May 22 2019 Journal Editor Perspectives Joseph S Ross MD MHS Section of General Internal Medicine School of Medicine Center for Outcomes Research and Evaluation YaleNew Haven Hospital Associate Editor JAMA Internal Medicine ID: 788980
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Digital Health Learning & Clinical Effectiveness Research Collaboratives
May 22, 2019
Journal Editor Perspectives
Joseph S. Ross, MD, MHS
Section of General Internal Medicine, School of Medicine
Center for Outcomes Research and Evaluation, Yale-New Haven HospitalAssociate Editor, JAMA Internal MedicineFormer Deputy Editor, Journal of General Internal Medicine
Slide2Source: Grady, Redberg and O’Malley JAMA Internal Medicine
2018;178:187.
Slide3Observational Research Studies
Studies using data from clinical registries, administrative claims, electronic health recordsIncreasingly, 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.
Slide4Special Considerations
Generalizability: Single system vs. multiple systemsWhat can be learned from single system evaluations?
Intervention and Control Groups: How defined?Accounting for non-random treatment allocationEffectiveness 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.