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Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials

BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and re...

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Autores principales: Rick, Jo, Graffy, Jonathan, Knapp, Peter, Small, Nicola, Collier, David J, Eldridge, Sandra, Kennedy, Anne, Salisbury, Chris, Treweek, Shaun, Torgerson, David, Wallace, Paul, Madurasinghe, Vichithranie, Hughes-Morley, Adwoa, Bower, Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4230578/
https://www.ncbi.nlm.nih.gov/pubmed/25344684
http://dx.doi.org/10.1186/1745-6215-15-407
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author Rick, Jo
Graffy, Jonathan
Knapp, Peter
Small, Nicola
Collier, David J
Eldridge, Sandra
Kennedy, Anne
Salisbury, Chris
Treweek, Shaun
Torgerson, David
Wallace, Paul
Madurasinghe, Vichithranie
Hughes-Morley, Adwoa
Bower, Peter
author_facet Rick, Jo
Graffy, Jonathan
Knapp, Peter
Small, Nicola
Collier, David J
Eldridge, Sandra
Kennedy, Anne
Salisbury, Chris
Treweek, Shaun
Torgerson, David
Wallace, Paul
Madurasinghe, Vichithranie
Hughes-Morley, Adwoa
Bower, Peter
author_sort Rick, Jo
collection PubMed
description BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.
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spelling pubmed-42305782014-11-14 Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials Rick, Jo Graffy, Jonathan Knapp, Peter Small, Nicola Collier, David J Eldridge, Sandra Kennedy, Anne Salisbury, Chris Treweek, Shaun Torgerson, David Wallace, Paul Madurasinghe, Vichithranie Hughes-Morley, Adwoa Bower, Peter Trials Study Protocol BACKGROUND: Randomized controlled trials play a central role in evidence-based practice, but recruitment of participants, and retention of them once in the trial, is challenging. Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies. As with other healthcare initiatives, the fairest test of the effectiveness of a recruitment strategy is a trial comparing alternatives, which for recruitment would mean embedding a recruitment trial within an ongoing host trial. Systematic reviews indicate that such studies are rare. Embedded trials are largely delivered in an ad hoc way, with interventions almost always developed in isolation and tested in the context of a single host trial, limiting their ability to contribute to a body of evidence with regard to a single recruitment intervention and to researchers working in different contexts. METHODS/DESIGN: The Systematic Techniques for Assisting Recruitment to Trials (START) program is funded by the United Kingdom Medical Research Council (MRC) Methodology Research Programme to support the routine adoption of embedded trials to test standardized recruitment interventions across ongoing host trials. To achieve this aim, the program involves three interrelated work packages: (1) methodology - to develop guidelines for the design, analysis and reporting of embedded recruitment studies; (2) interventions - to develop effective and useful recruitment interventions; and (3) implementation - to recruit host trials and test interventions through embedded studies. DISCUSSION: Successful completion of the START program will provide a model for a platform for the wider trials community to use to evaluate recruitment interventions or, potentially, other types of intervention linked to trial conduct. It will also increase the evidence base for two types of recruitment intervention. TRIAL REGISTRATION: The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial. BioMed Central 2014-10-25 /pmc/articles/PMC4230578/ /pubmed/25344684 http://dx.doi.org/10.1186/1745-6215-15-407 Text en © Rick et al.; licensee BioMed Central Ltd. 2014 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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 Study Protocol
Rick, Jo
Graffy, Jonathan
Knapp, Peter
Small, Nicola
Collier, David J
Eldridge, Sandra
Kennedy, Anne
Salisbury, Chris
Treweek, Shaun
Torgerson, David
Wallace, Paul
Madurasinghe, Vichithranie
Hughes-Morley, Adwoa
Bower, Peter
Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
title Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
title_full Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
title_fullStr Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
title_full_unstemmed Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
title_short Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
title_sort systematic techniques for assisting recruitment to trials (start): study protocol for embedded, randomized controlled trials
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4230578/
https://www.ncbi.nlm.nih.gov/pubmed/25344684
http://dx.doi.org/10.1186/1745-6215-15-407
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