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CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

2015; Elsevier BV; Volume: 76; Linguagem: Inglês

10.1016/j.jclinepi.2015.05.004

1878-5921

Sunita Vohra, Larissa Shamseer, Margaret Sampson, Cecilia Bukutu, Christopher H. Schmid, Robyn Tate, Jane Nikles, Deborah R. Zucker, Richard L. Kravitz, Gordon Guyatt, Douglas G. Altman, David Moher, Douglas G. Altman, Cecilia Bukutu, Jocalyn Clark, Elise Cogo, Nicole B. Gabler, Gordon Guyatt, Richard L. Kravitz, Janine E. Janosky, Bradley C. Johnston, Bob T. Li, Jeff Mahon, Robin J. Marles, David Moher, Jane Nikles, Margaret Sampson, Christopher H. Schmid, William R. Shadish, Larissa Shamseer, Robyn Tate, Sunita Vohra, Deborah R. Zucker,

Clinical practice guidelines implementation

N-of-1 trials provide a mechanism for making evidence-based treatment decisions for an individual patient. They use key methodological elements of group clinical trials to evaluate treatment effectiveness in a single patient, for situations that cannot always accommodate large-scale trials: rare diseases, comorbid conditions, or in patients using concurrent therapies. Improvement in the reporting and clarity of methods and findings in N-of-1 trials is essential for reader to gauge the validity of trials and to replicate successful findings. A Consolidated Standards of Reporting Trials (CONSORT) extension for N-of-1 trials (CENT 2015) provides guidance on the reporting of individual and series of N-of-1 trials. CENT provides additional guidance for 14 of the 25 items of the CONSORT 2010 checklist, recommends a diagram for depicting an individual N-of-1 trial, and modifies the CONSORT flow diagram to address the flow of a series of N-of-1 trials. The rationale, development process, and CENT 2015 checklist and diagrams are reported in this document.