Abstract
The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions actually deliver the good outcomes they promise, and the use of scientific methods to optimize care under uncertainty. Pragmatic care trials have been designed to address these problems. Care trials are all-inclusive randomized trials integrated into care. Every item of trial design is selected in the best medical interest of participating patients. Care trials can eventually show what constitutes good medical practice based on patient outcomes. In the meantime, care trials give clinicians and patients the scientific methods necessary for optimization of medical care when no one really knows what to do.We report the progress of 9 randomized care trials that were used to guide the endovascular or surgical management of 1212 patients with acute stroke, intracranial aneurysms, and arteriovenous malformations in a single center in an elective or acute care context. Care trials were used to address long-standing dilemmas regarding rival medical, surgical, or endovascular management options or to offer innovative instead of standard treatments. The trial methodology, by replacing unrepeatable treatment decisions by 1:1 randomized allocation whenever reliable knowledge was not available, had an immediate impact, transforming unverifiable dogmatic medical practice into verifiable outcome-based medical care. We believe the approach is applicable to all medical or surgical domains, but widespread adoption may require the revision of many currently prevalent views regarding the role of research in clinical practice.
Highlights
The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions deliver the good outcomes they promise, and the use of scientific methods to optimize care under uncertainty
How are we to provide reliable medical care when no one knows what to do? When and how are we to verify the results of care interventions? Clinical trials can provide a solution to these two problems, but they must be designed
Trial designs Outcome-based medical care can be defined when the results of care are rigorously assessed using scientific methods provided by clinical trials
Summary
The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions deliver the good outcomes they promise, and the use of scientific methods to optimize care under uncertainty. Trial designs Outcome-based medical care can be defined when the results of care are rigorously assessed using scientific methods provided by clinical trials.
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