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title	Information for Reviewers

Text Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

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Title

Hamilton Depression Rating Scale 17-Item (HAMD 17)

CDISC Reference

Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials

QRS Short Name

HAMD 17

QRS Permission Status

Public Domain

Team

Major Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam

Supplement Version

2.1

Status

REVISION DRAFT

Date

20212024-1203-0906

Notes to Readers

This supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide

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for Human Clinical Trials.

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Revision History

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Date

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Version

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Summary of Changes
2024-03-06

Revision History

Date	Version	Summary of Changes
2021-12-09	2.1 Draft	The HAMD 17 v2.0 supplement was updated to the wiki Clinical Classifications supplement template. Annotated CRF was revised to a CDISC CRF to avoid complications with HAMD 17 CRFs included in copyrighted publications. The RSEVAL assumption and variable was removed from this supplement, because it is not captured on the CRF and no assumptions are made on the potential values. Section 3.1 reference to the total score of 54 was revised to 53. Revised assumption 2 to be a sponsor's stated evaluation interval. Added assumption 4 describing how items 16A and 16B are handled and included with the “logically skipped item” data rule. The example replaced the RSBLFL variable with RSLOBXFL, added the RSDTC variable, and uses the RSTAT and RSREASND variables for the unanswered item 16B. All responses were updated to end in a period (".") to reflect punctuation on the CRF. The following example row values were revised: Row 3 RSTESTCD = “HAMD103" original RSORRES = “Ideas or gestures suicide.” was revised to “Ideas or gestures of suicide.” Row 8 RSTESTCD = “HAMD108" original RSORRES = “Complete stupor.”, RSSTRESC = 4, and RSSTRESN = 4 was revised to RSORRES = “Slight retardation during the interview.”, RSSTRESC = 1, and RSSTRESN = 1. Updated the data example to include a missing visit 2 set of "NOT DONE" records for each item. Added assumptions 3b and 5c regarding RSTESTCD = "HAMD116A" and "HAMD116B", a response of RSORRES = "Not assessed." (RSSTRESC and RSSTRESN = 3). removed 0-3 from assumption 1.
2016-05-23	2.0	This measure was re-evaluated to fit the definition of a clinical classification measure. The domain was changed from the QS to RS domain.
2013-05-15	1.1	Q16 only uses Part A or Part B and not both items Revised annotated CRF to meet annotation font standards
2012-08-07	1.0	Final

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This document describes the CDISC implementation of the Hamilton Depression Rating Scale 17-Item (HAMD 17) instrument.

CDISC created this There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument.

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Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/Based on the reference papers “Guy W, ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, 1976” and “The Hamilton Rating Scale for Depression: The making of a ‘‘gold standard’’ and the unmaking of a chronic illness, 1960–1980.”, CDISC made a case for using the current CDISC created CRF for the HAMD 17 CDISC standard. This is not an endorsement of the instrument. The creation of this instrument was based on published articles describing the instrument. Sponsors may create this instrument’s CRF using their style guidelines, but they need to maintain the wording and order of the questions/items and responses as described on the CRF.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

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CDISC specifies how to structure the data that data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols. CDISC disclaims any liability for your use of this material.

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The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated

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with the CDISC SDTMIG variables

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with submission values.

Info

title	Information for Reviewers

The CRF is attached at the top of the wiki. When you click the paperclip image, you will find the file for the annotated CRF.

with the CDISC SDTMIG variables with submission values.

Info

title	Information for Reviewers

The CRF is attached at the top of the wiki. When you click the paperclip image, you will find the file for the annotated CRF.

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.

References

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for for the HAMD 17:

Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.
Development of a Rating Scale for Primary Depressive Illness BY MAX HAMILTON, Department of Psychiatry, University of Lee, Brit. J. soc. Clin. Psychol. (1967), 6, pp. 278-296, Printed in Great Britain.
Guy W, ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, 1976.
The Hamilton Rating Scale for Depression: The making of a ‘‘gold standard’’ and the unmaking of a chronic illness, 1960–1980.
Assessment Scales in Depression, Mania and Anxiety, Raymond W Lam, MD, FRCPC, Erin E. Michalak, PhD, Richard P Swinson, MD, FRCPsych, FRCPC, Copyright 2005 Taylor & Francis, an imprint of the Taylor & Francis Group.

...

The HAMD 17 is a multiple-choice instrument that clinicians may use to assess the severity of major depression. Max Hamilton originally published the scale in 1960 and revised it in 1967. The measure, which is designed for adult subjects, rates the severity of symptoms observed in depression (e.g., low mood, insomnia, agitation, anxiety, weight loss). It consists of 17 items, each rated on a 3-, 4-, or 5-point scale. A total score between 0-53 is 53

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is also captured.

The scale points include original scores include a numeric rating (0-2 , 0-3, or 0-4) and a definition of what is represented by the rating (e.g., 0 = "Absent.", 4 = "Incapacitating."). For the HAMD 17, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
The time period of evaluation for the HAMD 17 is populated in the RSEVLINT variable in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the HAMD 17 is determined based on the sponsor's stated evaluation interval.
The HAMD 17 instrument includes a total score that is considered as captured data on the CRF and is not considered as derived in the example below. This score may be submitted in SDTM or derived in the Analysis Data Model (ADaM).
1. If operationally defined by the sponsor, it is the sponsor's responsibility to set the --DRVFL flag based on their eCRF process to derive subtotals and total scores. An investigator-derived score will be considered a captured score and not flagged. When subtotal and total scores are derived by the sponsor, the derived flag (--DRVFL) is set to "Y". However, when the subtotal and total scores are received from a central provider or vendor, the value would go into --ORRES and --DRVFL would be null (see SDTMIG Section 4.1.8.1, Origin Metadata for Variables).
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2. if scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
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for the HAMD 17 is determined based on the sponsor's stated evaluation interval.
Records are created in rs.xpt for every instrument item:
1. For items with no data, RSORRES, RSSTRESC, and RSSTRESN are all missing and RSSTAT = "NOT DONE". If the reason is known then that reason is represented in RSREASND (e.g., RSREASND = "PREFER NOT TO ANSWER"). If the reason is unknown, then RSSTAT = "NOT DONE" and RSREASND is missing.
2. Items with RSTESTCD = HAMD116A
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  and HAMD116B have a response of RSORRES = "Not assessed." (RSSTRESC and RSSCTRESN = 3
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  ). Subject data for this response is included in the SDTM representation of the data as QSSTAT = "NOT DONE" and QSREASND = "Not assessed.".
3. Due to the variability of copyright holder and public domain derived subscore and overall score generation processes, records are not included for derived subscores or overall scores that are not provided.
Some items on the HAMD 17 may be conditionally branched per the instrument instructions. Item 16 contains 2 components: Part A, which is loss of weight according to the patient, and Part B, which is loss of weight according to weekly measurements. Only 1 of these items is answered when administering the HAMD 17 instrument. A record is created in rs.xpt for all items. The unanswered component is considered conditionally branched in the data and is represented as follows:
1. QNAM = “RSCBRFL”, QLABEL = “Conditionally Branched Item Flag“, QVAL = “Y” (this is a RS supplemental qualifier variable related to the record).
2. RSORRES, RSSTRESC, and RSSTRESN are set to null (missing).
The HAMD 17 instrument includes an overall score that is considered as captured data on the CRF and is not considered as derived in the example below. This overall score may be submitted in SDTM or derived in the Analysis Data Model (ADaM) per scoring instructions from the refwrence articles.
Item 16 contains 2 components: Part A, which is loss of weight according to the patient, and Part B, which is loss of weight according to weekly measurements. Only 1 of these items is answered when administering the HAMD 17 instrument
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. A record is created in rs.xpt for all items. The unanswered component is considered as a logically skipped item in the data and is represented as follows:
1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
2. If subscores or overall scores are received or derived by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM whenever feasible. It is the sponsors responsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
3. For RSTESTCD = "HAMD116A" and "HAMD116B", a response of RSORRES = "Not assessed."
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740
1. 757
  (RSSTRESC and RSSTRESN = 3) is not included in scoring for the HAMD 17
2. RSSTAT = "NOT DONE".
3. RSREASND = "LOGICALLY SKIPPED ITEM".
4. RSORRES, RSSTRESC, and RSSTRESN are set to null.
Terminology
1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.
2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

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The HAMD 17 example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit and a and visit 2 represented as not being collected collected for the HAMD 17 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented with preferred terminology in RSORRESin QSORRES.This result is then transformed into the represented as a standard numeric score in RSSTRESN QSSTRESN and as a standard character representation of the standard numeric score in RSSTRESC.

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in QSSTRESC. The sponsor's evaluation interval for the example is the past week (RSEVLINT = "-P1W").

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Dataset wrap

Name	rs

Rowcaps

Row 16:

Represents item 16 Part A when the subject answered the weight loss according to the patient.

Row 17:

Represents item 16 Part B as a logically skipped item when the 16 Part A item is answered.

Row 19:

Represents the total score. All total scores are considered as captured data unless the sponsor operationally derives it via an EDC system.

Rows 20-38:

Show the

Show the subject was not evaluated on this instrument at visit 2.

Because the

The reason for not completing the visit

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was not collected, no date

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was not collected, no date is assumed for when the visit would have occurred

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.

Dataset2

QRSSUPP-746serverIdHAMD 17

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ROW	STUDYID	DOMAIN	USUBJID	RSSEQ	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSSTRESN	RSSTAT	RSREASND	RSLOBXFL	VISITNUM	RSDTC	RSEVLINT
1	STUDYX	RS	2324-P0001	1	HAMD101	HAMD1-Depressed Mood	HAMD 17	Absent.	0	0		0	0			YY
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key	1	2019-11-16	-P1W
2	STUDYX	RS	2324-P0001	2	HAMD102	HAMD1-Feelings of Guilt	HAMD 17	Self reproach, feels he/she has let people down.	1	1			Y	1	2019-11-16	-P1W
3	STUDYX	RS	2324-P0001	3	HAMD103	HAMD1-Suicide	HAMD 17	Ideas or gestures of suicide.	3	3			Y	1	2019-11-16	-P1W
4	STUDYX	RS	2324-P0001	4	HAMD104	HAMD1-Insomnia Early - Early Night	HAMD 17	No difficulty falling asleep.	0	0			Y	1	2019-11-16	-P1W
5	STUDYX	RS	2324-P0001	5	HAMD105	HAMD1-Insomnia Middle - Middle Night	HAMD 17	No difficulty.	0	0			Y	1	2019-11-16	-P1W
6	STUDYX	RS	2324-P0001	6	HAMD106	HAMD1-Insomnia Early Hours -Morning	HAMD 17	No difficulty.	0	0			Y	1	2019-11-16	-P1W
7	STUDYX	RS	2324-P0001	7	HAMD107	HAMD1-Work and Activities	HAMD 17	No difficulty.	0	0			Y	1	2019-11-16	-P1W
8	STUDYX	RS	2324-P0001	8	HAMD108	HAMD1-Retardation	HAMD 17	Slight retardation during the interview.	1	1			Y	1	2019-11-16	-P1W
9	STUDYX	RS	2324-P0001	9	HAMD109	HAMD1-Agitation	HAMD 17	Fidgetiness.	1	1			Y	1	2019-11-16	-P1W
10	STUDYX	RS	2324-P0001	10	HAMD110	HAMD1-Anxiety Psychic	HAMD 17	No difficulty.	0	0			Y	1	2019-11-16	-P1W
11	STUDYX	RS	2324-P0001	11	HAMD111	HAMD1-Anxiety Somatic	HAMD 17	Moderate.	2	2			Y	1	2019-11-16	-P1W
12	STUDYX	RS	2324-P0001	12	HAMD112	HAMD1-Somatic Symptoms Gastrointestinal	HAMD 17	None.	0	0			Y	1	2019-11-16	-P1W
13	STUDYX	RS	2324-P0001	13	HAMD113	HAMD1-General Somatic Symptoms	HAMD 17	None.	0	0			Y	1	2019-11-16	-P1W
14	STUDYX	RS	2324-P0001	14	HAMD114	HAMD1-Genital Symptoms	HAMD 17	Mild.	1	1			Y	1	2019-11-16	-P1W
15	STUDYX	RS	2324-P0001	15	HAMD115	HAMD1-Hypochondriasis	HAMD 17	Not present.	0	0			Y	1	2019-11-16	-P1W
16	STUDYX	RS	2324-P0001	16	HAMD116A	HAMD1-Loss of WT According to Patient	HAMD 17	Definite (according to patient) weight loss.	2	2			Y	1	2019-11-16	-P1W
17	STUDYX	RS	2324-P0001	17	HAMD116B	HAMD1-Loss of WT According to WK Meas	HAMD 17				NOT DONE	LOGICALLY SKIPPED ITEM	Y	1	2019-11-16	-P1W
18	STUDYX	RS	2324-P0001	18	HAMD117	HAMD1-Insight	HAMD 17	Denies being ill at all.	2	2			Y	1	2019-11-16	-P1W
19	STUDYX	RS	2324-P0001	19	HAMD118	HAMD1-Total Score
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13	13	13			Y	1	2019-11-16	-P1W
20	STUDYX	RS	2324-P0001	20	HAMD101	HAMD1-Depressed Mood	HAMD 17				NOT DONE			2
21	STUDYX	RS	2324-P0001	21	HAMD102	HAMD1-Feelings of Guilt	HAMD 17				NOT DONE			2
22	STUDYX	RS	2324-P0001	22	HAMD103	HAMD1-Suicide	HAMD 17				NOT DONE			2
23	STUDYX	RS	2324-P0001	23	HAMD104	HAMD1-Insomnia Early - Early Night	HAMD 17				NOT DONE			2
24	STUDYX	RS	2324-P0001	24	HAMD105	HAMD1-Insomnia Middle - Middle Night	HAMD 17				NOT DONE			2
25	STUDYX	RS	2324-P0001	25	HAMD106	HAMD1-Insomnia Early Hours -Morning	HAMD 17				NOT DONE			2
26	STUDYX	RS	2324-P0001	26	HAMD107	HAMD1-Work and Activities	HAMD 17				NOT DONE			2
27	STUDYX	RS	2324-P0001	27	HAMD108	HAMD1-Retardation	HAMD 17				NOT DONE			2
28	STUDYX	RS	2324-P0001	28	HAMD109	HAMD1-Agitation	HAMD 17				NOT DONE			2
29	STUDYX	RS	2324-P0001	29	HAMD110	HAMD1-Anxiety Psychic	HAMD 17				NOT DONE			2
30	STUDYX	RS	2324-P0001	30	HAMD111	HAMD1-Anxiety Somatic	HAMD 17				NOT DONE			2
31	STUDYX	RS	2324-P0001	31	HAMD112	HAMD1-Somatic Symptoms Gastrointestinal	HAMD 17				NOT DONE			2
32	STUDYX	RS	2324-P0001	32	HAMD113	HAMD1-General Somatic Symptoms	HAMD 17				NOT DONE			2
33	STUDYX	RS	2324-P0001	33	HAMD114	HAMD1-Genital Symptoms	HAMD 17				NOT DONE			2
34	STUDYX	RS	2324-P0001	34	HAMD115	HAMD1-Hypochondriasis	HAMD 17				NOT DONE			2
35	STUDYX	RS	2324-P0001	35	HAMD116A	HAMD1-Loss of WT According to Patient	HAMD 17				NOT DONE			2
36	STUDYX	RS	2324-P0001	36	HAMD116B	HAMD1-Loss of WT According to WK Meas	HAMD 17				NOT DONE			2
37	STUDYX	RS	2324-P0001	37	HAMD117	HAMD1-Insight	HAMD 17				NOT DONE			2
38	STUDYX	RS	2324-P0001	38	HAMD118	HAMD1-Total Score	HAMD 17				NOT DONE			2

...

RSORRES	RSSTRESC	RSSTRESN
No difficulty.	0	0
Subjective tension and irritability.	1	1
Worrying about minor matters.	2	2
Apprehensive attitude apparent in face or speech.	3	3
Fears expressed without questioning.	4	4	4	4

RSTESTCD = "HAMD111" RSTEST = "HAMD1-Anxiety SomaticRSTESTCD = "HAMD111" RSTEST = "HAMD1-Anxiety Somatic

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"

RSORRES	RSSTRESC	RSSTRESN
Absent.	0	0
Mild.	1	1
Moderate.	2	2
Severe.	3	3
Incapacitating.	4	4

...

RSTESTCD = "HAMD114" RSTEST = "HAMD1-Genital Symptoms

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"

RSORRES	RSSTRESC	RSSTRESN
Absent.	0	0
Mild.	1	1
Severe.	2	2

...

RSORRES	RSSTRESC	RSSTRESN
No weight loss.	0	0
Probable weight loss associated with present illness.	1	1
Definite (according to patient) weight loss.	2	2	Not assessed.	3	3

RSTESTCD = "HAMD116B" RSTEST = "HAMD1-Loss of WT According to WK Meas"

RSORRES	RSSTRESC	RSSTRESN
Less than 1 lb weight loss in week.	0	0
Greater than 1 lb weight loss in week.	1	1
Greater than 2 lb weight loss in week.	2	2	Not assessed.	3	3

RSTESTCD = "HAMD117" RSTEST = "HAMD1-Insight"

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