 
the other foot. Are you ready? 
Beginl" 

35. Romberg 

"Now stand up like this on both 
feet but keep your eyes closed.' 



'VAre you ready to do that? 
All right, beginl" 



(Stand up on either foot with the 
arms hanging naturally down at 
the sides.) 



(No demonstration necessary.) 



(The examiner stands in front 
of the child on both feet, 
erectly, with his hands at his 
sides and his eyes tightly 
closed.) 



402 



36. Tandem Romberg 

"Now put one heel against the (Demonstrate eyes closed 

other toe and stand with your tandem stance, arms at 

eyes closed until I tell you to sides.) 
stop. Either foot may be in 
front." 

D. Questions 37 - ^3 

In these tests, the examiner should assure himself of exactly what 
constitutes a four-per-second beat. A general tendency is to make this 
beat faster than it should be. The examiner should appraise his own 
sense of rhythm by listening to a four-per-second example; either with 
a clock or, if available, a metronome. A typical alarm clock or wrist 
watch (but not a stopwatch) ticks at a four-per-second rate. 

Each test is of five seconds duration. The child is seated at the 
table facing the dark backgroupd wall, and the examiner's demonstrations 
should be clear and perhaps exaggerated. The child should be allowed 
three or four seconds practice at Nos . 37, 39. ^1 , and k3 . If a mistake 
IS seen for which the child would be downgraded, such as a lack of smooth 
delivery, the child should be informed. He should also be told at the 
outset not tq move the rest of his body, but rather just the part that 
IS supposed to be moving. 

Adventitious movement will be considered any movement unnecessary to 
the task at hand, whether it be a jerk, twitch, grimace, body contortion, 
sticking out of the tongue, etc. Contralateral rigidity is not considered 
adventitious. The starting point of each of these tasks for the purpose 
of timing should be aclear-cut signal. 

37. Finger Tapping 

"Now watch ho^y I tap only my (Demonstrate sitting erectly 

finger just this fast. Notice with the tapping motion 

thPt I leave my other arm down mainly comprised of finger 

at my side." action not hand motion.) 

'You see that I am just moving 
my finger and not my hand and 
arm? Would you like to prac- 
tice t|iat quickly before we 
§tart?" 

At this point, if the child is going too slowly he should be told 
"Go a little faster", and allowed to practice again. 

"That looks good. Are you ready 
now? All right, begin." 



403 



Scoring: The examiner is actually grading tiiree things at once. 
A brief familiarization and practice is needed to 
accomplish this. The first type of scoring is the 
actual count of the number of taps performed in the 
five-second period. The child must be shown the proper 
rate of tapping at the beginning. The number of taps 
is scored in the proper position. Simultaneously, one 
is making mental note of adventitious movements. Their 
number represents a separate score and is indicated by 
a marl< in the proper position. 

"Q.uality" is also scored 1 through k; the examiner marks 
the appropriate number based on his best judgment of per- 
formance. This evaluation is not meant to reflect absolute- 
ly correct rhythmicity, but rather the smoothness of delivery 
overall. Points should not be taken away if the child ends 
the task at a more rapid or more slow tapping rate than that 
with which he began, as long as he phases in and out of such 
changes smoothly. We downgrade the child for sporadicism, or 
for the appearance of "bursts" in his sequencing. If the 
child only makes one such change in rhythm, he will receive 
a score of 1 in the quality position; if he makes this error 
twice, he will receive a score of 2; three times, a score of 
3; and a score of k could represent a completely arrhythmic 
performance. 



38. Finger Tapping - Other Hand 

"Now we are going to do it with 
the other hand; why don't you 
practice that for a moment?" 



(No repeat demonstration 
necessary.) 



"That's fine. Are you ready 
now? Begin." 



39. 



Scoring as in Test No. 37 
Foot Tapping 



"Now watch how I sit and tap only 
my foot just this fast. Would 
you like to practice that for a 
moment?" 



(Demonstrate accordingly. 
The heel remains on the floor. 
Assure that there is moderate 
extension at the knee or the 
resultant angle on the foot 
makes the task difficult.) 



"That's fine. Are you ready 
now? Begin." 

Scoring as in Test No. 37 



kok 



'+0. Foot Tapping - Other Foot 

"Now let's do it with the other (No repeat demonstration 
foot; you may practice for a necessary.) 
moment." 

Scoring as in Test No. 37 

k] . Finger and Foot Synchronization 

"Now we are going to try the (Examiner must be careful 

finger and the foot at the to synchronize finger and 

same time. You must tap them foot tapping through several 
together at the same rate you repetitions at an adequately 
have been tapping them separately. fast rate. Like sides are 
Watch how I do it." always paired; right hand with 

right foot; left hand with 

left foot.) 

"Do you want to practice that now?" 

"That's fine, do you think you are 
ready to start? All right. Begin." 

Scoring: The scoring of tap count and adventitious movement 
count is the same here as in previous examples. 
However, the "Quality" score now reflects the actual 
number of times the child deviates from synchronized 
tapping. A complication of this scoring immediately 
becomes obvious; that is, if the child is unsynchron ized 
from the start. In such a circumstance one must grade 
quality according to the amount of time during the test 
asyncnrony is apparent. A quality score of 1 is well 
synchronized, hand and foot, through the entire study. 
If the child is not wel 1 -synchronized for some portion 
of the test, divide total test time into thirds. If 
the child's tapping is not synchronized for one-third 
of the time, a quality score of 2 is recorded; if two- 
thirds of the time asynchrony is demonstrated, a score 
of 3 is received; and a quality score of ^ is recorded 
for gross asynchrony throughout. 

42. Synchronous Finger and Foot Tapping - the Opposite Side 

"Now I want you to tap your foot (No repeat demonstra- 

and finger on the other side tion necessary.) 

together. Do you want to practice 

that? All right, begin." 

Scoring as in Test No. k] . 



405 



43. String Test 

This is an opt icoki net ic test performed with a rapid and a slow 
component. An object on the examiner's hand should serve as a target 
on which the child may fix his gaze; a ring on a finger or a piece of 
chalk between fingers is adequate. The motion is made against the dark 
background, and tfirough a distance of about two feet. The test hand is 
moved away from the body rather quickly, then brought back to the 
examiner's side more slowly. It is performed approximately two feet 
from the child with first the right and then the left hand. The examiner 
should step to the right or left far enough so that the demonstrating 
hand will be directly in front of the child's face. The child's head 
must remain still, following only with the eyes. 

"Now I 'm going to pretend that (The hand is moved away from 
I am pulling on a piece of the body in a quick motion and 

string several times that is then more slowly brought back 
hooked to my belt. I want you medially. This is done five 
to follow my hand with your consecutive times rhythmically.) 
eyes everywhere it moves. But 
you can't move your head. It 
may help you if you watch this 
ring on my finger." 

"Now I'm going to do it on the 
other side." 

It is permissible for the examiner to place a hand on the child's head, 
if it would help to stabilize him. The number of times the patient 
successfully follows the target movement out of the possible five is 
scored. I'f nystagmus is present, the direction of the fast component 
should be noted. 



406 



THE 
PSYCHOLOGIST 

PACKET 



The Psychologist Packet consists of a series of formats upon which data 
from psychological tests may be transcribed. Unlike the other packets, the 
Psychologist Packet does not contain the actual scales - merely locations where 
scores may be encoded. There are two sets of scales - one for children and one 
for adults. Wherever possible, scales were selected which had applicability to 
both populations. Two measures of test behavior per se have also been included. 
The inventory of scales is: 



CHILDREN 



ADULTS 



Wechsler Intelligence Scale for Children 
Porteus Mazes 

Wide Range Achievement Test 
Goodenough-Harr is Draw-a-Man Test 
Bender Gestalt Test - Koppitz Scoring 

Psychological Examination Behavior Profile 



Wechsler Adult Intelligence Scale 
Porteus Mazes 



Bender Gestalt - Pascal -Suttel 1 Scoring 
Wechsler Memory Scale 
Friedhoff Task Behavior Scale 



All of the scales in each set are formatted to fit on one General Scoring 
Sheet. Matrices for the Children's and Adult Psychometric Scales are given in 
Figures 2^ and 25. It is essential that the rater ALWAYS USE THE ASSIGNED SHEET 
NUMBER for the packet - Sheet Number 15 for both the Children's and the Adult 
sections. Remember that PERIOD number changes; but Sheet Number remains constant 
regardless of the time of assessment. 

Should an investigator wish to encode other psychometric or psychological 
information, he must follow the procedures outlined for the encoding of non- 
standard data, (pp 59-64). Modifications of any of the standard scales are con- 
sidered "non standard instruments"; e.g., the Canter scoring of the Bender Gestalt. 

While entitled "Psychologist Packet", psychometr ists or other individuals with 
appropriate testing experience may administer the scales. Supervision by a pro- 
fessional psychologist is suggested when non-professional test administrators are 
emp 1 oyed . 



408 



PSYCHOMETRIC 
SCALES-CHILDREN 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 







ECDEU GENERAL SCORING SHEET {50-GSS) 












— 


PATIENT INITIALS 










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DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 

ALCOHOL, DRUG ABUSE, AND MENTAL HEALTH ADMINISTRATION 

NATIONAL INSTITUTE OF MENTAL HEALTH 







ECDEU GENERAL SCORING SHEET (50-GSS) 












— 


PATIENT INITIALS 












NUMBER MALES 001 TO 499 


MUMBER 


FEMALES SOC 


TO 


998 


— 


zztiz lift: ::e: ::D: ::&= 

FIRST 
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1 12 13 U IB 





PSYCHOMETRIC SCALES 



Code 15 for Sheet Number when encoding any or all of the 
standard Children's Psychometric Scales. 

The texts for all children's scales are printed on PINK templates. 

IVIH-9-60 (Wise) 

62 (WRAT) 
61 (MAZE) 

63 (GOOD) 
64 
66 



Wechsler Intelligence Scale for Children 
Wide Range Achievement Test 
Porteus Mazes 
Goodenough-Harris Drawing Test 



(BENDK) Bender Gestalt Test - Koppitz Scoring 
(PEBP) Psychological Examination Behavior Profile 



Mark on right half of scoring sheet on row specif ied (Cols. 11 


-20) 


ROW 
NO. 


WECHSLER INTELLIGENCE SCALE FOR CHILDREN 






(60-wiSC) (Code 15 for Sheet Number) 






INSTRUCTIONS: Code scaled scores, NOT raw scores, in 2 digits. 


code 




lO's in 3 digits. When using "short forms" or abbreviated versions of 




Wise, be sure to encode subtests and IQ's on the proper rows. 


Leave 




blank all unused rows. 






Information . . . 




12 


Comprehension . . 




3-4 


Arithmetic .... 




5-6 


Similarities .... 




78 


Vocabulary . . . 




9-10 


Digit Span .... 




11 12 


Picture Completion . 




13 14 


Picture Arrangement 




15-16 


Block Design . . . 




17-18 


Object Assembly . . 




19-20 


Coding or Mazes . . 




21 22 


Verbal IQ . . . . 




2325 


Performance 10 . . 




26 28 


Full IQ 




29-31 


WIDE RANGE ACHIEVEMENT TEST 






(62-WRAT) ICode ISfor Sheet Number 






Code Standard Scores in 3 digits Reading 




3234 


Spelling 




35-37 


Arithmetic 




38 40 



IVIark on left half of scoring sheet on rows specified 



PORTEUS MAZES 

(Code 15 for Sheet Number) 
Code 3 digits for each of the two scores 
. . . Maze Quotient 
. . . Qualitative Score 



GOODENOUGH-HARRIS DRAWING TEST 

(Code 15 for Sheet Number) (63-GOOD) 

Code 3 digits for Standard Score; 2 digits for Quality Scale 
. . . Standard Score 
. . . Quality Scale 



BENDER GESTALT TEST - Koppitz Scoring 

(Code 15 for Sheet Number) (64-BENDK) 

For each figure, record the errors by encoding all appropriate 
numbers on the ROW designated. Encode "0" for rio errors. 
Encode Total Score in 2 digits. 



Figure A 



= No errors 

1 = Distortion of Shape 
3 = Disproportion 

5 = Rotation 
7 = Integration 



Figure 1 



= No errors 

1 = Circles for Dots 
3 = Rotation 

5 = Perseveration 



Figure 2 



= No errors 

1 = Rotation 

3 = Row added, omitted 
5 = Perseveration 



Figure 3 



= No errors 

1 = Circles for Dots 
3 = Rotation 

5 = Shape Lost 
7 = Lines for Dots 



412 



PSYCHOMETRIC SCALES 



ROW 


Continue marking on left half of scoring sheet on row specified 


ROW 
NO. 


Mark on left half of scoring sheet on row specified. (Cols. 1-5) 


16 
17 


BENDER GESTALT TEST-Koppitz Scoring (Continued) 




PSYCHOLOGICAL EXAMINATION BEHAVIOR PROFILE 

(Code 15 for Sheet Number) (66-PEBP) 

Adapted from the Collaborative Study on Cerebral Palsy, Mental 
Retardation and Other Neurological and Sensory Disorders of In- 
fancy and Childhood, Perinatal Research Branch, National Institute 
of Neurological Diseases and Stroke, National Institutes of Health 

INSTRUCTIONS: Rateeach item on the basis of behavior observed 
or elicited during the psychological examination. 


Figure 4 = No errors 
1 = Rotation 
3 = Integration 


Figure 5 = No errors 

1 = Circles for Dots 
3 = Rotation 
5 = Shape Lost 
7 = Line for Dots 


23 


1. SEPARATION FROM MOTHER 

0= Shows no concern; eager to leave mother and go with 
examiner 

1 = Shows very little concern 

2 = May show some initial reticence, which is felt to be 

entirely appropriate 

3 = More than usual amount of concern 

4 = Very upset, cries, clings to mother 


18 


Figure 6 = No errors 

1 = Angles in Curves 
3 = Straight Line 
5 = Integration 
7 = Perseveration 


24 


2. FEARFULNESS 

= No apparent awareness of strange situation 

1 = Very little fear evidenced 

2 = Normal amount of caution in the situation 

3 = Inhibited and uneasy throughout with some slowing of 

responses 

4 = Very fearful and apprehensive 


19 


Figure 7 = No errors 

1 = Disproportion 
3 = Incorrect Angles 
5 = Rotation 
7 = Integration 


20 


Figure 8 = No errors 

1 = Incorrect Angles 
3 = Rotation 


25 


3. RAPPORT WITH EXAMINER 

= Exceptionally shy; withdrawn 

1 = Shy; waits for friendly gestures 

2 = Perhaps some initial shyness; feels at ease 

3 = Very friendly and at ease 

4 = extreme friendliness 


21 22 


Total Bender Score 








26 


4. SELF-CONFIDENCE 

= Lacks self-confidence; extremely self-critical 

1 = Distrusts own ability 

2 = Adequately self-confident 

3 = More than usual amount of self-confidence 

4 = Very self-confident 



413 



PSYCHOMETRIC SCALES 



CHILDREN 



ROW 
NO. 


Continue marking on left half of scoring sfieet on row specified 




27 


Psychological Examination Behavior Profile - Continued 




5. EMOTIONAL REACTIVITY 






= Extremely flat; no change in facial expression 






1 = Somewhat flat; little change in emotional tone 






2 = Normal responsiveness; affect appropriate to situation 






3 = Mood more variable than average 






4 = Extreme instability of emotional responses, marked 






emotional lability 




28 


6. DEGREE OF COOPERATION 

= Extreme negativism 

1 = Resistive to demands or directions a good deal of the time 

2 = Cooperative with reasonable amount of discomfort and 

anxiety 

3 = Accepts direction or demands more easily 

4 = Extremely suggestible and conforming 




29 


7. LEVEL OF FRUSTRATION TOLERANCE 

= Withdraws completely 

1 = Occasionally withdraws from task where difficulty is 

encountered 

2 = Attempts to cope with difficult situations 

3 = Becomes quite upset by difficulty 

4 = Extreme acting out behavior and/or crying 




30 


8. DEGREE OF DEPENDENCY 

= Very self-reliant; refuses help 

1 = Rarely needs reassurance 

2 = Dependent in appropriate situations 

3 = Demands more attention than average 

4 = Constant need for attention or help 




31 

— 


9. DURATION OF ATTENTION SPAN 

= Attends to tasks very briefly 

1 = Spends short time with tasks 

2 = Spends adequate amount of time on tasks 

3 = Spends more than average time on tasks 

4 = Highly perseverative 





ROW 
NO. 



Pi.BP— Continued Marii on left half of scoring sheet 



GOAL ORIENTATION 

= No effort to reach a goal 

1 = Briefly attempts to achieve goal 

2 = Able to keep goal or direction in mind 

3 = Keeps goal and questions in mind 

4 = Compulsive absorption with task 



LEVEL OF ACTIVITY 

= Extreme inactivity and passivity; placid, sluggish 

1 = Little activity; content to sit still most of the time 

2 = Normal arnount of activity 

3 = Unusual amount of activity and restlessness 

4 = Extreme overactivity and restlessness; can't sit still 



NATURE OF ACTIVITY 

= Extreme rigidity, unable to shift activity or approach 

to task 

1 = Some rigidity 

2 = Flexible behavioral patterns; activity appropriate to 

different situations 

3 = Behavior frequently impulsive 

4 = Extremely impulsive; explosive and uncontrolled behavior 



NATURE OF COMMUNICATION 

= Little or no verbal communication 

1 = Verbal or non-verbal responses confined to answering 

directed questions 

2 = Readily answers questions; may elaborate 

3 = Answers questions freely 

4 = Difficult to follow child's thinking 



ASSERTIVENESS 

= Extremely assertive, willful personality 

1 = Quite forceful, unnecessarily rough and careless in 

handling materials 

2 = Self-assertive but accepting of the situation and capable 

of control 

3 = Passive acceptance; permits self to be somewhat controlled 

by exarrjiner and situation 

4 = Extreme passivity; malleability and acquiescence to 

everything 



HOSTILITY 

= Very hostile, obstructive 

1 = Unusual amount of hostility present 

2 = No unusual amount of hostility evidenced 

3 = Very agreeable child who rarely shows hostility even where 

it migtit be 
4= Ingratiating child ^^^ 



414 



WECHSLER INTELLIGENCE SCALE FOR CHILDREN 



(060-WISC) 



The Wechsler Scales (WISC and WISC-R) are widely used standardized measures 
of intelligence, or, in Wechsler's words, "for assessing an individual's potential 
for purposive and useful behavior". The 19^9 WISC was a logical outgrowth of the 
original Wechs ler-Bel levue Scales. An extensive revision of the WISC - designated 
as the WISC-R - was published in 197^ ^nd it is this version which is recommended 
for use. The WISC-R - like its predecessor - consists of 12 subtests - 10 of which 
are considered mandatory. Wechsler strongly urges the inclusion of Digit Span and 
Mazes in clinical situations because of the diagnostic information they add. 

REFERENCES 1. Wechsler, D., Manual for the Wechsler Intelligence Scale 
for Children, Psychological Corporation, New York, 19^9- 

2. Wechsler, D., Wechsler Intelligence Scale for Children - 
Revised, Psychological Corporation, New York, 197^- 

3. Wechsler, D., Wechsler Preschool and Primary Scale of 

Intelligence, Psychological Corporation, New York, 1 967 . 

Manuals and materials for the WISC, WISC-R and WPPS I may be 
obtained from the publisher 

APPLICABILITY WISC - 5 to 15 years. WISC-R - 6 to 16 years 

UTILIZATION At the discretion of the investigator. May be used at the 
initial assessment only or as a change measure. 

CARD FORMAT - ITEMS 

CARD 01 = (19x, II 12, 313) 

I tern Column Item Column 



Information 


20 ■ 


- 21 


Comprehension 


22 ■ 


- 23 


Arithmetic 


Ik ■ 


- 25 


S imi lar i t ies 


26 ■ 


■ 27 


Vocabulary 


28 ■ 


■ 29 


Digit Span 


30 • 


- 31 


Picture Completion 


32 • 


- 33 



Picture Arrangement 3^ - 35 

Block Design 36 - 37 

Object Assembly 38 - 39 

Coding or Mazes hO - 41 

Verbal IQ kl - kk 

Performance IQ ^5 - ^7 

Full la 48 - 50 



SPECIAL INSTRUCTIONS 

1. The Instructions given in the WISC or WISC-R Manuals on the scoring of items 
should be followed by the test administrator. Be sure to encode SCALED SCORES, 
not raw scores. When using an abbreviated WISC encode each of the subtests 
used'and the pro-rated IQ's in thei r appropriate data fields. When the WISC-R 
is employed the investigator should note the part by adding the letter R to 
60-WISC on page 4 of the Data Sh ipment (07I -DS) ; i.e., 60-WISC-R. 



415 



Abbreviated Versions - Many investigators employ "sinort" versions of the 
Wechsler scales; i.e., a selected number of subtests rather than the full 
set. These versions may be encoded according to the procedures for non- 
standard scales or may be encoded directly in the matrix for the full WISC 
as f ol lows : 

i) Each subtest and/or prorated IQ. must be encoded in its 
standard location. 

2) The investigator MUST make note of the fact on the Data 
Shipment form and give the composition of his abbreviated 
vers ion. 

Example: The abbreviated WISC consists of Information, Comprehension, 
Vocabulary and a prorated Verbal |Q. Encode as follows: 



Row 




:: .2:: 
i: ::2:: 


iiii 
i.3r: 


tNFORMAfmN 

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:*: 

:*: 


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:*: 


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:*: 


3 ©:: ---- 
4:«=: ---- 


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'^'COMPREHENSmN 

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I*: 


^*3 
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s-^- ---- 


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VOCABULA'^" 

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I*: 



NOTE - WECHSLER PRESCHOOL AND PRIMARY SCALE OF INTELLIGENCE - This scale may 
also be employed for the appropriate age group {k - 6-^ years) and may be en- 
coded in the same data field as the WISC or WISC-R. The investigator should 
note the fact that the WPSS I was used by crossing out "60-WISC" on page k of 



416 



the Data Shipment (071-DS)ancl inserting "WPPSI". The format for encoding 
scaled scores is; 



I tern 



Col umn 



I tem 



Col umn 



1 nformat ion 


20 


- 21 


Comprehens ion 


22 


- 23 


Ar i thmet ic 


2k 


- 25 


S imi lar it ies 


26 


- 27 


Vocabulary 


28 


- 29 


Sentences 


30 


- 31 


Picture Completion 


32 


- 33 



Animal House 


3k 


- 35 


Block Design 


36 


- 37 


Geometric Design 


38 


- 39 


Mazes 


40 


- 41 


Verbal IQ. 


42 


- 44 


Performance IQ 


45 


- 47 


Full Id 


48 


- 50 



DOCUMENTATION 



a. Scaled score printout 

b. Means and standard deviations 

c. Variance analyses - when appropriate 



WIDE RANGE ACHIEVEMENT TEST (062-WRAT) 

The Wide Range Achievement Test (WRAT) is a relatively brief test which 
assesses the level of skill in 3 areas - Reading, Spelling and Arithmetic. Its 
content is concerned primarily with the mastery of the mechanics of the basic 
subjects rather than their comprehension. As its name implies, it is applicable 
from kindergarten to college. 



REFERENCES 



APPLICABILITY 
UTILIZATION 



1. Jastak, J. F., and Jastak, S. R., WRAT Manual, 
Guidance Associates , Wilmington, Delaware, 1965. 
Materials may be purchased from Psychological 
Corporation, 304 E. 45th Street, New York, New 
York. 10017 

2. National Health Survey, School Achievement of 
Children 6-11 years as Measured by the Reading 
and Arithmetic Subtests of the Wide Range Achieve- 
ment Test, PHS Publication No. 1000 - Series 11 - 

No. 103, U. S. Government Printing Office, Washington, 
D. C. June, 1970. 

5 years old to adulthood 

Once at pretreatment ; at least one posttreatment assess- 
ment. Additional ratings are at the discretion of the 
investigator. 



CARD FORMAT - ITEMS CARD 01 = (19x, 313) 
Item Column 



Reading 
Spel 1 ing 
Arithmetic 



20 - 22 
23 - 25 
26 - 28 



417 



SPECIAL INSTRUCTIONS 

1. Test administrators should follow the instructions given in the WRAT Manual, 

2. Standard scores for the Reading and Arithmetic subtests should be obtained 
from Tables 31 and 32 rather than from Jastak's manual. These tables have 
been reproduced from the National Health Survey. (Reference 2 above) and 
are based on a much larger probability sample of 7100 children aged 6 to 1 1 
y^ars. Unfortunately, the Spelling subtest was not employed in the Nations' 
Health Survey so the standard scores given in the jastak manual should be 
used for this subtest. 



USE OF WRAT FOR ADULTS - Investigators wishing to use the WRAT with adult popula- 
tions must encode the scale as a non-standard instrument. (See instructions 
(p. 59 ) ■ A 9 X 10 matrix (9 rows and 10 columns) is required and should be en- 
coded as foil ows : 



Read i ng 



Spel 1 i ng 



A r i thmet ic 



-C 



©:: :: 


:: r2:: 


.a 


zAz- 


:i&: 


:*: 


:-7-: 


"8:: 


::9:r 


«:: :: 


:: .:2r-. 


:*: 


Z-A-.Z 


::5:: 


:*:: 


::7:: 


I*: 


:;»: 


O:: :: 


;: :2:: 


:i: 


:d4:: 


:i5:: 


zdBzz 


"7:: 


::&: 


:A: 


©:: -.: 


:: :2:: 


-a.-. 


:4i: 


::&: 


::&: 


::7:: 


::&: 


::ai 


S-.: .: 


:: :2:: 


:3:: 


lA: 


::&: 


::&: 


::7:: 


::&: 


:i9?-- 


1&.Z := 


:: i2- 


:3:: 


:3*:r 


;5:: 


"&: 


:r7:: 


"ft: 


::a: 


Sr: :: 


:: :2:: 


:i: 


1-4:: 


:i5:: 


::&: 


::7r: 


::a: 


::&: 


-:&-. :: 


:: ::2:: 


:3:: 


;:4- 


::5:: 


-a: 


::7:: 


:ift: 


zia. 


:«:: :: 


(:: --:Zz. 


:i: 


:d4:: 


::&: 


::&: 


::7- 


::a= 


-a: 



The standard scores given in the Jastak manual (Reference 1 above) should be encoded, 
Be sure to describe the matrix location and the Sheet Number in Item 11 -of the Data 
Shipment (071-DS). 

DOCUMENTATION 

a. Standard score printout 

b. Means and standard deviations 

c. Variance analyses 



PORTEUS MAZES 



(061-MAZE) 



Introduced about 60 years ago, the Porteus Maze Test is a nonverbal test which 
has been used in a wide diversity of settings and has been shown to be sensitive to 
drug effects in both children and adults. There are 3 series of mazes - the Original 
series of 12, an Extension series of 8 and a Supplement series of 8. The latter two 
series have been developed to reduce practice effects when retesting subjects and the 
author considers them to be equivalent tests. 



k]8 



TABLE 31 



Table for converting raw Bcores on the Reading subtest of the Wide Range Achievement Test to standard 
scores, for children, 6-11 years, by 6-month-age Intervals: United States, 1963-65 



Age In months 



72-77 78-83 84-89 90-95 96-101 102-107 108-113 lU-119 120-125 126-131 132-137 138-143 



Standard score 



069 


063 


056 


049 


* 


071 


064 


057 


050 


* 


072 


065 


058 


051 


* 


074 


067 


059 


052 


* 


075 


068 


060 


053 


* 


077 


069 


062 


055 


051 


078 


070 


063 


055 


052 


079 


072 


064 


057 


053 


081 


073 


055 


058 


054 


082 


074 


066 


059 


055 


084 


075 


067 


050 


057 


085 


077 


069 


061 


058 


087 


078 


070 


063 


059 


088 


079 


071 


064 


060 


089 


080 


072 


065 


061 


091 


082 


073 


066 


062 


092 


083 


074 


067 


053 


094 


084 


076 


068 


064 


095 


085 


077 


069 


065 


097 


086 


078 


071 


066 


098 


088 


079 


072 


067 


100 


089 


080 


073 


068 


101 


090 


081 


074 


069 


102 


091 


083 


075 


070 


104 


093 


084 


076 


072 


105 


094 


085 


077 


073 


107 


095 


086 


079 


074 


108 


096 


087 


080 


075 


110 


098 


088 


081 


076 


111 


099 


089 


082 


077 


112 


100 


091 


083 


078 


114 


101 


092 


084 


079 


115 


103 


093 


085 


080 


117 


104 


094 


087 


081 


118 


105 


095 


088 


082 


120 


106 


096 


089 


083 


121 


107 


098 


090 


084 


123 


109 


099 


091 


085 


124 


110 


100 


092 


086 


125 


111 


101 


093 


088 


127 


112 


102 


095 


089 


128 


114 


103 


096 


090 


130 


115 


105 


097 


091 


131, 


116 


105 


098 


092 


133 


117 


107 


099 


093 


134 


119 


108 


100 


094 


136 


120 


109 


101 


095 


137 


121 


110 


103 


096 


138 


122 


112 


104 


097 


140 


124 


113 


105 


098 


141 


125 


114 


106 


099 



042 
043 
044 
045 
047 
048 
049 
050 
051 
053 
054 
055 
056 
057 
058 
060 
061 
062 
063 
064 
066 
067 
058 
069 
070 
072 
073 
074 
075 
076 
077 
079 
080 
081 
082 
083 
085 
086 
087 
088 
089 
091 
092 
093 
094 
095 



042 
043 
044 
045 
046 
048 
049 
050 
051 
052 
053 
054 
055 
055 
058 
059 
060 
061 
062 
063 
064 
065 
066 
067 
069 
070 
071 
072 
073 
074 
075 
076 
077 
079 
080 
081 
082 
083 
084 
085 
086 
087 
088 
090 
091 
092 



043 
044 
045 
046 
047 
048 
049 
050 
051 
052 
053 
054 
055 
055 
057 
058 
060 
061 
052 
063 
064 
065 
055 
067 
068 
069 
070 
071 
072 
073 
074 
075 
075 
077 
078 
079 
080 
081 
083 
084 
085 
086 
087 
088 
089 
090 



038 
040 
041 
042 
043 
044 
045 
046 
047 
048 
049 
050 
051 
052 
053 
054 
055 
056 
057 
058 
059 
061 
062 
063 
054 
065 
066 
067 
068 
069 
070 
071 
072 
073 
074 
075 
076 
077 
078 
079 
081 
082 
083 
084 
085 
086 



039 
040 
041 
042 
043 
044 
045 
046 
047 
048 
049 
050 
051 
052 
053 
054 
055 
056 
057 
058 
059 
050 
061 
062 
053 
064 
065 
065 
067 
068 
069 
070 
071 
072 
073 
074 
075 
076 
077 
078 
080 
081 
082 
083 
084 
085 



037 
038 
039 
040 
041 
042 
043 
045 
046 
047 
048 
049 
050 
051 
052 
053 
054 
055 
056 
057 
058 
059 
060 
061 
062 
063 
064 
055 
067 
058 
059 
070 
071 
072 
073 
074 
075 
076 
077 
078 
079 
080 
081 



033 
034 
035 
036 
037 
038 
039 
040 
041 
043 
044 
045 
046 
047 
048 
049 
050 
051 
052 
053 
054 
055 
056 
058 
059 
050 
051 
062 
063 
064 
065 
066 
067 
068 
069 
070 
071 
073 
074 
075 
076 
077 
078 



419 



TABLE 31 (Continued) 



Table for converting raw scores on th^ Reading subtest of the Wide Range Achievement Test to standard 
scores, for children, 6-11 years, by b-month-age intervals: United States, 1953-65— Con. 



Age In months 



72-77 78-83 8^-89 90-95 96-101 102-107 108-113 1U-H9 120-125 126-131 132-137 138-143 



Standard score 



051 
052 
053 
054 
055 
056 
057 
058 
059 
060 
061 
062 
063 
064 
065 
066 
067 
068 
069- 
070- 
071 
072 
073- 
074- 
075- 
076- 
077- 
078- 
079- 
080- 
081- 
082- 
083- 
084- 
085- 
086- 
087- 
088- 
089- 
090- 
091- 
092- 
093- 
094- 
095- 
096- 
097- 
098- 
099- 
100- 



143 


126 


115 


107 


101 


096 


093 


091 


087 


086 


082 


144 


127 


116 


108 


102 


098 


094 


092 


088 


087 


083 


146 


128 


117 


109 


103 


099 


095 


093 


089 


088 


084 


147 


130 


119 


HI 


104 


100 


096 


094 


090 


089 


085 


148 


131 


120 


112 


105 


101 


097 


095 


091 


090 


086 


150 


132 


121 


113 


106 


102 


098 


096 


092 


091 


088 


151 


133 


122 


114 


107 


104 


099 


097 


093 


092 


089 


153 


135 


123 


115 


108 


105 


101 


098 


094 


093 


090 


154 


136 


124 


116 


109 


106 


102 


099 


095 


094 


091 


156 


137 


126 


117 


110 


107 


103 


100 


096 


095 


092 


157 


138 


127 


119 


111 


108 


104 


101 


097 


096 


093 


159 


140 


128 


120 


112 


110 


105 


102 


098 


097 


094 


160 


141 


129 


121 


113 


111 


106 


103 


099 


098 


095 


161 


142 


130 


122 


114 


112 


107 


104 


100 


099 


096 


163 


143 


131 


123 


116 


113 


108 


106 


102 


100 


097 


164 


145 


133 


124 


117 


114 


109 


107 


103 


101 


098 


166 


146 


134 


125 


118 


115 


111 


108 


104 


102 


099 


167 


147 


135 


127 


119 


117 


112 


109 


105 


103 


100 


169 


148 


136 


128 


120 


118 


113 


110 


106 


104 


101 


170 


149 


137 


129 


121 


119 


114 


111 


107 


105 


102 


* 


* 


138 


130 


122 


120 


115 


112 


108 


106 


103 


* 


* 


139 


131 


123 


121 


116 


113 


109 


107 


104 


* 


* 


141 


132 


124 


123 


117 


114 


110 


108 


105 


* 


* 


142 


133 


125 


124 


118 


115 


111 


109 


106 


* 


* 


143 


135 


126 


125 


119 


116 


112 


110 


107 


* 


* 


144 


136 


127 


126 


120 


117 


113 


111 


109 


* 


* 


145 


137 


128 


127 


122 


118 


114 


112 


110 


* 


* 


146 


138 


129 


128 


123 


119 


115 


113 


111 


* 


* 


148 


139 


131 


130 


124 


120 


116 


114 


112 


* 


* 


149 


140 


132 


131 


125 


121 


117 


115 


113 


* 


* 


150 


141 


133 


132 


126 


122 


118 


116 


114 


* 


* 


151 


143 


134 


133 


127 


123 


119 


117 


115 


* 


* 


152 


144 


135 


134 


128 


124 


120 


118 


116 


* 


* 


153 


145 


136 


136 


129 


125 


121 


119 


117 


* 


* 


155 


146 


137 


137 


130 


126 


123 


120 


118 


* 


* 


* 


* 


138 


138 


132 


127 


124 


121 


119 


* 


* 


* 


* 


139 


139 


133 


129 


125 


122 


120 


* 


* 


* 


* 


140 


140 


134 


130 


126 


123 


121 


* 


* 


* 


* 


141 


142 


135 


131 


127 


125 


122 


* 


* 


* 


* 


142 


143 


136 


132 


128 


126 


123 


* 


* 


■* 


* 


143 


144 


137 


133 


129 


127 


124 


* 


* 


* 


* 


144 


145 


138 


134 


130 


128 


125 


* 


* 


* 


* 


146 


146 


139 


135 


131 


129 


126 


* 


* 


* 


* 


147 


147 


140 


136 


132 


130 


127 


* 


* 


* 


* 


148 


149 


141 


137 


133 


131 


128 


* 


* 


* 


* 


* 


* 


143 


138 


134 


132 


129 


* 


* 


* 


* 


* 


* 


144 


139 


135 


133 


131 


* 


* 


* 


* 


* 


* 


145 


140 


136 


134 


132 


* 


* 


* 


* 


* 


* 


146 


141 


137 


135 


133 


* 


* 


* 


4r 


* 


* 


147 


142 


138 


136 


134 



420 



TABLE 32 



Table for converting raw scores on the Arithmetic eubteat of the Wide Range Achievement Test to standard 
scores, for children, 6-11 years, by 6-monCh-age Intervals: United States, 1963-65 



Age in months 



78-83 I 84-89 
\ 



102-107 108-113 114-119 



120-125 126-131 132-137 138-143 



Standard score 



050 
053 
056 
Q60 


041 
045 
048 
051 


* 

* 
* 
* 


* 
* 


* 

* 


063 
066 
070 
073 


054 
057 
060 
064 


* 
050 
053 
056 


* 

032 
036 
040 


* 

* 
* 


076 
079 
083 
086 


067 
070 
073 
076 


059 
063 
066 
069 


043 
047 
051 
054 


039 
043 
046 
050 


089 
093 
096 
099 


080 
083 
086 
089 


072 
075 
078 
082 


058 
062 
065 
069 


053 
057 
061 
064 


102 
106 
109 
112 


092 
095 
099 
102 


085 
088 
091 
094 


073 
076 
080 

084 


068 
071 
075 
078 


116 
119 
122 
125 


105 
108 
111 
115 


098 
101 
104 
107 


088 
091 
095 
099 


082 
085 
089 
092 


129 
132 
135 
139 


118 
121 
124 
127 


110 
114 
117 
120 


102 
106 
110 
113 


096 
100 
103 
107 


142 
145 
148 
152 


130 
134 
137 
140 


123 
126 
130 
133 


117 
121 
124 
128 


110 
114 
117 
121 


155 
158 
162 
165 


143 
146 
149 
153 


136 
139 
142 
146 


132 
135 
139 
143 


124 
128 
131 
135 


168 
171 
175 
178 


156 
159 
162 
165 


149 
152 
155 
158 


146 
150 
154 
157 


138 
142 
146 
149 


181 

* 
* 
* 


169 

* 

* 


162 
165 
168 

* 


161 
165 
169 

* 


153 
156 
160 
163 


* 

* 
* 


* 
* 


* 
* 


* 
* 
* 


167 

170 

* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


•k 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


•k 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 


* 



028 
032 
035 
039 

043 
047 
051 
054 

058 
062 
066 
069 

073 
077 
081 
085 

088 
092 
096 
100 

104 
107 
111 
115 

119 
123 
126 
130 

134 
138 
141 
145 

149 
153 
157 
160 

164 
168 



035 
038 

042 
045 
049 
052 

055 
059 
062 
066 

069 
073 
076 
080 

083 
087 
090 
094 

097 
101 
104 
108 

111 
115 
118 
122 

125 
128 
132 
135 

139 
142 
146 
149 

153 
156 
160 
163 

167 
170 
174 



035 
038 

041 
044 
048 
051 

054 
057 
061 
064 

067 
070 
074 
077 

080 
083 
087 
090 

093 
097 
100 
103 

106 
110 
113 
116 

119 
123 
126 
129 

132 
136 
139 
142 

145 
149 
152 
155 

158 
162 
165 



036 
039 

042 
045 
048 
051 

054 
057 
060 
063 

066 
068 
071 
074 

077 
080 
083 
086 

089 
092 
095 
098 

101 
104 
106 
109 

112 
115 
118 
121 

124 
127 
130 
133 

136 
139 

141 
144 

147 
150 
153 
156 

159 
162 
165 
168 

171 
174 
176 
179 



038 
041 

043 
046 
048 
051 

054 
056 
059 
061 

064 
066 
069 
072 

074 
077 
079 
082 

085 
087 
090 
092 

095 
097 
100 
103 

105 
108 
110 
113 

116 
118 
121 
123 

126 
128 
131 
134 

136 
139 
141 

144 

147 
149 
152 
154 

157 
159 
162 
165 



041 
043 

045 
047 
050 
052 

054 
057 
059 
061 

063 
066 
068 
070 

072 
075 
077 
079 

081 
084 
086 
088 

091 
093 
095 
097 

100 
102 
104 
106 

109 
111 
113 
115 

118 
120 
122 
125 

127 
129 
131 
134 

136 
138 
140 
143 

145 
147 
150 
152 

154 
156 
159 
161 



040 
042 

044 
046 
048 
051 

053 
055 
057 
059 

061 
063 
065 
067 

069 
072 
074 
076 

078 
080 
082 
084 

086 
088 
090 
092 

095 
097 
099 
101 

103 
105 
107 
109 

111 
113 
116 
118 

120 
122 
124 
126 

128 
130 
132 
134 

136 
139 
141 
143 

145 
147 
149 
151 



^21 



REFERENCE Porteus, S. D., Porteus Maze Tests: Fifty Years 

Application, Pacific Books, Palo Alto, California, 
1965. Materials for the Porteus Maze Tests may be 
purchased from the Psychological Corporation, 
30^ E. ^Sth Street, New York, New York, IOOI7. 

APPLICABILITY Children - 3 to l4 years through Adult 

UTILIZATION Once at pretreatment ; at least one posttreatment 

assessment. Additional ratings are at the discre- 
tion of the investigator. 

CARD FORMAT CARD 01 = (19x, 213) 

I tem Col umn 

Maze Quotient 20 - 22 

Qualitative Score 23 - 25 

SPECIAL INSTRUCTIONS 

Instructions for the test are given in Porteus Maze Tests (see Reference) and 
should be followed by the test administrator. 

DOCUMENTATION 

a. Raw score printout 

b. Means and standard deviations 

c. Variance analyses 

GOODENOUGH-HARRIS FIGURE DRAWING TEST (O63-GOOD) 

The Goodenough-Harr is Figure Drawing Test (GOOD) - often referred to as the 
"Draw a Man" test - is a brief, convenient, non-language measure of intellectual 
or conceptual maturity. The original I926 scoring and norms have been revised and 
extended by Harris. 

REFERENCES 1. Harris, D. B., Children's Drawings as Measures 

of Intellectual Maturity. Harcourt, Brace and 
World, New .York, I963. 

2. National Health Survey, Intellectual Maturity of 
Children as Measured by the Goodenough-Harr is 
Drawing Test, PHS Publication No. lOOO-Series 11- 
No. 105, U. S. Government Printing Office, Wash- 
ington, D. C, December, 1970. 

APPLICABILITY Optimum usage - 6 - 11 years 



422 



UTILIZATION Once at pretreatment ; at least one post-treatment 

rating; additional ratings are at the discretion 
of the investigator. 

CARD FORMAT CARD 01 = ( 1 9x , 13, 12) 

I tern Col umn 

Standard Score 20 - 22 

Qual ity Score 23 - 2k 

SPECIAL INSTRUCTIONS 

1. Instructions for the administration and scoring of the test are contained in 
Harris' book; (See Reference No. 1) and should be followed by the test examiner 
with the exception that only the score for the first figure drawn by the child 
should be encoded. 

2. Standard scores as given in Tables 33 to 36 should be encoded in Rows 7-9, 
Columns 1 - 10. These standard scores are based on a probability sample of 
approximately 7^00 non- i nst i tut iona ] ized children aged 6 through 11 years. 
(See Reference No. 2). Be sure to use the appropriate table when converting 
raw scores into standard scores; e.g., use Table 28 when a man figure is drawn 
first by a boy. 

DOCUMENTATION 

a. Standard score printout 

b. Means and standard deviations of standard scores and quality scores 

c. Variance analyses 

BENDER GESTALT TEST - Koppitz Scoring (064-BENDK) 

The Bender Gestalt Test is a non-verbal perceptual test and was originally 
introduced in 1938. A developmental scoring system was published by Koppitz in 
1963 to provide a means to measure perceptual maturity, possible neurological 
impairment and emotional adjustment in children. The scoring system was standard- 
ized on more than 1200 public school children. 

REFERENCE Koppitz, E. M., The Bender Gestalt Test for 

Young Children, Grune and Stratton, New York, 
1964. 

APPLICABILITY 5 to 11 years 

UTILIZATION Once at pretreatment, at least one posttreatment 

rating. Additional ratings are at the discretion 
of the investigator. 



423 



TABLE 33 

Goodenough-Ha rr is 
Figure Drawing Test 
Standard Scores for 
Man Figure Drawn by Boy 
(National Health Survey) 



00 
01 ■ 
02 
03- 

Cl- 
os- 
07- 
08- 
09- 



Age (years) 

8 



Standard score 



23 

2h- 

25 

26- 

27- 

28- 

29- 

30- 

31 - 

32- 

33- 

35- 
36- 
37- 
38- 
39- 

l40- 

Ul- 
U2- 
1*3- 



US- 
kl- 
hi,- 

SC- 
SI- 
52- 
53- 
bh- 
55- 
56- 
57- 
56- 
59- 
60- 
61 - 
62- 
63- 
61,- 
65- 
66- 
67- 
68- 
69- 
70- 
71- 

7i- 
73 



bh 


52 


57 


51* 


59 


57 


62 


59 


bk 


61 


67 


61* 


69 


66 


72 


68 


Ih 


71 


76 


73 


79 


76 


81 


78 


81* 


80 


86 


83 


89 


85 


91 


88 


3h 


90 


96 


92 


99 


95 


01 


97 


01* 


99 


o6 


102 


09 


101* 


11 


107 


13 


109 


16 


111 


19 


111* 


21 


116 


21* 


118 


26 


121 


29 


123 


31 


126 


31* 


128 


36 


130 


39 


133 


1*1 


135 


Uh 


138 


1*6 


11*0 


1*9 


11*2 


51 


|l4S 


51* 


I '47 


56 


11*9 


58 


152 


61 


151* 


63 


157 


66 


159 


68 


161 


71 


161* 


73 


166 


76 


168 


78 


171 


■k 


173 


-■.- 


176 


V.- 


178 


;■.- 


180 


■!; 


183 



1*8 
50 
53 
55 
57 
59 
61 
61* 
66 
68 
70 
72 
75 
77 
79 
81 
83 
85 
88 
90 
92 
91* 
96 
99 
101 
103 
105 
107 

no 

112 
111* 
116 
118 
120 
123 
12s 
127 
129 
131 
1 3'* 
136 
138 
1 1*0 
11*2 

1145 

\hl 
11*9 
151 
153 
156 
158 
160 
162 
161* 
166 
169 
171 
173 
175 
177 
180 



1.6 

1*8 

50 

52 

51* 

56 

58 

60 

62 

61* 

66 

68 

70 

72 

71* 

76 

78 

81 

83 

85 

87 

89 

91 

93 

95 

97 

99 

101 

103 

105 

107 

109 

111 

113 

115 

117 

119 

121 

123 

125 

127 

129 

131 

133 

135 

137 

139 

11*1 

|i*3 

11*5 

11*7 

11*9 

151 

153 

155 

157 

159 

161 

163 

165 

167 

169 

171 

173 

175 

177 



1*6 

1*7 

1*9 

51 

53 

55 

57 

58 

60 

62 

61* 

66 

68 

70 

71 

73 

75 

77 

79 

81 

82 

81* 

86 

88 

90 

92 

93 

95 

97 

99 

10) 

103 

105 

106 

108 

110 

112 

III* 

116 

117 

119 

I2t 

123 

125 

127 

128 

130 

132 

13'* 

136 

138 

11*0 

|i*i 
11.3 
11*5 
1 1*7 
1 1*9 
151 
152 
151* 
156 
158 
160 
162 
163 
165 
167 
169 
171 
173 
175 



klk 



1*6 
i*« 
50 
51 
53 
55 
56 
58 
60 
62 
63 
65 
67 
69 
70 
72 
71* 
76 
77 
79 
81 
83 
81* 
86 
68 
89 
91 
93 
95 
96 
98 
100 
t02 
103 
105 
107 
109 

no 
112 
ni« 

116 

117 
119 
121 
122 

121* 

126 

128 

129 
131 
133 
135 

136 
138 
|l*0 
|1*2 
11*3 
11*5 
11*7 
11*9 
150 
152 
151* 
155 
4 57 
159 
161 
162 
161* 
166 
168 
169 
171 
173 



TABLE Ik 

Goodenough-Harr i s 
Figure Drawing Test 
Standard Scores for 
Woman Figure Drawn by Boy 
(National Health Survey) 



Ik- 



ko- 



kz- 
ki- 
Uh- 
Ub- 

ue- 
ki- 
k%- 
u^- 

50- 
51 - 
52- 
53- 
514- 
55- 
56- 
57- 
58- 
59- 
60- 
61- 
62- 
63- 
64- 
65- 
66- 
67- 



Ase (yedfs) 



Standard score 



51 
53 
56 
58 
61 
63 
66 
68 
71 
73 
76 
79 
81 
8A 
86 



h7 
^3 
51 
53 
55 
58 
60 
62 
6U 
66 
69 
71 
73 
75 
77 
79 
82 
8h 



k(> 
kS 
50 
52 
Sk 
56 
58 
60 
62 
(A 
66 
68 
70 
72 
7k 
76 



kl 
k8 
50 
52 
Sk 
56 
58 
60 
62 
63 
65 
67 
69 
71 
73 
75 
77 
78 



US 
kB 
50 
5) 
53 
55 
57 
59 
61 
62 
Sk 
66 



91 


86 


82 


80 


79 


94 


88 


84 


82 


81 


96 


90 


86 


84 


82 


99 


93 


88 


86 


84 


101 


95 


90 


88 


86 


104 


97 


92 


90 


88 


107 


99 


94 


9Z 


90 


109 


101 


96 


93 


92 


112 


104 


98 


95 


93 


114 


106 


100 


97 


95 


117 


108 


102 


99 


97 


119 


110 


104 


101 


99 


122 


112 


106 


103 


101 


124 


114 


108 


105 


103 


127 


117 


110 


106 


104 


129 


119 


112 


103 


106 


132 


121 


114 


no 


108 


135 


123 


116 


112 


110 


137 


125 


118 


114 


112 


140 


128 


120 


116 


114 


142 


130 


122 


118 


115 


145 


132 


124 


120 


117 


147 


13^4 


126 


121 


119 


150 


136 


128 


123 


121 


152 


139 


130 


125 


123 


155 


141 


132 


127 


125 


157 


143 


13'^ 


129 


126 


160 


145 


136 


131 


128 


162 


147 


138 


133 


130 


165 


149 


140 


135 


132 


168 


152 


142 


136 


n** 


170 


154 


144 


138 


136 


173 


156 


146 


140 


137 


175 


158 


148 


142 


139 


178 


160 


150 


144 


141 


ISO 


163 


152 


146 


143 


183 


165 


154 


148 


145 


185 


167 


156 


150 


147 


■,v 


169 


158 


151 


148 




1/1 


160 


153 


150 




174 


162 


155 


152 




pe 


164 


157 


154 


-.V 


178 


165 


159 


156 






167 


161 


157 






169 


163 


159 




■:; 


171 


165 


161 




-.'; 


173 


166 


163 


* 


V.- 


175 


168 


165 


iV 


i- 


* 


170 


167 




f 


" 


172 

174 


168 

170 


* 


* 




176 


172 


*. 


* 


K 


178 


174 


■k 




i- 


* 


176 


-■•- 




* 


* 


178 


< 


» 


>* 


. * 


179 



i+25 



TABLE 35 

Goodenough-Harr is 
Figure Drawing Test 
Standard Scores for 
Man Figure Drawn by Girl 
(National Health Survey) 



00 
01 
02 
03 
Ok 
05 
06 
07 
08 
09 
10 
n 

12 
13 
\k 
15 
16 
17 
18 
19 
20 
21 
22 
23 
2'* 
25 
26 

27 ■ 

28 • 

29 ■ 

30 • 

31 • 

32 - 

33 • 

3'4 ■ 

35 ■ 

36 - 

37 - 

38 ■ 

39 - 
Uo - 
k] - 
'*2 - 

i43 - 

W - 
kS - 
k(, ■ 
Uf - 
k8 - 
i.9 - 

50 - 

51 - 

52 - 

53 - 
S^ - 

55 - 

56 - 

57 - 

58 - 
55 - 

60 - 

61 - 

62 - 

63 - 
6k - 
6§ - 

66 - 

67 - 

68 - 
69'- 

70 - 

71 - 
72- 
73 - 



Age (years) 

7 8 9 



40 



Standard score 



61 


61 


56 


6-5 


63 


S6 


65 


65 


60 


67 


66 


61 


69 


68 


63 


72 


70 


65 


7** 


72 


67 


76 


7^^ 


69 


78 


76 


71 


80 


78 


73 


82 


80 


7^* 


8k 


82 


76 


86 


8^4 


78 


88 


86 


80 


90 


88 


82 


92 


90 


81* 


<)k 


92 


86 


96 


93 


87 


98 


95 


89 


100 


97 


91 


103 


99 


93 


105 


101 


<)5 


107 


103 


97 


109 


105 


99 


in 


107 


100 


113 


109 


102 


115 


III 


\0k 


117 


113 


106 


iiq 


115 


108 


121 


117 


no 


123 


119 


III 


125 


120 


113 


127 


122 


115 


129 


12'* 


117 


132 


126 


119 


ni* 


128 


121 


136 


130 


123 


138 


132 


121* 


||40 


\3k 


126 


11*2 


136 


128 


\kh 


138 


130 


]k(> 


\ko 


132 


\kS 


\k2 


131* 


150 


\kk 


136 


152 


\kS 


137 


\Sk 


ik7 


139 


156 


\ks 


11*1 


158 


151 


I'*3 


160 


153 


11*5 


163 


155 


11*7 


165 


157 


11*9 




159 


150 




161 


152 




163 


151. 




165 


156 




167 


158 


-.v 


i- 


160 




i 


162 
163 
165 


* 


* 


167 



53 

55 
56 
58 
60 
62 
63 
65 
67 
69 
70 
72 
ik 
75 
77 
79 
81 

9? 
81* 
86 
88 
8? 
91 
93 
95 
9i5 
98 
100 
102 
103 
105 
107 
109 
no 

112 

111* 

116 
117 
119 
121 
122 
1 21* 
126 
128 
129 
131 
133 
135 
136 
138 
11*0 
1 1*2 
11*3 
11*5 
11*7 
11*9 
150 
152 
151* 
156 
157 
159 
161 
163 
161* 
166 



50 
52 
53 
55 
57 
58 
60 
62 
63 
65 
67 
68 
70 
72 
73 
75 
77 
78 
80 
81 
83 
85 
86 
88 
90 
91 
93 
9ii 
96 
98 
100 
101 
103 
105 
106 
108 
110 
III 
113 
IIS 
116 
118 
119 
121 
123 
121) 
12^ 
128 
129 
lil 
133 
131* 
136 
138 
139 
11*1 
11*3 
\kk 
11*6 
11*8 
1 1*9 
151 
152 
151* 
156 
157 
159 
161 
162 
161* 
166 



426 



51 
53 

SI* 
56 

II 

60 
62 
6i» 
65 
66 
68 
70 
71 
73 
7'» 
76 
77 
79 
80 
8? 
83 
85 
87 
68 
90 
91 
93 
9i» 
96 
97 
99 
100 
102 
loi» 
I OS 

'°g 
108 

no 

111 

Ml 

lib 
116 
li7 

H9 
121 
122 

I2'» 
125 
127 
128 

i3o 
131 
133 
131* 

''t 

138 
139 

lUl 
142 
IM* 
11*5 
11*7 
148 

iso 

151 
153 

156 
158 
159 
161 

162 
164 



TABLE 36 

Goodenough-Harr i s 
Figure Drawing Test 
Standard Scores for 
Woman Figure Drawn by Girl 
(National Health Survey) 



00 
01 
02 
03 
ou 
05 
06 
07 
08 
09 
10 

n 

12 
13 
\u 
IS 

16 
17 
16 
19 
20 
21 
22 
23 
2k 
25 
26 

26 
29 
30 
31 
32 
33 
3'* 
35 
36 
37 
38 
39 
««0 
U] 
«»2 
'♦3 
W» 

^5 
U6 
^7 
U8 
i<9 
50 
51 
52 
53 

su 

55 
56 
57 
58 

53 
60 
6) 
62 
6i 
6k 
65 
66 
67 
68 
69 
70 
71 
72 
73 



^9 


i<6 


51 


1.9 


53 


51 


55 


53 


57 


55 


60 


57 


62 


59 


614 


62 


66 


6U 


69 


66 


71 


68 


73 


70 


75 


72 


78 


7'' 


80 


77 


82 


79 


8U 


81 


87 


83 


89 


85 


91 


87 


93 


90 


96 


92 


98 


9'* 


100 


96 


(02 


98 


105 


100 


107 


102 


109 


105 


III 


107 


ni« 


109 


116 


III 


118 


113 


120 


115 


123 


118 


125 


120 


127 


122 


129 


I2'4 


132 


126 


U** 


128 


136 


130 


138 


133 


\U\ 


135 


l'*3 


137 


^ks 


139 


l'*7 


\k\ 


150 


l'«3 


15? 


1'46 


I5'4 


}k& 


156 


150 


159 


152 


161 


15^. 




156 




158 




161 




163 




165 



Age (years) 
8 '. 
Siandard score 

1*2 

i,U 

ii6 

'<8 

50 

52 

i'* 

56 

58 

60 

63 

65 

67 

69 

71 

73 

75 

77 

79 

81 

63 

§5 

87 

89 

91 

93 

95 

97 

99 
101 
103 
105 
107 
109 
111 
113 
115 
117 
119 
122 
12'* 
126 
128 
130 
132 

^3'* 
136 
138 

I '40 
1^42 

\kk 

]U6 
]h8 
150 
152 

15'4 

156 
158 
160 
162 

16*4 



i+27 



140 


38 


37 


1-1 


39 


39 


"43 


141 


k\ 


^i 


^3 


k2 


k7 


^45 


kk 


U9 


k7 


ke 


51 


k8 


k8 


53 


50 


kS 


55 


52 


51 


57 


514 


53 


59 


56 


55 


61 


58 


56 


63 


59 


58 


6^4 


61 


60 


66 


63 


62 


68 


65 


63 


70 


67 


65 


72 


68 


67 


7^4 


70 


69 


76 


72 


70 


78 


7'4 


72 


80 


76 


7** 


82 


77 


76 


8k 


79 


77 


85 


81 


79 


87 


83 


81 


89 


85 


82 


91 


86 


81* 


93 


88 


86 


95 


90 


88 


97 


92 


89 


99 


9^ 


91 


101 


95 


93 


103 


97 


95 


105 


99 


96 


107 


101 


98 


108 


103 


100 


110 


105 


102 


112 


106 


103 


III* 


108 


105 


116 


110 


107 


118 


112 


109 


120 


IIU 


110 


122 


115 


112 


12^4 


117 


\lk 


126 


119 


116 


128 


121 


117 


130 


123 


119 


131 


12'* 


121 


133 


126 


123 


135 


128 


121* 


137 


130 


126 


139 


132 


128 


\k\ 


133 


130 


I'43 


135 


131 


1145 


137 


133 


1^7 


139 


135 


\kS 


1'4l 


137 


151 


1'43 


138 


153 


11414 


|1*0 


15'4 


I146 


11*2 


156 


11*8 


11*1+ 


158 


150 


11*5 


160 


152 


J^7 


162 


155 


11*9 


16't 


155 


151 




157 


152 


* 


159 


15'* 


-.'.- 


161 


156 


* 


162 


158 




16'* 


159 


i! 


* 


161 


V.- 


* 


163 




■ 4 


165 



CARD FORMAT 




CARD 


Item 


Col 


umn 


Fig. A 


20 


- 21 


Fig. 1 


22 


- 23 


Fig. 2 


24 


- 25 


Fig. 3 


26 


- 27 


Fig. 4 


28 


- 29 



CARD 01 = (19x, 1012) 



I ten 

Fig. 5 
Fig. 6 
Fig. 7 
Fig. 8 
Total Score 



Col umn 

30 - 31 
32 - 33 
3^+ - 35 
36 - 37 
38 - 39 



SPECIAL INSTRUCTIONS 

Follow the instructions given in the Koppitz Manual (See Reference). 

On data decks, a 2-digit coding system has been designed to record the 
types of errors made by the subject. The codes are: 





Response Pos 


t ions 




















Des igns for which 




Code 





1 


3 


5 


7 


code is legal 


Score 


01 











X 


All 


1 


02 








X 




All 


1 


03 








X 


X 


All 


2 


Ok 






X 






A, 1.2, 3, 5, 6, 7 


1 


05 






X 




X 


A, 1,2, 3, 5, 6, 7 


2 


06 






X 


X 




A, 1,2, 3, 5, 6, 7 


2 


07 






X 


X 


X 


A, 1,2, 3, 5. 6, 7 


3 


08 




X 








A, 3, 5, 6, 7 


1 


09 




X 






X 


A, 3, 5, 6, 7 


2 


10 




X 




X 




A, 3, 5, 6, 7 


2 


11 




X 




X 


X 


A. 3, 5, 6, 7 


3 


12 




X 


X 






A, 3, 5. 6. 7 


2 


13 




X 


X 




X 


A, 3, 5, 6, 7 


3 


]k 




X 


X 


X 




A, 3, 5, 6, 7 


3 


15 




X 


X 


X 


X 


A, 3, 5, 6, 7 


4 


16 


X 










All 






Examples: 07 

08 
16 



in Cols. 24-25 = 3 errors on Des. 2: rotation, 
rows added and perseveration' 
in Cols. 32-35 = 1 error on Des. 6: perseveration 
in any column pair = no errors on the particular 
des ign 



DOCUMENTATION 



a. Raw score printout 

b. Means and standard deviations 

c. Variance analyses 



428 



PSYCHOLOGICAL EXAMINATION BEHAVIOR PROFILE 



(066-PEBP) 



The Psychological Examination Behavior Profile (PEBP) is a 15-item scale 
formatted for use with the General Scoring Sheet. The scale is designed to 
assess the behavior of the subject during the administration of psychological 
tests. The PEBP was developed as part of a collaborative study conducted by 
the Perinatal Research Branch, National Institute of Health. 



REFERENCE 



APPLICABILITY 
UTILIZATION 



Manual for the Collaborative Study on Cerebral 
Palsy Mental Retardation and Other Neurological 
and Sensory Disorders of Infancy and Childhood, 
Perinatal Research Branch, National Institute of 
Neurological Diseases and Stroke, National Insti- 
tute of Health, Public Health Service, Department 
of Health, Education and Welfare, Part lll-E, 
April, 1970. 

For children, 5-15 years old. 

To be used in conjunction with each psychological 
examinat ion. 



TIME SPAN RATED 



CARD FORMAT 




Item 


Column 


1 


20 


2 


21 


3 


22 


k 


23 


5 


2k 


6 


25 


7 


26 



The duration of the psychological examination. 
CARD 01 = (19x, 1511 , 12) 

Item Column 



8* 


27 


9 


28 


10 


29 


11 


30 


12 


31 


13 


32 


1^* 


33 


15^v 


3^ 


Total Score 


35 - 36 



* = Items reflected in scoring 

Total Score = Sum of Items 1 through 15 



Total Score Range = - 60 



429 



SPECIAL INSTRUCTIONS 

A. On the PEBP form itself, only cue words are provided for each scale point. 
A more detailed description of each scale point is given below to aid the 
rater in making his judgments. 

1. Separation from Mother - The range is from "shows no concern" to "very upset". 

= Shows no concern; eager to leave mother and go with examiner. 

1 = Shows very little concern; shows little cautiousness and comes 

with examiner without preamble, needs little or no explanations. 

2 = May show some initial reticence, which is felt to be entirely 

appropriate; separates from mother after some minimal reassurances 
and explanations. 

3 = More than usual amount of concern; more disturbed than most, but 

finally is able to separate; may need continuing reassurances. 

4 = Very upset, cries, clings to mother, may have tantrum or withdraw, 

refusing to look at or talk to the examiner; mother's presence 
may be required in the test room. 

2. Tearfulness - The range is from "no apparent awareness of strange situation" 
to "very fearful and apprehensive". 

= No apparent awareness of strange situation; completely unafraid, and 

behavior uninhibited. 

1 = Very little fear evidenced; quickly at ease in the situation. 

2 = Normal amount of caution in the situation but able to cope with it. 

3 = Inhibited and uneasy throughout with some slowing of responses. 

k = Very fearful and apprehensive; acute discomfort interferes significantly 
with test performance. 

3. Rapport with Examiner - The range is from "exceptionally shy" to "extreme 
f r iendl iness". 

= Exceptionally shy; withdrawn; unresponsive or ignores any friendly 

overtures . 

1 = Shy; waits for friendly gestures; very little social interaction or 

social contact on his own initiative. 

2 = Perhaps some initial shyness; feels at ease; relates in a friendly 

manner. 

3 = Very friendly; and at ease. 

k = Extreme friendliness; focuses on social interaction with little or 
no interest in test materials. 

k. Self-Conf idence - The range is from "lacks self-confidence" to "very self- 
confident". 

= Lacks self-confidence; extremely self-critical; may refuse to attempt 

many tasks because they seem too difficult. 

1 = Distrusts own ability; tends to minimize his performance and often 

points out what is wrong. 

2 = Adequately self-confident; usually sure of himself but recognizes 

difficulty of certain tasks and may be a little hesitant with them. 



430 



3 = More than usual amount of self-confidence; works easily without 
tensions and is usually satisfied with his performance. 

k = Very self-confident; child extremely proud of performance and acts 
as if he can tackle anything. 

5. Emotional Reactivity - The range is from "extremely flat" to "extreme 
instability of emotional responses". 

= Extremely flat; no change in facial expression; responds to all 

activities in same manner. 

1 = Somewhat flat; little change in emotional tone, some slight varia- 

tions at times. 

2 = Normal responsiveness; affect appropriate to situation. 

3 = Mood more variable than average; may be motivated internally or 

exaggerated responsiveness to situation. 
k = Extreme instability of emotional responses; marked emotional lability; 
either overreactive to external situations or to undetermined stimuli. 

6. Degree of Cooperation - The range is from "extreme negativism" to 
"extremely suggestible and conforming". 

= Extreme negativism; continually resistant to directions or demands 

of the situation; examiner's suggestions or directions have little 
obvious effect on child. 

1 = Resistive to demands or directions a good deal of the time; willing 

to comply only when faced with success, or requires considerable 
prompting to elicit response. 

2 = Cooperative with reasonable amount of discomfort and anxiety when 

faced with difficulty or failure, responds well to directions most 
of the time. 

3 = Accepts direetion or demands more easily; eager to conform even when 

faced with failure; rarely attempts to do anything unless examiner 
has explicitly stated it. 
k = Extremely suggestible and conforming; no apparent discomfort when 
faced with failure, completely dependent upon specific directions 
from examiner. 

7. Level of Frustration Tolerance - The range is from "withdraws completely" 
to "extreme acting out behavior and/or crying". 

= Withdraws completely; refuses to continue or attempt any task which 

appears too difficult for him. 

1 = Occasionally withdraws from task where difficulty is encountered or 

appears too difficult for success. 

2 = Attempts to cope with difficult situations; does not become unduly 

upset if task is too difficult. 

3 = Becomes quite upset by difficulty; may react with some disorganized 

behavior; some anger may be displayed against the test materials or 
examiner; may resort to crying. 
M = Extreme acting out behavior and/or crying; considerable anger displayed; 
behavior becomes uncontrolled and continuation of examination may 
become impossible or very difficult. 



431 



8. Degree of Dependence - The range is from "very self-reliant to "constant 
need for attention or help". 

= Very self-reliant; refuses help; extreme overt confidence. 

1 = Rarely needs reassurance; primarily absorbed with test materials; 

little attention demanded. 

2 = Dependent in appropriate situations; enjoys attention but can function 

easily without it; adequately confident. 

3 = Demands more attention than average; needs frequent help, reassurance, 

approval and encouragement. 
k = Constant need for attention or help; cannot function without continual 
approval or support. 

9. Duration of Attention Span - The range is from "attends to tasks very briefly" 
to "highly perseverat ive". 

= Attends to tasks very briefly; highly distractible, fleeting and sporadic 

attention; lack of concentration interferes significantly with test 
performance. 

1 = Spends short time with tasks; easily distractible; frequently needs help 

in maintaining attention; brief attention may interfere somewhat with 
test performance. 

2 = Spends adequate amount of time on tasks; able to concentrate until success- 

ful or until failure is clear. 

3 = Spends more than average time on tasks; eventually is able to turn to new 

activity. 
k = Highly perseverat ive; unable to shift attention; fixated at one task; 
requires examiner's intervention in order to change activity. 

10. Goal Orientation - The range is from "no effort to reach a goal" to "compulsive 
absorption with task". 

= No effort to reach a goal; extremely lacking in persistence or unable to 

keep goal or questions in mind. 

1 = Briefly attempts to achieve goal; easily forgets goal or question, or 

fails to persist; less than average ability to continue to completion. 

2 = Able to keep goal or directions in mind; able to persist until completion; 

able to "give up" when appropriate. 

3 = Keeps goal and questions in mind; persists for more than usual amount of 

time; continues effort beyond necessary point. 

4 = Compulsive absorption with task; unwilling or unable to "give up"; resists 

or ignores examiner's attempts to change activity. 

11. Level of Activity - The range is from "extreme inactivity and passivity" to 
"extreme overactivity and restlessness". 

= Extreme inactivity and passivity; placid, sluggish; posture adjustments 

in chair may be slow and infrequent. 

1 = Litt1,e activity; content to sit still most of the time. 

2 = Normal amount of activity; able to sit quietly when interested; may fidget 

and become restless at times. 

3 = Unusual amount of activity and restlessness; very seldom able to sit 

quietly. 
k = Extreme overactivity and restlessness; can't sit still; constantly in 
motion; activities not in response to specific external stimulation. 



432 



12. Nature of Activity - The range is from "extreme rigidity" to "extremely 
impuls i ve". 

= Extreme rigidity; unable to shift activity or approach to task; 

cannot vary or adapt responses; stays with one aspect of task. 

1 = Some rigidity; tends to be inflexible in most situations but does 

shift approach in some instances; at times can change to appropriate 
response to task. 

2 = Flexible behavioral patterns; activity appropriate to different 

s i tuat ions . 

3 = Behavior frequently impulsive; fluid and sometimes uncontrollable. 
h = Extremely impulsive; explosive and uncontrolled behavior. 

13. Nature of Communication - The range is from "little or no verbal communica- 
tion" to "difficult to follow child's thinking". 

= Little or no verbal communication; uses gestures and/or pantomime; 

verbal communication limited to "yes" and "no", or one or two words. 

1 = Verbal or non-verbal responses confined to answering directed 

questions; communication generally elicited rather than initiated by 
child. 

2 = Readily answers questions; may elaborate responses; may initiate 

conversation; content generally appropriate and easily followed. 

3 = Answers questions freely, initially appropriate but tends to lose 

main idea by elaborations or free associations; at times content 
seems inappropriate or illogical. 
k = Difficult to follow child's thinking; content usually irrelevant 
and inappropriate; at times bizarre. 

14. Assert iveness - The range is from "extremely assertive, wilful personality" 
to "extreme passivity". 

= Extremely assertive, wilful personality; approach dominating, aggressive 

and lacking in reserve; attempts to manipulate session, and resists 
externally imposed limitations. 

1 = Quite forceful, unnecessarily rough and careless in handling materials; 

littJe inhibited by examiner's presence from doing exactly what he 
wants; often ignores imposed limits. 

2 = Self-assertive but accepting of the situation and capable of control 

and reserve when demanded; looks for feedback and becomes less assertive; 
more pliant, when this is indicated. 

3 = Passive acceptance; permits self to be somewhat controlled by examiner 

and situation; rarely shows inclination to want to do something different 
from what examiner suggests. 
k = Extreme passivity; malleability, and acquiescence to everything, with no 
trace of resistance; seems extremely overcompl iant . 



433 



15. Hostility - The range is from "very hostile, obstructive" to "ingratiating 
child". 

= Very hostile, obstructive; engages in overt physical or verbal attacks 

on examiner, test materials or testing room objects. May have tantrums. 

1 = Unusual amount of hostility present; very uncooperative and/or becomes 

angry when restrictions are imposed; may introduce frequent aggressive 
themes into verbal productions. May want to engage in irrelevant con- 
versation and games, thus indirectly refusing or hindering progress in 
test ing. 

2 = No unusual amount of hostility evidenced; negative behavior or affect 

is generally appropriate and controlled. 

3 = Very agreeable child who rarely shows hostility, even where it might be 

appropriate; never seems to balk at any imposed limitations or react in 
displeased manner to them. 
k = Ingratiating child. Desire to please examiner seems to be the main 
determinant of behavior, 

B. Interpretation of Scores - The items of the PEBP are bipolar. Scale point 
"2" is a neutral or zero point between the poles and represents "normal" or 
appropriate behavior. I tern scores at the lower end (0.1) tend to reflect 
low levels of arousal or interaction; while higher scores (3.^) indicate 
high arousal and interaction. Similarly, a total score of 30 represents 
"normal" or appropriate behavior. Total scores below 30 indicate lower levels 
of arousal; while total scores above 30 represent higher levels of arousal. 

DOCUMENTATION 

a. Raw score printout 

b. Means and standard deviations 

c. Variance analyses 



k3k 



PERFORMANCE TESTS FOR MEASURING PSYCHOPHARMACOLOG I CAL EFFECTS ON CHILDREN 

Robert L. Sprague 
Children's Research Center 
Uni vers i ty of ll 1 inois 

The following recommendations have used a few basic assumptions about experi- 
mentation in the area of psychopharmacology . One, if the area of research interest 
is psychotropic drugs, then it seems that one of the target areas of measurement 
should be the behavior of the child. Two, in measuring behavior of the child, one 
should measure this behavior as precisely as can be done within the limits of the 
methods available today. This means that the test used should have high reliabili- 
ty, I.e., it should give the same results when repeated if there has been no change 
in the child. The test should also have validity, which means that the tests 
actually are measuring what they purport to measure and furthermore, the test 
should be related in a logical fashion to a theoretical system. Three, since one 
of the primary characteristics of children is development, then the behavioral tests 
should measure what is thought to be important in developmental processes. 

Listed below are major subdivisions of important developmental processes in 
ch i Idren. 

The cognitive area of development is one of the most important for children. 
Children have learning as their main occupation: both formally in school and in- 
formally in the family. It is almost trite to say that what they learn shapes 
their life for the future. For these obvious reasons, tests which measure the 
effects of psychotropic drugs on learning should be included in the battery of tests. 
The development of standardized tests in this area is quite uneven in that there 
has been heavy emphasis on the creation of psychological tests to assess Intellec- 
tual development with relatively little emphasis on tests to measure current learn- 
ing efficiency and current memory ability of the children. Recent theoretical 
developments in the area of attention should hot be ignored because often psycho- 
tropic drugs are administered to improve the attention of the distractable child. 
These theoretical foundations give a foothold for beginning of sound experimentation 
in this area. 

Motor development is another major area which should be investigated. Unfortu- 
nately, there has been relatively little emphasis on the development of standardized 
tests to assess the development of motor ability in children. Consequently, only 
one test which measures one aspect of motor development has been suggested. 

Social development is extremely important for the child, but again, unfortu- 
nately, relatively few standardized tests have been developed to measure the social 
ability of the child. Most of this information must then necessarily be taken from 
rating scales which attempt to assess the social behavior of the child in a variety 
of situations. Dr. Conners has prepared material in this area. 

Finally, the academic achievement of the child or what he learns from formalized 
instruction in the public school is of prime interest. Most problem children who 
receive psychotropic drugs also have problems with academic performance, therefore 
it is felt that academic achievement should be evaluated. 



435 



Recommended Performance Tests 

1 . Intel lectual Tests 

A. Draw-A-Person 

This test is listed first because clinicians often give it to start 
a testing session with the child by using something that is easy 
and understandable. It can give information both about the child's 
intellectual level and his motor ability. 

B. Porteus Mazes 

This test has repeatedly been shown to be sensitive to drug effects. 
It is relatively quick and with some practice easy to administer. 

Optional Tests 

C. Wechsler Intelligence Scale for Children 

Since this IQ test is so commonly given in clinics across the nation, 
it is also listed. It is suggested as an optional test because it 
requires about 1 - 1 1/2 hours to administer, and many research pro- 
jects might not have the necessary personnel nor the time. 

d. Peabody Picture Vocabulary Test 

This is a fairly reliable, very quick intelligence test that can be 
given in cases where an intellectual estimate is needed but not enough 
time is available to administer the WISC. 

2. Learning Tests - Optional 

It is quite difficult to satisfactorily measure learning without using some 
equipment. Equipment is needed to obtain a precise measurement, e.g., latency 
of responding, which is the length of time (usually in tenths of a second) from 
the onset of a stimulus until the child responds. Although the equipment is 
somewhat expensive and requires some technical knowledge to operate, it is felt 
that the precision which comes with the use of this kind of apparatus warrants 
its inclusion. It should be also pointed out that in other areas, such as clini- 
cal chemistry, laboratory apparatus is accepted as absolutely necessary to con- 
duct the investigations. 

Commercial equipment available from three companies has been listed in the 
back of this report. This is only a sample of the equipment available and is not 
intended to be exhaustive, although the companies probably represent the best 
equipment that is available today for the type of behavioral assessment suggested 
herein. Experimenters planning to use these learning measures should be warned 
that some minimum amount of knowledge about this equipment is needed. Most of 
these firms offer extensive manuals in the use of their equipment and some of the 
firms even offer short workshops to teach the unsophisticated how to use their 
equipment. Most psychologists, particularly those with training in experimental 
psychology, can readily utilize such equipment. Thus, any project that has the 
services of a psychologist probably can benefit from this kind of equipment. 



436 



A. Continuous Performance Task 

This task has been used extensively in assessing the effects of 
psychotropic drugs on human behavior. This type of task is 
within the ability of a wide range of children, and it is relative- 
ly easy to program. 

B. Paired Associate Learning 

This is one of the oldest techniques to evaluate learning ability 
in both adults and children. A variety of stimuli and responses 
can be utilized that are appropriate with children. For example, 
pictures from the picture vocabulary subtest of the Stanford Binet 
or fjictures from the Peabody Picture Vocabulary Test can be paired 
with numbers or letters to form an acceptable paired associate task. 

C. Recognition Memory 

Recognition tests are generally enjoyable for the child. They can 
be used to measure the attention of the child and also to investi- 
gate both short-term and long-term memory of the child. Some of the 
most useful data coming from this test is the latency data. 

3. Motor Performance 

The motor test of the Kl«5ve-Matthews modified version of the Halsted Battery 
would provide a useful measure of motor performance. These tests include tapping 
speed, steadiness task, and finger mazes. All of the tests give reliable quanti- 
tative information. The tests can be purchased from Dr. Halgrim Kl«5ve, Neuro- 
psychology Laboratory, Department of Neurology, University of Wisconsin Medical 
Center, 1300 University Avenue, Madison, Wisconsin 53706, 

A. Stab i 1 imetr ic Cushion 

The s tab i 1 imetr ic cushion developed and used by Sprague might be of 
use in situations where the child is seated at a school desk or seated 
at a table while performing psychological or behavioral tasks. It 
measures rather accurately the amount of wiggling, and it has been 
shown to be sensitive to drug effects. Anyone interested in this de- 
vice should contact Robert Sprague, Children's Research Center, Univer- 
sity of Illinois, Champaign, Illinois 61820. 

k. Achievement Tests 

A. Wide Range Achievement Test 

There are a variety of achievement tests on the market, but most of 
them are lengthy and difficult to administer. For these reasons, the 
WRAT has been suggested because it is simple and easy to administer. 

5. Apparatus to Measure Learning Performance 

Listed below are sets of apparatus from three different companies which cuuld 
be utilized to measure the effects of psychotropic drugs on learning performance 
of children. Each of the sets have some advantages and some disadvantages, but it 
is thought that they are representative samples of the kind of equipment that can 



^37 



be purchased commercially to measure learning performance in children. These 
lists have been developed with four types of performance measures in view: 
(1) the continuous performance task, (2) paired-associates learning task, 
(3) recognition and memory task, and [k) match to sample task. 

A. Behavioral Controls, Inc. 
1506 West Pierce Street 
Milwaukee, Wisconsin 532^6 
Telephone: 414-671-1255 

The advantage of equipment manufactured by Behavior Controls is that it is 
small and compact, it is self contained, and it requires relatively little skill 
or equipment to make the stimulus material. 

The disadvantages of this equipment (as 1 isted -below) are that it provides no 
printout of the responses and latency. To obtain a printout, additional equipment 
must be purchased. Further disadvantages are that it permits less precise control 
of the time intervals between the presentation of the stimuli which are of some 
considerable importance if one measures latency of responding accurately, and the 
changing of the stimulus material is somewhat more difficult than the other two sets 
of apparatus in that the machine must be opened up and a length of fan folded mate- 
rial changed. 

Quantity I tern 

SR-400 Stimulus Programmer with press panel cover 
Standard 400 cover 
5M Fan folded program paper 

4 hole indexing punch 
4 choice auxilliary control console 
Dual 4-digit reset response counters 
Timing control module 
Continuous loop attachment 

Continuous performance/delayed response module 
Component mounting and display console 
Function control network 

Set-sample programs and operating instructions for 
each mode of use 

FOB Milwaukee $3,450 

B. Behavior Apparatus Builders 
305 Water Street 
St . Joseph, I 1 1 inois 
Telephone: 217-469-7108 

The advantage of the equipment built by Behavior Apparatus Builders is that 
it automatically provides a printout on a roll- of paper of the number of correct 
responses, the number of the trial, and the latency in tenths of a second; one can 
program as many stimuli as needed; the stimuli can easily be changed by simply plac- 
ing on or removing a Kodak slide tray; and the equipment is automatically programmed 
with a paper tape reader. 



438 



The disadvantages of the equipment are that it consists of three major units 
which are a projection tunnel, a Kodak projector and base, and a relay rack of 
equipment which means that it is somewhat bulky in comparison with the Behavior 
Controls equipment. In order to make the stimuli, some photography is necessary 
because the stimuli are on 35mm slides which are projected by the Kodak projector. 
Some knowledge of programming equipment is essential to use the equipment satis- 
factor i ly . 

Quantity I tern 

1 Projection tunnel 

1 Reinforcement-dispensing system 

1 Shutter-projector control 

1 Paper tape reader 

1 Manual paper tape punch 

2 Dual relays 

3 Pulse formers 

1 Adjustable timer 

2 Power panels 

1 2k VDC power supply 

1 Automatic printer with 6 channels 

of data printout 

TOTAL (S) $3,^63 

The above price does not include the Kodak Carousel projector, a relay rack 
for the programming equipment, and cross patch cords for interconnecting the pro- 
gramming equipment. 

C. Lehigh Valley Electronics, Inc. 
Box 125 

Fogelsville, Pennsylvania 18051 
Telephone: 215-285-^211 

The advantages of the Human Test System built by Lehigh Valley is that there 
are a great number of other types of modules available for the system and a great 
variety of programming equipment including a computer system which could be at- 
tached to the Human Test System. 

The disadvantages of the apparatus as currently listed are considerable in 
that it will only handle one of the four tests listed in the introduction, namely 
the recognition memory task. It would be possible to buy equipment from Lehigh 
Valley which would handle all four tests, but this would require more expense and 
more equipment or a special order. The apparatus as it now stands would require 
extensive knowledge of programming equipment to operate it satisfactorily. 



^39 



Quantity 


part # 


1 


111-10 


1 


520-13 


1 


520-22 


3 


521-41 


1 


521 -7^ 


2 


1357 


6 


1360 


3 


1419 


1 


1660 



I tern 

Projector with slide reader and control 
panel 

Two-rail console for projector 
Connector harness 
Rear screen projection key 
Coin dispenser 
Pulse formers 
Dual relays 
Timers 
Printer 
1384 Timing pulse generator 



TOTAL (S $3,149 



REFERENCES 

1. Bandura, A. Principles of behavior modification. New York: Holt, 1969. 

2. Barnes, K. R. Effects of methyl phen idate and thioridazine on learning, 
reaction time and activity level in hyperactive emotionally disturbed 
children. Unpublished B. S. thesis at University of Illinois, 1968. 

3. Belmont, J. M. & Butterfield, E. C. The relations of short-term memory 
to development and intelligence. In L. P. Lipsitt S- H. W. Reese (Eds.), 
Advances in child development and behavior. Vol. 4. New York: Academic 
Press, 1969. Pp. 29-82. 

4. Brady, J. P. Drugs in behavior therapy. In D. H. Efron, J. 0. Cole, 
J. Levine, & J. R. Wittenborn (Eds.), Psychopharmacology: A review of 
progress 1957-1967, Public Health Service Number I836, I968. Pp. 271-280. 

5. Conners, C. K., Eisenberg, L., & Sharpe, L. Effects of methylphen idate 
(Ritalin) on paired-associate learning and Porteus Maze performance in 
emotionally disturbed children. Journal of Consulting Psychology, 1964, 
28, 14-22. 

6. Conners, C. K. & Rothschild, G. H. Drugs and learning in children. In 
J. Hellmuth (Ed.) Learning Disorders, Vol. 3- Seattle: Special child 
publications, I968. Pp. 193-223- 

7. Cytryn, L., Gilbert, A., & Eisenberg, L. The effectiveness of tranquil iz- 
ing drugs plus supportive psychotherapy in treating behavior disorders of 
children: A double-blind study of eighty outpatients. American Journal 
of Orthopsychiatry, I96O, 30, 113-128. 



440 



8. Edelson, R. I. & Sprague, R. L. Conditioning of activity in a classroom 
for institutionalized retardates. Paper read at Amer ican Assoc iat ion on 
Mental Deficiency, San Francisco, May, 1969. 

9. Eisenberg, L., Conners, C. K., & Sharpe, L. A controlled study of the 
differential application of outpatient psychiatric treatment for children. 
Japanese Journal of Child Psychiatry, 1965, 6, 125-132. 

10. Epstein, L. C, Lasagna, L., Conners, C. K., & Rodriguez, A. Correlation 
of dextroamphetamine excretion and drug response in hyperactive children. 
Journal of Nervous and Mental Disease, 1968, 1^+6, 136-1^6. 

11. Freeman, R. D. Drug effects on learning in children: A selective review 
of the past thirty years. Journal of Special Education, 1966, 1, 17-^3. 

12. Helper, M. M., Wilcott, R. C. & Garfield, S. L. Effects of chlorpromaz ine 
on learning and related processes in emotionally disturbed children. 
Journal of Consulting Psychology, 1963, 27, 1-9. 

13. Knights, R. M. Normative data on tests for evaluating brain damage in 
children from 5 to 14 years of age. Research Bulletin No. 20, September I966, 
University of Western Ontario. 

14. Knights, R, M. & Hinton, G. The effects of methyl phen idate (Ritalin) on the 
motor skills and behavior of children with learning problems. Research 
Bulletin No. 102, University of Western Ontario, I968. 

15. MacKintosh, N. J. Selective attention in animal discrimination learning. 
Psychological Bulletin, 1965, 64, 124-150. 

16. Milichap, J. G. & Boldrey, E. E. Studies in hyperkinetic behavior. II. 
Laboratory and clinical evaluations of drug treatments. Neurology, I967. 
17. 467-471 & 519. 

17- Overton, D. A. Dissociated learning in drug states (State dependent 

learning). In D. H. Efron, J. 0. Cole, J. Levine, £■ J. R. Wittenborn. 
Psychopharmacology : A review of progress 1957-'967. Public Health Service 
Publication No. 1 836 , I968, Pp. 918-930. 

18. Rosenblum, S. Practices and problems in the use of tranquilizers with 
exceptional children. In E. Trapp & P. Himelstein (Eds.) Readings on the 
exceptional child. New York: Appleton, I962. Pp. 639-657. 

19. Russell, R. W. Drugs as tools in behavioral research. In L. Uhr & 

J. G. Miller (Eds.), Drugs and behavior. New York: Wiley, I96O. Pp. 19-40. 

20. Schulman, J. L. t Reisman, J. M. An objective measure of hyperactivity. 
American Journal of Mental Deficiency, 1959, 64, 455-456. 



441 



21. Scott, K. G. Short-term memory in the retarded child. Progress Report 
No. 1 , June 1 969 • 

22. Scott, K. G. A multiple-choice audio-visual discrimination apparatus 
with quick interchange display and response panels. Journal of 
Experimental Child Psychology, in press. 

23. Sprague, R. L. S- Toppe, L. K. Relationship between activity level and 
delay of reinforcement. Journal of Experimental Child Psychology, I966, 
3, 390-397. 

2k. Sprague, R. L. S- Werry, J. S. (Eds.) Survey of research on psychopharma- 
cology of children. Unpublished manuscript. University of Illinois, I968. 

25. Sprague, R. L., Werry, J. S., & Davis, K. V. Psychotropic drug effects on 
learning and activity level of children. Paper presented at the meeting 
of the Gatlinburg Conference on Research and Theory in Mental Retardation, 
Gatlinburg, Tenn., March I969. 

26. Sprague, R. L., Werry, J. S., Greenwold, W. E., & Jones, H. Dosage effects 
of methylphenidate on learning of children. Paper presented at the meeting 
of the Psychonomic Society, St. Louis, November, 1969- 

27. Turner, R. CNS stimulant drugs and conditioning treatment of nocturnal 
enuresis: A long term follow up study. Behavior, Research and Therapy, 
1966, k, 225-228. 

28. Werry, J. S. & Sprague, R. L. Hyperactivity. In C. G. Costello (Ed.), 
Symptoms of Psychopathology . New York: Wiley, in press. 

29. Young, G. & Turner, E. CNS stimulant drugs and conditioning treatment of 
nocturnal enuresis. Behavior, Research and Therapy, 1965, 3, 93-101. 

30. Zeaman, D. & House, B. J. The role of attention in retardate discrimina- 
tion learning. In N. R. Ellis (Ed.), Handbook of mental deficiency. 

New York: McGraw, I963. Pp. 159-223. 



kk2 



PSYCHOMETRIC 
SCALES-ADULT 





PSYCHOMETRIC SCALES 








ADULT 






Code 15 for Sheet Number when encoding any or all of the 






standard Adult Psychometric Scales. 






The texts for all adult scales are printed on GREEN templates. 






MH-9-67 (WAIS) Wechsler Adult Intelligence Scale 






70 (FTBS) Friedhoff Task Behavior Scale 
61 (MAZE) Porteus Mazes 

68 (BEIMDPS) Bender Gestalt Test - Pascal Suttell Scoring 

69 (WMEM) Wechsler Memory Scale 




Mark on right half of scoring sheet on row specif ied (Cols. 11-20) 


ROW 
NO. 




WECHSLER ADULT INTELLIGENCE SCALE 

(67WAIS) (Code 15 for Sheet Number) 

INSTRUCTIONS: Code scaled scores, NOT raw scores, in 2 digits; code 






Continue marking on right half of scoring sheet on row specified 


ROW 
NO. 


FRIEDHOFF TASK BEHAVIOR SCALE - Continued 




IQ's in 3 digits. When using "short forms" or abbreviated versions of 
WAIS, be sure to encode subtests and IQ's on the proper rows. Leave 






33 


2. GRASP INSTRUCTIONS 


blank all unused rows. 




1 = Good Understands quickly 




Information 


1-2 


2 = Fair Occasional repetition and correction 

required 






Comprehension .... 


31 


3 = Poor Constant repetition and correction 

required 

4 = Very poor Unable to understand 






5-6 








3. SHOWS ANNOYANCE OR HOSTILITY 


34 


Similarities 


7-8 


1 = Not at all 






Vocabulary 


9-10 


2= A little 
3 = Quite a bit 






Digit Span 


11-12 


4 = Extremely 








4. WITHDRAWN 


35 


Picture Completion . . . 


13-14 


1 = Not at all 




Picture Arrangement 


15 16 


2 = A little 
3= Quite a bit 




Block Design 


17-18 


4 = Extremely 






5. SHOWS AGITATION OR EXCITEMENT 


36 


Object Assembly .... 


19-20 


1 = Not at all 




Digit Symbol 


21-22 


2= A little 
3 = Quite a bit 






Verbal IQ 


23-25 


4 = Extremely 






6. APPEARS APPREHENSIVE OR TENSE 


37 


Performance 10 . . . . 


26-28 


1 = Not at all 




Full IQ 


29-31 


2 = A little 

3 = Quite a bit 

4 = Extremely 






FRIEDHOFF TASK BEHAVIOR SCALE 








(70-FTBS) (Code 15 for Sheet Number) 




7. ATTENTION TO TASK 


38 


INSTRUCTIONS: At the close of the testing session please rate the 
patient on the following aspects of his behavior and performance. 




1 = Good Complete attention 

2 = Fair Usually attentive 

3 = Poor Attention limited and wandering 




1. COOPERATION 

■l = Good No urging needed 


32 


4 = Very poor Complete inattention 




8. RELATIONSHIP WITH TEST ADMINISTRATOR 


39 


2= Fair Little urging 




1 = Good Friendly, at ease 




3 = Poor Much urging 




2 = Fair Reserved, took a while before warming 




4 = Very poor Refuses completely 




up 

3 = Poor III at ease, uncomfortable 

4 = Very poor Preoccupied; ignored me; acted as if 








1 weren't present; practically no 








444 


interpersonal contact 





PSYCHOMETRIC SCALES 



ADULT 





ROW 
NO. 


Mark on left half of scoring sheet on rows specified 






PORTEUS MAZES 






(Code 15 for Sheet Number) (61 -MAZE) 






Code 3 digits for each of the 2 scores 




1-3 


. . . Maze Quotient 




4-6 


. . . Qualitative Score 






BENDER GESTALT TEST - Pascal, Suttell Scoring 






(Code 15 for Sheet Number) (68-BENDPS) 






Code score for each design in 2 digits; code total score in 3 digits 




7-8 








Figure 1 (Record total score for design) 




9-10 








Figure 2 




11-12 








Figure 3 




13-14 








Figure 4 




15-16 








Figure 5 




17-18 








Figure 6 




19-20 








Figure 7 




21-22 








Figure 8 




23-24 








Configuration Score 




25-27 








Total Test Score 






WECHSLER MEMORY SCALE 






(Code 15 for Sheet Number) (69-WMEM) 






Unless otherwise indicated, code scores in 1 digit 




28 


. . . Personal and Current Information 




29 








Orientation 




30 








Mental Control 




31-32 








Logical Memory (Code in 2 digits) 




33 








Digits Forward 




34 








Digits Backward 




35-36 








Visual Reproduction (Code in 2 digits) 




37-38 








Associate Learning (Code in 2 digits) 




39-41 








MEMORY QUOTIENT (Code in 3 digits) 



kkS 



This section is formatted to encode five psychological scales on a single 
General Scoring Sheet. Other psychometric data may be encoded according to the 
instructions given in the section "Encoding of Non-Standard Data". (pp. 59-64), 



WECHSLER ADULT INTELLIGENCE SCALE 



(067-WAIS) 



Introduced by Wechsler in 1955, the WAIS is a revision and restandard izat ion 
of the original Wechsler scales. As, with its precursor, the WAIS is composed of 
verbal and performance subtests yielding a total score which is converted into an 
age-related IQ.. 



REFERENCES 



APPLICABILITY 
UTILIZATION 



1. Wechsler, D., Manual for the Wechsler Adult 
Intelligence Scale, Psychological Corporation, 
New York, 1955- 

2. Matarazzo, J. D., Wechsler 's Measurement and 
Appraisal of Adult Intelligence, 5th Ed. 
Williams and Wilkens, Baltimore, 1972. 
Materials for the WAIS may be obtained from 
the Psychological Corporation, 304 E. 45th 
Street, New York, New York. 100 17 

Adults 16 to 75 years 

At the discretion of the investigator. May be 
used at initial assessment only or as a change 
measure. 



CARD FORMAT 

Item 

' I nformat ion 
Comprehens ion 
Ar i thmet ic 
S imi lar i t ies 
Vocabulary 
Digit S pa n 
Picture Completion 

SPECIAL INSTRUCTIONS 



CARD 01 = (19x, II 12, 313) 
Column Item 



20-21 
22 - 23 
2k - 25 
26 - 27 
28 - 29 
30 - 31 
32 - 33 



Picture Arrangement 
Block Design 
Object Assembly 
Digit Symbol 
Verbal |Q 
Performance IQ. 
Full la 



Col umn 

34 - 35 
36 - 37 
38 - 39 
kO - k] 
kl - hk 
k5 - 47 
48 - 50 



The instructions given in the WAIS Manual (Reference 1) should be followed 
by the test administrator. Be sure to encode SCALED SCORES, not raw scores. When 
using any abbreviated WAIS, encode the scaled scores of the subjects used and the 
prorated IQ's in their appropriate rows and columns. 



446 



Example: The psychologist plans to employ only k WA I S subtests: Information, 
Vocabulary, Block Design and Digit Symbol. She should encode these subtests - 
and the prorated IQ.'s as follows: 



.1 nformat ion 



Vocabulary 



Block Des ign 



Digit Symbol 



Prorated Verbal \Q_ 




Prorated Performance IQ, 



Prorated Ful 1 \Q. 



21 ---.&: 

22 ::e: 

23 ::a: 

24 ---.oz 

25 ---.&: 

26 ::e: 

27 :;e: 

28 --zoz 
29irez 

30:* 
31 :ie: 



-t: r:3=: 

:r2:: :=3:: 

r:i: ::3:: 

i:2:: :=*:: 

zzf. :*: 

i:J:r i*i 

lit: i=3=: 

::2:r r*r 

iri: :*: 

::2=: :*: 

=:*:: =:3:: 



S: 


::6:: 


::?:: 


::8:: 


::* 


&: 


r:6:: 


zir--. 


::8:: 


::»: 


tr 


::6:: 


z.r-z 


::8:: 


::»: 


S:: 


::6:: 


zzT-Z 


::ft: 


::»:. 


S: 


::fc: 


::?:: 


r:ft: 


--9z 


*: 


::fc: 


::?:: 


::8:: 


::* 


ft: 


::«(:: 


::J:: 


::«:: 


::* 


ft: 


::6:: 


::?:: 


::ft: 


::»: 


ft: 


::6:: 


::?:: 


::»:: 


::»: 


ft: 


::fc: 


::?:: 


::»:: 


-z9z 


ft: 


::6:: 


::?:: 


::8:: 


::* 



DOCUMENTATION 



a. Scaled score printout 

b. Means and standard deviations 

c. Variance analyses 



kk7 



BENDER GESTALT TEST (O68-BENDPS) - Pasca 1 -Suttel 1 Scoring 

In wide use since its introduction by Bender, the BENDPS is a nonverbal 
visua 1 -motor test which has been employed for the estimation of maturation, 
intelligence, psychological disturbance and cortical impairment. Pascal and 
Suttel 1 published their scoring system in 1951 and have attempted to differ- 
entiate cortical deficit ('"organ ic i ty") from psychogenic disorders. 

REFERENCES 1. Pascal, G. R., and Suttell, B. J., The Bender 

Gestalt Test, Grune and Stratton, New York, 1951 

2. Bender, L., A Visual Motor Gestalt Test and its 
Clinical Use, American Orthopsych iat r ic Associa- 
tion, Monograph No. 3, New York, 1938. 

Test material may be obtained from the Psychological Corporation, New York. 



APPLICABILITY 
UTILIZATION 



15 years to adul t 

Once at pretreatment ; at least one posttreatment 
rating. Additional ratings are at the discretion 
of the investigator. 



CARD FORMAT 






1 tern 


Col 


umn 


Fig. 1 


20 


- 21 


Fig. 2 


22 


- 23 


Fig. 3 


2k 


- 25 


Fig. k 


26 


- 27 


Fig. 5 


28 


- 29 



CARD 01 = (19x, 912, 13) 
I tem 



Col umn 



Fig. 6 30-31 

Fig. 7 32-33 

Fig. 8 3^-35 

Config. Score 36 - 37 

Total Score 38 - ^0 



SPECIAL INSTRUCTIONS 

Instructions for s;:oring the test are contained in the Pasca 1 1 -Suttel 1 volume. 
(See Reference 1). Investigators wishing to employ other scoring systems should en- 
code the data according to the instructions for "Encoding Non-Standard Data" (pp. 59-64) 

DOCUMENTATION 

a. Raw score printout 

b. Means and standard deviations 

c. Variance analyses 



448 



WECHSLER MEMORY SCALE 



(O69-WMEM) 



The Wechsler Memory Scale (WMEM) , is a brief, widely used measure of memory 
deficit. It consists of 7 subtests winose raw scores are summated to obtain a 
memory quotient. Two forms of the scale are available and are considered to be 
equivalent. It is suggested that investigators alternate the 2 forms to reduce 
practice effects. 



REFERENCE 



APPLICABILITY 
UTILIZATION 



CARD FORMAT 


( 


1 tern 


Column 


Information 


20 


Orientation 


21 


Control 


22 


Logical 


23 - 24 


Digits Forward 


25 



Wechsler, D., and Stone, C. P., Manual for 
Wechsler Memory Scale, Psychological Corporation, 
New York. (Originally published in J. of Psychol. 
19, 87-95, 19^5). Materials for the WMEM may be 
obtained from the Psychological Corporation. 

Adul ts 

Once at pretreatment ; at least one posttreatment 
rating. Additional ratings are at the discretion 
of the investigator. 

CARD 01 = (19x, 311 , 12, 211 , 212, 13) 



tern 



Digits Backward 
Reproduct ion 
Assoc. Learning 
Memory Quot lent 



Col umn 

26 
27 - 28 
29 - 30 
31 - 33 



SPECIAL INSTRUCTIONS 

Instructions for scoring the items are contained in the manual (see Reference) 
DOCUMENTATION 

a. Raw score printout 

b. Means and standard deviations 

c. Variance analyses 



kkS 



FRIEDHOFF TASK BEHAVIOR SCALE 



(070-FTBS) 



The Friedhoff Task Behavior Scale (FTBS) is an 8-item, 4-point scale for the 
assessment of the subject's behavior during the administration of psychological 
tests. It is the adult analogue of the Psychological Examination Behavior Profile 
and, like the PEBP, is formatted for use with the GSS . 



REFERENCE 

APPLICABILITY 
UTILIZATION 
TIME SPAN RATED 
CARD FORMAT 
! tern 

1 . Cooperation 

2. Grasp 

3. Annoyance 
k. Withdrawn 



Friedhoff, A. J. and Alpert, M., The Effect of 
Chlorpromazine on the Variability of Motor Task 
Performance in Schizophrenics, J. Nerv. Ment. Dis., 
130, 110-116, i960. 

Adult Populations 

To be used in conjunction with each psychological examination, 

The duration of the psychological examination. 

CARD 01 = (19x, 811, 12) 

Column Item 



20 
21 
22 
23 



5. Agitation 

6. Apprehensive 

7. Attention 

8. Relationship 
Total Score 



Column 

2k 

25 

26 

27 

28 - 29 



Total Score = Sum of items 1 through 8. Total Score Range =8-32. 
SPECIAL INSTRUCTIONS 

Clues for each scale point are given on the scale itself. 
DOCUMENTATION 

a. Raw score printout 

b. Means and standard deviations 

c. Variance analyses 



450 



ASSEMBLING 

DATA 

FOR SHIPMENT 



Perhaps the least exhilarating aspect of research is the data collection phase 
since it demands close and constant attention to a myriad of details. However, the 
care expended here is subsequently justified in the analytic phase. Since the great- 
est amount of processing time is spent in creating an error-free data set, it is as 
much in the interest of the Biometric Laboratory to campaign for strict data control 
as it is in the investigator's interest. 

Experience has shown that processing time is reduced substantially when an in- 
vestigator establishes his own control procedures prior to sending data for computer 
processing. This is best accomplished when the responsibilities for data control and 
coordination are assigned to some member of his research staff. The data coordinator 
has the task of seeing that the requirements of the protocol - particularly the data 
collection aspects - are carried out. By constructing an overall assessment table 
showing rater assignment and required rating instruments, the coordinator can drasti- 
cally reduce subsequent "missing data" problems. By monitoring each set of ratings 
as they are obtained, the coordinator can ensure the completeness and correctness of 
the encoding. To accomplish this, the coordinator must be thoroughly familiar with 
the proper encoding procedures for all the instruments used in a study. In the past, 
the Biometric Laboratory has conducted several group workshops for coordinators in 
the use of the ECDEU Battery and has found the resultant interchange of information 
most rewarding. Consultation with coordinators on the problems of data collection 
continues to be a function of the Laboratory and investigators are welcome to make 
use of this service. 

ASSEMBLING DATA FOR SHIPMENT 

Predominantly, input data has been received at the Biometric Laboratory in the 
form of completed op-scan sheets which represent the data collection for an entire 
study. In preparing a data set for shipment, the following instructions should be 
noted: 

1. Check all forms for completeness both in the ID block and in the 
data matrix. Erase extraneous marks or writing. Check to see that 
a #2 pencil was used. Above all, do not use staples or clips: do 
not punch holes in the forms, etc. 

2. Only the original copy (white) should be sent as it alone can be op- 
scanned. The yellow copy should be retained by the investigator. 
Xeroxed copies cannot be op-scanned and therefore should not be sent. 
If a form is mutilated, recopy the data on another form. 

3. Sorting data in a uniform manner serves to alert the unit coordinator 
to missing ratings or other errors and, later, aids BLIPS editors to 
locate a specific form during their editing procedures. Two of the 
most frequently-used sorting arrangements are: 



452 



Subjects and periods ordered within Sheet and/or Form as follows: 

Treatment Group A 

Sheet or Form Number (in numeric order) 

Subject 001 Period 00 

Subject 001 Period 01 

Subject 001 Period 02 

Subject 001 Period k 



Subject 002 

Subject 002 

Subject 002 

Subject 002 



Period 00 
Period 01 
Period 02 
Pe r i od k 



Subject n Period 00 
Sheet or Form Number 

(as above) 

Treatment Group B (Repeat as in "A") 

Sheets, forms and periods ordered by subject as follows: 

Treatment Group A 



Subject 001 

Sheet 01 
Sheet 01 
Sheet 01 
Sheet 01 

Sheet 03 
Sheet 03 
Form n 



Period 00 
Period 01 
Period 02 
Pe r i od k 

Period 00 
Period 01 
Period 00 



Treatment Group B (Repeat as in "A") 

k. Note in the above sorting examples (3a and 3b) that data is always separated 
into treatment groups. Identify each treatment group by writing its name on 
a sheet of paper and placing it on top of the data and tie the data together 
to make a bundle of each group's data. 

Example: 




453 



5. Make sure that you've enclosed the completed Data Shipment (07I-DS). 
If you have additional special requests or comments, state them in 

a letter even though you may have discussed them previously by tele- 
phone. 

6. Place all the data into a stout box and wrap securely. Please enclose 
ONLY ONE STUDY TO A BOX. More than one box may, of course, be used 
for large studies. To avoid mistakes, however, we urge that you do not 
enclose 2 or more different studies in a single box. 

7. Mail to: ECDEU DATA ANALYSES 

BIOMETRIC LABORATORY 

11501 HUFF COURT 

KENSINGTON, MARYLAND 20795 

When data is received at the Laboratory, a notice will be sent acknowledg- 
ing its receipt and giving an estimate of turnaround time. If, after a 
reasonable time, you do not receive this notice, notify the Laboratory so 
that tracing can begin. 

ALTERNATIVE TYPES OF DATA SUBMISSIONS 

In the majority of cases, submission of "complete study" data is logistical ly 
the preferred one since much of BLIPS has been predicated on this kind of input. 
Increasingly, however, investigators have made inquiries concerning alternative ways 
of submitting data. Consequently, the following types of data submissions are 
acceptable: 

1. Partial submissions - Often, there is a need to examine data before 
a study is completed; e.g., multi-phase studies where one phase of 
the design is dependent upon the results of a preceding one. Given 
the need, investigators should inform the Biometric Laboratory of 
their requirements in detail - giving as much "lead-time" as possible. 

2. Card Input - Data submitted in this manner is acceptable as long as it 
conforms to the standard ECDEU card formats. (p. 26 ). Investigators 
should recognize the need to undertake their own editing of the source 
documents; since BLIPS editing will necessarily be limited to the cards 
themselves. When absolutely necessary, card input with formats other 
than ECDEU will be accepted - provided the precise "non-standard" formats 
are stated. 

3. Tape Input - Tapes may be submitted provided the following specifications 
are met: 

Tape Restrictions 

a. 9 track 

b. 1600 bits per inch 

c. Maximum block size = 32,000 

d. IBM mode 
Information Required 

a. Blocking factor 

b. Number of records 

c. Label information 

As noted with card formats, BLIPS editing is limited to the tape*, 



k5k 



071 DS 

DATA 

SHIPMENT 



DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE 


FOR BIOMETRIC LABORATORY USE 


NATIONAL INSTITUTE OF MENTAL HEALTH 


ECDEU NUMBER 


DATA SHIPMENT (DS) 


DATE RECEIVED 



PRINCIPAL INVESTIGATOR/S 



TITLE OF STUDY 



1. Have you previously submitted a Research Plan Report (21 -RPR) for this study? 

D Yes 

D No (If "No," please complete an RPR and enclose along with data. Studies can not be processed without an RPR.) 

2. Were there any revisions from the original protocol as described on the RPR which you have submitted? 

D Yes (If "Yes," please submit revised RPR) 

D No 



INSTRUCTIONS 

The Data Shipment form has been designed to facilitate processing of studies and to 
involve the investigator in the decision process regarding analyses to a greater extent than 
heretofore possible. In completing the form, the investigator can select or delete ratings 
and/or raters for analyses; construct a factorial design and request special analyses. For 
the Biometric Laboratory, the Data Shipment will serve as a "master control form" - 
selecting the appropriate programs for use in processing and analyses. Errors of patient 
assignment and/or period (rating) utilization can be minimized. Further, output displays 
can be labeled by drug name and/or other factor names. Since the form serves such a 
crucial role, A DATA SHIPMENT FORM MUST ACCOMPANY THE DATA WHEN IT 
IS MAILED TO THE BIOMETRIC LABORATORY. Answer all items as completely as 
possible. Should the form be inappropriate for your data or should you be uncertain 
about its completion, please contact the Laboratory. 



ITEM I - INVENTORY OF FORMS 

1. New and Old Scales 

For each scale, check whether new or old versions of the 
scales have been used in the study. The use of both the 
old and new versions of a single scale in a single study is 
discouraged since it complicates processing and increases 
the probability of error. 

2. Sheet Number 

Sheet numbers routinely assigned to the standard scales are 
preprinted on the DS. When non-standard scales are 
employed, the investigator must assign the same Sheet 
number to a given data set throughout the study. Any. 2- 
digit number not already assigned may be used. 

3. Time Unit 

Indicate whether the time units are hours = H; days = D; 
weeks = W or months = M. 



4. Periods 

For each scale, record all time periods (ratings) which were 
made during the study. The initial (first) rating should be 
designated "00"; others by the week (or other time unit) 
when they were made. CIRCLE the ratings where drug 
medication began and ended. UNDERLINE those periods 
(ratings) you wish to employ in subsequent analyses. 

EXAMPLES: 

a. A pretreatment rating is obtained following which medi- 
cation is begun. Ratings are then made at 2 weeks and 
4 weeks when medication is stopped. The investigator 
wishes to use only the first and la^t ratings in analyses. 
The correct coding is: 



02 



MH 9-71 
4-73 



k5S 



Ratings are made at the beginning and end of a 2-week 
drying out period following which medication begins. 
Ratings are also made at 4 and 6 weeks when medi- 
cation is stopped. A final rating is made 2 weeks later. 
The investigator wishes to use all ratings in analyses. 
The appropriate coding is: 



00 



I DRY I 



04 



MEDICATION 



Begin 



End 



08 



FoMowu^* 



For CROSSOVER designs, designate the medication 
changeover points by x's. For example, three drugs A, 
B and C are alternated every 4 weeks and ratings are 
made every 2 weeks. Only ratings at the beginning and 
end of medications are to be used in analyses. The 
appropriate coding is: 



02 



06 



B 



10 



5. Last Available Rating 

A check in this box signifies that there was an uneven end 
point in the study, i.e., patients were terminated after 
different durations of treatment. For example; in a 4-week 
study with weekly ratings, the investigator found that all 
subjects completed at least 2 weeks of treatment and were 
rated at weeks 00, 01 and 02. However, some subjects 
were so improved that they could be terminated prior to 
the 4th week. He wishes to use all subjects in a repeated 
model design. He wishes to use the first 3 ratings (00, 01, 
02) and the final rating for each subject whether it is the 
03 or 04 week rating. The appropriate coding is: 



01 



02 



■J in the 

appropriate 
column 



6. Rater 

For each scale, give the number/s of the rater/s. Circle 
those rater numbers which you wish used in analyses. 



ITEM IV - VARIANCE ANALYSES 

The present analyses of variance/covariance (AVACOV) pro- 
gram used in BLIPS allows for a 4-factor design. RESERVING 
ONE FACTOR FOR PERIOD EFFECT, the investigator may 
designate the number of additional factors (maximum of 3) he 
wishes to employ in his statistical design. In the usual clinical 
trial. Factor 1 would be named "DRUG" and the drug/s 
employed in the study labeled as Group A, B, C, etc. Factors 
2 and 3 can be any designated effect that the investigator 
wishes to study, e.g., age, diagnosis, hospital, chronicity, 
dosage, experimental manipulation, etc. A maximum of 10 
groups may be categorized under any one factor. Part 2 of 
Item 4 asks for a choice of the standard variance models; while 
Part 3 provides for requests for special analyses. 

EXAMPLES: 

a. For a study in which only one drug (UGH) was employ- 
ed; the coding is: 



FACTOR 1. 
Group A 



Name 



Drug 



Ugh 



This, in essence, would indicate a one-way analyses of 
periods. 

b. Two drugs - WOW and GEE - were employed in the 
study, in addition, and the investigator wishes to test 
the effect of diagnosis - schizophrenic vs. nonschizo- 



phrenic. The coding is: 

FACTOR 1 Name 

Group A 
Group B 

FACTOR 2 Name 

Group A 
Group B 



ITEMV - PATIENT IDENTIFICATION 



Drug 



Diagnosis 



Schizophrenic 

Non-Schizophrenic 



ITEM II - NON-ECDEU FORMS 

This item is to be completed in the same manner as Item I 
with the exceptions of the columns named "Form" and 
"Matrix". Under Form, give the title of the scale or data set. 
For Sheet Number use any number not already assigned. Use 
the same Sheet Number for the same data set for all assessment 
periods. Under Matrix, give the numbers of the rows which 
encompass the items of the scale; e.g., a 25 item scale coded 
in Rows 1 to 25; give the numbers of the columns which 
encompass the scale points, e.g., a 5 point scale coded in 
Column 16 to 20. If the scale contains items with different 
number of scale points, e.g., some 3 point, 4 point and 5 point 
items, give the dimensions of the largest set of scale points, 
e.g., 5 points. 



This listing will be used for editing and processing procedures. 
In addition to the patient's number, sex and initials, the 
investigator is asked to categorize the factorial assignment of 
the patient. By specifically categorizing each subject, subse- 
quent analyses can be checked for misassignment. Males are 
numbered 001 to 499; females 500 to 998. 

EXAMPLE: 

Patient 507, a female whose initials are ZZ, received the 
drug WOW during the study and she is nor schizophrenic. 
(See Item IV, example b. above). The coding is: 



Patient 
Number 



507 



Factor Assignment 



ZZ 



ITEM III 



RATER IDENTIFICATION 



This item becomes crucial if investigators contemplate con- 
ducting reliability studies across a number of trials. It is 
suggested that investigators try to use the same number for a 
rater who participates in a series of trials as this will simplify 
identification for both the investigator and the Biometric 
Laboratory. Do NOT use duplicate numbers in a single study. 



ITEM VI - OUTPUT 

Check whether one or two copies of the data package and one 
or two decks of cards are desired. 

ITEM VII - DOSAGE DATA 

This information is requested ONCE on this form rather than 
asking raters to complete it at every dosage change. 



MH 9-71 
4-73 



^57 



I. INVENTORY OF FORMS 



SCALES 


SHEET 
NUMBER 


SCALES 


TIME 
UNIT 


PERIODS 


CHECK IF 

LAST 

AVAILABLE 

RATING TO 

BE USED 


GIVE RATER 

NUMBER/STO 

BE USED IN 

ANALYSES 


New 


Check 


Old 


Check 


27-CPRS 




01 






















28-CGI 




01 


12-CGI 












29-DOTES 




02 


03TESS 












30-CDS 




03 
























03 














31-CDC 


















04 


04-DSR 






' 






32PTR 




< 






















33-TWIS 






















34-CBI 




20 














35-TQ 


























36-PQ 








III 










37-PTQ 


















38-STESS 


















39-NOSIE 




20 


07NOSIE 












40-PLUT 




20 




ill 










41-PANESS 








11 










42-NGI 




20 


07NOSIE 












43-CPDI 




10 














44-CSH 




11 














■APDI 




12 


01 PDI 












^^ -TRAITS 




13 




46-PMR 




- 














47-BPRS 




01 


06 BPRS 












48-HAMA 




01 














49-HAMD 




01 


08 HAM 












51-ASI 




01 


■ 












52-WITT 




01 


11-WITT 












53-SCL90 






10-SRSS 












54-SAS 



















MH 9-71 
4-73 



k58 



I. INVENTORY OF FORMS 



SCALES 


SHEET 
NUMBER 


SCALES 


TIME 
UNIT 


PERIODS 


CHECK IF 

LAST 

AVAILABLE 

RATING TO 

BE USED 


GIVE RATER 
NUMBER/S TO 


New 


Check 


Old 


Check 


BE USED IN 
ANALYSES 


55- LAB 




T-;;;'-' 


05LD 












56-POMS 




















57-SADJ 




14 














58-DRI 




14 


||:||;i; - 


-.:.::' 


— 






■-■■■ ' ■ 






15 


-rl-'--"— !■""-; 








'^ 


60-WISC 








61-MAZE 




15 


















15 




S*ftS 










62-WRAT 




















15 














63-GOOD 


;| llll 




64-BENDK 




15 


I- ixSii: 












■:■:■■ i ^'iS 




65- FROST 




15 














66-PEBP 




16 
























15 














67-WAIS 










15 














68-BENDPS 








69-WMEM 




15 














70-FTBS 




16 




: 

























































































































































































































MH 9-71 
4-73 



459 



NON-ECDEU FORMS 

Complete this section only if you are submitting data from scales which are not part of the ECDEU Assessment battery. 
Copies of the scales and any relevant material would be appreciated and would aid in processing. 



TITLE 
OF 


SHEET 
NUMBER 


MATRIX - Coded in the 
following location 


TIME 
UNIT 


PERIODS 


CHECK IF 

LAST 

AVAILABLE 

RATING TO 

BE USED 


RATER 
NUMBER/STO 


FORM 


ROW 


COLUMN 


BE USED 




From 


To 


From To 





























































































































III. RATER IDENTIFICATION 

Complete items for all raters utilized in the study. 



RATER 
NUMBER 


RATER'S NAME 
(First initial and last name) 


RATER 
NUMBER 


RATER'S NAME 
(First initial and last name) 











































































































NOTE: When "multiple raters" are used; i.e., 2 or more individuals performing simultaneous or 

concurrent ratings of the same subject, and the Investigator wishes to include this dimension 
in analyses, the raters should be identified under a factor entitled "Rater" (Item IV). 



MH 9-71 
4-73 



460 



IV, VARIANCE ANALYSES 



FACTOR 
IDENTIFICATION: 



Group A 
Group B 
Group C 
Group D 
Group E 
Group F 



Group A 
Group B 
Group C 
Group O 
Group E 
Group F 



Group A 
Group B 
Group C 
Group D 
Group E 
Group F 



VARIANCE 
MODEL DESIRED 



3. 

SPECIAL 
ANALYSES: 
(Describe) 



Analyses of Variance - Regular Model 
Analyses of Variance - Repeated Model 
Analyses of Covariance - Regular Model 
Analyses of Covariance - Repeated Model 



MH9-71 
4-73 



461 



PATIENT IDENTIFICATION 

Please complete all items. Use additional sheets if necessary. Males are numbered 001 to 499; females 500 to 998. 



PATIENT 
NUMBER 



SEX 
(M or F) 



INITIALS 
(First - last) 



FACTOR ASSIGNMENT 



PATIENT 
NUMBER 



SEX 
(MorF) 



INITIALS 
(First - last) 



FACTOR ASSIGNMENT 



MH 9-71 
4-73 



462 



VI. OUTPUT 



A. Number of Data packages requested: 

B. Number of Card decks requested: 



C. If two data packages/card decks are requested, should both sets be sent to you? 
Dyes 

D NO If NO. give name and address of other recipient: 



D. Do you want the original data forms returned to you? DYES 

To another address? D YES D NO 

If YES, give name and address of recipient: 



D NO 



VII. DOSAGE DATA 

Check appropriate units for dosages coded on Dosage Record and Treatment Emergent Symptoms (DOTES) for each 
treatment group. 



DRUG 


UNITS (Check) 


GROUP 


mg 


meg 


gm 


mg/kg 


Other (Specify): 


A 












B 












C 












D 












E 












F 

















FOR BIOMETRIC LABORATORY USE ONLY 


CODE: 


Start 


Finish 


Comments 


OPSCAN: 








EDIT: 








ANALYSES: 









Date mailed: 



MH 9-7^ 
A-73 



Editor: 



i+63 



Developed within the ECDEU program, the Data Shipment contains 7 items and is 
designed to supply information necessary for BLIPS processing. Not in opscan 
format, the data from DS are key-punched and serve as control cards to select the 
appropriate programs for processing. 



APPLICABILITY - 
UTILIZATION 

CARD FORMATS - 



All research populations 

Once per study - when shipping data to the 
Biometric Laboratory 

Cards generated from the DS are used internally 
by the Biometric Laboratory for data processing. 



SPECIAL INSTRUCTIONS 

Instructions are printed directly on the form. Since DS information is 
essential to BLIPS processing, this form is MANDATORY and must be submitted 
with shipments of data. If uncertain about completing the DS or any of its 
items, the investigator is urged to contact the Biometric Laboratory. 

I tern 1. Inventory of Forms - The shaded areas within the item indicate that 
no entries are required. These data are used to: 

a. Identify and locate each scale used in a study. 

b. Record the total number of assessment periods as well as 
those to be used in subsequent analyses. 

c. Call forth the appropriate programs for the editing and routine 
displaying of the data. 

CDS - While t'he Children's Diagnostic Scale (CDS) is usually employed only at 
pretreatment , some investigators may want to use the first 8 items for repeated 
assessment. Encoding of these two usages is as follows: 

At pretreatment only 



As repeated measures (pre-post) 



PQ. and TQ. - Since the Parent Questionnaire and Teacher Questionnaire can be used 
for repeated assessments by themselves or in conjunction with the Parent-Teacher 
Questionnaire, (PTQ), investigators may have difficulty in describing their usage 



k6k 



of these scales. Examples - In a 6-week study, the investigator 
■makes an initial rating and 3 subsequent ratings at 2-week intervals using 
the PQ. and TQ. at each rating. Encode as follows: 



35-TQ 
36-PQ- 


1/ 


Xv-X-X-;-;-:'; 




Hi 


u/ 
w 






n 


37-PTQ 




■1 








^ ' / 







The investigator, using the same assessment schedule as above, uses the 
PQ and TQ. only at the initial rating - substituting the PTQ. at the 3 subsequent 
ratings. Encode as follows: 



35-TQ 


/ 








v/ 


oo ^ 




^5" 


36-PQ 


/ 








v^ 


CK>. 




'/ 


37-PTQ 


/ 








w 


c>-i-,o«f^ ou 




11,^ 



STESS - This scale may be rated by the subject and/or a parent or other 
knowledgeable adult. If the investigator wishes to indicate that he has 
used concurrent ratings - the subject (S = 00) rating each week for h 
weeks and his mother (M = 11) rating every 2 weeks for 4 weeks, he would 
encode as follows: 



38-STESS 



/ 



^ 






£: 



PMR - No recording of PERIODS is necessary for Prior Medication Record. The 
lack of shading on the form is an error and it should have been printed as 
fol lows : 



vn**n******««««««««**«wi 



46-PMR 



Item II. Non-ECDEU Forms - This item serves the same purpose as Item I, but 
requires an alternative set of programs for processing. Location of the data 
matrices for each non-standard scale is particularly crucial. To insure pre- 
cise labeling and correct interpretation in data displays, it is strongly 



465 



suggested that a copy of the instrument - showing items and scale points - be 
sent to the Biometric Laboratory. If the data is composed of factor or cluster 
scores, their names, the data fields they occupy and the range of the scale 
points should be given. Should the investigator wish to have the Biometric 
Laboratory "factor score" the items on the basis of his own factor analysis, 
inclusion of the item composition of each factor is required. The more Informa- 
tion an investigator can supply about a non-standard data set; the less likely 
it will be that BLIPS makes an error. 

I tern \\l-3- Special Analyses - The investigator can describe additional analyses 
here. It should be kept in mind that special analyses requests will have a lower 
priority than routine (standard) analyses. An investigator requesting special in 
addition to standard analyses will receive lower p-riority ONLY for the special 
requests . 

Item v. Patient Identification - This item provides both a clerical and a com- 
puter check of patient identity and treatment assignment. The item conveys the 
necessary information for the identification of data while maintaining the anonyni- 
mity of the subject. Only the principal investigator will know the identity of the 
subjects and this identity cannot be ascertained from the data package or, later, 
when the data are entered into the data bank. By asking for treatment assignment 
once, the rater's task will be reduced, i.e., he need not encode treatment assign- 
ment for each subject on several scales as the earlier BLIPS required. 

Item Vl. Output - Here the investigator can specify how many copies of the data 
package and card decks he desires as well as to whom they should be sent. It is 
necessary to state the number at this time, since a later request for an addition- 
al package would require a complete "rerun" of the study. By requesting here that 
a copy of the data package be sent to another part, e.g., a drug firm, the investi- 
gator is assumed to be giving his formal' consent for such transmission of data. 

Item VII. Dosage Data - By asking for this information here and only once, raters 
will be spared the task of marking "units" ad nauseum throughout a study. Computer 
programming will insert "units" in the appropriate data displays. 



466 



DOCUMENTATION 
(The Data Package) 



Documentation refers to the presentation of data in a manner which describes 
what happened during a study and permits inferences to be drawn from it. It is 
vital, therefore, that the documentation depict the events of the tr'hal as accu- 
rately and comprehensibly as possible. All too frequently, failure to document a 
trial properly has led to incomplete or ambiguous findings which make it impossible 
to arrive at a substantive judgment of the trial itself or to compare its results 
with other similar trials. The effects of the drug cannot be assessed under these 
conditions and its true merits may be obscured. 

For many, the first exposure to computer output can be bewildering. The neo- 
phyte finds himself lost in the bulk of the package; and, even upon finding the loca- 
tion he desires, he is confused by the way in which the data is presented. He must 
learn to "decipher" the output before he can begin to interpret the findings of his 
study. Experience with the adult standard package has shown that there are almost as 
many inquiries relating to "deciphering" as there are regarding the interpretation of 
results. In the majority of these instances, more elaborate labeling - in English - 
would have avoided the need for "deciphering". 

In the 10 years of its existence, the BLIPS data package has undergone repeated 
changes in an attempt to increase its clarity and comprehensiveness. The pressure of 
service requirements necessitated the introduction of changes in the package one by 
one - rather than by a systematic overhaul. Coincident with the introduction of the 
new Battery, rnajor revision of the Biometric Laboratory Information Processing System 
has been undertaken. The major goals of this revision (called BLIPS II) are to in- 
crease the efficiency and general izab i I i ty of processing and to enhance the clarity 
of documentation. The concept of a standard data package remains; since, in concert 
with a standard assessment battery, it has proven advantageous as a method of docu- 
menting the single trial and for facilitating comparisons across several trials. In 
order that the uniqueness of a trial is not lost, however, a greater degree of varia- 
tion within the standard package has been introduced in the form of increased display 
and analytic options. 

THE PROCESSING SYSTEM (BLIPS II) 

The Biometric Laboratory Information Processing System (BLIPS) is a fully opera- 
tional, integrated series of computer programs that produce documentation for a vari- 
ety of scientific data inputs. Since I967, BLIPS has produced documentation for over 
500 clinical drug trials conducted by 80 different investigators and involving approx- 
imately 17,000 patients. Based on a common assessment battery and standard documenta- 
tion, BLIPS, nevertheless, attempts to minimize the constraints placed upon the invest! 
gator. 

In its original version, BLIPS consists of numerous programs which were each de- 
signed to process a particular form. This created processing and analytic weaknesses 
whenever deviations from preprogrammed designs occurred. In 1972, BLIPS was extensive- 
ly modified - and designated as BLIPS II - with the following objectives in mind: 

1. Flexibility to process any scientific data which may be converted to 
computer readable form. 

2. Exhaustive verification of data validity. 

3. Simplification of external controls to a level at which non-technical 
personnel can manage routine system operations. 



468 



k. Capability to produce a final documentation report tailored to 
the investigator's needs. 

Acceptable input data may be any type which can be converted into computer read- 
able form. At the present, however, most data are recorded on assessment instruments 
designed to be processed by an optical scan reader device. Through use of the univer- 
sal answer sheet and certain control information, any non-standard assessment instru- 
ment may also be entered into the system. The merits of such non-standard instruments 
can be analyzed and, if warranted, added to the standard Battery, thereby increasing 
i ts capab i 1 i ty. 

The verification of data validity is executed by an error detection and correc- 
tion subsystem which is called the preprocessor. The preprocessor consists of basic 
and specialized functions which detect missing information, duplicate identification 
fields, invalid entries and the logical consistency of interrelated items either with- 
in a single form or across several forms; e.g., the natural mother's age should not be 
less than or equal to her children's ages. When errors are detected, they are correc- 
ted via punched cards. These cards contain all the necessary information to locate 
the exact field within the data file where the correction is to be inserted and corres- 
pond in format to an error listing which is produced as a visual aid. The correction 
cards are resubmitted to the system. The preprocessor will then make the corrections 
and reprocess the data set. This process is repeated until no further errors are 
detected . 

To maintain the external control at a level which non-technical personnel can 
manage, the transformation and analysis of the data is done via a semi -automated sub- 
system called DATRAN. Fixed control information needed to process the data is stored 
permanently on disk, while the variable control information, e.g., the number of pa- 
tients, the number of assessment periods, etc., is generated via a series of programs 
which examine the data as well as the Data Shipment form, completed by the investigator, 
In addition to self-generating complex control information, the subsystem will select 
the appropriate combination of procedures necessary to fully analyze the data. This 
selection is performed by testing criterion variables such as forms used in the drug 
trial, number of patients in the study, analysis desired, etc. The subsystem will run 
fully automated until new assessment instruments are introduced. Then additional con^ 
trol information must be generated to process the new entries. 

To obtain a final documentation report tailored to meet most of the needs of the 
investigator, an output generator subsystem transforms the output obtained from exist- 
ing analysis programs. This subsystem provides extensive labeling information; merges 
several data sets, and combines the results to facilitate comparisons and make inter- 
pretation an easier task for the investigator. An indexed, paginated document is the 
final product, 

CONTENTS OF STANDARD DATA PACKAGE 

The bulkiness of a data package necessarily varies from study to study depending 
upon the number of subjects, scales, and rating periods. The output for a given scale, 
however, is standardized regardless of the size of a study. For small studies, this 
may give the package the appearance of overelaborateness ; while, for larger studies, 
the output may seem pedestrian. This lack of precise tailoring is inevitable, however, 
in a system which attempts to cover the diversity which exists among psychotropic drug 
trials. The usual order of presentation in the data package is as follows: 



469 



1 . Table of Contents 

2. Narrative Summary 

3. Patient Listing 
k. Data Inventory 

5. Demographic Data 

a. Adult or Children's Personal Data Inventory 

b. Prior Medication Record 

c. Children's Symptom History 

d. Children's Diagnostic Scale and Children's Diagnostic Classification 

e. Patient Termination Record 

6. F^ficacy Data 

a. Psychiatric Rating Scales; --'-e.g., 028-CG I , 047-BPRS, 049-HAMD, etc. 

b. Paraprofessional Rating Scales; e.g., 035-T(i, 039-NOSIE, etc. 

c. Self-Rating Scales; e.g., 05^-SAS , 073-SDS, etc. 

d. Psychological Tests; e.g., 060-WISC, 062-WRAT, etc. 

e. Social Adjustment Scales; e.g., 057-SADJ 
"Within each subgroup, scales are ordered by number. 

7. Adverse Reaction Data 

a. Dosage Record and Treatment Emergent Symptoms (Including 033-TWIS) 

b. Laboratory Data 

c. Subject's Treatment Emergent Symptom Scale 

8. Medical Data 

Physical and Neurological Examination for Soft Signs 

9. Non-standard Data 

Scales are ordered by number 

10. Multi-instrument displays 

Presentations of data from two or more scales 

11. Error Diagnostics 



Data displays for the individual assessment instrument are arranged as follows: 



Legend 

Raw score printout 

Computed score printout 

Means and standard deviations 

Frequency tables 

Cross tabulations 

Graphic displays 

Variance analyses 



While not every display is present for each and every instrument, the order of, the 
displays is maintained throughout. 

The standard package has evolved through the continual exchange of ideas among 
investigators, Biometric Laboratory and Psychopharmacology Researcli Branch. Data 
displays have been designed to provide maximal acuity and relevance to the clinician. 
Information regarding the individual subject as well as the various treatment groups 
has been provided in a variety of displays to increase the utility of the analyses 
and to provide meaningful clinical comparisons. In the design of the standard data 
package, a basic objective has been the utilization of all items in the assessment 
battery. Considering the great expenditure in time, effort and resources which goes 
into the collection of data, it is obligatory to generate an output which maximally 
utilizes the available material. Output has been therefore universally generated on 
an idiographic and a nomothetic level - enabling the investigator to follow the pro- 
gress of individual subjects as well as to compare various treatment groups. 



kyo 



There are a number of genera] features in the new package which should increase 
i ts ut i 1 i ty . 

1. Consistent with legibility, the bulkiness of the package 
has been reduced by conserving space whenever possible. 

2. Since study protocols and the number of scales used are 
not fixed by BLIPS, pagination of the package has been 
difficult to routinize. These problems, however, have 
been overcome, and pagination is now a standard part of 
the data package. 

3. Preceding each data subset, i.e., all the data relating 
to one assessment instrument, a legend - defining all 
terms used in the subsequent displays - is provided. 

k. For convenience in comparing treatment groups, equivalent 
data displays are juxtaposed on the same page. In earlier 
data packages, all displays relating to a treatment group 
were located together - making direct comparisons between 
groups difficult. Using the cross tabulat i ve display as an 
example, the earlier package had the following alignment 
on a s ingle page: 

GROUP 1 



ITEM 1 



ITEM 2 





The new alignment juxtaposes treatment groups as follows: 
GROUP 1 GROUP 2 GROUP 1 GROUP 2 






OR 



ITEM 1 



GROUP 3 GROUP k 



ITEM 2 



ITEM 2 




ITEM 1 



^71 



EDITING AND ERROR DIAGNOSTICS 

The editing of data has been, by far, the most time-consuming element in BLIPS. 
The procedure has been complicated by the fact that errors can enter the system by 
three avenues: the rater, BLIPS editors and machine (op-scan) malfunctions. Errors 
by BLIPS editors have been substantially reduced by shifting the responsibility for 
coding the identification block to the investigator. While experience with the 
system has reduced errors from all sources, the preparation of data for analyses re- 
mains most vulnerable to delays. In dealing with the problem, the central premise 
has been to transfer human effort to computer operations insofar as possible. Thus, 
there has been a continuous development of editing programs especially designed to 
prepare diverse data sets for standard BLIPS analyses. 

The frequency of errors attributable to the rater seems inversely proportional 
to the length of his experience with the forms. Neophyte raters tend to make a high- 
er proportion of errors of commission in comparison to errors of omission. These con- 
sist primarily of illegal marks and enscribers, mutilated forms and unidentifiable 
subjects or assessment periods. With experience, these correnission errors diminish 
and errors of omission remain the primary problem. 

The major portion of error detection is carried out by computer programs. An 
error is first specifically located, then define'd and space provided for correction 
in an error diagnostics listing. Any and all errors are cited even though, in a 
specific study, certain items may have been purposely deleted by the investigator. 
Number and frequency of errors is summarized for each form and a table of this 
summary comprises part of the error diagnostics listing. (Table 37). Both the 
quality and quantity of errors serve as bases for the decision whether to proceed 
with analyses. A significant proportion of errors in any given study can be corrected 
by BLIPS personnel. For example, poorly erased changes or extraneous marks within the 
response areas of the forms will often produce multiple op-scan punches. Such errors 
are usually readily detectable and can be corrected without recourse to the investiga- 
tor. However, BLIPS editors never presume what an ambiguous response should or might 
represent. In all cases, resolution of the ambiguity resides with the investigator. 

The error citations employed in error diagnostics are defined as follows: 

CITATION DEFINITION 

Missing I tern or part of item is missing, e.g., 

item requiring 3 digits is encoded with 
two. 

Illegal I tern requiring only one entry contains 

two or more entries or the entry is out 
of range; e.g., a 4 is encoded for a 
3-point item. 

Logical Two or more items are logically inconsistent; 

e.g., one cannot be the 5th child of a cohort 
of 3. diarrhea and constipation are present 
s imul taneously. 

Identification Error occurs within the identification block. 

Data Error occurs within the data matrix. 



472 



s 



a- o 



O LU 



2 Q. 
O — 
Q- (- 



II 



2 ^ 



^5 

< o 



< Qi 
P= O 

o u. 



< 

00 =) 

CC Q 

O — 

CC CO 

Q£ LU 

LU DC 



^ 



o 


o — 




Q. t/) 


o 


CO en 


? 


LU — 


II 


II 



i 



&5 



— — X 



tj 


CJ 


a: 


q: 


UJ 


LU 


Q. 


a. 


o 


Q 


z 


z 


< < 


>- 


>- 


o 


o 


■z. 


■z. 


LU 


LU 


r) 


3 


o'o' 


LU 


LU 


CC 


a: 



X. X 
X X 
X X 



Ul >4. 



^73 



RAW AND COMPUTED SCORE LISTINGS 

When the editing process is completed and retrieval of erroneous data accom- 
plished, raw and computed scores are generated in tabular form. Descriptive head- 
ings; e.g., patient, period and rater numbers, are given along the top of the table: 
data are displayed in columns. (Table 38). When possible, items are labeled, but 
for lengthy scales, item numbers are used. Spacing between sets of items, e.g., 
every 5, every 10, etc., aids in locating a specific item. 

Computed scores are obtained by combining raw item scores according to some 
rule or set of operations. Most common are factor scores in which item scores are 
statistically combined on the basis of a factor analysis. Empirical clusters; i.e., 
combinations on the basis of logical decisions developed from clinical experience, 
are another example. Since many of the scales used in the Pediatric Battery are new- 
ly developed, cluster scores will be employed until sufficient data are collected for 
factor analytic procedures. Displays for computed scores follow the same format as 
raw scores. 

MEANS AND STANDARD DEVIATIONS 

These displays differ from raw and derived score printouts in that they present 
nomothetic (group) rather than idiographic (individual) data. Means, standard devia- 
tions and number of subjects involved in their calculations are displayed by period 
along the vertical; items by group(s) and total sample appear as headings along the 
horizontal. (Table 39). Grand item means and standard deviations for each group and 
the total sample are displayed following the last assessment period. 

FREQUENCY TABLES 

This display is used primarily for categorical data such as demographic items, 
descriptive events, etc. Items and their response positions are listed vertically; 
frequency and percent of occurrence by group and total sample along the horizontal. 
(Table 40) , -Means and standard deviations are also supplied where relevant. Because 
of their complexity, some items, e.g.. Family Psychiatric History, require special 
formatting or computation; e.g.. Social Class. 

CROSS-TABULATION 

The purpose of cross-tabulation is to condense and organize data so that direc- 
tional changes can be readily detected. The usual comparison is between pre and 
post-treatment data although any two sets of data may be compared. The schema below 
illustrates some general principles of interpretation. The diagonal (AD) contains 
those cells in which patients exhibit no pre/post changes in rating. The upper 
triangle, ABD, contains cells in which some degree of improvement is rated. As 
cells approach pole B, greater degrees of improvement are implied. Conversely, the 
lower triangle, ACD, reflects degrees of exacerbation - greater degrees as pole C 



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Js approached. The cell at pole A contains patients who are asymptomat.ic; 
pole B, the zenith of treatment success; pole C, the nadir of treatment 
failure and pole D, the "untouchables" - sickest at pretreatment and sick- 
est at posttreatment . 



PRETREATMENT 




PRETREATMENT TOTALS 



Table 4l represents a cross-tabulation of the BPRS symptom, Somatic Concern. 
The distribution of 15 pre and pK)st treatment ratings on a 7-point scale ranging 
from Wn PRESENT to EXTREMELY SEVERE is shown. Pretreatment scores (presum) are 
read horizontally; (7 = Not Present; 2 = Very Mild; k = Mild, etc.); posttreatment 
scores (postsum) vertically (8 = Not Present; k = Very Mild, etc.). The diagonal 
of the matrix is emphasized by underlining. Scores which fall here reflect static 
scores, i.e., scores which remain at the same intensity level at both ratings. 
When both pre and posttreatment scores are "NOT PRESENT", this is designated as 
asymptomatic. Asymptomatic is, of course, a variant of a static score and, in the 
example, there are 4 asymptomatic subjects. Any scores above the diagonal represent 
improvement; any below .represent worsening (increased severity). Three subjects, 
for example, changed from "Mild" at pretreatment to "Very Mild" at posttreatment. 
One subject changed from "Not Present" at pretreatment to "Moderately Severe" at 
posttreatment - a change of k points in a negative direction. 



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Cross-tabulation accomplishes data reduction and facilitates interpretation of 
group results without losing sight of the individual patient. The exact nature of 
changes between two ratings can be followed in detail irrespective of sample size or 
tests of significance. Cross-tabulations can be examined to ascertain whether the 
result is due to modest unidirectional changes in a large proportion of the sample 
or to dramatic changes in a few individuals. Noting bipolar changes, the investiga- 
tor may find that specific subgroups are responding differentially under the same 
drug condition. It should be remembered, however, that cross-tabulation involves 
comparison between only two ratings. Investigators are cautioned that changes may 
have occurred at other points in the course of the study, e.g., pre vs. posttreat- 
ment ratings will not reveal changes which occur at the midpoint of a study. Perusal 
of other data sets; e.g., means and SD, variance analyses, will alert the investiga- 
tor to the possibility of change not revealed in the cross-tabulations. 

GRAPHIC DISPLAYS 

These displays are of two types. The first presents data derived from a single 
assessment instrument in unaltered raw form. Only the format is changed to facili- 
tate rapid assimilation of results. In Figure 26 pre and posttreatment factor means 
obtained from a hypothetical scale are shown and, further, data for 2 treatment groups 
are juxtaposed - greatly increasing the usefulness of the display. Graphics of this 
type will be employed in BLIPS II to a much greater extent to present, in addition to 
the traditional pre-post differences, data from diagnostic instruments; e.g.. Children' 
Diagnostic Scale and from analogous instruments; e.g., Depression Status Inventory vs. 
Self-Rating Depression Scale; Parent vs. Teacher Questionnaires, the 10 common items 
from each, as rated by the parent vs. the teacher. 

The second type of graphic involves the conversion of data from several assess- 
ment instruments into standard scores and their presentation in one composite display. 
Conversion into standard scores, of course, does not alter the relative magnitude of 
data while permitting instruments with differing scale points to be plotted together 
for rapid comparison. (Figure 27). Routinely, standard scores will be based on sam- 
ple parameters. For each variable, the sample mean and standard deviation will be cal- 
culated and a standard score, for each treatment group derived on that basis. The for- 
mula for conversion is: 



Group Standard Score = 50 + 10 (Group Mn - Sample Mn) 

Sample SD 

Norms for various research populations are currently being constructed for most of 
the standard ECDEU assessment instruments and will be employed in future BLIPS docu- 
men tat ion. 



480 



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482 



DATA INVENTORY 

The Data Inventory serves two purposes: 

1. For an individual study, a subject by subject itemization of each 
form present in the data matrix. 

2. Across studies, the source material for a cumulative inventory of 
the contents of the ECDEU data bank. 

Table ^2 illustrates the display provided for the individual study. The dots indicate 
"present" - the crosses "absent". Totals are provided for each form by subject, assess- 
ment period and grand sum. The inventory gives the investigator an accurate picture of 
the magnitude and distribution of his data matrix and provides a basis for decisions on 
further data transformations or analyses. 

Cumulative inventories are generated across all studies in the ECDEU data bank. The 
number of forms, subjects, studies and items is summed for each rating scale as well as 
across all scales. This display - while not part of the standard data package - provides 
periodic information to members of the ECDEU program regarding the magnitude and distri- 
bution of the total data bank at a given time and, in conjunction with preceding inven- 
tories, an estimate of the rate of growth of the bank. It also provides a general esti- 
mate of the amount of data available for any particular research purpose. 

THE ANALYTIC COHORT 

Preceding each statistical analyses, a listing of subjects excluded from that anal- 
ysis along with the reason for exclusion is given. (Table ^3) . The display continues 
with a listing of all subjects included in the analysis as well as the periods and raters 
used. Specification of the analytic cohort has proved to be highly desirable for inter- 
preting the results of any statistical analyses performed. 

NARRATIVE SUMMARY 

The Narrative Summary provides the investigator or reviewer with an overview of the 
study. Though brief, it contains sufficient detail to enable the reader to grasp the 
essential nature of the study and its results. As with all other segments of the stan- 
dard package, the Narrative Summary is non-judgmental and contains only statements based 
directly on the data received and the analyses performed. Final judgment as to the clin- 
ical meaningful ness of the data or the efficacy of the drugs involved remains entirely 
with the investigator. Narrative summaries consist of four paragraphs: 

1. Description - Data are derived from the Research Plan Report and 
consist of details of the research design, the drugs and dosages 
employed and the research procedures. 

2. Efficacy - derived primarily from variance analyses. All statis- 
tici^lly significant findings - or their absence - are cited for 
each of the psychopa thol og ica 1 rating scales employed. 

3. Toxicity - Derived primarily from Dosage Record and Treatment 
Emergent Symptom Scales. Toxicity is described in terms of the 
number and kinds of symptoms evolving under each treatment condi- 
tion, as well as the clinical actions necessitated by the emer- 
gence of such symptoms. 

k. Demography - Derived primarily from the Adult or Children's 

Personal Data Inventory. Distributions for a number of pertinent 
demographic variables are given for each treatment group. 



483 



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485 



COMMENTS ON STATISTICAL PROCEDURES 
P. A. deary and K. Yang 

This discussion is divided into three areas. The first deals with the 
repeated measures analysis of variance and the use of stricter criteria in 
detecting significance for the within-subject variables. The second part 
concerns the multiple comparisons problem. By focusing on two methods it is 
expected that the decision to use a particular technique will be made clearer 
to our audience. The last section is an explanation of the displays of the 
statistical methods just discussed. 

Those statistical techniques previously introduced in BLIPS I are not 
discussed here. These comments are not intended as definitive but only as 
guidance. 

Repeated Measures Model 

A popular research design in psychoJDharmacolog ical research is the analy- 
s i.s of variance model in which a single dependent variable is measured on more 
than one occasion on the same subjects. This is often called a repeated measures 
analysis of variance. Several authors (1, 2, 3, ^) have discussed the problems 
which arise when this type of analysis is performed. One of the more serious 
problems is the distortions of p levels and confidence levels caused by the 
heterogeneity of covariance. The conclusions drawn are that multivariate tests 
are exact with repeated measurements but in many instances the n is too small. 
It is suggested that the Greenhouse-Geisser three step procedure might be most 
useful. However, even this approach is discouraged i f yO (populat ion correlation) 
is not constant or relatively constant over treatments. That is, the assumption 
of homogeneity of covariances between repeated measurements must be met. When 
the design involves more than one factor the covariance assumptions are more strin- 
gent. For example, in a two-factor experiment in which factor A with levels a^ and 
32 is not repeated but factor B with occasions b, , b2. b., and b. is repeated, two 
covariance assumptions must be made. First, the matrix of variances and covariances 
among the several repeated assessments (b, through b^^) must be the same within each 
level of the nonrepeated factor (the matrix must be the same within a, as within 32). 
Second, the covariances pooled across levels of the independent factor must be 
homogeneous. Procedures for testing these assumptions are given by Winer 
(1971, pp. 594-599). 

Figure 28 outlines the Greenhouse-Geisser procedure when employing univariate 
analyses of repeated measures; (a) Use the regular degrees of freedom for the F tests 
on the repeated factors. If the result is not significant the analysis is completed. 
Clearly, if the obtained F value using the conventional degrees of freedom is not 
significant then there is no need to examine the effect further using the more con- 
servative test. (b) If the result of (a) is significant the most stringent test is 
employed. The degrees of freedom for the numerator and denominator of the obtained 
F are multiplied by the inverse of the degrees of freedom for the wi th in-subjects 
variable. If the obtained F is still significant the analysis can stop at this point, 



486 



FI.GURE 28 
GREENHOUSE-GEISSER PROCEDURE 



^* Test Main Effects in Repeated Measures Model 



b. 



Not S ign i f icant 



S ign if icant 



i 



Stop 



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S ign if icant 



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Stop 



c. Use Univariate Apisroximate F test of Box 
Need var iance/covariance matrix to get £^ 



487 



(c) If step (b) indicates a lack of significance the researcher may try the 
Box approximate F test in which ^, a function of the heterogeneity of the 
variance and covariances, must be calculated. The degrees of freedom for 
the numerator and the denominator for the obtained F are then each multiplied 
by this function. These degrees of freedom will lie in the middle of the 
most liberal and the most conservative sets of degrees of freedom. 

The Greenhouse-Geisser procedure is routinely applied in the analysis of 
Var iance-covar iance program (AVACOV) used in ECDEU analyses with the modifica- 
tion that the Box approximate test is not used. When an obtained F is signifi- 
cant at the .05 level, main effects and interactions using repeated measures 
are further tested using the reduced degrees of freedom. If they still indi- 
cate a significant result a (-v) is printed. A ( ) indicates significance was 
not reached using the conservative degrees of freedom. At this point the pro- 
cedure stops. 

When a two-factor experiment in which factor A with levels a. and a is 
repeated as is factor B with occasions b,, b2, b,, and b/^ AVACOV cannot 5^ em- 
ployed. In this type of design the Statistical -^Analysis System (SAS) procedure 
entitled Analysis of Variance and Covariance is employed." The model includes a 
subject by factor A interaction, as well as a subject by factor B interaction, 
and also a subject by factor A by factor B. These interactions are employed to 
test the main effects A and B and the AB interact ion. 9 In the last section the 
output from the AVACOV and the SAS procedure will be explained in more detail. 

Multiple Comparisons Techniques 

When an analysis of variance indicates a significant difference among two 
or more means, paired comparisons aid the researcher in determining which differ- 
ences contribute to the overall significance. It is generally agreed that the 
use of t-tests to carry out all possible two-group comparison produces a high rate 
of erroneous conclusions. Aside from this there is no consensus among statisti- 
cians about the multiple comparisons methods most appropriate. Any single test 
of a comparison has probability of a type 1 error. However, as the number of com- 
parison increases the probability of at least one type 1 error increases. The 
usual ^level , the probability that a single comparison results in a type Terror 
is referred to as the error rate per comparison (EC). The probability tha^t an en- 
tire set of comparisons contains at least one type 1 error is called the error rate 
experimentwise (EW) . What is needed is a technique to adjust the EC downwards as 
the total number of comparisons increases and adjusting in such a way that the 
change in the number of comparisons does not alter EW. The literature is replete 
with proposals for dealing with the multiple comparison-error rate problem. How- 
ever, only the Scheffe and the Tukey A or HSD (honestly significant difference) 
techniques hold the EW as T^for the entire possible set of contrasts. The Scheffe 
method is very conservative and it is possible that a significant test of main 
effects will not be followed by at least one significant contrast. The power of 
the Scheffe test is equal to that of the overall F test only when detection of the 
maximum possible contrast is at issue. Scheffe recommends use of Tukey 's B method 
where sample sizes are equal and only paired comparisons are made. The Tukey B 
method fixes experimentwise error rates at conventional levels. This method is 
affected by those violations such as unequal sample size, unequal variances, non- 
normal populations to the degree that they also influence the obtained F value. 



488 



Tukey B method is based on the distribution of Q, the studentized range 
statistic. It is a compromise between the Tukey A which like the Scheffe 
yields too few significances and the Newman-Keuls which can give too many 
erroneous results. Briefly the procedure followed is: 



Critical Value 



(K,df) + Q (r 



.df)] 



/ 2 



K = number of means in entire set 

r = number of steps between the two means being compared 
df = degrees of freedom for appropriate error term 



Qr = M. 



MS 



/ n 



if ri; are not equal use the harmonic means of the n.'s in the set 



Qr 

Mi 
MS 



is the test statistic and is known to have a distribution 
known as the studentized range. Q.r must be greater than 
the critical value for significance to be indicated 
and M. are means for the two levels being compared 

is the mean square for the error term used in testing 
error 

the effect 



The treatment means are ordered from the lowest to the highest. In BLIPS II 
output, these differences are given in the lower half of a matrix on the right in 
which the upper half is occupied by the Qr statistics. Table kO of the sample 
output display shows the treatment's means differences and the Qr statistics for 
the study effect. The number 4.05 is the ratio of 



1.8333 - 1.3351 / 



1.1358 



where n = harmonic mean = 75.0750 

The critical value for means two steps apart is 3.31 which is the average of 
the critical values for means 2 steps apart and 5 means in a set 

Critical Value = (2.77 + 3.86) / 2 = 3.31 

These values are given in the lower half of the matrix on the left of page 485. The 
top half of matrix consists of " for those Qr's which are greater than the corres- 
ponding critical value. In our sample output on page 485, 5 studies are compared. 
The first comparison is treatment 1 versus treatment 4. Since the obtained Q of 5.96 
is greater than the critical value of 3.86 an asterisk is placed in the upper portion 
of this matrix. In reading the significances we can discover that study 1 is signifi- 
cantly different from the other four but they are not different from one another. 



489 



SAMPLE OUTPUT 



AVACOV 

AVACOV (Analysis of Var iance-Covariance) is a modification of MANOVA. 
Tiiis program can perform analyses of variance on models consisting of four 
factors each with ten levels. It has the ability to analyze repeated mea- 
sures on one factor only. Analysis of covariance can also be performed. 

Additional features consist of: 

1. Detection of F-Ratio's significant at the .05 probability 
level - with asterisks indicating significance. 

2. M