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Title	Kurtzke Expanded Disability Status Scale (EDSS)
CDISC Reference	Clinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name	EDSS
QRS Permission Status	Public Domain
Team	Multiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version	2.0
Status	DRAFT
Date	20212022-1106-3003
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.

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Date

Version

Summary of Changes

2021

2022-

11

06-

30

03

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2.0 Draft

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 EDSS v2.0 supplement was updated to the wiki Clinical Classifications supplement template.
The RSEVAL assumption was removed from this supplement, because it is not captured on the CRF and no assumptions are made on the potential values to include in the example.
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The example was reduced from 20 to 16 subjects. The original VISITNUM = 2 was revised to 1 and the RSLOBXFL variable was added to represent a baseline response.
The example was updated by adding USUBJID = "P0016" to represent how a missing visit is handled when the instrument was not filled out.
Added the description of the Functional Systems (FS) to section 4 SDTM Mapping Strategy.

2013-10-23

1.0 Final

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This document describes the CDISC implementation of the Kurtzke Expanded Disability Status Scale (EDSS) instrument.

CDISC does did not not modify this questionnaires, ratings, and scales (QRS) instruments instrument to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards.

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All assumptions and business rules described in the SDTMIG RS domain are applicable to this supplement. Additional assumptions specific to the EDSS are listed below.

The EDSS is an is an ordinal clinical rating scale that is used to measure the disability status of subjects. The item response is a range from 0 to 10 in half-point increments that measures the disability status. Functional Systems (FS) are described in the reference article Appendix A.

The scale points include a numeric rating (0-10) and a definition of what is represented by the rating (e.g., 2.5 = "Minimal disability in two
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FS
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."). For the EDSS, RSORRES is populated with the text description while the numeric rating is represented in the standardized character and numeric result variables RSSTRESC and RSSTRESN.
Three responses to the EDSS ratings 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.
Terminology
1. RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.
2. A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

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EDSS CRF Text over 200 characters	RSORRES Value	RSSTRESC	RSSTRESN
	Normal neurological exam.	0	0
	No disability, minimal signs in one FS.	1	1
	No disability, minimal signs in more than one FS.	1.5	1.5
	Minimal disability in one FS.	2	2
	Minimal disability in two FS.	2.5	2.5
	Moderate disability in one FS or mild disability in three or four FS though fully ambulatory.	3	3
	Fully ambulatory but with moderate disability in one FS and one or two FS grade 2; or two FS grade 3 or five grade 2.	3.5	3.5
Fully ambulatory without aid, self-sufficient, up and about some 12 hours a day despite relatively severe disability consisting of one FS grade 4, or combination of lesser grades exceeding limits of previous steps; able to walk without aid or rest some 500 meters.	Fully ambulatory without aid, self-sufficient, up and about some 12 hours a day despite relatively severe disability; able to walk without aid or rest some 500 meters.	4	4
Fully ambulatory without aid, up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance; characterized by relatively severe disability usually consisting of one FS grade 4 or combinations of lesser grades exceeding limits of previous steps; able to walk without aid or rest some 300 meters.	Fully ambulatory without aid, up much of the day, able to work a full day, may have some limitation of full activity or require minimal assistance; able to walk without aid or rest some 300 meters.	4.5	4.5
	Ambulatory without aid or rest for about 200 meters; disability severe enough to impair full daily activities (e.g., to work a full day without special provisions).	5	5
	Ambulatory without aid for about 100 meters; disability severe enough to preclude full daily activities.	5.5	5.5
	Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.	6	6
	Constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting.	6.5	6.5
Unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hours a day.	Unable to walk beyond approximately 5 meters even with aid, essentially restricted to wheelchair; wheels self in standard wheelchair and transfers alone; up and about in wheelchair some 12 hrs a day.	7	7
	Unable to take more than a few steps; restricted to wheelchair; may need aid in transfer; wheels self but cannot carry on in standard wheelchair a full day; May require motorized wheelchair.	7.5	7.5
	Essentially restricted to bed or chair or perambulated in wheelchair, but may be out of bed itself much of the day; retains many self-care functions; generally has effective use of arms.	8	8
	Essentially restricted to bed much of day; has some effective use of arm(s); retains some self-care functions.	8.5	8.5
	Helpless bed patient; can communicate and eat.	9	9
	Totally helpless bed patient; unable to communicate effectively or eat/swallow.	9.5	9.5
	Death due to MS.	10	10

The EDSS Functional Systems (FS) are described in the reference article Appendix A as the following:

Pyramidal Functions

0. Normal.

1. Abnormal signs without disability.

2. Minimal disability.

3. Mild or moderate paraparesis or hemiparesis; severe monoparesis.

4. Marked paraparesis or hemiparesis; moderate quadriparesis; or monoplegia.

5.Paraplegia, hemiplegia, or marked quad-riparesis.

6. Quadriplegia.

V. Unknown.

Cerebellar Functions

0. Normal.

1. Abnormal signs without disability.

2. Mild ataxia.

3. Moderate truncal or limb ataxia.

4. Severe ataxia, all limbs.

5. Unable to perform coordinated movements due to ataxia.

V. Unknown.

X. Is used throughout after each number when weakness (grade 3 or more on pyramidal) interferes with testing.

Brain Stem Functions

0. Normal.

1. Signs only.

2. Moderate nystagmus or other mild disability.

3. Severe nystagmus, marked extra& weakness, or moderate disability of other cranial nerves.

4. Marked dysarthria or other marked disability.

5. Inability to swallow or speak.

V. Unknown.

Sensory Functions (revised 1982)

0. Normal.

1. 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.

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.

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.

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.

6. Sensation essentially lost below the head.

V. Unknown.

Bowel and Bladder Functions (revised 1982)

0. Normal.

1. Mild urinary hesitancy, urgency, or retention.

2. Moderate hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence.

3. Frequent urinary incontinence.

4. In need of almost constant catheterization.

5. Loss of bladder function.

6. Loss of bowel and bladder function.

V. Unknown.

Visual (or Optic) Functions

0. Normal.

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

2. Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/59.

3. Worse eye with large scotoma, or moderate decrease in fields, but with maximal visual acuity (corrected) of 20/60 to 20/99.

4. 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.

5. Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less.

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

V. Unknown.

X. Is added to grades 0 to 6 for presence of temporal pallor.

Cerebral (or Mental) Functions

0. Normal.

1. Mood alteration only (Does not affect DSS score).

2. Mild decrease in mentation.

3. Moderate decrease in mentation.

4. Marked decrease in mentation (chronic brain syndrome-moderate).

5. Dementia or chronic brain syndrome-severe or incompetent.

V. Unknown.

Other Functions

0. None.

1. Any other neurologic findings attributed to MS (specify).

V. Unknown.

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