Thursday, May 17
08:15 – 09:00
Comparative Effectiveness Research: Implications for Practice and Policy
Michael Lauer, MD, FACC
Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute
Comparative effectiveness research (or “CER”) is the type of clinical research that most directly impacts clinical practice and/or public policy. We can understand what CER is by focusing on the three letters: “C” stands for comparison, contest, or choice among existing options for diagnosis, prevention, monitoring, or management of medical conditions; “E” stands for effectiveness, meaning outcomes relevant to patients (such as mortality, morbidity, or quality of life) or health care systems within real-world settings; and “R” stands for research, meaning randomized trials, observational studies, or systematic syntheses of existing research. CER has drawn much attention recently because of its explicit inclusion in the 2009 American Recovery and Reinvestment Act (ARRA) and the 2010 Affordable Care Act, which led to the formation of the non-governmental, non-profit Patient-Centered Outcomes Research Institute (“PCORI”). CER has also drawn controversy, as some have criticized it of creating “death panels” that would lead to the withholding of expensive health services from patients.
Despite the recent attention, CER is in fact nothing new. Critical physicians and policy makers have noted for many years (centuries in fact) that doctors often adopt technologies and services in the absence of rigorous scientific evidence. Examples among many include bloodletting, anti-arrhythmic drugs, hormone-replacement therapy, bone marrow transplantation for metastatic breast cancer, anti-oxidant vitamins to prevent cancer, and intracranial stents after stroke. In each of these cases, rigorous large-scale comparative effectiveness trials were need to evaluate value. In other cases, rigorous CER trials established value: examples include revascularization for acute myocardial infarction, and more recently helical CT for lung cancer screening. CER is the center of a number of policy questions, including prioritization, role of stakeholders, governance, implementation, role of observational data, and incorporation of personalized medicine.
Michael S Lauer, MD, has served as Director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute since October 14, 2009. Dr. Lauer is a cardiologist and clinical epidemiologist noted for his work on diagnostic testing, clinical manifestations of autonomic nervous system dysfunction, and clinical comparative effectiveness. Dr. Lauer received a BS in biology from the Rensselaer Polytechnic Institute and an MD from Albany Medical College; he also participated in the Program in Clinical Effectiveness at the Harvard School of Public Health. He received post-graduate training at Massachusetts General Hospital, Boston's Beth Israel Hospital, and the Framingham Heart Study. Prior to coming to the NIH, Dr. Lauer was a Professor of Medicine, Epidemiology, and Biostatistics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University and a Contributing Editor for JAMA (Journal of the American Medical Association). He is an elected member of the American Society of Clinical Investigation and won the Ancel Keys Award of the American Heart Association in 2008. In 2010, he won the NIH Equal Employment Opportunity (EEO) Award of the Year.