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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 | 2022-1012-2012 |
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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 |
2022-1012-2012 | 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 (i.e., intended to be used in conjunction with one another) in Section 3.1, Assumptions for the RS Domain Model.
- Reordered the assumptions based on the current QRS supplement template. No new content was added to any assumptions.
- Updated the example with row cations
| 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-503 |
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instead of retaining the descriptions in paragraph form. - Updated the 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 example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 1 subject collected at the baseline visit and a visit 2 represented as not being collected for the KFSS instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented in QSORRESRSORRES| 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-502 |
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.This result is then represented as a standard numeric score in QSSTRESN and in RSSTRESN and as a standard character representation in QSSTRESCin RSSTRESC. Character only responses, such as "Unknown" are represented in RSORRES and RSSTRESC and QSSTRESN RSSTRESN is null as there are no standardized numeric result.
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