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. 2014 Mar 25:14:58.
doi: 10.1186/1471-2377-14-58.

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  1 , You-Shan Feng, Mathias Maeurer, Franz-Werner Dippel, Thomas Kohlmann
Affiliations

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 et al. BMC Neurol. .

Abstract

Background: There 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.

Methods: We 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.

Results: For 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).

Conclusions: Recognizing 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.

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Figures

Figure 1
Figure 1
Selection process of methodological publications for EDSS and/or MSFC.
See this image and copyright information in PMC

References

    1. Weinshenker BG. The natural history of multiple sclerosis. Clin Neurol Neurosurg. 1995;13:119–146. - PubMed
    1. Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale. Neurology. 1983;5:580–583. - PubMed
    1. Cutter GR, Baier ML, Rudick RA, Cookfair DL, Fischer JS, Petkau J, Syndulko K, Weinshenker BG, Antel JP, Confavreux C, Ellison GM, Lublin F, Miller AE, Rao SM, Reingold S, Thompson A, Willoughby A. Development of a multiple sclerosis functional composite as a clinical trial outcome measure. Brain. 1999;122:871–882. doi: 10.1093/brain/122.5.871. - DOI - PubMed
    1. Fischer JS, Rudick RA, Cutter GR, Reingold SC. The Multiple Sclerosis Functional Composite Measure (MSFC): an integrated approach to MS clinical outcome. National MS Society Clinical Outcomes Assessment Task Force. Mult Scler. 1999;5(4):244–250. - PubMed
    1. Baier ML, Cutter GR, Ruck RA. Low-contrast letter acuity testing captures visual dysfunction in patients with multiple sclerosis. Neurology. 2005;64:992–995. doi: 10.1212/01.WNL.0000154521.40686.63. - DOI - PubMed

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