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| title | Information for Reviewers |
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Text in black is part of the template used to create this document and is not revised under CDISC internal or public review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument. |
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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 | 20222023-1009-2005 |
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| Notes for Reviewers | 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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20222023-1009-2005| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-382 |
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| 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.
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-381 |
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- 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.
- Added the description of the relationship
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-485 |
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between the Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments (i.e., intended to be used in conjunction with one another) in Section 3.1, Assumptions for theRSDomain Model. - Updated the example to include a subject's example of the KFSS responses
| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-484 |
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serving as the source to determine the subject's EDSS score.
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| 2013-10-23 | 1.0 Final |
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The EDSS is an ordinal clinical rating scale that is used to measure the disability status of subjects. The item response is a range from 0 to 10 in half-point increments that measures the disability status.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-726 |
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The Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments are intended to be used in conjunction with one another. The KFSS should first be administered by the evaluator; results from this assessment are then applied to determine an EDSS scale score (Kurtzke, 1983). A change in the EDSS should only occur if there has been a change of 1 or more Functional System (FS)| Jira |
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| server | Issue Tracker (JIRA) |
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| columnIds | issuekey,summary,issuetype,created,updated,duedate,assignee,reporter,priority,status,resolution |
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| columns | key,summary,type,created,updated,due,assignee,reporter,priority,status,resolution |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-479 |
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scores| Jira |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-727 |
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. Please review the published Kurtzke Functional Systems Scores (KFSS) for details on the functional system scores.| Jira |
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| showSummary | false |
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| server | Issue Tracker (JIRA) |
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| serverId | 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 |
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| key | QRSSUPP-482 |
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