Practicing outcome-based medical care using pragmatic care trials.
Tim E DarsautJean RaymondPublished in: Trials (2020)
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.
Keyphrases
- healthcare
- palliative care
- quality improvement
- end stage renal disease
- pain management
- affordable care act
- primary care
- clinical trial
- type diabetes
- chronic kidney disease
- metabolic syndrome
- mental health
- clinical practice
- skeletal muscle
- study protocol
- prognostic factors
- total knee arthroplasty
- peritoneal dialysis
- acute care
- electronic health record
- mass spectrometry
- patient reported outcomes
- patient reported
- replacement therapy