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Comparative Effectiveness Research (CER) Designing Sustainable Evidence-based Health Care in Times of Crisis Cochrane Colloquium 2011 Madrid, Spain Kay Dickersin, MA, PhD October 22, 2011 CER: Why now? Orzag, CBO. 2007. Comparative Effectiveness Research Medicare spending and quality of care Baicker et al. Health Affairs web exclusives, October 7, 2004 December 2007 IOM (Institute of Medicine) Report: Knowing What Works in Healthcare. A Roadmap for the Nation January 24, 2008 Proposed a new entity with authority to produce systematic reviews of clinical effectiveness • Set priorities, fund, manage systematic reviews • Develop common language and standards IOM recommendations (selected) 2008 A National Clinical Effectiveness Assessment Program should: Invest in advancing the scientific methods underlying the conduct of systematic reviews; Assess the capacity of the research workforce to meet the Program’s needs. o If deemed appropriate, expand training opportunities in systematic review and comparative effectiveness research methods. IOM Report: Initial National Priorities for CER June 30, 2009 Methods commonly used in CER • Controlled trials • Observational studies – Registry studies, large datasets – Cohort studies – Case control studies – Cross sectional studies – Case series • Research synthesis – Systematic reviews and metaanalysis – Technology assessment “And part of what we want to do is to make sure that those decisions are being made by doctors and medical experts based on evidence, based on what works, because that's not how it's working right now.” "The whole point of this is to try to encourage what works.” President Barack Obama July 22, 2009 March 23, 2010 PL 111-148 The Patient Protection & Affordable Care Act The Patient Protection & Affordable Care Act 2010 Established a non-profit Patient‐Centered Outcomes Research Institute (PCORI) to conduct CER: • Identify national priorities for research • Appoint Board of Governors – AHRQ and NIH, 3 patients/consumers, 5 providers, 3 payers, 3 industry, 1 representing quality improvement or independent health services researcher, 2 representing federal or state interests. • Establish Methodology Committee to set standards for CER • Perform patient-centered CER Medicare Improvement for Patients and Providers Act of 2008 Mandated two IOM studies: Standards for conducting SRs Standards for trustworthy CPGs Reports of the two committees released March 22, 2011 Federally-supported initiatives related to systematic reviews Internal programs - agency or contractual investigators: AHRQ - EPCs (evidence-based practice centers) (n=14) CDC - Guide to Community Preventive Services CDC - HIV/AIDS Prevention Research Synthesis Dept. Health & Human Services/SAMHSA mental health and substance abuse disorders Dept. Education - What Works Clearinghouse Dept. Justice – Model Programs Guide Federally-supported initiatives related to systematic reviews External programs: NICHD – Cochrane Neonatal Review Group NEI – Cochrane Eyes and Vision Group NCCAM – Cochrane Complementary and Alternative Medicine Field Source: Science 329:516; 2010 • Learn from other countries • Provide support for: – A coordinated approach – Infrastructure funds to external organizations – Methods research for clinical trials and systematic reviews – Infrastructure for investigator- initiated & commissioned systematic reviews • Ensure that mechanisms for CER support are sustained • Require a systematic review before funding a trial http://www.pcori.org/ http://www.pcori.org/ PCORI Pilot Projects (Due Dec 1 2011) • Inform the national comparative effective research priorities; • Bring together different stakeholders; • Translate research into practice; • Identify gaps in relation to issues for disadvantaged populations; and • Identify predictors of patient outcomes PCORI Pilot Projects (Due Dec 1 2011) – Identify choices within patient control that may influence outcomes. – Better understand patient-clinician interactions – Assess strategies promoting patient autonomy & informed decision-making. A future for Cochrane reviews & infrastructure Under the US-CER banner? • Depends on how Cochrane needs match up with PCORI’s goals • Depends on PCORI decision to support internal vs external systematic reviews • Is Cochrane adaptable? March to its own drummer vs workable partnerships. • Right now, we have chosen to be cautiously optimistic………….