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

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• 作者：Sunita Vohra^a ; ^{svohra@ualberta.ca" class="auth_mail" title="E-mail the corresponding author} ; Larissa Shamseer^b ; Margaret Sampson^c ; Cecilia Bukutu^d ; Christopher H. Schmid^e ; Robyn Tate^f ; Jane Nikles^g ; Deborah R. Zucker^h ; Richard Kravitzⁱ ; Gordon Guyatt^j ; Douglas G. Altman^k ; David Moher^b ; the CENT GroupDouglas G. Altman ; Cecilia Bukutu ; Jocalyn Clark ; Elise Cogo ; Nicole B. Gabler ; Gordon Guyatt ; Richard Kravitz ; Janine Janosky ; Bradley C. Johnston ; Bob Li ; Jeff Mahon ; Robin Marles ; David Moher ; Jane Nikles ; Margaret Sampson ; Christopher H. Schmid ; William R. Shadish ; Larissa Shamseer ; Robyn Tate ; Sunita Vohra ; Deborah R. Zucker
• 关键词：N-of-1 ; Reporting guideline ; CENT ; CONSORT
• 刊名：Journal of Clinical Epidemiology
• 出版年：2016
• 出版时间：August 2016
• 年：2016
• 卷：76
• 期：Complete
• 页码：9-17
• 全文大小：544 K

文摘

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.