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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
TeamCDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusREVISION DRAFT 
Date2020-07-0809
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.


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Date

Version

Summary of Changes

2020-07-0809

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 update the example accordingly.
  • Update 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)

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  1. For each functional system of the KFSS, the scale points include a numeric rating and a definition of what is represented by the rating (e.g., 0 = “Normal”) with the exception of the “Unknown” option, which does not have a numeric rating. For the KFSS, for functional systems with a numeric rating, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN. Otherwise, RSSTRESC is populated with the rating description and RSSTRESN is left blank.

  2. Some responses to the KFSS items exceeded the 200-character limit for the RSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which item responses were revised in order to fit the 200-character limit. For item KFSS104, one of the rating responses is longer than the 200 character limit.

  3. Items KFSS102A and KFSS106A have the instruction “check here” when the subject has the specified condition (e.g., weakness, temporal pallor). RSORRES and RSSTRESC = “CHECKED” or “NOT CHECKED”. RSSTRESN is always left blank.

  4. Terminology:
    1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
    2. A full list of value sets for result fields is provided in Section 4: SDTM Mapping Strategy.

3.2 Example for the Kurtzke Functional System Scores (KFSS) Domain Model

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 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 items from the KFSS form. The subject did not experience weakness that interfered with the testing, but did have temporal pallor. The subject had unknown brain stem functions. A record for RSTESTCD=KFSS108A is represented with RSSTAT = "NOT DONE" since for RSTESTCD = KFSS108 the RSORRES = “None”. 

  1. When RSTESTCD = "KFSS108"  is not answered, the result is considered a not done record with RSORRES/RSSTRESC/RSSTRESN represented as missing values and RSSTAT = "NOT DONE”. Item RSTESTCD = "KFSS108A" will only be answered if RSTESTCD = "KFSS108" has a QSORRES = “Any other neurologic findings attributed to MS (specify)”, otherwise it will be considered a not done record with RSORRES/RSSTRESC/RSSTRESN represented as missing values and RSSTAT = "NOT DONE”.  

  2. Terminology:
    1. RSCAT, RSTESTCD, and RSTEST are approved CDISC controlled terminology.
    2. A full list of value sets for result fields is provided in Section 4: SDTM Mapping Strategy.

3.2 Example for the Kurtzke Functional System Scores (KFSS) Domain Model

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 items from the KFSS form. The subject did not experience weakness that interfered with the testing (RSTESTCD = "KFSS102A"), but did have temporal pallor (RSTESTCD = "KFSS106A"). The subject had unknown Cerebral or Mental Functions (RSTESTCD = "KFSS107"). Since there were no other functions, RSTESTCD = "KFSS108" is represented with the response RSORRES = “None”. The record for RSTESTCD="KFSS108A" is represented with RSORRES/RSSTRESC/RSSTRESN as missing values and RSSTAT = "NOT DONE". The instrument was not done at visit 2.

Dataset wrap
Namers


Dataset2


RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1STUDYXRSP00011KFSS101KFSS1-Pyramidal FunctionsKFSSMinimal disability22 Y12012-11-16
2STUDYXRSP00012KFSS102KFSS1-Cerebellar FunctionsKFSSSevere ataxia, all limbs44 Y12012-11-16
3STUDYXRSP00013KFSS102AKFSS1-Weakness Interferes With TestingKFSSNOT CHECKEDNOT CHECKED   Y12012-11-16
4STUDYXRSP00014KFSS103KFSS1-Brain Stem FunctionsKFSSNormal00 Y12012-11-16
5STUDYXRSP00015KFSS104KFSS1-Sensory FunctionsKFSSVibration or figure-writing decrease only, in one or two limbs11 Y12012-11-16
6STUDYXRSP00016KFSS105KFSS1-Bowel and Bladder FunctionsKFSSFrequent urinary incontinence33 Y12012-11-16
7STUDYXRSP00017KFSS106KFSS1-Visual or Optic FunctionsKFSSGrade 5 plus maximal visual acuity of better eye of 20/60 or less66 Y12012-11-16
8STUDYXRSP00018KFSS106AKFSS1-Presence of Temporal PallorKFSSCHECKEDCHECKED  Y12012-11-16
9STUDYXRSP00019KFSS107KFSS1-Cerebral or Mental FunctionsKFSSUnknownUnknown  Y12012-11-16
10STUDYXRSP000110KFSS108KFSS1-Other FunctionsKFSSNone00 Y12012-11-16
11STUDYXRSP000111KFSS108AKFSS1-Other Functions SpecifyKFSS   NOT DONEY12012-11-16
12STUDYXRSP000112
Dataset wrap
Namers
Dataset2
RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1STUDYXRSP00011KFSS101KFSS1-Pyramidal FunctionsKFSSMinimal disability 2 2  NOT DONEY122012-1112-16
213STUDYXRSP0001213KFSS102KFSS1-Cerebellar FunctionsKFSSSevere ataxia, all limbs44   NOT DONE Y122012-1112-16
314STUDYXRSP0001314KFSS102AKFSS1-Weakness Interferes With TestingKFSSNOT CHECKED NOT CHECKED   NOT DONEY122012-1112-16
415STUDYXRSP0001415KFSS103KFSS1-Brain Stem FunctionsKFSSUnknown Unknown  NOT DONEY122012-1112-16
516STUDYXRSP0001516KFSS104KFSS1-Sensory FunctionsKFSSVibration or figure-writing decrease only, in one or two limbs11KFSS   NOT DONE Y122012-1112-16
617STUDYXRSP0001617KFSS105KFSS1-Bowel and Bladder FunctionsKFSSFrequent urinary incontinence 3 3  NOT DONEY122012-1112-16
718STUDYXRSP0001718KFSS106KFSS1-Visual or Optic FunctionsKFSSGrade 5 plus maximal visual acuity of better eye of 20/60 or less66   NOT DONE Y122012-1112-16
819STUDYXRSP0001819KFSS106AKFSS1-Presence of Temporal PallorKFSSCHECKED CHECKED   NOT DONEY122012-1112-16
920STUDYXRSP0001920KFSS107KFSS1-Cerebral or Mental FunctionsKFSSUnknown Unknown   NOT DONEY122012-1112-16
1021STUDYXRSP00011021KFSS108KFSS1-Other FunctionsKFSSNone 0 0  NOT DONEY122012-1112-1611
22STUDYXRSP00011122KFSS108AKFSS1-Other Functions SpecifyKFSS   NOT DONEY122012-1112-16




4 SDTM Mapping Strategy

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