Listening Session of the Federal Coordinating Council for Comparative Effectiveness Research
U.S. Department of Health & Human Services
Hubert H. Humphrey Building
April 14, 2009
The purpose of this meeting was to gather input from a broad range of diverse stakeholders on how the Council should approach its mission and to obtain public input on priorities, concerns, and ideas on how this comparative effectiveness research (CER) can empower patients and providers and improve care for all Americans.
An analysis of comparative effectiveness is simply a rigorous evaluation of the impact of different options available for treating a given medical condition for a particular set of patients, according to the Research on the Comparative Effectiveness of Medical Treatments Report released in 2007 by Congress.
Such a study may compare treatments, drugs, technologies, or other approaches, and the analysis may focus only on medical risk and benefits, costs and benefits, effectiveness, appropriateness, or other measures.
CER provides information on the relative strengths and weakness of various medical interventions. This information is essential for clinicians and patients to decide on the best treatments, and it also enables our nation to improve the performance of the health system.
The 2009 American Recovery and Reinvestment Act authorized $1.1 billion for comparative effectiveness research, including $300 million for the Agency for Healthcare Research and Quality, $400 million for the National Institutes of Health, and $400 million for the Secretary of Health and Human Services to support CER.
The same law also created a 15-member Federal Coordinating Council for Comparative Effectiveness Research, which will assist the agencies of the Federal Government, including HHS and the Departments of Veterans Affairs and Defense, in coordinating comparative effectiveness and related health services research.
Although the Council will not recommend clinical guidelines for payment, coverage, or treatment, it will consider the needs of populations served by Federal programs as well as opportunities to build and expand on current investments and priorities. The Council will submit a report to the President and Congress on these priorities and recommendations by June 20, 2009.
The Council will hold two additional listening sessions over the next 6 weeks and also will be taking online written comments at least until the end of May 2009.
Public comment was obtained from 3 consecutive panels, each consisting of roughly 10 individuals. Each panel member was allowed 3 minutes to provide comments and recommendations. The Council then had the opportunity to ask questions. Following the last panel, a period of open public comment was extended to as many speakers as time allowed. Below are some of the most salient recommendations from the panelists.
- Patients need a defined road in the CER process. There needs to be transparent processes and venues for patient voices to be heard. The Council should consider:
- Developing a national citizen’s advisory board, which could be modeled after the United Kingdom’s NICE Citizens Council model (www.nice.org.uk)
- Establishing an explicit channel for patients to advise HHS on CER, which could be modeled after the FDA Patient Representative Program (http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/PatientInvolvement/ucm123858.htm)
- Establishing an HHS Office on Patient Values and Inclusion to ensure patients assist in all aspects of developing the systems to deliver therapies for the major medical problems we face as a nation
- Incorporating all health community stakeholders in the governance
- The Council should establish procedures for meaningful and ongoing public input and invite opportunity for public comment on any draft reports of recommendations
- The Council should commit to full openness and transparency
- The Council also should describe criteria and rationale for any recommendations it makes and priorities for CER investments. Priority setting should be explicit so that people can trace backwards from results to inputs to satisfy themselves that the process was fair
- Encourage collaboration at the Federal, State and local levels early and often. Also collaborate early and often with policymakers
- Federal Government must draw together data from various Agencies including those covering public health, behavioral health, labor, housing, criminal justice, defense, and veteran’s affairs. The same collaboration should be required from their State agency counterparts
- Encourage public/private collaborations on the design, conduct, analysis, and reporting of CER
- The scope, selection, and prioritization of research are critical. The agenda should be prioritized focusing on areas that have major clinical significance and the greatest impact on health care delivery in the U.S. Preventive care and behavioral health interventions should also be included
- Priorities should focus on medical conditions with the greatest impact on morbidity and costs (these are most often chronic conditions). CER should encompass all health care services used to treat those conditions including prescription drugs, medical and surgical procedures, diagnostics, medical devices, and health care delivery methods. The research should also include insurance benefit designs
Define effectiveness broadly
- Effectiveness should be defined broadly and be inclusive in scope. In other words, quality, safety, and efficiency of care should be considered independently so that there are no tradeoffs between studies
- Consider using the Institute of Medicine’s definition of evidence-based practice which combines three factors: best research evidence, best clinical experience, and consistency with patient values
Use and develop current data sources
- Use as many currently available data as possible including
- Phase IIIb and IV studies
- Electronic health record systems
- Data systems developed by regional health improvement collaboratives
- Health care claims databases
- Administrative databases
- Databases of various Government health plans such as CMS and VA
- A coordinated effort to link currently isolated public and private databases has the potential to generate an unprecedented amount of information for a variety of research activities and could be a useful hypothesis-generating tool
- With these and other new data sources expanding the number of observations and the richness of clinical detail, new analytic methods to aid valid inference from observational research should be a high priority
- Consider using the Perioperative Nursing Data Set (PNDS), a standardized language for the documentation and evaluation of care in surgery in operating rooms of our nation’s hospitals and ambulatory surgery centers
- It is important that various treatments be compared for specific subpopulations including the working age population, women, minorities, diabetics, children, and people with comorbid conditions
- CER must take into consideration the need for personalized care. Findings should not overlook special subpopulations that may benefit from a particular treatment or neglect the needs of patients for whom the findings are not necessarily supportive
- Consider CER of multiple treatment options available for those with chronic, debilitating and life-threatening conditions. This could help educate individuals on their options and better equip them for the decisions they make with their physicians regarding the best course of action in treatment
- Clinical trials generally underrepresent older people as well as people with multiple chronic illnesses. The former is particularly true for people over 75. Therefore, results of clinical studies that focus on younger populations cannot be presumed to be applicable to older adults who have reduced kidney function, multiple chronic illnesses, and may already be taking five or more medications
- Consider drug safety. CER often focuses on drug effectiveness, but for older adults, an important issue is drug safety. In some cases, a medicine that is considered less effective in the general population will be preferred for older adults because it is less toxic and has a lower risk of producing adverse effects and drug interactions
Develop infrastructure and research
- Build a strong quality improvement infrastructure at the regional level building on the regional health improvement collaboratives and the charter value exchanges. Funding could be used to maintain and expand patient registries, pool claims databases and health information exchanges, and to expand the comparative performance reporting they do for providers, researchers, and the public
- Support research to inform clinical care delivery and the development of delivery system reforms
- Extend research training and the disciplines relevant to comparative effectiveness. Such investments are greatly needed to enhance the skills, supply, and diversity of the research work force
Consider real-world settings
- Research is needed not only to provide the evidence base for the best disease prevention, health promotion, or clinical interventions but also to know how to best implement findings in real-world complex organizational settings in communities
- Consider reliable, relevant, and usable research as the key criteria for CER
- Due to the current critical shortage in the health care work force, research should reflect the reality that an optimally trained clinician may not be available to provide preferred treatments
- CER results must not drive de facto coverage or reimbursement recommendations until they have been evaluated in real-world settings so we can determine their impact on individuals in various subpopulations
- CER information should be relevant to policymakers by providing information for local decisions to improve quality
- Encourage innovation while providing ongoing evidence of value
- Support the development and use of CER for means that are synergistic in the continued discovery of clinical innovations in biomedical science
- The Council should look at approaches that address how to perform CER when introducing innovative therapies, which by definition have less known about them in the real world than existing therapies
Include other areas, factors, and data sources
- Examine other areas of the health care system including health care delivery system reform, as well as prevention and wellness programs
- CER should include a wide range of factors that affect health, including nonclinical programs and interventions, organizational system characteristics, policies, and regulations
- CER should consider data from a wide range of studies and designs. For many programs and policies, it’s not feasible to conduct randomized trials. Therefore, in addition to randomized trials, CER should consider designs that are more common for evaluating comprehensive population-focused interventions, such as observational cross sectional studies, quasi experimental designs, and time series analyses
- CER relating to persons with disabilities is required in four areas
- Research is needed about the most effective interventions to prevent or mitigate disability and the disabling effects of chronic diseases
- As persons with disabilities age, they risk the same diseases of aging as other individuals (e.g., breast cancer and cardiovascular disease). However, persons with disabilities are often excluded from clinical trials for these conditions. Because of this, often there is not a lot of information to guide their treatment decisions. Future clinical trials should exclude people with disability only when there are clear and compelling reasons
- Studies should investigate comparative effectiveness in person-focused interventions aimed at restoring or maintaining functioning or minimizing its loss. Much more research is needed to identify effective physical and occupational therapy interventions as well as various assistive technologies that address sensory deficits, communication impairments, and physical and motor limitations
- Research is needed to expand on the effectiveness of environmental modifications and to improve an individual’s quality of life as well as his/her participation in daily life. Examples include technologies and design changes within the built environment to make a home safer, more accessible, and to allow persons with disabilities to live independently in communities
- There is meager science regarding the long-term functional benefit of many rehabilitation therapies and equipment for children. The lack of evidence base is reflected in the wide regional variation of services and programs
- Effectiveness comparison should determine the indication for rehabilitation therapies in major disabling conditions, their components, timing, duration, outcomes, and quality of life expectations
- There is a need for effectiveness comparison of conventional treatments to newer interventions for which evidence exists but is more time consuming or costly (e.g., constraint induced therapy to improve hand use or body weight support to facilitate walking)
- Consider comparing health care that provides active health promotion to conventional services. Although no evidence supports continuous lifetime therapy, there is evidence that health-promoting behaviors including exercise can improve health, function, and quality of life in those with disabilities
- Families often seek alternative therapies and improvements when conventional treatment is lacking. It is important to establish rigorous comparison of alternative therapies to conventional care in order to clarify their role in patient care
- Children with disabilities and complex health care needs eventually become adults, and as adults, they often have difficulty transitioning to health care services. They need exceptional services and yet their providers may be penalized by becoming outliers in quality audits. Successful transition programs that incorporate many elements already exist. Such programs improve not only satisfaction but also health outcomes. CER of transition programs could help identify the elements that are required for successful programs
Address disparities and cultural differences
CER must be mobilized to improve the health outcomes of various racial and ethnic populations in order to end the gap that exists between the health status of some minority populations and other Americans. Clinical trial design and infrastructures of CER research must accommodate this goal
CER can add to the body of knowledge for reducing disparities with the following priority areas
- Knowledge about health disparity interventions between hospital systems and clinics that have long-standing experience with minority physicians, their patients, and other individuals
- Cultural competence in health literacy research in order to ultimately change behaviors and improve lifestyles
- Effective ways of communicating with minority patients and their families
- Integrative care that is outcome-based and includes mental health, oral health, and physical health
- Developing minority health professionals
Given the growth of the Hispanic population, there is a need to create regional areas for Hispanic health research and to follow the health care decision making within the health systems in that region
- Findings should not result in one-size-fits-all coverage recommendations
- To support the growth of personalized medicine, the analysis of data from integrated networks can help identify those factors that contribute to disease susceptibilities and characteristics that result in different outcomes to treatment
- CER should sponsor research that is designed to improve clinical decision making by both clinicians and patients. This would include research that considers individuality and health conditions as well as factors such as family history, patients’ values and preferences, and individual experience and treatment
- The Council should continue the Personalized Health Care Initiative at the Department of Health and Human Services and incorporate the initiative into CER
- CER should outline a process for decision reconsideration. Comparative approaches such as metanalysis and systemic reviews of the literature reward old medicine and one-size-fits-all methods that are inefficient and expensive. Therefore, the Council should outline a plan by which comparative effectiveness findings can be reconsidered such as when the FDA changes the label of a drug or when a professional organization changes the suggested standard of care
Focus on patients
- CER must address the needs and the life circumstances of individual patients. It must integrate clinical expertise with the best evidence and individual patient’s predicaments, rights, and preferences
- Research should include complex behavioral, environmental, and genetic components of comorbid conditions
- CER research should not only be about one product against another or treatment process or combination thereof. It should also include health care delivery issues such as the organization, design, and management of patient care
- CER should never be employed by payers or regulators to diminish the importance of clinical experience or patient/family values and experiences
Address potential conflicts of Interest
- CER should develop a strong and clear policy for conflict of interest in biomedical research and publishing
- It should consider steps that would make the CER program, over time, essentially free of conflict of interests
- It should strongly favor researchers and institutions that are devoted to doing research in the public interest and have no current conflicts
- It should require from the outset 100 percent disclosure and transparency of all conflicts from all researchers and institutions
Consider the potential legal implications and legal barriers
- Studies should scrupulously account for pre-treatment severity of illness in all of the conclusions that are made, as this is always a major issue in liability actions
- There is a need to have very statistically significant conclusions. Physicians are very concerned about being able to obtain clinically specific guidance from these studies
- The Council should ensure that there aren’t any clinical or non-clinical factors that can impact the outcome (e.g., preventive measures, lifestyle changes, or environmental influence). These need to be teased out from any conclusions made concerning recommendations
- The Council should also address any possible legal impediments to comparative effectiveness tools such as practical clinical trials and CED
- Opinions on cost were conflictive and included the following
- Do not focus on cost, rather keep the focus on clinical effectiveness. A focus on cost could lead to limiting access and benefits
- Reconsider the framework that providing informative cost information would limit access
- Study all factors that are contributing to increased costs in the health care system including the examination of some of the inherent root causes (e.g., obesity epidemic). Tackling such issues early on can have a far greater impact on cost savings in the future than our current thinking on CER indicates
- All stakeholders, including patients, should be involved in disseminating CER findings
- The most effective dissemination approaches should be locally organized and implemented. They should be carried out through a collaborative effort of providers, payers, consumers, and employers and should also be implemented in conjunction with quality reporting and quality improvement initiatives
- CER must disseminate findings to the end user and the patient population. It should ensure that people are aware of the information, understand how to use it, and have few or no barriers to be able to use it
- All aspects of CER must be disseminated by an essential independent body to the provider, patient, and payer
- The Council should take into account the significant disease burden and economic burden of oral health when establishing priorities areas
- The Council should take a holistic approach that includes factors such as addiction, mental illness, HIV, prevention, treatment, and early identification
Open Public Comment
- Existing teleradiology and telemedicine resources should be developed and utilized as part of the infrastructure to establish registries, networks, and other e-health data to analyze comparative effectiveness on diagnostic and treatment pathways for targeted health conditions
- Reimbursement policies and claims processing systems aimed at controlling cost are currently impeding rather than facilitating the development of teleradiology. Conflicting quality credentialing and State policies under Medicare/Medicaid also impede access to quality teleradiology. Comparative effectiveness studies involving diagnostic services must be cognizant of the impact of these forces and provide solutions to improve access
- One of the priorities should be coordinating, leveraging, and providing synergies with the Recovery Act and ongoing projects in developing and implementing the infrastructure for health IT, digital image transmission, e-health records, telemedicine, and teleradiology
Environmental control units
- The Council should recommend funding for an environmental control unit, which is a set of patient rooms in either the wing of a medical facility or a freestanding building. These rooms are constructed with special building materials that do not emit chemicals. The air in the unit is filtered, and the entire environment of these patients is strictly controlled. Using environmental control units can help us determine the influences on chronic disease, discern psychological illness from primary physical illness, and interpret symptom clusters previously thought to be unrelated
- The Council should look at comparative effectiveness research to include evaluation of EHR-mediated interventions. Studies have resulted in conflicting results in this area. Some interventions and some sites improved quality, while seemingly similar interventions at other sites resulted in no effect, and, in a few cases, quality was negatively impacted. Our understanding of which specific EHR features impact which quality attributes needs to become as nuanced as our selection of chemotherapy agents for specific cancers. This will only happen if we conduct appropriately designed, sufficiently powered, and meticulously analyzed multi-centered studies of these interventions
Complementary and alternative medicine
- The Council should consider complementary and alternative medicine (CAM). Some CAM interventions can have a positive effect that is approximately equal to conventional medicine. However, more research is needed to know what kind of modalities work best for what kinds of conditions
- The Council should consider using Continuing Medical Education (CME) in disseminating results to a widespread professional audience. CME reaches over a million physicians each month and almost as many nurses. Some studies have shown that CME participants were more likely than non-participants to make diagnostic and therapeutic choices based on clinical evidence. It is particularly critical to include educational components and outcome studies in order to determine the effectiveness of CER on changes in clinician behavior and patient health
Minority and rural groups
- Comparative effectiveness research should be designed to address the medical problems for minority groups and people living in rural areas. A disproportionate number of these people suffer from multiple chronic illnesses, such as diabetes, renal, and cardiovascular disease
- CER also should be designed to provide data for policy development and an organized system of care for those with multiple chronic conditions instead of comparisons for discrete treatments
Council’s Questions to the Panel
- Dr. Kilpatrick asked Mr. Findlay if he could elaborate what he meant by conflict of interest. We need funding into research that is completely independent of that source of funds, said Mr. Findlay. I think this initiative is an opportunity to move to a platform of getting research funded that is independent and unbiased, not tainted, methodologically flawed, or influenced by industry.
- Dr. Valuck asked the panel if they were given a billion dollars to spend over the next 2 years, what proportion would they devote to data infrastructure. I think a substantial portion of the billion could be used to build that infrastructure and to collect and analyze those data initially, said Mr. Scanlon.
This would be an expensive undertaking to start from scratch, said Mr. Lewis, so I think it is very important to look at what current data sources exist out there and what is the feasibility of reasonably linking some of these together while recognizing the shortcomings of this approach. To give some sort of idea of a specific number, I believe funding levels would have to be at or above the level of those in the FDA reauthorization to create a safety surveillance data network.
I suggested $25 million, which is a starting point to build on the infrastructure that already exists, said Dr. Harold Miller. There are regions around the country that are already assembling data and have registries. Those monies could help build on them and develop something similar in other areas around the country. I think that you could get extraordinarily high leverage for a very small amount of money.
I think this entity has the opportunity to work with others, such as the Quality Alliance Steering Committee, said Mr. Martin. There has been a lot of disparate activities in this area, a lot of very good work has been done, analytic work, and actual demonstration projects. I think you have an opportunity to feed into that.
- Dr. Clancy asked Dr. Martin if he could elaborate on his comment about “this being about improving quality, efficiency, and safety but also about learning about effectiveness and trade-offs.” Our point is that we want to make sure that if there is some sort of comparative effectiveness research that is done, we should have the ability to know all the inputs that go into such an analysis, said Mr. Martin. We want to make sure that the patient and provider can weigh the costs, safety, and quality issues appropriately in each instance, so they can do their own analyses.
- Dr. Parham Hopson asked panelists what patient involvement would look like in terms of CER. They would be involved from the very get-go, said Ms Moran. They need to be equal players at the table every step of the way. Patient representatives would be there throughout the process of conducting the research, disseminating the findings, and being part of the evaluation process. They can provide feedback on the question “is the research actually helpful to me as an individual when I make health care decisions with my family doctor or other health care provider.”
We have certainly seen over the years that consumers of mental health services can be involved in designing the services as well as in collecting, reporting, and analyzing the data, said Mr. Lewis. They also can be involved in the decisions that go into developing policy.
- Dr. Hunt asked the panel if they had any recommendations for being able to score or to judge the quality of patient input in trial design. In our case, we knew from the beginning that there needed to be patient involvement at every instance, said Ms. Weinberg. We actually have legal agreements that set specific numbers of patients on the Board of Directors, on the group that sets the standards, and the peer review teams that go out to universities, NIH, and other places. So there are models for how to incorporate and how to train participants to be as effective as possible.
The National Working Group on Evidence Based Health Care has also developed principles for patient inclusion throughout the CER process, said Ms. Moran. I would also be happy to share with you the Patient Bill of Rights for Participation in Particular Clinical Trials.
- Dr. Goodman remarked that Mr. Novelli spoke on the importance of the effort at hand in eliminating health disparities. He asked if he could provide some examples based on his organizational experience of things that the Council could learn. He also asked Ms. Miller to respond but in relation to using personalized health care. We are developing technologies that have a broad array of applicability, said Mr. Novelli. Those technologies can be specifically designed for specific study populations. I would be happy to provide the Council with more information.
We would just like to see that CER takes into consideration individual variations, said Dr. Miller. Variations can be genetic, based on biomarkers, or specific to groups of people based on age and gender, etc. What we want to try to answer is, “Why is this drug working for me, and why does this drug work for you?” When we get to that underlying level of answering, I think that's where we are going to get to the highest quality research.
- Dr. Delaney asked Dr. Couch what he thought should be the level of responsibility of those that use the information versus the Government's responsibility to set guidelines. He asked if Dr. Couch was raising more of a dissemination issue or if he had a concern about restriction. Plaintiff's attorneys can use anything they want in any way they want, said Dr. Couch. We already find them using the "never events," those events that are not no longer reimbursed, as “swords” in liability actions. They feel they have a lot of credibility because there is a certain governmental “imprimatur” behind them. We also are seeing that some physicians and their defense attorneys believe plaintiffs are going to use the results of comparative effectiveness studies in similar ways. I know this was never your intention or that of the researchers for them to use it in that way, but there is that concern.
- Dr. Delaney asked where one is supposed to draw the line on stakeholder representation, as the term “stakeholder” could be defined very broadly. Does this include only patients or also doctors and other members of the health care community? Sometimes people are worried that what works best for them in terms of health care will be put to a test and changed so that it benefits most people, but it no longer benefits them, said Dr. Miller. So we just need a layer of engagement where a consumer can voice those concerns in a real way and give you a vignette and talk about kinds of research that would be useful to them.
- Dr. Parham Hopson remarked that Mr. Novelli said that comparative effectiveness research should also be extended to prevention and wellness. She asked the panel whether that extension should reach beyond the hospital and clinic setting to other delivery sites. I think it definitely needs to extend beyond the hospital and clinic settings to private practice and to other venues, such as the workplace setting, said Dr. Hayes.
We believe that preventive care and behavioral health intervention should be included, said Ms. Lee. That would include things like screening and even diet and exercise as potential interventions to improve care.
The ultimate goal of personalized medicine and the mapping of the human genome is to get disease interventions much earlier, ideally to the point of preventing disease from ever taking hold, said Dr. Miller.
- Dr. Hunt said that as a surgeon, he is very sensitive to the added costs of malpractice. He asked whether this research should cut both ways and be an opportunity to provide a more solid and substantial defense. I agree, said Dr. Couch. I see this as providing a much more certain way for physicians and their defense attorneys to be able to defend themselves to the extent that they adhere to the best evidence-based standards that come out of comparative effectiveness research.
- Dr. Hunt said that he heard again and again how much dissemination of the information is important. He asked panelists what percentage they think should be spent on the dissemination piece. It’s great to have solid evidence by which to inform decisions, but the reality is that evidence is frequently not used, said Dr. Hayes. However, it is important that we figure out how to get evidence into practice and how to get it into decision making. My personal feeling is that 20 or 30 percent of the funds should go to dissemination.
Dissemination is a very, very important issue, said Mr. Burkholder. The work of Dr. McGlenn and others on the quality of care makes clear why, in addition to thinking about evidence-based care, we also need to think about how we can do a better job in getting patients the care that we already know is evidence-based. The evidence base we develop around comparative clinical effectiveness offers a substantial opportunity to ultimately improve value in health care if the
information gets disseminated and applied by physicians and patients. I think our primary goal is to orient information to the patient and provider, while also recognizing there are a lot of decision makers in health care.
When it comes to consumers, we have to make this information available in mechanism they can use and understand, said Dr. Keckley. The current language we use in our studies, even comparative effectiveness, glosses over and is a negative to consumers. So dissemination is huge, but it involves the end user, not just the delivery system.
- Mr. Marge mentioned that Stephen Bennett, of United Cerebral Palsy, had a robust research program for a number of years. He asked if he had moved into CER. We actually had a separation from our research organization because we felt like it wasn't moving in that direction, to be quite blunt, said Mr. Bennett. We want to put our focus, our money, and our time in stuff that is much more applicable today.
- Mr. Scanlon observed that Dr. Spencer had recommended that some of the CER focus on prevention wellness, health promotion, and community-based interventions. He asked if it should also open up to non-clinical, community-based interventions as well. Yes, said Dr. Spencer. Those of us working in that area think it is a continuum. It doesn't stop and start. I think it is very short-sighted to say “this is clinical and that is non-clinical.”
- Dr. Goodman asked what the Council could learn from the organizations represented by the panelists about applying CER to help reduce health disparities. We’ve heard testimony today about how outcome of disease management and the ultimate success of disease management are influenced by a number of factors that are considered in comparative effectiveness research, said Ms. Davenport-Ennis. When you begin to evaluate through CER, we believe you will reach nuanced findings due to genetic differences and comorbidities in individuals. That is, no two people are the same. We also believe that financial and socioeconomic status as well as insured and uninsured status will seriously impact the ultimate result of what treatment the patient is going to receive and ultimately what their outcomes are going to be. I think the lesson that we would share with you is to expect nuanced findings.
You need to broaden your perspective. If you don't broaden your perspective, you're not going to get the information you need, said Dr. Spencer. If you think that through small, well-defined studies you will translate what you learned to other populations to even approach disparities, I believe you are wrong. So if you are really going to approach disparities, we would offer a very strong argument for broadening your perspective.
From the perspective of the oral health research community, I think there is a great deal to be learned from studying the disparity centers supported by the National Institute of Dental and Craniofacial Research, said Dr. Fox. They have a number of centers across the country and one of them (UCSF) is examining it from a systems approach. Most of what we deal with is eminently preventable, but it’s a question of getting the right prevention to the right person at the right time.
- Dr. Emanuel asked, by a show of hands, how many panelists thought that what needs to be evaluated when doing comparative effectiveness research is comprehensive outcome, including things like hospitalizations, emergency room visits, and use of other interventions. The vast majority of the panelists raised their hands.
- Dr. Emanuel asked, by show of hands, how many panelists thought that we should use registries, claims data, and other data sources other than clinical trials. Everyone raised their hands.
- Dr. Emanuel asked, by show of hands, how many panelists thought costs should be used as an outcome measure. The vast majority raised their hands.
Advanced Medical Technology Association
Teresa Lee, Vice President
American Association for Dental Research
Dr. Christopher Fox, Executive Director
American Society of Consultant Pharmacists
Claudia Schlosberg, Director*
Association of American Medical Colleges
Dr. Eugene Rich, Scholar in Residence
Association of Clinical Research Organizations
John Lewis, Vice President of Public Affairs
Association of Perioperative Registered Nurses
Paula Grailing, Past President
Association of Schools of Public Health
Dr. Harrison Spencer, President and Chief Executive Officer
Campaign for Mental Health Reform
William Emmet, Director
Steven Findlay, Senior Health Policy Analyst*
Deloitte Center for Health Solutions
Paul Keckley, Executive Director
Friends of Cancer Research
Dr. Jeff Allen, Executive Director
Dr. Winifred Hayes, President and Chief Executive Officer
Harvard Medical School
Dr. Lisa Iezzoni, Professor
Johnson & Johnson
Kathleen Buto, Vice President of Health Policy
Medical Device Manufacturers Association
Thomas Novelli, Director of Federal Affairs*
National Health Council
Myrl Weinberg, Chief Executive Officer
National Hispanic Medical Association
Dr. Elena Rios, President and Chief Executive Officer
National Patient Advocate Foundation
Nancy Davenport-Ennis, President and Chief Executive Officer*
National Business Group on Health
Steve Wojcik, Vice President of Public Policy
National Pharmaceutical Council
Gary Persinger, Vice President
The National Working Group on Evidence Based Health Care
Hazel Moran, Convener
Network for Regional Healthcare Improvement
Harold Miller, President and Chief Executive Officer
Open Society Institute
Victor Capoccia, Director
Patient Safety Solutions, LLC
James Couch, Chief Medical Officer
Personalized Medicine Coalition
Dr. Amy Miller, Public Policy Director*
Joseph Burkholder, Senior Health Policy Analyst*
Premier Research Services
John Martin, Director
SUNY Upstate Medical University
Dr. Margaret Turk, Professor
United Cerebral Palsy
Stephen Bennett, President and Chief Executive Officer
WA State Health Care Authority
Leah Hole-Curry, Health Technology Assessment Director
* Self-identified as a registered lobbyist
Open Public Comment Speakers
The AIDS Institute
American Library for Health
Jeffrey Cooper, President and CEO
Former journalist and certified healing touch practitioner
Justin Starren, Director, Biomedical Informatics Research Center
Carol Peckham, Director of Editorial Development
Private practice physician
Dr. Adrienne Sprouse, specialist in environmental medicine
Virtual Radiologic Corporation
Stephanie Mensh (on behalf of VRC)
Anne C. Haddix, Ph.D.
Chief Policy Officer, Office of Strategy and Innovation
Centers for Disease Control and Prevention
Thomas B. Valuck, M.D., MHSA, J.D.
Medical Officer and Senior Advisor, Center for Medicare Management
Centers for Medicare & Medicaid Services
Peter Delany, PhD, LCSW-C
Director, Office of Applied Studies
Substance Abuse & Mental Health Services Administration
Carolyn M. Clancy, M.D.
Agency for Healthcare Research and Quality
Deborah Parham Hopson, Ph.D., RN, FAAN
Associate Administrator, HIV/AIDS Bureau
Health Resources and Services Administration
David Hunt, M.D.
Chief Medical Officer, Office of the National Coordinator
U.S. Department of Health and Human Services
Acting Assistant Secretary for Planning and Evaluation
U.S. Department of Health and Human Services
Elizabeth Nabel, M.D.
Director, National Heart, Lung, and Blood Institute
National Institutes of Health
Garth N. Graham, M.D., M.P.H.
Deputy Assistant Secretary, Office of Minority Health
U.S. Department of Health and Human Services
Jesse L. Goodman, M.D., M.P.H.
Acting Chief Medical Officer
Director, Center for Biologics Evaluation and Research
U.S. Food and Drug Administration
Michael Marge, Ed.D.
Acting Director, Office on Disability
U.S. Department on Health and Human Services
Neera Tanden, J.D.
Counselor for Health Reform
Office of the Secretary
U.S. Department of Health and Human Services
Joel Kupersmith, M.D.
Chief Research and Development Officer
Michael Kilpatrick, M.D.
Director of Strategic Communications for the Military Health System
Department of Defense
Ezekiel J. Emanuel, M.D., Ph.D.
Special Advisor for Health Policy
Office of Management and Budget