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	Multiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	2.1
Status	Revision Draft
Date	2022-10-20
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
2022-10-20	2.1 Revision Draft	Added the description of the relationship between the Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments (i.e., intended to be used in conjunction with one another) in Section 3.1, Assumptions for the RS Domain Model. Reordered the assumptions based on the current QRS supplement template. No new content was added to any assumptions. Updated the example with row cations instead of retaining the descriptions in paragraph form. Updated the example's missing visit, by removing the RSDTC value, based on the current QRS supplement template.
2021-04-03	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 updated the example accordingly. Updated 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.
2013-11-13	1.0	Kurtzke Functional Systems Scores (KFSS)

1 Introduction

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

CDISC did not modify this questionnaires, ratings, and scales (QRS) instrument 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 instrument 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. 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.

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/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 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; results from this assessment are then applied to determine an EDSS scale score (Kurtzke, 1983). A change in the EDSS should only occur if there has been a change in 1 or more Functional System (FS) scores. Please review the published Kurtzke Expanded Disability Status Scale (EDSS) for details on the related EDSS score.

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.
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.
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 RSORRES = “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”.
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.
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, matching the CRF item response text, are represented in QSORRES. This result is then represented as a standard numeric score in QSSTRESN and as a standard character representation in QSSTRESC. Character only responses, such as "Unknown" are represented in RSORRES and RSSTRESC and QSSTRESN is null as there are no standardized numeric result.

The table represents the items from the KFSS form.

Row 3: The subject did not experience weakness that interfered with the testing (RSTESTCD = "KFSS102A").

Row 8: The subject did have temporal pallor (RSTESTCD = "KFSS106A").

Row 9: The subject had unknown Cerebral or Mental Functions (RSTESTCD = "KFSS107").

Rows 10-11: 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".

Rows 12-22: Show the subject was not evaluated on this instrument at visit 2. Since the visit was missed, the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred.

rs.xpt

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSSTRESN	RSSTAT	RSLOBXFL	VISITNUM	RSDTC
1	STUDYX	RS	P0001	1	KFSS101	KFSS1-Pyramidal Functions	KFSS	Minimal disability	2	2		Y	1	2012-11-16
2	STUDYX	RS	P0001	2	KFSS102	KFSS1-Cerebellar Functions	KFSS	Severe ataxia, all limbs	4	4		Y	1	2012-11-16
3	STUDYX	RS	P0001	3	KFSS102A	KFSS1-Weakness Interferes With Testing	KFSS	NOT CHECKED	NOT CHECKED			Y	1	2012-11-16
4	STUDYX	RS	P0001	4	KFSS103	KFSS1-Brain Stem Functions	KFSS	Normal	0	0		Y	1	2012-11-16
5	STUDYX	RS	P0001	5	KFSS104	KFSS1-Sensory Functions	KFSS	Vibration or figure-writing decrease only, in one or two limbs	1	1		Y	1	2012-11-16
6	STUDYX	RS	P0001	6	KFSS105	KFSS1-Bowel and Bladder Functions	KFSS	Frequent urinary incontinence	3	3		Y	1	2012-11-16
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		Y	1	2012-11-16
8	STUDYX	RS	P0001	8	KFSS106A	KFSS1-Presence of Temporal Pallor	KFSS	CHECKED	CHECKED			Y	1	2012-11-16
9	STUDYX	RS	P0001	9	KFSS107	KFSS1-Cerebral or Mental Functions	KFSS	Unknown	Unknown			Y	1	2012-11-16
10	STUDYX	RS	P0001	10	KFSS108	KFSS1-Other Functions	KFSS	None	0	0		Y	1	2012-11-16
11	STUDYX	RS	P0001	11	KFSS108A	KFSS1-Other Functions Specify	KFSS				NOT DONE	Y	1
12	STUDYX	RS	P0001	12	KFSS101	KFSS1-Pyramidal Functions	KFSS				NOT DONE		2
13	STUDYX	RS	P0001	13	KFSS102	KFSS1-Cerebellar Functions	KFSS				NOT DONE		2
14	STUDYX	RS	P0001	14	KFSS102A	KFSS1-Weakness Interferes With Testing	KFSS				NOT DONE		2
15	STUDYX	RS	P0001	15	KFSS103	KFSS1-Brain Stem Functions	KFSS				NOT DONE		2
16	STUDYX	RS	P0001	16	KFSS104	KFSS1-Sensory Functions	KFSS				NOT DONE		2
17	STUDYX	RS	P0001	17	KFSS105	KFSS1-Bowel and Bladder Functions	KFSS				NOT DONE		2
18	STUDYX	RS	P0001	18	KFSS106	KFSS1-Visual or Optic Functions	KFSS				NOT DONE		2
19	STUDYX	RS	P0001	19	KFSS106A	KFSS1-Presence of Temporal Pallor	KFSS				NOT DONE		2
20	STUDYX	RS	P0001	20	KFSS107	KFSS1-Cerebral or Mental Functions	KFSS				NOT DONE		2
21	STUDYX	RS	P0001	21	KFSS108	KFSS1-Other Functions	KFSS				NOT DONE		2
22	STUDYX	RS	P0001	22	KFSS108A	KFSS1-Other Functions Specify	KFSS				NOT DONE		2

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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 "

RSORRES	RSSTRESC	RSSTRESN
Normal	0	0
Abnormal signs without disability	1	1
Minimal disability	2	2
Mild or moderate paraparesis or hemiparesis; severe monoparesis	3	3
Marked paraparesis or hemiparesis; moderate quadriparesis; or monoplegia	4	4
Paraplegia, hemiplegia, or marked quadriparesis	5	5
Quadriplegia	6	6
Unknown	Unknown

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

RSORRES	RSSTRESC	RSSTRESN
Normal	0	0
Abnormal signs without disability	1	1
Mild ataxia	2	2
Moderate truncal or limb ataxia	3	3
Severe ataxia, all limbs	4	4
Unable to perform coordinated movements due to ataxia	5	5
Unknown	Unknown

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

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

RSORRES	RSSTRESC
CHECKED	CHECKED
NOT CHECKED	NOT CHECKED

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

RSORRES	RSSTRESC	RSSTRESN
Normal	0	0
Signs only	1	1
Moderate nystagmus or other mild disability	2	2
Severe nystagmus, marked extraocular weakness, or moderate disability of other cranial nerves	3	3
Marked dysarthria or other marked disability	4	4
Inability to swallow or speak	5	5
Unknown	Unknown

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

RSORRES	RSSTRESC	RSSTRESN
Normal	0	0
Vibration or figure-writing decrease only, in one or two limbs	1	1
Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure writing) decrease alone in three or four limbs	2	2
Moderate decrease in touch or pain or position sense, and/or lost vibration in 1 or 2 limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in 3 or 4 limbs	3	3
Marked decrease in touch or pain or loss of proprioception, alone or combined, in one or two limbs; or moderate decrease in touch or pain and/or severe proprioceptive decrease in more than two limbs	4	4
Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioception for most of the body below the head	5	5
Sensation essentially lost below the head	6	6
Unknown	Unknown

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

RSORRES	RSSTRESC	RSSTRESN
Normal	0	0
Mild urinary hesitancy, urgency, or retention	1	1
Moderate hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence	2	2
Frequent urinary incontinence	3	3
In need of almost constant catheterization	4	4
Loss of bladder function	5	5
Loss of bowel and bladder function	6	6
Unknown	Unknown

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

RSORRES	RSSTRESC	RSSTRESN
Normal	0	0
Scotoma with visual acuity (corrected) better than 20/30	1	1
Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/59	2	2
Worse eye with large scotoma, or moderate decrease in fields, but with maximal visual acuity (corrected) of 20/60 to 20/99	3	3
Worse eye with marked decrease of fields and maximal visual acuity (corrected) of 20/100 to 20/200; grade 3 plus maximal acuity of better eye of 20/60 or less	4	4
Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less	5	5
Grade 5 plus maximal visual acuity of better eye of 20/60 or less	6	6
Unknown	Unknown

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

RSORRES	RSSTRESC	RSSTRESN
Normal	0	0
Mood alteration only (does not affect DSS score)	1	1
Mild decrease in mentation	2	2
Moderate decrease in mentation	3	3
Marked decrease in mentation (chronic brain syndrome – moderate)	4	4
Dementia or chronic brain syndrome – severe or incompetent	5	5
Unknown	Unknown

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

RSORRES	RSSTRESC	RSSTRESN
None	0	0
Any other neurologic findings attributed to MS (specify)	1	1
Unknown	Unknown

Original and RSORRES Comparison - RSTESTCD=KFSS104

RSSTRESN	KFSS1-Sensory Functions (Original)	RSORRES Value
0	Normal	Normal
1	Vibration or figure-writing decrease only, in one or two limbs	Vibration or figure-writing decrease only, in one or two limbs
2	Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure writing) decrease alone in three or four limbs	Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure writing) decrease alone in three or four limbs
3	Moderate decrease in touch or pain or position sense, and/or essentially lost vibration in one or two limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in three or four limbs	Moderate decrease in touch or pain or position sense, and/or lost vibration in 1 or 2 limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in 3 or 4 limbs
4	Marked decrease in touch or pain or loss of proprioception, alone or combined, in one or two limbs; or moderate decrease in touch or pain and/or severe proprioceptive decrease in more than two limbs	Marked decrease in touch or pain or loss of proprioception, alone or combined, in one or two limbs; or moderate decrease in touch or pain and/or severe proprioceptive decrease in more than two limbs
5	Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioception for most of the body below the head	Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioception for most of the body below the head
6	Sensation essentially lost below the head	Sensation essentially lost below the head
	Unknown	Unknown

End of Document

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