Comparative Effectiveness Excellence & Mediocrity Turning Evidence Into Action Making Comparative Effectiveness More than a Dream 21st Century Health Care Carolyn M. Clancy, MD Director Agency for Healthcare Research and Quality AcademyHealth’ AcademyHealth’s 2008 National Health Policy Conference Washington, DC – February 4, 2008 Scope of the Opportunity in Health Care Excellence & Mediocrity “A society which scorns excellence in plumbing simply because it is plumbing, but rewards mediocre philosophy simply because it is philosophy will soon become a society in which neither its pipes nor its theories will hold water.” water.” John W. Gardner (1961) Major challenges in 21st Century health care include evaluating all of the innovations and determining which: – Represent added value – Offer minimal enhancements over existing choices – Fail to reach their potential – Work for some patients and not for others Improving Evidence about Benefits and Risks AHRQ FY 2008 Priorities Comparative effectiveness research addresses issues including: Relevancy Timeliness Impact on priority populations Disproportionate impact on subpopulations – The ability to impact treatment decisions – – – – Patient Safety ¾ Health IT ¾ Patient Safety Ambulatory Patient Safety ¾ Safety & Quality Measures, ¾ Effective Health Care Program Organizations ¾ New Patient Safety Grants Drug Management and Patient-Centered Care Patient Safety Improvement Corps Medical Expenditure Panel Surveys ¾ Comparative Effectiveness Reviews ¾ Comparative Effectiveness Research ¾ Clear Findings for Multiple Audiences Other Research & Dissemination Activities ¾ Visit-Level Information on ¾ Quality & Cost-Effectiveness, e.g. Medical Expenditures ¾ Annual Quality & Disparities Reports Prevention and Pharmaceutical Outcomes ¾ U.S. Preventive Services Task Force ¾ MRSA/HAIs 1 AHRQ Comparative Effectiveness Research AHRQ FY 2008 Funding $334.6 million – – FY 2008 Request – $329.6 million FY 2007 Appropriation – $318.7 million FY 2008 appropriation includes: – Double the $15 million designated in FY 2007 – $5 million for research and activities to reduce Methicillin Resistant Staphylococcus aureus (MRSA) and related infections The number of comparative effectiveness reviews and technical briefs will double New research initiated will include studies on surgery, prescription drugs, biologics and vaccines for Medicare beneficiaries in priority condition areas – A new series of technical reports will establish a foundation for guiding the evaluation of genegene-based test performance – The number of products designed to help patients and clinicians make informed decisions will increase – $30 million for comparative effectiveness research – The additional funding for comparative effectiveness will help ARHQ generate a wealth of new products and tools: The first such federal grant to AHRQ for MRSA/HAIs MRSA/HAIs Congress also encouraged AHRQ to: – – Consider proposals to detect medical errors and preemptively control injury via compact medical devices Investigate the feasibility of an openopen-source, nono-cost license computer model capable of predicting the effects of health care policy alternatives to improve quality and costcost-effectiveness The Promise of Genomics: Recent Activities Program Enhancements Two reports will be commissioned for use by AHRQ to: – Enhance the Effective Health Care Program’ Program’s infrastructure and growth needs – Begin assessing the Program’ Program’s impact Money from the initial funding will be used for awards to develop and enhance individual scientist research and methodological capacities for conducting future comparative effectiveness research AHRQ is funding a Randomized Control Trial to clarify the added value of genetic testing to improve warfarin dosing. AHRQ and CDC are coco-funding a DEcIDE project to review databases focusing on utilization and outcomes of genegene-based tests and therapies EPC Reports: – Genomic testing in ovarian cancer – – – – (completed) CYP450 testing in depression (completed) HNPCC testing in colorectal patients (completed) Horizon scan on cancer genetic tests for CMS (completed) BRCA testing in breast and ovarian cancers (w/USPSTF recommendation) Comparative Effectiveness: Effective Health Care Program Uses current, unbiased evidence in making headhead-toto-head comparisons to show which health interventions: – Add Value – Offer minimal benefit above current choices – Fail to reach their potential – Work for some patients, but not others Builds on years of experience gained through AHRQ’ AHRQ’s EvidenceEvidence-Based Practice centers Goal: To develop and disseminate better evidence about benefits and risks of alternative choices – HERHER-2-Neu testing in breast cancer (ongoing) – Expression profile tests in breast cancer (completed) – Family history in breast, ovarian, colorectal and prostate cancers (completed) – Screening for hemochromatosis (w/USPSTF recommendation) Effective Health Care Program A. Evidence synthesis (EPC program) – – Systematically reviewing, synthesizing, comparing existing evidence on treatment effectiveness Identifying relevant knowledge gaps B. Evidence generation (DEcIDE, CERTs) – – Development of new scientific knowledge to address knowledge gaps. Accelerate practical studies C. Evidence communication/translation (Eisenberg Center) – – Translate evidence into improvements Communication of scientific information in plain language to policymakers, patients, and providers 2 21st Century Health Care The Social Case: Potential lives saved through quality improvement Improving quality by promoting a culture of safety through ValueValue-Driven Health Care InformationInformation-rich, patientpatientfocused enterprises Evidence is continually refined as a byby-product of care delivery 21st Century Health Care Information and evidence transform interactions from reactive to proactive (benefits and harms) Actionable information available – to clinicians AND patients – “just in time” time” Woolf and Johnson, How Can We Enhance Our Efforts? Making Better Decisions The Evolution of Translational Research Many decisions in healthcare require different types of evidence The demand side is as important as the production of evidence Wise and prudent use of resources and opportunities to advance effective health care is imperative AHRQ’ AHRQ’s Effective Health Care Program is the model for how this can be achieved www.effectivehealthcare.ahrq.gov “Comparative Effectiveness Research typically will focus on realistic decisions confronting patients and their clinicians in actual practice… practice…. Because of this focus on effectiveness as opposed to efficacy, these investigations will likely rely on both prospective trials and observational data to determine relative value in realreal-world settings.” settings.” IOM Roundtable on EvidenceEvidence-Based Medicine 3