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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 | 2022-0910-2907 |
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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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2022-0910-2907| 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 are intended to be used in conjunction with one another in section 3.1 Assumptions for theRSDomain Model. - Updated the example to include a subjects 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 subjects EDSS score.
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| 2013-10-23 | 1.0 Final |
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The KFSS responses are used to determine the EDSS score.| 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-488 |
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Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, 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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| Rowcaps |
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Rows 12-22: Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. |
| Dataset2 |
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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 | KFSS101 | KFSS1-Pyramidal Functions | KFSS | Minimal disability | 2 | 2 |
| Y | 1 | 2012-11-16 | | 2 | STUDYX | RS | P0001 | 2 | KFSS102 | KFSS1-Cerebellar Functions | KFSS | Mild ataxia | 2 | 2 |
| Y | 1 | 2012-11-16 | | 3 | STUDYX | RS | P0001 | 3 | KFSS102A | KFSS1-Weakness Interferes With Testing | KFSS | NOT CHECKED | NOT CHECKED |
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| Y | 1 | 2012-11-16 | | 4 | STUDYX | RS | P0001 | 4 | KFSS103 | KFSS1-Brain Stem Functions | KFSS | Normal | 0 | 0 |
| Y | 1 | 2012-11-16 | | 5 | STUDYX | RS | P0001 | 5 | KFSS104 | KFSS1-Sensory Functions | KFSS | Vibration or figure-writing decrease only, in one or two limbs | 1 | 1 |
| Y | 1 | 2012-11-16 | | 6 | STUDYX | RS | P0001 | 6 | KFSS105 | KFSS1-Bowel and Bladder Functions | KFSS | Normal | 0 | 0 |
| Y | 1 | 2012-11-16 | | 7 | STUDYX | RS | P0001 | 7 | KFSS106 | KFSS1-Visual or Optic Functions | KFSS | Scotoma with visual acuity (corrected) better than 20/30 | 1 | 1 |
| Y | 1 | 2012-11-16 | | 8 | STUDYX | RS | P0001 | 8 | KFSS106A | KFSS1-Presence of Temporal Pallor | KFSS | CHECKED | CHECKED |
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| Y | 1 | 2012-11-16 | | 9 | STUDYX | RS | P0001 | 9 | KFSS107 | KFSS1-Cerebral or Mental Functions | KFSS | Unknown | Unknown |
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| Y | 1 | 2012-11-16 | | 10 | STUDYX | RS | P0001 | 10 | KFSS108 | KFSS1-Other Functions | KFSS | None | 0 | 0 |
| Y | 1 | 2012-11-16 | | 11 | STUDYX | RS | P0001 | 11 | KFSS108A | KFSS1-Other Functions Specify | KFSS |
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| NOT DONE | Y | 1 | 2012-11-16 | | 12 | STUDYX | RS | P0001 | 12 | KFSS101 | KFSS1-Pyramidal Functions | KFSS |
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| NOT DONE |
| 22012-12-16 |
| | 13 | STUDYX | RS | P0001 | 13 | KFSS102 | KFSS1-Cerebellar Functions | KFSS |
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| NOT DONE |
| 2 | 2012-12-16 |
| | 14 | STUDYX | RS | P0001 | 14 | KFSS102A | KFSS1-Weakness Interferes With Testing | KFSS |
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| NOT DONE |
| 2 | 2012-12-16 |
| | 15 | STUDYX | RS | P0001 | 15 | KFSS103 | KFSS1-Brain Stem Functions | KFSS |
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| NOT DONE |
| 2 |
| | 2012-12-16 | 16 | STUDYX | RS | P0001 | 16 | KFSS104 | KFSS1-Sensory Functions | KFSS |
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| NOT DONE |
| 22012-12-16 |
| | 17 | STUDYX | RS | P0001 | 17 | KFSS105 | KFSS1-Bowel and Bladder Functions | KFSS |
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| NOT DONE |
| 2 | 2012-12-16 |
| | 18 | STUDYX | RS | P0001 | 18 | KFSS106 | KFSS1-Visual or Optic Functions | KFSS |
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| NOT DONE |
| 22012-12-16 |
| | 19 | STUDYX | RS | P0001 | 19 | KFSS106A | KFSS1-Presence of Temporal Pallor | KFSS |
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| NOT DONE |
| 2 | 2012-12-16 |
| | 20 | STUDYX | RS | P0001 | 20 | KFSS107 | KFSS1-Cerebral or Mental Functions | KFSS |
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| NOT DONE |
| 2 | 2012-12-16 |
| | 21 | STUDYX | RS | P0001 | 21 | KFSS108 | KFSS1-Other Functions | KFSS |
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| NOT DONE |
| 22012-12-16 |
| | 22 | STUDYX | RS | P0001 | 22 | KFSS108A | KFSS1-Other Functions Specify | KFSS |
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| NOT DONE |
| 22012-12-16 | |
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| Dataset wrap |
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| Rowcaps |
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| Row 1: | Represent he subjects EDSS score based on the subjects KFSS visit 1 responses including 2 FS grade 2 and others either 0 or 1 responses. | | Row 2: | Represent that the subject| 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-391 |
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that was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred |
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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 | Minimal disability in two FS. | 2.5 | 2.5 |
| Y | 1 | 2012-11-16 | | 2 | STUDYX | RS | P0001 | 1 | EDSS0101 | EDSS01-Expanded Disability Score | EDSS |
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| NOT DONE |
| 2 | 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-390 |
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