Revision History

© 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.

The table represents the items from the HAMD 17 form.

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.

5 Supplemental Qualifier Name Codes

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

End of Document