Real World Solutions, IQVIA, London, UK.
Arthritis Research UK Centre for Epidemiology, The University of Manchester, Manchester, UK.
Pharmacoepidemiol Drug Saf. 2020 Dec;29(12):1540-1549. doi: 10.1002/pds.5169. Epub 2020 Nov 13.
Epidemiology and pharmacoepidemiology frequently employ Real-World Data (RWD) from healthcare teams to inform research. These data sources usually include signs, symptoms, tests, and treatments, but may lack important information such as the patient's diet or adherence or quality of life. By harnessing digital tools a new fount of evidence, Patient (or Citizen/Person) Generated Health Data (PGHD), is becoming more readily available. This review focusses on the advantages and considerations in using PGHD for pharmacoepidemiological research. New and corroborative types of data can be collected directly from patients using digital devices, both passively and actively. Practical issues such as patient engagement, data linking, validation, and analysis are among important considerations in the use of PGHD. In our ever increasingly patient-centric world, PGHD incorporated into more traditional Real-Word data sources offers innovative opportunities to expand our understanding of the complex factors involved in health and the safety and effectiveness of disease treatments. Pharmacoepidemiologists have a unique role in realizing the potential of PGHD by ensuring that robust methodology, governance, and analytical techniques underpin its use to generate meaningful research results.
流行病学和药物流行病学经常利用来自医疗团队的真实世界数据(RWD)来为研究提供信息。这些数据源通常包括体征、症状、检查和治疗,但可能缺乏重要信息,如患者的饮食、依从性或生活质量。通过利用数字工具,一种新的证据来源——患者(或公民/个人)生成的健康数据(PGHD)变得更容易获得。本综述重点介绍了使用 PGHD 进行药物流行病学研究的优势和注意事项。可以使用数字设备直接从患者那里被动和主动地收集新的和补充类型的数据。在使用 PGHD 时,患者参与、数据链接、验证和分析等实际问题是重要的考虑因素之一。在我们这个日益以患者为中心的世界中,将 PGHD 纳入更传统的真实世界数据源为扩大我们对健康相关复杂因素以及疾病治疗的安全性和有效性的理解提供了创新机会。药物流行病学学家通过确保使用强大的方法学、治理和分析技术来支持其使用以产生有意义的研究结果,在实现 PGHD 的潜力方面发挥着独特的作用。