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DateVersionSummary of Changes
2021-01-122.0 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 wiki Clinical Classifications supplement template.
  • The RSEVAL assumption was removed from this supplement, since 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.
  • Updated the example by 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

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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 and 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.

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The table represents the item 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 not complete the instrument at the baseline visit.

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The EDSS CRF text for ratings of 4, 4.5, and 7 on the table were abbreviated to fit the 200-character RSORRES limit.

RSTESTCD = "EDSS0101" RSTEST = "EDSS01-Expanded Disability Score"

EDSS CRF Text over 200 charactersRSORRES ValueRSSTRESCRSSTRESN

Normal neurological exam.00

No disability, minimal signs in one 1 FS.11

No disability, minimal signs in more than one 1 FS.1.51.5

Minimal disability in one 1 FS.22

Minimal disability in two 2 FS.2.52.5

Moderate disability in one 1 FS or mild disability in three 3 or four 4 FS though fully ambulatory.33

Fully ambulatory but with moderate disability in one 1 FS and one 1 or two 2 FS grade 2; or two 2 FS grade 3 or five 5 grade 2.3.53.5
Fully ambulatory without aid, self-sufficient, up and about some 12 hours a day despite relatively severe disability consisting of one 1 FS grade 4, or combination of lesser grades exceeding limits of previous steps; able to walk without aid or rest some 500 meters.Fully ambulatory without aid, self-sufficient, up and about some 12 hours a day despite relatively severe disability; able to walk without aid or rest some 500 meters.44
Fully ambulatory without aid, up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance; characterized by relatively severe disability usually consisting of one 1 FS grade 4 or combinations of lesser grades exceeding limits of previous steps; able to walk without aid or rest some 300 meters.Fully ambulatory without aid, up much of the day, able to work a full day, may have some limitation of full activity or require minimal assistance; able to walk without aid or rest some 300 meters.4.54.5

Ambulatory without aid or rest for about 200 meters; disability severe enough to impair full daily activities (e.g., to work a full day without special provisions).55

Ambulatory without aid for about 100 meters; disability severe enough to preclude full daily activities.5.55.5

Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.66

Constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting.6.56.5
Unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day.Unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hrs a day.77

Unable to take more than a few steps; restricted to wheelchair; may need aid in transfer; wheels self but cannot carry on in standard wheelchair a full day; May require motorized wheelchair.7.57.5

Essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms.88

Essentially restricted to bed much of day; has some effective use of arm(s); retains some self-care functions.8.58.5

Helpless bed patient; can communicate and eat.99

Totally helpless bed patient; unable to communicate effectively or eat/swallow.9.59.5

Death due to MS.1010

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