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Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials
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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5153862/ https://www.ncbi.nlm.nih.gov/pubmed/27965844 http://dx.doi.org/10.1186/s40814-016-0065-z |
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author | Thabane, Lehana Hopewell, Sally Lancaster, Gillian A. Bond, Christine M. Coleman, Claire L. Campbell, Michael J. Eldridge, Sandra M. |
author_facet | Thabane, Lehana Hopewell, Sally Lancaster, Gillian A. Bond, Christine M. Coleman, Claire L. Campbell, Michael J. Eldridge, Sandra M. |
author_sort | Thabane, Lehana |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-5153862 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-51538622016-12-13 Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials Thabane, Lehana Hopewell, Sally Lancaster, Gillian A. Bond, Christine M. Coleman, Claire L. Campbell, Michael J. Eldridge, Sandra M. Pilot Feasibility Stud Methodology 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. BioMed Central 2016-05-20 /pmc/articles/PMC5153862/ /pubmed/27965844 http://dx.doi.org/10.1186/s40814-016-0065-z Text en © Thabane et al. 2016 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Methodology Thabane, Lehana Hopewell, Sally Lancaster, Gillian A. Bond, Christine M. Coleman, Claire L. Campbell, Michael J. Eldridge, Sandra M. Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials |
title | Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials |
title_full | Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials |
title_fullStr | Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials |
title_full_unstemmed | Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials |
title_short | Methods and processes for development of a CONSORT extension for reporting pilot randomized controlled trials |
title_sort | methods and processes for development of a consort extension for reporting pilot randomized controlled trials |
topic | Methodology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5153862/ https://www.ncbi.nlm.nih.gov/pubmed/27965844 http://dx.doi.org/10.1186/s40814-016-0065-z |
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