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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 | 2022-0910-2907 |
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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 |
2022-0910-2907 | 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 intended to be used in conjunction with one another in section 3.1 Assumptions for the RS Domain Model.
- Re-ordered the assumptions based on the current QRS supplement template. Not new content was added to any assumptions.
- Updated the example with row cations instead of retaining the descriptions in paragraph form.
- Updated the examples 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 are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC. Character only responses, such as "Unknown" are represented in RSORRES and RSSTRESC.
The table represents The table represents the items from the KFSS form. The subject did not experience KFSS form.
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Row 3: The subject did not experience weakness that interfered with the testing (RSTESTCD = "KFSS102A") |
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. Row 8: The subject did have temporal pallor (RSTESTCD = "KFSS106A"). |
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Row 9: The subject had unknown Cerebral or Mental |
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Functions (RSTESTCD = "KFSS107"). |
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Rows 10-11: Since there were no other functions, RSTESTCD = "KFSS108" is represented with the |
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response RSORRES = “None”. |
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The record for RSTESTCD="KFSS108A" is represented with RSORRES/RSSTRESC/RSSTRESN |
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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. |
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| Name | rs| 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 | Severe ataxia, all limbs | 4 | 4 |
| 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 | Frequent urinary incontinence | 3 | 3 |
| Y | 1 | 2012-11-16 | | 7 | STUDYX | RS | P0001 | 7 | KFSS106 | KFSS1-Visual or Optic Functions | KFSS | Grade 5 plus maximal visual acuity of better eye of 20/60 or less | 6 | 6 |
| 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 |
2 | 2012-12-16 |
| | 13 | STUDYX | RS | P0001 | 13 | KFSS102 | KFSS1-Cerebellar Functions | KFSS |
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| NOT DONE |
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2012-12-16 |
| | 14 | STUDYX | RS | P0001 | 14 | KFSS102A | KFSS1-Weakness Interferes With Testing | KFSS |
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| NOT DONE |
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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 |
| 2 |
2012-12-16 |
| | 17 | STUDYX | RS | P0001 | 17 | KFSS105 | KFSS1-Bowel and Bladder Functions | KFSS |
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| NOT DONE |
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2012-12-16 |
| | 18 | STUDYX | RS | P0001 | 18 | KFSS106 | KFSS1-Visual or Optic Functions | KFSS |
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| NOT DONE |
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2012-12-16 |
| | 19 | STUDYX | RS | P0001 | 19 | KFSS106A | KFSS1-Presence of Temporal Pallor | KFSS |
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| NOT DONE |
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2012-12-16 |
| | 20 | STUDYX | RS | P0001 | 20 | KFSS107 | KFSS1-Cerebral or Mental Functions | KFSS |
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| NOT DONE |
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2012-12-16 |
| | 21 | STUDYX | RS | P0001 | 21 | KFSS108 | KFSS1-Other Functions | KFSS |
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| NOT DONE |
| 2 |
2012-12-16 |
| | 22 | STUDYX | RS | P0001 | 22 | KFSS108A | KFSS1-Other Functions Specify | KFSS |
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| NOT DONE |
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2012-12-16 |
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4 SDTM Mapping Strategy
This section is used for reference regarding the CRF data capture and to understand the alignment of the instrument to the SDTM RS domain. It also provides guidance on how the result variables (RSORRES, RSSTRESC, and RSSTRESN) should be populated.
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