Revision History

© 2020 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.

These specific implementation details for this clinical classification are meant to be used in conjunction with the SDTMIG. All CDISC QRS documentation packages can be found on the CDISC website at: https://www.cdisc.org/foundational/qrs.

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 has been collected in a database, not what should be collected or how to conduct clinical assessments or protocols.

2 Copyright Status

This instrument is in the public domain. CDISC has included the Kurtzke Functional System Scores (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 clinical classification. 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. 

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.

Reference for the Kurtzke Functional System Scores (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 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 Kurtzke Functional System Scores (KFSS) are listed below.

Kurtzke Functional Systems Scores (KFSS): 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 (e.g. “0”) and a description of what is represented by the rating (e.g. “Normal”) with the exception of the “Unknown” option, which does not have a numeric rating. RSORRES is populated with the rating description.  For the options with a numeric rating, RSSTRESC and RSSTRESN are populated with the numeric rating.  Otherwise, RSSTRESC is populated with the rating description and RSSTRESN is left blank.
2. For item KFSS104, one of the rating definitions is longer than the 200 character limit imposed by SAS v5 transport files.  The QRS sub-team has paraphrased the text to shorten the responses.  The original and modified values are summarized in Section 5.
3. Items KFSS102A and KFSS106A have the instruction “check here” when the subject has the specified condition (weakness, temporal pallor).  RSORRES and RSSTRESC = “CHECKED” or “NOT CHECKED”.  RSSTRESN is always left blank.
4. Item KFSS108A will only be answered if KFSS108 has RSORRES = “Any other neurologic findings attributed to MS (specify)”.  If KFSS108A is not answered, do not create a record in SDTM for it.
5. Terminology:
   1. RSCAT, RSTESTCD and RSTEST are approved CDISC controlled terminology.
   2. A full list of value sets for qualifier and result fields is provided in Section 4: SDTM Mapping Strategy.

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

The Kurtzke Functional System Scores (KFSS) example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for one subject collected at the baseline visit for a KFSS questionnaire. The subject did not experience weakness that interfered with the testing, but did have temporal pallor. The example uses CDISC controlled terminology for RSTESTCD, RSTEST, and RSCAT. RSBLFL is Y based on VISITNUM=1. All original results are represented with preferred terminology in RSORRES. Typically, this result is then transformed into a standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.

Rows 1-10:     Shows the questions from the KFSS form. Note that a record for RSTESTCD=KFSS108A is not shown since RSORRES=“None” for RSTESTCD=KFSS108.

Rows 3 and 8 show RSORRES = “NOT CHECKED” and “CHECKED”, respectively, since the subject did not experience weakness that interfered with the testing and the subject had temporal pallor.

rs.xpt

rs.xpt (cont)

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.

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

RSTESTCD = "KFSS102" RSTEST = "KFSS1-Cerebellar Functions"

RSTESTCD = "KFSS102A" RSTEST = "KFSS1-Weakness Interferes With Testing"

RSTESTCD = "KFSS106A" RSTEST = "KFSS1-Presence of Temporal Pallor"

RSTESTCD = "KFSS103" RSTEST = "KFSS1-Brain Stem Functions"

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

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

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

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

RSTESTCD = "KFSS108" RSTEST = "KFSS1-Other Functions"

5 Original and RSORRES Comparison - RSTESTCD=KFSS104

???? SHOULD I MAKE THE TABLE IN QRS Maker????? or just copy from the version 1.1 word file??

End of Document