Opportunities & Challenges for Comparative Effectiveness Research

1. Opportunities & Challenges for Comparative Effectiveness Research Engaging the Community to Enhance CER Lucy A. Savitz, Ph.D., MBA January 26, 2009 lucy.savitz@imail.org

2. Objectives • Participants will acquire a foundational knowledge of the policy implications and priorities for CER in the U.S. • Participants will be familiarized with the various steps across the research process--from development/design through dissemination--and strategies for actively engaging in CER activities • Participants will be provided with resources to support active engagement in CER.

3. Value to Clinical Researchers Clinicians represent a vital community to actively engage in comparative effectiveness research (CER) for3 primary reasons: • the quality of the CER is enhanced (meeting real clinical needs/priorities), strengthening the evidence base for practice; • there is direct translation of the research into practice; and • they see the direct utility of CER results.

4. Institute of Medicine (IOM) ReportReleased June 30, 2009 The purpose of CERis to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels. Ø Comparative Effectiveness Research (CER)

5. IOM’s CER Working Definition • CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care.

6. 100 Research Priorities Identified

7. CER Challenges • Which questions are most appropriately answered by trials vs. which ones are best answered via observational study design? • How do observational studies extend RCTs? • What are the core team credentials & strategic issues required for winning awards? • Can we enhance the evidence base?Knowing What Works in Health Care (www.nap.edu) • What do various “community” members want and need to know? • How do we effectively engage the “community?”

8. What is a “Community?” • A group of people linked by social ties who share common perspectives or interests, and may also share a geographic location (MacQueen et al) • Examples of communities • Utah County residents • Somali immigrants • Persons with AIDS • Primary care physicians in Southern Utah • And many others…. • Communities are not homogeneous and seldom speak with a single voice

9. CER Funding to Date • Omnibus Appropriations Act, 2009 $50 million to AHRQ • American Recovery and Reinvestment Act (ARRA) of 2009 $1.1 billion • $300 million for AHRQ • $400 million for NIH • $400 million to Secretary

10. Funding Mechanisms • Investigator Initiated • Indefinite Delivery/Indefinite Quantity (IDIQ) or Master Task Orders • DEcIDE

11. DEcIDE (Developing Evidence to Inform Decisions about Effectiveness) Network • University of Colorado Center for Health Outcomes is prime • AHRQ has indicated that they will distribute the bulk of CER $ via DEcIDE

12. Rocky Mountain Center for CER • University of Utah--CCTS CE • Intermountain Healthcare • SLC VA Medical Center • University of Colorado • Denver Health

13. Clinical Translational Science Award or CTSAhttp://www.ctsaweb.org/ • Funded by National Institutes of Health (NIH) • 46 medical institutions in 26 states • University of Utah Center for Clinical & Translational Science (CCTS) • 9 Core areas: Administration; Novel Clinical & Translational Methods; Biomedical Informatics; Biostatistics; Participant & Clinical Interactions; Patient Care; Community Engagement; Translational Technologies & Resources; Research Education, Training & Career Development

14. CTSA Purpose To improve the way biomedical research is conducted nationwide. Consortium members share a common vision to reduce the time it takes for laboratory discoveries to become treatments for patients, to engage communities in clinical research efforts, and to train clinical and translational researchers.

15. CE Core: Primary Functions Serve as: Collaboration liaison Knowledge connector (bidirectional exchange) Outreach service GIVE ME A PLACE TO STAND AND I WILL MOVE THE EARTH A remark of Archimedes quoted by Pappus of Alexandria

16. CCTS Community Engagement (CE) Core • Leadership • Lucy Savitz, Ph.D., MBA, Director • Louisa Stark, Ph.D., Associate Director • Steve Alder, Ph.D., Technical Advisor • Leveraging resources to support participatory research and training • Annual pilot projects & administrative supplements • Creation of the Rocky Mountain Center for Comparative Effectiveness Research

17. National CTSA KFCs: CE KFC Community Partners Integration Outcomes of CE Educational Competencies CTSA Strategic Goal 4a & 4b Rocky Mountain Center for Comparative Effectiveness Research (RMCCER) National CTSA Service Other CCTS Cores AHRQ ACTION Denver VAMC Denver Health CO CTSI Local Consults/ Mentoring COHO CCTS CE Core RMCCER AHRQ DEcIDE Knowledge Exchange SLC VAMC Inter- mountain Org Community Community Reps COHO: Colorado Health Outcomes Program, University of Colorado at Denver KFC: Key Function Committee VAMC: Veterans Affairs Medical Center

18. A regional, multi-state consortium of vertically integrated health care organizations and translational research programs designed to leverage state-of-the-art, existing QI and HIT capacities to support a collective goal of collaborative, comparative effectiveness research in diverse populations, health care settings, and information technology environments; actively bridging the participatory research perspective with: • state-of-the-art technology and • scrupulous adherence to rigorous application & advancing CER methods.

19. CCTS Community Engagement 2010 Goals Serve as a connector to bring together academic, institutional, governmental and community organizations that are working on complementary programs; submit at least one application for external funding to support this work. Continue to build and sustain our regional CTSA collaboration via RMCCR; produce at least two funded projects and two manuscripts submitted for publication. Actively contribute to national CTSA activities via Key Function Committee participation and attendance at national and regional meetings. Measurably provide consultation and technical assistance for translational research related to bi-directional community engagement. Work with communities to identify meaningful and valuable knowledge exchange opportunities; implement at least 2 of these “events”.

20. Research Training Resources • CER Certificate at the University of Utah (forthcoming) • K award proposal submitted by Carrie Byington (pending)

21. Why are we talking about “community engagement?” • Deficiency in traditional research approaches • ~98% of Americans receive their health care outside of academic medical centers • The challenge of “translational research” • How to reach Dr. Smith and Billy in Delta, UT?

22. The Translational Research Continuum What works under controlled conditions? (Up to phase III trials) “Bench” “Bedside” Basic Biomedical Discovery Clinical Efficacy T1 What works in real world settings? (e.g., Comparative Effectiveness Research) What is the effect on population health? (Outcomes research) T2 T4 Clinical Effectiveness T3 Clinical Practice How can we change practice? (Dissemination and Implementation Research) Community Practices Community Practices

23. “Community engagement” as a key component of translational research • How to reach Dr. Smith and Billy? • Include them in the research process • The NIH response • Roadmap, CTSA, etc. • Issues arise… • The ethics of conducting research in communities - e.g., who benefits? unique needs/requirements?

24. What is “Community Engagement”? …community engagement is a process of inclusive participation that supports mutual respect of values, strategies, and actions for authentic partnership of people affiliated with or self-identified by geographic proximity, special interest, or similar situations to address issues affecting the well-being of the community of focus. NIH Council of Public Representatives, October 2008

25. Unpacking Community Engagement… • A broad framework that includes the full spectrum of approaches that involve the community in the research process • Includes research ranging from that which incorporates only a few elements of community engagement with minimal collaboration to research in which community organizations and researchers are equal partners throughout the process • Builds on community strengths • Emphasis on partnerships and collaboration

26. Researcher or funding source identifies problem Researcher writes protocol, selects community to be studied, obtains funding Researcher recruits subjects from the community Researcher collects and analyzes data Traditional Research Approach Researcher writes article, obtains academic rewards, thanks community (sometimes)

27. COMMUNITY Community-engaged Research Approaches Problem identified of interest and relevance to the community Protocol tailored to specific community of interest, funding obtained and shared as appropriate Community members are participants in research, not just subjects Data analyzed and collected with community input as appropriate Results disseminated to both the academic world and the community Studies that recruit subjects in community settings are not necessarily community-engaged

28. Examples of community-engaged research approaches • Identifying research topic • Community members or researcher may make the initial approach • Example – chronic pain in Native Americans • Researcher and community may work together to refine • Plan developed and funding secured • Researcher contributes scientific expertise • Community also contributes; • Ideas on logistics and recruitment • Advice on tailoring for community context • Community receives research funds as appropriate

29. Examples of community-engaged research approaches • Study conduct • Community members involved as appropriate • e.g., hire study staff • Promote study within the community • Advice on study problems • Data analysis and reporting • Involvement of community as appropriate • Dissemination of results to the community and to the academic world • Community determines appropriate/relevant media for their members

30. Community-based Participatory Research (CBPR) • One end of the community-engaged research spectrum • Equitable partnership between researcher and community in all research phases • Community identifies the problem to be addressed • Aims at achieving meaningful changes that will directly improve community health • Requires major investments of time and energy in building the relationships necessary for successful partnerships

31. Challenges of community-engaged research approaches • Requires considerable investment of time and energy to build relationships • And any relationship has high and low points…. • Trust is essential • Community priorities may not reflect your research priorities • Community may have little capacity/experience with research and follow a different timeline • Funding mechanisms/study sections may be unfamiliar with these approaches

32. Benefits of community-engaged research approaches • Can improve reliability and validity of study tools and procedures • Helps recruitment and study flow • Results more likely to be relevant • May improve external validity • Minimizes translation burden • Expanded opportunities for funding • NIH expanding RFAs • Foundation funding • Relationships have their own rewards

33. Successful Community-engaged Researchers… • View community partners as knowledgeable and important contributors to research • Acknowledge that they and community members bring their own beliefs to research • Think that the beliefs and values of community members should be recognized • Value relationships with the community as one of the benefits of research

34. Value of Research Partnerships • Research partnerships can engage multiple entities to enhance the generalizability and potential for modeling and spread of results. • Successful partnerships are engaged beyond a one-time research opportunity and are able to keep the flame of change burning and build a critical mass for change • Interaction & engagement is bi-directional

35. Definitions • Research partnerships are broadly defined to include inter-organizational relationships where resources are shared to advance a collective purpose—in this case, applied, participatory research. • Participatory research then “… is an approach that involves all potential users of the research and other stakeholders (as partners)

36. Foundation for Participatory Research • The rich tradition of participatory research is anchored in community development and since the mid1960s, has been embraced in • social, educational, health services, and public health research. • Therefore, the literature or evidence base for participatory research is dispersed

37. Organizational-Based Participatory Research (OBPR) • a subset of CBPR • OBPR is distinctly culled out to describe collaborative work among organizational research partners are engaged around a shared problem or goal to improve the quality of care and, ultimately, patient outcomes.

38. Framework for Assessing Partnership Strength Learning from Demonstrated Research Endeavors that Generate Evidence • Individual • Empowerment • Social Capital • Synergy Collaborative Problem Solving Critical Characteristics of the Process Leadership & Management Mapping Organizational Needs to Identified Collaborative Projects Adapted from RD Lasker & ES Weiss, Journal of Urban Health, 2003—Model of Community Health Governance

39. Evidence: Knowledge that is… • Explicit (codified) • Systematic (with transparent & explicit methods) • Replicable

40. Framework for the Continuum of Translational Research seeks to move a basic science discovery into a candidate health application T1 T2 assesses value of application for health practice leading to development of EB guidelines T3 attempts to move EB guidelines into health practice assesses "real world" health outcomes of application in practice T4 Increasing community engagement

41. Conducting real-world, CER that engages the community.