Functional clinical outcomes in multiple sclerosis: Current status and future prospects
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Elsevier B.V.
Abstract
For decades, the Expanded Disability Status Scale (EDSS) has been the principal measure of disability in clinical trials in patients with multiple sclerosis (MS) and in clinical practice. However, this test is dominated by effects on ambulation. Composite endpoints may provide a more sensitive measure of MS-related disability through the measurement of additional neurological functions. The MS Functional Composite (MSFC) includes a walking test (25-ft walk) plus tests of upper extremity dexterity (9-hole peg test) and cognitive function (Paced Auditory serial Addition test [PASAT]). Replacing PASAT with the Symbol Digit Modality test, a more sensitive test preferred by patients, may improve the clinical utility of the MSFC. In addition, disease-specific measures of QoL may be used alongside the MSFC (which does not include measurement of QoL). Clinical data suggest that disease-modifying therapies may delay or prevent relapse, and better composite measures will be valuable in the assessment of disease activity-free status in people with MS. © 2015 Elsevier B.V.
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Keywords
Clinical outcome measures, Clinical trials, Disease-modifying therapies, Multiple sclerosis, Disability evaluation, Endpoint determination, Female, Humans, Male, Outcome assessment (health care), Quality of life, Treatment outcome, Alemtuzumab, Beta1a interferon, Article, Brain function, Clinical assessment, Clinical practice, Clinical study, Cognition, Dexterity test, Drug efficacy, Expanded disability status scale, Functional assessment, Functional status, Human, Mobilization, Motor dysfunction, Neurologic examination, Nine hole peg test, Paced auditory serial addition test, Relapse, Sensitivity analysis, Symbol digit modality test, Timed 25 ft walk, Walking, Bioassay, Disability, Outcome assessment, Procedures