Nine leading medical journals publish clinical trial reporting guidelines developed by Ottawa researcher

March 24, 2010

New guidance to improve the reporting of trial findings is published simultaneously today (March 24, 2010) by nine leading medical journals, including the British Medical Journal (BMJ), The Lancet, Annals of Internal Medicine, BMC Medicine, the Journal of Clinical Epidemiology, Obstetrics and Gynecology, Open Medicine, PLoS 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 randomized 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 the BMJ, provides published examples of transparent reporting.

CONSORT 2010 was developed by Dr. David Moher, a senior scientist at the Ottawa Hospital Research Institute and associate professor of medicine at the University of Ottawa, along with Dr. Douglas Altman, Dr. Kenneth Schultz and others in the CONSORT Group. The authors emphasize that CONSORT 2010 represents an evolving guideline, that will be further revised with accumulating comments, criticisms, experiences and evidence. Readers are invited to submit recommendations via the CONSORT website (

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 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 a BMJ 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.

The development of CONSORT 2010 was funded by the Canadian Institutes of Health Research, the United Kingdom National Institute for Health Research, the Medical Research Council (UK), Johnson & Johnson, BMJ and the American Society for Clinical Oncology.

Adapted from BMJ press release “Leading journals publish new guidelines to improve trial reports”.

About the Ottawa Hospital Research Institute
The Ottawa Hospital Research Institute (OHRI) is the research arm of The Ottawa Hospital and is an affiliated institute of the University of Ottawa, closely associated with the University’s Faculties of Medicine and Health Sciences. The OHRI includes more than 1,300 scientists, clinical investigators, graduate students, postdoctoral fellows and staff conducting research to improve the understanding, prevention, diagnosis and treatment of human disease.

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