CONSORT 2010 statement: extension to randomised pilot and feasibility trials

The Consolidated Standards of Reporting Trials (CONSORT) statement is a guideline designed to improve the transparency and quality of the reporting of randomised controlled trials (RCTs). In this article we present an extension to that statement for randomised pilot and feasibility trials conducted in advance of a future definitive RCT. The checklist applies to 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.

The development of the extension was motivated by the growing number of studies described as feasibility or pilot studies and by research that has identified weaknesses in their reporting and conduct. We followed recommended good practice to develop the extension, including carrying out a Delphi survey, holding a consensus meeting and research team meetings, and piloting the checklist.

The aims and objectives of pilot and feasibility randomised studies differ from those of other randomised trials. Consequently, although much of the information to be reported in these trials is similar to those in randomised controlled trials (RCTs) assessing effectiveness and efficacy, there are some key differences in the type of information and in the appropriate interpretation of standard CONSORT reporting items. We have retained some of the original CONSORT statement items, but most have been adapted, some removed, and new items added. The new items cover how participants were identified and consent obtained; if applicable, the prespecified criteria used to judge whether or how to proceed with a future definitive RCT; if relevant, other important unintended consequences; implications for progression from pilot to future definitive RCT, including any proposed amendments; and ethical approval or approval by a research review committee confirmed with a reference number.

This article includes the 26 item checklist, a separate checklist for the abstract, a template for a CONSORT flowchart for these studies, and an explanation of the changes made and supporting examples. We believe that routine use of this proposed extension to the CONSORT statement will result in improvements in the reporting of pilot trials.

Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites.

The Consolidated Standards of Reporting Trials (CONSORT) statement (www.consort-statement.org) is a guideline designed to improve the transparency and quality of the reporting of randomised trials. It was first published in 1996, revised in 2001, last updated in 2010 [1, 2] and published simultaneously in 10 leading medical journals, including the Lancet, JAMA, BMJ, Annals of Internal Medicine, and PLoS Medicine. The CONSORT statement comprises a checklist of the minimum essential items that should be included in reports of randomised trials and a diagram documenting the flow of participants through the trial.

The development of CONSORT guidelines has received considerable international recognition. The CONSORT statement has been cited more than 8000 times and has received support from the World Association of Medical Editors, Council of Science Editors, International Committee of Medical Journal Editors, and more than 600 journals worldwide. Several studies have examined the impact of the statement on the reporting quality of published randomised trials and found that adoption of the statement leads to an increase in reporting quality [3].

In addition to the CONSORT statement, extensions to the CONSORT checklist for reporting trials with non-inferiority, equivalence, and cluster or pragmatic designs have been published [4, 5, 6], as have extension checklists for reporting harms [7], different types of interventions (non-drug treatments [8] and herbal interventions [9]), and patient reported outcomes [10]. The main CONSORT statement and all of the current extensions focus on trials for which the research question centres on the effectiveness or efficacy of an intervention. However, some randomised trials, that we refer to as pilot and feasibility trials, do not have effectiveness or efficacy as their primary focus. Rather, they are designed to support the development of a future definitive RCT. By “definitive” in this context we mean an appropriately powered study focusing on effectiveness or efficacy. The need for high standards in conduct and reporting applies just as much to pilot and feasibility trials as it does to definitive trials.