Evidence map›Paper›PMID 29926371›Full record

ReviewCNS drugs2018

Disability Outcome Measures in Phase III Clinical Trials in Multiple Sclerosis.

Bernard M J Uitdehaag

Abstract readReview
In one paragraph

Review in CNS drugs, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Rituximab in secondary progressive multiple sclerosis: a meta-analysis.Annals of clinical and translational neurology · 2024
    Pooled it
  2. Ocrelizumab for multiple sclerosis.The Cochrane database of systematic reviews · 2022
    Pooled it
  3. Pooled it
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  8. Review
  9. Effect of impairment on health-related quality of life in people with multiple sclerosis: association of functional systems and EQ-5D-5L index values in a cross-sectional study.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2025
    Article
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  18. Article
  19. Recurrent disability progression endpoints in multiple sclerosis clinical trials.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023
    Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

1 author.

Bernard M J UitdehaagDepartment of Neurology, Amsterdam Neuroscience, VUmc MS Center Amsterdam, VU University Medical Center, De Boelelaan 1117, 1081, HV Amsterdam, The Netherlands. bmj.uitdehaag@vumc.nl.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Accumulating neurological disability has a substantial impact on the lives of patients with multiple sclerosis (MS). As well as the established Expanded Disability Status Scale (EDSS), several other outcome measures are now available for assessing disability progression in MS. This review extends the findings of a previous analysis of relapsing-remitting MS (RRMS) trials published up to 2012, to determine whether there has been a shift in outcome measures used to assess disability in phase III clinical trials in RRMS and progressive MS. Forty relevant trials were identified (RRMS, n = 16; progressive MS, n = 18; other/mixed phenotypes, n = 6). Sustained EDSS worsening, particularly over 3 months, was included as an endpoint in almost all identified trials. Other disability-related endpoints included the Multiple Sclerosis Functional Composite z-score and scores for the physical component summary of the Multiple Sclerosis Impact Scale and Medical Outcomes Study Short-Form (36-item) Health Survey. Tests assessing manual dexterity, ambulation, vision and cognition were also employed, and in some trials, composite endpoints were used. However, there was no obvious trend in choice of disability outcome measures over time. Sustained EDSS worsening over short time periods continues to be the most widely used measure of disability progression in pivotal MS trials, despite its well-recognised limitations. A new tool set is needed for use in MS clinical trials that detects the benefit of potential treatments that slow (or reverse) progressive disability.

Indexed as

Persons with DisabilitiesClinical Trials, Phase III as TopicHumansMultiple Sclerosis

Identifiers

PMID29926371
PMCPMC6061412

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.