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| Title | Kurtzke Functional System Scores (KFSS) |
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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 | 2.1 |
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| Status | Revision Draft |
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| Date | 2022-10-0720 |
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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 |
2022-10-07 | 2.1 Revision Draft | - Added the description of the relationship between the Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments are (i.e., intended to be used in conjunction with one another) in section Section 3.1, Assumptions for the RS Domain Model.
- Re-ordered Reordered the assumptions based on the current QRS supplement template. Not No new content was added to any assumptions.
- Updated the example with row cations instead of retaining the descriptions in paragraph form.
- Updated the examples example's missing visit, by removing the RSDTC value, based on the current QRS supplement template.
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2021-04-03 | 2.0 | - 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 RSEVAL assumption and variable was removed from this supplement, since it is not captured on the CRF and no assumptions are made on the potential values.
- The example replaced the RSBLFL variable with RSLOBXFL.
- Updated assumption 4 on the handling of results for RSTESTCD = "KFSS108" and "KFSS108A" and updated the example accordingly.
- Updated the example description for clarity and included the representation that at visit 2, the instrument was not conducted.
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2014-02-19 | 1.1 | Kurtzke Functional Systems Scores (KFSS) Revised - Added “Other Functions” category to the CRF, resulting in two additional QSTESTCDs (KFSS108 and KFSS108A).
- Added Assumption 4 specifying how to record responses to KFSS108A.
- Modified wording of answer choices on CRF to match wording in reference article.
- Modified Assumptions 1 and 3 to reflect the updated CRF.
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| 2013-11-13 | 1.0 | Kurtzke Functional Systems Scores (KFSS) |
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The KFSS consists of 7 functional systems (plus “other”) with an ordinal clinical rating scale for each functional system in either a 7-point, 6-point, or 2-point scale. The functional systems included in the KFSS are the pyramidal, cerebellar, brain stem, sensory, bowel/bladder, visual, cerebral, and other functions. In addition to the functional system rating scales, there are 2 additional questions asking about weakness and temporal pallor, which could affect the ratings.
The Kurtzke Functional Systems Scores (KFSS) and Kurtzke Expanded Disability Status Scale (EDSS) instruments are intended to be used in conjunction with one another. The KFSS should first be administered by the evaluator and ; 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 one in 1 or more in the Functional System (FS) scores. Please review the published Kurtzke Expanded Disability Status Scale (EDSS) for details on the related EDSS score.
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