Cargando…
CONSORT 2010 statement: extension to randomised pilot and feasibility trials
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...
Autores principales: | , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5154046/ https://www.ncbi.nlm.nih.gov/pubmed/27965879 http://dx.doi.org/10.1186/s40814-016-0105-8 |
_version_ | 1782474805769928704 |
---|---|
author | Eldridge, Sandra M. Chan, Claire L. Campbell, Michael J. Bond, Christine M. Hopewell, Sally Thabane, Lehana Lancaster, Gillian A. |
author_facet | Eldridge, Sandra M. Chan, Claire L. Campbell, Michael J. Bond, Christine M. Hopewell, Sally Thabane, Lehana Lancaster, Gillian A. |
author_sort | Eldridge, Sandra M. |
collection | PubMed |
description | 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. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-5154046 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2016 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-51540462016-12-13 CONSORT 2010 statement: extension to randomised pilot and feasibility trials Eldridge, Sandra M. Chan, Claire L. Campbell, Michael J. Bond, Christine M. Hopewell, Sally Thabane, Lehana Lancaster, Gillian A. Pilot Feasibility Stud Research 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. Editor’s note: In order to encourage its wide dissemination this article is freely accessible on the BMJ and Pilot and Feasibility Studies journal websites. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s40814-016-0105-8) contains supplementary material, which is available to authorized users. BioMed Central 2016-10-21 /pmc/articles/PMC5154046/ /pubmed/27965879 http://dx.doi.org/10.1186/s40814-016-0105-8 Text en © The Author(s). 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 | Research Eldridge, Sandra M. Chan, Claire L. Campbell, Michael J. Bond, Christine M. Hopewell, Sally Thabane, Lehana Lancaster, Gillian A. CONSORT 2010 statement: extension to randomised pilot and feasibility trials |
title | CONSORT 2010 statement: extension to randomised pilot and feasibility trials |
title_full | CONSORT 2010 statement: extension to randomised pilot and feasibility trials |
title_fullStr | CONSORT 2010 statement: extension to randomised pilot and feasibility trials |
title_full_unstemmed | CONSORT 2010 statement: extension to randomised pilot and feasibility trials |
title_short | CONSORT 2010 statement: extension to randomised pilot and feasibility trials |
title_sort | consort 2010 statement: extension to randomised pilot and feasibility trials |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5154046/ https://www.ncbi.nlm.nih.gov/pubmed/27965879 http://dx.doi.org/10.1186/s40814-016-0105-8 |
work_keys_str_mv | AT eldridgesandram consort2010statementextensiontorandomisedpilotandfeasibilitytrials AT chanclairel consort2010statementextensiontorandomisedpilotandfeasibilitytrials AT campbellmichaelj consort2010statementextensiontorandomisedpilotandfeasibilitytrials AT bondchristinem consort2010statementextensiontorandomisedpilotandfeasibilitytrials AT hopewellsally consort2010statementextensiontorandomisedpilotandfeasibilitytrials AT thabanelehana consort2010statementextensiontorandomisedpilotandfeasibilitytrials AT lancastergilliana consort2010statementextensiontorandomisedpilotandfeasibilitytrials AT consort2010statementextensiontorandomisedpilotandfeasibilitytrials |