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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 | 20202021-0801-1605 |
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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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20202021-0801-1605 | 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 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.
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2013-10-23 | 1.0 | Final |
© 2020 2021 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
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Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at: https://www.cdisc.org/standards/terminology/controlled-terminology.
Reference for the EDSS:
- Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52.
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