National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre (NETSCC), University of Southampton, Southampton, SO16 7NS, UK.
Southampton Clinical Trials Unit, University of Southampton and University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, SO16 6YD, UK.
Trials. 2020 Apr 3;21(1):304. doi: 10.1186/s13063-020-04234-0.
Recruitment and retention of participants in randomised controlled trials (RCTs) is a key determinant of success but is challenging. Trialists and UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs) are increasingly exploring the use of digital tools to identify, recruit and retain participants. The aim of this UK National Institute for Health Research (NIHR) study was to identify what digital tools are currently used by CTUs and understand the performance characteristics required to be judged useful.
A scoping of searches (and a survey with NIHR funding staff), a survey with all 52 UKCRC CTUs and 16 qualitative interviews were conducted with five stakeholder groups including trialists within CTUs, funders and research participants. A purposive sampling approach was used to conduct the qualitative interviews during March-June 2018. Qualitative data were analysed using a content analysis and inductive approach.
Responses from 24 (46%) CTUs identified that database-screening tools were the most widely used digital tool for recruitment, with the majority being considered effective. The reason (and to whom) these tools were considered effective was in identifying potential participants (for both Site staff and CTU staff) and reaching recruitment target (for CTU staff/CI). Fewer retention tools were used, with short message service (SMS) or email reminders to participants being the most reported. The qualitative interviews revealed five themes across all groups: 'security and transparency'; 'inclusivity and engagement'; 'human interaction'; 'obstacles and risks'; and 'potential benefits'. There was a high level of stakeholder acceptance of the use of digital tools to support trials, despite the lack of evidence to support them over more traditional techniques. Certain differences and similarities between stakeholder groups demonstrated the complexity and challenges of using digital tools for recruiting and retaining research participants.
Our studies identified a range of digital tools in use in recruitment and retention of RCTs, despite the lack of high-quality evidence to support their use. Understanding the type of digital tools in use to support recruitment and retention will help to inform funders and the wider research community about their value and relevance for future RCTs. Consideration of further focused digital tool reviews and primary research will help to reduce gaps in the evidence base.
招募和保留随机对照试验（RCT）的参与者是成功的关键决定因素，但具有挑战性。试验人员和英国临床研究合作组织（UKCRC）临床试验单位（CTU）越来越多地探索使用数字工具来识别、招募和保留参与者。这项英国国家卫生研究院（NIHR）研究的目的是确定 CTU 目前使用的数字工具，并了解被判断为有用所需的性能特征。
进行了一次范围广泛的搜索（并对 NIHR 资助人员进行了一项调查），对所有 52 个 UKCRC CTU 和 16 个定性访谈进行了调查，涉及包括 CTU 内的试验人员、资助者和研究参与者在内的五个利益相关者群体。在 2018 年 3 月至 6 月期间，采用有针对性的抽样方法进行了定性访谈。使用内容分析和归纳方法对定性数据进行了分析。
24 个（46%）CTU 的回复表明，数据库筛选工具是招募中使用最广泛的数字工具，大多数被认为是有效的。这些工具被认为有效的原因（以及对谁有效）是识别潜在参与者（既针对站点工作人员，也针对 CTU 工作人员）并达到招募目标（针对 CTU 工作人员/CI）。使用的保留工具较少，报告最多的是给参与者发送短消息服务（SMS）或电子邮件提醒。定性访谈揭示了所有群体共有的五个主题：“安全性和透明度”；“包容性和参与度”；“人际互动”；“障碍和风险”；和“潜在利益”。尽管缺乏支持使用数字工具超过传统技术的证据，但利益相关者高度接受使用数字工具来支持试验。在利益相关者群体之间存在一定的差异和相似性，这表明使用数字工具招募和保留研究参与者的复杂性和挑战。
尽管缺乏支持使用数字工具的高质量证据，但我们的研究确定了在 RCT 招募和保留中使用的一系列数字工具。了解用于支持招募和保留的数字工具类型将有助于为资助者和更广泛的研究界提供有关其未来 RCT 价值和相关性的信息。考虑进一步进行有针对性的数字工具审查和基础研究将有助于缩小证据基础的差距。
