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| Title | Kurtzke Expanded Disability Status Scale (EDSS) |
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| CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
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| QRS Short Name | |
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| QRS Permission Status | Public Domain |
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| Team | Multiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
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| Supplement Version | 2.0 |
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| Status | DRAFT |
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| Date | 2021-0102-1219 |
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| Notes | This 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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| Date | Version | Summary of Changes |
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| 2021-0102-1219 | 2.0 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 Cinical 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.
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| 2013-10-23 | 1.0 | Final |
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| Info |
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We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below. |
The table represents the item items from the the EDSS instrument. Rows 8, 9, 14 and 14 represent RSORRES values that needed to be shortened in order to meet the 200 character SAS transport file V5 restriction. Row -character SAS V5 transport file V5 restriction. Row 16 represents a subject that did 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"
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