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P05.50. CONSORT extension for N-of-1 trials (CENT) guidelines

  • L Shamseer
  • M Sampson
  • C Bukutu
  • N Barrowman
  • D Altman
  • D Moher
  • S Vohra
Open Access
Poster presentation

Keywords

Care Provider Health Care Provider Clinical Care Critical Appraisal Alternative Medicine 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Purpose

N-of-1 trials have been used in medicine to generate treatment information when evidence from randomized controlled trials (RCTs) is not available or applicable. N-of-1 study design maintains the methodological safeguards provided by RCTs (blinding, randomization and controls) yet avoids the disadvantages associated with large trials. A standardized method of reporting of N-of-1 trials, such as the Consolidated Standards of Reporting Trials (CONSORT), would greatly improve the quality and consistency of trial reports in this area. The objective of this study was to develop a CONSORT Extension for N-of-1 Trials (CENT).

Methods

Checklist items for the CENT guidelines were derived from three systematic reviews on N-of-1 conduct, analysis and meta-analysis. A structured process of obtaining information from a group of experts to refine and finalize the CENT guidelines was carried out. Two stages of questionnaires asked participants to rate the relative importance of suggested checklist items; the second questionnaire was refined based on feedback from the previous one. Participants included those known to have interests in either RCT reporting or N-of-1 methodology. Items included after the Delphi process were debated and finalized during an in-person meeting.

Results

There were 44 unique respondents between the two rounds of questionnaires. Based on questionnaire results, topics chosen for discussion at the in person meeting included: terminology (what is “N-of-1”?), randomization and blinding, research vs. clinical care, and analysis and meta-analysis. The CENT checklist was refined and adapted to the format of the most recent CONSORT 2010 statement.

Conclusion

N-of-1 trials may promote an evidence-based approach to therapy so that families, health care providers and policy-makers can make informed choices, and are relevant to both conventional and complementary and alternative medicine. The CONSORT ‘extension’ will facilitate critical appraisal and interpretation of N-of-1 trials by providing authors with guidance on how to improve reporting.

Copyright information

© Shamseer et al; licensee BioMed Central Ltd. 2012

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Authors and Affiliations

  • L Shamseer
    • 1
  • M Sampson
    • 2
  • C Bukutu
    • 5
  • N Barrowman
    • 2
  • D Altman
    • 3
  • D Moher
    • 4
  • S Vohra
    • 5
  1. 1.5University of Ottawa Evidence-based Practice CenterOttawaCanada
  2. 2.Children’s Hospital of Eastern OntarioOttawaCanada
  3. 3.Centre for Statistics in MedicineInstitute of Health SciencesOxfordUnited Kingdom
  4. 4.University of Ottawa Evidence-based Practice CenterOttawaCanada
  5. 5.University of AlbertaEdmontonCanada

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