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

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

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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.

Original languageEnglish (US)
JournalJournal of Clinical Epidemiology
StateAccepted/In press - 2015

ASJC Scopus subject areas

  • Epidemiology

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    Shamseer, L., Sampson, M., Bukutu, C., Schmid, C. H., Nikles, J., Tate, R., Johnston, B. C., Zucker, D., Shadish, W. R., Kravitz, R. L., Guyatt, G., Altman, D. G., Moher, D., & Vohra, S. (Accepted/In press). CONSORT extension for reporting N-of-1 trials (CENT) 2015: Explanation and elaboration. Journal of Clinical Epidemiology.