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

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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.

authors

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

publication date

  • August 2016