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titleInformation for Reviewers

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

Page properties
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

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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
StatusREVISION DRAFT
Date20212023-1209-0907
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

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for Human Clinical Trials.

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Revision History

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Date

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Version

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Summary of Changes
2023-09-072.1

Revision History

DateVersionSummary of Changes
2021-12-092.1 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.
2016-05-232.0
  • 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

© 2021 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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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  The creation of this instrument was based on 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.  describing the instrument.

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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. 

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

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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.

  1. The scale points include original scores 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 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).

    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.

  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. 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. 8.1, Origin Metadata for Variables).

    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

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    737

    739
    . 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:.

    if scores are received by the sponsor, it is recommended that they are submitted to SDTM and verified in ADaM. JirashowSummary
    1. QNAM = “RSCBRFL”, QLABEL = “Conditional Branched Item Flag“, QVAL = “Y” (this is a RS supplemental qualifier variable related to the record).
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    2. RSORRES, RSSTRESC, and RSSTRESN are set to null (miss

  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.

    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
    1. Subscores and overall scores are represented in--ORRES, --STRESC, and --STRESN.
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    739. 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. 737
    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 repsonsibility to do this verification based on the instrument's user manual or instructions from the copyright owner.
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    1. RSSTAT = "NOT DONE".

    2. RSREASND = "LOGICALLY SKIPPED ITEM".

    3. RSORRES, RSSTRESC, and RSSTRESN are set to null.
      738

  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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