PCORI Methodology Standards: Categories 3, 4, & 5 — Data Integrity, Preventing and Handling Missing Data, and Heterogeneity of Treatment Effects

This CME activity has expired. You may still view the program content, however, you will not be able to obtain CME/CE credit.

Faculty Biographies & Disclosures

Mark Helfand, M.D., M.S., M.P.H., is Professor of Medicine and Professor of Medical Informatics and Clinical Epidemiology at the Oregon Health & Science University. He is board-certified in Internal Medicine and practices hospital medicine at the Portland VA Medical Center, where he is a staff physician and directs the VA Evidence-Based Synthesis Program Coordinating Center. He directs the Scientific Resource Center for the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program and, in 2014, was named the director of the new West Coast Branch of the US Cochrane Center. He was Editor-in-chief of Medical Decision Making from 2005 to 2012. Dr. Helfand received an A.B. and B.S. from Stanford University, an M.D. and M.P.H. from University of Illinois Medical School, and an M.S. in health services research from Stanford University.

Disclosure: Consultant for Consumer Reports Best Buy Drugs.

Sharon-Lise Normand, Ph.D., is Professor of Health Care Policy (Biostatistics) in the Department of Health Care Policy at Harvard Medical School and Professor in the Department of Biostatistics at the Harvard School of Public Health. Together with Dr. Fred Resnic, Lahey Hospital & Medical Center, she co-directs the MDEpiNet Methodology Center where statistical methodology for assessing medical device safety and effectiveness is developed and applied. Dr. Normand's research focuses on the development of statistical methods for health services and outcomes research, primarily using Bayesian approaches, including the evaluation of medical devices in randomized and non-randomized settings for both pre- and post-market assessments, causal inference, provider profiling, evidence synthesis, item response theory, and latent variables analyses. Her application areas include cardiovascular disease, severe mental illness, hip degeneration, and medical technology diffusion. She served on several task forces for the American Heart Association and the American College of Cardiology, was a consultant to the U.S. Food and Drug Administration's Circulatory System Devices Advisory Panel after serving a four-year term on the panel, was a member of the Medicare Evidence Development and Coverage Advisory Committee, and is Director of Mass-DAC, a data coordinating center that monitors the quality of all adult cardiac surgeries and coronary interventions in all Massachusetts' acute care hospitals. Dr. Normand was the 2010 President of the Eastern North American Region of the International Biometrics Society and the first Vice Chair of the Patient Centered Outcomes Research Institute's Methodology Committee (2010–2012).

Dr. Normand earned her Ph.D. in Biostatistics from the University of Toronto. She holds a Masters of Science degree and a Bachelor of Science degree in Statistics, and completed a post-doctoral fellowship in Health Care Policy at Harvard Medical School. She is a Fellow of the American Statistical Association, a Fellow of the American College of Cardiology, a Fellow of the American Heart Association, and an Associate of the Society of Thoracic Surgeons. In 2011, Dr. Normand was awarded the American Statistical Association Health Policy Statistics Section's Long Term Excellence Award; in 2012, the American Heart Association's Distinguished Scientist Award; and in 2013 she was elected to the Society for Research Synthesis Methodology.

Disclosure: Nothing to disclose.