Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials

Abstract

BackgroundFeasibility and pilot studies are essential components of planning or preparing for a larger randomized controlled trial (RCT). They are intended to provide useful information about the feasibility of the main RCT—with the goal of reducing uncertainty and thereby increasing the chance of successfully conducting the main RCT. However, research has shown that there are serious inadequacies in the reporting of pilot and feasibility studies. Reasons for this include a lack of explicit publication policies for pilot and feasibility studies in many journals, unclear definitions of what constitutes a pilot or feasibility RCT/study, and a lack of clarity in the objectives and methodological focus. All these suggest that there is an urgent need for new guidelines for reporting pilot and feasibility studies.ObjectivesThe aim of this paper is to describe the methods and processes in our development of an extension to the Consolidated Standards of Reporting Trials (CONSORT) Statement for reporting pilot and feasibility RCTs, that are executed in preparation for a future, more definitive RCT.Methods/designThere were five overlapping parts to the project: (i) the project launch—which involved establishing a working group and conducting a review of the literature; (ii) stakeholder engagement—which entailed consultation with the CONSORT group, journal editors and publishers, the clinical trials community, and funders; (iii) a Delphi process—used to assess the agreement of experts on initial definitions and to generate a reporting checklist for pilot RCTs, based on the 2010 CONSORT statement extension applicable to reporting pilot studies; (iv) a consensus meeting—to discuss, add, remove, or modify checklist items, with input from experts in the field; and (v) write-up and implementation—which included a guideline document which gives an explanation and elaboration (E&E) and which will provide advice for each item, together with examples of good reporting practice. This final part also included a plan for dissemination and publication of the guideline.ConclusionsWe anticipate that implementation of our guideline will improve the reporting completeness, transparency, and quality of pilot RCTs, and hence benefit several constituencies, including authors of journal manuscripts, funding agencies, educators, researchers, and end-users.

Value of surgical pilot and feasibility study protocols

“…Previous guidance regarding the optimal design and conduct of PFS has been theoretical or generic. The IDEAL framework, for example, describes a pathway for new surgical interventions from first in man (stage 1) to long‐term study (stage 4), with stage 2a (development) and 2b (exploration) studies considered to be PFS, focusing on addressing uncertainties before stage 3 assessment in a definitive RCT.…”

“…Well designed pilot and feasibility studies (PFS) may help to overcome challenges associated with undertaking RCTs in surgery, by allowing uncertainties to be addressed, and optimal design of the main trial to be determined. Previous methodological work has considered the use and misuse of PFS in general.…”

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

“…The development of this CONSORT extension for pilot trials is described briefly here and in detail elsewhere [30]. Before developing the checklist for this extension, the research team agreed on the definitions of pilot and feasibility studies.…”

Improving the efficiency of trials using innovative pilot designs: the next phase in the conduct and reporting of pilot and feasibility studies

“…The methods and processes used to develop the CONSORT guideline have been described elsewhere [6]. Since its inception, Pilot and Feasibility Studies has received numerous submissions of pilot work, leading to over 140 publications—with 89 study protocols and 44 research reports of pilot and feasibility studies as the most frequent types of publication (Table 1).…”