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

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 - Trials (2014)

Bottom Line: Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies.Systematic reviews indicate that such studies are rare.It will also increase the evidence base for two types of recruitment intervention.

View Article: PubMed Central - PubMed

Affiliation: Medical Research Council North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of Manchester, Oxford Road, Manchester M13 9PL, UK. peter.bower@manchester.ac.uk.

ABSTRACT

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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Web-based platform study-specific pages blank template.
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Related In: Results  -  Collection

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Fig3: Web-based platform study-specific pages blank template.

Mentions: Specially designed infographics (animated information videos) were developed to accompany the clips in order to visually explain some of the more difficult concepts used in medical research (such as randomization). Each infographic was developed by our digital partners (Reason Digital, Manchester, United Kingdom) based on visual and text material provided by the research team and our Patient and Public Involvement representatives, who all commented extensively on the finished infographic. The third and final component, study-specific pages, were designed as a blank template for host trials to insert their own bespoke content, ideally to outline the purpose of the trial and what it is like to take part. Specifically, the pages have been split to reflect concerns raised by potential participants who wish to make an informed decision on participating in the trial. For example, these pages cover ‘Why are we doing the study and why do we need your help?’, ‘What will happen during the study?’, ‘Questions and answers’, ‘Study care and safety’, and ‘What happens after the study?’The plan is for the START team to work with each host trial team to produce bespoke content for the study-specific section. The bespoke content is intended to convey key points about the study in an accessible form, with templates for video clips of key people involved in the host trial (such as the principal investigator and trial manager) and previous participants of the trial describing their experiences (see Figure 3). The platform, which has been designed to be easily accessed and navigated by potential participants, is web-based and viewable on PCs, laptops, and smartphones. Potential participants will be able to gain access to the multimedia intervention via a URL and a quick response (QR) code specific to the host trial placed at the top of the standard PIS and/or on the patient invitation letter. Potential participants in each host trial will then be randomized to either have access to the multimedia intervention in addition to the standard PIS, or the standard PIS alone.Figure 3


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

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 - Trials (2014)

Web-based platform study-specific pages blank template.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4230578&req=5

Fig3: Web-based platform study-specific pages blank template.
Mentions: Specially designed infographics (animated information videos) were developed to accompany the clips in order to visually explain some of the more difficult concepts used in medical research (such as randomization). Each infographic was developed by our digital partners (Reason Digital, Manchester, United Kingdom) based on visual and text material provided by the research team and our Patient and Public Involvement representatives, who all commented extensively on the finished infographic. The third and final component, study-specific pages, were designed as a blank template for host trials to insert their own bespoke content, ideally to outline the purpose of the trial and what it is like to take part. Specifically, the pages have been split to reflect concerns raised by potential participants who wish to make an informed decision on participating in the trial. For example, these pages cover ‘Why are we doing the study and why do we need your help?’, ‘What will happen during the study?’, ‘Questions and answers’, ‘Study care and safety’, and ‘What happens after the study?’The plan is for the START team to work with each host trial team to produce bespoke content for the study-specific section. The bespoke content is intended to convey key points about the study in an accessible form, with templates for video clips of key people involved in the host trial (such as the principal investigator and trial manager) and previous participants of the trial describing their experiences (see Figure 3). The platform, which has been designed to be easily accessed and navigated by potential participants, is web-based and viewable on PCs, laptops, and smartphones. Potential participants will be able to gain access to the multimedia intervention via a URL and a quick response (QR) code specific to the host trial placed at the top of the standard PIS and/or on the patient invitation letter. Potential participants in each host trial will then be randomized to either have access to the multimedia intervention in addition to the standard PIS, or the standard PIS alone.Figure 3

Bottom Line: Moreover, there is a dearth of evidence that research teams can use to inform the development of their recruitment and retention strategies.Systematic reviews indicate that such studies are rare.It will also increase the evidence base for two types of recruitment intervention.

View Article: PubMed Central - PubMed

Affiliation: Medical Research Council North West Hub for Trials Methodology Research, Manchester Academic Health Science Centre, Centre for Primary Care, University of Manchester, Oxford Road, Manchester M13 9PL, UK. peter.bower@manchester.ac.uk.

ABSTRACT

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.

Show MeSH