← Registries for Evaluating Patient Outcomes: A User's Guide

Contributors and Reviewers

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Contributors and Reviewers

Contributors

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 Coordinator

1. Patient Registries

*Richard E. Gliklich, M.D.

Chief Executive Officer and Chairman

OM1

Boston, MA

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1

Boston, MA

2. Planning a Registry

Thomas Gross, M.D., M.P.H.

Director, Office of Surveillance and Biometrics

Center for Devices and Radiological Health

U.S. Food and Drug Administration

Silver Spring, MD

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1

Boston, MA

3. Registry Design

Nancy A. Dreyer, Ph.D., M.P.H., FISPE

Chief Scientific Officer

IQVIA Real-World & Analytic Solutions

Cambridge, MA

Hesha J. Duggirala, Ph.D., M.P.H.

Senior Epidemiologist, Office of Surveillance and Compliance

Center for Veterinary Medicine

U.S. Food and Drug Administration

Silver Spring, MD

*Vandana Menon, M.D.

Vice President, Research

OM1

Boston, MA

4. Selecting and Defining Outcome Measures for Registries

Richard E. Gliklich, M.D.

Chief Executive Officer and Chairman

OM1

Boston, MA

*Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1

Boston, MA

5. Data Elements for Registries

Irene Katzan, M.D., M.S.

Director, Neurological Institute Center for Outcomes Research & Evaluation

Cleveland Clinic Foundation

Cleveland, OH

*Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1

Boston, MA

Christina Mack, Ph.D., M.S.P.H.

Sr. Director, Epidemiology and Clinical Evidence; Head, Injury Surveillance and Analytics

IQVIA Real-World & Analytic Solutions

Chapel Hill, NC

John Spertus, M.D., M.P.H., FACC, FAHA

Director of CV Education and Outcomes Research

Saint Luke's Hospital

Kansas City, MS

6. Data Sources

Fang Li, M.D.

Formerly Sr. Director, Clinical Informatics

OM1

Boston, MA

*Keith Marsolo, Ph.D.

Associate Professor, Department of Population Health Sciences

Member, Duke Clinical Research Institute

Duke University School of Medicine

Durham, NC

7. Principles of Registry Ethics, Data Ownership, and Privacy

*Jiayan Chen, J.D.

Partner

McDermott Will & Emery LLP

Washington, DC

Andy DeMayo, J.D.

Senior Counsel and Head, Strategic Partnerships

OM1

Boston, MA

Deepali Doddi, J.D.

Associate

McDermott Will & Emery LLP

Chicago, IL

Scott A. Weinstein, J.D.

Partner

McDermott Will & Emery LLP

Washington, DC

*Jessica Berg, J.D., M.P.H.

Dean, School of Law; Tom J.E. and Bette Lou Walker Professor of Law; Professor of Bioethics & Public Health

Case Western Reserve University

Cleveland, OH

9. Registry Governance

*Nancy A. Dreyer, Ph.D., M.P.H., FISPE

Chief Scientific Officer

IQVIA Real-World & Analytic Solutions

Cambridge, MA

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1

Boston, MA

10. Recruiting and Retaining Participants in the Registry

*Richard E. Gliklich, M.D.

Chief Executive Officer and Chairman

OM1

Boston, MA

Ralph G. Brindis, M.D., M.P.H., MACC, FSCAI

Clinical Professor of Medicine, Department of Medicine & the Philip R. Lee Institute for Health Policy Studies

University of California, San Francisco

Senior Medical Officer, External Affairs – ACC National Cardiovascular Registry

San Francisco, CA

Robert E. Harbaugh, M.D., FAANS, FACS, FAHA

Senior Vice President, Penn State Health; Distinguished Professor and Chair, Department of Neurosurgery; Professor, Department of Engineering Science and Mechanics

Penn State University, M.S. Hershey Medical Center

Hershey, PA

11. Obtaining Data and Quality Assurance

*Keith Marsolo, Ph.D.

Associate Professor in Population Health Sciences

Duke University School of Medicine

Durham, NC

Richard E. Gliklich, M.D.

Chief Executive Officer and Chairman

OM1

Boston, MA

12. Adverse Event Detection, Processing, and Reporting

Nancy A. Dreyer, M.P.H., Ph.D.

Chief Scientific Officer

IQVIA Real-World & Analytic Solutions

Cambridge, MA

Richard E. Gliklich, M.D.

Chief Executive Officer and Chairman

OM1

Boston, MA

*Marnie Hall, Ph.D., M.P.H., M.A.

Vice President, Center for Advanced Evidence Generation

IQVIA

Washington, DC

13. Analysis, Interpretation, and Reporting of Registry Data To Evaluate Outcomes

Nancy A. Dreyer, M.P.H., Ph.D.

Chief Scientific Officer

IQVIA Real-World & Analytic Solutions

Cambridge, MA

*Zhaohui Su, Ph.D.

Vice President, Biostatistics

OM1

Boston, MA

14. Assessing Quality

Nancy A. Dreyer, M.P.H., Ph.D.

Chief Scientific Officer

IQVIA Real-World & Analytic Solutions

Cambridge, MA

Richard E. Gliklich, M.D.

Chief Executive Officer and Chairman

OM1

Boston, MA

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

Previous Edition Contributors

We would also like to acknowledge the authors who contributed to previous editions of the User’s Guide. These authors are listed below in alphabetical order:

Amy P. Abernethy, M.D.

Susan Adams, J.D.

Fred Anderson, Ph.D.

Anthony L. Asher, M.D., FACS

Landen Bain

Ethan Basch, M.D., M.Sc.

Marc L. Berger, M.D.

Maya A. Bernstein, J.D.

Stella Blackburn, M.B., B.S., M.Sc., FRCP (Edin), FISPE

Jaclyn L. F. Bosco, Ph.D., M.P.H.

Brian D. Bradbury, M.A., D.Sc.

Jeanette M. Broering, R.N., Ph.D., M.P.H.

Laura D. Buccini, Dr.P.H., M.P.H.

Christina Chambers, Ph.D., M.P.H.

J. Alexander Cole, D.Sc., M.P.H.

Deborah Covington, Dr.P.H.

Janet D. Cragan, M.D., M.P.H.

David C. Dale, M.D.

Andy DeMayo, J.D.

Wei Dong, M.D., Ph.D.

Paul Eggers, Ph.D.

Alexander Elbert, Ph.D.

Benjamin C. Eloff, Ph.D.

Sara A. Ephross, Ph.D.

Sarah Garner, Ph.D., B.Pharm., M.R.Pharm.S.

Eric Gemmen, M.A.

Lisa Griffin Vincent, M.A., Ph.D.

Melissa M. Goldstein, J.D.

Stephen C. Groft, Pharm.D.

Stephen E. Fienberg, Ph.D., FRSC

Joanna Haas, M.D., M.Sc.

Melanie J. Harrison, M.D., M.S.C.E.

Sonia Hernández-Díaz, M.D., M.P.H., Dr.P.H.

Adrian F. Hernandez, M.D., M.H.S.

Kathleen Hewitt, M.S.N., R.N., A.A.C.C.

Holly L. Howe, Ph.D.

Alan F. Karr, Ph.D.

David W. Kaufman, Sc.D.

Stuart Kim, J.D., M.S.

James K. Kirklin, M.D.

Catherine Koepper

Joel M. Kremer, M.D.

Harlan M. Krumholz, M.D., S.M.

Kimary Kulig, Ph.D., M.P.H.

Richard E. Kuntz, M.D., M.Sc

Debra R. Lappin, J.D.

Timothy L. Lash, D.Sc., M.P.H.

Daniel Levy, M.S.

David J. Malenka, M.D.

Bradley Malin, Ph.D.

Keith Mandel, M.D.

Neal Mantick, M.S.

Danica Marinac-Dabic, M.D., Ph.D.

Bruce C. Marshall, M.D.

David Matcher, M.D.

C. Geoffrey McDonough

Benjamin Miriovsky, M.D.

Barry Mirrer, M.S., CMQ/OE

David C. Naftel, Ph.D.

Sharon-Lise T. Normand, Ph.D.

Elizabeth Paxton, M.A.

Eric Peterson, M.D., M.P.H.

Rachel L. Richesson, Ph.D., M.P.H.

Sara Rosenbaum, J.D.

Kenneth J. Rothman, Dr.P.H.

Yaffa Rubinstein, Ph.D.

Gregory Samsa, Ph.D.

Gillian D. Sanders, Ph.D.

Lee H. Schwamm, M.D., FAHA

Art Sedrakyan, M.D., Ph.D.

David M. Shahian, M.D.

Neha Sheth, Pharm.D.

Henrik Toft Sørensen, M.D., Ph.D., Dr.Med.Sci.

Paul Stang, Ph.D.

Kathryn Starzyk, Sc.M.

Charlie Strange, M.D.

Michelle Tarver, M.D., Ph.D.

Melissa S. Tassinari, Ph.D.

Dale R. Tavris, M.D., M.P.H.

Joseph Terdiman, M.D., Ph.D.

Jane Hyatt Thorpe, J.D.

Stephen Toovey, M.D., Ph.D.

Anne E. Trontell, M.D., M.P.H.

Priscilla Velentgas, Ph.D.

Marianne Ulcickas Yood, D.Sc., M.P.H.

Reviewers

Amisha Barochia, M.B.B.S., M.H.S.

Staff Clinician

National Heart, Lung, and Blood Institute

Bethesda, MD

Regan W. Bergmark, M.D.

Associate Surgeon, Otolaryngology-Head and Neck Surgery

Patient Reported Outcomes, Value and Experience (PROVE) Center; Center for Surgery and Public Health

Brigham and Women’s Hospital

Instructor, Department of Otolaryngology, Harvard Medical School

Boston, MA

Seth Blumenthal, M.B.A.

Director, Clinical Review Group, Integrated Health Model Initiative

American Medical Association

Chicago, IL

Allison Bryant, M.P.H.

Epidemiologist

OM1

Boston, MA

Gary Curhan, M.D., Sc.D.

Professor of Medicine, Harvard Medical School

Professor, Department of Epidemiology, Harvard T.H. Chan School of Public Health

Boston, MA

Nancy A. Dreyer, M.P.H., Ph.D.

Chief Scientific Officer

IQVIA Real-World & Analytic Solutions

Cambridge, MA

Paula DiStabile, R.N., M.S.N., J.D.

Health Scientist Administrator

Center for Quality Improvement and Patient Safety (CQuIPS)

Agency for Healthcare Research and Quality

Rockville, MD

Chris Crowe, Ph.D.

National Mental Health Director-Psychotherapy

Office of Mental Health and Suicide Prevention

U.S. Department of Veterans Affairs

Washington, DC

Diane Cousins, R.Ph.

Center for Quality Improvement and Patient Safety (CQuIPS)

Agency for Healthcare Research and Quality

Rockville, MD

Andy DeMayo, J.D.

Senior Counsel and Head, Strategic Partnerships

OM1

Boston, MA

Richard E. Gliklich, M.D.

Chief Executive Officer and Chairman

OM1

Boston, MA

Julia G. Gorey, J.D.

Executive Director, SACHRP

U.S. Department of Health and Human Services

Rockville, MD

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

Daniel Levy, M.S.

Vice President, Data Solutions

OM1

Boston, MA

Theodore Lystig, Ph.D.

Director, Corporate Biostatistics, Strategic & Scientific Operations

Medtronic

Minneapolis, MN

Elisha Malanga, M.S.

Chief Research Officer

COPD Foundation

Washington, DC

Sonia Maruti, Ph.D.

Director of Epidemiology

Sanofi Genzyme

Cambridge, MA

Aaron B. Mendelsohn, Ph.D., M.P.H.

Research Scientist, Department of Population Medicine

Harvard Medical School and Harvard Pilgrim Health Care Institute

Boston, MA

Vandana Menon, M.D.

Vice President, Research

OM1

Boston, MA

Sanghamitra Mohanty, M.D., M.S., FHRS

Director, Translational Research

Texas Cardiac Arrhythmia Institute

Austin, TX

Kathleen Mortimer, Ph.D.

Director of Epidemiology

OM1

Boston, MA

Marissa Gordon-Nguyen, J.D.

Senior Advisor for HIPAA Policy, Office for Civil Rights

U.S. Department of Health and Human Services

Washington, D.C.

Bryan Olin, Ph.D.

Senior Vice President, Clinical, Quality Assurance & Regulatory Affairs

LivaNova PLC

London, UK

Sarah Rittner, M.A.

Director of Operations, Center for Health Equity Transformation

Northwestern University

Chicago, IL

Kathryn Starzyk, Sc.M.

Senior Director, Real-World Evidence

OM1

Boston, MA

Zhaohui Su, Ph.D.

Vice President, Biostatistics

OM1

Boston, MA

Paul Wallace, M.D.

Senior Scholar

AcademyHealth

Washington, DC

David S. Wendler, M.A., Ph.D.

Head, Unit on Vulnerable Populations, Department of Bioethics

National Institutes of Health Clinical Center

Bethesda, MD

Albert Wu, M.D., M.P.H.

Professor of Health Policy and Management; Director, Center for Health Services and Outcomes Research

Johns Hopkins Bloomberg School of Public Health

Baltimore, MD

Previous Edition Reviewers

We would also like to acknowledge the reviewers who contributed to previous editions of the User’s Guide. These reviewers are listed below in alphabetical order:

Susan Adams, J.D.

Paul S. Appelbaum, M.D.

Diane J. Aschman, M.S.

Steven J. Atlas, M.D., M.P.H.

Stephen W. Bernstein, J.D.

Marcella Blackledge, B.A.

Kathleen Blake, M.D., M.P.H.

Jaclyn L. F. Bosco, Ph.D., M.P.H.

Jeanette M. Broering, R.N., Ph.D., M.P.H.

Jeffrey Brown, Ph.D.

Daniel Caños

Michael A. Carome, M.D.

J. Alexander Cole, D.Sc., M.P.H.

Jack L. Cronenwett, M.D.

Jay Crowley

Theresa Cullen, M.D., M.S.

David C. Dale, M.D.

Leonard D’Avolio, Ph.D.

Joseph A.C. Delaney, Ph.D.

Patrice Desvigne-Nickens, M.D.

Douglas S. Diekema, M.D., M.P.H.

Rachel S. Dokholyan, M.P.H.

Pamela S. Douglas, M.D., FACC

Joseph P. Drozda, Jr., M.D., FACC

Hesha J. Duggirala, Ph.D., M.P.H.

Brenda K. Edwards, Ph.D.

Paul Eggers, Ph.D.

Jonathan S. Einbinder, M.D., M.P.H.

Benjamin C. Eloff, Ph.D.

Barbara Evans, J.D., Ph.D.

Shamiram Feinglass, M.D., M.P.H.

T. Bruce Ferguson, M.D., FAHA

Leslye K. Fitterman, Ph.D.

Sally Flanzer, Ph.D., CIP

Mark J. Fox

Lori Frank, Ph.D.

Gregg C. Fonarow, M.D.

Sarah Garner, Ph.D., B.Pharm., M.R.Pharm.S.

Yvonne Geissbuehler, Ph.D.

Eric Gemmen, M.A.

Julian M. Goldman, M.D.

Marissa Gordon-Nguyen, J.D.

Julia G. Gorey, J.D.

Marie R. Griffin, M.D., M.P.H.

Thomas Gross, M.D., M.P.H.

Claudia Grossmann, Ph.D.

Joanna Haas, M.D., M.Sc.

Rosemarie Hakim, Ph.D.

John D. Halamka, M.D., M.S.

Stephen C. Hammill, M.D.

Melanie J. Harrison, M.D., M.S.C.E.

Christina M. Heide, J.D.

Kathleen Hewitt, M.S.N., R.N., A.A.C.C., CPHQ

Janet Hiller, M.P.H., Ph.D.

Barrie J. Hurwitz, M.B., MRCP

Michael Ibara, Pharm.D.

Solomon Iyasu, M.D., M.P.H.

Emma James, Ph.D.

Robert A. Jenders, M.D., M.S., FACP, FACMI

Peter I. Juhn, M.D., M.P.H.

Michael Kahn, M.D., Ph.D.

Clifford Ko, M.D.

Catherine Koepper

Rebecca D. Kush, Ph.D.

Joseph A. Ladapo, M.D., Ph.D.

Julia I. Lane

Wendy Lipworth, M.D., Ph.D.

Peter Littlejohns, M.D.

Danica Marinac-Dabic, M.D., Ph.D.

Bruce C. Marshall, M.D.

Susan McAndrew, J.D.

Newell McElwee, Pharm.D., M.S.P.H.

J. Michael McGinnis, M.D., M.P.P.

Deven McGraw, J.D., M.P.H., L.L.M.

Charles R. McKay, M.D., FACC

Aaron B. Mendelsohn, Ph.D., M.P.H.

Marissa A. Miller, D.V.M., M.P.H.

Barry Mirrer, M.S., CMQ/OE

Kristi R. Mitchell, M.P.H.

Lawrence H. Muhlbaier, Ph.D.

Barbara Muth

David C. Naftel, Ph.D.

Steven E. Nissen, M.D.

J. Marc Overhage, M.D., Ph.D.

Dimitrios Pappas, M.D., M.P.H.

Gareth Parry, Ph.D.

Steven Pearson, M.D.

Eric Peterson, M.D., M.P.H.

Steve E. Phurrough, M.D., M.P.A.

Richard Platt, M.D., M.Sc.

Richard L. Prager, M.D.

Victoria M. Prescott, J.D.

Michael T. Rapp, M.D., J.D., FACEP

Robert Reynolds, Sc.D.

Gerald F. Riley, M.S.P.H.

Sara Rosenbaum, J.D.

Kenneth J. Rothman, Dr.P.H.

Yaffa Rubinstein, Ph.D.

Patricia Russo, Ph.D.

Susan T. Sacks, Ph.D.

Grannum Sant, M.D., FRCS, FACS

Brian C. Sauer, Ph.D., M.S.

William B. Saunders, Ph.D., M.P.H.

Judy A. Staffa, Ph.D., R.Ph.

Juergen Schmider, M.D., Ph.D.

Art Sedrakyan, M.D., Ph.D.

James G. Snell, J.D.

Paul Stang, Ph.D.

Michael Steinbuch, Ph.D.

Walter L. Straus, M.D., M.P.H.

Elizabeth J. Swain

Michelle Tarver, M.D., Ph.D.

Hugh Tilson, M.D., M.P.H., Dr.P.H.

Anne E. Trontell, M.D., M.P.H.

Kelly Trout, B.S.N., R.N.

Jack V. Tu, M.D., Ph.D.

Paul D. Varosy, M.D.

Priscilla Velentgas, Ph.D.

Cunlin Wang, M.D., Ph.D.

Jennifer Weisman, Ph.D.

Suzanne L. West, M.P.H., Ph.D.

Marcy Wilder, J.D.

Marcus D. Wilson, Pharm.D.

Albert Wu, M.D., M.P.H.

John Yee, M.D., M.P.H.

Case Example Contributors

1. Creating a Registry To Fulfill Multiple Purposes and Using a Publications Committee To Review Data Requests

Edna Stoehr

Global Study Manager

Genentech, Inc.

South San Francisco, CA

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

2. Determining When To Stop an Open-Ended Registry

Jessica Albano, Ph.D., M.P.H.

Executive Director, Epidemiology & Health Outcomes

Syneos Health Clinical Solutions

Sewickley, PA

Ann Mallard, M.P.H.

Executive Director, Non-interventional Studies

Evidera

Wilmington, NC

Pattra Mattox, S.M.

Senior Manager

Aetion

Boston, MA

3. Modifying a Registry Due To Changes in Standards of Care

Dawn Eng, R.N., B.S.N.

Formerly Senior Clinical Trial Head, Oncology Global Medical Affairs

Novartis Pharmaceuticals Corporation

East Hanover, NJ

Alexandra Parnell, M.S.

Regulatory Affairs Manager, Real World Analytics Solutions

IQVIA

Boston, MA

4. Using Registries To Understand Rare Diseases

Betsy Bogard, M.S.

Head of Real-World Evidence

bluebird bio

Cambridge, MA

Catherine Koepper

Vice President, Head of Alliance Management

Sanofi Genzyme

Cambridge, MA

Nicole Robichaud

Senior Project Manager, Global Registry Program

Sanofi Genzyme

Cambridge, MA

John Yee, M.D., M.P.H.

Senior VP, Medical Affairs

Flexion Therapeutics

Burlington, MA

5. Using a Registry To Assess Long-Term Product Safety

Pattra Mattox, S.M.

Senior Manager

Aetion

Boston, MA

Deborah Symmons, M.D.

Professor of Rheumatology and Musculoskeletal Epidemiology (retired)

University of Manchester

Manchester, United Kingdom

Kimme Hyrich, M.D., Ph.D., F.R.C.P.C.

Professor of Epidemiology and Honorary Consultant in Rheumatology

Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology Medicine and Health

The University of Manchester

Manchester, United Kingdom

6. Expanding an Ongoing Pregnancy Registry

Jessica Albano, Ph.D., M.P.H.

Executive Director, Epidemiology & Health Outcomes

Syneos Health Clinical Solutions

Sewickley, PA

Deborah Covington, Dr.P.H.

Senior Research Leader, Real-World Evidence

Evidera

Wilmington, NC

7. Designing a Registry To Address Unique Patient Enrollment Challenges

Karen Domino, M.D., M.P.H.

Professor, Department of Anesthesiology and Pain Medicine

University of Washington

Seattle, WA

Laura Khurana, M.P.H.

Senior Scientific Advisor

ERT

Boston, MA

Karen L. Posner, Ph.D.

Research Professor, Department of Anesthesiology and Pain Medicine

University of Washington

Seattle, WA

8. Using Registries To Drive Quality Improvement in Chronic Conditions

Pattra Mattox, S.M.

Senior Manager

Aetion

Boston, MA

Peter Schmidt, Ph.D.

Senior Vice President, Chief Research & Clinical Officer

National Parkinson’s Foundation

Miami, FL

9. Developing and Validating a Patient-Administered Questionnaire

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

Grannum Sant, M.D., FRCS, FACS

Formerly Vice President and Head, Oncology and Urology Medical Affairs, Sanofi-aventis U.S., Bridgewater, NJ

Adjunct Professor of Urology, Tufts University School of Medicine

Boston, MA

10. Using Validated Measures To Collect Patient-Reported Outcomes

Kathleen M. Fox, Ph.D., M.H.S.

President

Strategic Healthcare Solutions, LLC

Aiken, SC

Susan Grandy, Ph.D., M.B.A.

Senior Director, Global Product and Portfolio Strategy

AstraZeneca

Gaithersburg, MD

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

11. Using Recognition Measures To Develop a Dataset

Kenneth A. LaBresh, M.D.

Senior Fellow

RTI International

Waltham, MA

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

Louise Morgan, M.S.N., CPHQ

Director, International Quality Improvement

American Heart Association

Scotch Plains, NJ

Lee H. Schwamm, M.D., FAHA

Executive Vice Chairman, Department of Neurology; C. Miller Fisher Endowed Chair; Director, MGH Stroke Services

Massachusetts General Hospital; Professor of Neurology, Harvard Medical School

Boston, MA

12. Patient-Powered Registries: Developing Scalable and Reusable Infrastructure To Support Harmonised Data Collection Across Rare Diseases

Vanessa Boulanger, M.Sc.

Director of Research Programs

National Organization for Rare Disorders

Danbury, CT

Suzanne Rossov

Research Programs Manager

National Organization for Rare Disorders

Danbury, CT

Allison Seebald

Research Programs Manager

National Organization for Rare Disorders

Danbury, CT

13. Using Claims Data Along With Patient-Reported Data To Identify Patients

D. Kevin Horton, Dr.P.H., M.S.P.H.

Chief, Environmental Health Surveillance Branch

Agency for Toxic Substances & Disease Registry

Centers for Disease Control and Prevention

Atlanta, GA

Paul Mehta, M.D.

Medical Epidemiologist, Environmental Health Surveillance Branch

Agency for Toxic Substances & Disease Registry

Centers for Disease Control and Prevention

Atlanta, GA

Pattra Mattox, S.M.

Senior Manager

Aetion

Boston, MA

Patricia D. Franklin, M.D., M.B.A., M.P.H.

Professor and Co-Director, Outcomes and Measurement Hub, Department of Medical Social Sciences

Northwestern University Feinberg School of Medicine; Senior Scientist, FORCE-TJR

Chicago, IL

Laura Khurana, M.P.H.

Senior Scientific Advisor

ERT

Boston, MA

15. Linking a Procedure-Based Registry With Claims Data To Study Long-Term Outcomes

Mark J. Fox

Privacy and Research Compliance Officer

American College of Cardiology

Washington, DC

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

Moira K. Kapral, M.D., M.Sc., FRCPC

Professor of Medicine, University of Toronto; Senior Scientist, ICES

Toronto, Canada

Janice A. Richards, R.N., B.A.

Formerly Project Manager

Registry of the Canadian Stroke Network

Toronto, Canada

Jack V. Tu, M.D., Ph.D.

Professor of Medicine, University of Toronto; Staff Physician, Sunnybrook Schulich Heart Centre; Senior Scientist, Institute for Clinical Evaluative Sciences

Toronto, Canada

Catherine Birken, M.D., M.Sc., FRCPC

Associate Professor, Department of Pediatrics, University of Toronto

Staff Paediatrician, The Hospital for Sick Children; Associate Scientist, Hospital for Sick Children Research Institute

Toronto, Canada

Laura Khurana, M.P.H.

Senior Scientific Advisor

ERT

Boston, MA

Jonathon Maguire, M.D., M.Sc., FRCPC

Associate Professor of Paediatrics, University of Toronto; Scientist, Li Ka Shing Knowledge Institute

Department of Pediatrics, St. Michael’s Hospital

Toronto, Canada

Magda Nunes de Melo, B.Sc.Pharm., M.Sc.

Formerly Manager, Observational Epidemiology and Qualitative Research Unit

Applied Health Research Centre, St. Michael’s Hospital

Toronto, Canada

Patricia Parkin, M.D., FRCPC

Research Director, Division of Pediatric Medicine and the Pediatric Outcomes Research Team

The Hospital for Sick Children

Toronto, Canada

Mark J. Fox

Privacy and Research Compliance Officer

American College of Cardiology

Washington, DC

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

19. Developing a Public-Private Partnership for Comparative Effectiveness Research

Elise Berliner, Ph.D.

Director, Technology Assessment Program

Center for Evidence and Practice Improvement (CEPI)

Agency for Healthcare Research and Quality

Rockville, MD

Flora Lum, M.D.

Vice President, Quality and Data Science

American Academy of Ophthalmology

San Francisco, CA

Pattra Mattox, S.M.

Senior Manager

Aetion

Boston, MA

20. Developing a Patient-Centred Governance Structure

Ben Nowell, Ph.D.

Director, Patient-Centred Research

Global Healthy Living Foundation and Patient Powered Arthritis Research Network

Nyack, NY

21. Using Registry Tools To Recruit Sites

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

22. Using a Scientific Advisory Board To Support Investigator Research Projects

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

Michael D. Taylor, Pharm.D., Ph.D.

Global Head of Epidemiology for Oncology

Genentech, A Member of the Roche Group

South San Francisco, CA

23. Understanding Baseline Characteristics of Combined Datasets Prior to Analysis

Maria Inacio, M.S.

Epidemiologist, Surgical Outcomes and Analysis

Kaiser Permanente

San Diego, CA

Laura Khurana, M.P.H.

Senior Scientific Advisor

ERT

Boston, MA

Gregory B. Maletis, M.D.

Chief of Orthopedics, Baldwin Park Medical Center

Kaiser Permanente

Baldwin Park, CA

Elizabeth Paxton, M.A.

Director, Kaiser Permanente National Implant Registries

Southern California Permanente Medical Group

San Diego, CA

24. Using Registry Data To Evaluate Outcomes by Practice

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA

Jeffrey Wagener, M.D.

Professor of Pediatrics

University of Colorado Medical School

Aurora, CO

25. Using Registry Data To Study Patterns of Use and Outcomes

Marnie L. Boron, Pharm.D.

Formerly Director, Scientific Communications

MedImmune

Gaithersburg, MD

Michelle B. Leavy, M.P.H.

Head, Healthcare Research and Policy

OM1, Inc.

Boston, MA