Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
Systematic techniques for assisting recruitment to trials (START): study protocol for embedded, randomized controlled trials
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DOI：
10.1186/1745-6215-15-407
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发表时间：
2014-10-25
期刊：
影响因子：
2.5
通讯作者：
Bower, Peter
中科院分区：
文献类型：
--
作者：
Rick, Jo;Graffy, Jonathan;Bower, Peter
背景资料：随机对照试验在循证医学实践中发挥着核心作用，但参与者的招募以及一旦进入试验就保留他们是具有挑战性的。此外，研究小组可用来制定征聘和留用战略的证据也很缺乏。与其他医疗保健计划一样，招募策略有效性的最公平测试是比较替代方案的试验，对于招募来说，这意味着将招募试验嵌入正在进行的宿主试验中。系统评价表明，此类研究非常罕见。嵌入式试验在很大程度上是以一种特别的方式进行的，干预措施几乎总是孤立地开发，并在单一宿主试验的背景下进行测试，限制了它们对单一招募干预措施和在不同背景下工作的研究人员的证据体系的贡献。方法/设计：辅助招募试验的系统技术（START）计划由英国医学研究理事会（MRC）资助。方法研究计划，以支持常规采用嵌入式试验，以测试正在进行的主机试验的标准化招募干预措施。为了实现这一目标，该计划涉及三个相互关联的工作包：（1）方法-制定嵌入式招募研究的设计，分析和报告指南;（2）干预措施-制定有效和有用的招募干预措施;（3）实施-通过嵌入式研究招募主机试验和测试干预措施。START项目的成功完成将为更广泛的试验社区提供一个平台模型，用于评估招募干预措施或可能与试验实施相关的其他类型的干预措施。它还将增加两类征聘干预措施的证据基础。
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.