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© 2021 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 not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

The representation of data collected for this instrument is based on the Study Data Tabulation Model Implementation Guide (SDTMIG) Disease Response and Clin Classification (RS) domain model, which can be found on the CDISC website at: https://www.cdisc.org/standards/foundational/sdtmig.

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

2 Copyright Status

CDISC believes this instrument to be in the public the public domain, but you should perform your own assessment. CDISC  CDISC has included the KFSS in KFSS in the CDISC library of QRS data standards supplements. Hence Hence, CDISC developed RSTESTCD and RSTEST for each item based on the actual text on the instrumentthe 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.

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) standard database structure with example(s), and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

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) CRF(s) annotated with the CDISC SDTMIG variables with submission values. 

Note: CDISC Controlled Terminology is maintained by National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS). The most recent version should be accessed through the CDISC website at:https://www.cdisc.org/standards/terminology/controlled-terminology.

Reference for the KFSS:

• 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 RS Domain Model

3.1 Assumptions for the RS Domain RS Domain Model

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

The KFSS consists of 7 functional systems (plus “other”) with an ordinal clinical rating scale for each. 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.

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 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 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 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  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. When RSTESTCD When RSTESTCD = "KFSS108"  is   is not answered, the result is considered a not done record with RSORRES/RSSTRESC/RSSTRESN represented as missing values and RSSTAT = "NOT DONE”. Item 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 not done record with RSORRES/RSSTRESC/RSSTRESN represented as RSSTRESN represented as missing values and RSSTAT = "NOT DONE”.  

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 are represented with preferred terminology in RSORRESin RSORRES. This result is then transformed into the standard the standard numeric score in RSSTRESN and a 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 formKFSS 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  Since there were no other functions, RSTESTCD = "KFSS108KFSS108" is represented with the response RSORRES response RSORRES = “None”. The record The record for RSTESTCD="KFSS108A" is represented with RSORRES/RSSTRESC/RSSTRESN as missing as missing values and RSSTAT and RSSTAT = "NOT DONE". The  The instrument was not done at visit 2.

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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 should be populated.

RSTESTCD = "KFSS101" RSTEST = "KFSS1-Pyramidal Functions "

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