Page History

...

1. Respondents respond to each of the 7 items using a 5-point verbal rating scale

   Jira
   showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-231

   from either "No <symptom> at All" to "Very Severe <symptom>", or from "Never" to "Always", (depending on the item's question structure) relative to either intensity or frequency. For the NSCLC-SAQ V1.0, QSORRES is populated with the text description of the rating scale response chosen.  

2. Jira
   server Issue Tracker (JIRA) columns key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-232

   No score is displayed for any item on the questionnaire in either the paper form or the electronic format; however, the user manual for the CRF includes the standardized representation of 0 (e.g., "No Coughing at All”, “No Pain at All”, “Never”) through 4 (e.g., “Very Severe Coughing”, "Very Severe Pain", “Always”). Because (a) electronic administration is expected frequently, (b) instructions are provided in the user manual

   Jira
   showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-233

   for scoring from C-Path's PRO Consortium, and (c) the numeric score for each question is expected to be submitted with the data, CDISC will represent the standardized scores in QSSTRESC and QSSTRESN.

3. The time period of evaluation for the NSCLC-SAQ V1.0 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 NSCLC-SAQ V1.0 is the past 7 days.
   

4. A total score ranging from 0-20, not collected on the NSCLC-SAQ V1.0 CRF, may be submitted as an Electronic Data Transfer (eDT)

   Jira
   showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-234

   along with the individual item data for the NSCLC-SAQ V1.0. This original result will be recorded in QSORRES and a standardized representation of the score will be populated in QSSTRESC and QSSTRESN when it is included. 

   Jira
   server Issue Tracker (JIRA) columns key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-235

   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.

      Jira
      showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-236

      However, when the subtotal and total scores are received from a central provider or vendor, the value would go into QSORRES and

      Jira
      server Issue Tracker (JIRA) columns key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-237

      would be null (See SDTMIG Section: 4.1.8.1, Origin Metadata for Variables).

5. Subscores for the NSCLC-SAQ V1.0 concept domains (e.g., cough) will be derived in the Analysis Data Model (ADaM).

   Jira
   showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-238

6. Terminology

   1. QSCAT, QSTESTCD, and QSTEST

      Jira
      server Issue Tracker (JIRA) columns key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-239

       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.

...