WMG, University of Warwick, Coventry, UK.
School of Engineering, University of Birmingham, Birmingham, UK.
BMJ Open. 2024 Apr 3;14(4):e076613. doi: 10.1136/bmjopen-2023-076613.
The COVID-19 pandemic accelerated changes to clinical research methodology, with clinical studies being carried out via online/remote means. This mixed-methods study aimed to identify which digital tools are currently used across all stages of clinical research by stakeholders in clinical, health and social care research and investigate their experience using digital tools.
Two online surveys followed by semistructured interviews were conducted. Interviews were audiorecorded, transcribed and analysed thematically.
SETTING, PARTICIPANTS: To explore the digital tools used since the pandemic, survey participants (researchers and related staff (n=41), research and development staff (n=25)), needed to have worked on clinical, health or social care research studies over the past 2 years (2020-2022) in an employing organisation based in the West Midlands region of England (due to funding from a regional clinical research network (CRN)). Survey participants had the opportunity to participate in an online qualitative interview to explore their experiences of digital tools in greater depth (n=8).
Six themes were identified in the qualitative interviews: 'definition of a digital tool in clinical research'; 'impact of the COVID-19 pandemic'; 'perceived benefits/drawbacks of digital tools'; 'selection of a digital tool'; 'barriers and overcoming barriers' and 'future digital tool use'. The context of each theme is discussed, based on the interview results.
Findings demonstrate how digital tools are becoming embedded in clinical research, as well as the breadth of tools used across different research stages. The majority of participants viewed the tools positively, noting their ability to enhance research efficiency. Several considerations were highlighted; concerns about digital exclusion; need for collaboration with digital expertise/clinical staff, research on tool effectiveness and recommendations to aid future tool selection. There is a need for the development of resources to help optimise the selection and use of appropriate digital tools for clinical research staff and participants.
新冠疫情加速了临床研究方法的变革，临床研究通过在线/远程方式进行。本混合方法研究旨在确定临床、卫生和社会保健研究利益相关者在临床研究的所有阶段目前使用哪些数字工具，并调查他们使用数字工具的经验。
进行了两次在线调查，随后进行了半结构化访谈。访谈进行了录音、转录，并进行了主题分析。
地点、参与者：为了探索疫情以来使用的数字工具，调查参与者（研究人员和相关工作人员（n=41）、研究与开发人员（n=25））需要在过去 2 年（2020-2022 年）内在位于英格兰西米德兰兹地区的用人单位从事临床、卫生或社会保健研究（由于得到了区域临床研究网络（CRN）的资助）。调查参与者有机会参加在线定性访谈，以更深入地探讨他们对数字工具的经验（n=8）。
定性访谈中确定了六个主题：“临床研究中数字工具的定义”；“新冠疫情的影响”；“数字工具的感知益处/缺点”；“数字工具的选择”；“障碍和克服障碍”和“未来数字工具的使用”。根据访谈结果讨论了每个主题的背景。
研究结果表明，数字工具如何在临床研究中得到广泛应用，以及在不同研究阶段使用的工具的多样性。大多数参与者对工具持积极态度，指出它们能够提高研究效率。研究强调了一些需要考虑的因素，包括对数字排斥的担忧、需要与数字专业知识/临床工作人员合作、对工具有效性的研究以及为帮助未来工具选择提出的建议。需要开发资源，以帮助临床研究人员和参与者优化选择和使用适当的数字工具。
