Making the switch: From case studies to N-of-1 trials

Epilepsy & Behavior Reports
Amanda Margolis, Christopher Giuliano

Abstract

Case studies can generate hypothesis based on unique clinical patient encounters and provide guidance among populations with limited numbers of patients. However, case studies are not blinded and are susceptible to a variety of factors that can influence study outcomes. One potential solution to minimize this bias is to use an N-of-1 trial. N-of-1 trials are a double-blinded randomized crossover trial within a limited number of patients, often as small as a single patient. These trials borrow many concepts from randomized controlled trials (RCTs), which in turn increases the validity of findings compared with a case report. Situations best suited for an N-of-1 trial include chronic disease states and therapies with quick onset and offset, such as in patients with seizures. There are many opportunities to use N-of-1 trials among patients with epilepsy, and providers are encouraged to explore and employ these methods. The purpose of this article was to describe N-of-1 trials along with considerations for conducting, publishing, and evaluating N-of-1 trials.

Citations

Jun 6, 2021·Nature Biotechnology·Stanley T Crooke
Aug 18, 2021·Contemporary Clinical Trials Communications·Jane NiklesSuzanne McDonald
Sep 17, 2021·Pain and Therapy·Wanying HeFengxian Li

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