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

Kenneth F Schulz, Douglas G Altman, David Moher, CONSORT Group, Jesse A Berlin, Isabelle Boutron, P J Devereaux, Kay Dickersin, Diana Elbourne, Susan Ellenberg, Val Gebski, Steven Goodman, Peter C Gøtzsche, Trish Groves, Steven Grunberg, Brian Haynes, Astrid James, 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, Jesse A Berlin, Isabelle Boutron, P J Devereaux, Kay Dickersin, Diana Elbourne, Susan Ellenberg, Val Gebski, Steven Goodman, Peter C Gøtzsche, Trish Groves, Steven Grunberg, Brian Haynes, Astrid James, 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

Kenneth Schulz and colleagues describe the 2010 version of the CONSORT Statement, which updates the previous reporting guideline based on new methodological evidence and accumulated experience.

Conflict of interest statement

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.

Figures

Figure 1. Flow diagram of the progress…
Figure 1. 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).
(For a downloadable version of this diagram see Figure S1 or the CONSORT website.)

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Source: PubMed

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