Information for Reviewers

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

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	2021-12-09
Notes	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 for Human Clinical Trials.

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.
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

1 Introduction

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

CDISC created this case report form (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. 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.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC questionnaires, ratings, and scales (QRS) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

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

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the HAMD 17 in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument. CDISC has chosen to use this version as the data standard.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with examples, and (3) CRF(s) annotated QRSSUPP-730 - Getting issue details... STATUS with the CDISC SDTMIG variables QRSSUPP-729 - Getting issue details... STATUS with submission values.

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) 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 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.

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the HAMD 17 are listed below.

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 also captured.

The scale points 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).
2. if scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM.
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 as a logically skipped item in the data and is represented as follows:
1. RSSTAT = "NOT DONE".
2. RSREASND = "LOGICALLY SKIPPED ITEM".
3. 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.

3.2 Example for the HAMD 17 RS Domain Model

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 visit 2 represented as not being collected for the HAMD 17 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC. The sponsor's evaluation interval for the example is the past week (RSEVLINT = "-P1W").

We are unable to make the example consistently show blue in the wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

The table represents the items from the HAMD 17 instrument. Note that visit 2 is represented as a missing visit.

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 subject was not evaluated on this instrument at visit 2. Because the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

rs.xpt

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			Y	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	HAMD 17	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

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

4 SDTM Mapping Strategy

This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

RSTESTCD = "HAMD101" RSTEST = "HAMD1-Depressed Mood"

RSORRES	RSSTRESC	RSSTRESN
Absent.	0	0
These feeling states indicated only on questioning.	1	1
These feeling states spontaneously reported verbally.	2	2
Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep.	3	3
Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication.	4	4

RSTESTCD = "HAMD102" RSTEST = "HAMD1-Feelings of Guilt"

RSORRES	RSSTRESC	RSSTRESN
Absent.	0	0
Self-reproach, feels he/she has let people down.	1	1
Ideas of guilt or rumination over past errors or sinful deeds.	2	2
Present illness is a punishment. Delusions of guilt.	3	3
Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.	4	4

RSTESTCD = "HAMD103" RSTEST = "HAMD1-Suicide"

RSORRES	RSSTRESC	RSSTRESN
Absent.	0	0
Feels life is not worth living.	1	1
Wishes he/she were dead or any thoughts of possible death to self.	2	2
Ideas or gestures of suicide.	3	3
Attempts at suicide (any serious attempt rates 4).	4	4

RSTESTCD = "HAMD104" RSTEST = "HAMD1-Insomnia Early - Early Night"

RSORRES	RSSTRESC	RSSTRESN
No difficulty falling asleep.	0	0
Complains of occasional difficulty falling asleep, i.e., more than ½ hour.	1	1
Complains of nightly difficulty falling asleep.	2	2

RSTESTCD = "HAMD105" RSTEST = "HAMD1-Insomnia Middle - Middle Night"

RSORRES	RSSTRESC	RSSTRESN
No difficulty.	0	0
Patient complains of being restless and disturbed during the night.	1	1
Waking during the night – any getting out of bed rates 2 (except for purposes of voiding).	2	2

RSTESTCD = "HAMD106" RSTEST = "HAMD1-Insomnia Early Hours - Morning"

RSORRES	RSSTRESC	RSSTRESN
No difficulty.	0	0
Waking in early hours of the morning but goes back to sleep.	1	1
Unable to fall asleep again if he/she gets out of bed.	2	2

RSTESTCD = "HAMD107" RSTEST = "HAMD1-Work and Activities"

RSORRES	RSSTRESC	RSSTRESN
No difficulty.	0	0
Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.	1	1
Loss of interest in activity, hobbies or work – either directly reported by the patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities).	2	2
Decrease in actual time spent in activities or decrease in productivity. Rate 3 if the patient does not spend at least three hours a day in activities (job or hobbies) excluding routine chores.	3	3
Stopped working because of present illness. Rate 4 if patient engages in no activities except routine chores, or if patient fails to perform routine chores unassisted.	4	4

RSTESTCD = "HAMD108" RSTEST = "HAMD1-Retardation"

RSORRES	RSSTRESC	RSSTRESN
Normal speech and thought.	0	0
Slight retardation during the interview.	1	1
Obvious retardation during the interview.	2	2
Interview difficult.	3	3
Complete stupor.	4	4

RSTESTCD = "HAMD109" RSTEST = "HAMD1-Agitation"

RSORRES	RSSTRESC	RSSTRESN
None.	0	0
Fidgetiness.	1	1
Playing with hands, hair, etc.	2	2
Moving about, can’t sit still.	3	3
Hand wringing, nail biting, hair-pulling, biting of lips.	4	4

RSTESTCD = "HAMD110" RSTEST = "HAMD1-Anxiety Psychic"

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

RSTESTCD = "HAMD111" RSTEST = "HAMD1-Anxiety Somatic QRSSUPP-731 - Getting issue details... STATUS "

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

RSTESTCD = "HAMD112" RSTEST = "HAMD1-Somatic Symptoms Gastrointestinal"

RSORRES	RSSTRESC	RSSTRESN
None.	0	0
Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.	1	1
Difficulty eating without staff urging. Requests or requires laxatives or medication for bowels or medication for gastrointestinal symptoms.	2	2

RSTESTCD = "HAMD113" RSTEST = "HAMD1-General Somatic Symptoms"

RSORRES	RSSTRESC	RSSTRESN
None.	0	0
Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability.	1	1
Any clear-cut symptom rates 2.	2	2

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

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

RSTESTCD = "HAMD115" RSTEST = "HAMD1-Hypochondriasis"

RSORRES	RSSTRESC	RSSTRESN
Not present.	0	0
Self-absorption (bodily).	1	1
Preoccupation with health.	2	2
Frequent complaints, requests for help, etc.	3	3
Hypochondriacal delusions.	4	4

RSTESTCD = "HAMD116A" RSTEST = "HAMD1-Loss of WT According to Patient"

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"

RSORRES	RSSTRESC	RSSTRESN
Acknowledges being depressed and ill.	0	0
Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc.	1	1
Denies being ill at all.	2	2

End of Document

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Hamilton Depression Rating Scale 17-Item (HAMD 17) Supp V2.1