Case Example 1: Using Registries To Understand Rare Diseases
Betsy Bogard, M.S
Associate Director, Program Management
Genzyme Corporation
Cambridge, MA
Cathy Koepper
Associate Director, Global Registry Program
Genzyme Corporation
Cambridge, MA
John Yee, M.D., M.P.H.
Vice President, US and Global Medical Affairs
Genzyme Corporation
Cambridge, MA
Case Example 2: Creating a Registry To Fulfill Multiple Purposes and Using a Publications Committee To Review Data Requests
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Edna J. Stoehr
Global Study Manager
Genentech, Inc.
South San Francisco, CA
Case Example 3: Using a Registry To Track Emerging Infectious Diseases
Nancy A. Dreyer, M.P.H., Ph.D.
Chief of Scientific Affairs
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Laura Whiteside
Research Assistant
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 4: Using a Collaborative Approach To Plan and Implement a Registry
Laura Whiteside
Research Assistant
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 5: Using a Scientific Advisory Board To Support Investigator Research Projects
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Michael D. Taylor, Pharm.D., Ph.D.
Senior Epidemiologist
Genentech
South San Francisco, CA
Case Example 6: Determining When To Stop an Open-Ended Registry
Ann Mallard, M.P.H.
Associate Director, Registries and Health Outcomes Kendle International Inc
Wilmington, NC
Pattra Mattox, M.Sc.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 7: Designing a Registry for a Health Technology Assessment
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Hannah Patrick
Consultant Clinical Advisor to the IP Programme
National Institute for Health and Clinical Excellence (NICE)
London, United Kingdom
Case Example 8: Assessing the Safety of Products Used During Pregnancy
Deborah Covington, Dr.P.H.
Global Head Observational Studies and Pregnancy Registries
PPD
Wilmington, NC
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 9: Designing a Registry To Study Outcomes
Sidney A. Cohen, M.D., Ph.D.
Vice President, Medical Affairs
Cordis Corporation and Conor Medsystems
Menlo Park, CA
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 10: Analyzing Clinical Effectiveness and Comparative Effectiveness in an Observational Study
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Barbara Lippe, M.D.
Principal Medical Director
Genentech, Inc.
South San Francisco, CA
Case Example 11: Using a Registry To Assess Long-Term Product Safety
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
Pattra Mattox, M.Sc.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Deborah Symmons, M.D.
Professor of Rheumatology and Musculoskeletal Epidemiology
University of Manchester
Manchester, UK
Case Example 12: Using a Registry To Monitor Long-Term Product Safety
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Rachel E. Sobel, Dr.P.H.
Senior Director, Epidemiology
Pfizer
New York, NY
Case Example 13: Identifying and Responding to Adverse Events Found in a Registry Database
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Liz Paxton, M.A.
Director Kaiser Permanente National Implant Registries
Southern California Permanente Medical Group
San Diego, CA
Case Example 14: Selecting Data Elements for a Registry
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Scott McKenzie, M.D.
Regional Director Outcomes Research
Ortho Biotech Clinical Affairs LLC
Dallas, TX
Case Example 15: Using Performance Measures To Develop a Dataset
Kenneth A. LaBresh, M.D.
Senior Vice President, Chief Medical Officer
MassPRO
Waltham, MA
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Louise Morgan, M.S.N., CPHQ
National Director, Get With The Guidelines®
American Heart Association
Scotch Plains, NJ
Lee H. Schwamm, M.D.
Professor of Neurology
Harvard Medical School
Vice Chair of Neurology and Director
TeleStroke & Acute Stroke Services
Massachusetts General Hospital
Boston, MA
Kathleen Turner, M.B.A.
Formerly Senior Manager, Quality Improvement Initiatives
American Heart Association
Dallas, TX
Case Example 16: Developing and Validating a Patient-Administered Questionnaire
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
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
Case Example 17: Understanding the Needs and Goals of the Registry Participants
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
John Spertus, M.D., M.P.H., FACC, FAHA
Deputy Editor, Circulation: Cardiovascular Quality and Outcomes Research
Professor, University of Missouri – Kansas City
Clinical Director of Outcomes Research
Mid America Heart Institute of Saint Luke’s Hospital
Kansas City, MO
Case Example 18: Using Validated Measures To Collect Patient-Reported Outcomes
Kathleen M. Fox, Ph.D., M.H.S.
President
Strategic Healthcare Solutions, LLC
Monkton, MD
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 19: Integrating Data from Multiple Sources With Patient ID Matching
Noam H. Arzt, Ph.D.
President
HLN Consulting, LLC
San Diego, CA
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 20: Linking Registries at the International Level
Luigi Naldi, M.D.
Director, Centro Studi GISED
Fondazione per la Ricerca Ospedale Maggiore (FROM)
Presidio Ospedaliero Matteo Rota
Bergamo, Italy
Laura Whiteside
Research Assistant
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 21: Linking a Procedure-Based Registry With Claims Data To Study Long-Term Outcomes
Mark J. Fox
Associate Director, Account Management and Contract Administration
National Cardiovascular Data Registry
American College of Cardiology Foundation
Washington, DC
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 22: Linking Registry Data To Examine Long-Term Survival
Richard Feltbower, Ph.D.
Senior Research Fellow, Paediatric Epidemiology
GroupCentre for Epidemiology & Biostatistics, University of Leeds
Leeds, United Kingdom
Pattra Mattox, M.Sc.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Patricia McKinney, Ph.D.
Professor of Paediatric Epidemiology, Paediatric Epidemiology Group
Centre for Epidemiology & Biostatistics, University of Leeds
Leeds, United Kingdom
Roger Parslow, Ph.D.
Senior Lecturer, Paediatric Epidemiology Group
Centre for Epidemiology and Biostatistics, Leeds Institute of Genetics, Health & Therapeutics (LIGHT)
Leeds, United Kingdom
Marlous Van Laar, M.Sc.
Research Statistician, Paediatric Epidemiology Group
Centre for Epidemiology & Biostatistics, University of Leeds
Leeds, United Kingdom
Case Example 23: Considering the Institutional Review Board Process During Registry Design
Brian P. Carey, J.D.
Foley Hoag LLP
Boston, MA
Barry A. Siegel, M.D.
Professor of Radiology and Medicine
Director, Division of Nuclear Medicine
Washington University School of Medicine
St. Louis, MO
Case Example 24: Issues With Obtaining Informed Consent
Moira K. Kapral, M.D., M.Sc., FRCPC
Associate Professor of Medicine, University of Toronto
Senior Scientist, Institute for Clinical Evaluative Sciences
Ontario, Canada
Janice A. Richards, R.N., B.A.
Project Manager
Registry of the Canadian Stroke Network
Toronto, Ontario, Canada
Jack V. Tu, M.D., Ph.D.
Senior Scientist
Institute for Clinical Evaluative Sciences
Ontario, Canada
Case Example 25: Building Value as a Means To Recruit Hospitals
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Kathleen Turner, M.B.A.
Formerly Senior Manager, Quality Improvement Initiatives
American Heart Association
Dallas, TX
Case Example 26: Using Registry Tools To Recruit Sites
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 27: Using Proactive Awareness Activities To Recruit Patients for a Pregnancy Exposure Registry
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Susan Sinclair Roberts, Ph.D.
Assistant Professor, Clinical Research Program
University of North Carolina Wilmington
Wilmington, NC
Case Example 28: Using Reimbursement as an Incentive for Participation
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Kristi R. Mitchell, M.P.H.
Senior Director, Research, Development, and Quality Products
American College of Cardiology
Washington, DC
Case Example 29: Data Collection Challenges in Rare Disease Registries
Joe Thomas Clarke, M.D.
Paediatrician
Centre Hospitalier Universitaire
Sherbrooke QC, Canada
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 30: Managing Care and Quality Improvement for Chronic Diseases
Carl Donisi
Director of Clinical Operations, Physician-Hospital Organization
Tri-State Child Health Service, Cincinnati Children’s Hospital
Cincinnati, OH
Keith Mandel, M.D.
Vice President of Medical Affairs, Physician Hospital Organization
Cincinnati Children’s Hospital Medical Center
Cincinnati, OH
Pattra Mattox, M.Sc.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Randy Woodward
Senior Application Developer
Division of Emergency Medicine, Center for
Simulation and Research
Cincinnati Children’s Hospital Medical Center
Cincinnati, OH
Case Example 31: Developing a Performance-Linked Access System
Michael Karukin, P.A., Ph.D.
Director, Registries
Teva Pharmaceuticals USA
Miami, FL
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 32: Using Audits To Monitor Data Quality
Jack L. Cronenwett, M.D.
Professor of Surgery
Dartmouth-Hitchcock Medical Center
Lebanon, NH
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 33: Challenges in Creating Electronic Interfaces Between Registries and Electronic Health Records
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Kristi R. Mitchell, M.P.H.
Senior Director, Research, Development, and Quality Products
American College of Cardiology
Washington, DC
Case Example 34: Creating a Registry Interface To Incorporate Data From Multiple Electronic Health Records
Jen Moore
Senior Director, Operations
MMC Physician-Hospital Organization
Portland, ME
Laura Whiteside
Research Assistant
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 35: Technical and Security Issues of Creating a Health Information Exchange
Jenifer Hughes, MedIT
Senior Vice President, Administrative Network, Inc
Oakland Southfield Physicians, PC
Southfield, MI
Michelle Bertagna Leavy, MPH
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 36: Developing a New Model for Gathering and Reporting Adverse Events
Dan Levy, M.S.
Vice President of Engineering
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Case Example 37: Using Registry Data To Evaluate Outcomes by Practice
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA
Jeffrey Wagener, M.D.
Medical Director
Genentech, Inc.
South San Francisco, CA
Case Example 38: Using Registry Data To Study Patterns of Use and Outcomes
Marnie L. Boron, Pharm.D
Associate Director, Medical Affairs
MedImmune, Inc.
Gaithersburg, MD
Michelle Bertagna Leavy, M.P.H.
Research Associate
Outcome Sciences, Inc. d/b/a Outcome
Cambridge, MA

From: Case Example Contributors

Cover of Registries for Evaluating Patient Outcomes: A User's Guide
Registries for Evaluating Patient Outcomes: A User's Guide. 2nd edition.
Gliklich RE, Dreyer NA, editors.

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