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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
Date2020-07-1522
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.


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DateVersionSummary of Changes
2020-07-1522
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, since 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 to be a sponsor's stated evaluation interval. 
  • Added assumption 4 describing how question item 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 question item 16B.
  • All responses were updated to end in a "." punctuation as represented 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.
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 questionsitems
  • Revised annotated CRF to meet annotation font standards
2012-08-071.0

Final

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  1. 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.

  2. The time period of evaluation for the HAMD 17 is populated in the RSEVINTX field as an evaluation interval text value, since it cannot be precisely described as an ISO 8601 duration. The evaluation interval for the HAMD 17 is determined based on the sponsor's stated evaluation interval. 

  3. 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.

    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. Question 16 Item 16 contains 2 components, Part A “Loss of weight according to the patient” and Part B “Loss of weight according to weekly measurements”. Only one 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.

  5. 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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Dataset wrap
Namers


Rowcaps


Row 16:Represents question item 16 Part A when the subject answered the weight loss according to the patient.
Row 17:

Represents question 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.



Dataset2


ROWSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSREASNDRSLOBXFLVISITNUMRSDTCRSEVLINT
1STUDYXRS2324-P00011HAMD101HAMD1-Depressed MoodHAMD 17Absent.00

Y12019-11-16-P1W
2STUDYXRS2324-P00012HAMD102HAMD1-Feelings of GuiltHAMD 17Self reproach, feels he/she has let people down.11

Y12019-11-16-P1W
3STUDYXRS2324-P00013HAMD103HAMD1-SuicideHAMD 17Ideas or gestures of suicide.33

Y12019-11-16-P1W
4STUDYXRS2324-P00014HAMD104HAMD1-Insomnia Early - Early NightHAMD 17No difficulty falling asleep.00

Y12019-11-16-P1W
5STUDYXRS2324-P00015HAMD105HAMD1-Insomnia Middle - Middle NightHAMD 17No difficulty.00

Y12019-11-16-P1W
6STUDYXRS2324-P00016HAMD106HAMD1-Insomnia Early Hours -MorningHAMD 17No difficulty.00

Y12019-11-16-P1W
7STUDYXRS2324-P00017HAMD107HAMD1-Work and ActivitiesHAMD 17No difficulty.00

Y12019-11-16-P1W
8STUDYXRS2324-P00018HAMD108HAMD1-RetardationHAMD 17Slight retardation during the interview.11

Y12019-11-16-P1W
9STUDYXRS2324-P00019HAMD109HAMD1-AgitationHAMD 17Fidgetiness.11

Y12019-11-16-P1W
10STUDYXRS2324-P000110HAMD110HAMD1-Anxiety PsychicHAMD 17No difficulty.00

Y12019-11-16-P1W
11STUDYXRS2324-P000111HAMD111HAMD1-Anxiety SomaticHAMD 17Moderate.22

Y12019-11-16-P1W
12STUDYXRS2324-P000112HAMD112HAMD1-Somatic Symptoms GIHAMD 17None.00

Y12019-11-16-P1W
13STUDYXRS2324-P000113HAMD113HAMD1-General Somatic SymptomsHAMD 17None.00

Y12019-11-16-P1W
14STUDYXRS2324-P000114HAMD114HAMD1-Genital SymptomsHAMD 17Mild.11

Y12019-11-16-P1W
15STUDYXRS2324-P000115HAMD115HAMD1-HypochondriasisHAMD 17Not present.00

Y12019-11-16-P1W
16STUDYXRS2324-P000116HAMD116AHAMD1-Loss of WT According to PatientHAMD 17Definite (according to patient) weight loss.22

Y12019-11-16-P1W
17STUDYXRS2324-P000117HAMD116BHAMD1-Loss of WT According to WK MeasHAMD 17


NOT DONELOGICALLY SKIPPED ITEMY12019-11-16-P1W
18STUDYXRS2324-P000118HAMD117HAMD1-InsightHAMD 17Denies being ill at all.22

Y12019-11-16-P1W
19STUDYXRS2324-P000119HAMD118HAMD1-Total ScoreHAMD 17161616

Y12019-11-16-P1W
20STUDYXRS2324-P000120HAMD101HAMD1-Depressed MoodHAMD 17


NOT DONE

22019-11-23-P1W
21STUDYXRS2324-P000121HAMD102HAMD1-Feelings of GuiltHAMD 17


NOT DONE

22019-11-23-P1W
22STUDYXRS2324-P000122HAMD103HAMD1-SuicideHAMD 17


NOT DONE

22019-11-23-P1W
23STUDYXRS2324-P000123HAMD104HAMD1-Insomnia Early - Early NightHAMD 17


NOT DONE

22019-11-23-P1W
24STUDYXRS2324-P000124HAMD105HAMD1-Insomnia Middle - Middle NightHAMD 17


NOT DONE

22019-11-23-P1W
25STUDYXRS2324-P000125HAMD106HAMD1-Insomnia Early Hours -MorningHAMD 17


NOT DONE

22019-11-23-P1W
26STUDYXRS2324-P000126HAMD107HAMD1-Work and ActivitiesHAMD 17


NOT DONE

22019-11-23-P1W
27STUDYXRS2324-P000127HAMD108HAMD1-RetardationHAMD 17


NOT DONE

22019-11-23-P1W
28STUDYXRS2324-P000128HAMD109HAMD1-AgitationHAMD 17


NOT DONE

22019-11-23-P1W
29STUDYXRS2324-P000129HAMD110HAMD1-Anxiety PsychicHAMD 17


NOT DONE

22019-11-23-P1W
30STUDYXRS2324-P000130HAMD111HAMD1-Anxiety SomaticHAMD 17


NOT DONE

22019-11-23-P1W
31STUDYXRS2324-P000131HAMD112HAMD1-Somatic Symptoms GIHAMD 17


NOT DONE

22019-11-23-P1W
32STUDYXRS2324-P000132HAMD113HAMD1-General Somatic SymptomsHAMD 17


NOT DONE

22019-11-23-P1W
33STUDYXRS2324-P000133HAMD114HAMD1-Genital SymptomsHAMD 17


NOT DONE

22019-11-23-P1W
34STUDYXRS2324-P000134HAMD115HAMD1-HypochondriasisHAMD 17


NOT DONE

22019-11-23-P1W
35STUDYXRS2324-P000135HAMD116AHAMD1-Loss of WT According to PatientHAMD 17


NOT DONE

22019-11-23-P1W
36STUDYXRS2324-P000136HAMD116BHAMD1-Loss of WT According to WK MeasHAMD 17


NOT DONE

22019-11-23-P1W
37STUDYXRS2324-P000137HAMD117HAMD1-InsightHAMD 17


NOT DONE

22019-11-23-P1W
38STUDYXRS2324-P000138HAMD118HAMD1-Total ScoreHAMD 17


NOT DONE

22019-11-23-P1W



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