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.
Objectives: 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/design: 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)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.
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.
Objectives: 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/design: 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)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.
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.
| Original language | English |
|---|---|
| Article number | 25 |
| Pages (from-to) | 1-13 |
| Number of pages | 13 |
| Journal | Pilot & Feasibility Studies |
| Volume | 2 |
| DOIs | |
| Publication status | Published - 20 May 2016 |
Bibliographical note
AcknowledgementsCC was funded by a National Institute for Health Research (NIHR) Research Methods Fellowship. This article therefore presents independent research 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. We are grateful to Alicia O’Cathain (University of Sheffield, Sheffield, UK) and Pat Hoddinott (University of Stirling, Scotland, UK) for attending and providing valuable input at one of our Healthrow Airport meetings. We thank the Clinvivo staff for their services and support in conducting the Delphi study. We are grateful to Dr. Stephen Walter for proofreading the paper.
Erratum to: Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials DOI: 10.1186/s40814-016-0078-7
Published: 19 July 2016
After publication of the original article [1], it came to the authors’ attention that there was an error in the Discussion section. In the final paragraph, “70,000 submissions” should have read “70,000 unique web accesses”. The article has been updated to rectify this error.
Keywords
- CONSORT extension
- pilot randomized controlled trial
- reporting guideline