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1
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2
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- This conference has been about strategies to develop evidence
- Maximizing the quality of evidence given limited research dollars.
- Cost-effective input into evidence-based policy decisions
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3
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- This conference has been about strategies to develop evidence
- Maximizing the quality of evidence given limited research dollars.
- Cost-effective input into policy decisions
- This session is about the quality of public decision making.
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4
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- Described CMS coverage policymaking
- Population-level expected outcome decision making
- Efficacy is the decision criterion, not cost.
- Cost enters with price setting
- How would decisions change if CE was a criterion?
- How much benefit is enough?
- At least as much as previously covered item
- Do coverage decisions consistently mirror the evidence?
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5
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- Advice about how to allocate research funding
- Argues for population health perspective in setting funding priorities
- Should use C-E as a measure of value when setting priorities.
- Who decides our national research funding priorities now? How?
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6
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- Get revenue from insurers and employers.
- A prudent buyer of “medically necessary services.”
- Tries to control volume, not unit price.
- Strives for consistency by using services of proven effectiveness.
- Frustrated by appeals to use unproven, costly therapy.
- Will costly new technology be judged only on efficacy or on cost per
QALY?
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7
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- The common theme: decisions about policies to allocate scarce resources
- Investment in research
- Investment in clinical services
- A common sub-theme: taking a population perspective
- Frustrated by appeals to make exceptions
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8
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- This conference has been about strategies to develop evidence to support
decision making about policy
- This session is about the quality of decision making about policy.
- What values drive these decisions?
- Do our policy decisions consistently reflect these values?
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9
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- We can certainly do better in our public policy decision-making.
- Inconsistency in applying principles
- Population perspective
- Evidence-based
- Focus on value (C-E)
- Consistency is good. Can we also
allow for reasonable variation in practice?
- Can we develop a consistent approach to allowing some flexibility?
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10
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- “A foolish consistency is the hobgoblin of little minds.”
- Ralph Waldo Emerson (as quoted in Next Stop Wonderland)
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- Consistency:
- Rules to evaluate evidence
- Rules for using evidence to make a decision
- Advantages
- To manufacturers (how to plan)
- To funding agencies (what research to fund)
- To researchers (which research to do)
- Doctors and patients (meaning of a recommendation)
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12
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- Consistency of approach:
- We have good decision processes but we’re not consistent in applying
them.
- USPSTF as a model of consistency and transparency
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13
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- A - Strongly recommend
- good evidence, benefits substantially outweigh harms
- B - Recommend
- at least fair evidence, benefits outweigh harms
- C - USPSTF makes no recommendation
- fair to good evidence, benefits and harms closely balanced
- D - Recommend against routine use
- ineffective or harms outweigh potential benefits
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14
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- Lack of evidence on clinical outcomes
- Poor quality of existing studies
- Good quality studies with conflicting results
- Confidence interval includes clinically important benefits
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- Consistent results
- Well-designed, well conducted
- Representative populations
- Directly assesses effects on health outcomes
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17
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- Evidence adequate to determine effects on health outcomes but limited
by:
- Number, quality, or consistency of studies
- Generalizability to routine practice
- Indirect character of the effect on health outcomes
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18
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- Evidence is insufficient to assess effects on health outcomes because
- Limited number studies
- Limited power of studies (wide 95% CI àinconclusive results)
- Important flaws in design or conduct
- Gaps in the chain of evidence
- Lack of information on health outcomes
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- A problem: the imposition of different value systems on the decision
process.
- Politicians, profit, and patients (the 3 Ps)
- Will better quality data lead to better quality decision making?
- Precise, unbiased estimates of health effects based on many studies
- Will better data lead to consistency in policymaking? Will it trump the 3 Ps?
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20
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- We can certainly do better in our public policy decision-making.
- Be more consistent in applying principles of good decision making.
- Learning to allow for reasonable variation in practice.
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