Nine leading medical journals, including the BMJ, the Annals of Internal Medicine, the Lancet and PLoS Medicine, have simultaneously published an updated version of the CONSORT statement, which aims to improve the transparency of clinical trial reporting.
The CONSORT (Consolidated Standards of Reporting Trials) 2010 guidance came as an accompanying study published in the BMJ found that, while reporting of several important aspects of trial methods had improved between 2000 (the year before the first revision of the CONSORT statement) and 2006, the quality of reporting overall “remains well below an acceptable level”.
The CONSORT statement was first published in 1996 and has earned the endorsement of the World Association of Medical Editors, the International Committee of Medical Journal Editors and the Council of Science Editors, as well as more than 400 journals worldwide.
It includes a 22-item checklist which, as the research team led by Sally Hopewell of Oxford University’s Centre for Statistics in Medicine notes in their review for the BMJ, is designed to “facilitate complete and transparent reporting of trial findings and aid their critical appraisal and interpretation”.
The latest version improves the specificity and clarity of this checklist, the BMJ says, with several new items “that will make it easier for decision makers to judge the soundness of trial results”. A separate explanatory paper in the BMJ gives published examples of transparent reporting.
Wider endorsement needed
In their comparative study of reporting quality, Hopewell et al looked at all primary reports of randomised trials indexed in PubMed in December 2000 (519 in total) and December 2006 (616), including parallel-group, crossover, cluster, factorial and split-body study designs.
Based on their findings, the researchers recommended that more journals should endorse the CONSORT statement “and, more importantly, they should do more to ensure adherence”. For example, they suggested, journals should incorporate the CONSORT checklist and flow diagram into their review processes, indicating this requirement in their published instructions to authors.
“Without wide endorsement, the CONSORT statement cannot fully yield the benefits it was intended to produce,” Hopewell et al wrote.
These views were backed up in a BMJ editorial by Gerd Antes, director of the German Cochrane Centre, who suggested that the relatively low level of adherence to CONSORT, despite “impressive” evidence of benefit, may be down to lack of awareness and “a considerable amount of ignorance” about recommendations of this kind, as well as expectations of a significant increase in workload and “mere lack of appreciation of the importance of publication ethics”.
As Antes pointed out, Hopewell and her colleagues found that, even among high-impact journals, fewer than 50% recommended that authors complied with the CONSORT statement and, among these, only a minority had introduced procedures supporting adherence by authors and reviewers.
Concerns have been raised that publication guidelines such as CONSORT “may be too prescriptive, impede the creativity of research, and lack authorisation of the self-selected author groups who write them”, Antes commented. “However, these concerns are clearly outweighed by the harm caused by poor reporting.”
