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

<p><strong>Background:</strong>&nbsp;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 inf...

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Main Authors: Rick, J, Graffy, J, Knapp, P, Small, N, Collier, DJ, Eldridge, S, Kennedy, A, Salisbury, C, Treweek, S, Torgerson, D, Wallace, P, Madurasinghe, V, Hughes-Morley, A, Bower, P
Format: Journal article
Language:English
Published: BioMed Central 2014
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author Rick, J
Graffy, J
Knapp, P
Small, N
Collier, DJ
Eldridge, S
Kennedy, A
Salisbury, C
Treweek, S
Torgerson, D
Wallace, P
Madurasinghe, V
Hughes-Morley, A
Bower, P
author_facet Rick, J
Graffy, J
Knapp, P
Small, N
Collier, DJ
Eldridge, S
Kennedy, A
Salisbury, C
Treweek, S
Torgerson, D
Wallace, P
Madurasinghe, V
Hughes-Morley, A
Bower, P
author_sort Rick, J
collection OXFORD
description <p><strong>Background:</strong>&nbsp;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&nbsp;<em>ad hoc</em>&nbsp;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.</p> <p data-test="abstract-sub-heading"><strong>Methods/Design:</strong>&nbsp;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.</p> <p data-test="abstract-sub-heading"><strong>Discussion:</strong>&nbsp;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.</p> <p data-test="abstract-sub-heading"><strong>Trial registration:&nbsp;</strong>The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.</p>
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spelling oxford-uuid:05edb348-9589-4980-9c6e-6b47d6da91cd2023-05-17T14:56:58ZSystematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trialsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:05edb348-9589-4980-9c6e-6b47d6da91cdEnglishSymplectic ElementsBioMed Central2014Rick, JGraffy, JKnapp, PSmall, NCollier, DJEldridge, SKennedy, ASalisbury, CTreweek, STorgerson, DWallace, PMadurasinghe, VHughes-Morley, ABower, P<p><strong>Background:</strong>&nbsp;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&nbsp;<em>ad hoc</em>&nbsp;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.</p> <p data-test="abstract-sub-heading"><strong>Methods/Design:</strong>&nbsp;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.</p> <p data-test="abstract-sub-heading"><strong>Discussion:</strong>&nbsp;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.</p> <p data-test="abstract-sub-heading"><strong>Trial registration:&nbsp;</strong>The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.</p>
spellingShingle Rick, J
Graffy, J
Knapp, P
Small, N
Collier, DJ
Eldridge, S
Kennedy, A
Salisbury, C
Treweek, S
Torgerson, D
Wallace, P
Madurasinghe, V
Hughes-Morley, A
Bower, P
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
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