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
Effective Health Care (EHC) Program, 2003 – Present • 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 • 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
Effective Health Care Program • Evidence synthesis (EPC program) • Systematically reviewing, synthesizing, comparing existing evidence on treatment effectiveness. • Identifying relevant knowledge gaps. • Evidence generation (DEcIDE, CERTs) • Development of new scientific knowledge to address knowledge gaps. • Accelerate practical studies. • Evidence communication/translation (Eisenberg Center) • Translate evidence into improvements • Communication of scientific information in plain language to policymakers, patients, and providers.
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.” Congressional Budget Office, 2007
Arthritis and non-traumatic joint disorders Cancer Cardiovascular disease, including stroke and hypertension Dementia, including Alzheimer’s Disease Depression and other mental health disorders Developmental delays, attention-deficit hyperactivity disorder, and autism Diabetes Mellitus Functional limitations and disability Infectious diseases, including HIV/AIDS Obesity Peptic ulcer disease and dyspepsia Pregnancy, including pre-term birth Pulmonary disease/Asthma Substance abuse Priority Conditions for the Effective Health Care Program
Evidence Generation • 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
What Does DEcIDE Primarily Do? • Analyze existing health care databases to compare the effectiveness & outcomes of treatment. • Analyze existing disease, device, and other registries. • Conduct methodological studies to improve research on clinical effectiveness of treatments.
Summary &“Unofficial” DEcIDE Statistics • 13 DEcIDE centers. • Over 60 core clinical scientists. • Over 500 affiliated personnel. • Access to >120 different health databases. • Health data on over 50 million Americans. • Nation’s largest network of researchers in therapeutic effectiveness.
Comparative Effectiveness and the Recovery Act • 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
Recovery Act Timeline: AHRQ May 1: Due date for Agency wide and program-specific Recovery Act plans July 30: AHRQ to submit FY ’09 Operations Plan December 31, 2010: All Recovery Act funding to be obligated February 17: The American Recovery and Reinvestment Act of 2009 is signed into law 2009 January April July October 2010 November 1: AHRQ FY ‘10 operations plan due March 19: Establishment of Federal Coordinating Council for Comparative Effectiveness Research June 30: Due date for IOM submission of a list of national priority conditions* * Stakeholder input required
CER Moving Forward: Issues to Consider 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 weigh the evidence and present it in a way that helps consumers and their doctors make the best possible decisions about health care choices
The Future • Public-private funding and participation likely a necessity • More effort to get better conditional reimbursement study designs/protocols • Patients should be engaged as partners at the local and national levels • Need to tackle important issues • Ethical • When to know when the evidence is sufficient • Transparency • Setting priorities