CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement Academic Article uri icon

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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.

authors

  • Vohra, Sunita
  • Shamseer, Larissa
  • Sampson, Margaret
  • Bukutu, Cecilia
  • Schmid, Christopher H
  • Tate, Robyn
  • Nikles, Jane
  • Zucker, Deborah R
  • Kravitz, Richard
  • Guyatt, Gordon
  • Altman, Douglas G
  • Moher, David
  • Altman, Douglas G
  • Bukutu, Cecilia
  • Clark, Jocalyn
  • Cogo, Elise
  • Gabler, Nicole B
  • Guyatt, Gordon
  • Kravitz, Richard
  • Janosky, Janine
  • Johnston, Bradley
  • Li, Bob
  • Mahon, Jeff
  • Marles, Robin
  • Moher, David
  • Nikles, Jane
  • Sampson, Margaret
  • Schmid, Christopher H
  • Shadish, William R
  • Shamseer, Larissa
  • Tate, Robyn
  • Vohra, Sunita
  • Zucker, Deborah R

publication date

  • August 2016