CONSORT 2010 Statement: extension to randomised pilot and feasibility trials

Sandra M. Eldridge, Claire L. Chan, Michael J. Campbell, Christine M. Bond, Sally Hopewell, Lehana Thabane, Gillian A. Lancaster, PAFS consensus group

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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.
Original languageEnglish
Article numberi5239
Pages (from-to)1-29
Number of pages29
Publication statusPublished - 24 Oct 2016

Bibliographical note

During the development of this work we presented our thinking at workshops and open meetings and would like to thank all participants for their valuable input and views: Society for Clinical Trials May 2013 Boston; Clinical Trials Methodology Conference Edinburgh November 2013; Royal Statistical Society October 2013; UK National Institute for Health Research (NIHR) Research Design Service London and South East March 2014 London; UK NIHR statisticians April 2015 London; Society for Academic Primary Care Annual Scientific Meeting July 2015 Oxford; HSRPP Health Services Research and Pharmacy Practice Conference April 2016. We also thank Colin Begg for feedback on the proposed items to be included in the guidelines during the two day consensus meeting in Oxford.

Funding: We received grants from Queen Mary University of London (£7495), University of Sheffield (£8000), NIHR RDS London and South East (£2000), NIHR Statisticians Group (£2400), and Chief Scientist Office Scotland (£1000). CLC (nee Coleman) was funded by a National Institute for Health Research (NIHR) research methods fellowship. This article presents independent research partly funded by the NIHR. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Marion
Campbell works at the Health Services Research Unit, University of Aberdeen, and the Unit receives core funding from the Scottish Government Health and Social Care Directorates; however, the opinions expressed are those of the authors alone. The funders had no role in this study.


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