Mueller Tanja, Laskey Jennifer, Baillie Kelly, Clarke Julie, Crearie Christine, Kavanagh Kimberley, Graham Janet, Graham Kathryn, Waterson Ashita, Jones Robert, Kurdi Amanj, Morrison David, Bennie Marion
Strathclyde Institute of Pharmacy and Biomedical Sciences, 3527University of Strathclyde, Glasgow, UK.
3529NHS Greater Glasgow & Clyde, Glasgow, UK.
Health Informatics J. 2022 Jan-Mar;28(1):14604582221077055. doi: 10.1177/14604582221077055.
The efficacy and safety of cancer medicines as reported from randomised clinical trials do not always translate into similar benefits in routine clinical practice; hence, post-marketing studies are a useful addition to the evidence base. With recent advances in digital infrastructure and the advent of electronically available health records, linkage of routinely collected data has emerged as a promising evaluation method for these studies. This paper discusses the opportunities and challenges when applying an electronic record linkage methodology with respect to systemic anti-cancer therapy by showcasing exemplar studies conducted over a three-year period in Scotland, and highlights some of the potential pitfalls spanning the entire breadth and depth of the research process. Our experiences as an interdisciplinary team indicate that there is scope to conduct large cohort studies to generate results from routine clinical practice within a reasonable time frame; however, close collaboration between researchers, data controllers and clinicians is required in order to obtain valid and meaningful results.
随机临床试验报告的癌症药物疗效和安全性在常规临床实践中并不总是能转化为类似的益处；因此，上市后研究是对证据基础的有益补充。随着数字基础设施的最新进展以及电子健康记录的出现，常规收集数据的关联已成为这些研究一种有前景的评估方法。本文通过展示在苏格兰进行的为期三年的范例研究，讨论了在应用电子记录关联方法进行全身抗癌治疗时的机遇和挑战，并强调了贯穿研究过程广度和深度的一些潜在陷阱。我们作为一个跨学科团队的经验表明，有开展大型队列研究以在合理时间内从常规临床实践中得出结果的空间；然而，为了获得有效且有意义的结果，研究人员、数据管理者和临床医生之间需要密切合作。
