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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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Exemplar original (left) and optimized (right) participant information sheets[25].
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
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Fig1: Exemplar original (left) and optimized (right) participant information sheets[25].

Mentions: To test the impact of involving consumers in the development of patient information, a revised version of the PIS will be prepared for each host trial. The process involves optimization of PIS readability through expertise in writing for patients and improved presentation via graphic design [24]. The revisions are informed by user testing [25–27], where the ability of patients to locate and understand key pieces of information is evaluated objectively to provide an assessment of the ability of the PIS to provide information in a way that can be understood. Initially the original PIS is tested, and then versions of the optimized PIS are tested (followed by further revision), until the resultant PIS is better able to inform potential trial participants. The optimized PIS would cover the same topics as the original version but the optimized version would likely differ in appearance, structure, and wording. See Figure 1 for an exemplar of an original and optimized PIS [25].Figure 1


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)

Exemplar original (left) and optimized (right) participant information sheets[25].
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig1: Exemplar original (left) and optimized (right) participant information sheets[25].
Mentions: To test the impact of involving consumers in the development of patient information, a revised version of the PIS will be prepared for each host trial. The process involves optimization of PIS readability through expertise in writing for patients and improved presentation via graphic design [24]. The revisions are informed by user testing [25–27], where the ability of patients to locate and understand key pieces of information is evaluated objectively to provide an assessment of the ability of the PIS to provide information in a way that can be understood. Initially the original PIS is tested, and then versions of the optimized PIS are tested (followed by further revision), until the resultant PIS is better able to inform potential trial participants. The optimized PIS would cover the same topics as the original version but the optimized version would likely differ in appearance, structure, and wording. See Figure 1 for an exemplar of an original and optimized PIS [25].Figure 1

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