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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
Date2022-0607-0311
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

2022-0607-0311

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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.


2013-10-231.0 Final


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  • Kurtzke JF. Rating neurologic impairment in multiple sclerosis: anAn
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    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 16 subjects collected at the baseline visit

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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 with preferred terminology in RSORRESin QSORRES.This result is then transformed into therepresented as a standard numeric score in RSSTRESN  QSSTRESN and as a standard character representation of the standard numeric score in RSSTRESCin QSSTRESC.

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.

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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