CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement.
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.
Department of Pediatrics, University of Alberta, Canada. Electronic address: svohra@ualberta.ca.
Sunita
S
Vohra
Clinical Epidemiology Program, Ottawa Hospital Research Institute, School of Epidemiology, Public health, and Preventative Medicine, University of Ottawa, Canada.
Larissa
L
Shamseer
Library Services, Children's Hospital of Eastern Ontario, Canada.
Margaret
M
Sampson
Alberta Centre for Child, Family and Community Research, Canada.
Cecilia
C
Bukutu
Center for Evidence Based Medicine, Brown University, USA.
Christopher H
CH
Schmid
Centre for Rehabilitation Research, Sydney Medical School-Northern, University of Sydney, Australia.
Robyn
R
Tate
University of Queensland, Australia.
Jane
J
Nikles
Public Health and Community Medicine, Tufts University School of Medicine, USA.
Deborah R
DR
Zucker
UC Davis Medical Centre, University of California, Davis, USA.
Richard
R
Kravitz
McMaster University, Canada.
Gordon
G
Guyatt
Centre for Statistics in Medicine, University of Oxford, UK.
Douglas G
DG
Altman
Clinical Epidemiology Program, Ottawa Hospital Research Institute, School of Epidemiology, Public health, and Preventative Medicine, University of Ottawa, Canada.
David
D
Moher
D035843:Biomedical Research / Q000592:standards*; D002986:Clinical Trials as Topic / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D011643:Publishing / Q000592:standards*; D012107:Research Design / Q000592:standards*; D058028:Research Report / Q000592:standards*; D009626:Terminology as Topic
CENT; CONSORT; N-of-1; Reporting guideline