The CONSORT extension for randomised pilot and feasibility trials is meant to provide reporting guidance for any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). The extension does not directly apply to internal pilot studies built into the design of a main trial, non-randomised pilot and feasibility studies, or phase II studies, but these studies all have some similarities to randomised pilot and feasibility studies and so many of the principles might also apply.
There are some key differences in pilot and feasibility studies from standard randomised trials, particularly in the type of information that needs to be reported and in the interpretation of standard CONSORT reporting items. Some of the original CONSORT Statement items are retained, but most have been adapted, some removed, and new items added.
|Document||Word Format||PDF Format|
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. PMID: 27777223
Thabane L, Hopewell S, Lancaster GA, Bond CM, Coleman CL, Campbell MJ, Eldridge SM. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials. Pilot Feasibility Stud. 2016 May 20;2:25. eCollection 2016. PMID: 27965844