Randomised Pilot and Feasibility Trials

Randomized Pilot and Feasibility Trials

The CONSORT extension  for randomized 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 randomized 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. 

Available Downloads

Document Word Format PDF Format
Statement Document n/a Download
Checklist n/a n/a
Flow Diagram n/a n/a
Explanation & Elaboration n/a n/a

Reference

Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA, on behalf of the PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot and Feasibility Studies. 2016 Oct 21;2(1):64.doi: 10.1136/bmj.i5239 Click Here

 

Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA, on behalf of the PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot and Feasibility Studies. 2016;2:64. DOI: 10.1186/s40814-016-0105-8 Click Here