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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 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
Date2022-09-15
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.


Revision History

DateVersionSummary of Changes

2022-09-15 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 Functional Systems (FS) to section 4 SDTM Mapping Strategy.
  • Added the description of the relationship between the Kurtzke Expanded Disability Status Scale (EDSS) and Kurtzke Functional Systems Scores (KFSS) instruments are intended to be used in conjunction with one another in section 3.1 Assumptions for the RS Domain Model.
2013-10-231.0 Final


© 2022 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 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 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 the Functional System (FS) scores. Functional Systems (FS) are described in the reference article Appendix A.

  1. 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.

  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 16 subjects collected at the baseline visit 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.

Note: Normally the dataset example represents multiple items for subject across multiple visits. In the case of the EDSS instrument, there is only 1 item assessed at a single timepoint. This example represents 16 individual subjects with 16 unique responses from the EDSS instrument to demonstrate how each response is formatted.

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  . QRSSUPP-389 - Getting issue details... STATUS

Rows 8, 9, 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) QRSSUPP-391 - Jira project doesn't exist or you don't have permission to view it. that was not evaluated on this instrument at visit 1. 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

rs.xpt

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 DONE
1 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


The EDSS Functional Systems (FS) are described in the reference article Appendix A as the following:

Pyramidal Functions

0. Normal.
1. Abnormal signs without disability.
2. Minimal disability.
3. Mild or moderate paraparesis or hemiparesis; severe monoparesis.
4. Marked paraparesis or hemiparesis; moderate quadriparesis; or monoplegia.
5.Paraplegia, hemiplegia, or marked quad-riparesis.
6. Quadriplegia.
V. Unknown.

Cerebellar Functions

0. Normal.
1. Abnormal signs without disability.
2. Mild ataxia.
3. Moderate truncal or limb ataxia.
4. Severe ataxia, all limbs.
5. Unable to perform coordinated movements due to ataxia.
V. Unknown.
X. Is used throughout after each number when weakness (grade 3 or more on pyramidal) interferes with testing.

Brain Stem Functions

0. Normal.
1. Signs only.
2. Moderate nystagmus or other mild disability.
3. Severe nystagmus, marked extra& weakness, or moderate disability of other cranial nerves.
4. Marked dysarthria or other marked disability.
5. Inability to swallow or speak.
V. Unknown.

Sensory Functions (revised 1982)

0. Normal.
1. Vibration or figure-writing decrease only, in one or two limbs.
2. Mild decrease in touch or pain or position sense, and/or moderate decrease in vibration in one or two limbs; or vibratory (c/s figure writing) decrease alone in three or four limbs.
3. Moderate decrease in touch or pain or position sense, and/or essentially lost vibration in one or two limbs; or mild decrease in touch or pain and/or moderate decrease in all proprioceptive tests in three or four limbs.
4. Marked decrease in touch or pain or loss of proprioception, alone or combined, in one or two limbs; or moderate decrease in touch or pain and/or severe proprioceptive decrease in more than two limbs.
5. Loss (essentially) of sensation in one or two limbs; or moderate decrease in touch or pain and/or loss of proprioception for most of the body below the head.
6. Sensation essentially lost below the head.
V. Unknown.

Bowel and Bladder Functions (revised 1982)

0. Normal.
1. Mild urinary hesitancy, urgency, or retention.
2. Moderate hesitancy, urgency, retention of bowel or bladder, or rare urinary incontinence.
3. Frequent urinary incontinence.
4. In need of almost constant catheterization.
5. Loss of bladder function.
6. Loss of bowel and bladder function.
V. Unknown.

Visual (or Optic) Functions

0. Normal.
1. Scotoma with visual acuity (corrected) better than 20/30.
2. Worse eye with scotoma with maximal visual acuity (corrected) of 20/30 to 20/59.
3. Worse eye with large scotoma, or moderate decrease in fields, but with maximal visual acuity (corrected) of 20/60 to 20/99.
4. Worse eye with marked decrease of fields and maximal visual acuity (corrected) of 20/100 to 20/200; grade 3 plus maximal acuity of better eye of 20/60 or less.
5. Worse eye with maximal visual acuity (corrected) less than 20/200; grade 4 plus maximal acuity of better eye of 20/60 or less.
6. Grade 5 plus maximal visual acuity of better eye of 20/60 or less.
V. Unknown.
X. Is added to grades 0 to 6 for presence of temporal pallor.

Cerebral (or Mental) Functions

0. Normal.
1. Mood alteration only (Does not affect DSS score).
2. Mild decrease in mentation.
3. Moderate decrease in mentation.
4. Marked decrease in mentation (chronic brain syndrome-moderate).
5. Dementia or chronic brain syndrome-severe or incompetent.
V. Unknown.

Other Functions

0. None.
1. Any other neurologic findings attributed to MS (specify).
V. Unknown.



End of Document

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