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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	2020-07-09
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
2020-07-09	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

update

updated the example accordingly.

Update

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)

...

Dataset wrap

Name	rs

Dataset2

Row

STUDYID

DOMAIN

USUBJID

RSSEQ

RSTESTCD

RSTEST

RSCAT

RSORRES

RSSTRESC

RSSTRESN

RSSTAT

RSLOBXFL

VISITNUM

RSDTC

STUDYX

P0001

KFSS101

KFSS1-Pyramidal Functions

KFSS

Minimal disability

	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	2012-11-16
12	STUDYX	RS	P0001	12	KFSS101	KFSS1-Pyramidal Functions	KFSS

				NOT DONE	Y	2	2012-12-16
13	STUDYX	RS	P0001	13	KFSS102	KFSS1-Cerebellar Functions	KFSS

			NOT DONE	Y	2	2012-12-16
14	STUDYX	RS	P0001	14	KFSS102A	KFSS1-Weakness Interferes With Testing	KFSS

				NOT DONE	Y	2	2012-12-16
15	STUDYX	RS	P0001	15	KFSS103	KFSS1-Brain Stem Functions	KFSS

			NOT DONE	Y	2	2012-12-16
16	STUDYX	RS	P0001	16	KFSS104	KFSS1-Sensory Functions	KFSS

				NOT DONE	Y	2	2012-12-16
17	STUDYX	RS	P0001	17	KFSS105	KFSS1-Bowel and Bladder Functions	KFSS

			NOT DONE	Y	2	2012-12-16
18	STUDYX	RS	P0001	18	KFSS106	KFSS1-Visual or Optic Functions	KFSS

				NOT DONE	Y	2	2012-12-16
19	STUDYX	RS	P0001	19	KFSS106A	KFSS1-Presence of Temporal Pallor	KFSS

			NOT DONE	Y	2	2012-12-16
20	STUDYX	RS	P0001	20	KFSS107	KFSS1-Cerebral or Mental Functions	KFSS

			NOT DONE	Y	2	2012-12-16
21	STUDYX	RS	P0001	21	KFSS108	KFSS1-Other Functions	KFSS

			NOT DONE	Y	2	2012-12-16
22	STUDYX	RS	P0001	22	KFSS108A	KFSS1-Other Functions Specify	KFSS

NOT DONE

2012-12-16

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

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4 SDTM Mapping Strategy