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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 Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.1
StatusDRAFT
Date2019-11-12
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
2019-11-122.1 Draft
  • The RSEVAL variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
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 QSTESTCD and QSTEST 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. It is presently one of the most commonly used scales for rating depression in medical research.

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 and 5-point scales. 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, QSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables QSSTRESC and QSSTRESN.

  2. The time period of evaluation for the HAMD 17 is populated in the QSEVLINT 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 (QSEVLINT = "-P1W").

  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. 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

RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSLOBXFLVISITNUMRSEVLINT
1STUDYXRS2324-P00011HAMD101HAMD1-Depressed MoodHAMD 17Absent.00Y1-P1W
2STUDYXRS2324-P00012HAMD102HAMD1-Feelings of GuiltHAMD 17Self reproach, feels he/she has let people down.11Y1-P1W
3STUDYXRS2324-P00013HAMD103HAMD1-SuicideHAMD 17Ideas or gestures suicide.33Y1-P1W
4STUDYXRS2324-P00014HAMD104HAMD1-Insomnia Early - Early NightHAMD 17No difficulty falling asleep.00Y1-P1W
5STUDYXRS2324-P00015HAMD105HAMD1-Insomnia Middle - Middle NightHAMD 17No difficulty.00Y1-P1W
6STUDYXRS2324-P00016HAMD106HAMD1-Insomnia Early Hours -MorningHAMD 17No difficulty.00Y1-P1W
7STUDYXRS2324-P00017HAMD107HAMD1-Work and ActivitiesHAMD 17No difficulty.00Y1-P1W
8STUDYXRS2324-P00018HAMD108HAMD1-RetardationHAMD 17Complete stupor.44Y1-P1W
9STUDYXRS2324-P00019HAMD109HAMD1-AgitationHAMD 17Fidgetiness.11Y1-P1W
10STUDYXRS2324-P000110HAMD110HAMD1-Anxiety PsychicHAMD 17No difficulty.00Y1-P1W
11STUDYXRS2324-P000111HAMD111HAMD1-Anxiety SomaticHAMD 17Moderate.22Y1-P1W
12STUDYXRS2324-P000112HAMD112HAMD1-Somatic Symptoms GIHAMD 17None.00Y1-P1W
13STUDYXRS2324-P000113HAMD113HAMD1-General Somatic SymptomsHAMD 17None.00Y1-P1W
14STUDYXRS2324-P000114HAMD114HAMD1-Genital SymptomsHAMD 17Mild.11Y1-P1W
15STUDYXRS2324-P000115HAMD115HAMD1-HypochondriasisHAMD 17Not present.00Y1-P1W
16STUDYXRS2324-P000116HAMD116AHAMD1-Loss of WT According to PatientHAMD 17Definite (according to patient) weight loss.22Y1-P1W
17STUDYXRS2324-P000117HAMD116BHAMD1-Loss of WT According to WK MeasHAMD 17XXXXXXXXXY1-P1W
18STUDYXRS2324-P000118HAMD117HAMD1-InsightHAMD 17Denies being ill at all.22Y1-P1W
19STUDYXRS2324-P000119HAMD118HAMD1-Total ScoreHAMD 17161616Y1-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 QS domain. It also provides guidance on how the result variables (QSORRES, QSSTRESC, and QSSTRESN) should be populated.

Include mappings for all sets of result values. For ease of use of this template, the complete set of response values for the example in Section 3.2 is not included.

If the instrument has been entered into QRS Maker (all instruments should be), then the complete set of response values can be copied from QRS Maker and pasted into this supplement.

Some example mappings are below.

For QRS instruments with subcategories:

When subcategories are used on an instrument, a table with the following introduction information should appear before the mappings for results.

QSSCAT alignment with QSTESTCD

As stated in Section 3.1 assumptions, items on the HAMD 17 are grouped into subcategories. The table below includes the subcategory names along with the applicable item numbers for each category. The values of the subcategories are used to populate QSSCAT and are annotated on the CRF.

QSSCATQSTESTCD
EMOTIONAL/INFORMATIONAL SUPPORTQSSS0101 - QSSS0108
TANGIBLE SUPPORTQSSS0109 - QSSS0112
AFFECTIONATE SUPPORTQSSS0113 - QSSS0115
POSITIVE SOCIAL INTERACTIONQSSS0116 - QSSS0118
ADDITIONAL ITEMQSSS0119

If all items have the same original result values, with the same standardized character and numeric values, then only include one table showing the values of QSORRES/QSSTRESC/QSSTRESN and put "All QSTESTCDs" (title case "All", and in quotes) above the table:

"All QSTESTCDs"

QSORRESQSSTRESCQSSTRESN
Original result 100
Original result 211
Original result 322

Similarly, if some, but not all, QSTESTCDs share the same original result and standardized values, then the QSTESTCD and corresponding QSTEST values are put in a list above the table rather than providing a separate table for each QSTESTCD/QSTEST.

If there are responses that correspond to non-consecutive items or 1-7 consecutive items, include the test codes and test names above the table with the responses as follows:

QSTESTCD = "test code 1" QSTEST = "test name 1"


QSTESTCD = "test code 4" QSTEST = "test name 4"


QSTESTCD = "test code 5" QSTEST = "test name 5"

QSTESTCD = "test code 6" QSTEST = "test name 6"

QSTESTCD = "test code 7" QSTEST = "test name 7"

QSTESTCD = "test code 8" QSTEST = "test name 8"

QSTESTCD = "test code 15" QSTEST = "test name 15"

QSTESTCD = "test code 22" QSTEST = "test name 22"


QSTESTCD = "test code 27" QSTEST = "test name 27"


QSTESTCD = "test code 29" QSTEST = "test name 29"

QSORRESQSSTRESCQSSTRESN
I never take longer than 30 minutes to fall asleep00
I take at least 30 minutes to fall asleep, less than half the time11
I take at least 30 minutes to fall asleep, more than half the time22
I take more than 60 minutes to fall asleep, more than half the time33

Omit the QSSTRESN column when it is not applicable to the dataset.

QSTESTCD = "test code" QSTEST = "test name"

QSORRESQSSTRESC
yesY
noN

For responses that are for 8 or more consecutive items, an override label should be used in QRS Maker to show the items that are included as follows:

QSTESTCD = "first test code in sequence" QSTEST = "first test name in sequence" through

QSTESTCD = "last test code in sequence" QSTEST = "last test name in sequence"

QSORRESQSSTRESCQSSTRESN
I have not experienced the physical sensation of feeling weighted down and without physical energy00
I have occasionally experienced periods of feeling physically weighted down and without physical energy, but without a negative effect on work, school, or activity level11
I feel physically weighted down (without physical energy) more than half the time22
I feel physically weighted down (without physical energy) most of the time, several hours per day, several days per week33

5 Supplemental Qualifier Name Codes

The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

Remove Section 5 if it does not apply to the new instrument.

The following table contains additional standard name codes for use in the Supplement Qualifiers for clinical classifications (SUPPQS) special purpose dataset.

QNAMQLABELQVAL
Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).Label for QNAM (e.g., Contact Type)Value of QNAM ( e.g., SUBJECT VISIT)


End of Document

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