Opportunities and challenges for improving the quality of reporting clinical research: CONSORT and beyond.

R eports of randomized controlled trials (RCTs) are the only tangible evidence of their conduct. Yet historians may well view the first 50 years of reporting of RCTs with some surprise. They will encounter what might be described as a cognitive dissonance: a disconnec-tion between the increasing sophistication of the design (and the swelling cost) of these studies and the apparent lack of care — disastrous in some cases — with which they have been reported. Improvements in the quality of reporting of RCTs must be based on strong evidence. A series of studies beginning in 1995 found empirical evidence that results may be biased when trials use inferior methods or are reported without adequate description of the methods; notably, failure to conceal the allocation process is associated with an exaggeration of the effectiveness of an intervention of 30% or more. The cause for concern is obvious: if the conduct or reporting of RCTs is poor, treatments may be introduced that are less effective than was thought or that might even be ineffective. This concern led the Consolidated Standards of Reporting Trials (CONSORT) group to formulate a series of recommendations in 1996 3 and 2001. 4,5 This commentary summarizes developments within CONSORT since 2001. In the 18 months since their publication, the revised CONSORT Statement 4 and an explanatory document 5 were downloaded approximately 25 000 times from the Web sites of the 3 journals initially publishing them (the Annals of Internal Medicine, the Journal of the American Medical Association and The Lancet) and were cited nearly 500 times. There are about 20 000 hits weekly to the CON-SORT Web site (www.consort-statement.org). International editorial groups, such as the World Association of Medical Editors and the Council of Science Editors, have endorsed the statement, as have several hundred biomed-ical journals, including this one. Three studies have suggested that the quality of RCT reporting in journals that have endorsed the CONSORT statement is superior to that in journals that have not endorsed the statement. 6–8 Even so, all journals continue to publish suboptimal reports of RCTs, and the global effort to improve the quality of reporting clinical research is far from over. When formulating and revising the CONSORT recommendations for reporting the results of RCTs, the CON-SORT group focused initially on trials that used a parallel group design with 2 treatment groups or " arms, " as this design is the most …