Appointments Announced to Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI)

WASHINGTON, DC (January 21, 2011) — Gene L. Dodaro, Comptroller General of the United States and head of the U.S. Government Accountability Office (GAO), today announced the appointment of 15 members to the Methodology Committee of the Patient-Centered Outcomes Research Institute (PCORI).

“The Methodology Committee has the responsibility of helping PCORI develop and update methodological standards and guidance for comparative clinical effectiveness research. The men and women named today bring impressive credentials and experience to this important task,” Dodaro said.

The Patient Protection and Affordable Care Act authorized PCORI as a non-profit corporation to assist patients, clinicians, purchasers, and policymakers in making informed health decisions by providing quality, relevant evidence on how best to prevent, diagnose, treat, and monitor diseases and other health conditions.

The Act directs the Comptroller General to appoint up to 15 members to PCORI’s Methodology Committee. In addition to the 15 members appointed today, the Director of the Agency for Healthcare Research and Quality and the Director of the National Institutes of Health, or their designees, will also serve on the committee.

The members appointed to the Methodology Committee are:

• Naomi Aronson, PhD, Executive Director, Blue Cross and Blue Shield Association Technology Evaluation Center.
• Ethan Basch, MD, MSc, medical oncologist and health services researcher, Department of Medicine and Department of Epidemiology, Memorial Sloan-Kettering Cancer Center.
• Alfred Berg, MD, MPH, Professor, Department of Family Medicine, University of Washington.
• David Flum, MD, MPH, Professor, Department of Surgery and Adjunct Professor, Department of Health Services, University of Washington Schools of Medicine and Public Health; Attending physician, General Surgery, University of Washington Medical Center.
• Sherine Gabriel, MD, MSc, Professor of Medicine and of Epidemiology, and the William J. and Charles H. Mayo Professor, Mayo Clinic.
• Steven Goodman, MD, PhD, Professor of Oncology, of Pediatrics, of Epidemiology and of Biostatistics, Johns Hopkins School of Medicine and Bloomberg School of Public Health.
• Mark Helfand, MD, MS, MPH, Professor of Medicine and of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University; Staff physician, Portland VA Medical Center.
• John Ioannidis, MD, DSc, the C.F. Rehnborg Professor in Disease Prevention, Professor of Medicine and Director, Stanford Prevention Research Center, Stanford University School of Medicine.
• David Meltzer, MD, PhD, Director, Center for Health and the Social Sciences, Chief of the Section of Hospital Medicine, and Associate Professor, Department of Medicine, Department of Economics, and Graduate School of Public Policy Studies, University of Chicago.
• Brian Mittman, PhD, Director, VA Center for Implementation Practice and Research Support, Department of Veterans Affairs Greater Los Angeles Healthcare System.
• Robin Newhouse, PhD, RN, Assistant Dean, Doctor of Nursing Practice Program and Associate Professor, Organizational Systems and Adult Health, University of Maryland School of Nursing.
• Sharon-Lise Normand, MSc, PhD, Professor of Health Care Policy, Harvard Medical School and Professor of Biostatistics, Harvard School of Public Health.
• Sebastian Schneeweiss, MD, ScD, Associate Professor, Department of Medicine, Harvard Medical School and Associate Professor, Department of Epidemiology, Harvard School of Public Health; Vice Chief and Director, Drug Evaluation and Outcomes Research, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.
• Mary Tinetti, MD, Professor of Medicine, Epidemiology, and Public Health, Division of Geriatrics, Yale University School of Medicine; Director, Program on Aging, Yale University School of Medicine.
• Clyde Yancy, MD, MSc, Chief, Cardiology, Northwestern University Feinberg School of Medicine; Associate Director, The Bluhm Cardiovascular Institute, Northwestern Memorial Hospital.

Attached are brief biographies of the new committee members. The official announcement of the appointments will be published in the Federal Register. For more information, contact Mary Giffin of GAO's Health Care team at (202) 512-7114 or Chuck Young in GAO's Office of Public Affairs at (202) 512-4800, or visit the GAO Health Care Advisory Committees web page at http://www.gao.gov/about/hcac/index.html. The Act requires the Comptroller General to disclose any conflicts of interest in appointing members of the Methodology Committee on GAO’s website. Please click here for more information.

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Following are brief biographies of the members of the PCORI Methodology Committee:

Naomi Aronson, PhD, is Executive Director of the Blue Cross and Blue Shield Association Technology Evaluation Center, a nationally recognized technology assessment program and an Evidence-based Practice Center of the Agency for Healthcare Research and Quality. Dr. Aronson has directed over 300 technology assessments and 14 evidence reports. She is a member of the Institute of Medicine Genomics Roundtable, the Chicago-Area DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Research Center’s Steering Committee, and the National Business Group on Health Committee on Evidence-Based Benefit Design. Dr. Aronson received a BA from Harpur College at State University of New York at Binghamton and a PhD in sociology from Brandeis University.

Ethan Basch, MD, MSc, is a practicing medical oncologist and health services researcher at Memorial Sloan-Kettering Cancer Center, with appointments in the Department of Medicine and in the Department of Epidemiology and Biostatistics. His research focuses on methods to use patient-reported data to evaluate the comparative effectiveness and safety of interventions. Dr. Basch is chair of the Health Outcomes Committee of the Cancer and Leukemia Group B of the National Cancer Institute (NCI), chair of the Clinical Practice Guidelines Committee of the American Society of Clinical Oncology (ASCO), and a member of ASCO’s Comparative Effectiveness Task Force. He leads the NCI’s PRO-CTCAE initiative to develop a standard system for patient-reporting of safety data in clinical trials. Dr. Basch received a BA from Brown University, an MD from Harvard Medical School, an MSc in epidemiology from Harvard School of Public Health, and an MPhil in literature from Oxford University.

Alfred Berg, MD, MPH, is Professor in the Department of Family Medicine at University of Washington. He is chair of the Institute of Medicine’s Committee on Standards for Systematic Reviews of Clinical Effectiveness Research and chair of the Panel on Evaluation of Genomic Applications in Practice and Prevention at the Centers for Disease Control and Prevention (CDC). He has served on numerous national expert panels using evidence based medicine to develop clinical guidelines, including service as chairman of the U.S. Preventive Services Task Force. Dr. Berg has also served as chair of the CDC Sexually Transmitted Disease Treatment Guidelines Panel, co-chair of AHRQ’s otitis media panel, and member of the AMA/CDC panel that produced Guidelines of Adolescent Preventive Services. Dr. Berg received a BA from Tabor College, an MD from Washington University School of Medicine, and an MPH in epidemiology from University of Washington School of Public Health and Community Medicine.

David Flum, MD, MPH, is Professor in the Department of Surgery and Adjunct Professor in the Department of Health Services at the University of Washington (UW) Schools of Medicine and Public Health. He is attending physician in General Surgery at University of Washington Medical Center. He is a co-founder and member of the Leadership Council of the UW Centers for Comparative and Health Systems Effectiveness Alliance (CHASE) and directs UW’s Surgical Outcomes Research Center. Dr. Flum’s investigations have compared interventional and noninterventional approaches for common clinical conditions such as appendicitis, peripheral vascular disease, obesity, and multiple types of cancer. He received his BA and MD from the University of Miami School of Medicine and his MPH from the University of Washington School of Public Health.

Sherine Gabriel, MD, MSc, is Professor of Medicine and of Epidemiology and the William J. and Charles H. Mayo Professor at Mayo Clinic. She has served as chair of the Department of Health Sciences Research at Mayo Clinic, which includes the divisions of Epidemiology, Health Care Policy & Research, Biomedical Informatics, and Biostatistics. Dr. Gabriel also has served as vice-chair of Mayo Clinic’s Research Committee and member of the Mayo Clinic Executive Board. She founded Mayo Clinic’s Center for Patient Oriented Research as well as clinical research training programs that later transitioned into Mayo Clinic’s Center for Translational Sciences Activities, where she serves as Co-Principal investigator. She has been president of the American College of Rheumatology (ACR) and founding chair of the ACR Quality Measures Committee. Dr. Gabriel received an MD, with distinction, from the University of Saskatchewan and an MSc in clinical epidemiology and biostatistics from McMaster University, Canada.

Steven Goodman, MD, PhD, is Professor of Oncology, Pediatrics, Epidemiology and Biostatistics, Johns Hopkins School of Medicine and Bloomberg School of Public Health. Dr. Goodman is co-chair of the Institute of Medicine’s Committee on Ethical and Scientific Aspects in Studying the Safety of Approved Drugs. He is Editor-in-chief of Clinical Trials: Journal of the Society for Clinical Trials and Associate Editor for Epidemiology and Statistics for Annals of Internal Medicine. Dr. Goodman received an AB from Harvard University, an MD from New York University School of Medicine, and an MHS in Biostatistics and PhD in Epidemiology from Johns Hopkins Bloomberg School of Public Health.

Mark Helfand, MD, MS, MPH, 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. He is founder and Director of the Oregon Evidence-Based Practice Center, and also directs the VA Evidence-Based Synthesis Program and the Scientific Resource Center for the Agency for Healthcare Research and Quality (AHRQ) Effective Health Care Program. He has been a member of the Institute of Medicine Committee on Standards for Systematic Reviews of Comparative Effectiveness Research. He is Editor-in-chief of Medical Decision Making. Dr. Helfand received an AB and BS from Stanford University, an MD and MPH from University of Illinois Medical School, and an MS in health services research from Stanford University.

John Ioannidis, MD, DSc, is the C.F. Rehnborg Professor in Disease Prevention, Professor of Medicine and Director of the Stanford Prevention Research Center at Stanford University School of Medicine. He is Adjunct Professor at the Harvard School of Public Health, and Tufts University School of Medicine and Visiting Professor at Imperial College London. Dr. Ioannidis serves on the executive board of the Human Genome Epidemiology Network and has served as president of the Society for Research Synthesis Methodology. He has been a member of the editorial boards of 26 international journals, including Lancet, Annals of Internal Medicine, PLoS Medicine, Journal of the National Cancer Institute, Journal of Clinical Epidemiology, and Clinical Trials, and is editor-in-chief of European Journal of Clinical Investigation. Dr. Ioannidis graduated from Athens College and received an MD and DSc in biopathology from the University of Athens School of Medicine.

David Meltzer, MD, PhD, is Director of the Center for Health and the Social Sciences and chief of Section of Hospital Medicine at University of Chicago. He is also Associate Professor in the Department of Medicine, Department of Economics, and Graduate School of Public Policy Studies at University of Chicago. Dr. Meltzer is chair of the Society of Hospital Medicine Research Committee. He is a research associate of the National Bureau of Economic Research and past president of the Society for Medical Decision Making. He recently served on an Institute of Medicine panel examining the effectiveness of the U.S. drug safety system and currently serves on the Health and Human Services Secretary's Advisory Committee on Healthy People 2020, which aims to establish health objectives for the U.S. population. He received a BS from Yale College, a PhD in economics from University of Chicago, and an MD from Pritzker School of Medicine at University of Chicago.

Brian Mittman, PhD, is Director, VA Center for Implementation Practice and Research Support, Department of Veterans Affairs Greater Los Angeles Healthcare System. He also serves as Senior Social Scientist of the VA/UCLA/RAND Center for the Study of Healthcare Provider Behavior. Dr. Mittman serves on the Association of American Medical Colleges Advisory Panel on Research and on the editorial board of the Agency for Healthcare Research and Quality Health Care Innovations Exchange. He chaired the planning committee that launched the journal Implementation Science and serves as Co-editor in Chief. He was a founding member of the Institute of Medicine Forum on the Science of Health Care Quality Improvement and Implementation. Dr. Mittman received a BSE (engineering) from Princeton University and a PhD in organizational behavior and management from Stanford University Graduate School of Business.

Robin Newhouse, PhD, RN, is Assistant Dean for the Doctor of Nursing Practice Program and Associate Professor, Organizational Systems and Adult Health, University of Maryland School of Nursing. She conducts randomized controlled trials and systematic reviews with research focusing on quality of care, evidence-based practice among clinicians and outcomes research in healthcare delivery systems. Dr. Newhouse has served as chair of the Johns Hopkins Nursing Evidence Based Practice Model and implemented a strategic plan for evidence-based practice and research at The Johns Hopkins Hospital. She is a peer reviewer for The Journal of Nursing Administration and for the Journal of Nursing Scholarship. Dr. Newhouse received her BS and her PhD in nursing from University of Maryland School of Nursing.

Sharon-Lise Normand, MSc, PhD, is Professor of Health Care Policy at Harvard Medical School and Professor of Biostatistics at the Harvard School of Public Health. She is Associate Editor of the American Heart Association’s journal Circulation: Cardiovascular Quality and Outcomes and she has served as Associate Editor ofStatistics in Medicine, Health Services Research and Outcomes Research Methodology, Biometrics, and Methods Editor of Psychiatric Services. Dr. Normand is a member of two Institute of Medicine (IOM) committees on Aerospace Medicine and the Medicine of Extreme Environments and on a National Surveillance System for Cardiovascular and Select Chronic Diseases. She also served on the IOM committee on Future Directions for the National Healthcare Quality and Disparities Reports. Dr. Normand received BSc and MSc degrees in statistics from University of Western Ontario and a PhD in biostatistics from University of Toronto.

Sebastian Schneeweiss, MD, ScD, is Associate Professor in the Department of Medicine at Harvard Medical School and in the Department of Epidemiology at Harvard School of Public Health. He serves as vice chief and director of Drug Evaluation and Outcomes Research for the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Dr. Schneeweiss is also director and chair of the Executive Board of the DEcIDE Research Center (Developing Evidence to Inform Decisions about Effectiveness) at Brigham and Women’s Hospital and of the DEcIDE Methods Center. His research interests include the comparative effectiveness and safety of pharmaceuticals and biotech products, and developing advanced methods for analyzing electronic healthcare databases and registries. Dr. Schneeweiss received a BA from Gymnasium Icking (Germany), an MD from Ludwig-Maximilians-University Medical School, and an ScD in Epidemiology from Harvard School of Public Health.

Mary Tinetti, MD is Professor of Medicine, Epidemiology, and Public Health in the Division of Geriatrics at Yale University School of Medicine. She also serves as Director of the Program on Aging at Yale University School of Medicine and Director for the Hartford Center of Excellence in Aging at Yale University. Dr. Tinetti served as chair of the National Institute on Aging (NIA) Advisory Council review of the NIA Gerontology and Clinical Geriatrics Program. She has been elected to the Institute of Medicine and in 2009 was named as a McArthur Foundation Fellow. Her research interests include the health effects of multiple chronic conditions, determining the relative and absolute benefits versus risks of different treatments, and identifying cross-disease health outcomes appropriate for measuring health outcomes for older adults. Dr. Tinetti received a BA from University of Michigan at Ann Arbor and an MD from University of Michigan Medical School.

Clyde Yancy, MD, MSc is Chief, Cardiology, Northwestern University Feinberg School of Medicine and Associate Director, The Bluhm Cardiovascular Institute at Northwestern Memorial Hospital. Until recently he was the Medical Director at Baylor Heart and Vascular Institute and Chief of Cardiothoracic Transplantation at Baylor University Medical Center. He co-chairs the Coalition to Reduce Racial and Ethnic Disparities in Cardiovascular Outcomes sponsored by the American College of Cardiology (ACC). He has served as President of the American Heart Association (AHA) and on the Executive Council of the Heart Failure Society of America. He is a member of the ACC Guideline Taskforce which oversees all ACC/AHA guidelines. His research interests include the emerging role of registries in cardiovascular diseases, management of advanced heart failure with new drugs and devices and heart failure in special populations. He received a BS from Southern University, an MD from Tulane University School of Medicine, and an MSc. from the University of Texas at Dallas.