Comparative Effectiveness Approaches with ARRA Funding and the Critical Role of Health IT Carolyn M. Clancy, MD Director Agency for Healthcare Research and Quality Scottsdale Institute’s 2010 Spring Conference Scottsdale – April 15, 2010

Comparing Evidence: Medical vs. Semiconductor Research “When I was doing semiconductor device research, it was expected that I would compare my results with other people's previously published results and that I would comment on any differences. But it seemed to be different in medicine. “When I was doing semiconductor device research, it was expected that I would compare my results with other people's previously published results and that I would comment on any differences. But it seemed to be different in medicine. “Medical practitioners primarily tended to publish their own data; they often didn’t compare their data with the data of other practitioners, even in their own field, let alone with the results of other types of treatments for the same condition.” “Medical practitioners primarily tended to publish their own data; they often didn’t compare their data with the data of other practitioners, even in their own field, let alone with the results of other types of treatments for the same condition.” Andy Grove Intel co-founder, prostate cancer patient Intel co-founder, prostate cancer patient Forbes May 13, 1996

AHRQ: New Resources, Program Highlights AHRQ: New Resources, Program Highlights The Right Treatment for the right Patient at the Right Time The Right Treatment for the right Patient at the Right Time 21 st Century Health Care 21 st Century Health Care Q&A Q&A Health Care Quality and Reform

AHRQ Priorities Effective Health Care Program Medical Expenditure Panel Surveys Ambulatory Patient Safety Patient Safety Patient 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 Pharmaceutical Outcomes  U.S. Preventive Services Task Force  MRSA/HAIs  Visit-Level Information on Medical Expenditures  Annual Quality & Disparities Reports  Safety & Quality Measures, Drug Management and Patient-Centered Care  Patient Safety Improvement Corps Other Research & Dissemination Activities

Fiscal 2011 Budget Proposal Obama Administration proposed FY 2011 budget includes $611 million for AHRQ – up from $397 million in FY 2010: Obama Administration proposed FY 2011 budget includes $611 million for AHRQ – up from $397 million in FY 2010: –$286 million for patient-centered health research, up $261 million over the FY 2010 budget – $65 million for patient safety research, including $34 million to reduce and prevent healthcare- associated infections – $32 million for health information technology research Plus ARRA Funding (More on This Later)

AHRQ Comparative Effectiveness Research http//:effectivehealthcare.ahrq.gov PolicymakersCliniciansConsumers

AHRQ’s Priority Conditions for the Effective Health Care Program Arthritis and non- traumatic joint disorders Arthritis and non- traumatic joint disorders Cancer Cancer Cardiovascular disease, including stroke and hypertension Cardiovascular disease, including stroke and hypertension Dementia, including Alzheimer Disease Dementia, including Alzheimer Disease Depression and other mental health disorders Depression and other mental health disorders Developmental delays, attention-deficit hyperactivity disorder and autism Developmental delays, attention-deficit hyperactivity disorder and autism Diabetes Mellitus Diabetes Mellitus Functional limitations and disability Functional limitations and disability Infectious diseases including HIV/AIDS Infectious diseases including HIV/AIDS Obesity Obesity Peptic ulcer disease and dyspepsia Peptic ulcer disease and dyspepsia Pregnancy including pre-term birth Pregnancy including pre-term birth Pulmonary disease/Asthma Pulmonary disease/Asthma Substance abuse Substance abuse

An Unprecedented Investment AHRQ’s Effective Health Care Program created by Medicare Modernization Act of 2003 AHRQ’s Effective Health Care Program created by Medicare Modernization Act of 2003 From , received $129 million from Congress for CER From , received $129 million from Congress for CER Program has published more than 45 products, including guides for clinicians and consumers Program has published more than 45 products, including guides for clinicians and consumers The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research, including $300 million to AHRQ The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research, including $300 million to AHRQ

IOM’s 100 Priority Topics Initial National Priorities for Comparative Effectiveness Research Initial National Priorities for Comparative Effectiveness Research Topics in 4 quartiles; groups of 25. Topics in 4 quartiles; groups of 25. First quartile is highest priority. Included in first quartile: First quartile is highest priority. Included in first quartile: – Treatment strategies for atrial fibrillation – Imaging technology for diagnosing, staging and monitoring patients with cancer – Genetic and biomarker testing Report Brief Available At

HorizonScanning Evidence Need Need Identification Identification EvidenceSynthesis Evidence Generation GenerationStrategiesInterventionsConditionsPopulations DisseminationTranslation Improvements in in Health Care Health Care Research Platform Infrastructure – Methods Development – Training A Framework for CER

Recovery Act CER Funding Investments (Examples) Data Infrastructure Data Infrastructure – Enhance Availability and Use of Medicare Data to Support Comparative Effectiveness Research – Distributed Data Research Networks, Including Linking Data Dissemination and Translation Dissemination and Translation – Dissemination of CER to Physicians, Providers, Patients and Consumers Through Multiple Vehicles – Accelerating Dissemination and Adoption of CER by Delivery Systems Research Research – Optimizing the Impact of Comparative Effectiveness Research Findings through Behavioral Economic RCT Experiments – Comparative Effectiveness Research on Delivery Systems

Translating the Science into Real-World Applications Examples of Recovery Act Evidence Generation projects with funding available/pending: Examples of Recovery Act Evidence Generation projects with funding available/pending: – Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE): First coordinated national effort to establish a series of pragmatic clinical comparative effectiveness studies ($100M) – Request for Registries: Up to five awards for the creation or enhancement of national patient registries, with a primary focus on the 14 priority conditions ($48M) – DEcIDE Consortium Support: Expansion of multi-center research system and funding for distributed data network models that use clinically rich data from electronic health records ($24M)

AHRQ Patient Engagement and the Recovery Act Citizen Forum on Effective Health Care Citizen Forum on Effective Health Care – Formally engages stakeholders in the entire Effective Health Care enterprise – A Workgroup on Comparative Effectiveness will be convened to provide formal advice and guidance

AHRQ Health IT Research Funding Long-term agency priority Long-term agency priority AHRQ has invested more than $300 million in contracts and grants since 2004 AHRQ has invested more than $300 million in contracts and grants since 2004 Focus on ambulatory safety, medication management, improved decision-making, patient-centered care, health information exchange Focus on ambulatory safety, medication management, improved decision-making, patient-centered care, health information exchange More than 200 communities, hospitals, providers and health care systems in 48 states More than 200 communities, hospitals, providers and health care systems in 48 states AHRQ Health IT Investment: $300 Million

Reach of AHRQ’s Health IT Program Core Health IT Health ITActivities AHRQ Effective Health Care Patient Safety Innovations/ Emerging Issues Priority Populations MEPS Value Prevention & Care Mgmt Private Sector Collaboration Office of the National Coordinator Centers for Medicare and Medicaid Services Federal Agencies National Quality Forum American Medical Informatics Association Healthcare Information & Management Systems Society National Institutes of Health The Leapfrog Group

‘Two-Way’ Role for Health IT in Comparative Effectiveness In: A pathway to clinical care for comparative effectiveness research Out: Digitizes and structures health care information for use in comparative effectiveness research

What Does It Really Mean to Be Patient-Centric?’

Technology and Consumers We create tools that make care more efficient for clinicians We create tools that make care more efficient for clinicians Consumers already are comfortable with the technology; they’re leading us, not the other way around Consumers already are comfortable with the technology; they’re leading us, not the other way around Consumers are demanding tools to make their care more about them; let’s satisfy the demand! Consumers are demanding tools to make their care more about them; let’s satisfy the demand!

Where to From Here? Assure that research is descriptive – not prescriptive Assure that research is descriptive – not prescriptive Identify synergies – methods and infrastructure – between CER and post- marketing surveillance: identification of signals and investigations of causes Identify synergies – methods and infrastructure – between CER and post- marketing surveillance: identification of signals and investigations of causes Identify incentives for participation Identify incentives for participation Anticipate unanticipated consequences Anticipate unanticipated consequences

Thank You AHRQ Mission To improve the quality, safety, efficiency, and effectiveness of health care for all Americans AHRQ Vision As a result of AHRQ's efforts, American health care will provide services of the highest quality, with the best possible outcomes, at the lowest cost