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The Multiple Sclerosis Functional Composite measure (MSFC): an integrated approach to MS clinical outcome assessment

Mellen Center (U-10), Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio OH 44195-5244 USA

R A Rudick

Mellen Center (U-10), Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio OH 44195-5244 USA

G R Cutter

Center for Research Methodology and Biometrics, AMC Cancer Research Center, 1600 Pierce Street, Lakewood, Colorado CO 80214 USA

S C Reingold

Research Programs Department, National MS Society, 733 Third Avenue, New York, NY 10017 USA

National MS Society Clinical Outcomes Assessment Task Force

Clinical outcome assessment in Multiple Sclerosis (MS) is challenging due to the diversity and fluctuating nature of MS symptoms. Traditional clinical scales such as the EDSS are inadequate in their assessment of key clinical dimensions of MS (e.g., cognitive function), and they have psychometric limitations as well. Based on analyses of pooled data from natural history studies and from placebo groups in clinical trials, the National MS Society's Clinical Outcomes Assessment Task Force recently proposed a new multidimensional clinical outcome measure, the MS Functional Composite (MSFC). The MSFC comprises quantitative functional measures of three key clinical dimensions of MS: leg function/ambulation, arm/hand function, and cognitive function. Scores on component measures are converted to standard scores (z-scores), which are averaged to form a single MSFC score. Preliminary analyses confirm that: (1) the three clinical dimensions of the MSFC are relatively independent; (2) the MSFC is sensitive to clinical changes over 1- and 2-year intervals; and (3) the MSFC has acceptable criterion validity (i.e., predicts both concurrent and subsequent EDSS change). The advantages and potential limitations of incorporating quantitative functional outcome measures such as the MSFC into collaborative databases are discussed.

Key Words: multiple sclerosis • clinical trials • clinical outcome assessment • MS Functional Composite (MSFC)

Multiple Sclerosis, Vol. 5, No. 4, 244-250 (1999)
DOI: 10.1177/135245859900500409


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