Wang Xiaoxia, Mobley Alastair R, Tica Otilia, Okoth Kelvin, Ghosh Rebecca E, Myles Puja, Williams Tim, Haynes Sandra, Nirantharakumar Krishnarajah, Shukla David, Kotecha Dipak
Institute of Cardiovascular Sciences, University of Birmingham, Birmingham, UK.
Health Data Research UK Midlands, Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
Eur Heart J Digit Health. 2022 Sep 16;3(3):426-436. doi: 10.1093/ehjdh/ztac046. eCollection 2022 Sep.
Improving the efficiency of clinical trials is key to their continued importance in directing evidence-based patient care. Digital innovations, in particular the use of electronic healthcare records (EHRs), allow for large-scale screening and follow up of participants. However, it is critical these developments are accompanied by robust and transparent methods that can support high-quality and high clinical value research.
The DaRe2THINK trial includes a series of novel processes, including nationwide pseudonymized pre screening of the primary-care EHR across England, digital enrolment, remote e-consent, and 'no-visit' follow up by linking all primary- and secondary-care health data with patient-reported outcomes. DaRe2THINK is a pragmatic, healthcare-embedded randomized trial testing whether earlier use of direct oral anticoagulants in patients with prior or current atrial fibrillation can prevent thromboembolic events and cognitive decline (www.birmingham.ac.uk/dare2think). This study outlines the systematic approach and methodology employed to define patient information and outcome events. This includes transparency on all medical code lists and phenotypes used in the trial across a variety of national data sources, including Clinical Practice Research Datalink Aurum (primary care), Hospital Episode Statistics (secondary care), and the Office for National Statistics (mortality).
Co-designed by a patient and public involvement team, DaRe2THINK presents an opportunity to transform the approach to randomized trials in the setting of routine healthcare, providing high-quality evidence generation in populations representative of the community at risk.
提高临床试验效率是其在指导循证患者护理方面持续发挥重要作用的关键。数字创新，特别是电子健康记录（EHR）的使用，使得能够对参与者进行大规模筛查和随访。然而，至关重要的是，这些进展要伴随着强大且透明的方法，以支持高质量和具有高临床价值的研究。
DaRe2THINK试验包括一系列新颖的流程，包括在英格兰对基层医疗电子健康记录进行全国范围的匿名预筛查、数字注册、远程电子同意，以及通过将所有基层和二级医疗健康数据与患者报告的结果相链接进行“无就诊”随访。DaRe2THINK是一项务实的、嵌入医疗保健的随机试验，旨在测试对于既往或当前患有心房颤动的患者，更早使用直接口服抗凝剂是否能够预防血栓栓塞事件和认知功能下降（www.birmingham.ac.uk/dare2think）。本研究概述了用于定义患者信息和结局事件的系统方法和流程。这包括在各种国家数据源（包括临床实践研究数据链Aurum（基层医疗）、医院事件统计（二级医疗）和国家统计局（死亡率））中，对试验中使用的所有医学编码列表和表型的透明度。
由患者和公众参与团队共同设计的DaRe2THINK提供了一个机会，可在常规医疗保健环境中改变随机试验的方法，在具有社区风险代表性的人群中提供高质量的证据生成。
