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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 QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS 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 depressive symptoms. It consists of 30 items, each rated on a 4-point scale. A total score between 0-84 is also captured.

• 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 QS Domain Model

3.1 Assumptions for the QS Domain Model

All assumptions and business rules described in the SDTMIG QS 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 0-84 is also captured.

1. The scale points include a numeric rating (0-2 or 0-4) and a definition of Include a description of scale score or other possible responses (You may need multiple numbered points for this, tho the IDS-SR did not.). For scale scores use the following language: The scale points include a numeric rating (0-3) and a definition of what is represented by the rating (e.g., 0 = "I never take longer than 30 minutes to fall asleepAbsent"). 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. Include a description of the evaluation interval if one exists. This may be numeric (QSEVLINT) or text (QSEVINTX). When the evaluation interval is provided in text and cannot be described in ISO 8601 format, use QSEVINTX instead of "The time period of evaluation for the HAMD 17 is populated in the QSEVLINT field in ISO 8601 format " and replace "the past 7 days" with the text (e.g., "DAYTIME'". Refer to SDTMIG Section 2.2.5 Timing Variables for All Classes. The evaluation interval needs to be clearly defined on the CRF. Remove this point if it does not apply.: The time period of evaluation for the HAMD 17 is populated in the QSEVLINT field in ISO 8601 format (or QSEVINTX, as appropriate) when the evaluation interval can be precisely described as duration. The evaluation interval for the HAMD 17 is the past 7 days (QSEVLINT = "-P7D").

3. If there are subcategories, include a note that subcategories will be represented in QSSCAT. Also provide a list of the subcategories unless one is already provided in the description preceding the assumptions. Remove this point if it does not apply.

4. If the instrument standards currently being developed includes logically skipped items, insert:  'Some items on the HAMD 17 may be logically skipped per the instrument instructions. Language to be used for this assumption is currently under review.'

   This language is currently under review. Remove this point if it does not apply.:  Some items on the HAMD 17 may be logically skipped per the instrument instructions.  Responses for logically skipped items should be (1) recorded and/or scored according to the instructions provided in the instrument’s user manual, scoring manual, or other documentation provided by the instrument developer and (2) included in the submission dataset. If such instructions are not available, then records for logically skipped items should be included in the submission dataset with:
   ·       QSSTAT = NOT DONE;
   ·       QSREASND = LOGICALLY SKIPPED ITEM; and
   ·       QSORRES, QSSTRESC, and QSSTRESN all set to null
   When submitting data to US FDA or some other regulatory authority to support regulatory review of a medical product, if the electronic data collection system is not capable of automatically populating records for logically skipped items, these records should be post-populated prior to submission and the sponsor will need to explain this in the corresponding reviewer's guide.

5. Include this point if score(s) are submitted to SDTM. Use the following language as stated if this point applies to the new instrument. Remove this point if it does not apply.: The HAMD 17 instrument includes a total score (and other scores as needed.  If so, change "that is" to "that are") 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).

6. This language is currently under review. Evaluator information is only to be included when the information is collected directly on the CRF. clinical classifications will no longer be using QSEVAL/QSEVALID; however RSEVAL/RSEVALID and FTEVAL/FTEVALID will continue to be used on Clinical Classifications and Functional Tests. Language for Clinical Classifications and Functional tests follows; language for clinical classifications is currently under review. Remove this point if it does not apply.

   For Clinical Classifications and Functional Tests (only when collected on the CRF):  The evaluator is stored in RSEVAL (FTEVAL). For HAMD 17, the evaluator is defined as the (the appropriate term from controlled terminology). Alternatively, if only evaluator name or initials could be collected: For HAMD 17, sponsors should follow their internal data management procedures on representing the name or initials of the evaluator. CDISC Controlled Terminology is available for Evaluator (e.g., --EVAL = "HEALTH CARE PROFESSIONAL") and Medical Evaluator (e.g., --EVALID = "RATER 1"). To reiterate, only include this point if the evaluator/administrator is collected directly on the CRF.

7. Include this point if there are comments at the end of the instrument. Remove this point if it does not apply.: Comments located at the end of the HAMD 17 will be recorded in the Comments domain (CO). All assumptions and business rules described in the SDTMIG CO domain are applicable.

8. when the evaluation interval can be precisely described as duration. The evaluation interval for the HAMD 17 is the past 7 week (QSEVLINT = "-P1W").

9. 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)

   Include this point if there are responses over 200 characters. Remove this point if it does not apply: Some responses to the HAMD 17 questions exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which question responses were revised in order to fit the 200-character limit

   1. .

10. Terminology

    1. QSCAT, QSTESTCD, and QSTEST (and other variables such as QSORRESU as needed) values are included in CDISC Controlled Terminology.

    2. A full list of value sets for the qualifier, timing, result, and unit fields is provided in Section 4, SDTM Mapping Strategy. (Note: Only the result field is always used. Include qualifier, timing, and unit fields as needed and remove this note.)

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