背景:临床试验包括处于试验生命周期各个阶段的多个过程。这些过程通常涉及复杂的行为,例如招募弱势患者人群和临床医生必须成功提供复杂的试验干预措施。很少有研究利用行为框架来评估挑战并制定有效的试验招募和实施试验干预措施的策略。这项研究报告了一种创新的方法学方法的应用,以了解核心试验过程,即招募和干预交付,使用行为科学方法制定旨在减轻试验过程问题的策略。
方法:UK-REBOA试验旨在评估主动脉内球囊阻断复苏术(一种新型干预措施)对失血出血的损伤患者的临床和成本效益。使用理论知情(理论领域框架,TDF)与UK-REBOA试验的现场工作人员进行半结构化访谈,以检查在试验招募和干预措施交付方面可以改进的试验过程。使用TDF分析访谈,以确定对行为的影响,然后将其映射到行为改变的技术,并发展成为潜在的解决方案。
结果:试验过程中遇到的挑战的行为诊断突出了与一系列TDF领域相关的因素:技能,环境背景和资源,关于能力的信念,关于后果的信念,社会影响,和记忆,注意,和决策过程。在解决方案开发阶段,我们确定了24种合适的行为改变技术,这些技术已发展成为针对报告的流程问题的建议解决方案,目的是改变行为以改善招募和/或干预交付.建议的解决方案包括对试用培训内容进行有针对性的更改,重组环境的建议(例如,通过提供有关社会和环境后果的信息来加强试验的目的)以及其他减少招募和干预措施障碍的策略.
结论:这项研究证明了在一项积极的创伤试验中应用行为方法来调查(“诊断”)行为试验过程问题并随后制定和实施有针对性的解决方案(“治疗”)的可行性。了解影响行为的因素,这种创伤试验中的态度和信念使我们能够实施理论上的知情,旨在加强审判实践的循证解决方案。
背景:ISRCTN16,184,981。
BACKGROUND: Clinical trials comprise multiple processes at various stages of the trial lifecycle. These processes often involve complex behaviours such as recruiting vulnerable patient populations and clinicians having to deliver complex trial interventions successfully. Few studies have utilised a behavioural framework to assess challenges and develop strategies for effective trial recruitment and delivery of trial interventions. This study
reports the application of an innovative methodological approach to understand core trial processes, namely recruitment and intervention delivery, using a behavioural science approach to develop strategies designed to mitigate trial process problems.
METHODS: The UK-REBOA trial aims to evaluate the clinical and cost-effectiveness of resuscitative endovascular balloon occlusion of the aorta (a novel intervention) in injured patients with exsanguinating haemorrhage. A behavioural investigation (\'diagnosis\') was conducted using theory-informed (Theoretical Domains Framework, TDF) semi-structured interviews with site staff from the UK-REBOA trial to examine trial processes which could be improved in relation to trial recruitment and delivery of the intervention. Interviews were analysed using the TDF to identify influences on behaviour, which were then mapped to techniques for behaviour change and developed into potential solutions.
RESULTS: The behavioural diagnosis of the challenges experienced during trial processes highlighted factors relevant to a range of TDF domains: Skills, Environmental context and resources, Beliefs about capabilities, Beliefs about consequences, Social influences, and Memory, attention, and decision-making processes. Within the solution development phase, we identified 24 suitable behaviour change techniques that were developed into proposed solutions to target reported process problems with the aim of changing behaviour to improve recruitment and/or intervention delivery. Proposed solutions included targeted changes to trial training content, suggestions to restructure the environment (e.g. reinforced the purpose of the trial with information about the social and environmental consequences) and other strategies to reduce barriers to recruitment and intervention delivery.
CONCLUSIONS: This study demonstrates the feasibility of applying a behavioural approach to investigate (\'diagnose\') behavioural trial process problems and subsequently develop and implement targeted solutions (\'treatment\') in an active trauma trial. Understanding the factors that affected behaviour, attitudes and beliefs in this trauma trial allowed us to implement theoretically informed, evidence-based solutions designed to enhance trial practices.
BACKGROUND: ISRCTN 16,184,981.