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Title

Kurtzke Expanded Disability Status Scale (EDSS)

CDISC ReferenceClinical Classification Supplement to the Study Data Tabulation Model Implementation Guide for Human Clinical Trials
QRS Short Name

EDSS

QRS Permission StatusPublic Domain
TeamMultiple Sclerosis Standards Team and CDISC Questionnaires, Ratings, and Scales (QRS) Subteam
Supplement Version2.0
StatusDRAFT
Date20192020-1108-2003
NotesThis 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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DateVersionSummary of Changes
2019-1108-20032.0 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, since it is not captured on the CRF and no assumptions are made on the potential values to include in the example.
  • The example was reduced from 20 to 15 subjects. The original VISITNUM = 2 was revised to 1 and the RSLOBXFL variable was added to represent a baseline response.
  • Updated the example by adding USUBJID = "P0016" to represent how a missing visit is handled when the instrument was not filled out.
2013-10-231.0

Final

© 2019 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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

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 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 clinical classification 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/foundational/qrs.

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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. 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

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

Info
titleInformation 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.

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. 

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The EDSS example below shows the terminology used to implement the instrument in the RS domain. This example shows the data for 15 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.

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 item from the EDSS form instrument. Rows 8, 9, 14 represent represent QSORRES values that needed to be shortened in order to meet the 200 character SAS transport file V5 restriction. Row 16 represents a subject that did not complete the instrument at the baseline visit.

Dataset wrap
Namers


Dataset2


RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1STUDYXRSP00011EDSS0101EDSS01-Expanded Disability ScoreEDSSNormal neurological exam.00
Y12012-11-16
2STUDYXRSP00021EDSS0101EDSS01-Expanded Disability ScoreEDSSNo disability, minimal signs in one FS.11
Y12012-11-16
3STUDYXRSP00031EDSS0101EDSS01-Expanded Disability ScoreEDSSNo disability, minimal signs in more than one FS.1.51.5
Y12012-11-16
4STUDYXRSP00041EDSS0101EDSS01-Expanded Disability ScoreEDSSMinimal disability in one FS.22
Y12012-11-16
5STUDYXRSP00051EDSS0101EDSS01-Expanded Disability ScoreEDSSMinimal disability in two FS.2.52.5
Y12012-11-16
6STUDYXRSP00061EDSS0101EDSS01-Expanded Disability ScoreEDSSModerate disability in one FS or mild disability in three or four FS though fully ambulatory.33
Y12012-11-16
7STUDYXRSP00071EDSS0101EDSS01-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 2.3.53.5
Y12012-11-16
8STUDYXRSP00081EDSS0101EDSS01-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.44
Y12012-11-16
9STUDYXRSP00091EDSS0101EDSS01-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.4.54.5
Y12012-11-16
10STUDYXRSP00101EDSS0101EDSS01-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).55
Y12012-11-16
11STUDYXRSP00111EDSS0101EDSS01-Expanded Disability ScoreEDSSAmbulatory without aid for about 100 meters; disability severe enough to preclude full daily activities.5.55.5
Y12012-11-16
12STUDYXRSP00121EDSS0101EDSS01-Expanded Disability ScoreEDSSIntermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.66
Y12012-11-16
13STUDYXRSP00131EDSS0101EDSS01-Expanded Disability ScoreEDSSConstant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting.6.56.5
Y12012-11-16
14STUDYXRSP00141EDSS0101EDSS01-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.77
Y12012-11-16
15STUDYXRSP00151EDSS0101EDSS01-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.7.57.5
Y12012-11-16
16STUDYXRSP00161EDSS0101EDSS01-Expanded Disability ScoreEDSS


NOT DONEY12012-11-16




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

EDSS CRF Text over 200 charactersQSORRES ValueRSSTRESCRSSTRESN

Normal neurological exam.00

No disability, minimal signs in one FS.11

No disability, minimal signs in more than one FS.1.51.5

Minimal disability in one FS.22

Minimal disability in two FS.2.52.5

Moderate disability in one FS or mild disability in three or four FS though fully ambulatory.33

Fully ambulatory but with moderate disability in one FS and one or two FS grade 2; or two FS grade 3 or five grade 2.3.53.5
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.44
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.4.54.5

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).55

Ambulatory without aid for about 100 meters; disability severe enough to preclude full daily activities.5.55.5

Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting.66

Constant bilateral assistance (canes, crutches, braces) required to walk about 20 meters without resting.6.56.5
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.77

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.7.57.5

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.88

Essentially restricted to bed much of day; has some effective use of arm(s); retains some self-care functions.8.58.5

Helpless bed patient; can communicate and eat.99

Totally helpless bed patient; unable to communicate effectively or eat/swallow.9.59.5

Death due to MS.1010


End of Document