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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

Critical Path Institute owns the copyright for the ADSD V1.0 instrument and has granted CDISC permission to include this supplement 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 instrument. 

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The ADSD V1.0 is a 6-item PRO measure to assess self-reported severity of asthma symptoms during the day. Each item is rated on an 11-point numeric rating scale. A total score is also capturedrepresented as described in the manual.

1. The scale points include a 0 to 10 rating with 0 = "None", 10 = "As bad as you can imagine", and all points in between only having a numeric value. For the ADSD V1.0, QSORRES is populated with the text description for "None" and "As bad as you can imagine" and the numeric value for all other answers, 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 ADSD V1.0 is populated in the QSEVINTXwhen the evaluation interval can be precisely described as duration. The evaluation interval for the ADSD V1.0 is since you got up this morning (QSEVINTX = "SINCE GETTING UP THIS MORNING").

3. The ADSD V1.0 instrument includes a total score that is not collected on the ADSD v1.0 CRF but is described in the manual

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   showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-179

   , 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

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      showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-178

      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. QSCAT, QSTESTCD, and QSTEST values are included in CDISC Controlled Terminology.

   2. A full list of value sets for the result field is provided in Section 4, SDTM Mapping Strategy.

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