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Gliklich RE, Dreyer NA, editors. Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition. Rockville (MD): Agency for Healthcare Research and Quality (US); 2010 Sep.

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Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition.

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[The findings and conclusions in this document are those of the contributors and reviewers. The contributors and reviewers participated as individuals and not necessarily as representatives of their organizations. No statement in this document should be construed as an official position of any organization represented here.]

Chapter 1. Patient Registries
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Janet Hiller, M.P.H., Ph.D.
Professor of Public Health
Director, Adelaide Health Technology Assessment (AHTA)
University of Adelaide
Adelaide, Australia
Chapter 2. Planning a Registry
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Patrice Desvigne-Nickens, M.D.
Medical Officer
Heart Failure and Arrhythmia Branch
Division of Cardiovascular Science
National Heart, Lung, and Blood Institute
Bethesda, MD
Paul Eggers, Ph.D.
Program Director for Kidney and Urology Epidemiology
National Institute of Diabetes and Digestive and Kidney Diseases
Bethesda, MD
Gregg C. Fonarow, M.D.
Professor of Medicine/Cardiology
Director, Ahmanson-UCLA Cardiomyopathy Center
Associate Chief, UCLA Division of Cardiology
The Eliot Corday Chair in Cardiovascular Medicine and Science
David Geffen School of Medicine at UCLA
Los Angeles, CA
Catherine Koepper
Associate Director, Global Registry Program
Genzyme Corporation
Cambridge, MA
Bruce C. Marshall, M.D.
Vice President of Clinical Affairs
Cystic Fibrosis Foundation
Bethesda, MD
Hugh Tilson, M.D., Dr.P.H.
Adjunct Professor of Epidemiology, Health Policy, and Public Health Leadership
University of North Carolina School of Public Health
Chapel Hill, NC
Adjunct Professor of Medicine
Duke University
Durham, NC
John Yee, M.D., M.P.H.
Vice President, US and Global Medical Affairs
Genzyme Corporation
Cambridge, MA
Section of Chapter 2:Planning for the End of a Registry
Susan Adams, J.D.
Director, Committee for the Protection of Human
Subjects
Dartmouth College
Hanover, NH
Nancy A. Dreyer, M.P.H., Ph.D.
Chief of Scientific Affairs
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Leslye K. Fitterman, Ph.D.
Centers for Medicare & Medicaid Services
Baltimore, MD
Richard E. Gliklich, M.D.
President
Outcome Sciences, Inc. d/b/a Outcome
Principal Investigator, Outcome DEcIDE Center
Professor, Harvard Medical School
Cambridge, MA
Rosemarie Hakim, Ph.D.
Senior Epidemiologist
Centers for Medicare & Medicaid Services
Baltimore, MD
Steven E. Nissen, M.D.
Chairman, Department of Cardiovascular Medicine
Cleveland Clinic
Cleveland, OH
Steve E. Phurrough, M.D., M.P.A.
Medical Officer
Agency for Healthcare Research and Quality
Rockville, MD
Anne E. Trontell, M.D., M.P.H.
Program Director, Centers for Education and Research on Therapeutics
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
Rockville, MD
Chapter 3. Registry Design
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Paul Eggers, Ph.D.
Program Director for Kidney and Urology Epidemiology
National Institute of Diabetes and Digestive and Kidney Diseases
Bethesda, MD
Sarah Garner, Ph.D., B.Pharm., M.R.Pharm.S
Associate Director, Research and Development
National Institute for Health and Clinical Excellence (NICE)
London, United Kingdom
Rosemarie Hakim, Ph.D.
Senior Epidemiologist
Centers for Medicare & Medicaid Services
Baltimore, MD
Kenneth J. Rothman, Dr.P.H.
Vice President, Epidemiology Research
RTI Health Solutions
Research Triangle Park, NC
Chapter 4. Use of Registries in Product Safety Assessment
Jeffrey Brown, Ph.D.
Research Director, Therapeutics Research and Infectious Disease Epidemiology Program
Lecturer, Department of Population Medicine
Harvard Pilgrim Health Care Institute/Harvard Medical School
Boston, MA
Leslye K. Fitterman, Ph.D.
Centers for Medicare & Medicaid Services
Baltimore, MD
Richard E. Gliklich, M.D.
President
Outcome Sciences, Inc. d/b/a Outcome
Principal Investigator, Outcome DEcIDE Center
Professor, Harvard Medical School
Cambridge, MA
Thomas Gross, M.D., M.P.H.
Deputy Director, Postmarket Science
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
Joanna Haas, M.D., M.Sc.
Vice President, Global Patient Safety and Risk Management
Genzyme Corporation
Cambridge, MA
Michael Ibara, Pharm.D.
Head of Pharmacovigilance Information Management
Pfizer, Inc.
New York, NY
Steven E. Nissen, M.D.
Chairman, Department of Cardiovascular Medicine
Cleveland Clinic
Cleveland, OH
Richard Platt, M.D., M.Sc.
Professor and Chair, Department of Population Medicine
Harvard Medical School and Harvard Pilgrim Health Care Institute
Boston, MA
Kenneth J. Rothman, Dr.P.H.
Vice President, Epidemiology Research
RTI Health Solutions
Research Triangle Park, NC
Juergen Schmider M.D., Ph.D.
Corporate Safety Officer and Vice President, Global
Pharmacovigilance & Epidemiology Cephalon, Inc.
Frazer, PA
Chapter 5. Data Elements for Registries
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Gregg C. Fonarow, M.D.
Professor of Medicine/Cardiology
Director, Ahmanson-UCLA Cardiomyopathy Center
Associate Chief, UCLA Division of Cardiology
The Eliot Corday Chair in Cardiovascular Medicine and Science
David Geffen School of Medicine at UCLA
Los Angeles, CA
Janet Hiller, M.P.H., Ph.D.
Professor of Public Health
Director, Adelaide Health Technology Assessment (AHTA)
University of Adelaide
Adelaide, Australia
Robert Reynolds, Sc.D.
Senior Director, Global Head, Epidemiology Safety and Risk Management
Pfizer, Inc.
New York, NY
Chapter 6. Data Sources for Registries
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Marcus D. Wilson, Pharm.D.
President
HealthCore
Wilmington, DE
Chapter 7. Linking Registry Data: Technical and Legal Considerations
Rachel S. Dokholyan, M.P.H.
Project Leader
Duke Clinical Research Institute
Durham, NC
Nancy A. Dreyer, M.P.H., Ph.D.
Chief of Scientific Affairs
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Richard E. Gliklich, M.D.
President
Outcome Sciences, Inc. d/b/a Outcome
Principal Investigator, Outcome DEcIDE Center
Professor, Harvard Medical School
Cambridge, MA
Thomas Gross, M.D., M.P.H.
Deputy Director, Postmarket Science
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
Julia I. Lane
National Science Foundation
Washington, DC
Lawrence Muhlbaier, Ph.D.
Duke Clinical Research Institute
Durham, NC
Eric Peterson, M.D., M.P.H.
Physician Investigator
Duke Clinical Research Institute
Durham, NC
Victoria M. Prescott, J.D.
CEO
McBroom Consulting, LLC
Tampa, FL
Gerald F. Riley, M.S.P.H.
Social Science Research Analyst
Office of Research, Development, and Information
Centers for Medicare & Medicaid Services
Baltimore, MD
Anne E. Trontell, M.D., M.P.H.
Program Director, Centers for Education and Research on Therapeutics
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
Rockville, MD
Cunlin Wang, M.D., Ph.D.
Medical Epidemiologist, Center for Device and Radiological Health
Food and Drug Administration
Silver Spring, MD
Assistant Professor
Johns Hopkins Medical Institutions
Baltimore, MD
Marcy Wilder, J.D.
Partner
Hogan & Hartson LLP
Washington, DC
Chapter 8. Principles of Registry Ethics, Data Ownership, and Privacy
Stephen W. Bernstein, J.D.
Head, Health Industry Practice Group
McDermott Will & Emery LLP
Boston, MA
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Steve E. Phurrough, M.D., M.P.A.
Medical Officer
Agency for Healthcare Research and Quality
Rockville, MD
Chapter 9. Recruiting and Retaining Participants in the Registry
Pamela S. Douglas, M.D., FACC
Ursula Geller Professor of Research in Cardiovascular Diseases
Director of Imaging Program at Duke Clinical Research Institute
Duke University
Durham, NC
Gregg C. Fonarow, M.D.
Professor of Medicine/Cardiology
Director, Ahmanson-UCLA Cardiomyopathy Center
Associate Chief, UCLA Division of Cardiology
The Eliot Corday Chair in Cardiovascular Medicine and Science
David Geffen School of Medicine at UCLA
Los Angeles, CA
Bruce C. Marshall, M.D.
Vice President of Clinical Affairs
Cystic Fibrosis Foundation
Bethesda, MD
Charles R. McKay, M.D., FACC
Professor of Medicine, Chief, Division of Cardiology
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, CA
Kristi R. Mitchell, M.P.H.
Senior Director, Research, Development, and Quality Products
American College of Cardiology
Washington, DC
Grannum R. Sant, M.D., FRCS, FACS
Vice President and Interim Head,
Oncology Medical Unit,
Head of Urology Portfolio
Sanofi-aventis U.S.
Bridgewater, NJ
Adjunct Professor of Urology, Tufts University School of Medicine
Boston, MA
Chapter 10. Data Collection and QualityAssurance
Daniel Caños
Epidemiologist, Division of Epidemiology
Office of Surveillance and Biometrics
Center for Devices and Radiological Health,
Food and Drug Administration
Silver Spring, MD
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Brenda K. Edwards, Ph.D.
Associate Director, Surveillance Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Bethesda, MD
Robert Reynolds, Sc.D.
Senior Director, Global Head, Epidemiology Safety and Risk Management
Pfizer, Inc.
New York, NY
Chapter 11. Interfacing Registries with Electronic Health Records
Susan Adams, J.D.
Director, Committee for the Protection of Human Subjects
Dartmouth College
Hanover, NH
Nancy A. Dreyer, M.P.H., Ph.D.
Chief of Scientific Affairs
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Jonathan S. Einbinder, M.D., M.P.H.
Brigham and Women’s Hospital
Boston, MA
Thomas Gross, M.D., M.P.H.
Deputy Director, Postmarket Science
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
John D. Halamka, M.D., M.S.
Beth Israel Deaconess Medical Center
Harvard Medical School
New England Health Electronic Data Interchange Network (NEHEN)
MA-SHARE
U.S. Healthcare Information Technology Standards Panel (HITSP)
Boston, MA
Michael A. Ibara
Head of Pharmacovigilance Information Management
Pfizer, Inc.
New York, NY
Rebecca D. Kush, Ph.D.
President and CEO
Clinical Data Interchange Standards Consortium (CDISC)
Austin, TX
Steve E. Phurrough, M.D., M.P.A.
Medical Officer
Agency for Healthcare Research and Quality
Rockville, MD
Michael T. Rapp, M.D., J.D., FACEP
Centers for Medicare & Medicaid Services
Baltimore, MD
Anne E. Trontell, M.D., M.P.H.
Program Director, Centers for Education and Research on Therapeutics
Center for Outcomes and Evidence
Agency for Healthcare Research and Quality
Rockville, MD
Chapter 12. Adverse Event Detection, Processing, and Reporting
Thomas Gross, M.D., M.P.H.
Deputy Director, Postmarket Science
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
Susan T. Sacks, Ph.D.
Director, Epidemiology
Roche Biometrics
Nutley, NJ
Chapter 13. Analysis and Interpretation of Registry Data To Evaluate Outcomes
Steve E. Phurrough, M.D., M.P.A.
Medical Officer
Agency for Healthcare Research and Quality
Rockville, MD
Rosemarie Hakim, Ph.D.
Senior Epidemiologist
Centers for Medicare & Medicaid Services
Baltimore, MD
Chapter 14. Evaluating Registries
Peter Littlejohns, M.D.
Clinical and Public Health Director
National Institute for Health and Clinical Excellence (NICE)
London, UK
Suzanne L. West, M.P.H, Ph.D.
Health, Social, and Economics Research
RTI International
Research Triangle Park, NC

We would also like to acknowledge the reviewers who contributed to the first version of the user’s guide. These reviewers are listed below in alphabetical order.

Steven J. Atlas, M.D., M.P.H.
Assistant Professor of Medicine
Harvard Medical School
Associate Physician, General Medicine Division
Massachusetts General Hospital
Boston, MA
Stephen W. Bernstein, J.D.
Head, Health Industry Practice Group
McDermott Will & Emery LLP
Boston, MA
Michael A. Carome, M.D.
Captain, U.S. Public Health Service
Associate Director for Regulatory Affairs
Office for Human Research Protections
Rockville, MD
Patrice Desvigne-Nickens, M.D.
Medical Officer
Heart Failure and Arrhythmia Branch
Division of Cardiovascular Science
National Heart, Lung, and Blood Institute
Bethesda, MD
Brenda K. Edwards, Ph.D.
Associate Director, Surveillance Research Program
Division of Cancer Control and Population Sciences
National Cancer Institute
Bethesda, MD
John P. Fanning, LL.B.
Retired
Washington, D.C.
Shamiram Feinglass, M.D., M.P.H.
Senior Medical Officer
Coverage and Analysis Group
Office of Clinical Standards and Quality
Centers for Medicare & Medicaid Services
U.S. Public Health Service
Baltimore, MD
Sally Flanzer, Ph.D., CIP
Regional Program Manager, Child Welfare
Administration for Children and Families Region IX
San Francisco, CA
Formerly Human Protections Administrator
Office of Extramural Research, Education and Priority Populations
Agency for Healthcare Research and Quality
Rockville, MD
Gregg C. Fonarow, M.D.
Professor of Medicine/Cardiology
Director, Ahmanson-UCLA Cardiomyopathy Center
Associate Chief, UCLA Division of Cardiology
The Eliot Corday Chair in Cardiovascular Medicine and Science
David Geffen School of Medicine at UCLA
Los Angeles, CA
Sarah Garner, Ph.D., B.Pharm., M.R.Pharm.S.
Associate Director, Research and Development
National Institute for Health and Clinical Excellence (NICE)
London, United Kingdom
Marie R. Griffin, M.D., M.P.H.
Professor of Preventive Medicine
Professor of Medicine
Vanderbilt University School of Medicine
Nashville, TN
Thomas Gross, M.D., M.P.H.
Deputy Director, Postmarket Science
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
Rockville, MD
Stephen C. Hammill, M.D.
Professor of Medicine
Mayo Clinic College of Medicine
Director, Electrocardiography Laboratory
Rochester, MN
Christina Heide
Senior Health Information Privacy Policy Specialist
Office for Civil Rights
U.S. Department of Health and Human Services
Washington, D.C.
Janet Hiller, M.P.H., Ph.D.
Professor of Public Health
Director, Adelaide Health Technology Assessment (AHTA)
University of Adelaide
Adelaide, Australia
Peter I. Juhn, M.D., M.P.H.
President
Therapeutic Resource Centers
Medco Health Solutions, Inc.
Franklin Lakes, NJ
Catherine Koepper
Associate Director, Global Registry Program
Genzyme Corporation
Cambridge, MA
Joseph A. Ladapo, M.D., Ph.D.
Beth Israel Deaconess Medical Center
Boston, MA
Peter Littlejohns, M.D.
Clinical and Public Health Director
National Institute for Health and Clinical Excellence (NICE)
London, UK
Susan McAndrew, J.D.
Deputy Director for Health Information Privacy
Office for Civil Rights
U.S. Department of Health and Human Services
Washington, D.C.
Newell McElwee, Pharm.D., M.S.P.H.
Senior Director/Team Leader
Global Outcomes Research
Pfizer, Inc.
New York, NY
J. Michael McGinnis, M.D., M.P.P.
Senior Scholar
Institute of Medicine
National Academy of Sciences
Washington, DC
Gareth Parry, Ph.D.
Director, Quality Measurement & Analysis
Department of Medicine
Children’s Hospital
Boston, MA
Steven Pearson, M.D.
Associate Professor of Ambulatory Care and Prevention
Harvard Medical School
Boston, MA
Robert Reynolds, Sc.D.
Senior Director, Global Head, Epidemiology Safety and Risk Management
Pfizer, Inc.
New York, NY
Sara Rosenbaum, J.D.
Hirsh Professor and Chair, Department of Health Policy
The George Washington University Medical Center
School of Public Health and Health Services
Washington, DC
Kenneth J. Rothman, Dr.P.H.
Vice President, Epidemiology Research
RTI Health Solutions
Research Triangle Park, NC
Susan T. Sacks, Ph.D.
Director, Epidemiology
Roche Biometrics
Nutley, NJ
Grannum R. Sant, M.D., FRCS, FACS
Vice President and Interim Head, Oncology Medical Unit, Head of Urology Portfolio
Sanofi-aventis U.S.
Bridgewater, NJ
Adjunct Professor of Urology, Tufts University School of Medicine
Boston, MA
William B. Saunders, Ph.D., M.P.H.
Manager, Research & Analytics
GE Medical
Charlotte, NC
Walter L. Straus, M.D., M.P.H.
Global Director for Scientific Affairs - Vaccines
Merck Research Laboratories
Adjunct Scholar, Center for Clinical Epidemiology and Biostatistics
University of Pennsylvania School of Medicine
Upper Gwynedd, PA
Hugh Tilson, M.D., Dr.P.H.
Adjunct Professor of Epidemiology, Health Policy, and Public Health Leadership
University of North Carolina School of Public Health
Chapel Hill, NC
Adjunct Professor of Medicine
Duke University
Durham, NC
Jack V. Tu, M.D., Ph.D.
Senior Scientist
Institute for Clinical Evaluative Sciences
Ontario, Canada
Suzanne L. West, M.P.H, Ph.D.
Research Associate Professor
Department of Epidemiology
School of Public Health
University of North Carolina at Chapel Hill
Chapel Hill, NC
Marcus D. Wilson, Pharm.D.
President
HealthCore
Wilmington, DE

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