Randomized Trials in Individual Patients

Abstract: Clinicians are not always able to find a randomized trial to guide their selection of the treatment most likely to help a specific patient; in these situations, randomized trials in single patients (n-of-1 trials) can be a useful tool. This article summarizes a stepwise approach for deciding if a n-of-1 trial is adequate and for its planning.An n-of-1 trial is indicated only if 1) the effectiveness of the treatment is really in doubt, the treatment is to be continued long-term, and the patient is eager to collaborate; 2) the treatment has a rapid onset, ceases soon after it is discontinued, and relevant outcomes can be measured; 3) it can be performed in the actual practice setting-, 4) the study is ethical.

Keyword(s): Single-case design

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