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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	20222023-09-2907
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

20222023-09-2907

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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 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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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, CDISC did not 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 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.

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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.

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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 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 theFunctional System (FS)

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scoresscale 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 on the functional system scores. JirashowSummaryfalsefor details.

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727

The scale points 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.

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The KFSS responses are used to determine the EDSS score.determine the EDSS score.

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Dataset wrap

rskfss

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

Y

1

2012-11-16

9

STUDYX

RS

P0001

9

KFSS107

KFSS1-Cerebral or Mental Functions

KFSS

Unknown

Y

1

2012-11-16

10

STUDYX

RS

P0001

10

KFSS108

KFSS1-Other Functions

KFSS

None

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

22012-12-16

13

STUDYX

RS

P0001

13

KFSS102

KFSS1-Cerebellar Functions

KFSS

NOT DONE

22012-12-16

14

STUDYX

RS

P0001

14

KFSS102A

KFSS1-Weakness Interferes With Testing

KFSS

NOT DONE

2

2012-12-16

15

STUDYX

RS

P0001

15

KFSS103

KFSS1-Brain Stem Functions

KFSS

NOT DONE

2

2012-12-16

16

STUDYX

RS

P0001

16

KFSS104

KFSS1-Sensory Functions

KFSS

NOT DONE

2

22012-12-16

17

STUDYX

RS

P0001

17

KFSS105

KFSS1-Bowel and Bladder Functions

KFSS

NOT DONE

22012-12-16

18

STUDYX

RS

P0001

18

KFSS106

KFSS1-Visual or Optic Functions

KFSS

NOT DONE

2

2012-12-16

19

STUDYX

RS

P0001

19

KFSS106A

KFSS1-Presence of Temporal Pallor

KFSS

NOT DONE

22012-12-16

20

STUDYX

RS

P0001

20

KFSS107

KFSS1-Cerebral or Mental Functions

KFSS

NOT DONE

2

2012-12-16

21

STUDYX

RS

P0001

21

KFSS108

KFSS1-Other Functions

KFSS

NOT DONE

22012-12-16

22

STUDYX

RS

P0001

22

KFSS108A

KFSS1-Other Functions Specify

KFSS

NOT DONE

22012-12-16

Dataset wrap

Name	rsedss

Rowcaps

Row 1:

Represent he subjects Represents the subject's EDSS score based on the subjects subject's KFSS visit 1 responses, including 2 FS grade 2 and others either 0 or 1 responses.

Row 2:

Represent Represents that the subject

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that was not evaluated on this instrument at visit 2. Since Because 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

EDSS0101

EDSS01-Expanded Disability Score

EDSS

Minimal disability in two FS.

2.5

Y

1

2012-11-16

2

STUDYX

RS

P0001

1

EDSS0101

EDSS01-Expanded Disability Score

EDSS

NOT DONE

2

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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.

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Page tree

Versions Compared

Old Version 59

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

3.2 Example for the EDSS RS Domain Model

4 SDTM Mapping Strategy

Page tree

Page History

Versions Compared

Old Version 59

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

3.2 Example for the EDSS RS Domain Model

4 SDTM Mapping Strategy