National Academies Press: OpenBook

Observational Studies in a Learning Health System: Workshop Summary (2013)

Chapter: Appendix A: Biographies of Workshop Speakers

« Previous: 8 Common Themes for Progress
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Appendix A

Biographies of Workshop Speakers

Peter Bach, MD, MAPP, holds research interests in health care policy, particularly as it relates to Medicare, racial disparities in cancer care quality, and the epidemiology of lung cancer. His research examining quality of care for Medicare beneficiaries has demonstrated that blacks do not receive care that is of as high a quality as that received by whites when they are diagnosed with lung cancer and that the aptitude and resources of primary care physicians who treat blacks are inferior to those of primary care physicians who primarily treat whites. In 2007, he was the senior author of a study demonstrating that care in Medicare is highly fragmented, with the average beneficiary seeing multiple primary care physicians and specialists. His work in lung cancer epidemiology has focused on the development and utilization of lung cancer prediction models that can be used to determine what lung cancer events that populations of elderly smokers will experience over a period of time. His health care policy analysis includes investigations into Medicare’s approaches to cancer payment, as well as the development of models of alternative reimbursement, payment systems, and coverage policies. He is funded by grants from the National Institute of Aging, a contract from the National Cancer Institute, and philanthropic sources. He formerly served as a senior adviser to the administrator of the Centers for Medicare & Medicaid Services (CMS). He serves on several national committees, including the Institute of Medicine’s National Cancer Policy Forum and the Committee on Performance Measurement of the National Committee on Quality Assurance. He chairs the Technical Expert Panel that is developing measures of cancer care quality for CMS. Along with publishing in medical literature, Bach’s opinion pieces have appeared in numerous

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

lay news outlets, including the New York Times , the Wall Street Journal, Forbes Online , and National Public Radio.

Anirban Basu, PhD, is an associate professor in the departments of health services, pharmacy, and economics at the University of Washington, Seattle, and directs the Program in Health Economics and Outcomes Methodology there. He is also a faculty research fellow at the National Bureau of Economic Research. Dr. Basu received his MS in biostatistics from the University of North Carolina at Chapel Hill in 1999 and his PhD in public policy from the University of Chicago in 2004. Dr. Basu works at the interface of microeconomics, statistics, and health policy. His work has enriched the theoretical foundations of comparative and cost-effectiveness analyses. He has developed innovative methods to study heterogeneity in clinical and economic outcomes in order to establish the value of individualized care. His works have appeared in many leading peer-reviewed journals, including Journal of Health Economics, Health Economics, PharmacoEconomics, Statistics in Medicine, Biostatistics, Medical Decision Making , and others. Dr. Basu is an associate editor for both Health Economics and the Journal of Health Economics and has taught courses on health economics, decision analysis, cost-effectiveness analysis, and health services research methods. He has received numerous recognitions for his work throughout his career: the NARSAD Wodecroft Young Investigator Award (2005), the Research Excellence Award for Methodological Excellence (2007), and the Bernie O’Brien New Investigator Award (2009) from the International Society for Pharmacoeconomics and Outcomes Research, the Alan Williams Health Economics Fellowship (2008) from the University of York, United Kingdom, and the Labelle Lectureship in Health Economics (2009) from McMaster University, Canada.

Robert M. Califf, MD, Vice Chancellor for Clinical and Translational Research, director of the Duke Translational Medicine Institute (DTMI), and professor of medicine in the Division of Cardiology at Duke University Medical Center in Durham, North Carolina, leads a multifaceted organization that seeks to transform how scientific discoveries are translated into improved health outcomes. Before leading DTMI, he was the founding director of the Duke Clinical Research Institute, one of the nation’s premier academic research organizations. He is editor in chief of the American Heart Journal , the oldest cardiovascular specialty journal, and a practicing cardiologist at Duke University Medical Center.

Mary E. Charlson, MD, is the William T. Foley Distinguished Professor in Medicine, the executive director of the Center for Integrative Medicine and the chief of the Division of Clinical Epidemiology and Evaluative Sci-

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

ences Research at Weill Medical College of Cornell University/New York Presbyterian Hospital. She is also the program chairperson for the master of science program in clinical epidemiology and health services research and director of the Agency for Healthcare Research and Quality. Dr. Charlson is an international leader in the measurement and improvement of risk-adjusted outcomes and developed a method of assessing the prognostic impact of comorbid conditions; the Charlson Comorbidity Index, which is one of the most widely utilized measurements in chronic disease. She is the principal investigator of the National Heart, Lung, and Blood Institute Small Changes and Lasting Effects, a randomized trial aimed to reduce weight among overweight/obese Black and Latino adults living primarily in Harlem and the South Bronx, through small changes in eating behavior and physical activity. She is co—principal investigator of the National Institute on Minority Health and Health Disparities’ Center for Excellence in Health Disparities Research and Community Engagement, which conducts health disparities research. Dr. Charlson received her MD from Yale University School of Medicine. After completing her residency at Johns Hopkins Hospital, she was a Robert Wood Johnson Clinical Scholar at Yale.

Mark R. Cullen, MD, is professor of medicine and chief of the Division of General Medical Disciplines at Stanford University. Trained in internal medicine and occupational health, he has devoted his research career to the study of the role of work, including social, physical, and economic dimensions, in the evolution of chronic disease, disability, and death. The focus of early work was the impact of physical and chemical hazards, including metals, solvents, and mineral dusts. In 1997, he was invited to join the Macarthur Foundation Research Network on Socioeconomic Status and Health. During the same year he entered into a long-term research agreement with Alcoa, a multinational aluminum producer, to study the determinants of health in Alcoa’s large stable workforce, for which exceptionally rich environmental, social, economic, and medical data were available; this has formed the basis of the multidisciplinary Alcoa study, which now includes researchers and trainees in medical and social sciences at a dozen academic institutions and which is primarily supported by funds from the National Institutes of Health. To date, the study has generated some 40 publications and about a dozen doctoral theses. In addition to this long-standing project, Dr. Cullen has embarked on the study of determinants of differences in premature mortality by race, sex, and geography both in U.S. counties and globally. Another new area of research involves development of methods to assess the impact of social and physical environments in large population studies to better understand how these factors, along with genetics, contribute to the risk for the development of chronic disease. Dr. Cullen is a faculty research fellow of the National Bureau of Economic Research

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

and was elected to the Institute of Medicine of the National Academy of Sciences in 1997.

Mitchell H. Gail, MD, PhD, is a senior investigator in the Biostatistics Branch of the Division of Cancer Epidemiology and Genetics, National Cancer Institute. He received an MD from Harvard Medical School and a PhD in statistics from George Washington University. His work at the National Cancer Institute included studies on the motility of cells in tissue culture; clinical trials of lung cancer treatments and preventive interventions for gastric cancer; and assessment of cancer biomarkers, AIDS epidemiology, and models to project the risk of breast cancer. Dr. Gail’s current research interests include statistical methods for the design and analysis of epidemiological studies, including studies of genetic factors, and models to predict the absolute risk of disease. Dr. Gail is a fellow and former president of the American Statistical Association and a member of the Institute of Medicine of the National Academy of Sciences.

Steven N. Goodman, MD, MHS, PhD, is associate dean for clinical and translational research and professor of medicine and health policy and research at the Stanford University School of Medicine. Before joining Stanford in 2011, Dr. Goodman was professor of oncology in the division of biostatistics of the Johns Hopkins Kimmel Cancer Center, with appointments in the departments of pediatrics, biostatistics, and epidemiology in the Johns Hopkins Schools of Medicine and Public Health. At Johns Hopkins he was co-director of the epidemiology doctoral program for 7 years and led two major curriculum design efforts. He is the editor of Clinical Trials: Journal of the Society for Clinical Trials and senior statistical editor for the Annals of Internal Medicine , where he has been since 1987. He has served on a wide range of Institute of Medicine committees, including Agent Orange and Veterans, Immunization Safety, Treatment of PTSD in Veterans, and most recently co-chaired the Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs. Dr. Goodman served on the Surgeon General’s committee to write the 2004 report on the Health Consequences of Smoking. He is a scientific advisor to the Medical Advisory Panel of the National Blue Cross/Blue Shield Technology Evaluation Center, and in 2011 was appointed by the Government Accountability Office to the Methodology Committee of the Patient-Centered Outcomes Research Institute. Dr. Goodman received a BA from Harvard, an MD from New York University, trained in pediatrics at Washington University in St. Louis, obtaining board certification, and received an MHS in biostatistics and PhD in epidemiology from Johns Hopkins University. He writes and teaches on evidence evaluation and inferential, methodological, and ethi-

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

cal issues in clinical research, epidemiology, and comparative effectiveness research.

Joel B. Greenhouse, PhD, is professor of statistics at Carnegie Mellon University and adjunct professor of psychiatry and epidemiology at the University of Pittsburgh. He is a fellow of the American Statistical Association and of the American Association for the Advancement of Science and an elected member of the International Statistical Institute. Dr. Greenhouse has been a member of the National Academy of Sciences’ Committee on National Statistics, the Institute of Medicine’s Committee on the Assessment of Family Violence Interventions, and the National Research Council’s Panel on Statistical Issues for Research in the Combination of Information. He is an editor of the journal Statistics in Medicine and is a past editor of the Institute of Mathematical Statistics’ Lecture Notes and Monograph Series . His research interests include methods for the analysis of data from longitudinal and observational studies and methods for clinical trials. Dr. Greenhouse is also interested in issues related to the use of research synthesis in practice, especially as it is used to synthesize evidence for scientific discovery and for making policy.

Miguel A. Hernán, MD, DrPH, is a professor for the departments of epidemiology and biostatistics, Harvard School of Public Health, and an affiliated faculty member of the Harvard—Massachusetts Institute of Technology Division of Health Sciences and Technology. He is the editor of Epidemiology , associate editor of the Journal of the American Statistical Association and the American Journal of Epidemiology , principal investigator of the HIVCAUSAL Collaboration (a consortium of prospective studies of human immunodeficiency virus [HIV]-infected individuals from Europe and the United States), and a fellow of the American Association for the Advancement of Science. He writes and teaches on methodology for causal inference, including comparative effectiveness of policy and clinical interventions. His applied research interests include the optimal use of antiretroviral therapy for HIV disease, clinical strategies to reduce mortality after kidney failure, and lifestyle and pharmacologic interventions to reduce the incidence of cardiovascular disease. He served on the Institute of Medicine’s Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs and currently serves on the National Research Council’s Committee to Review the IRIS Process.

Mark A. Hlatky, MD, is professor of health research and policy and professor of medicine (cardiovascular medicine) at Stanford University. He is a cardiologist with major research interests in clinical research methods, outcomes research, and clinical trials. Dr. Hlatky has participated in several

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

large, multicenter randomized clinical trials, including studies of coronary revascularization, treatment of acute myocardial infarction, hormone therapy to prevent cardiovascular disease, and management of life-threatening ventricular arrhythmias. He has also conducted large outcomes research studies of the comparative effectiveness of coronary revascularization procedures and of drug treatments for heart disease. He is currently studying methods for assessing how the effectiveness of treatments is modified by patient characteristics and how to apply these methods to personalize treatment recommendations. Dr. Hlatky has served on numerous national advisory panels and clinical guideline committees and is the associate editor of the Journal of the American College of Cardiology.

Ralph I. Horwitz, MD, MACP, is senior vice president for clinical evaluation sciences and senior advisor to the chairman of research and development at GlaxoSmithKline (GSK), and Harold H. Hines, Jr. Professor Emeritus of medicine and epidemiology at Yale University. Dr. Horwitz trained in internal medicine at institutions (Royal Victoria Hospital of McGill University and the Massachusetts General Hospital) where science and clinical medicine were connected effortlessly. These experiences as a resident unleashed a deep interest in clinical research training that he pursued as a fellow in the Robert Wood Johnson Clinical Scholars Program at Yale under the direction of Alvan R. Feinstein. He joined the Yale faculty in 1978 and remained there for 25 years as co-director of the Clinical Scholars Program and later as chair of the department of medicine. Before joining GSK, Dr. Horwitz was chair of medicine at Stanford University and dean of Case Western Reserve Medical School. He is an elected member of the Institute of Medicine of the National Academy of Sciences; the American Society for Clinical Investigation; the American Epidemiological Society; and the Association of American Physicians (he was president in 2010). He was a member of the advisory committee to the National Institutes of Health director (under both Elias Zerhouni and Francis Collins). Dr. Horwitz served on the American Board of Internal Medicine and was chairman in 2003. He is a master of the American College of Physicians.

Eloise E. Kaizar, PhD, is associate professor of statistics at The Ohio State University. She received a doctorate in statistics from Carnegie Mellon University in 2006. Her primary research focus is on assessing the efficacy and safety of medical interventions, especially those whose effects are heterogeneous across populations or that are measured with rare event outcomes. As such, she has worked on a methodology to combine multiple sources of information relevant to, but perhaps containing different kinds of information about, the same broad policy or patient-centered question. She is particularly interested in how data collected via different study

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

designs (randomized trials, administrative data, or sample surveys) can contribute complementary information. Dr. Kaizar also examines statistical methodology to identify and verify subpopulations for whom treatment is particularly effective and safe. Her work has appeared in a variety of journals, including Statistics in Medicine and the Journal of the American Statistical Association.

Michael W. Kattan, MBA, PhD, is chairman of the Department of Quantitative Health Sciences at The Cleveland Clinic and professor of medicine, epidemiology, and biostatistics at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University. Dr. Kattan has a PhD in management information systems with a minor in statistics. He also holds an MBA with a concentration in quantitative sciences. Following his studies, he completed a postdoctoral program in medical informatics before joining the faculty at the Baylor College of Medicine in Houston, Texas. He has published more than 350 peer-reviewed publications and is best known for his prediction models, called nomograms, in various cancers. He has received two patents for this work and serves on the editorial boards for Cancer Investigation and Nature Clinical Practice Urology . Dr. Kattan is interested in the development, validation, and use of prediction models. He has developed several such models in cancer and released them as freely available software from www.nomograms.org. Dr. Kattan is also interested in quality-of-life assessment to support medical decision making, such as utility assessment. Other interests include decision analysis and cost-effectiveness analysis.

David M. Kent, MD, MSc, is director of the clinical and translational science (CTS) MS/PhD program at the Sackler School of Graduate Biomedical Sciences at Tufts University and associate professor of medicine, neurology, and CTS at the Tufts Medical Center/Tufts University School of Medicine. A general internist, Dr. Kent is a clinician-methodologist most interested in the problems of making inferences to individual patients based on effects measured in groups. He has a broad background in clinical epidemiology with a focus on predictive modeling in cardiovascular and cerebrovascular disease, as well as experience in meta-analytic approaches, particularly individual patient data (IPD) meta-analysis. Dr. Kent has substantial experience leading collaborative projects involving the secondary analysis of large clinical trial databases. Prior federally funded work involving IPD meta-analysis includes predictive modeling to balance patient-specific risks and benefits for thrombolytics in acute stroke, a project that pooled data from 6 clinical trials, and for coronary reperfusion therapy, which combined 10 databases. Dr. Kent is also the principal investigator (PI) of the National Institute of Neurological Disorders and Stroke—sponsored Risk of Paradoxi-

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

cal Embolism Study, pooling 12 observational databases to create predictive models to be applied to 3 on-going clinical trials. His research also addresses fundamental analytic issues in how to employ a risk-modeling approach to clinical trial analysis, and he is currently the PI of a Patient-Centered Outcomes Research Institute—funded methods project in this area.

Michael Lauer, MD, is the director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health. In this position, Dr. Lauer provides leadership for the institute’s national program for research on the causes, prevention, and treatment of cardiovascular (basic, clinical, population, and health sciences) diseases. Dr. Lauer joined NHLBI in July 2007. Dr. Lauer’s primary research interests include cardiovascular clinical epidemiology and comparative effectiveness, with a focus on diagnostic testing. He also has a strong background in leadership of the cardiovascular community and longstanding interests in medical editing—for 7 years he was a contributing editor for the Journal of the American Medical Association —and human subjects protection. Prior to joining NHLBI, Dr. Lauer served as the director of the Cleveland Clinic Foundation Exercise Laboratory and vice chair of the clinic’s institutional review board. He also served as co-director of the Coronary Intensive Care Unit and director of clinical research in the clinic’s department of cardiology. Dr. Lauer earned his BS in biology, summa cum laude, from Rensselaer Polytechnic Institute in 1983 and his MD, magna cum laude, from Albany Medical College in 1985. Following internal medical training at the Massachusetts General Hospital, Harvard Medical School, he completed a clinical fellowship in cardiology at the Boston Beth Israel Hospital, Harvard Medical School. His further training in epidemiology included a research fellowship at the NHLBI’s Framingham Heart Study, Boston University; the program in clinical effectiveness, Harvard School of Public Health, Harvard University; and the Program for Physician Educators, Harvard Macy Institute. Dr. Lauer is an elected fellow of the American College of Cardiology and American Heart Association (AHA), and has been elected to membership in the American Society for Clinical Investigation. He also served as chairman of the Exercise, Cardiac Rehabilitation, and Prevention Committee of AHA’s Council of Clinical Cardiology, and has received numerous awards in recognition of his scientific and teaching accomplishments.

J. Michael McGinnis, MD, MPP, is a physician, epidemiologist, and longtime contributor to national and international health programs and policy. An elected member of the Institute of Medicine (IOM) of the National Academy of Sciences, he has since 2005 also served as IOM senior scholar and executive director of the IOM Roundtable on Value & Science-Driven

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Health Care. He founded and stewards the IOM’s Learning Health System initiative and, in prior posts, also served as founding leader for the Robert Wood Johnson Foundation’s (RWJF’s) Health Group, the World Bank/ European Commission Task Force for Health Reconstruction in Bosnia, and, in the U.S. government, the Office of Research Integrity, the Nutrition Policy Board, and the Office of Disease Prevention and Health Promotion. In the last post, he held continuous policy responsibilities for prevention through four administrations (those of Presidents Jimmy Carter, Ronald Reagan, George H. W. Bush, and Bill Clinton), during which he conceived and launched a number of initiatives of ongoing policy importance, including the Healthy People national goals and objectives, the U.S. Preventive Services Task Force, the Dietary Guidelines for Americans, and development of the Ten Essential Services of Public Health. At RWJF, he founded the Health & Society Scholars program, the Young Epidemiology Scholars program, and the Active Living family of programs. Early in his career he served in India as an epidemiologist and state director for the World Health Organization’s Smallpox Eradication Program. Widely published, he has made foundational contributions to understanding the basic determinants of health (e.g., “Actual Causes of Death,” Journal of the American Medical Association 270:18, 1993, and “The Case for More Active Policy Attention to Health Promotion,” Health Affairs 21:2, 2002). National leadership awards include the Arthur S. Flemming Award, the Distinguished Service Award for public health leadership, the Health Leader of the Year Award, and the Public Health Hero Award. He has held visiting or adjunct professorships at George Washington University, the University of California, Los Angeles (UCLA), Princeton University, and Duke University. He is a graduate of the University of California, Berkeley, the UCLA School of Medicine, and the John F. Kennedy School of Government at Harvard University and was the graduating commencement speaker at each.

Sally C. Morton, PhD, is professor and chair of biostatistics and director of the Comparative Effectiveness Research Core at the University of Pittsburgh. Previously, she was vice president for statistics and epidemiology at RTI International and head of the RAND Corporation Statistics Group. Her research interests include the use of statistics in evidence-based medicine, particularly meta-analysis. She serves as a statistical expert for the Patient-Centered Outcomes Research Institute Methodology Committee and as an evidence synthesis expert for Agency for Healthcare Research and Quality Evidence-Based Practice Centers. She has been a member of several Institute of Medicine committees on comparative effectiveness research, geographic variations in Medicare and systematic reviews, and serves on the National Academy of Sciences’ Committee on National Statistics. She received a PhD in statistics from Stanford University.

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Cynthia D. Mulrow, MD, MSc, MACP, is senior deputy editor of the Annals of Internal Medicine and clinical professor of medicine at the University of Texas Health Science Center at San Antonio. She has been a program director of the Robert Wood Johnson Foundation Generalist Physician Faculty Scholars Program and director of the San Antonio Cochrane Collaboration Center and the San Antonio Evidence-Based Practice Center. She was elected to the American Society of Clinical Investigation in 1997, honored as a master of the American College of Physicians in 2005, and elected to the Institute of Medicine in 2008. Dr. Mulrow’s academic work followed several themes, including systematic reviews, evidence synthesis, practice guidelines, research methodology, and chronic medical conditions. Early in her career, she published the article “The Medical Review Article: State of the Science” (Annals of Internal Medicine 106:485–488, 1987). She followed it with publication of a series of articles in the Annals of Internal Medicine and a book, Systematic Reviews and Synthesis of Best Evidence for Health Care Decisions . She also authored several information syntheses and technology reports and served on several guideline panels, including the U.S. Preventive Services Task Force. She currently contributes to three groups that set standards for reporting research: PRISMA (systematic reviews and meta-analyses), STROBE (observational studies), and CONSORT (clinical trials).

Richard Platt, MD, MS, is professor and chair of the Harvard Medical School department of population medicine at the Harvard Pilgrim Health Care Institute, Boston, Massachusetts. He is the principal investigator of the Food and Drug Administration Mini-Sentinel program, of a Centers for Disease Control and Prevention (CDC) Prevention Epicenter, a CDC Center of Excellence in Public Health Informatics, and an Agency for Healthcare Research and Quality DEcIDE center. He is a member of the Institute of Medicine Roundtable on Value & Science-Driven Health Care and co-chair of its Clinical Effectiveness Research Innovation Collaborative. He is also a member of the American Association of Medical Colleges Advisory Panel on Research.

Patrick Ryan, PhD, is the head of epidemiology analytics at Johnson &Johnson Pharmaceutical Research and Development, where he has leading efforts to develop and apply analysis methods to better understand the effects of medical products. He also currently serves as a research investigator of the Observational Medical Outcomes Partnership, a public—private partnership chaired by the Food and Drug Administration. As part of this effort, he is conducting methodological research to assess the appropriate use of observational health care data to identify and evaluate drug safety issues.

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Sebastian Schneeweiss, MD, ScD, is professor of medicine and epidemiology at Harvard Medical School and vice chief of the Division of Pharmacoepidemiology and Pharmacoeconomics of the Department of Medicine, Brigham and Women’s Hospital (BWH). He is principal investigator of the BWH DEcIDE Research Center on Comparative Effectiveness Research and the DEcIDE Methods Center, both funded by Agency for Healthcare Research and Quality, and director of the Harvard-Brigham Drug Safety Research Center, funded by the Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA). His research is funded by multiple National Institutes of Health grants and focuses on the comparative effectiveness and safety of biopharmaceuticals and analytic methods to improve the validity of epidemiological studies through the use of complex health care databases, particularly for newly marketed medical products. His work is published in high-ranking journals and was featured in Discover magazine. Dr. Schneeweiss is past president of the International Society for Pharmacoepidemiology and is a fellow of the American College of Epidemiology, the American College of Clinical Pharmacology, and the International Society for Pharmacoepidemiology. He is a voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and a member of the Methods Committee of the Patient-Centered Outcomes Research Institute. He received his medical training at the University of Munich Medical School and a doctoral degree in pharmacoepidemiology from Harvard University.

Joe V. Selby, MD, MPH, is the first executive director of the Patient-Centered Outcomes Research Institute (PCORI). A family physician, clinical epidemiologist, and health services researcher, he has more than 35 years of experience in patient care, research, and administration. He will identify strategic issues and opportunities for PCORI and implement and administer programs authorized by the PCORI Board of Governors. Building on the work of the board and interim staff, Dr. Selby will lead the organizational development of PCORI, which was established by Congress through the 2010 Patient Protection and Affordable Care Act. In addition to creating an organizational structure to carry out a national research agenda, Dr. Selby will lead PCORI’s external communications, including work to establish effective two-way communication channels with the public and stakeholders about PCORI’s work. Dr. Selby joined PCORI from Kaiser Permanente, Northern California, where he was director of the division of research for 13 years and oversaw a department of more than 50 investigators and 500 research staff working on more than 250 ongoing studies. He was with Kaiser Permanente for 27 years. An accomplished researcher, Dr. Selby has authored more than 200 peer-reviewed articles and continues to conduct research, primarily in the areas of diabetes outcomes and qual-

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

ity improvement. His publications cover a spectrum of topics, including effectiveness studies of colorectal cancer screening strategies; treatment effectiveness, population management, and disparities in diabetes mellitus; and primary care delivery and quality measurement. Dr. Selby was elected to membership in the Institute of Medicine in 2009 and was a member of the Agency for Healthcare Research and Quality study section for Health Care Quality and Effectiveness from 1999 to 2003. A native of Fulton, Missouri, Dr. Selby received his medical degree from Northwestern University and his master’s in public health from the University of California, Berkeley. He was a commissioned officer in the Public Health Service from 1976 to 1983 and received the Commissioned Officer’s Award in 1981. He serves as lecturer in the department of epidemiology and biostatistics at the University of California, San Francisco, School of Medicine, and as a consulting professor, health research and policy at the Stanford University School of Medicine.

Burton Singer, PhD, MS, is adjunct professor in the Emerging Pathogens Institute and department of mathematics at the University of Florida. From 1993 to July 2009, he was the Charles & Marie Robertson Professor of Public and International Affairs at Princeton University. He has served as chair of the National Research Council’s Committee on National Statistics and as chair of the Steering Committee for Social and Economic Research in the World Health Organization Tropical Disease Research program. He has centered his research in three principal areas: identification of social, biological, and environmental risks associated with vector-borne diseases in the tropics; integration of psychosocial and biological evidence to characterize pathways to alternative states of health; and health impact assessments associated with economic development projects. He was elected to the National Academy of Sciences (1994) and the Institute of Medicine of the National Academy of Sciences (2005) and was a Guggenheim Fellow in 1981–1982. He received his PhD in statistics from Stanford University in 1967.

Jean R. Slutsky, PA, MS, has directed the Center for Outcomes and Evidence (COE), Agency for Healthcare Research and Quality (AHRQ) of the U.S. Department of Health and Human Services since June 2003. Prior to Ms. Slutsky’s appointment as director of COE, she served as acting director of the Center for Practice and Technology Assessment at AHRQ. In 2005, Ms. Slutsky implemented a comparative-effectiveness research program that includes evidence synthesis, evidence gap analysis, evidence generation, and evidence translation and implementation. The Effective Health Care Program is authorized under Section 1013 of the Medicare Modernization Act. Ms. Slutsky oversees several outcomes and effectiveness research ac-

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

tivities, including the Evidence-Based Practice Center program, Technology Assessment Program, extramural and intramural research portfolios concerning translating research into practice, pharmaceutical outcomes, and cost-effectiveness analyses, and the National Guideline, Quality Measures, and Health Care Innovations Exchange Clearinghouses. She is a member of the AcademyHealth Methods Council and a member of the Methods Committee of the Patient-Centered Outcomes Research Institute. Prior to becoming acting director of the Center for Practice and Technology Assessment, Ms. Slutsky served as project director of the U.S. Preventive Services Task Force, an internationally recognized panel of experts who make evidence-based recommendations on clinical preventive services. Ms. Slutsky received a BS (general science) at the University of Iowa and an MS in public health (health policy and administration) from the University of North Carolina at Chapel Hill and trained as a physician assistant at the University of Southern California.

Dylan Small, PhD, received a bachelor’s degree in mathematics from Harvard University and a PhD degree in statistics from Stanford University. His dissertation was about instrumental variables regression, and his adviser Tze Leung Lai. Dr. Small started as an assistant professor in 2002 in the Department of Statistics of the Wharton School of the University of Pennsylvania. He was promoted to associate professor in 2008. Dr. Small’s main areas of research interest are the following: design and analysis of experiments and observational studies for comparing treatments, policies, and programs; causal inference; measurement error; longitudinal data; and applications of statistics to improving health.

Harold Sox, MD, is a general internist and editor emeritus of the Annals of Internal Medicine . Dr. Sox spent most of his professional life at Stanford University and the Geisel School of Medicine at Dartmouth, the latter as chair of the department of medicine, and he is now associate director for faculty of The Dartmouth Institute for Health Policy and Clinical Practice. He chaired the U.S. Preventive Services Task Force, the Medicare Coverage Advisory Committee, and the Institute of Medicine’s (IOM’s) Committee to Set Priorities for Comparative Effectiveness Research. He was president of the American College of Physicians. He is a member of the IOM of the National Academy of Sciences. His books include Medical Decision Making , a standard textbook in this field.

Nicholas Tatonetti, PhD, joined the faculty at Columbia University in the department of biomedical informatics, Columbia Initiative in Systems Biology, and department of medicine in September 2012. His lab at Columbia is focused on expanding on his previous work at Stanford University in detect-

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

ing drug effects and drug interactions from large-scale observational clinical data. Widely published in both clinical and bioinformatics, Dr. Tatonetti is passionate about the integration of hospital data (stored in electronic health records) and high-dimensional biological data (captured using next-generation sequencing, high-throughput screening, and other “omics” technologies). His lab develops the algorithms, techniques, and methods for analyzing enormous and diverse data by designing rigorous computational and mathematical approaches that address the fundamental challenges of observational analysis—bias and confounding. Foremost, they integrate medical observational with systems and chemical biology models to not only explain clinical observations but also to further our understanding of basic biology and human disease. Dr. Tatonetti has been featured as a rising star in the fields of computational biology and biomedical informatics by the New York Times , Genome Web, and Science Careers. His work as been picked up by the mainstream media and generated hundreds of news articles.

William S. Weintraub, MD, FACC, joined Christiana Care Health System in Delaware as cardiology section chief in 2005, after retiring from Emory University as professor emeritus of medicine and public health. Currently, Dr. Weintraub supervises the clinical, educational, research, and administrative activities of 20 full-time and 43 private-practice cardiologists as well as 15 cardiology fellows. He supervises busy interventional, noninvasive, and electrophysiology laboratories as well as an active heart failure service, spanning inpatient and outpatient care. Dr. Weintraub also holds appointments as professor of medicine at Jefferson University and professor of health sciences (adjunct) at the University of Delaware. Dr. Weintraub also leads the Christiana Care Center for Outcomes Research and is on the Research Committee and Coordinating Council of the Delaware Health Sciences Alliance. Dr. Weintraub was the first chairman of the National Cardiovascular Data Registry of the American College of Cardiology (ACC) and remains on the management board. Dr. Weintraub has also served on the American Heart Association (AHA) Database Executive Committee. He is the incoming chair of the AHA/ACC Task Force on Data Standards. Dr. Weintraub has also worked on multiple randomized clinical trials. These activities afforded him extensive experience participating in and leading multi-institutional research activities. Dr. Weintraub has specialized knowledge and skill in health status assessment and health care economics. He leads a $10 million innovation award from the Centers for Medicare & Medicaid Services to use advanced information technology and patient management to coordinate inpatient and outpatient care. In addition to extensive AHA and ACC committee activity, Dr. Weintraub has served on the ACC Board of Trustees and is currently president of the AHA

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

Great Rivers Affiliate. His multiple activities have focused on quality and outcomes of care, and he has deep experience in developing and assessing metrics to evaluate quality and outcomes.

John B. Wong, MD, FACP, is the chief of the Division of Clinical Decision Making, Informatics, and Telemedicine in the department of medicine of Tufts Medical Center and the Clinical and Translational Science Institute of the Tufts University School of Medicine and a practicing general internist. He is a past president of the Society for Medical Decision Making, the statistical editor in decision and cost-effectiveness analysis for the Annals of Internal Medicine at the American College of Physicians, co-director of the Tufts Evidence-Based Practice Center, and co-chair of the Methods Workgroup of the National Clinical Translational Sciences Award Strategic Goal Committee on Comparative Effectiveness Research. In addition to serving on study sections for the Agency for Healthcare Research and Quality and the National Institutes of Health, Dr. Wong has been a member of guideline committees for the American Association for the Study of Liver Disease Practice, the European League Against Rheumatism, OMERACT (Outcome Measures in Rheumatology), and the American College of Chest Physicians Antithrombotic Therapy. He has been the course director for evidence-based medicine at the Tufts University School of Medicine, the fellowship codirector for the National Library of Medicine—sponsored fellowship training program in medical informatics at Tufts Medical Center, and the medical informatics concentration leader for the Clinical Research Graduate Program of the Tufts University Sackler School of Biomedical Sciences. Dr. Wong’s research focuses on the application of decision analysis to help patients, physicians, and policy makers choose among alternative tests, treatments, and policies and to promote rational evidence-based efficient and effective patient-centered care, reflecting individualized risk assessment and patient preferences. Dr. Wong received an MD from the University of Chicago and had postgraduate training in internal medicine at Tufts Medical Center.

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×

This page intentionally left blank.

Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 85
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 86
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 87
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 88
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 89
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 90
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 91
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 92
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 93
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 94
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 95
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 96
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 97
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 98
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 99
Suggested Citation:"Appendix A: Biographies of Workshop Speakers." Institute of Medicine. 2013. Observational Studies in a Learning Health System: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/18438.
×
Page 100
Next: Appendix B: Workshop Agenda »
Observational Studies in a Learning Health System: Workshop Summary Get This Book
×
Buy Paperback | $40.00 Buy Ebook | $31.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

Clinical research strains to keep up with the rapid and iterative evolution of medical interventions, clinical practice innovation, and the increasing demand for information on the clinical effectiveness of these advancements. In response to the growing availability of archived and real-time digital health data and the opportunities this data provides for research, as well as the increasing number of studies using prospectively collected clinical data, the Institute of Medicine's Roundtable on Value & Science-Driven Health Care convened a workshop on Observational Studies in a Learning Health System. Participants, including experts from a wide range of disciplines - clinical researchers, statisticians, biostatisticians, epidemiologists, health care informaticians, health care analytics, research funders, health products industry, clinicians, payers, and regulators - explored leading edge approaches to observational studies, charted a course for the use of the growing health data utility, and identified opportunities to advance progress. Workshop speakers and individual participants strove to identify stakeholder needs and barriers to the broader application of observational studies.

Observational Studies in a Learning Health Systemis the summary of the workshop. This report explores the role of observational studies in the generation of evidence to guide clinical and health policy decisions. The report discusses concepts of rigorous observational study design and analysis, emerging statistical methods, and opportunities and challenges of observational studies to complement evidence from experimental methods, treatment heterogeneity, and effectiveness estimates tailored toward individual patients.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!