Randomized Quality Improvement (RQI) trials integrate randomization into routine healthcare improvements to generate strong evidence on interventions’ effectiveness.
Despite potential benefits, RQI trials are infrequently conducted due to uncertainties about applying ethical principles and regulatory frameworks.
A novel, fit-for-purpose ethical oversight framework balances the need for careful justification and monitoring with pragmatic conduct of RQI trials, particularly when informed consent is impractical.
Implementing standardized randomization, data registration, and analysis systems can enable routine use of RQI trials to optimize care quality continuously.
