News

New guidance to improve the reporting of trial findings was published simultaneously on 24 March 2010 by nine leading journals around the world - BMJ, Annals of Internal Medicine, BMC Medicine, Journal of Clinical Epidemiology, The Lancet, 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 (1), 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 (2), also published today in the BMJ and the Journal of Clinical Epidemiology provides published examples of transparent reporting and elaborates on the empirical evidence that forms the basis for the guidance.

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 emphasizes 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)."

As with the previous revision between 1996 and 2001, the publication of CONSORT 2010 now makes the previous version, CONSORT 2001 Statement, out-dated. Authors, editors, reviewers and readers are recommended to refer to this most up-to-date version while writing or appraising reports of clinical trials.

A study by Sally Hopewell et al (3) 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 an editorial (4) 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.

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

References

1. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ  2010;340: c332-c332 [Full text]  

2. Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche PC, Devereaux PJ, Elbourne D, Egger M, Altman DG. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. BMJ  2010;340: c869-c869 [Full text]   

3. Hopewell S, Dutton S, Yu LM, Chan AW, Altman DG. The quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed. BMJ 2010;340:c723 [Full text].

4. Antes, G. The new CONSORT statement. BMJ  2010;340: c1432-c1432 [Full text]   

Other editorials:
Williams HC. Cars, CONSORT 2010, and Clinical Practice. Trials 2010, 11:33 [full text]

Posted by Mary Ocampo
Reporting Guidelines Research Coordinator
Clinical Epidemiology Methods Centre, Ottawa Health Research Institute


References to the new CONSORT Statement 2010 were updated on the EQUATOR website (see Reporting of experimental studies)

Download:
CONSORT 2010 checklist (Word and pdf)
CONSORT 2010 flow diagram (Word and pdf)

See the CONSORT website for more details about the new 2010 Statement and all available publications.

Extensions of the CONSORT Statement:
Work is underway to modify various CONSORT extensions to reflect the revised checklist.