Source:Book Publishing Service

Public release date: 23-Mar-2010

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Contact: Emma Dickinson
edickinson@bmjgroup.com
44-207-383-6529
BMJ-British Medical Journal

Leading journals publish new guidance to improve trial reports

Research: The quality of reports of randomized trials in 2000 and 2006: Comparative study of articles indexed in PubMed

New guidance to improve the reporting of trial findings is published simultaneously today (24 March 2010) by the BMJ and eight other leading journals around the world.

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 by the BMJ today, provides published examples of transparent reporting.

Speaking on behalf of co-authors, 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).”

A study also published by the BMJ today to accompany the guidance shows that, although the quality of trial reporting has improved since publication of the revised CONSORT statement in 2001, it remains well below an acceptable level. The researchers conclude that more journals should endorse CONSORT and, most importantly, they should do more to ensure adherence.

This view is supported in an editorial which says that the guidance is clear, but awareness and endorsement are lagging behind. Author Gerd Antes, Director of the German Cochrane Centre, believes that journal editors should do more to incorporate the CONSORT checklist into the peer review process. He also warns that, although CONSORT has been translated into 10 other languages, not much is known about endorsement and adherence in those areas.

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

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