Are Observational Studies Any Good?

• Activity Number: 521
• Type: Roundtables
• Date/Time: Wednesday, August 6, 2014 : 12:30 PM to 1:50 PM
• Sponsor: Health Policy Statistics Section
• Author(s): David Madigan*+
• Companies: Columbia University
• Keywords: epidemiology ; observational data ; drug safety ; healthcare

Abstract

Observational health care data, such as administrative claims and electronic health records, play an increasingly prominent role in health care. Pharmacoepidemiologic studies in particular routinely estimate temporal associations between medical product exposure and subsequent health outcomes of interest, and such studies influence prescribing patterns and health care policy more generally. Some authors have questioned the reliability and accuracy of such studies, but few efforts have attempted to measure their performance. The Observational Medical Outcomes Partnership (OMOP, http://omop.org) conducted a series of experiments to empirically measure the performance of various observational study designs with regard to predictive accuracy for discriminating between true drug effects and negative controls. I will describe past work of the partnership, explore opportunities to expand the use of observational data to further our understanding of medical products, and highlight areas for future research and development.