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CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration

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

10.1016/j.jclinepi.2015.05.018

1878-5921

Larissa Shamseer, Margaret Sampson, Cecilia Bukutu, Christopher H. Schmid, Jane Nikles, Robyn Tate, Bradley C. Johnston, Deborah R. Zucker, William R. Shadish, Richard L. Kravitz, Gordon Guyatt, Douglas G. Altman, David Moher, Sunita Vohra, 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,

Statistical Methods in Clinical Trials

N-of-1 trials are a useful tool for clinicians who want to determine the effectiveness of a treatment in a particular individual. The reporting of N-of-1 trials has been variable and incomplete, hindering their usefulness in clinical decision making and by future researchers. This document presents the CONSORT (Consolidated Standards of Reporting Trials) extension for N-of-1 trials (CENT 2015). CENT 2015 extends the CONSORT 2010 guidance to facilitate the preparation and appraisal of reports of an individual N-of-1 trial or a series of prospectively planned, multiple, crossover N-of-1 trials. CENT 2015 elaborates on 14 items of the CONSORT 2010 checklist, totalling 25 checklist items (44 sub-items), and recommends diagrams to help authors document the progress of one participant through a trial or more than one participant through a trial or series of trials, as applicable. Examples of good reporting and evidence based rationale for CENT 2015 checklist items are provided.