Pushing Mobile Interventions Forward Seminar Series: Tze Lai, Department of Statistics, Stanford University

Cardiovascular Mobile Health, Shared Decision Making, and Stage-Wise Design of Point-of-Care Clinical Trials

We have entered a new era in the US health care system, following the health care reform legislation in 2010. Mobile health is an exciting development in this new era and offers new opportunities and challenges for disease prevention or management. Closely related is the development of tools or aids for shared decision making, which is characterized by patient and clinician partnership and joint deliberation of which treatment to adopt. Another important development, related to evidence-based treatment selection, is the design of point-of-care clinical trials to create a "learning health care system". After an overview of these developments, we focus on a trial currently being planned to compare the effectiveness of newly approved oral anticoagulants for patients with atrial fibrillation. We describe how ongoing contemporaneous technological developments in shared decision making (including Cardiovascular mHealth) and in new anticoagulants awaiting approval have led to a novel stage-wise design for point-of-care comparative effectiveness trials.