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

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 an...

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Vydáno v:BMC neurology Ročník 14; číslo 1; s. 58
Hlavní autoři: Meyer-Moock, Sandra, Feng, You-Shan, Maeurer, Mathias, Dippel, Franz-Werner, Kohlmann, Thomas
Médium: Journal Article
Jazyk:angličtina
Vydáno: London BioMed Central 25.03.2014
Springer Nature B.V
Témata:
Clinical Trials as Topic - methods
Demyelinating diseases
Disability Evaluation
Humans
Medicine
Medicine & Public Health
Multiple Sclerosis - diagnosis
Multiple Sclerosis - epidemiology
Multiple Sclerosis - physiopathology
Neurochemistry
Neurology
Neurosurgery
Psychometrics - methods
Psychometrics - standards
Research Article
Expanded Disability Status Scale (EDSS)
Validity
Multiple sclerosis
Multiple Sclerosis Functional Composite (MSFC)
Sensitivity of change
Reliability
Psychometric properties
ISSN:1471-2377, 1471-2377
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Shrnutí: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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ISSN:1471-2377
1471-2377
DOI:10.1186/1471-2377-14-58