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

Vohra, Sunita, Shamseer, Larissa, Sampson, Margaret, Bukutu, Cecilia, Schmid, Christopher H., Tate, Robyn, Nikles, Jane, Zucker, Deborah R., Kravitz, Richard, Guyatt, Gordon, Altman, Douglas G., Moher, David and the CENT group (2015) CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. Journal of Clinical Epidemiology, 76 9-17. doi:10.1016/j.jclinepi.2015.05.004

Author Vohra, Sunita
Shamseer, Larissa
Sampson, Margaret
Bukutu, Cecilia
Schmid, Christopher H.
Tate, Robyn
Nikles, Jane
Zucker, Deborah R.
Kravitz, Richard
Guyatt, Gordon
Altman, Douglas G.
Moher, David
the CENT group
Title CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement
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.2015.05.004
Open Access Status DOI
Volume 76
Start page 9
End page 17
Total pages 9
Place of publication Philadelphia, PA, United States
Publisher Elsevier
Language eng
Subject 2713 Epidemiology
Abstract 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.
Keyword N-of-1
Reporting guideline
Q-Index Code CX
Q-Index Status Provisional Code
Grant ID MR/J004871/1
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, 18:28:22 EST by Mary-Anne Marrington on behalf of Discipline of General Practice