Why the study?
Traditional RCTs are expensive, inherently slow, and face generalisability challenges, whereas integrating routine health care data has potential to overcome these limitations despite accompanying technical, practical, and privacy challenges.
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Design
Review and case study
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Integrating routine health care data into pragmatic RCTs can reduce costs and effort, though it presents privacy and technical challenges.
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.
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Handoko et al. (2024) studied this question.
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