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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 | 2021-0309-2608 |
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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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| 2021-0309-2608 | 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, 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.
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| 2013-10-23 | 1.0 Final |
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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 (P0016) who did not complete the instrument at the baseline visitthat was not evaluated on this instrument at visit 1. Since the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.
| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | RSSEQ | RSTESTCD | RSTEST | RSCAT | RSORRES | RSSTRESC | RSSTRESN | RSSTAT | RSLOBXFL | VISITNUM | RSDTC | | 1 | STUDYX | RS | P0001 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Normal neurological exam. | 0 | 0 |
| Y | 1 | 2012-11-16 | | 2 | STUDYX | RS | P0002 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | No disability, minimal signs in one FS. | 1 | 1 |
| Y | 1 | 2012-11-16 | | 3 | STUDYX | RS | P0003 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | No disability, minimal signs in more than one FS. | 1.5 | 1.5 |
| Y | 1 | 2012-11-16 | | 4 | STUDYX | RS | P0004 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Minimal disability in one FS. | 2 | 2 |
| Y | 1 | 2012-11-16 | | 5 | STUDYX | RS | P0005 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Minimal disability in two FS. | 2.5 | 2.5 |
| Y | 1 | 2012-11-16 | | 6 | STUDYX | RS | P0006 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Moderate disability in one FS or mild disability in three or four FS though fully ambulatory. | 3 | 3 |
| Y | 1 | 2012-11-16 | | 7 | STUDYX | RS | P0007 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Fully ambulatory but with moderate disability in one FS and one or two FS grade 2; or two FS grade 3 or five grade 2. | 3.5 | 3.5 |
| Y | 1 | 2012-11-16 | | 8 | STUDYX | RS | P0008 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | 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. | 4 | 4 |
| Y | 1 | 2012-11-16 | | 9 | STUDYX | RS | P0009 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | 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. | 4.5 | 4.5 |
| Y | 1 | 2012-11-16 | | 10 | STUDYX | RS | P0010 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | 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). | 5 | 5 |
| Y | 1 | 2012-11-16 | | 11 | STUDYX | RS | P0011 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Ambulatory without aid for about 100 meters; disability severe enough to preclude full daily activities. | 5.5 | 5.5 |
| Y | 1 | 2012-11-16 | | 12 | STUDYX | RS | P0012 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting. | 6 | 6 |
| Y | 1 | 2012-11-16 | | 13 | STUDYX | RS | P0013 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | Constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting. | 6.5 | 6.5 |
| Y | 1 | 2012-11-16 | | 14 | STUDYX | RS | P0014 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | 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. | 7 | 7 |
| Y | 1 | 2012-11-16 | | 15 | STUDYX | RS | P0015 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS | 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. | 7.5 | 7.5 |
| Y | 1 | 2012-11-16 | | 16 | STUDYX | RS | P0016 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS |
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| NOT DONEY |
| 12012-11-16 |
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4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.
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