Evidence map›Paper›PMID 24666846›Full record

SynthesisBMC neurology2014

Systematic literature review and validity evaluation of the Expanded Disability Status Scale (EDSS) and the Multiple Sclerosis Functional Composite (MSFC) in patients with multiple sclerosis.

Sandra Meyer-Moock, You-Shan Feng, Mathias Maeurer, Franz-Werner Dippel, Thomas Kohlmann

2 registry-linked trialsAbstract readEvaluation StudySystematic ReviewValidation Study
In one paragraph

Synthesis in BMC neurology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 305 papers, 18 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
305citing papers in PubMed, 18 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.

NCT04178005 phase4active not recruitingnot on this mapstarted 2020, after this paper: background citation

Cladribine Tablets After Treatment With Natalizumab (CLADRINA)

TypeinterventionalSponsorUniversity of Texas Southwestern Medical CenterRan2020 to 2026Enrolled40ConditionsMultiple SclerosisArmsCladribine
NCT05003388 phase1recruitingnot on this mapstarted 2021, after this paper: background citation

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Multiple Sclerosis

TypeinterventionalSponsorThe Foundation for Orthopaedics and Regenerative MedicineRan2021 to 2025Enrolled15ConditionsMultiple SclerosisArmsAlloRx
3 · Its place in the literature

Who cites it

305 citing papers in PubMed, 18 syntheses or guidelines pooled it.

  1. Pooled it
  2. Rituximab for people with multiple sclerosis.The Cochrane database of systematic reviews · 2025
    Pooled it
  3. Azathioprine for people with multiple sclerosis.The Cochrane database of systematic reviews · 2024
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Pooled it
  15. Pooled it
  16. Rituximab for people with multiple sclerosis.The Cochrane database of systematic reviews · 2021
    Pooled it
  17. Pooled it
  18. Effectiveness of Motor Imagery on Motor Recovery in Patients with Multiple Sclerosis: Systematic Review.International journal of environmental research and public health · 2021
    Pooled it
  19. Trial
  20. Trial

245 more citing papers are in PubMed but not listed here.

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

5 authors.

Sandra Meyer-MoockInstitute for Community Medicine, University Medicine Greifswald, Walther-Rathenau-Strasse 48, 17475 Greifswald, Germany. sandra.meyer-moock@uni-greifswald.de.
You-Shan Feng
Mathias Maeurer
Franz-Werner Dippel
Thomas Kohlmann

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThere are a number of instruments that describe severity and progression of multiple sclerosis and they are increasingly used as endpoints to assess the effectiveness of therapeutic interventions. We examined to what extent the psychometric properties of two accepted instruments--EDSS and MSFC--meet methodological standards and the value they have in clinical trials.

methodsWe conducted a systematic literature search in relevant databases [MEDLINE (PubMed), ISI Web of Science, EMBASE, PsycINFO & PSYNDEX, CINAHL] yielding 3,860 results. Relevant full-text publications were identified using abstract and then full-text reviews, and the literature was reviewed.

resultsFor evaluation of psychometric properties (validity, reliability, sensitivity of change) of EDSS and MSFC, 120 relevant full-text publications were identified, 54 of them assessed the EDSS, 26 the MSFC and 40 included both instruments. The EDSS has some documented weaknesses in reliability and sensitivity to change. The main limitations of the MSFC are learning effects and the z-scores method used to calculate the total score. However, the methodological criterion of validity applies sufficiently for both instruments.For use in clinical studies, we found the EDSS to be preferred as a primary and secondary outcome measure in recent studies (50 EDSS, 9 MSFC).

conclusionsRecognizing their strengths and weaknesses, both EDSS and MSFC are suitable to detect the effectiveness of clinical interventions and to monitor disease progression. Almost all publications identify the EDSS as the most widely used tool to measure disease outcomes in clinical trials. Despite some limitations, both instruments are accepted as endpoints and neither are discussed as surrogate parameters in identified publications. A great advantage of the EDSS is its international acceptance (e.g. by EMA) as a primary endpoint in clinical trials and its broad use in trials, enabling cross-study comparisons.

Indexed as

Disability EvaluationClinical Trials as TopicHumansMultiple SclerosisPsychometrics

Identifiers

PMID24666846
PMCPMC3986942

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.