You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 14 Next »

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 ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

HAMD 17

QRS Permission StatusPublic Domain
TeamMajor Depressive Disorder (MDD) Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.1
StatusDRAFT
Date2019-11-13
NotesThis 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

DateVersionSummary of Changes
2019-11-132.1 Draft
  • The HAMD 17 v2.0 supplement was updated to the WIKI clinical classifications supplement template.
  • The RSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
  • The example replaced the RSBLFL variable with RSLOBXFL and added the RSDTC variable.
  • All responses were updated to end in a "." punctuation as represented on the CRF.
2016-05-232.0
  • This measure was re-evaluated to fit the definition of a clinical classification measure.  The domain was changed from the QS to RS domain.
2013-05-151.1
  • Q16 only uses Part A or Part B and not both questions
  • Revised annotated CRF to meet annotation font standards
2012-08-071.0

Final

© 2019 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

1 Introduction

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

CDISC does not modify clinical classifications, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this clinical classification 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 clinical classification are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/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.

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

This instrument is in the public domain. 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 clinical classification. There may be many versions of this instrument in the public domain or copyrighted. 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 with the CDISC SDTMIG variables with submission values (attach QRS instrument here). (Note: Most copyright approvals allow annotated case report forms; if this is the case with the current instrument, keep item #3 and just remove this note. If however, the copyright agreement does not allow for annotated case report forms, remove item #3 along with this note.)

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.

Reference for the Hamilton Depression Rating Scale 17-Item (HAMD 17):

  • Hamilton M., Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 1967; 6(4):278-96. 
  • Background: Max Hamilton originally published the scale in 1960 and reviewed and evaluated it in 1966, 1967, 1969, and 1980. The measure, which is designed for adult patients and is in the public domain, rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss.

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 clinical classification that clinicians may use to assess the severity of major depression. It consists of 17 items, each rated on 3-point, 4-point or 5-point scale. A total score between 0-54 is also captured.

  1. The scale points include a numeric rating (0-2 or 0-4) and a definition of what is represented by the rating (e.g., 0 = "Absent", 2 = "Severe", 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.

  2. The time period of evaluation for the HAMD 17 is populated in the RSEVLINT field in ISO 8601 format when the evaluation interval can be precisely described as duration. The evaluation interval for the HAMD 17 is the past week (RSEVLINT = "-P1W").

  3. The HAMD 17 instrument includes a total score on the CRF that is considered as captured data on the CRF and is not considered as derived in the example below.

    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 written on a CRF 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).

  4. 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 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.

Question 16 contains Part A “Loss of WT According to Patient” and Part B “Loss of WT According to WK Meas”.  Only one of the questions is answered when administering the HAMD-17 questionnaire.  In this example Part A is answered and Part B is shown for illustration purposes only with RSORRES=XXX, RSSTRESC=XXX and RSSTRESN=XXX.

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 form.

Row 17:Represents question 16 Part B for illustration purposes only. This row would not be included in the actual dataset, since Part A of this question 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.

rs.xpt

rs.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSLOBXFLVISITNUMRSDTCRSEVLINT
1STUDYXRS2324-P00011HAMD101HAMD1-Depressed MoodHAMD 17Absent.00Y12012-11-16-P1W
2STUDYXRS2324-P00012HAMD102HAMD1-Feelings of GuiltHAMD 17Self reproach, feels he/she has let people down.11Y12012-11-16-P1W
3STUDYXRS2324-P00013HAMD103HAMD1-SuicideHAMD 17Ideas or gestures suicide.33Y12012-11-16-P1W
4STUDYXRS2324-P00014HAMD104HAMD1-Insomnia Early - Early NightHAMD 17No difficulty falling asleep.00Y12012-11-16-P1W
5STUDYXRS2324-P00015HAMD105HAMD1-Insomnia Middle - Middle NightHAMD 17No difficulty.00Y12012-11-16-P1W
6STUDYXRS2324-P00016HAMD106HAMD1-Insomnia Early Hours -MorningHAMD 17No difficulty.00Y12012-11-16-P1W
7STUDYXRS2324-P00017HAMD107HAMD1-Work and ActivitiesHAMD 17No difficulty.00Y12012-11-16-P1W
8STUDYXRS2324-P00018HAMD108HAMD1-RetardationHAMD 17Complete stupor.44Y12012-11-16-P1W
9STUDYXRS2324-P00019HAMD109HAMD1-AgitationHAMD 17Fidgetiness.11Y12012-11-16-P1W
10STUDYXRS2324-P000110HAMD110HAMD1-Anxiety PsychicHAMD 17No difficulty.00Y12012-11-16-P1W
11STUDYXRS2324-P000111HAMD111HAMD1-Anxiety SomaticHAMD 17Moderate.22Y12012-11-16-P1W
12STUDYXRS2324-P000112HAMD112HAMD1-Somatic Symptoms GIHAMD 17None.00Y12012-11-16-P1W
13STUDYXRS2324-P000113HAMD113HAMD1-General Somatic SymptomsHAMD 17None.00Y12012-11-16-P1W
14STUDYXRS2324-P000114HAMD114HAMD1-Genital SymptomsHAMD 17Mild.11Y12012-11-16-P1W
15STUDYXRS2324-P000115HAMD115HAMD1-HypochondriasisHAMD 17Not present.00Y12012-11-16-P1W
16STUDYXRS2324-P000116HAMD116AHAMD1-Loss of WT According to PatientHAMD 17Definite (according to patient) weight loss.22Y12012-11-16-P1W
17STUDYXRS2324-P000117HAMD116BHAMD1-Loss of WT According to WK MeasHAMD 17XXXXXXXXXY12012-11-16-P1W
18STUDYXRS2324-P000118HAMD117HAMD1-InsightHAMD 17Denies being ill at all.22Y12012-11-16-P1W
19STUDYXRS2324-P000119HAMD118HAMD1-Total ScoreHAMD 17161616Y12012-11-16-P1W
$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.00
These feeling states indicated only on questioning.11
These feeling states spontaneously reported verbally.22
Communicates feeling states non-verbally, i.e. through facial expression, posture, voice and tendency to weep.33
Patient reports virtually only these feeling states in his/her spontaneous verbal and non-verbal communication.44

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

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Self reproach, feels he/she has let people down.11
Ideas of guilt or rumination over past errors or sinful deeds.22
Present illness is a punishment. Delusions of guilt.33
Hears accusatory or denunciatory voices and/or experiences threatening visual hallucinations.44

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

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Feels life is not worth living.11
Wishes he/she were dead or any thoughts of possible death to self.22
Ideas or gestures of suicide.33
Attempts at suicide (any serious attempt rates 4).44

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

RSORRES

RSSTRESC

RSSTRESN

No difficulty falling asleep.00
Complains of occasional difficulty falling asleep, i.e. more than ½ hour.11
Complains of nightly difficulty falling asleep.22

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

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Patient complains of being restless and disturbed during the night.11
Waking during the night – any getting out of bed rates 2 (except for purposes of voiding).22

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

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Waking in early hours of the morning but goes back to sleep.11
Unable to fall asleep again if he/she gets out of bed.22

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

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Thoughts and feelings of incapacity, fatigue or weakness related to activities, work or hobbies.11
Loss of interest in activity, hobbies or work – either directly reported by patient or indirect in listlessness, indecision and vacillation (feels he/she has to push self to work or activities).22
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.33
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.44

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

RSORRES

RSSTRESC

RSSTRESN

Normal speech and thought.00
Slight retardation during the interview.11
Obvious retardation during the interview.22
Interview difficult.33
Complete stupor.44

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

RSORRES

RSSTRESC

RSSTRESN

None.00
Fidgetiness.11
Playing with hands, hair, etc.22
Moving about, can’t sit still.33
Hand wringing, nail biting, hair-pulling, biting of lips.44

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

RSORRES

RSSTRESC

RSSTRESN

No difficulty.00
Subjective tension and irritability.11
Worrying about minor matters.22
Apprehensive attitude apparent in face or speech.33
Fears expressed without questioning.44

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

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Mild.11
Moderate.22
Severe.33
Incapacitating.44

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

RSORRES

RSSTRESC

RSSTRESN

None.00
Loss of appetite but eating without staff encouragement. Heavy feelings in abdomen.11
Difficulty eating without staff urging. Requests or requires laxatives or medications for bowels or medication for gastro-intestinal symptoms.22

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

RSORRES

RSSTRESC

RSSTRESN

None.00
Heaviness in limbs, back or head. Backaches, headaches, muscle aches. Loss of energy and fatigability.11
Any clear-cut symptom rates 2.22

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

RSORRES

RSSTRESC

RSSTRESN

Absent.00
Mild.11
Severe.22

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

RSORRES

RSSTRESC

RSSTRESN

Not present.00
Self-absorption (bodily).11
Preoccupation with health.22
Frequent complaints, requests for help, etc.33
Hypochondriacal delusions.44

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

RSORRES

RSSTRESC

RSSTRESN

No weight loss.00
Probable weight loss associated with present illness.11
Definite (according to patient) weight loss.22
Not assessed.33

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

RSORRES

RSSTRESC

RSSTRESN

Less than 1 lb weight loss in week.00
Greater than 1 lb weight loss in week.11
Greater than 2 lb weight loss in week.22
Not assessed.33

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

RSORRES

RSSTRESC

RSSTRESN

Acknowledges being depressed and ill.00
Acknowledges illness but attributes cause to bad food, climate, overwork, virus, need for rest, etc.11
Denies being ill at all.22




End of Document

  • No labels