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N-of-1 Trials Are a Tapestry of Heterogeneity

Salima Punja, Cecilia Bukutu, Larissa Shamseer, Margaret Sampson, Lisa Hartling, Liana Urichuk, Sunita Vohra

J Clin Epidemiol. 2016 Aug;76:47-56.

PMID: 27079847

Abstract:

Objectives:
To summarize the methods of design, analysis, and meta-analysis used in N-of-1 trials.
Study design and setting:
Electronic search for English language articles published from 1950 to 2013. N-of-1 trials were selected if they followed an ABAB design and if they assessed a health intervention for a medical condition. Elements of design, analysis, and meta-analysis were extracted.
Results:
We included 100 reports representing 1,995 participants. N-of-1 trials have been conducted in over 50 health conditions. Most reports incorporated the use of elements that maintain methodological rigor, including randomization, blinding, and formal outcome assessment; however, many failed to address trial registration, funding source, and adverse events. Most reports statistically analyzed individual N-of-1 trials; however, only a small proportion of included series meta-analyzed their results.
Conclusions:
N-of-1 trials have the ability to assess treatment response in individual participants and can be used for a variety of health interventions for a wide range of medical conditions in both clinical and research settings. Considerable heterogeneity exists in the methods used in N-of-1 trials.

Chemicals Related in the Paper:

Catalog Number Product Name Structure CAS Number Price
AP919973834 OF-1 OF-1 919973-83-4 Price
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