Versions Compared

Old Version 28

changes.mady.by.user Steve Kopko

Saved on

compared with

New Version 29

changes.mady.by.user Lorraine Sobson

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

Page properties


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
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusREVISION DRAFT Final
Date2021-04-0203
NotesThis 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.


...

Date

Version

Summary of Changes

2021-04-0203

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)

...