Rick Jo, Graffy Jonathan, Knapp Peter, Small Nicola, Collier David J, Eldridge Sandra, Kennedy Anne, Salisbury Chris, Treweek Shaun, Torgerson David, Wallace Paul, Madurasinghe Vichithranie, Hughes-Morley Adwoa, Bower Peter
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.
Trials. 2014 Oct 25;15:407. doi: 10.1186/1745-6215-15-407.
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.
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.
The START protocol covers the methodology for embedded trials. Each embedded trial is registered separately or as a substudy of the host trial.
随机对照试验在循证实践中发挥着核心作用，但招募参与者以及在试验中使他们留在试验中具有挑战性。此外，几乎没有证据可供研究团队用于制定其招募和保留策略。与其他医疗保健举措一样，对招募策略有效性的最公平测试是进行一项比较不同方法的试验，对于招募而言，这意味着在正在进行的主要试验中嵌入一项招募试验。系统评价表明此类研究很少见。嵌入式试验大多是以临时方式进行的，干预措施几乎总是单独开发并在单个主要试验的背景下进行测试，这限制了它们为关于单一招募干预措施的证据体系做出贡献的能力，也限制了在不同背景下工作的研究人员的能力。
方法/设计：协助试验招募的系统技术（START）计划由英国医学研究理事会（MRC）方法学研究计划资助，以支持常规采用嵌入式试验来测试正在进行的主要试验中的标准化招募干预措施。为实现这一目标，该计划涉及三个相互关联的工作包：（1）方法学——制定嵌入式招募研究的设计、分析和报告指南；（2）干预措施——开发有效且有用的招募干预措施；（3）实施——招募主要试验并通过嵌入式研究测试干预措施。
START计划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干预措施。它还将增加两类招募干预措施的证据基础。
START方案涵盖嵌入式试验的方法学。每个嵌入式试验单独注册或作为主要试验的子研究注册。
