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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	20192023-1109-1307
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.

...

Date

Version

Summary of Changes

2023-09-07

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2019-11-13

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

wiki Clinical Classifications supplement template.
The RSEVAL assumption was removed from this supplement,

since

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

15

16 subjects. The original VISITNUM = 2 was revised to 1 and the RSLOBXFL variable was added to represent a baseline response.

2013-10-23

1.0

Final

1 Introduction

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

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

The representation of data collected for this clinical classification 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 clinical classification 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.

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

This instrument is in the public domain. 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 clinical classification. 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 (https://wiki.cdisc.org/download/attachments/92790019/EDSS%20Annotated%20CRF.pdf?api=v2).

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 relationship
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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 theRSDomain Model.
Updated the example to include a subject's example of the KFSS responses
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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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server	Issue Tracker (JIRA)
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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.

The CDISC Intellectual Property Policy can be found on 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/standardsabout/terminology.

Reference for the Kurtzke Expanded Disability Status Scale (EDSS):

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 EDSS are listed below.

The EDSS is an ordinal clinical rating scale ranging from 0 to 10 in half-point increments that measures the disability status of people with Multiple Sclerosis.

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 FS.". 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.
Some responses (3 specifically) to the EDSS ratings exceeded the 200-character limit for the QSORRES variable and needed to be reduced to fewer than 200 characters. Section 4, SDTM Mapping Strategy, indicates which question 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 15 subjects collected at the baseline visit for the EDSS instrument. The example uses CDISC Controlled Terminology for RSTESTCD, RSTEST, and RSCAT. All original results are represented with preferred terminology in RSORRES. This result is then transformed into the standard numeric score in RSSTRESN and a character representation of the standard numeric score in RSSTRESC.

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.

...

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

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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.

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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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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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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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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 tables

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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

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

2

STUDYX

RS

P0001

2

KFSS102

KFSS1-Cerebellar Functions

KFSS

Mild ataxia

2

Y

1

2012-11-16

3

STUDYX

RS

P0001

3

KFSS102A

KFSS1-Weakness Interferes With Testing

KFSS

NOT CHECKED

Y

1

2012-11-16

4

STUDYX

RS

P0001

4

KFSS103

KFSS1-Brain Stem Functions

KFSS

Normal

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

Y

1

2012-11-16

6

STUDYX

RS

P0001

6

KFSS105

KFSS1-Bowel and Bladder Functions

KFSS

Normal

0

Y

1

2012-11-16

7

STUDYX

RS

P0001

7

KFSS106

KFSS1-Visual or Optic Functions

KFSS

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

1

Y

1

2012-11-16

8

STUDYX

RS

P0001

8

KFSS106A

KFSS1-Presence of Temporal Pallor

KFSS

CHECKED

Dataset wrap

Name	rs

0

Rowcaps
Rows 8,9,14:	Represent QSORRES values that needed to be shortened in order to meet the 200 character SAS transport file V5 restriction.
Dataset2

Row	STUDYID	DOMAIN	USUBJID	RSSEQ	RSTESTCD	RSTEST	RSCAT	RSORRES	RSSTRESC	RSSTRESN	RSLOBXFL	VISITNUM	RSDTC
1	STUDYX	RS	P0001	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Normal neurological exam.	0

Y

1

2012-11-16

2

9

STUDYX

RS

P0002

P0001

1

9

EDSS0101

KFSS107

EDSS01-Expanded Disability Score

EDSS

No disability, minimal signs in one FS.

1

KFSS1-Cerebral or Mental Functions

KFSS

Unknown

1

Y

1

2012-11-16

3

10

STUDYX

RS

P0003

P0001

1

10

EDSS0101

KFSS108

EDSS01-Expanded Disability ScoreEDSSNo disability, minimal signs in more than one FS.1.5

KFSS1-Other Functions

KFSS

None

0

1.5

Y

1

2012-11-16

4

11

STUDYX

RS

P00041EDSS0101EDSS01-Expanded Disability ScoreEDSSMinimal disability in one FS.2

P0001

11

KFSS108A

KFSS1-Other Functions Specify

KFSS

NOT DONE

2

Y

1

2012-11-16

5

12

STUDYX

RS

P0005

P0001

1

12

EDSS0101

KFSS101

EDSS01-Expanded Disability ScoreEDSSMinimal disability in two FS.2.52.5Y12012-11-16

KFSS1-Pyramidal Functions

KFSS

NOT DONE

2

13

STUDYX

RS

P0001

13

KFSS102

KFSS1-Cerebellar Functions

KFSS

NOT DONE

2

14

6

STUDYX

RS

P0006

P0001

1

14

EDSS0101

KFSS102A

EDSS01-Expanded Disability ScoreEDSSModerate disability in one FS or mild disability in three or four FS though fully ambulatory.33Y12012-11-16

KFSS1-Weakness Interferes With Testing	KFSS				NOT DONE		2
15

7

STUDYX

RS

P0007

P0001

1

15

EDSS0101

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

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

Page tree

Versions Compared

Old Version 9

New Version Current

Key

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

1 Introduction

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

3.2 Example for the EDSS 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

4 SDTM Mapping Strategy

Page tree

Page History

Versions Compared

Old Version 9

New Version Current

Key

1 Introduction

1.1 Representations and Warranties, Limitations of Liability, and Disclaimers

2 Copyright Status

1 Introduction

3 The RS Domain Model

3.1 Assumptions for the RS Domain Model

3.2 Example for the EDSS 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

4 SDTM Mapping Strategy