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Title

Kurtzke Functional System Scores (KFSS)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

KFSS

QRS Permission StatusPublic Domain
TeamMultiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.1
StatusRevision Draft
Date20222023-1209-1205
Notes to ReadersThis 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

20222023-1209-1205

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 captions
    Jira
    showSummaryfalse
    serverIssue Tracker (JIRA)
    serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
    keyQRSSUPP-503
    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.

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.

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.
2013-11-131.0Kurtzke Functional Systems Scores (KFSS)


© 2022 Clinical 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved.
 

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