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View a 1 minute video overview of the conference from ECRI Institute's President and CEO Jeffrey C. Lerner, PhD.

ECRI Institute’s 18th Annual Conference, Patient-Centeredness in Policy and Practice: A conference on evidence, programs, and implications, held November 29 and 30, 2011, was planned with and co-organized by the U.S. Food and Drug Administration; in cooperation with the U.S. Agency for Healthcare Research and Quality, Health Affairs, Foundation for Informed Medical Decision-Making, Kaiser Permanente Institute for Health Policy, American Board of Internal Medicine, Milbank Memorial Fund, and the Leonard Davis Institute for Health Economics at the University of Pennsylvania.

Current health reform and many prior initiatives are moving the healthcare system towards patient-centeredness. In a series of interactive and engaging sessions, healthcare leaders discussed these and other provocative questions: 

  • What is patient-centeredness, actually?
  • What programs are working and how do we know?
  • Will patient-centeredness have staying power?

Leading policy makers such as Margaret Hamburg, MD, commissioner, FDA; Carolyn Clancy, MD, director, Agency for Healthcare Research and Quality; Jeffrey Shuren, MD, JD, director, Center for Devices and Radiologic Health, FDA; Janet Woodcock, MD, director, Center for Drug Evaluation and Research (CDER), FDA; Joe V. Selby, MD, MPH, executive director, Patient Centered Outcomes Research Institute; leaders in the field of shared decision-making between patients and their caregivers; and a host of other nationally-recognized experts including policy makers, practitioners, and researchers examined the meaning, state of the evidence, progress, and implications of patient-centeredness.

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Tuesday, November 29, 2011

Welcome and Introduction (video start time - 06:17)

  • Margaret A. Hamburg, MD, Commissioner, Food and Drug Administration
  • Jeffrey C. Lerner, PhD, President and Chief Executive Officer, ECRI Institute

Session 1 (video start time - 21:45)
Policy Discussion – Researching and Regulating for Patient-Centeredness

This policy discussion among the leaders of key Federal agencies addresses their perspectives as well as the programs they are implementing to research and regulate a healthcare system that values and seeks to implement patient centeredness. This discussion is designed to probe lynchpin issues so that we can increase our collective understanding of what we know and do not know about patient centeredness, and how we can give it practical expression after proper evaluation.

  • Margaret A. Hamburg, MD, Commissioner, U.S. Food and Drug Administration
  • Carolyn M. Clancy, MD, Director, U.S Agency for Healthcare Research and Quality
  • Joe V. Selby, MD, MPH, Executive Director, Patient-Centered Outcomes Research Institute 
  • Moderator: Susan Dentzer, Editor-in-Chief, Health Affairs

Session 2 (video start time - 01:42:25)
Patient-Centeredness in Health Law and Regulation

This session addresses how the term/concept "patient-centeredness" is used in the Affordable Care Act and in regulations, and in other health reform-related legislation/regulation. It also covers legal aspects of FDA initiatives relevant to patient-centeredness.

  • David Dorsey, JD, Acting Deputy Commissioner for Policy, Planning and Budget, U.S. Food and Drug Administration 
  • Michael Park, JD, Counsel, Alston and Bird
  • Jane Hyatt Thorpe, JD, Associate Research Professor, School of Public Health and Health Services, and Director, Healthcare Corporate Compliance Graduate Certificate Program, College of Professional Studies, George Washington University
  • Moderator: John B. Reiss, JD, PhD, Partner, Saul Ewing, LLP

Session 3 (video start time - 03:03:36)
Patient-Centeredness as a Core Medical Skill

This session will address physician competencies necessary for patient-centered care, such as communication and interpersonal skills that includes shared decision making, clinical reasoning and medical knowledge, quality improvement and systems-based practice. It draws on data from several research initiatives from the American Board of Internal Medicine that focus on the concept of comprehensive care, teamwork and patient reported experiences of care. The session also discusses the perspectives of the American College of Physicians on how delivery of primary care is being transformed through development of Patient-Centered Medical Homes, summarizing some of the efforts and results in putting the concept into practice. It addresses Initiatives at the American College of Surgeons focused on surgical decision making, patient safety, quality measurement and public reporting.

  • Eric Holmboe, MD, Chief Medical Officer, American Board of Internal Medicine
  • Steven E. Weinberger, MD, FACP, Executive Vice-President, Chief Executive Officer,  American College of Physicians
  • David Hoyt, MD, FACS, Executive Director, American College of Surgeons
  • Moderator: Malcolm Cox, MD, Chief Academic Affiliations Officer, Veterans Health Administration

Session 4 (video start time - 00:34)
The Use of Evidence in Patient-Centered Informed Consent in Practice and in Clinical Trials

Many law and policy leaders identify a need to overhaul informed consent, but what would this overhaul encompass and how would it keep patients' needs, values, preferences and goals at the center of the reform? This session examines the literature and thinking on this issue. It also references ethical issues such as conflict of interest.

  • Benjamin Moulton, JD, MPH, Senior Legal Advisor, The Foundation for Informed Medical Decision Making 
  • Annette Bar-Cohen, Executive Director, The Center for National Breast Cancer Coalition Advocacy and Training
  • Diane Dorman, Public Policy Vice President, National Organization for Rare Disorders
  • Moderator: Jeffrey C. Lerner, PhD, President and Chief Executive Officer, ECRI Institute

Session 5 (video start time - 01:30:30)
Role of Decision Quality Measurement in Building Accountability for Patient Centered Care

Patient experience is a recognized gap in existing quality measurement protocols. The session includes discussion of a body of research developed to address patient knowledge that there is a decision to make; the pros and cons of their range of options, taking into account their goals and concerns. Speakers will cover the development of quality measures and using these measures in clinical practice. AHRQ's Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program will be addressed, as will initiatives at the FDA using decision analysis.

Karen Sepucha, PhD, Senior Scientist, Health Decision Research Unit, Massachusetts General Hospital, Instructor, Harvard Medical School, Boston 

  • Susan Edgman-Levitan, Executive Director, John D. Stoeckle Center for Primary Care Innovation, Mass General Hospital, Boston
  • Dale Collins Vidal, MD, Director, The Center for Informed Choice, Professor of Surgery and of Community and Family Medicine: Medical Director, Comprehensive Breast Program, Dartmouth Hospital and Medical School 
  • Gregory Campbell, PhD, Director, Division of Biostatistics, US Food and Drug Administration 
  • Moderator: Clarion E. Johnson, MD, Medical Director - Global, Medicine and Occupational Health, Exxon Mobil Corporation

Session 6 (video start time - 02:48:40)
Influencing Consumer Perception and Behavior: Communicating Evidence, Social Media, and Behavioral Economics

The session includes current efforts to communicate in a patient centered way about comparative effectiveness research. It also examines communications among patients using social media, and it addresses what we can learn from behavioral economics about patient–centered communication aimed at changing behavior.

  • Kevin Volpp, MD, PhD, Staff Physician, Philadelphia VA Medical Center; Director, Center for Health Incentives and Behavioral Economics, Leonard Davis Institute ; Director, UPHS Center for Innovations in Health Care Financing; Professor of Medicine and Health Care Management, Perelman School of Medicine and the Wharton School, University of Pennsylvania 
  • C. Michael Fordis, MD, Baylor College of Medicine, Senior Associate Dean Continuing Medical Education, and AHRQ Effective Healthcare Program 
  • Christopher M. Schroeder, Chief Executive Officer, HealthCentral
  • Moderator: Murray N. Ross, PhD, Vice President, Kaiser Foundation Health Plan; Director, Kaiser Permanente Institute for Health Policy

Wednesday, November 30, 2011

Session 7 (video start time - 15:30)
How Do We Obtain Patient-reported Information Through Technology?

This session examines information that a patient can report best, drawing on examples of technologies and their applications. This session includes a discussion of home based care technologies such as remote patient monitoring and mobile medical applications.

  • Mary Weick-Brady, MSN, RN, Senior Policy Analyst, Center for Devices and Radiological Health, U.S. Food and Drug Administration 
  • Richard Kuntz, MD, MSc, Senior Vice President and Chief Scientific, Clinical and Regulatory Officer, Medtronic, Inc.; and member, PCORI Board of Governors 
  • Amy Schwartz, PhD, Founder, IDEO Chicago's User Research Group and Healthcare Lead
  • Moderator: J. Sanford Schwartz, MD, Leon Hess Professor of Medicine, Health Care Management, and Economics, School of Medicine and the Wharton School, University of Pennsylvania

Session 8 (video start time - 01:20:00)
An FDA Perspective on the Critical Role that Patients Play in the Life Cycle of Medical Products

Dr. Shuren will cover patient-centeredness in clinical trials (e.g., using patient outcome measures), as well as benefit-risk determinations (e.g., taking into consideration patient tolerances for different risks), device development (e.g., the role patients play in human factors engineering of devices), medical product use (e.g., home use of devices), and patient labeling. Dr. Woodcock will address FDA's patient-centered initiatives related to pharmaceuticals, including patient reported outcome development, drug development tools guidance, patient centered benefit- risk assessment (including FDA's PDUFA proposal), and aspects of patient communication.

  • Jeffrey Shuren, MD, JD, Director, Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration 
  • Janet Woodcock, MD, Director, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration
  • Moderator: Kay Dickersin, PhD, Professor, Johns Hopkins Bloomberg School of Public Health and Director, Center for Clinical Trials; Director, U.S. Cochrane Center

Session 9 (video start time - 00:04:03)
Patient Centeredness in Health Systems

This session examines how major healthcare systems as well as smaller ones approach deploying patient-centered systems and what some of these systems are achieving. Kaiser-Permanente is often perceived as a model for accountable care organizations as well as many other initiatives, and we will learn their perspectives. The Veterans Health Administration is another leader in research and program development in the area of patient-centered care. This session is balanced by a consumer perspective on initiatives in health systems.

  • Christine Bechtel, Vice President, National Partnership for Women & Families
  • Joel Kupersmith, MD, Chief Research and Development Officer, Veterans Health Administration 
  • Sharon Levine, MD, Associate Executive Medical Director, The Permanente Medical Group 
  • Moderator: Jeffrey C. Lerner, PhD, President and CEO, ECRI Institute

Session 10 (video start time - 06:22)
Federal and State Models: Patient Centered Policy to Practice

States are often seen as laboratories for innovation. This session looks at examples of state and state/federal policies and programs with patient-centered components. For example, Washington State enacted legislation in 2007 on shared decision making and authorized pilots based on research from Dartmouth and other sources demonstrating unexplained variation in practice. Part of this variation may be explained by not adequately determining patient preference when treatments have different trade-offs. This session also discusses Vermont's Blueprint for Health, a model that includes the Centers for Medicare & Medicaid Services' Advanced Primary Care Practices Demonstration Project. Other participating states include: Maine, Michigan, Minnesota, New York, North Carolina, Pennsylvania and Rhode Island. The demonstration allows Medicare to come on board as a participating insurer with the Blueprint for Health – joining private insurers and Vermont Medicaid. 

  • Carolyn (Cindy) A. Watts, PhD, Professor and Chair, Department of Health Administration, Virginia Commonwealth University
  • Craig Jones, MD, Executive Director, Vermont Blueprint for Health 
  • Moderator: Carmen Hooker-Odom, MRP, President, Milbank Memorial Fund

Session 11 (video start time - 01:09:25)
The Business Case for Patient Centeredness: a Policy and Practice Discussion about Aligning Incentives

This session addresses key questions: what is the evidence for "follow the money" being the guiding principle in what moves the health system? If this is case, are incentives being aligned to foster patient-centeredness?

  • Karen M. Ignagni, President and Chief Executive Officer, America's Health Insurance Plans (AHIP) 
  • L. Allen Dobson, MD, President and CEO, Community Care of North Carolina 
  • John J. Lynch III, FACHE, President and Chief Executive Officer, Main Line Health 
  • Robert Galvin, MD, Chief Executive Officer of Equity Healthcare, The Blackstone Group 
  • John M. Colmers, MPH, Vice President, Health Care Transformation and Strategic Planning, Johns Hopkins Medicine  
  • Moderator: Daniel M. Fox, PhD, President Emeritus, Milbank Memorial Fund

Planned and organized by:

  • ​​ECRI Institute
  • The Food and Drug Administration
  • Foundation for Informed Medical Decision-Making
  • The U.S. Agency for Healthcare Research and Quality
  • Health Affairs
  • American Board of Internal Medicine
  • Kaiser Permanente Institute for Health Policy
  • Leonard Davis Institute of Health Economics at the University of Pennsylvania, University of Pennsylvania School of Medicine
  • Milbank Memorial Foundation

​This event occurred in the past at:
FDA's White Oak Campus, Silver Spring, MD