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1 Introduction

This document describes the CDISC implementation of the Hamilton Depression Rating Scale 17-Item (HAMD 17) instrument.

CDISC created this There is no known standard case report form (CRF) available for this instrument. CDISC created this CRF to represent the instrument, which CDISC believes is in the public domain. This is not an endorsement of the instrument. The creation of this instrument was 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. 

The representation of data collected for this instrument 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 instrument are meant to be used in conjunction with the SDTMIG. All CDISC questionnaires, ratings, and scales (QRS) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/qrs.

Based on the reference papers “Guy W, ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, 1976” and “The Hamilton Rating Scale for Depression: The making of a ‘‘gold standard’’ and the unmaking of a chronic illness, 1960–1980.”, CDISC made a case for using the current CDISC created CRF for the HAMD 17 CDISC standard. This is not an endorsement of the instrument. The creation of this instrument was 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. 

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/aboutstandards/foundational/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. CDISC disclaims any liability for your use of this material.

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

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. 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 instrument. There may be many versions of this instrument. 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/controlled-terminology.

Reference for the HAMD 17:

sdtmig.

These specific implementation details for this instrument are meant to be used in conjunction with the SDTMIG. All CDISC questionnaires, ratings, and scales (QRS) documentation packages can be found on the CDISC website at: https://www.cdisc.org/standards/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 implement protocols. CDISC disclaims any liability for your use of this material.

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

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. 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 instrument. There may be many versions of this instrument. 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/controlled-terminology.

References for the HAMD 17:

• Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.

• Development of a Rating Scale for

• Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:56–62.

• Development of a Rating Scale for Primary Depressive Illness BY MAX HAMILTON, Department of Psychiatry, University of Lee, Brit. J. soc. Clin. Psychol. (1967), 6, pp. 278-296, Printed in Great Britain.

• Assessment Scales in Depression, Mania and Anxiety, Raymond W Lam, MD, FRCPC, Erin E. Michalak, PhD, Richard P Swinson, MD, FRCPsych, FRCPC, Copyright 2005 Taylor & Francis, an imprint of the Taylor & Francis Group.

• Guy W, ECDEU Assessment Guy W, ECDEU Assessment Manual for Psychopharmacology. Rockville, MD: US Department of Health, Education, and Welfare, 1976.

• The Hamilton Rating Scale for Depression: The making of a ‘‘gold standard’’ and the unmaking of a chronic illness, 1960–1980.

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

• Assessment Scales in Depression, Mania and Anxiety, Raymond W Lam, MD, FRCPC, Erin E. Michalak, PhD, Richard P Swinson, MD, FRCPsych, FRCPC, Copyright 2005 Taylor & Francis, an imprint of the Taylor & Francis Group.

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules 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 instrument that clinicians may use to assess the severity of major depression. Max Hamilton originally published the scale in 1960 and reviewed and evaluated revised it in 1966, 1967, 1969, and 1980. The measure, which . The measure, which is designed for adult subjects, rates the severity of symptoms observed in depression such as (e.g., low mood, insomnia, agitation, anxiety and , weight loss). It consists of 17 items, each rated on a 3-, 4-, or 5-point scale. A total score between 0-53 is 53

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 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 the HAMD 17 is populated in the RSEVLINT  field as an evaluation interval text value, since it cannot variable in ISO 8601 format when the evaluation interval can 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.

   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 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. 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

      Jira
      showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-756

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

      Jira
      showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key ADQRS-332

      ). 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.

5. 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

   Item 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 rs.

   xpt 

   xpt for all items.

    

   The unanswered component is considered conditionally branched in the data and is represented as

   a logically skipped item in the data and is represented as follows:

   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).

6. 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."

      Jira
      showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-757

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

   4. RSSTAT = "NOT DONE".       

   5. RSREASND = "LOGICALLY SKIPPED ITEM".
      

   6. RSORRES, RSSTRESC, and RSSTRESN are set to null.

7. Terminology

   1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result fields 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 and a and  visit 2 represented as not being collected collected for the HAMD 17 instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results original results, matching the CRF item response text, are represented with preferred terminology in RSORRESin QSORRES.This result is then transformed into the represented as a standard numeric score in RSSTRESN  QSSTRESN and as a standard character representation of the standard numeric score in RSSTRESCin QSSTRESC. The sponsor's evaluation interval for the example is the past week (RSEVLINT = "-P1W").

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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.

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

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

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

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

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