CONSORT extension for reporting N-of-1 trials (CENT) 2015: explanation and elaboration.
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.
Clinical Epidemiology Program, Ottawa Hospital Research Institute; University of Ottawa, Canada.
Larissa
L
Shamseer
Library Services, Children's Hospital of Eastern Ontario, Canada.
Margaret
M
Sampson
Child and Youth Data Laboratory, Alberta Centre for Child, Family and Community Research, Canada.
Cecilia
C
Bukutu
Department of Biostatistics and Center for Evidence Based Medicine, Brown University, USA.
Christopher H
CH
Schmid
University of Queensland, Australia.
Jane
J
Nikles
Centre for Rehabilitation Research, Sydney Medical School - Northern, University of Sydney, Australia.
Robyn
R
Tate
Department of Anesthesia and Pain Medicine, The Hospital for Sick Children, University of Toronto, Canada; Institute of Health Policy, Management and Evaluation, Dalla Lana School of Public Health, University of Toronto, Canada.
Bradley C
BC
Johnston
Tufts University School of Medicine, USA.
Deborah
D
Zucker
University of California, Merced, USA.
William R
WR
Shadish
Department of Internal Medicine, University of California, Davis, USA.
Richard
R
Kravitz
Department of Clinical Epidemiology & Biostatistics, 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; University of Ottawa, Canada.
David
D
Moher
Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Canada. Electronic address: svohra@ualberta.ca.
Sunita
S
Vohra
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