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

详细信息    查看全文

• 作者：Larissa Shamseer^a ; Margaret Sampson^b ; Cecilia Bukutu^c ; Christopher H. Schmid^d ; Jane Nikles^e ; Robyn Tate^f ; Bradley C. Johnston^g ; Deborah Zucker^h ; William R. Shadishⁱ ; Richard Kravitz^j ; Gordon Guyatt^k ; Douglas G. Altman^l ; David Moher^a ; Sunita Vohra^m ; ^{svohra@ualberta.ca" class="auth_mail" title="E-mail the corresponding author} ; 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 Zucker
• 刊名：Journal of Clinical Epidemiology
• 出版年：2016
• 出版时间：August 2016
• 年：2016
• 卷：76
• 期：Complete
• 页码：18-46
• 全文大小：2179 K

文摘

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.