Engaging Decision Makers in Comparative Effectiveness
Research
Sean Tunis MD, MSc
July 11, 2008
Calls for a National Institute of Comparative Effectiveness Research
(NICER)• MMA Section 1013 (2003)• Gail Wilenksy, Health Affairs (11/06)• Health Industry Forum (11/06)• AHIP, BCBSA proposals (early 2007)• MedPAC report, CBO testimony (6/07)• Obama, Clinton, Edwards reform plans (mid 2007)• CBO final report (12/07)• Commonwealth ‘Bending the Curve’ report (12/07)• House and Senate legislative proposals
Medicare Spending per Capita in the United States, 2003
Source: Dartmouth Atlas of Health Care.
$7,000$7,000 to to 11,35211,352 (63)(63)
6,5006,500 to < to < 7,0007,000 (53)(53)
6,0006,000 to < to < 6,5006,500 (56)(56)
5,5005,500 to < to < 6,0006,000 (64)(64)
4,2724,272 to < to < 5,5005,500 (70)(70)
Not PopulatedNot Populated
Source: www.dartmouthatlas.org.
CER Definition
• “Research evaluating and comparing the implications and outcomes of 2 or more health care strategies to address a particular medical condition”
• Primary focus on drugs, devices, procedures, diagnostics
Methods
• Systematic reviews / HTA• Retrospective studies
– with claims and/or EMR data
• Modeling (+/- cost data)• Prospective observational or experimental
studies
How is CER Different
• More political insulation• Oversight by multi-stakeholder board• Increased transparency• Improved observational methods• Adoption of electronic health records• Much more money• Greater determination (and panic)
Built By and For Decision Makers
• Evidence enterprise designed around the needs and use of decision makers– Patients, clinicians, payers, policymakers
• They must be meaningfully engaged in all aspects (priority setting, study design, etc)
• Limited success with meaningfully engaging decision makers – some notable exceptions: CUE, NBCC, JDRF– limited effort to broadly, systematically improve
Center for Medical Technology Policy
• Structure: private, non-profit– First 2 years: foundations, government– 2008+: diverse membership
• Primary Mission: to support collaborative efforts that will improve the quality and efficiency of prospective studies of new and existing medical technologies
• Focus: Evidence development guided by decision makers (DBEM)– Patients, clinicians, payers, policy makers
Applied POLICY and METHODS ProjectsApplied POLICY and METHODS Projects
PRIORITIESfor
Evidence Development
PRIORITIESfor
Evidence Development
Trial DESIGN and IMPLEMENTATION
Trial DESIGN and IMPLEMENTATION
EffectivenessGUIDANCE Documents
EffectivenessGUIDANCE Documents
IMPROVE THE QUALITY AND EFFICIENCY
OF RESEARCH FOR DECISION MAKING
IMPROVE THE QUALITY AND EFFICIENCY
OF RESEARCH FOR DECISION MAKING
CMTP Project Categories
Coronary CTA Protocol DevelopmentWorkgroup Members and Observers
• Aetna• Kaiser Permanente• UnitedHealth• MN Medicaid• BCBSA• GE Healthcare• Siemens Medical• Philips Medical• Toshiba
• AHA• Patient reps• ACC, ACRIN• FDA, • CMS• AHRQ• Clinical researchers• Health economist
Coverage for Evidence Development Workgroup Members
• General Electric• Blue Shield of California• Wellpoint/Anthem• Aircraft Gear• Fidelity• Kaiser Permanente• Washington State Office of TA• SEIU• University of Michigan• MD Anderson• Oklahoma Medical Authority
• PacFed Benefits Administrators
• Patient Advocates in Research
• Center for Medical Consumers
• Harvard University• Aetna• United Healthcare• California Association of
Physician Groups• National Business Group on
Health• California Pacific Medical Ctr
Engaging Patients - 1
• There is not a natural patient advocacy group for every topic. (Tele-ICU workgroup)
• If there is group, members have to care about research. – For some patient groups, it’s all about access, all
the time.
• Technical nature of work requires belief that the results will matter
Engaging Patients - 2
• Need subject-specific patient advocates as well as more general advocates – each brings a different perspective to the table
• One of the most important characteristics of an effective and engaged advocate is “strong intellectual curiosity”
• Smart people get energized by other smart people – bringing a variety of perspectives to the table makes the “stew” a lot spicier
Clinician Advisors Meeting
• Multi-stakeholder clinician group convened to discuss how to engage clinicians in CER
• practicing MDs (community and academic), medical group medical directors, nurses, hospital system CMO
• Broad agreement on willingness to help• Time pressure, money, and unfamiliarity with
research were key constraints
Key Take Home Messages
• Decision makers will engage in evidence review and development if – they believe their perspective is valued– they believe that the activity will have some impact– Carefully selected for being smart, energetic
• We (academics, researchers, etc) need to be more systematic learning to do this well
• If we don’t meaningfully engage the decision makers, the enterprise will always struggle