AHRQ ’ S Perspective on Comparative Effectiveness Research

1. AHRQ’S Perspective on Comparative Effectiveness Research Jean Slutsky Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality TEACH 2011 NYAM August 10, 2011

2. Overview • Role of effectiveness research in decision making • Understanding effectiveness research • Comparative effectiveness research at AHRQ • Lessons learned throughout

4. Why the Need for Effectiveness Research? Interventions that are efficacious under a highly specific set of circumstances often fail to replicate across a wide variety of settings, conditions, patients. Glasgow, 2003

5. What Healthcare Decision Makers Need To Know • Can it work? • Will it work? • For this patient? • In this setting? • Is it worth it? • Do benefits outweigh harms? • Do benefits justify costs? • Does it offer important advantages over existing alternatives? adapted from Brian Haynes ACP Journal Club

6. CER – Helping to Make Better Health Care Decisions? • Improve research base • Relevance • Quality • Improve use of data in decision making • Informed decision making

7. Uses of Evidence for Decisionmaking • Product approval • Product purchasing and formulary selection • Benefit and coverage decisions • Practice guidelines • Quality review and improvement • Clinician/patient decision-making • Choosing plans or providers • Organizational and management decisions • Program financing and priority setting

8. Alternatives to Evidence-Based Medicine • Eminence-based • Vehemence-based • Eloquence-based • Providence-based • Diffidence-based • Nervousness-based • Confidence-based • Reimbursement-based • Celebrity-based • Gastronomically-based • K-street-based Isaacs and Fitzgerald. BMJ 1999 319(7225): 1618.

9. Some Perspective on Comparative Effectiveness Research at AHRQ

10. Comparative Effectiveness: AHRQEffective Health Care Program • Created in 2005, authorized by Section 1013 of the Medicare Prescription Drug, Improvement, and Modernization Act (MMA) of 2003 • To improve the quality, effectiveness, and efficiency of health care delivered through Medicare, Medicaid, and Children’s programs by focusing on • What is known now • What research gaps are critical to fill • Clinical effectiveness

11. A Framework for CER at AHRQ Evidence Generation Strategies Interventions Conditions Populations Improvements in Health Care Horizon Scanning Translation Dissemination Implementation Evidence Need Identification Evidence Synthesis Research Platform Infrastructure – Methods Development – Training StakeholderEngagement

12. Engaging the Public

13. Categorical Investments in Evidence Generation • Distributed data networks and related infrastructure development • Methods development • Non-experimental/observational studies, both retrospective and prospective • Sponsorship of pragmatic clinical trials addressing key foci of comparative effectiveness

14. Recovery Act: Grants by Priority Condition* *Grants by Priority Condition, AHRQ Effective Health Care Program, May 2011

15. AHRQ Recovery Act Evidence Generation Activities • Request for Registries: the creation or enhancement of national patient registries, with a primary focus on the 14 priority conditions • 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 • Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE): Coordinated national effort to establish a series of 10 pragmatic clinical comparative effectiveness studies • iADAPT: Innovative dissemination and implementation grants for CER

16. A Word About Translation

17. Why is Translation Needed? “Evidence may be necessary, but it is certainly not sufficient. The findings of research need to be translated into information that is useful for each health care decision maker.” EisenbergJAMA 1999; 282:1865-9.

18. If Researchers Ruled the World • Food in grocery stores would be alphabetized • Holiday sales would be advertised in peer reviewed journals • School room size would be directly related to sample size needed for NNL (numbers needed to learn)

19. Sagan Effect One of the most frequently cited reasons for scientists’ reluctance to talk to the press is the so-called Carl Sagan effect, that is, renowned scientist Carl Sagan was criticized by his fellow scientists who assumed that because Sagan was spending so much time communicating with the public, he must not have been devoting enough time to his research. J. Hartz and R. Chappel, Worlds Apart: How the Distance Between Science and Journalism Threatens America’s Future. Nashville, TN: Freedom Forum First Amendment Center, 1997.

20. Fact or Fiction Throughout his career, Sagan averaged a scientific peer-reviewed paper per month. Michael B. Shermer (August 2002). Social Studies of Science 32/4:489-525.

21. A Quantitative Analysis of Carl Sagan’s Scientific and Popular Articles by Year

22. It is Hard to Change Beliefs Popularization…is traditionally seen as a low status activity, unrelated to research work, which scientists are often unwilling to do and for which they are ill-equipped…Essentially, popularization is not viewed as part of the knowledge production and validation process but as something external to research which can be left to non-scientists, failed scientists or ex-scientists … Richard Whitley (1995), ‘Knowledge producers and knowledge acquirers: popularizations as a relation between scientific fields and their publics,’ in Terry Shinn and Richard Whitley (eds.), Expository Science: Forms and Functions of Popularization. Dordrecht/Boston, MA: D. Reidel Publishing

23. Educating Clinicians • Concise • Actionable • Paired with consumer guides • Convey level of uncertainty/certainty of findings

24. Informing Patients and Consumers There is a suspicious area on my mammogram and my doctor said I need to have a breast biopsy to tell if it is cancer. What are my options?

26. Continuing Medical Education/Continuing Education Activities

31. www.effectivehealthcare.ahrq.gov

32. What We’ve Learned (1) • It is necessary to: • Understand policy and practice context • Involve stakeholders early • Broaden approach to evidence • Link evidence gaps to future research • Translate findings for different audiences

33. What Have We Learned • Often, there are no clear winners and losers • Need to think of questions years in advance of decision makers asking • It is amazing what we don’t know about common and ubiquitous treatments

34. Contact Jean Slutsky Director, Center for Outcomes and Evidence Agency for Healthcare Research and Quality 301-427-1601 jean.slutsky@ahrq.hhs.gov Or effectivehealthcare@ahrq.hhs.gov