Kurtzke Functional Systems Scores (KFSS)

Kurtzke Functional Systems Scores 

(KFSS) 

Questionnaire Supplement to the Study Data 

Tabulation Model Implementation Guide 

for Human Clinical Trials 

Prepared by 

Multiple Sclerosis Outcomes Assessment Consortium 

and the CDISC Questionnaire Sub-team 

Notes to Readers 

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) 

© 2013 Clinical Data Interchange Standards Consortium, Inc. All rights reserved Page 1 

November 13, 2013

CDISC SDTM KFSS Questionnaire Supplement (Version 1.0) 

1 Introduction 

This document describes the CDISC implementation of the Kurtzke Functional Systems Scores 

(KFSS) questionnaire, a standard questionnaire that is typically used in clinical trials to provide a 

standardized measure of global neurological impairment in Multiple Sclerosis. 

The KFSS questionnaire preceded the CDISC CDASH CRF standards and based on its public 

domain status, cannot be modified to CDASH standards. 

The representation of data collected for this questionnaire is based on the Study Data Tabulation 

Model Implementation Guide (SDTMIG) QS domain model, which can be found at the CDISC 

website at: (http://www.cdisc.org/sdtm). 

These specific implementation details for this questionnaire are meant to be used in conjunction 

with the SDTMIG. All questionnaire documentation can be found on the CDISC web site at: 

(http://www.cdisc.org/content2909). 

The CDISC Intellectual Property Policy can be found on the CDISC web site at: 

(http://www.cdisc.org/bylaws-and-policies). 

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers 

This document is a supplement to the Study Data Tabulation Model Implementation Guide 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. 

2 Copyright Status 

This instrument is in the public domain. CDISC has included the Kurtzke Functional Systems 

Scores (KFSS) as part of CDISC Data Standards. Hence, CDISC developed QSTESTCD and 

QSTEST for each question based on the actual question text on the questionnaire. There may be 

many versions of this questionnaire in the public domain. CDISC has chosen to use this version 

as the data standard. The Kurtzke Functional Systems Scores is commonly known as the FSS, 

but the QSCAT=KFSS to differentiate this from the Fatigue Severity Scale, which is also 

commonly known as the FSS. 

The CDISC documentation of this instrument consists of: (1) controlled terminology, (2) 

standard database structure with examples, and (3) case report forms annotated with the CDISC 

SDTMIG submission values. 

Note: CDISC controlled terminology is maintained by NCI EVS. The most recent version should 

be accessed through the CDISC website. (http://www.cdisc.org/terminology) 

The KFSS questionnaire is included in the following reference: 

Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability 

status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. 


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3 The QS Domain Model 

3.1 Assumptions for Questionnaire Domain Model 

All assumptions and business rules described in the SDTMIG QS domain are applicable to this 

supplement. Additional assumptions specific to the Kurtzke Functional Systems Scores 

questionnaire are listed below. 

Kurtzke Functional Systems Scores (KFSS): The KFSS consists of 7 functional systems with an 

ordinal clinical rating scale for each. The functional systems included in the KFSS are the 

pyramidal, cerebellar, brainstem, sensory, bowel/bladder, visual, and cerebral 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. The scale points include a rating (e.g. “0”) and a definition of what is represented by the 

rating (e.g. “Normal”). For KFSS, QSORRES is populated with the rating definition. 

QSSTRESC and QSSTRESN are populated with the numerical rating only. 

2. For item KFSS104, one of the rating definitions is longer than the 200 character limit 

currently mandated by the FDA, and hence, CDISC. The QS 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 “record #1 in small box” when the 

subject has the specified condition (weakness, temporal pallor). If 1 is recorded in the 

box, QSORRES, QSSTRESC, and QSSTRESN have the value “1”. Otherwise, do not 

include a record for the item. 

4. The questionnaire evaluator is stored in QSEVAL. For KFSS, the evaluator is defined as 

INVESTIGATOR. Additional identifying information to further distinguish the rater in 

QSEVAL should be stored in QSEVALID. An example is rater initials. 

5. Terminology: 

a. QSCAT, QSTESTCD and QSTEST are approved CDISC controlled terminology. 

b. A full list of value sets for qualifier and result fields is provided in Section 4: SDTM 

Mapping Strategy. 


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3.2 Example for Kurtzke Functional Systems Scores (KFSS) QS Domain Model 

The KFSS example below shows the terminology used to implement the questionnaire in the QS domain. This example shows the data for one 

subject collected at the baseline visit for a KFSS questionnaire. The subject experienced weakness which interfered with the testing, but did not 

have temporal pallor. The example uses CDISC controlled terminology for QSTESTCD, QSTEST, and QSCAT. QSBLFL is Y based on 

VISITNUM=1. All original results are represented with preferred terminology in QSORRES. This result is then transformed into a standard 

numeric score in QSSTRESN and a character representation of the standard numeric score in QSSTRESC, with the exception of items KFSS102A 

and KFSS106A. 

Rows 1-8: Shows the questions from the KFSS form. 

Row 3: Shows the QSORRES, QSSTRESC, and QSSTRESN values of “1” since the subject experienced weakness which interfered with the 

testing. Note that since the subject did not have temporal pallor, a record for item KFSS106A is not created. 

qs.xpt 

Row STUDYID DOMAIN USUBJID QSSEQ QSTESTCD QSTEST QSCAT QSORRES QSSTRESC QSSTRESN 

1 STUDYX QS P0001 1 KFSS101 KFSS1-Pyramidal Functions KFSS Minimal disability 2 2 

2 STUDYX QS P0001 2 KFSS102 KFSS1-Cerebellar Functions 

3 STUDYX QS P0001 3 KFSS102A 

KFSS1-Weakness Interferes With 

Testing 

KFSS 


Severe ataxia in all limbs (most function is very 

difficult) 

4 4 

1 1 1 

4 STUDYX QS P0001 4 KFSS103 KFSS1-Brainstem Functions KFSS Normal 0 0 

5 STUDYX QS P0001 5 KFSS104 KFSS1-Sensory Function 

6 STUDYX QS P0001 6 KFSS105 

KFSS1-Bowel and Bladder 

Function 

7 STUDYX QS P0001 7 KFSS106 KFSS1-Visual Function 

8 STUDYX QS P0001 8 KFSS107 

KFSS1-Cerebral (or Mental) 

Functions 





Vibration or figure-writing decrease only in one or 

two limbs 

1 1 

Frequent urinary incontinence 3 3 

Grade 5 plus maximal visual acuity of better eye of 

20/60 or less 

6 6 

(Unknown) 9 9 

Row QSBLFL QSEVAL VISITNUM QSDTC 

1 (cont) Y INVESTIGATOR 1 2012-11-16 






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4 SDTM Mapping Strategy 

KFSS specific mapping strategy: This section is used for reference with the annotated CRF for 

further details on the CRF data capture and to understand the alignment of the questionnaire to 

the SDTM QS domain. It also provides guidance on how the result variables (QSORRES, 

QSSTRESC, and QSSTRESN) should be populated for the questionnaire. 

QSTESTCD=KFSS101 

QSTEST=KFSS1-Pyramidal Functions 

QSORRES QSSTRESC QSSTRESN 

Normal 0 0 

Abnormal signs without disability 1 1 

Minimal disability 2 2 

Mild to moderate paraparesis or hemiparesis (detectable 

weakness but most function sustained for short periods, 

3 3 

fatigue a problem); severe monoparesis (almost no function) 

Marked paraparesis or hemiparesis (function is difficult), 

moderate quadriparesis (function is decreased but can be 

4 4 

sustained for short periods); or monoplegia 

Paraplegia, hemiplegia, or marked quadriparesis 5 5 

Quadriplegia 6 6 

(Unknown) 9 9 


QSTEST=KFSS1-Cerebellar Functions 


Normal 0 0 

Abnormal signs without disability 1 1 

Mild ataxia (tremor or clumsy movements easily seen, minor 

interference with function) 

2 2 

Moderate truncal or limb ataxia (tremor or clumsy 

movements interfere with function in all spheres) 

3 3 

Severe ataxia in all limbs (most function is very difficult) 4 4 

Unable to perform coordinated movements due to ataxia 5 5 

(Unknown) 9 9 

QSTESTCD=KFSS102A 

QSTESTCD=KFSS106A 

QSTEST=KKFSS1-Weakness Interferes With Testing 

QSTEST=KKFSS1-Presence of Temporal Pallor 


1 1 1 


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QSTEST=KKFSS1-Brainstem Functions 


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) 9 9 


QSTEST=KKFSS1-Sensory Function 


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 

2 2 

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 

3 3 

or 4 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 

4 4 

decrease in more than two limbs 

Loss (essentially) of sensation in one or two limbs; or 

moderate decrease in touch or pain and/or loss of 

5 5 

proprioception for most of the body below the head 

Sensation essentially lost below the head 6 6 

(Unknown) 9 9 


QSTEST=KKFSS1-Bowel and Bladder Function 


Normal 0 0 

Mild urinary hesitance, urgency, or retention 1 1 

Moderate hesitance, urgency, retention of bowel or bladder, 

or rare urinary incontinence (intermittent selfcatheterization, 

manual compression to evacuate bladder, or 

2 2 

finger evacuation of stool) 

Frequent urinary incontinence 3 3 

In need of almost constant catheterization (and constant use 

of measures to evacuate stool) 

4 4 


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Loss of bladder function 5 5 

Loss of bowel and bladder function 6 6 

(Unknown) 9 9 


QSTEST=KKFSS1-Visual Function 


Normal 0 0 

Scotoma with visual acuity (corrected) better than 20/30 1 1 

Worse eye with scotoma with maximal visual acuity 

(corrected) of 20/30-20/59 

2 2 

Worse eye with large scotoma, or moderate decrease in 

fields, but with maximal visual acuity (corrected) of 20/60- 

3 3 

20/99 

Worse eye with marked decrease of fields and maximal 

visual acuity (corrected) of 20/100-20/200; grade 3 plus 

4 4 

maximal acuity of better eye of 20/60 or less 

Worse eye with maximal visual acuity (corrected) less than 

20/200; grade 4 plus maximal acuity of better eye of 20/60 

5 5 

or less 

Grade 5 plus maximal visual acuity of better eye of 20/60 or 

less 

6 6 

(Unknown) 9 9 


QSTEST=KKFSS1-Cerebral (or Mental) Functions 


Normal 0 0 

Mood alteration only (does not affect EDSS 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) 9 9 


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5 Original and QSORRES Comparison- QSTESTCD=KFSS104 

QSSTRESN KKFSS1-Sensory Function (Original) QSORRES Value 

0 Normal Normal 

Vibration or figure-writing decrease only in one or Vibration or figure-writing decrease 

1 

two limbs 

only in one or two limbs 

Mild decrease in touch or pain or 

Mild decrease in touch or pain or position sense, position sense, and/or moderate 

and/or moderate decrease in vibration in one or decrease in vibration in one or two 

2 

two limbs; or vibratory (c/s figure writing) limbs; or vibratory (c/s figure 

decrease alone in three or four limbs writing) decrease alone in three or 

four limbs 

3 

4 

5 

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 

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 

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 

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 

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 

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 

Sensation essentially lost below the 

head 

9 (Unknown) (Unknown) 

End of Document 


November 13, 2013

Kurtzke Functional Systems Scores (KFSS)

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