1 Maximizing the Impact of Comparative Effectiveness Research: The Role of the DEcIDE Consortia Scott R. Smith, PhD AHRQ Center for Outcomes & Evidence US Department of Health & Human Services

2 Effective Health Care (EHC) Program, 2 Effective Health Care (EHC) Program, 2003 – Present Authorized in 2003 by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act Authorized in 2003 by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act Conducts objective comparisons of the effectiveness of different health care interventions Conducts objective comparisons of the effectiveness of different health care interventions Goal: To support informed health care decisions by patients, clinicians, and policymakers and improve the quality, effectiveness, and efficiency of health care to support evidence-based practice Goal: To support informed health care decisions by patients, clinicians, and policymakers and improve the quality, effectiveness, and efficiency of health care to support evidence-based practice

3 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.

4 Congressional Budget Office, 2007 CBO Comparative Effectiveness Definition Comparative Effectiveness “…a rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients.”

5 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’s Disease Dementia, including Alzheimer’s 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

6 Available EHC Products Research Reviews New Research Reports Technical Briefs Summary Guides

7 Evidence Generation DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network. DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network. – Capitalizing on data – New methods – Answers for questions that don’t require multi- year, multi-million $ trials

8 What Does DEcIDE Primarily Do? A. A. Analyze existing health care databases to compare the effectiveness & outcomes of treatment. B. B. Analyze existing disease, device, and other registries. C. C. Conduct methodological studies to improve research on clinical effectiveness of treatments.

9 Summary &“Unofficial” DEcIDE Statistics 13 DEcIDE centers. 13 DEcIDE centers. Over 60 core clinical scientists. Over 60 core clinical scientists. Over 500 affiliated personnel. Over 500 affiliated personnel. Access to >120 different health databases. Access to >120 different health databases. Health data on over 50 million Americans. Health data on over 50 million Americans. Nation’s largest network of researchers in therapeutic effectiveness. Nation’s largest network of researchers in therapeutic effectiveness.

AHRQ DEcIDE Research Centers 10

11 DEcIDE Focus Areas in Comparative Effectiveness

12 Comparative Effectiveness and the Recovery Act The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research: The American Recovery and Reinvestment Act of 2009 includes $1.1 billion for comparative effectiveness research: – AHRQ: $300 million – NIH: $400 million (appropriated to AHRQ and transferred to NIH) – Office of the Secretary: $400 million (allocated at the Secretary’s discretion) Funding for health IT, prevention and other areas could have implications for the Agency

13 Today’s Speakers 3:15-3:35Cardiovascular Consortium Eric D. Peterson, MD, MPH, FAHA, FACC Professor of Medicine, Division of Cardiology Duke University Medical Center 3:35-3:55Diabetes Consortium Joe Selby, MD, MPH & Director, Division of Research Kaiser Permanente, North California 3:55-3:10Cancer Consortium Deborah Schrag, MD & Caprice Greenberg, MD,MP Dana-Farber Cancer Institute Department of Medicine, Harvard Medical School 3:10-3:25Audience Questions to Panel

14 Recovery Act Timeline: AHRQ 2009 March 19: Establishment of Federal Coordinating Council for Comparative Effectiveness Research February 17: The American Recovery and Reinvestment Act of 2009 is signed into law JanuaryAprilJuly June 30: Due date for IOM submission of a list of national priority conditions* May 1: Due date for Agency wide and program- specific Recovery Act plans October November 1: AHRQ FY ‘10 operations plan due July 30: AHRQ to submit FY ’09 Operations Plan 2010 December 31, 2010: All Recovery Act funding to be obligated * Stakeholder input required

15 CER Moving Forward: Issues to Consider Comparative Effectiveness is a useful tool in a much larger toolkit – it is not “the answer” Comparative Effectiveness is a useful tool in a much larger toolkit – it is not “the answer” Comparative Effectiveness does not make policy or health care decisions, tell doctors how to practice medicine or make final decisions about what kind of treatments insurers will pay for Comparative Effectiveness does not make policy or health care decisions, tell doctors how to practice medicine or make final decisions about what kind of treatments insurers will pay for Comparative Effectiveness does weigh the evidence and present it in a way that helps consumers and their doctors make the best possible decisions about health care choices Comparative Effectiveness does weigh the evidence and present it in a way that helps consumers and their doctors make the best possible decisions about health care choices

16 The Future Public-private funding and participation likely a necessity Public-private funding and participation likely a necessity More effort to get better conditional reimbursement study designs/protocols More effort to get better conditional reimbursement study designs/protocols Patients should be engaged as partners at the local and national levels Patients should be engaged as partners at the local and national levels Need to tackle important issues Need to tackle important issues – Ethical – When to know when the evidence is sufficient – Transparency – Setting priorities