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Title

Kurtzke Expanded Disability Status Scale (EDSS)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

EDSS

QRS Permission StatusPublic Domain
TeamMultiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusDRAFT
Date2020-08-1516
NotesThis supplement is intended to be used with other CDISC user guides for specific therapeutic/disease areas and follows the CDISC Study Data Tabulation Model Implementation Guide for Human Clinical Trials.


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DateVersionSummary of Changes
2020-08-15162.0 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 clinical classifications supplement template.
  • The RSEVAL assumption was removed from this supplement, since 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 15 subjects. The original VISITNUM = 2 was revised to 1 and the RSLOBXFL variable was added to represent a baseline response.
  • Updated the example by adding USUBJID = "P0016" to represent how a missing visit is handled when the instrument was not filled out.
2013-10-231.0

Final

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  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 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. Some responses (3 specifically) to Three responses to the EDSS ratings exceeded the 200-character limit for the QSORRES 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.

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The EDSS example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 16 subjects collected at the baseline visit for the EDSS instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.

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