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

（标题续）试验干预措施的包容性和针对性。2019冠状病毒病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，导致快速适应，使试验能够在不熟悉和具有挑战性的环境中继续进行。目前了解如何应对这一影响的研究侧重于适应分析计划和报告以及适应试验程序，例如管理药物供应或远程识别、招募和数据收集过程。由于适应复杂的干预措施，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单个患者或患者群体提供，很少有人注意到方法上的挑战。这些干预措施往往迅速转变为远程交付，例如通过电话或视频通话，而不是从一开始就开发为不进行面对面互动的交付。这种对干预措施实施的适应有可能造成意想不到的后果，并影响试验的普遍性和解释的重要方面。例如，可能存在与干预实施有关的问题，例如保持保真度，或允许针对不同个体进行调整。该项目旨在应用2019冠状病毒病大流行期间的知识，以加深我们对哪些干预措施可以成功转化为远程交付、为谁以及如何成功转化为远程交付的理解。结果将用于帮助设计未来在资源受限的环境下进行的试验，如NHS，在那里远程提供医疗干预变得越来越普遍。该项目将包括开展系统审查，以确定在COVID-19大流行期间适合远程交付的试验。将审查任何相关的过程评估，以了解所遇到的具体实施问题。还将对试验工作人员、干预设计人员和干预提供者进行定性研究，以更详细地了解他们快速调整试验以适应远程交付的经验。还将探讨在实践中使用指导。将召集一个由PPIE代表和试验参与者组成的利益相关者小组，以了解可接受性和包容性方面的问题。所有这些研究的结果将为如何在未来的试验中适应远程交付的复杂干预提供指导。

(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.