Chapter

The Essential Guide to N-of-1 Trials in Health

pp 175-194

Reporting N-of-1 Trials to Professional Audiences

  • Margaret SampsonAffiliated withChildren’s Hospital of Eastern Ontario Email author 
  • , Larissa ShamseerAffiliated withOttawa Hospital Research Institute
  • , Sunita VohraAffiliated withDepartment of Pediatrics, University of Alberta

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Abstract

Whether an N-of-1 trial is undertaken to inform a particular clinical decision or to test a hypothesis, publishing it in the professional literature may inform other clinical decisions and contribute to the research evidence base. A well-reported N-of-1 trial will provide the transparency needed for readers to critically appraise the work and determine if it is applicable to their situation. A well reported trial can be replicated and, once replicated, results can be aggregated to provide stronger and more compelling evidence. This chapter will consider how to describe the individual and aggregated data of N-of-1 trials for professional audiences. It describes in detail a reporting guideline for N-of-1 trials, CENT (Consort Extension for reporting N-of-1 Trials). CENT provides a structured format to ensure that the main journal report is sufficiently detailed that it can be critically appraised and replicated. As well, prospective registration of the trial and data deposit is discussed as means to further increase the transparency and completeness of reporting.

Keywords

N-of-1 trials Reporting guideline CENT CONSORT Checklist Transparency Replication Publishing Protocol registration Data deposit