• Larissa Shamseer, Margaret Sampson, Cecilia Bukutu, Christopher H Schmid, Jane Nikles, Robyn Tate, Bradley C Johnston, Deborah Zucker, William R Shadish, Richard Kravitz, Gordon Guyatt, Douglas G Altman, David Moher, Sunita Vohra, and CENT group.
• Clinical Epidemiology Program, Ottawa Hospital Research Institute; University of Ottawa, Canada.
• J Clin Epidemiol. 2016 Aug 1; 76: 18-46.

AbstractN-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.Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

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