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Guidelines and Guidance

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CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials

  • Kenneth F. Schulz mail,

    kschulz@fhi.org

    Affiliation: Family Health International, Research Triangle Park, North Carolina, United States of America

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  • Douglas G. Altman,

    Affiliation: Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, United Kingdom

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  • David Moher,

    Affiliation: Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada

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  • for the CONSORT Group

    Membership of the CONSORT Group is provided in the Acknowledgments.

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  • Published: March 24, 2010
  • DOI: 10.1371/journal.pmed.1000251

About the Authors

Kenneth F. Schulz
Family Health International, Research Triangle Park, North Carolina, United States of America
Douglas G. Altman
Centre for Statistics in Medicine, University of Oxford, Wolfson College, Oxford, United Kingdom
David Moher
Ottawa Methods Centre, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Department of Epidemiology and Community Medicine, University of Ottawa, Ottawa, Canada

Corresponding Author

Email: kschulz@fhi.org

Competing Interests

Uniform disclosure of potential conflicts of interest: all authors have completed the ICMJE unified competing interest form at http://www.icmje.org/coi_disclosure.pdf (available from the corresponding author) and declare (1) DM received grants for this work from Johnson & Johnson, BMJ, and American Society for Clinical Oncology; KFS and DGA received support for travel to meetings for this work from Johnson & Johnson, BMJ, and American Society for Clinical Oncology; (2) KFS and DA had travel expenses reimbursed by the EQUATOR Network; KFS has received honoraria for delivering educational presentations for the American Board of Obstetrics and Gynecology Foundation for Excellence in Women's Health Care, Ortho-McNeil Janssen Scientific Affairs, and the American College of Obstetrics and Gynecology; and has done consultancy for Wyeth. All authors also declare (3) no spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; (4) no non-financial interests that may be relevant to the submitted work.

Author Contributions

ICMJE criteria for authorship read and met: KFS DGA DM. Wrote the first draft of the paper: KFS. Contributed to the writing of the paper: KFS DGA DM. KFS, DGA, and DM participated in meetings and regular conference calls, planned the CONSORT 2007 meeting at Montebello, developed the agenda, prepared background research, identified and invited participants, contributed to the CONSORT meeting, drafted the manuscript, and, after critical review by the CONSORT Group, finalized the text of the manuscript. Members of the CONSORT Group attended the meeting, except for those noted in the Acknowledgments, and provided input on and review of the revised checklist and text of this article. Some members also prepared background material.