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.

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
Date2023-09-07
Notes for ReviewersThis 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

DateVersionSummary of Changes

2023-09-07 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.
  • Added the description of the relationship QRSSUPP-485 - Getting issue details... STATUS 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 the RS Domain Model.
  • Updated the example to include a subject's example of the KFSS responses QRSSUPP-484 - Getting issue details... STATUS serving as the source to determine the subject's EDSS score.
2013-10-231.0 Final


© 2023 Clinical Data Interchange Standards Consortium, Inc. All rights reserved. 

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. 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 implement 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. QRSSUPP-726 - Getting issue details... STATUS

QRSSUPP-479 - Getting issue details... 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; 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. QRSSUPP-482 - Getting issue details... STATUS

QRSSUPP-727 - Getting issue details... STATUS

  1. 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 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.

  2. 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.

  3. 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 QRSSUPP-388 - Getting issue details... STATUS 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.

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 QRSSUPP-483 - Getting issue details... STATUS represents the items from the KFSS and EDSS instruments to show their relationship. QRSSUPP-389 - Getting issue details... STATUS

The KFSS responses are used to determine the EDSS score. QRSSUPP-488 - Getting issue details... STATUS

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.

rs.xpt

rskfss.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1STUDYXRSP00011KFSS101KFSS1-Pyramidal Functions QRSSUPP-728 - Jira project doesn't exist or you don't have permission to view it. KFSSMinimal disability22
Y12012-11-16
2STUDYXRSP00012KFSS102KFSS1-Cerebellar FunctionsKFSSMild ataxia22
Y12012-11-16
3STUDYXRSP00013KFSS102AKFSS1-Weakness Interferes With TestingKFSSNOT CHECKEDNOT CHECKED

Y12012-11-16
4STUDYXRSP00014KFSS103KFSS1-Brain Stem FunctionsKFSSNormal00
Y12012-11-16
5STUDYXRSP00015KFSS104KFSS1-Sensory FunctionsKFSSVibration or figure-writing decrease only, in one or two limbs11
Y12012-11-16
6STUDYXRSP00016KFSS105KFSS1-Bowel and Bladder FunctionsKFSSNormal00
Y12012-11-16
7STUDYXRSP00017KFSS106KFSS1-Visual or Optic FunctionsKFSSScotoma with visual acuity (corrected) better than 20/3011
Y12012-11-16
8STUDYXRSP00018KFSS106AKFSS1-Presence of Temporal PallorKFSSCHECKEDCHECKED

Y12012-11-16
9STUDYXRSP00019KFSS107KFSS1-Cerebral or Mental FunctionsKFSSUnknownUnknown

Y12012-11-16
10STUDYXRSP000110KFSS108KFSS1-Other FunctionsKFSSNone00
Y12012-11-16
11STUDYXRSP000111KFSS108AKFSS1-Other Functions SpecifyKFSS


NOT DONEY12012-11-16
12STUDYXRSP000112KFSS101KFSS1-Pyramidal FunctionsKFSS


NOT DONE
2
13STUDYXRSP000113KFSS102KFSS1-Cerebellar FunctionsKFSS


NOT DONE
2
14STUDYXRSP000114KFSS102AKFSS1-Weakness Interferes With TestingKFSS


NOT DONE
2
15STUDYXRSP000115KFSS103KFSS1-Brain Stem FunctionsKFSS


NOT DONE
2
16STUDYXRSP000116KFSS104KFSS1-Sensory FunctionsKFSS


NOT DONE
2
17STUDYXRSP000117KFSS105KFSS1-Bowel and Bladder FunctionsKFSS


NOT DONE
2
18STUDYXRSP000118KFSS106KFSS1-Visual or Optic FunctionsKFSS


NOT DONE
2
19STUDYXRSP000119KFSS106AKFSS1-Presence of Temporal PallorKFSS


NOT DONE
2
20STUDYXRSP000120KFSS107KFSS1-Cerebral or Mental FunctionsKFSS


NOT DONE
2
21STUDYXRSP000121KFSS108KFSS1-Other FunctionsKFSS


NOT DONE
2
22STUDYXRSP000122KFSS108AKFSS1-Other Functions SpecifyKFSS


NOT DONE
2


Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.

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

Represents that the subject QRSSUPP-391 - Jira project doesn't exist or you don't have permission to view it. not evaluated on this instrument at visit 2. 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

rs.xpt

rsedss.xpt

RowSTUDYIDDOMAINUSUBJIDRSSEQRSTESTCDRSTESTRSCATRSORRESRSSTRESCRSSTRESNRSSTATRSLOBXFLVISITNUMRSDTC
1STUDYXRSP00011EDSS0101EDSS01-Expanded Disability ScoreEDSSMinimal disability in two FS.2.52.5
Y12012-11-16
2STUDYXRSP00011EDSS0101EDSS01-Expanded Disability ScoreEDSS


NOT DONE

2 QRSSUPP-390 - Jira project doesn't exist or you don't have permission to view it.


Dataset Debug Message

When the JIRA issue(s) present in the dataset have been resolved, and their resolution has been confirmed by governance, please remove them.

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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 charactersRSORRES 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

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1 Comment

  1. Steve Kopko

    This supplement has been updated to the current QRS supplement template.