Schumacher Lauren, Crutzen Rik, Kwah Kayleigh, Brown Katherine, Bailey Julia V, Bremner Stephen, Jackson Louise J, Newby Katie
Public Health and Applied Behaviour Change (PHAB) Lab, University of Hertfordshire, Hatfield, United Kingdom.
Department of Health Promotion, Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.
PLOS Digit Health. 2025 May 29;4(5):e0000875. doi: 10.1371/journal.pdig.0000875. eCollection 2025 May.
Randomised controlled trials (RCTs) must have sufficient power if planned analyses are to be performed and strong conclusions drawn. A prerequisite of this is successful participant recruitment and retention. Designing a comprehensive plan for participant recruitment and retention prior to trial commencement is recommended, but evidence concerning successful strategies, and how to go about developing a comprehensive plan, is lacking. This paper reports on the application of a six-stage process to develop a recruitment and retention strategy for a future RCT. Stage 1) Rapid evidence review: strategies used in previous trials were identified through database searching. This informed Stage 2) PPI workshop: workshops with public and patient involvement (PPI) group were used to select a sub-set of these strategies based on their potential to be successful and acceptable with the target audience. Stage 3) Focus groups with the target audience: the sub-set was refined through feedback from 15 young people (data subjected to content analysis). Strategies the PPI and focus groups mutually agreed upon proceeded directly to Stage 5; those without consensus proceeded to Stage 4. Stage 4) PPI workshop: PPI members voted on the remaining strategies; those without consensus were discarded. Stage 5) Observation of strategies during feasibility RCT (fRCT): the retained set of strategies were observed in practice in a fRCT in which recruitment and retention data and qualitative feedback from participants was collected. Stage 6) PPI workshop: the fRCT findings were reviewed and strategies for use in the future RCT were finalised. The finalised strategy included set of adverts; schedule of financial incentives; instructions to send survey invite by email, one prompt by SMS prior to data collection, and up to three SMS reminders; procedure to keep participants engaged (e.g., newsletters, personalisation of communications); and procedure if participants fail to complete a research activity (follow-up email/phone call).
如果要进行计划中的分析并得出有力的结论，随机对照试验（RCT）必须具备足够的效力。而这的一个先决条件是成功招募和留住参与者。建议在试验开始前设计一个全面的参与者招募和保留计划，但缺乏关于成功策略以及如何制定全面计划的证据。本文报告了一个六阶段过程在为未来的随机对照试验制定招募和保留策略中的应用。第一阶段）快速证据审查：通过数据库搜索确定先前试验中使用的策略。这为第二阶段）患者和公众参与（PPI）研讨会提供了信息：与PPI小组举办的研讨会用于根据这些策略在目标受众中取得成功和被接受的潜力选择其中一部分策略。第三阶段）与目标受众进行焦点小组讨论：通过15名年轻人的反馈（数据进行内容分析）对该子集进行完善。PPI和焦点小组共同认可的策略直接进入第五阶段；没有达成共识的策略进入第四阶段。第四阶段）PPI研讨会：PPI成员对其余策略进行投票；没有达成共识的策略被淘汰。第五阶段）在可行性随机对照试验（fRCT）中观察策略：在fRCT中实际观察保留的策略集，收集招募和保留数据以及参与者的定性反馈。第六阶段）PPI研讨会：审查fRCT的结果并确定未来随机对照试验中使用的策略。最终确定的策略包括一组广告；经济激励时间表；通过电子邮件发送调查邀请的说明、数据收集前通过短信进行一次提醒以及最多三次短信提醒；保持参与者参与的程序（例如时事通讯、通信个性化）；以及参与者未完成研究活动时的程序（后续电子邮件/电话）。
