title: Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials.
abstract: BACKGROUND
  Feasibility 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.
  
  
  OBJECTIVE
  The 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
  There 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) aDelphi 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) aconsensus 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.
  
  
  CONCLUSIONS
  We 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.
authors.affiliation: Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario Canada.
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
authors.affiliation: Oxford Clinical Trials Research Unit, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.
authors.forename: Sally
authors.initials: S
authors.lastname: Hopewell
authors.affiliation: Department of Mathematics and Statistics, Lancaster University, Lancaster, Lancashire UK.
authors.forename: Gillian A
authors.initials: GA
authors.lastname: Lancaster
authors.affiliation: Centre of Academic Primary Care, University of Aberdeen, Aberdeen, Scotland, UK.
authors.forename: Christine M
authors.initials: CM
authors.lastname: Bond
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Coleman
authors.affiliation: School of Health and Related Research, University of Sheffield, Sheffield, South Yorkshire UK.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Campbell
authors.affiliation: Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.
authors.forename: Sandra M
authors.initials: SM
authors.lastname: Eldridge
keywords: CONSORT extension; Pilot randomized controlled trial; Reporting guideline