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N-of-1 Trials as a Decision Support Tool in Clinical Practice: A Protocol for a Systematic Literature Review and Narrative Synthesis

McGovern Medical School, The University of Texas Health Science Center at Houston, 6431 Fannin St, Houston, TX 77030, USA
Houston Academy of Medicine, The Texas Medical Center Library, 1133 John Freeman Blvd, Houston, TX 77030, USA
Author to whom correspondence should be addressed.
Healthcare 2019, 7(4), 136;
Received: 29 August 2019 / Revised: 28 October 2019 / Accepted: 2 November 2019 / Published: 6 November 2019
(This article belongs to the Special Issue N-of-1 Trials in Healthcare)
The n-of-1 trial can utilized in clinical practice as a decision support tool, which may improve patient outcomes by providing both the patient and the clinician with objective evidence to inform personalized treatment decisions. As its use broadens, it will be important to study whether the added time and effort of an n-of-1 trial results in measurable improvements in important patient outcomes compared to usual clinical practice. Parallel-group randomized clinical trials testing the n-of-1 approach versus usual care have been undertaken in a number of medical settings. A systematic review will be performed according to PRISMA guidelines, using MEDLINE, Embase, Cochrane, CINAHL, PsycINFO, Scopus, and Web of Science to search for randomized clinical trials in humans, without date or language restriction. Reports from the gray literature and ongoing studies in trial registries will be included. Articles will be screened by two independent reviewers with a third reviewer consulted to adjudicate disagreement. The quality of included studies will be assessed using the Cochrane Collaboration’s tool for assessing risk of bias. A narrative synthesis will explore the differing methodological approaches of the included studies. The protocol will be registered in the PROSPERO registry, and the results of the review will be published in a peer-reviewed journal. To our knowledge, this systematic review will be the first to comprehensively assess the existing research on randomized trials testing the n-of-1 trial approach in clinical practice. View Full-Text
Keywords: n-of-1 trial; single case experimental design; personalized trial n-of-1 trial; single case experimental design; personalized trial
MDPI and ACS Style

Samuel, J.; Holder, T.; Molony, D. N-of-1 Trials as a Decision Support Tool in Clinical Practice: A Protocol for a Systematic Literature Review and Narrative Synthesis. Healthcare 2019, 7, 136.

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