CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials

Kenneth F Schulz, Douglas G Altman, David Moher, CONSORT Group, D G Altman, Virginia Barbour, Isabelle Boutron, P J Devereaux, Kay Dickersin, Diana Elbourne, Susan Ellenberg, Val Gebski, Steven Goodman, Peter C Gøtzsche, Trish Groves, Steven Grunberg, Brian Haynes, Sally Hopewell, Peter Juhn, Philippa Middleton, Don Minckler, D Moher, Victor M Montori, Cynthia Mulrow, Stuart Pocock, Drummond Rennie, David L Schriger, K F Schulz, Iveta Simera, Elizabeth Wager, Kenneth F Schulz, Douglas G Altman, David Moher, CONSORT Group, D G Altman, Virginia Barbour, Isabelle Boutron, P J Devereaux, Kay Dickersin, Diana Elbourne, Susan Ellenberg, Val Gebski, Steven Goodman, Peter C Gøtzsche, Trish Groves, Steven Grunberg, Brian Haynes, Sally Hopewell, Peter Juhn, Philippa Middleton, Don Minckler, D Moher, Victor M Montori, Cynthia Mulrow, Stuart Pocock, Drummond Rennie, David L Schriger, K F Schulz, Iveta Simera, Elizabeth Wager

Abstract

The CONSORT statement is used worldwide to improve the reporting of randomised controlled trials. Kenneth Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience

Conflict of interest statement

Competing interests: Uniform disclosure of potential conflicts of interest: all authors have completed the ICMJE unified competing interest form at 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.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4787720/bin/schk712109.f1_default.jpg
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)

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Source: PubMed

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