...
| Page properties |
|---|
| Title | Kurtzke Expanded Disability Status Scale (EDSS) |
|---|
| CDISC Reference | Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials |
|---|
| QRS Short Name | |
|---|
| QRS Permission Status | Public Domain |
|---|
| Team | Multiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam |
|---|
| Supplement Version | 2.0 |
|---|
| Status | DRAFT |
|---|
| Date | 2021-0911-0830 |
|---|
| 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. |
|---|
|
...
| Date | Version | Summary of Changes |
|---|
| 2021-0911-0830 | 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.
|
| 2013-10-23 | 1.0 Final |
|
...
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 restrictionfile restriction. Row 16 represents a subject (P0016) that was not evaluated on this instrument at visit 1. Since Because the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.
...