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Published in: Trials 1/2014

Open Access 01-12-2014 | Study protocol

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

Authors: Jo Rick, Jonathan Graffy, Peter Knapp, Nicola Small, David J. Collier, Sandra Eldridge, Anne Kennedy, Chris Salisbury, Shaun Treweek, David Torgerson, Paul Wallace, Vichithranie Madurasinghe, Adwoa Hughes-Morley, Peter Bower

Published in: Trials | Issue 1/2014

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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.
Appendix
Available only for authorised users
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Metadata
Title
Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
Authors
Jo Rick
Jonathan Graffy
Peter Knapp
Nicola Small
David J. Collier
Sandra Eldridge
Anne Kennedy
Chris Salisbury
Shaun Treweek
David Torgerson
Paul Wallace
Vichithranie Madurasinghe
Adwoa Hughes-Morley
Peter Bower
Publication date
01-12-2014
Publisher
BioMed Central
Published in
Trials / Issue 1/2014
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-15-407

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