2022-09-29

• This measure was re-evaluated to fit the definition of a clinical classification measure. The domain was changed from the QS to RS domain.
  
• The EDSS v2.0 supplement was updated to the wiki Clinical Classifications supplement template.
• The RSEVAL assumption was removed from this supplement, because it is not captured on the CRF and no assumptions are made on the potential values to include in the example.

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  showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key QRSSUPP-381

  
  
• The example was reduced from 20 to 16 subjects. The original VISITNUM = 2 was revised to 1 and the RSLOBXFL variable was added to represent a baseline response.
• The example was updated by adding USUBJID = "P0016" to represent how a missing visit is handled when the instrument was not filled out.
• Added the description of the Functional Systems (FS) to section 4 SDTM Mapping Strategy.Added the description of the relationship between the Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments are intended to be used in conjunction with one another in section 3.1 Assumptions for theRSDomain Model.
• Updated the example to include a subjects example of the KFSS responses serving as the source to determine the subjects EDSS score.