Haase Christoffer Bjerre, Bearman Margaret, Brodersen John, Hoeyer Klaus, Risor Torsten
Department of Public Health, University of Copenhagen, Denmark.
Centre for Research in Assessment and Digital Learning (CRADLE), Deakin University, Australia.
Scand J Public Health. 2021 Feb;49(1):33-36. doi: 10.1177/1403494820980268. Epub 2020 Dec 18.
In three days at the beginning of the COVID-19 pandemic, the Copenhagen Emergency Medical Services developed a digital diagnostic device. The purpose was to assess and triage potential COVID-19 symptoms and to reduce the number of calls to public health-care helplines. The device was used almost 150,000 times in a few weeks and was described by politicians and administrators as a solution and success. However, high usage cannot serve as the sole criterion of success. What might be adequate criteria? And should digital triage for citizens by default be considered low risk?
This paper reflects on the uncertain aspects of the performance, risks and issues of accountability pertaining to the digital diagnostic device in order to draw lessons for future improvements. The analysis is based on the principles of evidence-based medicine (EBM), the EU and US regulations of medical devices and the taxonomy of uncertainty in health care by Han et al.
Lessons for future digital devices are (a) the need for clear criteria of success, (b) the importance of awareness of other severe diseases when triaging, (c) the priority of designing the device to collect data for evaluation and (d) clear allocation of responsibilities.
A device meant to substitute triage for citizens according to its own criteria of success should not by default be considered as low risk. In a pandemic age dependent on digitalisation, it is therefore important not to abandon the ethos of EBM, but instead to prepare the ground for new ways of building evidence of effect.
在新冠疫情开始的三天内，哥本哈根紧急医疗服务部门开发了一种数字诊断设备。其目的是评估和分流潜在的新冠症状，并减少拨打公共医疗保健热线的电话数量。该设备在几周内被使用了近15万次，政治家和管理人员将其描述为一种解决方案和成功案例。然而，高使用率不能作为成功的唯一标准。哪些标准可能是合适的呢？默认情况下，为公民进行数字分流是否应被视为低风险呢？
本文反思了与数字诊断设备相关的性能、风险和问责问题的不确定方面，以便为未来的改进吸取教训。分析基于循证医学（EBM）原则、欧盟和美国的医疗器械法规以及Han等人提出的医疗保健不确定性分类法。
对未来数字设备的教训包括：（a）需要明确的成功标准；（b）分流时认识到其他严重疾病的重要性；（c）设计设备以收集评估数据的优先性；（d）明确责任分配。
一种旨在根据自身成功标准替代公民分流的设备，默认情况下不应被视为低风险。在一个依赖数字化的大流行时代，因此重要的是不要摒弃循证医学的理念，而是要为建立效果证据的新方法奠定基础。
