Information for Reviewers

Text in black is part of the template used to create this document and is not under review. Please review the blue text; this text represents the changes made to the template that are specific to this QRS instrument.

Title	Kurtzke Functional System Scores (KFSS)
CDISC Reference	Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name	KFSS
QRS Permission Status	Public Domain
Team	CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	2.0
Status	REVISION DRAFT
Date	2020-06-15
Notes	This 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
2013-10-18	1.0	Kurtzke Functional Systems Scores (KFSS) Draft
2013-11-13	1.0	Kurtzke Functional Systems Scores (KFSS)
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.
2020-06-15	2.0	Converted from Questionnaires (QS) domain to Disease Response and Clin Classification (RS)

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 (spell out "questionnaires, ratings, and scales" if this is a CDISC-created CRF and put QRS in parentheses.) 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.

Information for Reviewers

The CRF is attached at the top of the Wiki. When you click the paperclip image, you will find the file for the annotated CRF.

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.

Include the following statements as standalone paragraphs for copyrighted instruments:

CDISC has developed this documentation at no cost to the copyright holder or any additional cost to users of the instrument beyond the normal license fees charged by the copyright holder.

CDISC acknowledges Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52 for the approval to include the Kurtzke Functional System Scores (KFSS) in the CDISC data standards.

Reference for the Kurtzke Functional System Scores (KFSS):

This is an example only. Use the reference from the CDISC definition of the --CAT.

do not include the parentheses.
do not include copyright information from the definition about copyright holder and version since that's already included above.
do add a period to the end.

If there are multiple references, please use the following format:

References for the Title:

CDISC Controlled Terminology reference.
additional reference.

Notes on the use of quotation marks:

Use for text values of a Likert scale: e.g., ...with response options ranging from “never” to “daily."
Actual numbers of the scale (e.g., 0-3) do not appear in quotation marks while the definitions of these anchors (e.g., 5 = “I always fall asleep”) do.
Enclose values for variables within quotation marks (e.g., QSTESTCD = "IPA0102")

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.

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.
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.
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.
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.
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.

Terminology
1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.
2. A full list of value sets for the qualifier, timing, result, and unit 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

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSSTRESN
1	STUDYX	RS	P0001	1	KFSS101	KFSS1-Pyramidal Functions	KFSS	Minimal disability	2	2
2	STUDYX	RS	P0001	2	KFSS102	KFSS1-Cerebellar Functions	KFSS	Severe ataxia, all limbs	4	4
3	STUDYX	RS	P0001	3	KFSS102A	KFSS1-Weakness Interferes With Testing	KFSS	NOT CHECKED	NOT CHECKED
4	STUDYX	RS	P0001	4	KFSS103	KFSS1-Brain Stem Functions	KFSS	Normal	0	0
5	STUDYX	RS	P0001	5	KFSS104	KFSS1-Sensory Functions	KFSS	Vibration or figure-writing decrease only, in one or two limbs	1	1
6	STUDYX	RS	P0001	6	KFSS105	KFSS1-Bowel and Bladder Functions	KFSS	Frequent urinary incontinence	3	3
7	STUDYX	RS	P0001	7	KFSS106	KFSS1-Visual or Optic Functions	KFSS	Grade 5 plus maximal visual acuity of better eye of 20/60 or less	6	6
8	STUDYX	RS	P0001	8	KFSS106A	KFSS1-Presence of Temporal Pallor	KFSS	CHECKED	CHECKED
9	STUDYX	RS	P0001	9	KFSS107	KFSS1-Cerebral or Mental Functions	KFSS	Unknown	Unknown
10	STUDYX	RS	P0001	10	KFSS108	KFSS1-Other Functions	KFSS	None	0	0

rs.xpt (cont)

Row	RSBLFL	VISITNUM	RSDTC
1 (cont)	Y	1	2012-11-16
2 (cont)	Y	1	2012-11-16
3 (cont)	Y	1	2012-11-16
4 (cont)	Y	1	2012-11-16
5 (cont)	Y	1	2012-11-16

The following is for illustrative purposes and would not really be included for the IDS-SR instrument in this template. It provides an example of what would need to be included if the instrument required supplemental qualifiers (see Section 5 Supplemental Qualifier Name Codes):

Text that would remain unchanged has been left in black:

The evaluation interval text value for data collection needs to be populated in SUPPQS as follows. The standard terminology for QNAM and QLABEL are listed below.

STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG
STUDYX	QS	P0001	QSSEQ	Sequence number corresponding to row of qs.xpt that supplemental qualifier is needed for (e.g., 8)	Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).	Label for QNAM (e.g., Contact Type)	Value of QNAM variable ( e.g., SUBJECT VISIT)	CRF

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.

Do I copy from the legacy document or from QRS maker?

what should be done for section 5? the legacy document has a table.

5 Supplemental Qualifier Name Codes

The instrument used as an example in this template did not require supplemental qualifiers, but this section has been included to provide guidance on those instruments which do require supplemental qualifiers. (Many instruments do not require it.) Text that always will be in the section when it is included has been left black.

Additional rows will be required in the suppqs.xpt dataset for each supplemental qualifier needed.

Remove Section 5 if it does not apply to the new instrument.

The following table contains additional standard name codes for use in the Supplement Qualifiers for Questionnaires (SUPPQS) special purpose dataset.

QNAM	QLABEL	QVAL
Appropriate variable name to provide more information about data in qs.xpt, no more than 8 characters long (e.g., CONTACT).	Label for QNAM (e.g., Contact Type)	Value of QNAM ( e.g., SUBJECT VISIT)

End of Document

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