Design Considerations in Embedded Pragmatic Trials: Separating Rigor from Idolatry

Gregory E. Simon, MD, MPH
Kaiser Permanente Washington Health Research Institute

ABSTRACT:
This presentation will consider specific considerations in the design and implementation of embedded pragmatic trials, including: eligibility criteria, unit of allocation, method of allocation, standardization of “active” interventions, standardization of “control” interventions, blinding, and analytic strategy. For each of these design decisions, investigators must focus on the specific study question and consider scientific rigor, practical constraints, and ethical obligations to potential study participants.