26 Mar 2010

New standards for reporting clinical trials were simultaneously published this week in PLoS Medicine, the British Medical Journal, and seven other research journals. The 2010 Consolidated Standards of Reporting Trials (CONSORT) statement is an update to a 2001 revision of a 1996 standard proposed by an international collaboration (the CONSORT Group). The CONSORT 2010 statement includes a checklist to help researchers prepare trial reports and readers evaluate them. But while these statements may be a move in the direction of full disclosure, not all journals are in step, with fewer than 50 percent of high-impact journals recommending that authors comply with CONSORT, according to recent publications. As Gerd Antes, the director of the German Cochrane Center, Freiburg, writes in an accompanying BMJ editorial, “the guidance is clear, but awareness and endorsement are lagging behind.”

Randomized, placebo-controlled clinical trials are the gold standard for judging therapeutic interventions. To properly assess their success, trial methodologies and outcomes must be adequately reported. The CONSORT Group, led by Kenneth Schulz, Family Health International, Research Triangle Park, North Carolina, contend that that is often not the case. Whether their 2010 statement will help improve trial reporting remains to be seen. However, earlier CONSORT statements appear to have had little impact. In an accompanying paper in the BMJ, CONSORT Group member Sally Hopewell, University of Oxford, U.K., and colleagues compare trial reporting in 2000 and 2006, just prior to, and five years after, the second CONSORT statement, respectively. While some improvements in trial reporting occurred, the quality of the 2001 publications was already very poor, with many items the CONSORT Group consider essential to clinical trial reporting frequently omitted. Details of the randomization procedure were missing from 79 percent of 2001 reports, and slightly fewer 2006 reports (66 percent). Descriptions of sample size estimates and concealment of treatment allocation did not fare much better, increasing from only 27 to 45 percent, and 18 to 25 percent of reports, respectively, over the six years. Antes notes that this could be considered a positive trend, but laments that the numbers are unacceptably low.

How does the 2010 statement differ from the 2006 version? There are general and specific improvements. Wording was simplified and clarified, and consistency in language improved. Some items have been split into sub-items to avoid confusion. Specific changes include requiring a description of how blinding is done, but eliminating the need to explain how its success was determined, since research has raised questions about the validity of such estimates. Numbers for “intention to treat” analysis are no longer required because the authors consider this term widely misused. Instead, they ask for the number of participants in each analysis and whether the analysis was by original assigned groups. These are just some examples. The full, 25-item checklist is available as part of the simultaneously submitted paper.—Tom Fagan