Health Services Research Unit, Health Sciences Building, University of Aberdeen, Foresterhill, Aberdeen, AB25 2ZD, UK.
Institute of Applied Health Sciences, University of Aberdeen, Aberdeen, UK.
BMC Med Res Methodol. 2022 Aug 25;22(1):231. doi: 10.1186/s12874-022-01708-4.
Retention (participants completing a trial) is a persistent, and often under-studied, challenge within clinical trials. Research on retention has focussed on understanding the actions of participants who decide to remain or withdraw from trial participation and developing interventions to target improvements. To better understand how trial staff may influence participants to remain or withdraw from trials, it is important to explore the experiences of staff that recruit and retain said participants and how the process of recruitment impacts retention.
Two qualitative interview studies informed by the Theoretical Domains Framework (TDF) were conducted with staff involved in various stages of clinical trials. The first set of interviews were focussed on staff perceptions about why participants failed to be retained and what helped to keep others engaged in trials, but also explored more generally what strategies or factors contributed to retention in trials. The second set of interviews were focussed on staff perceptions specifically about the recruitment and informed consent process and how that may influence trial retention. All interviews were analysed using the TDF and assigned to relevant behavioural domains according to perceived barriers/facilitators of the target behaviour. Belief statements were generated, summarising the narrative content of related responses within these behavioural domains. These belief statements were further analysed for themes that captured higher order relationships between separate beliefs within and between behavioural domains.
Twenty-five participants (9 retention staff and 16 recruitment staff) were interviewed. Themes describing the barriers/facilitators to retention broadly, and to communication of retention information at consent, were generated. Four themes on retention broadly and six themes on communication of retention information at consent were identified. Overall, beliefs within all fourteen TDF domains populated these themes.
This study explored staff perspectives on retention and how they interpret their behaviour as contributing to retention success. Perspectives varied considerably but several key themes regarding communication were seen consistently. Specific barriers and facilitators within these findings will serve to guide the design of a behavioural intervention aimed at addressing issues within retention. Findings contribute to a notable gap in the literature on staff behaviour in trials and on retention generally.
在临床试验中，保留（参与者完成试验）是一个持续存在且经常被忽视的挑战。关于保留的研究侧重于理解决定继续或退出试验的参与者的行为，并开发针对改进的干预措施。为了更好地了解试验人员如何影响参与者继续或退出试验，了解招募和保留参与者的工作人员的经验以及招募过程如何影响保留非常重要。
根据理论领域框架（TDF）进行了两项定性访谈研究，涉及参与各种临床试验阶段的工作人员。第一组访谈集中于工作人员对参与者未能保留的原因以及帮助他人参与试验的原因的看法，但也更广泛地探讨了有助于试验保留的策略或因素。第二组访谈集中于工作人员对招募和知情同意过程的看法，以及这些过程如何影响试验保留。所有访谈均使用 TDF 进行分析，并根据目标行为的感知障碍/促进因素分配给相关行为领域。生成信念陈述，总结这些行为领域内相关回应的叙述内容。进一步对这些信念陈述进行主题分析，以捕捉不同行为领域内和之间的单独信念之间的更高阶关系。
对 25 名参与者（9 名保留工作人员和 16 名招募工作人员）进行了访谈。生成了描述保留的障碍/促进因素以及在同意时保留信息沟通的主题。确定了关于保留的四个主题和关于在同意时沟通保留信息的六个主题。总体而言，这些主题涵盖了所有 14 个 TDF 领域的信念。
这项研究探讨了工作人员对保留的看法，以及他们如何解释自己的行为对保留成功的贡献。观点差异很大，但在沟通方面看到了一些一致的关键主题。这些发现中的特定障碍和促进因素将有助于指导旨在解决保留问题的行为干预措施的设计。研究结果为关于试验中工作人员行为和保留的文献中的一个重要空白做出了贡献。
