A guide to the reporting of protocols of pilot and feasibility trials

Abstract

Publishing protocols of trials including protocols of pilot and feasibility trials-designed to inform the designs of main trials-has been advocated as an important strategy towards improving transparency in the conduct and reporting of main trials and pilot/feasibility trials. This editorial aims to provide some general guidance on how to report protocols of pilot and feasibility trials, drawing upon two available resources-the CONSORT extension to pilot trials and the SPIRIT guideline for main trials. We describe how these might be adapted for the reporting of protocol manuscripts of pilot and feasibility trials for submission in Pilot and Feasibility Studies journal.