Comparative Effectiveness Research: 21st Century Health Care

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Comparative Effectiveness Research 21st Century
Health Care

• Carolyn M. Clancy, MD
• Agency for Healthcare Research and Quality
• Penn State University College of Medicine
• July 31, 2009

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(No Transcript)
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Health Care Reform in the Current Economic
Environment
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It is more important than ever to take on health
care reform now
We cannot afford to take on health care reform
right now
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Kaiser Family Foundation Health Tracking Poll
(Conducted (April 2-8, 2009)
Dont Know/Refused
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More Say Reform Would Help
Country
Do you think (you and your family/the country as
a whole) would be better off if the president and
Congress passed health care reform, or dont you
think it would make much difference?
Kaiser Family Foundation Health Tracking Poll
(Conducted April 2-8, 2009)
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Current Challenges

• Concerns about health spending about 2.3
  trillion per year in the U.S. and growing
• Large variations in clinical care
• A lot of uncertainty about best practices
  involving treatments and technologies
• Pervasive problems with the quality of care that
  people receive
• Translating scientific advances into actual
  clinical practice
• Translating scientific advances into usable
  information for clinicians and patients

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Comparative Effectiveness Research

• AHRQ Resources Priorities
• Comparative Effectiveness Research
• Comparative Effectiveness and Health IT
• QA

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HHS Secretary Kathleen Sebelius

• It is an honor to lead the Department of Health
  and Human Services and I am grateful for the
  opportunity to serve at such a pivotal moment in
  our history

Kathleen Sebelius
Sworn in as the 21st Secretary of the Department
of Health and Human Services
April 29, 2009
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HHS Organizational Focus
NIH Biomedical research to prevent, diagnose and
treat diseases
CDC Population health and the role of
community-based interventions to improve health
AHRQ Long-term and system-wide improvement of
health care quality and effectiveness
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AHRQs Mission
Improve the quality, safety, efficiency and
effectiveness of health care for all Americans
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AHRQ Roles and Resources

• Health IT Research
• Funding
• Support advances that improve patient
  safety/quality of care
• Continue work in hospital settings
• Step up use of HIT to improve ambulatory patient
  care

• Develop Evidence Base for Best Practices
• Four key domains
• Patient-centered care
• Medication management
• Integration of decision support tools
• Enabling quality measurement

• Promote Collaboration
• and Dissemination
• Support efforts of AHIC, ONC, HRSA and Centers
  for Medicare and Medicaid Services
• Build on public and private partnerships
• Use web tools to share knowledge and expertise

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AHRQ FY 2009 Funding

• 372 million
• 37 million more than FY 2008
• 46 million more than the presidents request
• FY 2009 appropriation includes
• 50 million for comparative effectiveness
  research, 20 million more than FY 2008
• 49 million for patient safety activities
• 45 million for health IT

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AHRQ Priorities
Patient Safety

• Health IT
• Patient SafetyOrganizations
• New PatientSafety Grants

Effective HealthCare Program
AmbulatoryPatient Safety

• Comparative Effectiveness Reviews
• Comparative Effectiveness Research
• Clear Findings for Multiple Audiences

• Safety Quality Measures,Drug Management
  andPatient-Centered Care
• Patient Safety ImprovementCorps

Medical ExpenditurePanel Surveys
Other Research Dissemination Activities

• Visit-Level Information on Medical Expenditures
• Annual Quality Disparities Reports

• Quality Cost-Effectiveness, e.g.Prevention and
  PharmaceuticalOutcomes
• U.S. Preventive ServicesTask Force
• MRSA/HAIs

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Multi-Media Campaigns Get Patients Involved

• AHRQ expands Ad Council campaign with a new
  series of TV and radio public service
  announcements along with printed consumer
  resources

http//www.ahrq.gov/questionsaretheanswer
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AHRQs Latest Reports on Quality and Disparities

• The median annual rate of change for all quality
  measures was 1.4
• Of 190 measures, 132 (69) showed some
  improvement
• Some reductions in disparities of care according
  to race, ethnicity, income
• Disparities persist in health care quality and
  access

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Quality Report Key Findings

• Median level of patients receiving needed care
  was 59 for core quality measures
• Quality improvements spread unevenly across
  settings of care (hospitals, home care, long-term
  care, ambulatory care)
• Measures of patient safety in the Quality Report
  indicate a 1 annual decline
• Need consensus on single core set of measures to
  be used by all payers and stakeholders to monitor
  improvement

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Disparities Report Key Findings

• 60 of measures of quality are not improving for
  Blacks, Asians, American Indians/Alaska Natives
  (AI/AN), Hispanics, poor populations trend for 6
  years
• 80 of access measures stayed the same or got
  worse for Hispanics
• 60 of access measures stayed the same or got
  worse for Blacks and Asians
• 57 of access measures stayed the same or got
  worse for poor populations

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PA Overall Health Care Quality
Performance vs. All States, One-Year Performance
Change
Average
Weak
Strong
Very Weak
Very Strong
Performance Meter
2008 National Healthcare Quality Report, State
Snapshots
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Pennsylvania Snapshot
National Healthcare Quality Report, State
Snapshots, 2008
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Comparative Effectiveness Research

• AHRQ Resources Priorities
• Comparative Effectiveness Research
• Comparative Effectiveness and Health IT
• QA

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U.S. Landscape for Comparative Effectiveness
Research

• Well intentioned
• Ad hoc except for AHRQs mandate
• Limited capacity to do the research and translate
  the research into meaningful and useable
  applications

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Comparative Effectiveness
and the Recovery Act

• The American Recovery and Reinvestment Act of
  2009 includes 1.1 billion for comparative
  effectiveness research
• AHRQ 300 million
• NIH 400 million (appropriated to AHRQ and
  transferred to NIH)
• Office of the Secretary 400 million (allocated
  at the Secretarys discretion)

www.hhs.gov/recovery
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Other Aspects of
the Recovery Act

• Comparative Effectiveness Research conducted with
  funds appropriated under the Recovery Act, shall
  be consistent with Departmental policies relating
  to the inclusion of women and minorities.
• Congress does not intend for the research money
  to be used to mandate coverage reimbursement or
  other policies for any public or private payer.
• Details about the types of research being funded
  or supported must be submitted to Congress every
  six months, beginning Nov. 1, 2009

www.hhs.gov/recovery
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Recovery Act Timeline AHRQ
May 1 Due date for Agency wide and
program-specific Recovery Act plans
July 30 AHRQ to submit FY 09 Operations
Plan
December 31, 2010 All Recovery Act funding to be
obligated
February 17 The American Recovery and
Reinvestment Act of 2009 is signed into law
2009
January
April
July
October
2010
November 1 AHRQ FY 10 operations plan
due
March 19 The Federal Coordinating Council for
Comparative Effectiveness Research is established
June 30 Due date for IOM submission of a list of
national priority conditions
Stakeholder input required
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Federal Coordinating Council

• Anne Haddix, CDC
• Thomas Valuck, CMS
• Peter Delany, SAMHSA
• Carolyn Clancy, AHRQ
• Deborah Hopson, HRSA
• David Hunt, ONC
• James Scanlon, HHS
• Garth Graham, Office of Minority Health

• Elizabeth Nabel, NIH
• Jesse Goodman, FDA
• Michael Marge, Office on Disability
• Neera Tanden, HHS
• Joel Kupersmith, VA
• Michael Kilpatrick, DoD
• Ezekiel Emanuel, OMB

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Definition Comparative Effectiveness Research

• Comparative effectiveness research (CER) is the
  generation and synthesis of evidence that
  compares the benefits and harms of alternative
  methods to prevent, diagnose, treat and monitor a
  clinical condition or to improve the delivery of
  care. The purpose of CER is to assist consumers,
  clinicians, purchasers and policy makers to make
  informed decisions that will improve health care
  at both the individual and population levels.
• National Priorities for Comparative Effectiveness
  Research
• Institute of Medicine Report Brief
• June 2009

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IOM Priorities for Comparative Effectiveness
Research

• 100 recommendations listed in four groups of 25,
  ranging from highest to lowest priority
• Includes the Federal Coordinating Councils
  definition of comparative effectiveness research
• Key elements of the definition
• Direct comparison of effective interventions
• Study of patients in typical day-to-day clinical
  care
• Tailoring decisions to the needs of individual
  patients

Report Brief Available At http//www.iom.edu
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AHRQs Role in Comparative
Effectiveness
Using Information to Drive Improvement
Scientific Infrastructure to Support Reform
Providing information that can be used on the
frontlines of treatment

• Helping to make decisions more consistent,
  transparent and rational

Promoting an open and collaborative approach to
comparative effectiveness
Ensuring the effectiveness data is more widely
used
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The Effective Health Care Program at AHRQ

• Evidence synthesis (EPC program)
• Systematically reviewing, synthesizing, comparing
  existing evidence on treatment effectiveness
• Identifying relevant knowledge gaps
• Evidence generation (DEcIDE, CERTs)
• Development of new scientific knowledge to
  address knowledge gaps.
• Accelerate practical studies
• Evidence communication/translation (Eisenberg
  Center)
• Translate evidence into improvements
• Communication of scientific information in plain
  language to policymakers, patients, and providers

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Transparent Collaborative Process with New
Opportunities

• Expanded infrastructure and capacity for
  Comparative Effectiveness Research
• Prospective studies that include
  under-represented populations
• Pushing forward on methods for Comparative
  Effectiveness Research
• Increasing investments in innovative broad
  dissemination and translation

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Comparative Effectiveness Funding Opportunities

• Opportunities for the field to become involved
  will be made available as soon as possible
• To sign up for updates, visit http//effectiveheal
  thcare.ahrq.gov
• To review AHRQs standing program and training
  award announcements http//www.ahrq.gov/fund/grant
  ix.htm

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Comparative Effectiveness Research

• AHRQ Resources Priorities
• Comparative Effectiveness Research
• Comparative Effectiveness and Health IT
• QA

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Health IT and Comparative Effectiveness Research

• As with comparative effectiveness research,
  health IT is a useful tool in a much larger
  toolkit it is necessary, but not the solution.
  With regards to comparative effectiveness
  research, health IT can play pivotal roles. For
  example
• Information gathering technology has the
  potential to enable studies to be completed
  much, much faster
• Dissemination Results about
  new findings can be widely
  distributed very quickly

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AHRQ Health IT Research Funding

• Long-term agency priority
• AHRQ has invested more than 260 million in
  contracts and grants
• More than 150 communities, hospitals, providers,
  and health care systems in 48 states

http//healthit.ahrq.gov
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Meaningful Use

• The Recovery Act calls for establishment of an
  incentive for providers who become meaningful
  users of electronic health records
• A Federal Health IT Policy Committee workgroup is
  developing criteria for a definition of
  meaningful use
• AHRQ provides Federal partners with the best
  available evidence on how proposed criteria for
  meaningful use might help to achieve the ultimate
  goal of high quality, high value health care

http//healthit.hhs.gov
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Health IT EPC Report

• First synthesis of existing evidence on factors
  influencing the usefulness, usability, barriers
  and drivers to use, and effectiveness of consumer
  applications
• The top factor associated with use by patients
  was the perception of a health benefit
• Patients prefer systems tailored to them that
  incorporate familiar devices

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Distributed Network Prototypes for
Population-Based Studies

• Aim to develop a federated network prototype
  that supports secure analyses of electronic
  information across multiple organizations to
  study risks, effects and outcomes of various
  medical therapies
• The long-term goal is a coordinated partnership
  of multiple research networks that provide
  information that can be quickly queried and
  analyzed
• Model 1 Colorado DEcIDE center with American
  Academy of Family Practice will develop the
  Distributed Ambulatory Research Network
  (DARTNet) using electronic health record (EHR)
  data from eight organizations representing over
  200 clinicians and over 350,000 patients
• Model 2 HMO Research Network (HMORN) DEcIDE will
  develop the Virtual Data Warehouse to assess
  the effectiveness and safety of different
  anti-hypertensive 5.5 to 6 million individuals
  cared for by six health plans

AHRQ Centers for Outcomes and Evidence
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Research Opportunities

• Health IT Funding Opportunities
• PAR-08-270 Utilizing Health Information
  Technology (IT) to Improve Health Care Quality
  (R18)
• PAR-08-269 Exploratory and Developmental Grant to
  Improve Health Care Quality through Health
  Information Technology (IT) (R21)
• PAR-08-268 Small Research Grant to Improve Health
  Care Quality through Health Information
  Technology (IT) (R03)

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Moving Forward
Issues to Consider

• Comparative Effectiveness is a useful tool in a
  much larger toolkit it is necessary but not
  sufficient
• It does not make policy or health care decisions,
  tell doctors how to practice medicine or make
  final decisions about what kind of treatments
  insurers will pay for
• It does weigh the evidence and present it in a
  way that helps consumers and their doctors make
  the best possible decisions about health care
  choices
• Its also an opportunity to identify what is not
  known/areas where research is needed

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Comparative Effectiveness Research

• Public-private funding and participation likely a
  necessity
• More effort to get better conditional
  reimbursement study designs/protocols
• Patients should be engaged as partners at the
  local and national levels
• Need to tackle important issues
• Ethical
• When to know when the evidence is sufficient
• Transparency
• Setting priorities

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Comparative Effectiveness Research

• AHRQ Resources Priorities
• Comparative Effectiveness Research
• Comparative Effectiveness and Health IT
• QA