Remote delivery of complex interventions within trials: understanding and applying knowledge from COVID-19 adaptations to guide future delivery, inclu

(标题续)试验干预的包容性和剪裁。新冠肺炎大流行对临床试验的设计和交付的许多方面产生了重大影响，导致快速调整，使试验能够继续在陌生和具有挑战性的环境中运行。目前为了解如何应对这一影响而进行的研究侧重于调整分析计划和报告，并调整试验程序，例如管理药物供应或远程识别、招募和数据收集过程。人们很少注意到适应复杂干预措施所产生的方法学挑战，如物理治疗、心理、行为或生活方式干预，通常由培训治疗师面对面地向个别患者或一组患者提供。这些干预措施往往被迅速转变为远程提供，例如通过电话或视频通话，而不是从一开始就发展为在没有面对面互动的情况下提供。这种对干预提供的适应有可能造成意想不到的后果，并影响试验通用性和口译的重要方面。例如，可能存在与实施干预有关的问题，如保持保真度，或允许为不同的个人量身定做。该项目旨在应用新冠肺炎大流行期间发生的知识，以提高我们对哪些干预措施可以成功地转变为远程交付、为谁以及如何实施的理解。结果将被用来帮助设计未来在资源受限的环境下进行的试验，例如NHS，在那里远程提供医疗干预正变得越来越常见。该项目将涉及开展一项系统审查，以确定在新冠肺炎大流行期间适应远程给药的试验。将审查任何相关的进程评价，以了解遇到的具体执行问题。还将与试验工作人员、干预设计人员和干预交付人员进行定性研究，以更详细地了解他们快速调整试验以进行远程交付的经验。还将探讨指导方针在实践中的使用。将召集一个由PPIE代表和试验参与者组成的利益攸关方小组，以了解有关可接受性和包容性的问题。所有这项研究的结果将为在未来的试验中如何使复杂的干预措施适应远程递送而制定指导方针。

(title continued) inclusivity and tailoring of trial interventions.The COVID-19 pandemic had a major impact on many aspects of the design and delivery of clinical trials, leading to rapid adaptations to enable trials to continue to operate in an unfamiliar and challenging environment. Current research to understand how to address this impact has focused on adaptations to analysis plans and reporting and adaptions to trial procedures, such as managing drug supplies or remote identification, recruitment and data collection processes. Little attention has been paid to methodological challenges arising from adaptations to complex interventions, such as physiotherapy, psychological, behaviour or lifestyle interventions, typically delivered face-to-face by a train therapist to individual patients or groups of patients. These of interventions were often rapidly converted to remote delivery, for instance via telephone or video calls, rather than being developed from the outset to be delivered without face-to-face interactions.Such adaptations to intervention delivery have the potential to cause unintended consequences and affect important aspects of trial generalisability and interpretation. For instance, there may be issues relating to the implementation of the intervention, such as maintaining fidelity, or allowing tailoring to different individuals. This project aims to apply knowledge from what happened during the COVID-19 pandemic, to increase our understanding of which interventions can be successfully converted to remote delivery, for whom and how. Results will be used to aid the design of future trials operating in resource-constrained settings, such as the NHS, where remote delivery of healthcare interventions is becoming more commonplace. This project will involve carrying out a systematic review to identify trials which were adapted to remote delivery during the COVID-19 pandemic. Any associated process evaluations will be reviewed to understand the specific implementation issues that were encountered. Qualitative research will also be conducted with trial staff, intervention designers and intervention deliverers to understand in more detail their experiences of adapting a trial quickly for remote delivery. The use of guidance in practice will also be explored. A stakeholder group of PPIE representatives and trial participants will be convened to understand issues around acceptability and inclusivity. The results of all of this research will inform the development of guidance around how to adapt complex intervention for remote delivery in future trials.