Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

DateVersionSummary of Changes
2021-02-192.0 Draft
  • 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 wiki Cinical 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.
  • 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.
2013-10-231.0 Final


...

  1. The scale points include a numeric rating (0-10) and a definition of what is represented by the rating (e.g., 2.5 = "Minimal disability in two FS."). For  For the EDSS, 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. Three responses to the EDSS ratings exceeded the 200-character limit for the RSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit.

  3. Terminology

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

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

...

The table represents the items from the EDSS instrument. Rows 8, 9, and 14 represent RSORRES values that needed to be shortened in order to meet the 200-character SAS V5 transport file V5 restriction. Row 16 represents a subject that Subject P0016 did (P0016) who did not complete the instrument at the baseline visit.

...