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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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Round 1 recruitment outcomes.
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Fig4: Round 1 recruitment outcomes.

Mentions: For the second round this procedure was repeated and followed up by the START project team who attempted to contact principal investigators up to three times by phone and a further time by follow-up email. For the final rounds of recruitment we are using project flyers, invitation letters, and intensive phone or email follow-up to establish a more comprehensive picture of the barriers or reasons for non-participation.FigureĀ 4 shows the first round of recruitment to the START project. A total of 60 out of 71 potential trials expressing an interest in START were excluded, primarily due to incompatible recruitment methods or aspects of the host trial design, indicating considerable scope for the development of other recruitment interventions. Of the 11 potential trials identified in the first round of recruitment, 4 became hosts to the PIS intervention, and 7 were subsequently lost due to delays in the development of the multimedia intervention. The second and third recruitment rounds are ongoing, with 10 of the 12 trials recruited to date.Figure 4


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)

Round 1 recruitment outcomes.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Fig4: Round 1 recruitment outcomes.
Mentions: For the second round this procedure was repeated and followed up by the START project team who attempted to contact principal investigators up to three times by phone and a further time by follow-up email. For the final rounds of recruitment we are using project flyers, invitation letters, and intensive phone or email follow-up to establish a more comprehensive picture of the barriers or reasons for non-participation.FigureĀ 4 shows the first round of recruitment to the START project. A total of 60 out of 71 potential trials expressing an interest in START were excluded, primarily due to incompatible recruitment methods or aspects of the host trial design, indicating considerable scope for the development of other recruitment interventions. Of the 11 potential trials identified in the first round of recruitment, 4 became hosts to the PIS intervention, and 7 were subsequently lost due to delays in the development of the multimedia intervention. The second and third recruitment rounds are ongoing, with 10 of the 12 trials recruited to date.Figure 4

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