Versions Compared

Old Version 15

changes.mady.by.user Steve Kopko

Saved on

compared with

New Version 16

changes.mady.by.user Fariba Alipour

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 
Date2020-07-01
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.



Revision History

Date

Version

Summary of Changes

2020-07-01

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.

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)


© 2020 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

...

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 (RSORRESRSORRES, RSSTRESC, and RSSTRESN) should be populated.

...

RSTESTCD = "KFSS104" RSTEST = "KFSS1-Sensory Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Vibration or figure-writing decrease only, in one or two limbs11
Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure writing) decrease alone in three or four limbs22
Moderate decrease in touch or pain or position sense, and/or lost vibration in 1 or 2 limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in 3 or 4 limbs33
Marked decrease in touch or pain or loss of proprioception, alone or combined, in one or two limbs; or moderate decrease in touch or pain and/or severe proprioceptive decrease in more than two limbs44
Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioception for most of the body below the head55
Sensation essentially lost below the head66
UnknownUnknown


RSTESTCD = "KFSS105" RSTEST = "KFSS1-Bowel and Bladder Functions"

...

RSTESTCD = "KFSS106" RSTEST = "KFSS1-Visual or Optic Functions"

RSORRES

RSSTRESC

RSSTRESN

Normal00
Scotoma with visual acuity (corrected) better than 20/3011
Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/5922
Worse eye with large scotoma, or moderate decrease in fields, but with maximal visual acuity (corrected) of 20/60 to 20/9933
Worse eye with marked decrease of fields and maximal visual acuity (corrected) of 20/100 to 20/200; grade 3 plus maximal acuity of better eye of 20/60 or less44
Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less55
Grade 5 plus maximal visual acuity of better eye of 20/60 or less66
UnknownUnknown


RSTESTCD = "KFSS107" RSTEST = "KFSS1-Cerebral or Mental Functions"

...