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

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:...

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Bibliographic Details
Published in:Journal of clinical epidemiology 2016-08, Vol.76, p.9-17
Main Authors: 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
Format: Article
Language:English
Subjects:
Biomedical Research - standards
CENT
Clinical trials
Clinical Trials as Topic - standards
Comorbidity
CONSORT
Design
Epidemiology
Funding
Guidelines as Topic
Humans
Internal Medicine
N-of-1
Patients
Publishing - standards
Reporting guideline
Research Design - standards
Research Report - standards
Studies
Terminology as Topic
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Summary: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.
ISSN:0895-4356
1878-5921
DOI:10.1016/j.jclinepi.2015.05.004