Journal of Clinical Epidemiology
Volume 63, Issue 8 , Pages e1-e37 , August 2010

CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials

  • David Moher

      Affiliations

    • Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa Hospital, Ottawa, Ontario, Canada, K1H 8L6
    • Corresponding Author InformationCorrespondence to: D Moher.
    • ,
  • Sally Hopewell

      Affiliations

    • Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford
    • ,
  • Kenneth F. Schulz

      Affiliations

    • Family Health International, Research Triangle Park, NC 27709, USA
    • ,
  • Victor Montori

      Affiliations

    • UK Knowledge and Encounter Research Unit, Mayo Clinic, Rochester, MN, USA
    • ,
  • Peter C. Gøtzsche

      Affiliations

    • The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, Copenhagen, Denmark
    • ,
  • P.J. Devereaux

      Affiliations

    • McMaster University Health Sciences Centre, Hamilton, Canada
    • ,
  • Diana Elbourne

      Affiliations

    • Medical Statistics Unit, London School of Hygiene and Tropical Medicine, London
    • ,
  • Matthias Egger

      Affiliations

    • Institute of Social and Preventive Medicine (ISPM), University of Bern, Switzerland
    • ,
  • Douglas G. Altman

      Affiliations

    • Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford

,Accepted 8 February 2010.

  • Image Result

    Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis) .

    Flow diagram of the progress through the phases of a parallel randomised trial of two groups (that is, enrolment, intervention allocation, follow-up, and data analysis) .

  • Image Result

    Flow diagram of a multicentre trial of fractional flow reserve versus angiography for guiding percutaneous coronary intervention (PCI) (adapted from Tonino et al [313]). The diagram includes detailed

    Flow diagram of a multicentre trial of fractional flow reserve versus angiography for guiding percutaneous coronary intervention (PCI) (adapted from Tonino et al [313]). The diagram includes detailed information on the excluded participants.

  • Image Result
    Flow diagram of minimal surgery compared with medical management for chronic gastro-oesophageal reflux disease (adapted from Grant et al [196]). The diagram shows a multicentre trial with a parallel n

    Flow diagram of minimal surgery compared with medical management for chronic gastro-oesophageal reflux disease (adapted from Grant et al [196]). The diagram shows a multicentre trial with a parallel non-randomised preference group.

 In order to encourage dissemination of the CONSORT 2010 Statement, this article is freely accessible on bmj.com and will also be published in the Journal of Clinical Epidemiology. The authors jointly hold the copyright for this article. For details on further use, see the CONSORt website (www.consort-statement.org).

 This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non-commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

PII: S0895-4356(10)00103-4

doi: 10.1016/j.jclinepi.2010.03.004

Journal of Clinical Epidemiology
Volume 63, Issue 8 , Pages e1-e37 , August 2010

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