Pragmatic RCTs

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Pragmatic RCTs include patients that are treated in real-world clinical practice. The patients are allocated one of the different treatment options based on randomization.

Pragmatic RCTs can be run fairly quickly and efficiently based on existing registries. The data structure and documentation already established in the registry can be used to identify and recruit the right patients into the registry-based RCT. Compared with other RCTs, these registry-based RCTs can include patient populations relevant to everyday care, accelerate the whole study, and reduce the costs of generating high-quality evidence. However, due to the randomization, registry-based RCTs are considered interventional studies. Thus, the treatments used in these studies are not reimbursed by the SHI funds.

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