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Embedding routine health care data in clinical trials: with great power comes great responsibility
Netherlands Heart Journal ( IF 2 ) Pub Date : 2024-01-15 , DOI: 10.1007/s12471-023-01837-5
M. Louis Handoko , Frances S. de Man , Jasper J. Brugts , Peter van der Meer , Hanneke F. M. Rhodius-Meester , Jeroen Schaap , H. J. Rik van de Kamp , Saskia Houterman , Dennis van Veghel , Alicia Uijl , Folkert W. Asselbergs

Randomised clinical trials (RCTs) are vital for medical progress. Unfortunately, ‘traditional’ RCTs are expensive and inherently slow. Moreover, their generalisability has been questioned. There is considerable overlap in routine health care data (RHCD) and trial-specific data. Therefore, integration of RHCD in an RCT has great potential, as it would reduce the effort and costs required to collect data, thereby overcoming some of the major downsides of a traditional RCT. However, use of RHCD comes with other challenges, such as privacy issues, as well as technical and practical barriers. Here, we give a current overview of related initiatives on national cardiovascular registries (Netherlands Heart Registration, Heart4Data), showcasing the interrelationships between and the relevance of the different registries for the practicing physician. We then discuss the benefits and limitations of RHCD use in the setting of a pragmatic RCT from a cardiovascular perspective, illustrated by a case study in heart failure.



中文翻译:

将常规医疗保健数据嵌入临床试验:能力越大,责任越大

随机临床试验(RCT)对于医学进步至关重要。不幸的是,“传统”随机对照试验价格昂贵且速度缓慢。此外,它们的普遍性也受到质疑。常规医疗保健数据 (RHCD) 和特定试验数据有相当大的重叠。因此,将 RHCD 整合到 RCT 中具有巨大的潜力,因为它将减少收集数据所需的工作量和成本,从而克服传统 RCT 的一些主要缺点。然而,RHCD 的使用还面临其他挑战,例如隐私问题以及技术和实践障碍。在此,我们概述了国家心血管登记处的相关举措(荷兰心脏登记处、Heart4Data),展示了不同登记处之间的相互关系以及不同登记处对执业医师的相关性。然后,我们从心血管角度讨论实用性随机对照试验中使用 RHCD 的益处和局限性,并通过心力衰竭的案例研究进行说明。

更新日期:2024-01-16
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