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

1 Introduction

This document describes the CDISC implementation of the Kurtzke Functional System Scores (KFSS) instrument.

CDISC does did not modify this questionnaires, ratings, and scales (QRS) instruments instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/about/bylaws.

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

This document is a supplement to the SDTMIG for Human Clinical Trials and is covered under Appendix F of that document, which describes representations, warranties, limitations of liability, and disclaimers. Please see Appendix F of the SDTMIG for a complete version of this material.

CDISC specifies how to structure the data that data that has been collected in a database, not what should be collected or how to conduct clinical assessments or implement protocols.   CDISC disclaims any liability for your use of this material.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the KFSS in the CDISC library of QRS data standards supplements. Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrument. There may be many versions of this instrument in the public domain or copyrighted. CDISC has chosen to use this version as the data standard.

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• Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52.
  

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the KFSS are listed below.

The KFSS consists of 7 functional systems (plus “other”) with an ordinal clinical rating scale for each functional system in either a 7-point, 6-point, or 2-point scale. The functional systems included in the KFSS are the pyramidal, cerebellar, brain stem, sensory, bowel/bladder, visual, cerebral, and other functions. In addition to the functional system rating scales, there are 2 additional questions asking about weakness and temporal pallor, which could affect the ratings.

The Kurtzke Functional Systems Scores (KFSS) and Kurtzke Expanded Disability Status Scale (EDSS) instruments are intended to be used in conjunction with one another. The KFSS should first be administered by the evaluator and ; results from this assessment are then applied to determine an EDSS scale overall score (Kurtzke, 1983). A change in the EDSS should only occur if there has been a change of one in 1 or more in the Functional System (FS) scores. Please review the published Kurtzke Expanded Disability Status Scale (EDSS) for details on the related EDSS overall score.

1. For each functional system of the KFSS,  the scale points the original scores include a numeric rating and a definition of what is represented by the rating rating (e.g., 0 = “Normal”) with the exception of the “Unknown” option, which does not have a numeric rating.  For For the KFSS, for functional systems with 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.  OtherwiseOtherwise, RSSTRESC is populated with the rating description and RSSTRESN is left blank.
2. 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.

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

4. 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.
5. 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 KFSS example below shows the terminology used to implement the instrument in the RS domainthe RS domain. This example shows the data for 1 subject collected at the baseline visit at the baseline visit and a visit 2 represented as not being collected for the KFSS instrumentfor the KFSS instrument. The example uses CDISC Controlled Terminology for RSTESTCDfor RSTESTCD, RSTEST, and RSCAT. All original results, matching the CRF item response text, are represented with preferred terminology in RSORRESin RSORRES.This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESCrepresented as a standard numeric score in RSSTRESN and as a standard character representation in RSSTRESC. Character only responses, such as "Unknown" are represented in RSORRES RSORRES and RSSTRESC and RSSTRESN is null as there are no standardized numeric result.

 The table represents the items from the KFSS forminstrument. 

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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