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

Larissa Shamseer; Margaret Sampson; Cecilia Bukutu; Christopher H Schmid; Jane Nikles; Robyn Tate; Bradley C Johnston; Deborah Zucker; William R Shadish; Richard Kravitz; Gordon Guyatt; Douglas G Altman; David Moher; Sunita Vohra; CENT group

doi:10.1016/j.jclinepi.2015.05.018

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

J Clin Epidemiol. 2016 Aug:76:18-46. doi: 10.1016/j.jclinepi.2015.05.018. Epub 2015 Aug 10.

Authors

Collaborators

Affiliations

¹ Clinical Epidemiology Program, Ottawa Hospital Research Institute; University of Ottawa, Canada.
² Library Services, Children's Hospital of Eastern Ontario, Canada.
³ Child and Youth Data Laboratory, Alberta Centre for Child, Family and Community Research, Canada.
⁴ Department of Biostatistics and Center for Evidence Based Medicine, Brown University, USA.
⁵ University of Queensland, Australia.
⁶ Centre for Rehabilitation Research, Sydney Medical School - Northern, University of Sydney, Australia.
⁷ 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.
⁸ Tufts University School of Medicine, USA.
⁹ University of California, Merced, USA.
¹⁰ Department of Internal Medicine, University of California, Davis, USA.
¹¹ Department of Clinical Epidemiology & Biostatistics, McMaster University, Canada.
¹² Centre for Statistics in Medicine, University of Oxford, UK.
¹³ Department of Pediatrics, Faculty of Medicine and Dentistry, University of Alberta, Canada. Electronic address: svohra@ualberta.ca.

PMID: 26272791
DOI: 10.1016/j.jclinepi.2015.05.018

Abstract

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Biomedical Research / standards*
Clinical Trials as Topic / standards*
Guidelines as Topic*
Humans
Publishing / standards*
Research Design / standards*
Research Report / standards*
Terminology as Topic*

Abstract

Publication types

MeSH terms

Grants and funding