Abstract
Sometime in the future, a multiple sclerosis (MS) patient comes to see the neurologist. Neurologist: “Well, your MRI looks great!” Patient: “That’s wonderful doc, because my life is falling apart, I feel lousy and that medication you gave me made me sicker than my MS did”. This situation is mirrored in clinical trials in which statistical imperatives dictate that outcomes be narrowly defined, often in terms of a single primary outcome measure. Although this strategy may help to avoid the type of error that occurs when so many outcomes are examined, it is problematic because a broad spectrum of other clinically relevant outcomes may be discounted.
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LaRocca, N.G., Ritvo, P.G., Miller, D.M., Fischer, J.S., Andrews, H., Paty, D.W. (1996). “Quality of Life” Assessment in Multiple Sclerosis Clinical Trials: Current Status and Strategies for Improving Multiple Sclerosis Clinical Trial Design. In: Goodkin, D.E., Rudick, R.A. (eds) Multiple Sclerosis. Springer, London. https://doi.org/10.1007/978-1-4471-1271-6_7
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