The new CONSORT statement

Full and transparent reporting of results of clinical trials is essential for assessing the quality of healthcare interventions. Inadequate reporting of trials is common, and it impedes the use of trial results in healthcare research and practice.1 Consequently, during the past 15 years, a series of reporting guidelines have been developed and recently collected by the Equator Initiative (www.equator-network.org).2 The pioneering first step of this framework was the CONSORT statement in 1996,3 which provided recommendations for the publication of randomised controlled clinical trials, the gold standard to assess healthcare interventions. The 2010 update of the statement (doi:10.1136/bmj.c332)4 is accompanied by a comparative study by Hopewell and colleagues (doi:10.1136/bmj.c723),5 which assesses whether the quality of reporting of randomised trials has improved since publication of the CONSORT statement in 2001.

Concerns have been raised that such publication guidelines may be too prescriptive, impede the creativity of research, and lack authorisation of the …