New guidance to improve the reporting of trial findings is published simultaneously today (24 March 2010) by PLoS Medicine and eight other leading journals around the world, BMJ, The Lancet, Obstetrics & Gynecology, Annals of Internal Medicine, Open Medicine, Journal of Clinical Epidemiology, BMC Medicine, and Trials. Full and transparent reporting of trials is crucial to ensure that decisions about health care are based on the best available evidence.
The guidance, known as the Consolidated Standards of Reporting Trials (CONSORT) statement, was first published in 1996 and revised in 2001. It includes a checklist to help authors write reports of randomised controlled trials so that others can judge the reliability and validity of the results.
More than 400 journals and three leading editorial groups across the world have now given their official support to CONSORT.
The latest version, CONSORT 2010, improves the specificity and clarity of the previous checklist. Several new items will also make it easier for decision makers to judge the soundness of trial results. A separate explanatory paper, also published today in BMJ, provides published examples of transparent reporting.
Speaking on behalf of coauthors, Douglas Altman and David Moher, and for the CONSORT Group, Kenneth Schulz, Distinguished Scientist and Vice President of Family Health International in the US emphasises that CONSORT 2010 represents an evolving guideline. He says: "In the future we will further revise the CONSORT material considering comments, criticisms, experiences, and accumulating new evidence. We invite readers to submit recommendations via the CONSORT website (www.consort-statement.org)."
Citation: Schulz KF, Altman DG, Moher D, CONSORT Group (2010) CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials. PLoS Med 7(3): e1000251. doi:10.1371/journal.pmed.1000251
Funding: The authors received financial support from United Kingdom National Institute for Health Research and the Medical Research Council; Canadian Institutes of Health Research; Presidents Fund, Canadian Institutes of Health Research; Johnson & Johnson; BMJ; and the American Society for Clinical Oncology. DGA is supported by Cancer Research UK, DM by a University of Ottawa Research Chair, and KFS by Family Health International. None of the sponsors had any involvement in the planning, execution, or writing of the CONSORT documents. Additionally, no funder played a role in drafting the manuscript. DM is on the Editorial Board of PLoS Medicine.
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 sp ouses, 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.
IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000251
CONTACT:
Kenneth F. Schulz
Distinguished Scientist and Vice President
Quantitative Sciences
Family Health International
P.O. Box 13950
Research Triangle Park, NC 27709 USA
KSchulz@FHI.org
+1 919-544-7040 x11542
Related paper published in PLoS Medicine:In February a paper by David Moher and colleagues from the EQUATOR Network (www.equator-network.org/) ) offered guidance and recommended steps for developing health research reporting guidelines.
Citation: Moher D, Schulz KF, Simera I, Altman DG (2010) Guidance for Developers of Health Research Reporting Guidelines. PLoS Med 7(2): e1000217. doi:10.1371/journal.pmed.1000217
LINK TO FREELY AVAILABLE ARTICLE: http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000217
Journal
PLoS Medicine