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© 2020 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 questionnaires, 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 RSTESTCD and RSTEST 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.

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. 
  

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. 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 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 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 qs.xpt for all items. The unanswered component is considered as a "logically skipped item" in the data and is represented as follows:

   1. QSSTAT = "NOT DONE".       

   2. QSREASND = "LOGICALLY SKIPPED ITEM".
      

   3. QSORRES, QSSTRESC, and QSSTRESN 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.

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. The sponsor's evaluation interval for the example is the past week (RSEVLINT = "-P1W").

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 RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.

RSTESTCD = "HAMD101" RSTEST = "HAMD1-Depressed Mood"

RSTESTCD = "HAMD102" RSTEST = "HAMD1-Feelings of Guilt"

RSTESTCD = "HAMD103" RSTEST = "HAMD1-Suicide"

RSTESTCD = "HAMD104" RSTEST = "HAMD1-Insomnia Early - Early Night"

RSTESTCD = "HAMD105" RSTEST = "HAMD1-Insomnia Middle - Middle Night"

RSTESTCD = "HAMD106" RSTEST = "HAMD1-Insomnia Early Hours - Morning"

RSTESTCD = "HAMD107" RSTEST = "HAMD1-Work and Activities"

RSTESTCD = "HAMD108" RSTEST = "HAMD1-Retardation"

RSTESTCD = "HAMD109" RSTEST = "HAMD1-Agitation"

RSTESTCD = "HAMD110" RSTEST = "HAMD1-Anxiety Psychic"

RSTESTCD = "HAMD111" RSTEST = "HAMD1-Anxiety Somatic"

RSTESTCD = "HAMD112" RSTEST = "HAMD1-Somatic Symptoms GI"

RSTESTCD = "HAMD113" RSTEST = "HAMD1-General Somatic Symptoms"

RSTESTCD = "HAMD114" RSTEST = "HAMD1-Genital Symptoms"

RSTESTCD = "HAMD115" RSTEST = "HAMD1-Hypochondriasis"

RSTESTCD = "HAMD116A" RSTEST = "HAMD1-Loss of WT According to Patient"

RSTESTCD = "HAMD116B" RSTEST = "HAMD1-Loss of WT According to WK Meas"

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

End of Document