Skip to main content

Thank you for visiting You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.


CONSORT statement extended for pilot trials

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.


  1. 1

    Eldridge, S. M. et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ (2016)

Download references


Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

McHugh, J. CONSORT statement extended for pilot trials. Nat Rev Rheumatol 12, 692 (2016).

Download citation


Quick links

Nature Briefing

Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily.

Get the most important science stories of the day, free in your inbox. Sign up for Nature Briefing