The Partnership to Improve Patient Care

Web site: www.improvepatientcare.org

About PIPC

Comparative effectiveness research (CER) seeks to "learn what works in health care" by comparing the patient health outcomes of different health care and treatment options. PIPC's Principles define a framework for CER policy that is centered on improving patient care. These principles address issues that are critically important to patients, providers and others in the health care community. These include focusing on quality improvement and patient health outcomes; communicating results rather than setting centralized coverage decisions, addressing the full range of information gaps that matter to patients, addressing differences in individual patient needs, and supporting continued medical advances.

News and Items of Interest

WEEKLY MEMBER UPDATE
November 12, 2010

GAO Appoints New Member to the PCORI Board

The Government Accountability Office has announced that Gail Gibson Hunt, President and CEO of the National Alliance for Caregiving, has been appointed to the Patient-Centered Outcomes Research Institute Governing Board.  In selecting Ms. Hunt, GAO has appointed a Board member who is a tireless advocate for caregivers and patients and an active member of PIPC. She will be replacing patient advocate Andrew Imparato who resigned from the PCORI Board when he stepped down as president of the American Association of People with Disabilities to be the disability policy director for Senator Tom Harkin (D-IA).

 A brief bio of Ms. Hunt is provided below:

Gail Gibson Hunt is President and CEO of the National Alliance for Caregiving, located in Bethesda, MD.  The Alliance is a diverse coalition of national organizations that seeks to advocate for and serve as a research and training resource for family caregivers of patients/consumers across the lifespan.  Ms. Hunt's previous positions include President of a management consulting firm specializing in aging and a senior manager for human services at KPMG Peat Marwick.  Ms. Hunt serves as a member of the Advisory Panel for Medicare Education, and as a board member of the Center for Advancing Health and of Vinson Hall in McLean, VA, and was on the NIH State of the Science Panel on Preventing Alzheimer's and Cognitive Decline.  She was a member of the Policy Committee of the 2005 White House Conference on Aging.  She has been active in many national and international conferences on family caregiving, and also helped to develop an international coalition of caregiving groups.  Ms. Hunt received her BA from Columbia University.

 PIPC In-Person Meeting Recap

 Thank you to those of you who were able to attend the PIPC member meeting.  We kicked off the meeting with a high level post mid-term elections overview by Jeff Birnbaum. The presentation detailed of the make-up of the 112th Congress and Governors.

Next, Greg Raab walked PIPC members through the PIPC White Paper on the procedural framework of PCORI. His presentation looked at 4 areas of PCORI processes (stakeholder involvement, transparency, public participation, and open decision-making) and key considerations and issues to monitor as PCORI moves forward to begin operations in the months ahead. All of these points are included in the White Paper which will be finalized early next week and released publicly.

In addition, PIPC has developed a website which inventories government sponsored CER in a searchable online database. We walked through the functions of this tool during the meeting. This site will go live next week. Please take a few minutes this week to check out the site and give us feedback. Here is the secure link: www.cerinventory.org/?q=user

username: preview
password: CERpreview1

Thanks again for everyone who attended. If others who were not able to join us want a more detailed meeting update please contact Mary-Lacey Reuther. If you would like copies of the presentations please email Ruth Osinski.

Reminder: NIH and AHRQ to Hold a Conference on CER Methodologies

 The National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) are cosponsoring a conference on Methodological Challenges in Comparative Effectiveness Research on December 2-3.

The conference will make use of case studies that pose difficult questions about what kinds of research, methods, and analyses should be used to address limitations in current evidence for interventions and tests being examined by decision-making bodies. The cases will address a variety of important CER questions facing researchers, care providers, health systems, and patients.

Click here for more information and to register for the conference.

AHRQ Effective Health Care Program Updates

The Effective Health Care Program announced key questions are available for comment.

• Comparative Effectiveness of Treatments of Phenylketonuria. Comments are due December 6. The key questions are available here.
• Comparative Effectiveness of Nitrous Oxide for the Management of Labor Pain. Comments are due December 8. The key questions are available here.

The Effective Health Care Program also announced the following reports are now available.

• Future Research Needs for Angiotensin Converting Enzyme Inhibitors or Angiotensin II Receptor Blockers Added to Standard Medical Therapy for Treating Stable Ischemic Heart Disease. Comments are due by December 3. The report is available here.
• Future Research Needs for the Management of Gestational Diabetes. Comments are due by December 3. The report is available here.
• Nonpharmacologic Interventions for Treatment-Resistant Depression in Adults. Comments are due December 6. The draft report is available here.
• A Framework for "Best Evidence" Approaches in Systematic Reviews. Comments are due December 8. The draft research report is available here.

The Effective Health Care Program also announced a draft technology assessment will be made available for review on November 17. The draft is titled “Outcomes of Sipuleucel-T Therapy.” The review will be available until December 6 and is available here.

 PIPC Member Call

 Please join us for the next PIPC Member Call. Chairman Tony Coelho will lead our discussion.

• Tuesday, November 23, at 4:30 p.m.
• Call in number is 1-888-820-9414 and the passcode is 7541120.
• Please call in 5-10 minutes early to allow time to go through the operator.

Letters supported by ICAN

Comparative Effectiveness Research (CER) and the Economic Stimulus Package

Letter to Chairman Inouye, Ranking Member Cochran,
Chairman Harkin and Ranking Member Specter

January 26, 2009

The Honorable Daniel Inouye, Chairman
The Honorable Thad Cochran, Ranking Member
Committee on Appropriations
The Capitol, S-131
Washington, DC 20510

The Honorable Tom Harkin, Chairman
The Honorable Arlen Specter, Ranking Member
Committee on Appropriations
Subcommittee on Labor, Health and Human Services, Education, and Related Agencies
131 Dirksen Senate Office Building
Washington, DC 20510

Dear Chairman Inouye, Ranking Member Cochran, Chairman Harkin and Ranking Member Specter:

Effectiveness information that reflects interactions among all various components of system has the greatest potential empower clinicians and patients make more appropriate decisions. In addition to comparing scientific treatment interventions, research should also on how innovations in care delivery models, such as disease management programs, may produce better health outcomes.

We are writing to urge you to ensure that any comparative effectiveness research (CER) included in the economic stimulus package establish a legislative framework that is strong and patient-centered. The goal of CER should be to arm individual patients and their doctors with the best available information to help assess the relative clinical outcomes of various treatment strategies and alternatives, recognizing that this will vary with circumstances. When used appropriately, comparative clinical effectiveness information can serve as a valuable tool that can contribute to improving health care delivery and outcomes by informing clinical decision making. By focusing on quality of patient care, such research also can help us achieve better health care value. However, we are very concerned that the House legislation and accompanying report language could have unintended and negative effects for patients, providers and medical innovators, leading to restrictions on patients’ access to treatments and physicians’ and other providers’ ability to deliver care that best meets the needs of the individual patient. Rather, we believe any provisions related to comparative effectiveness should:

• Focus CER on comparative clinical benefit, rather than cost-effectiveness.
  Any legislation should state that funding will be used only to support clinical comparative effectiveness research, and define clinical comparative effectiveness as research evaluating and comparing the clinical effectiveness of two or more medical treatments, services, items and care processes and management. Additionally, CER should not encourage a generalized, "one-size fits all" approach. Rather, it is necessary to design studies and communicate results in ways that reflect variation in individual patient needs, that help patients and doctors make informed choices, and account for differences among patients including co-morbidities, sex, race and ethnicity. Recognizing these differences is important to allowing patients optimal treatment today and to encouraging the development of innovative targeted therapies which will advance personalized medicine.
• Be conducted through an open and transparent process that allows for patients, providers and other stakeholders to participate equally in governance and input, starting from the research planning stage.
  There are many challenges in successfully conducting and communicating high-quality, patient-centered CER. Therefore, comparative effectiveness programs should include transparent decision-making procedures and broad stakeholder representation to enhance the credibility and usefulness of such studies.
• Ensure that research supports providers in delivering the best possible care to their patients. To maintain a focus on patient and provider needs, the research entity should not engage in making policy recommendations or coverage decisions.
  Patients may respond differently to the same intervention and the needs of the individual must be taken into consideration. Imposing rigid, federally-proscribed practice guidelines, which fail to recognize such variations, among patients can lead to poor patient outcomes and increased health care costs.

Comparative effectiveness information that reflects interactions among all of the various components of the health care system has the greatest potential to empower clinicians and patients to make more appropriate decisions. In addition to comparing scientific treatment interventions, research should also focus on how innovations in care delivery models, such as disease management programs, may produce better health outcomes.

We look forward to working with you to create a system that improves information about clinical outcomes, ensures that patients continue to have access to life-saving treatments and the tools necessary to advance a better quality of life for all Americans. Thank you for your consideration.

Sincerely,

AACSA Foundation
The AIDS Institute
Alliance for Aging Research
Alliance for Better Medicine
Alliance for Patient Access
Alpha-1 Association
Alpha-1 Foundation
American Association for Cancer Research
American Association for Respiratory Care
American Association of Neurological Surgeons (AANS)
American Association of Orthopaedic Surgeons
American Association of People with Disabilities
American Autoimmune Related Diseases Association
American College of Obstetricians and Gynecologists
American Institute for Medical and Biological Engineering (AIMBE)
American Osteopathic Association
Association of Clinical Research Organizations (ACRO)
Association of Reproductive Health Professionals
Asthma and Allergy Foundation of America
Autism Society of America
Breast Cancer Network of Strength
C3: Colorectal Cancer Coalition
Californians for Cures
Celiac Disease Center at Columbia University
Children's Tumor Foundation
Coalition of State Rheumatology Organizations
Colon Cancer Alliance
Congress of Neurological Surgeons (CNS)
COPD Foundation
Cure Arthritis Now
Cutaneous Lymphoma Foundation
Easter Seals
FasterCures
Foundation for Sarcoidosis Research
Friends of Cancer Research
GBS/CIDP Foundation International
The Government Accountability Project
Interamerican College of Physicians & Surgeons, Inc.
Intercultural Cancer Council Caucus
International Cancer Advocacy Network (ICAN)
International Myeloma Foundation
Kidney Cancer Association
Lung Cancer Circle of Hope
Malecare Cancer Support
Men's Health Network
Muscular Dystrophy Association
National Alliance for Hispanic Health
National Alliance on Mental Illness
National Alopecia Areata Foundation
National Foundation for Ectodermal Dysplasias
National Hemophilia Foundation
National Kidney Foundation
National Spinal Cord Injury Association
Ovarian Cancer National Alliance
Plasma Protein Therapeutics Association
Prostate Cancer International, Inc.
Prostate Health Education Network, Inc. (PHEN)
RetireSafe
Society for Women’s Health Research
Tuberous Sclerosis Alliance
United Spinal Association
Us TOO International Prostate Cancer Education and Support Network
VHL Family Alliance
Virginia Prostate Cancer Coalition
Vital Options International
ZERO - The Project to End Prostate Cancer

cc: The Honorable Max Baucus
The Honorable Kent Conrad
The Honorable Charles Grassley
The Honorable Edward Kennedy
The Honorable Michael Enzi
The Honorable Harry Reid
The Honorable Mitch McConnell

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