CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement

Sunita Vohra, Larissa Shamseer, Margaret Sampson, Cecilia Bukutu, Christopher H. Schmid, Robyn Tate, Jane Nikles, Deborah R. Zucker, Richard L Kravitz, Gordon Guyatt, Douglas G. Altman, David Moher

Research output: Contribution to journalArticle

37 Scopus citations

Abstract

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.

Original languageEnglish (US)
JournalJournal of Clinical Epidemiology
DOIs
StateAccepted/In press - 2015

Keywords

  • CENT
  • CONSORT
  • N-of-1
  • Reporting guideline

ASJC Scopus subject areas

  • Epidemiology

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