March 24, 2010
New Guidelines Announced to Improve Trials
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.
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