The Consolidated Standards of Reporting Trials (CONSORT) statement, which has a continuing aim to improve randomized controlled trial (RCT) quality and minimize bias, has now been extended to randomized pilot and feasibility trials. In the extension, the guidelines have been adapted to suit the different focus of pilot trials, which assess feasibility of conducting a future definitive RCT rather than effectiveness or efficacy of an intervention. Additional items in the extension include the criteria used in deciding whether to progress to a future definitive RCT, to proceed with amendments, or not to proceed; they also cover the implications in going forward and how any proposed amendments should be taken into consideration. It is hoped this proposed extension will improve the conduct and reporting of pilot trials.
Eldridge, S. M. et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ http://dx.doi.org/10.1136/bmj.i5239 (2016)
About this article
Cite this article
McHugh, J. CONSORT statement extended for pilot trials. Nat Rev Rheumatol 12, 692 (2016). https://doi.org/10.1038/nrrheum.2016.187