Journal Editor Perspectives Digital Health Learning & Clinical Effectiveness Research Collaboratives Journal Editor Perspectives May 22, 2019 Joseph S. Ross, MD, MHS Section of General Internal Medicine, School of Medicine Center for Outcomes Research and Evaluation, Yale-New Haven Hospital Associate Editor, JAMA Internal Medicine Former Deputy Editor, Journal of General Internal Medicine

Source: Grady, Redberg and O’Malley JAMA Internal Medicine 2018;178:187.

Observational Research Studies Studies using data from clinical registries, administrative claims, electronic health records Increasingly, medical product evaluations … … but also quality improvement studies, health system innovations, policy evaluations, and more. Source: Corrigan-Curay et. al., JAMA 2018;320:867-868. Califf et. al., NEJM 2016;375:2395-2400.

Special Considerations Generalizability: Single system vs. multiple systems What can be learned from single system evaluations? Intervention and Control Groups: How defined? Accounting for non-random treatment allocation Effectiveness and Safety Endpoints: How ascertained? Codes accurate and clinically meaningful? Over what period of follow-up? Negative “control” endpoint? Study protocol / registration? Public pre-specification of data source; inclusion/exclusion criteria; primary, secondary and safety endpoints; and statistical analysis plan.