Randomized clinical trials (RCTs) are recognized as the gold-standard approach to assessing the efficacy of medical interventions. High-quality (rigorously designed, conducted, and analyzed) RCTs provide reliable evidence on which to base clinical practice. Rehabilitation interventions are widely used in the management of patients with multiple sclerosis (MS); however, relatively few interventions have been evaluated by RCTs. Compared to drug trials, the design and conduct of RCTs to assess rehabilitation presents a number of major problems. This chapter examines sources of error in RCTs in general, discusses specific problems related to rehabilitation trials, and finally summarizes the available evidence regarding the methodological rigor of rehabilitation interventions in MS in three major areas: physiotherapy, cognitive retraining, and multidisciplinary rehabilitation. Clinical aspects of these interventions are discussed in other chapters of this volume. Sources of error in RCTs Randomized clinical trials are susceptible to two main types of error, those due to chance (random departure of results from the truth), and those due to bias (deviation of results from the truth). Many clinicians are familiar with errors due to chance, embodied in the concept of statistical significance or the p value, which estimates whether a difference between, say a treated and a control group, can reasonably be attributed to chance or considered real.
|Title of host publication||Multiple Sclerosis: Recovery of Function and Neurorehabilitation|
|Publisher||Cambridge University Press|
|Number of pages||8|
|ISBN (Print)||9780511781698, 9780521888325|
|Publication status||Published - Jan 1 2010|
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