Information for Reviewers

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

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	2021-11-30
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
2021-11-30 QRSSUPP-382 - Getting issue details... STATUS	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. QRSSUPP-381 - Getting issue details... STATUS 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.
2013-10-23	1.0 Final

1 Introduction

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

CDISC does not modify questionnaires, ratings, and scales (QRS) instruments to meet Clinical Data Acquisition Standards Harmonization (CDASH) case report form (CRF) standards. QRSSUPP-383 - Getting issue details... STATUS

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 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 QRSSUPP-384 - Getting issue details... STATUS . 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.

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 QRSSUPP-385 - Getting issue details... STATUS 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 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 QRSSUPP-387 - Getting issue details... STATUS FS QRSSUPP-386 - Getting issue details... STATUS ."). 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 16 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.

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) 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.

rs.xpt

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	2		Y	1	2012-11-16
5	STUDYX	RS	P0005	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Minimal disability in two FS.	2.5	2.5		Y	1	2012-11-16
6	STUDYX	RS	P0006	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Moderate disability in one FS or mild disability in three or four FS though fully ambulatory.	3	3		Y	1	2012-11-16
7	STUDYX	RS	P0007	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	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		Y	1	2012-11-16
8	STUDYX	RS	P0008	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	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		Y	1	2012-11-16
9	STUDYX	RS	P0009	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	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		Y	1	2012-11-16
10	STUDYX	RS	P0010	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	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		Y	1	2012-11-16
11	STUDYX	RS	P0011	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Ambulatory without aid for about 100 meters; disability severe enough to preclude full daily activities.	5.5	5.5		Y	1	2012-11-16
12	STUDYX	RS	P0012	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.	6	6		Y	1	2012-11-16
13	STUDYX	RS	P0013	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	Constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting.	6.5	6.5		Y	1	2012-11-16
14	STUDYX	RS	P0014	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	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		Y	1	2012-11-16
15	STUDYX	RS	P0015	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS	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		Y	1	2012-11-16
16	STUDYX	RS	P0016	1	EDSS0101	EDSS01-Expanded Disability Score	EDSS				NOT DONE		1

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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.

The EDSS CRF text for ratings of 4, 4.5, and 7 on the table were abbreviated to fit the 200-character RSORRES limit.

RSTESTCD = "EDSS0101" RSTEST = "EDSS01-Expanded Disability Score"

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

End of Document

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