Making Comparative Effectiveness Making Comparative Effectiveness More than a Dream More than a Dream

Carolyn M. Clancy, MDCarolyn M. Clancy, MD

DirectorDirector

Agency for Healthcare Research and QualityAgency for Healthcare Research and Quality

AcademyHealth’s 2008 National Health Policy ConferenceAcademyHealth’s 2008 National Health Policy Conference

Washington, DC – February 4, 2008Washington, DC – February 4, 2008

Excellence & MediocrityExcellence & Mediocrity

Turning Evidence Into ActionTurning Evidence Into Action

2121stst Century Health Care Century Health Care

Comparative EffectivenessComparative Effectiveness

Excellence & MediocrityExcellence & Mediocrity

““A society which scorns A society which scorns excellence in plumbing excellence in plumbing simply because it is simply because it is plumbing, but rewards plumbing, but rewards mediocre philosophy simply mediocre philosophy simply because it is philosophy will because it is philosophy will soon become a society in soon become a society in which neither its pipes nor its which neither its pipes nor its theories will hold water.”theories will hold water.”

John W. Gardner (1961)John W. Gardner (1961)

Scope of the Opportunity Scope of the Opportunity in Health Carein Health Care

Major challenges in 21Major challenges in 21stst Century health care include Century health care include evaluating all of the evaluating all of the innovations and innovations and determining which:determining which:– Represent added valueRepresent added value

– Offer minimal enhancements Offer minimal enhancements over existing choicesover existing choices

– Fail to reach their potentialFail to reach their potential

– Work for some patients and Work for some patients and not for othersnot for others

Improving Evidence about Improving Evidence about Benefits and RisksBenefits and Risks

Comparative effectiveness Comparative effectiveness research addresses issues research addresses issues including:including:– RelevancyRelevancy

– TimelinessTimeliness

– Impact on priority populationsImpact on priority populations

– Disproportionate impact on subpopulationsDisproportionate impact on subpopulations

– The ability to impact treatment decisionsThe ability to impact treatment decisions

AHRQ FY 2008 PrioritiesAHRQ FY 2008 Priorities

Effective HealthEffective HealthCare ProgramCare Program

Medical ExpenditureMedical ExpenditurePanel SurveysPanel Surveys

AmbulatoryAmbulatoryPatient SafetyPatient Safety

PatientPatient Safety Safety

Health IT Patient Safety

Organizations New Patient

Safety Grants Comparative Effectiveness Reviews

Comparative Effectiveness Research

Clear Findings for Multiple Audiences

Quality & Cost-Effectiveness, e.g.Prevention and PharmaceuticalOutcomes

U.S. Preventive ServicesTask Force

MRSA/HAIs

Visit-Level Information on Medical Expenditures

Annual Quality & Disparities Reports

Safety & Quality Measures,Drug Management andPatient-Centered Care

Patient Safety ImprovementCorps

Other Research & Other Research & Dissemination ActivitiesDissemination Activities

AHRQ FY 2008 FundingAHRQ FY 2008 Funding

$334.6 million $334.6 million – FY 2008 Request – $329.6 millionFY 2008 Request – $329.6 million– FY 2007 Appropriation – $318.7 millionFY 2007 Appropriation – $318.7 million

FY 2008 appropriation includes:FY 2008 appropriation includes:– $30 million for comparative effectiveness research$30 million for comparative effectiveness research

Double the $15 million designated in FY 2007Double the $15 million designated in FY 2007– $5 million for research and activities to reduce Methicillin Resistant $5 million for research and activities to reduce Methicillin Resistant

Staphylococcus aureusStaphylococcus aureus (MRSA) and related infections (MRSA) and related infections The first such federal grant to AHRQ for MRSA/HAIsThe first such federal grant to AHRQ for MRSA/HAIs

Congress also encouraged AHRQ to:Congress also encouraged AHRQ to:– Consider proposals to detect medical errors and preemptively Consider proposals to detect medical errors and preemptively

control injury via compact medical devicescontrol injury via compact medical devices– Investigate the feasibility of an open-source, no-cost license Investigate the feasibility of an open-source, no-cost license

computer model capable of predicting the effects of health care computer model capable of predicting the effects of health care policy alternatives to improve quality and cost-effectivenesspolicy alternatives to improve quality and cost-effectiveness

AHRQ Comparative AHRQ Comparative Effectiveness ResearchEffectiveness Research

The additional funding for comparative The additional funding for comparative effectiveness will help ARHQ generate effectiveness will help ARHQ generate a wealth of new products and tools:a wealth of new products and tools:– The number of comparative effectiveness The number of comparative effectiveness

reviews and technical briefs will doublereviews and technical briefs will double– New research initiated will include studies New research initiated will include studies

on surgery, prescription drugs, biologics on surgery, prescription drugs, biologics and vaccines for Medicare beneficiaries in and vaccines for Medicare beneficiaries in priority condition areaspriority condition areas

– A new series of technical reports will A new series of technical reports will establish a foundation for guiding the establish a foundation for guiding the evaluation of gene-based test performance evaluation of gene-based test performance

– The number of products designed to help The number of products designed to help patients and clinicians make informed patients and clinicians make informed decisions will increasedecisions will increase

Program EnhancementsProgram Enhancements

Two reports will be commissioned for Two reports will be commissioned for use by AHRQ to:use by AHRQ to:– Enhance the Effective Health Care Enhance the Effective Health Care

Program’s infrastructure and growth needsProgram’s infrastructure and growth needs

– Begin assessing the Program’s impactBegin assessing the Program’s impact

Money from the initial funding will be Money from the initial funding will be used for awards to develop and used for awards to develop and enhance individual scientist research enhance individual scientist research and methodological capacities for and methodological capacities for conducting future comparative conducting future comparative effectiveness researcheffectiveness research

The Promise of Genomics: The Promise of Genomics: Recent ActivitiesRecent Activities

AHRQ is funding a Randomized Control Trial to clarify the added AHRQ is funding a Randomized Control Trial to clarify the added value of genetic testing to improve warfarin dosing.value of genetic testing to improve warfarin dosing.

AHRQ and CDC are co-funding a DEcIDE project to review AHRQ and CDC are co-funding a DEcIDE project to review databases focusing on utilization and outcomes ofdatabases focusing on utilization and outcomes of gene-based gene-based tests and therapiestests and therapies

EPC Reports:EPC Reports:– Genomic testing in ovarian cancer Genomic testing in ovarian cancer

(completed)(completed)– CYP450 testing in depression CYP450 testing in depression

(completed)(completed)– HNPCC testing in colorectal HNPCC testing in colorectal

patients (completed)patients (completed)– Horizon scan on cancer genetic Horizon scan on cancer genetic

tests for CMS (completed)tests for CMS (completed)– BRCA testing in breast and BRCA testing in breast and

ovarian cancers (w/USPSTF ovarian cancers (w/USPSTF recommendation)recommendation)

– HER-2-Neu testing in breast HER-2-Neu testing in breast cancer (ongoing)cancer (ongoing)

– Expression profile tests in breast Expression profile tests in breast cancer (completed)cancer (completed)

– Family history in breast, ovarian, Family history in breast, ovarian, colorectal and prostate cancers colorectal and prostate cancers (completed)(completed)

– Screening for hemochromatosis Screening for hemochromatosis (w/USPSTF recommendation)(w/USPSTF recommendation)

Comparative Effectiveness:Comparative Effectiveness:Effective Health Care ProgramEffective Health Care Program

Uses current, unbiased evidence in making Uses current, unbiased evidence in making head-to-head comparisons to show which head-to-head comparisons to show which health interventions:health interventions:– Add ValueAdd Value

– Offer minimal benefit above current choicesOffer minimal benefit above current choices

– Fail to reach their potentialFail to reach their potential

– Work for some patients, but not othersWork for some patients, but not others

Builds on years of experience gained through Builds on years of experience gained through AHRQ’s Evidence-Based Practice centersAHRQ’s Evidence-Based Practice centers

Goal: To develop and disseminate better evidence Goal: To develop and disseminate better evidence about benefits and risks of alternative choicesabout benefits and risks of alternative choices

Effective Health Care ProgramEffective Health Care Program

A.A. Evidence synthesis (EPC program)Evidence synthesis (EPC program)– Systematically reviewing, synthesizing, comparing existing Systematically reviewing, synthesizing, comparing existing

evidence on treatment effectivenessevidence on treatment effectiveness– Identifying relevant knowledge gapsIdentifying relevant knowledge gaps

B.B. Evidence generation (DEcIDE, CERTs)Evidence generation (DEcIDE, CERTs)– Development of new scientific knowledge to address Development of new scientific knowledge to address

knowledge gaps. knowledge gaps. – Accelerate practical studiesAccelerate practical studies

C.C. Evidence communication/translation Evidence communication/translation (Eisenberg Center)(Eisenberg Center)– Translate evidence into improvements Translate evidence into improvements – Communication of scientific information in plain language to Communication of scientific information in plain language to

policymakers, patients, and providerspolicymakers, patients, and providers

2121stst Century Health Care Century Health Care

Improving quality by promoting a culture of safety Improving quality by promoting a culture of safety through Value-Driven Health Care through Value-Driven Health Care

21st Century Health Care

Information-rich, patient-Information-rich, patient-focused enterprisesfocused enterprises

Information and Information and evidence transform evidence transform

interactions from interactions from reactive to reactive to

proactive (benefits proactive (benefits and harms)and harms)

Evidence is Evidence is continually refined continually refined as a by-product of as a by-product of

care deliverycare delivery

Actionable information available – to Actionable information available – to clinicians AND patients – “just in time”clinicians AND patients – “just in time”

The Social Case: Potential lives The Social Case: Potential lives saved through quality improvementsaved through quality improvement

Woolf and Johnson,

How Can We How Can We Enhance Our Efforts?Enhance Our Efforts?

The Evolution of Translational Research

Making Better DecisionsMaking Better Decisions

Many decisions in healthcare require different Many decisions in healthcare require different types of evidencetypes of evidence

The demand side is as important as the The demand side is as important as the production of evidenceproduction of evidence

Wise and prudent use of resources and Wise and prudent use of resources and opportunities to advance effective health care opportunities to advance effective health care is imperativeis imperative

AHRQ’s Effective Health Care Program is the AHRQ’s Effective Health Care Program is the model for how this can be achievedmodel for how this can be achieved

www.effectivehealthcare.ahrq.govwww.effectivehealthcare.ahrq.gov

““Comparative Effectiveness Research typically will focus Comparative Effectiveness Research typically will focus on realistic decisions confronting patients and their on realistic decisions confronting patients and their clinicians in actual practice…. Because of this focus on clinicians in actual practice…. Because of this focus on effectiveness as opposed to efficacy, these investigations effectiveness as opposed to efficacy, these investigations will likely rely on both prospective trials and observational will likely rely on both prospective trials and observational data to determine relative value in real-world settings.data to determine relative value in real-world settings.” ” IOM Roundtable on Evidence-Based IOM Roundtable on Evidence-Based

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