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

27 Citations (Scopus)

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

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Rare Diseases
Clinical Trials
Therapeutics

Keywords

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

ASJC Scopus subject areas

  • Epidemiology

Cite this

Vohra, S., Shamseer, L., Sampson, M., Bukutu, C., Schmid, C. H., Tate, R., ... Moher, D. (Accepted/In press). CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. Journal of Clinical Epidemiology. https://doi.org/10.1016/j.jclinepi.2015.05.004

CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. / Vohra, Sunita; Shamseer, Larissa; Sampson, Margaret; Bukutu, Cecilia; Schmid, Christopher H.; Tate, Robyn; Nikles, Jane; Zucker, Deborah R.; Kravitz, Richard L; Guyatt, Gordon; Altman, Douglas G.; Moher, David.

In: Journal of Clinical Epidemiology, 2015.

Research output: Contribution to journalArticle

Vohra, S, Shamseer, L, Sampson, M, Bukutu, C, Schmid, CH, Tate, R, Nikles, J, Zucker, DR, Kravitz, RL, Guyatt, G, Altman, DG & Moher, D 2015, 'CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement', Journal of Clinical Epidemiology. https://doi.org/10.1016/j.jclinepi.2015.05.004
Vohra, Sunita ; Shamseer, Larissa ; Sampson, Margaret ; Bukutu, Cecilia ; Schmid, Christopher H. ; Tate, Robyn ; Nikles, Jane ; Zucker, Deborah R. ; Kravitz, Richard L ; Guyatt, Gordon ; Altman, Douglas G. ; Moher, David. / CONSORT extension for reporting N-of-1 trials (CENT) 2015 Statement. In: Journal of Clinical Epidemiology. 2015.
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