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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 blank template homepage[42].
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig2: Web-based platform blank template homepage[42].

Mentions: The content was based on relevant theoretical and empirical work about patient decision-making both generally [38, 39] and in trials [40, 41]. It was agreed that the content would not repeat the standard PIS, but be designed specifically to help potential participants make better informed decisions by providing additional information about medical research and trial participation including, where possible, information on previous participants’ experiences of medical studies.To design the web-based platform, the research team developed a draft specification to outline the three components. The first component was a homepage, which needed to be relevant to each specific host trial, giving a brief pitch about the trial to engage potential participants and offering them the options of more information on medical research in general or, finding more about the specific trial (see Figure 2). The second component, generic pages on medical research, included video clips of previous participants describing their experiences taking part in medical research, and cover issues of relevance to potential participants, such as ‘Why get involved?’, ‘Agreeing to take part’, ‘What happens in a study?’, ‘Leaving a study’, and ‘Protecting privacy’.Figure 2


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 blank template homepage[42].
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig2: Web-based platform blank template homepage[42].
Mentions: The content was based on relevant theoretical and empirical work about patient decision-making both generally [38, 39] and in trials [40, 41]. It was agreed that the content would not repeat the standard PIS, but be designed specifically to help potential participants make better informed decisions by providing additional information about medical research and trial participation including, where possible, information on previous participants’ experiences of medical studies.To design the web-based platform, the research team developed a draft specification to outline the three components. The first component was a homepage, which needed to be relevant to each specific host trial, giving a brief pitch about the trial to engage potential participants and offering them the options of more information on medical research in general or, finding more about the specific trial (see Figure 2). The second component, generic pages on medical research, included video clips of previous participants describing their experiences taking part in medical research, and cover issues of relevance to potential participants, such as ‘Why get involved?’, ‘Agreeing to take part’, ‘What happens in a study?’, ‘Leaving a study’, and ‘Protecting privacy’.Figure 2

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