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title	Information for Reviewers

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

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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	20222023-09-07-15
Notes for Reviewers	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

20222023-09-07-15

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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.Added the description of the relationship between the Kurtzke Expanded relationship
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between the Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments are (i.e., intended to be used in conjunction with one another) in section Section 3.1, Assumptions for theRSDomain Model.

2013-10-23

1.0 Final

1 Introduction

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

...

Updated the example to include a subject's example of the KFSS responses
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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/standards/foundational/qrs.

484
serving as the source to determine the subject's EDSS score.

2013-10-23

1.0 Final

1 Introduction

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

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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: The CDISC Intellectual Property Policy can be found on the CDISC website at: https://www.cdisc.org/aboutstandards/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

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server	Issue Tracker (JIRA)
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. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the EDSS 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 examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Info

title	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/controlled-terminology.

Reference for the EDSS:

Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An
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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 EDSS are listed below.

The EDSS 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. The Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments are intended to be used in conjunction with one another. The KFSS should first be administered by the evaluator and 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 of one or more in the FS scores. Functional Systems (FS) are described in the reference article Appendix A.

...

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/standards/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 implement protocols

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	QRSSUPP-384

. CDISC disclaims any liability for your use of this material.

Although the United States Food and Drug Administration (US FDA) has provided input with regard to this supplement, this input does not constitute US FDA endorsement of any particular instrument.

2 Copyright Status

CDISC believes this instrument to be in the public domain, but you should perform your own assessment. CDISC has included the EDSS 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 examples, and (3) CRF(s) annotated with the CDISC SDTMIG variables with submission values.

Info

title	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/controlled-terminology.

Reference for the EDSS:

Kurtzke JF. Rating neurologic impairment in multiple sclerosis: An
Jira
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server Issue Tracker (JIRA)
serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key QRSSUPP-385
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 EDSS are listed below.

The EDSS 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.

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726

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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.

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The Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) 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 of 1 or more Functional System (FS). Please review the published Kurtzke Functional Systems Scores (KFSS) for details.

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Terminology

RSCAT, RSTESTCD, and RSTEST values are included in CDISC Controlled Terminology.
A full list of value sets for the result fields is provided in Section 4, SDTM Mapping Strategy.

3.2 Example for the EDSS RS Domain Model

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The original scores 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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387
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.

3.2 Example for the EDSS RS Domain Model

The EDSS 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 and visit 2

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Info
We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

The table represents the items from the EDSS instrument. Rows 8, 9, and 14 represent RSORRES values that needed to be shortened in order to meet the 200-character SAS V5 transport file restriction. Row 16 represents a subject (P0016) JirashowSummaryfalseserverIssue

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for the EDSS 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.

Info
We are unable to make the example consistently show blue in the Wiki. All examples are updated for each QRS instrument so we ask that you please review the example below.

The tables391 that was not evaluated on this instrument at visit 1. Because the reason for not completing the visit was not collected, no date is assumed for when the visit would have occurred. JirashowSummary

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389

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represents the items from the KFSS and EDSS instruments to show their relationship.

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The KFSS responses are used to determine the EDSS score.

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Dataset wrap

Name	rskfss

Rowcaps
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.

Dataset2

Dataset wrap

Name	rs

Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSSTRESN	RSSTAT	RSLOBXFL	VISITNUM	RSDTC
1	STUDYX	RS	P0001	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Normal neurological exam.	0	0	Y	1	2012-11-16	2	STUDYX	RS	P0002	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	No disability, minimal signs in one FS.	1	1	Y	1	2012-11-16	3	STUDYX	RS	P0003	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	No disability, minimal signs in more than one FS.	1.5	1.5	Y	1	2012-11-16	4	STUDYX	RS	P0004	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Minimal disability in one FS.	2

Row

STUDYID

DOMAIN

USUBJID

RSSEQ

RSTESTCD

RSTEST

RSCAT

RSORRES

RSSTRESC

RSSTRESN

RSSTAT

RSLOBXFL

VISITNUM

RSDTC

1

STUDYX

RS

P0001

1

KFSS101

KFSS1-Pyramidal Functions

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KFSS

Minimal disability

2

Y

1

2012-11-16

5

2

STUDYX

RS

P0005

P0001

1

2

EDSS0101

KFSS102

EDSS01-Expanded Disability Score

EDSS

Minimal disability in two FS.

2.5

KFSS1-Cerebellar Functions

KFSS

Mild ataxia

2

2.5

Y

1

2012-11-16

6

3

STUDYX

RS

P0006

P0001

1

3

EDSS0101

KFSS102A

EDSS01-Expanded Disability ScoreEDSSModerate disability in one FS or mild disability in three or four FS though fully ambulatory.3

KFSS1-Weakness Interferes With Testing

KFSS

NOT CHECKED

3

Y

1

2012-11-16

7

4

STUDYX

RS

P0007

P0001

1

4

EDSS0101

KFSS103

EDSS01-Expanded Disability ScoreEDSSFully 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

KFSS1-Brain Stem Functions

KFSS

Normal

0

3.5

Y

1

2012-11-16

8

5

STUDYX

RS

P0008

P0001

1

5

EDSS0101

KFSS104

EDSS01-Expanded Disability ScoreEDSSFully 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

KFSS1-Sensory Functions

KFSS

Vibration or figure-writing decrease only, in one or two limbs

1

4

Y

1

2012-11-16

9

6

STUDYX

RS

P0009

P0001

1

6

EDSS0101

KFSS105

EDSS01-Expanded Disability ScoreEDSSFully 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.4.54.5Y1

KFSS1-Bowel and Bladder Functions

KFSS

Normal

0

Y

1

2012-11-16

10

7

STUDYX

RS

P0010

P0001

1

7

EDSS0101

KFSS106

EDSS01-Expanded Disability ScoreEDSSAmbulatory 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

KFSS1-Visual or Optic Functions

KFSS

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

1

5

Y

1

2012-11-16

11

8

STUDYX

RS

P0011

P0001

1

8

EDSS0101

KFSS106A

EDSS01-Expanded Disability ScoreEDSSAmbulatory without aid for about 100 meters; disability severe enough to preclude full daily activities.5.5

KFSS1-Presence of Temporal Pallor

KFSS

CHECKED

5.5

Y

1

2012-11-16

12

9

STUDYX

RS

P0012

P0001

1

9

EDSS0101

KFSS107

EDSS01-Expanded Disability ScoreEDSSIntermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.6

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

6

Y

1

2012-11-16

13

11

STUDYX

RS

P0013

P0001

1

11

EDSS0101

KFSS108A

EDSS01-Expanded Disability ScoreEDSSConstant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting.6.56.5Y

KFSS1-Other Functions Specify

KFSS

NOT DONE

Y

1

2012-11-16

14

12

STUDYX

RS

P0014

P0001

1

12

EDSS0101

KFSS101

EDSS01-Expanded Disability ScoreEDSSUnable 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.77Y12012-11-16

KFSS1-Pyramidal Functions

KFSS

NOT DONE

2

13

STUDYX

RS

P0001

13

KFSS102

KFSS1-Cerebellar Functions

KFSS

NOT DONE

2

14

15

STUDYX

RS

P0015

P0001

1

14

EDSS0101

KFSS102A

EDSS01-Expanded Disability ScoreEDSSUnable 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.7.57.5Y12012-11-16

KFSS1-Weakness Interferes With Testing	KFSS				NOT DONE		2
15

16

STUDYX

RS

P0016

P0001

1

15

EDSS0101

KFSS103

EDSS01-Expanded Disability Score

KFSS1-Brain Stem Functions

KFSS

EDSS

NOT DONE

1

2

jira

16

showSummary

STUDYX

false

RS

serverIssue Tracker (JIRA)serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45keyQRSSUPP-390

Page tree

Versions Compared

Old Version 44

New Version Current

Key

1 Introduction

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

3.2 Example for the EDSS RS Domain Model

3.2 Example for the EDSS RS Domain Model

4 SDTM Mapping Strategy

4 SDTM Mapping Strategy

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

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Page History

Versions Compared

Old Version 44

New Version Current

Key

1 Introduction

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

3.2 Example for the EDSS RS Domain Model

3.2 Example for the EDSS RS Domain Model

4 SDTM Mapping Strategy

4 SDTM Mapping Strategy