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Research Methods & Reporting

CONSORT 2010 statement: extension to randomised pilot and feasibility trials

BMJ 2016; 355 doi: https://doi.org/10.1136/bmj.i5239 (Published 24 October 2016) Cite this as: BMJ 2016;355:i5239
  1. Sandra M Eldridge, professor1,
  2. Claire L Chan, statistician1,
  3. Michael J Campbell, professor2,
  4. Christine M Bond, professor3,
  5. Sally Hopewell, associate professor4,
  6. Lehana Thabane, professor5,
  7. Gillian A Lancaster, director postgraduate statistics centre6
  8. on behalf of the PAFS consensus group
  1. 1Centre for Primary Care and Public Health, Queen Mary University of London, London, UK
  2. 2School of Health and Related Research, University of Sheffield, Sheffield, UK
  3. 3Centre of Academic Primary Care, University of Aberdeen, Aberdeen, Scotland, UK
  4. 4Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
  5. 5Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  6. 6Department of Mathematics and Statistics, Lancaster University, Lancaster, UK
  1. Correspondence to: S M Eldridge s.eldridge{at}qmul.ac.uk
  • Accepted 18 September 2016

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 …

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