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

Shamseer, Larissa, Sampson, Margaret, Bukutu, Cecilia, Schmid, Christopher H., Nikles, Jane, Tate, Robyn, Johnston, Bradley C., Zucker, Deborah, Shadish, William R., Kravitz, Richard, Guyatt, Gordon, Altman, Douglas G., Moher, David, Vohra, Sunita and the CENT group (2015) CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration. Journal of Clinical Epidemiology, . doi:10.1016/j.jclinepi.2015.05.018

Author Shamseer, Larissa
Sampson, Margaret
Bukutu, Cecilia
Schmid, Christopher H.
Nikles, Jane
Tate, Robyn
Johnston, Bradley C.
Zucker, Deborah
Shadish, William R.
Kravitz, Richard
Guyatt, Gordon
Altman, Douglas G.
Moher, David
Vohra, Sunita
the CENT group
Title CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration
Journal name Journal of Clinical Epidemiology   Check publisher's open access policy
ISSN 0895-4356
Publication date 2015-08-10
Year available 2015
Sub-type Article (original research)
DOI 10.1016/j.jclinepi.2015.05.018
Open Access Status DOI
Total pages 29
Place of publication Philadelphia, PA, United States
Publisher Elsevier
Language eng
Abstract 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.
Keyword Randomized Controlled Trials
Single Case Research
Clinical Trial
Herbal Interventions
Individual Patients
Crossover Trials
General Practice
Q-Index Code CX
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Discipline of General Practice Publications
School of Medicine Publications
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Created: Thu, 11 Aug 2016, 08:52:54 EST by Mary-Anne Marrington on behalf of Discipline of General Practice