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Comment: updated so 16A and B response of 3 (not assessed) is treated as stat not done.

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DateVersionSummary of Changes
2024-03-062.1 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 a note that for assumptions 3b and 5c regarding RSTESTCD = "HAMD116A" and "HAMD116B", a response of RSORRES = "Not assessed." (RSSTRESC and RSSTRESN = 3) is not included in scoring.
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 items
  • Revised annotated CRF to meet annotation font standards
2012-08-071.0

Final

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  1. The original scores include a numeric rating (0-2 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.

    1. Items with RSTESTCD = HAMD116A and HAMD116B also have a response of RSORRES = "Not assessed." (RSSTRESC and RSSCTRESN = 3). Subject data for this response is included in the SDTM representation of the data, but not included in the scoring of the HAMD 17.

  2. 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.

  3. 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 and HAMD116B have a response of RSORRES = "Not assessed." (RSSTRESC and RSSCTRESN = 3). 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.

  4. 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).

  5. 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.

    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." (RSSTRESC and RSSTRESN = 3) is not included in scoring for the HAMD 17.

  6. 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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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.22Not assessed.33

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

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