Versions Compared

Old Version 51

changes.mady.by.user Steve Kopko

Saved on

compared with

New Version 52

changes.mady.by.user Steve Kopko

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Page properties


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
Date2020-0206-2804
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.


...

DateVersionSummary of Changes
2020-0206-2804
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 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 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.
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

...

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 http://www.cdisc.org/standards/terminology/controlled-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. .

  • Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

...

The HAMD 17 is a multiple-choice clinical classification that clinicians may use to assess the severity of major depression. 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 subjects, rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. It consists of 17 items, each rated on a 3-point, 4-point, or 5-point scale. A total score between 0-53 is also captured.

  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.", 3 = "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 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  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 total score is considered as captured data when provided as part of Electronic Data Transfer (eDT) 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 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 qsin rs.xpt for all items. The unanswered component is considered as a "logically skipped item" in the data and is represented as follows:

    1. QSSTAT RSSTAT = "NOT DONE".       

    2. QSREASND RSREASND = "LOGICALLY SKIPPED ITEM".

    3. QSORRESRSORRES, QSSTRESCRSSTRESC, and QSSTRESN 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.

...