Real-world experiences with generating real-world evidence: Case Studies from PCORI's pragmatic clinical Studies program.

Background: Over the last decade, randomized studies evaluating outcomes of health care interventions conducted in real-world settings-often termed "pragmatic trials"-have come to be seen as an important means of obtaining relevant, actionable evidence to guide health care decisions. Despite extensive writing on methodological considerations in pragmatic trial design, limited information exists regarding the practical and logistical challenges encountered in carrying out rigorous randomized evaluations in highly representative, real-world contexts.

Methods: The Patient Centered Outcomes Research Institute (PCORI) convened an expert panel in 2017 to examine common tradeoffs in study design and implementation through 3 "case studies" of in-progress, PCORI-funded pragmatic trials.