Towards Building a Bridge between Community Engagement in Research (CEnR) and Comparative Effectiveness Research (CER) Syed M. Ahmed, M.D., M.P.H., Dr.P.H.1, David Nelson, Ph.D.1, Anne Kissack, M.P.H.1, Zeno Franco, Ph.D.1, Jeff Whittle, M.D., M.P.H.2, Theodore Kotchen, M.D.2, John R. Meurer, M.D., M.B.A.3, Jeffrey Morzinski, Ph.D.1, and Terry Brandenburg, M.P.H., C.P.H.3 Abstract A major national priority is establishing an effective infrastructure for translation of scientific discoveries into the community. Knowledge and practice continue to accelerate in health research yet healthcare recommendation adoption remains slow for practitioners, patients, and communities. Two areas of research placed in the later stages of the translational research spectrum, Community Engagement in Research and Comparative Effectiveness Research, are ideal for approaching this challenge collaboratively. The Clinical and Translational Science Institute of Southeastern Wisconsin convened academics and community-based organizations familiar with these fields of research in a 1-day workshop to establish an initial dialogue on similarities and differences with a goal of exploring ways to operationalize a collective effort. Participants represented four academic institutions and twelve other healthcare and community-based service organizations. Primary fields of study included community engaged research, comparative effectiveness research, psychology, clinical research, administration, nursing, public health, education, and other professionals. This initial report outlines the results of this diverse discussion and provides insights into the priorities, diverging issues, and areas for future examination and practice. Key discoveries reveal clear crosscutting issues, value in philosophical and provocative discussions among investigators, a need for practice and lessons learned, and bidirectional exchange with community representation. Clin Trans Sci 2015; Volume 8: 160–165
Keywords: community engagement, comparative effectiveness, translational research Introduction
There is growing, mutual recognition that some interdependence between researchers, including the Community Engagement in Research (CEnR) and Comparative Effectiveness Research (CER) disciplines, will produce mutual benefits.1–8 Support for collaborative research comes from the US Institute of Medicine (IOM),1 National Institutes of Health’s National Center for Advancing Translational Research (NIH NCATS),2,3 and appropriations for the Patient Centered Outcomes Research Institute (PCORI).4 The healthcare and health research enterprise includes stakeholders who collectively strive to reach the goal of expedited scientific discovery that will lead to improvements in efficiency, quality, and health outcomes. The success of these efforts ultimately stands with the engagement and acceptance of individual patients and the larger population comprised of varying communities. CEnR and CER experts are essential conduits for accomplishing this goal as they directly interact with these groups but at the same time have distinct sets of needs that must be addressed before synergy and collaboration can be achieved.5–8 These issues motivated the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI)9 to host a CEnR-CER Bridge Building Day that initiated dialogue and gain understanding from local experts and challenged workshop participants to explore questions about each disciplines’ attributes and needs. This paper describes what was learned from the participants, similar challenges, and diverging areas of priority, and suggests next steps for operationalization. The paper’s aim is to clarify a vision and strategies for adopting and applying these approaches in community and healthcare settings. Background
The United States has established a growing foundation for translation of scientific discoveries into the community. The NIH
continues to support public health engagement and translational science.1–3,8,10 The IOM recently recommended that academic medical centers with Clinical Translational Science Awards (CTSAs) ensure community engagement through “active and substantive … participation in priority setting and decision making across all phases of clinical and translational research.”1 “Bench to bedside to curbside”10 describes a continuum of inclusivity and bi-directionality11 fostering collaboration with researchers and communities.3 Interdisciplinary approaches among basic scientists, clinical investigators, and community engaged researchers will “accelerated discoveries toward better health”1 and the “Triple Aim” of healthcare reform: improving the experience of care and population health and reducing costs12 while including communities in the process. Aforementioned federal investments and the national consortium of CTSAs support the concept of bridging CEnR and CER to enhance research overall. Definitions and Need
Despite progress in supporting scientific discovery, adoption of healthcare recommendations by the community remains a challenge. Gaps exists for quality and efficiency of US healthcare, particularly among populations with the greatest needs. All researchers (bench, clinical, CER, and CEnR) have the responsibility of advancing their fields while assuring relevance and importance to patients, communities, and policy makers. Researchers must actively engage stakeholders in all stages of research.1–8,10,13 The most clear and current roadmap for researchers to accomplish such a task in a conscientious, mutualistic manner is through research that is genuinely community engaged.6,8,10,13 Institutional complexities in infrastructure, policy, curriculum, and other support mechanisms limit researchers’ capacity to be dedicated to such efforts.13
Department of Family and Community Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA; 2Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA; 3Institute for Health and Society, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 1
Correspondence: Anne Kissack ([email protected]) DOI: 10.1111/cts.12236
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Community Engagement in Research (CEnR) 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 or focus. It is a core element of any research effort involving communities which requires academic members to become part of the community and community members to become part of the research team, thereby creating a unique working and learning environment before, during, and after the research.6 Comparative Effectiveness Research (CER) is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, behavioral change strategies, and delivery system interventions. This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness.23 Table 1. Definitions for Community Engagement in Research and Comparative Effectiveness Research.
CEnR dominant case examples
CER dominant case examples
1. Can CER inform CEnR in measuring and improving treatment fidelity with research team members as well as controlling intervention delivery in a nonclinical/lab setting?
1. How can CER engage all members of a community without obscuring the impact of the intervention while still gaining the approval for the validity of the intervention?
2. Can CER inform CEnR in improving management of knowledge and consistency of data when facing high research staff turnover?
2. How can a CER study make outcomes be of relevancy and importance to its stakeholders?
Table 2. Examples of questions for workgroup discussion.
Philosophical and practical differences between CEnR and CER complicate translation and interdisciplinary research. A central focus of CEnR is to prioritize social change and reduce health inequities5,8,13,14 arising from individual, sociological, economic, and environmental issues too complex for a single solution.14–18 CEnR embraces a comprehensive approach to human health by applying the principles of community-based participatory research.15,19,21 Proponents of CEnR support systematic community participation to optimize research relevance and impact.21,22 In comparison, the design of CER focuses attention on evidence relevant to the expressed needs of patients, healthcare professionals, and other key decision makers across diverse settings to make informed healthcare decisions.20,23 In the CER framework, knowledge and practicality of clinical care comes from evidence about benefits, risks, and costs for different patient or clinician populations.20,23 CER strategically focuses on a practical comparison of two or more health interventions to determine what works best for which patients and populations.20,23 Practitioners of CER believe that developing and disseminating better evidence on which treatments work best is part of the healthcare reform solution.22 CEnR and CER researchers will be more effective through collaboration. CER practitioners seek to implement practice changes that follow from an improved understanding of “best” approaches to treating common conditions. They confront a need to obtain buy-in from communities to successfully translate efficacious interventions from clinical trials to widespread practice. Those who support CEnR seek to develop novel programs or interventions to address common health issues in collaboration with communities. They confront the need to demonstrate outcomes that support the validity of their approach over a variety of alternatives. Despite major differences between CER and CEnR—differences of philosophies, approaches, and aims—both value stakeholder engagement in their research and both see significant potential in collaboration in order to improve WWW.CTSJOURNAL.COM
the health of communities. Of concern, is that the differences in research approaches could limit capacity to collaborate or create unintended, negative consequences on the communities they seek to benefit. Workshop Description
The CTSI9 invited workshop participants from its multiple institutional consortia. A large scope in practitioner type was desired including faculty and staff from disciplines including CEnR; CER; clinical researchers; population and public health; medicine, nursing, biomedical, informatics, and technology. Members of community-based organizations involved in community–academic partnerships participated. The all-day interactive format used case examples to foster dialogue on problems and needs related to either CER or CEnR. The format was intended to drive discussions on how disciplines can work together. Table 1 states the definitions for CEnR and CER utilized for participants’ reference. Two CER and two CEnR cases were authored by workgroup leaders. Cases were designed to generate multidirectional dialogue. The composition of four case discussion workgroups was predesignated to balance representation from community members, CEnR, and CER including a composite of participants by field of study and appointment type. Facilitated workgroups used the cases to develop and begin to categorize a broad set of needs and problems and to discuss collaborative solutions and practical next steps. Table 2 lists questions from which the facilitators could choose to aid discussion. Program Outcomes
The workshop convened a diverse set of participants from four academic institutions and twelve other organizations. Detailed notes of the discussions produced feedback from workgroup participants that helped to frame similar and difference challenges in CEnR and CER as well as generalizable themes and priority areas. Table 3 is a brief summary of workgroup feedback. VOLUME 8 • ISSUE 2
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Similar challenges 1. Study design 2. Study population 3. Regulation 4. Funding and sustainability Challenges with diverging priority areas Community Engagement in Research (CEnR)
Comparative Effectiveness Research (CER)
1. Policy implications relate to social issues in the community
Policy implications relate to healthcare and multiple stakeholders
2. Dissemination traditionally is in the form of sharing results with community based organizations and the general citizenry
Dissemination traditionally is in the form of published results from research that is intended for clinical or healthcare settings to adopt
3. Engagement is with communities as stakeholders
Engagement focuses on multiple stakeholders
Table 3. CEnR–CER bridge day case study workgroup feedback on similar and different challenges.
Education
1. Support building capacity at community-based organizations to become more engaged and active in CEnR and CER. 2. Support opportunities for community-based organizations and academic researchers to network and discuss current research news, trends, and opportunities.
Research
1. Support the discovery of shared local interests and need among investigators and community-based resources. 2. Support a comprehensive, collaborative enterprise of investigators for transdisciplinary projects utilizing a compliment of CEnR and CER methods and approaches.
Policy
1. Expand support through institutional change that better enables CEnR–CER collaboration by allowing for sustainability and capacity among both community and academic partners.
Table 4. Summary of next step recommendations from workshop participants.
Workshop participants generated a wealth of information for next step recommendations based on their knowledge of existing resources available and in response to the conversations occurring throughout the day. Table 4 outlines a distinct set of actions proposed for establishing stronger relationships in CEnR– CER locally. Over 100 comments as suggested next steps were categorized into specific theme areas relevant to research paradigm and process.24 Figures 1 and 2 in the discussion section identify common critical areas and topics for debate between CEnR and CER to evolve assumptions and practices for interdisciplinary work. The authors made this distinction to avoid addressing more specific points on engaging stakeholders and communities, which have been so clearly described in a recent commentary by Burke et al.8 Discussion
This CEnR–CER workshop explored obstacles and assets for closing gaps in application of these research approaches in both community and healthcare settings. Rather than establishing specific hypotheses or consensus on practice changes, this opportunity began to lay groundwork to establish a common place for local CEnR and CER colleagues to discuss problems together. It was an effective way to initially understand one another’s perspectives and increase collective knowledge. Ultimately and of high relevance, we discovered that despite the fact that differences exist between CER and CEnR, these are a matter of degree rather than in stark contrast to one another. Although case example discussions produced several key findings in relation to their distinct topic, more issues were 162
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crosscutting regardless of the focus area. Knowledge of the generalizability of issues also lends itself to deeper investigation of the overlap, discrepancies, and priority of shared need for more enthusiastic, engaged dialogue. Figure 1 is a detailed portrayal of the data that were gathered from the shared dialogue of participants broken into Community Engagement in Research A and Comparative Effectiveness Research B. It is within the intersection that a set of congruent, pervasive themes overlap C; methodology or study design, engagement or study population, institutional review boards, funding and sustainability, dissemination, and policy implications. The Venn diagram within the figure suggests that the symmetric difference of the two sets is less than their intersection. Upon further exploration of these themes, those involved in the process specified diverging issues within the themes and thus created different priorities (CEnR Priority Impact Areas D and CER Priority Impact Areas E). This information can be utilized as a springboard for CTSAs to support discussions and future interdisciplinary research. The particular principles and priorities by which CEnR has as a foundation for community–academic partnerships and the approach to conducting research could appear limiting in scientific methods or rigor to CER.13 For this particular example, one may ask questions such as “How far will a CEnR investigator deviate from a community partner’s priority in order to assist in creating a comparator for a CER project?” or “If a CER investigator wants a community as a stakeholder early in developing a research question, how willing are they to structure a research study that develops a solution rather than compares existing resources?” Thoughtful reflection and discussion between WWW.CTSJOURNAL.COM
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Figure 1. Overlapping challenges and the diverging priority areas of impact shared among workshop participants during four, facilitated case study examples led by local Community Engagement in Research and Comparative Effectiveness Research practitioners.
investigators and their limitations, convictions, commitment, and perceptions are important exchanges to support health improvement and discovery. These discussions may include each researcher’s understanding of how they and others in their field justify knowledge through their research from theory to assumptions, best practices, and research approaches to obtaining evidence.13,25 Using participant feedback, we identified potential questions for dialogue to align transdisciplinary work among CEnR– CER. Because our participants were only beginning to develop relationships, at this point in time, our intentions do not extend past mutual exploration into specific recommendations for practice change actions. Figure 2 includes major underpinnings for research and differentiates questions within each category.25 We have defined the categories in the following way: • Assumptions: Investigators can share, debate, and explore what they value and assume for developing questions they think would lead to the most impactful answers. • Dialect: A general understanding of shared and different definitions, taxonomy, and ontology between fields and concepts can be important to identify throughout the process of learning each other’s foundational aspects of research. • Best practices: Those working in two different areas of research can examine why and how they proceed with inquiry and experimentation. Discipline-based best practices, personal experiences, and world views or constructs will be foundational. Gaining a deeper understanding of another researcher’s ways of thinking that influence the aims, objectives and design of their research could increase trust and establish a starting point for approaching a similar interest area or question. • Obtaining evidence: CEnR and CER have a variety of methods for conducting research. Sharing more about how their WWW.CTSJOURNAL.COM
protocols are designed for sampling, what are considered comparators, data collection, tools for measurement and statistical methods could benefit both practices as well as transdisciplinary efforts. The stage of practical applications of collaborative thinking is pivotal for continued learning and growing between CEnR– CER. Within the conference planning group, CEnR and CER investigators continue to share research interests and are eager to develop foundations for future funded research. More examples of where these two domains practice together are needed. The lessons and guidance from such pioneers will help to direct another generation that can follow similar paths. Examples should justify the blending of CEnR–CER as a useful effort that brings highly impactful benefits to community health and demonstrates effective outcomes. Otherwise, community-based organizations and citizens will not engage and establish trust in the process or protocol. Some questions to gauge progress of working together are: • Can or does collaboration among CEnR and CER form shared assumptions? • Can investigators approach a research question and implement a study with adoption of the others’ practices and processes? What of these are distinct and what can be shared? • Can a deeper understanding of the issue be reached by working in collaboration between the two orientations? • What of research paradigms are new, necessary to concede in collaborative work, or shared for the advantage and science of the others’ discipline? Community members and academics regularly attend CTSI-sponsored conferences and thus we have been successful in gaining leadership from community-based organizations and VOLUME 8 • ISSUE 2
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Figure 2. Critical discussions for CEnR–CER bridge building. Based on findings from this workshop, this figure is a revision of a seminal publication by Carter and Little25 (original in italic). It includes key areas of inquiry supported by our findings, leading to future research that may more closely align CEnR and CER.
general citizenry who have an interest in research. Dialogue was not only between CEnR and CER researchers but also among and between communities. This conference demonstrated that community played a dual role—one as key contributors and the other as necessary connectors. Key moments occurred during the workshop when community input assisted in bridging CEnR and CER investigators around a solution or similarity. They identified organizational and service population needs as well as their perspectives on approaches to research and practicality of methods in a community setting. Rather than having a bidirectional exchange, these contributions from the community representation created a circular loop. Next Steps
Proximally, our CTSA must find ways to bridge between differences and enable greater collaboration based on the workshop participant’s very specific next step suggestions. Support is needed in areas of education, research, and policy. 164
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Our CTSI 9 must now maintain and monitor interactions between participants to assess evolution of new CEnR–CER transdisciplinary efforts. Distally, other CTSAs can join in addressing next steps outlined in this paper as well as foster future discussions through developing focus and action around themes and priority impact areas identified in Figure 1. One example may be making determinations on blending methodologies to enhance CEnR and CER metrics and outcomes. Finally, CTSAs could find and pose questions to key stakeholders regarding research that uses community–academic partnerships or comparative effectiveness as an approach, but which require skill or knowledge from the both disciplines. While more work needs to be done in the area of converging CER and CEnR, the results of this workshop provide support for discovering new ways for individuals from seemingly different points of view to work together. This effort established groundwork for approaching collaboration through dialogue and shared learning. Demonstration is the next challenge. While federal and institutional supports along with grassroots demands for authentic WWW.CTSJOURNAL.COM
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engagement continue to push researchers and community on the cutting edge of individual and population health, stronger ties and a significant common ground in conjunction with the appropriate supports will successfully align assets and innovate to solve challenges and improve outcomes. Acknowledgments
This project has been funded in in part with federal funds from the National Center for Research Resources (NCRR), the National Center for Advancing Translational Sciences (NCATS), and the National Institutes of Health (NIH) through the Clinical and Translational Science Award Program through funding for the Clinical and Translational Science Institute of Southeast Wisconsin (#8UL1TR000055). Support was also provided through the Advancing a Healthier Wisconsin Research and Education Initiative Fund, a component of the Advancing a Healthier Wisconsin endowment at the Medical College of Wisconsin (#5520190). The Medical College of Wisconsin institutional review board approved the research component of this article. The views in this article are those of the authors—and not of their institutions or funding agencies. References
1. Leshner AI, Terry SF, Schultz AM, Liverman CT. Committee to Review the Clinical and Translational Science Awards Programs at the National Center for Advancing Translational Sciences; Board of Health Sciences Policy; Institute of Medicine. The CTSA Program at NIH: Opportunities for Advancing Clinical and Translational Research. Washington, D.C.: The National Academies Press; 2013. 2. CTSA Strategic Goal 4: Enhancing the Health of Our Communities and Nation. https://www. ctsacentral.orgcommitteesg4-enhancing-health-our-communities-and-nation as assessed on December 18, 2013. 3. Zerhouni EA. US biomedical research: basic, translational, and clinical sciences. JAMA 2005; 294(11): 1352–1358. 4. Selby JV, Beal AC, Frank L. The Patient-Centered Outcomes Research Institute (PCORI) national priorities for research and initial research agenda. JAMA 2012; 307(15): 1583–1584. 5. Michener L, Cook J, Ahmed SA, Yonas MA, Coyne-Beasley T, Aguilar-Gaxiola S. Aligning the goals of community-engaged research: why and how academic health centers can successfully engage with communities to improve health. Acad Med. 2012 March; 87(3): 285–291. 6. Ahmed SM, Palermo AG. Community Engagement in Research: frameworks for education and peer review. Am J Public Health. Aug 2010; 100(8): 1380–1387. 7. Concannon TW, Meissner P, Grunbaum JA, McElwee N, Guise JM, Santa J, Conway PH, Daudelin D, Morrato EH, Leslie LK. A new taxonomy for stakeholder engagement in patient-centered outcomes research. J Gen Intern Med. 2012; 27(8): 985–991.
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8. Burke JG, Jones J, Yonas M, Guizzetti L, Virata MC, Costlow M, Morton SC, Miller E. PCOR, CER, and CBPR: alphabet soup or complementary fields of health research? Clin Transl Sci. 2013; 6: 493–496. 9. Clinical and Translational Science Institute of Southeast Wisconsin (CTSI). Available at: www.ctsi. mcw.edu. Accessed March 2, 2014. 10. Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010; 100(Suppl 1): S40–S46. 11. Danka-Mullan I, Rhee K, Stoff D, Pohlhaus J, Sy F, Stinson N, Ruffin J. Moving toward paradigmshifting research in health disparities through translational, transformational, and transdisciplinary approaches. Am J Public Health. 2010; 100(1): S19–S24. 12. Berwick DM, Nolan TW, Whittington J. The triple aim: care, health, and cost. Health Affairs 2008; 27(3): 759–769. 13. Ahmed SM, Beck B, Maurana CA, Newton G. Overcoming barriers to effective community-based participatory research in US medical schools. Educ Health 2004; 17(2): 141–151. 14. Aguilar-Gaxiola S, Ahmed S, Franco Z, Kissack A, Gabriel D, Hurd T, Ziegahn L, Bates NJ, Calhoun K, Carter-Edwards L, et al. Towards a unified taxonomy of health indicators: academic health centers and communities working together to improve population health. Acad Med. 2014 Apr; 89(4): 564–572. 15. Israel BA, Schulz AJ, Parker EA, Becker AB. Review of community-based research: assessing partnership approaches to improve public health. Ann Rev Public Health 1998; 19: 173–202. 16. McLeroy KR, Bibeau D, Setckler A, Glanz K. An ecological perspective on health promotion programs. Health Educ Quart. 1988; 15(4): 351–377. 17. Winett RA. A framework for health promotion and disease prevention programs. Am Psychol. 1995; 50(5): 341–350. 18. Stokols D. Translating social ecological theory in to guidelines for community health promotion. Am J Health Promot. 1996; 10(4): 282–298. 19. Green LW. Study of Participatory Research in Health Promotion: Review and Recommendations for the Development of Participatory Research in Health Promotion in Canada. Ottawa: Royal Society of Canada; 1995. 20. IOM Roundtable on Evidence-Based Medicine. Learning What Works Best: The Nation’s Need for Evidence on Comparative Effectiveness in Health Care: An Issue Overview. Institution of Medicine (US) Roundtable on Value and Science-Driven Health Care. Learning What Works: Infrastructure Required for Comparative Effectiveness Research: Workshop Summary. Washington, DC: National Academies Press; 2011. Appendix A. Available at: http:www.ncbi.nlm.nih.govbooksNBK64784. Accessed December 18, 2013. 21. Wallerstein NB, Duran B. Using community-based participatory research to address health disparities. Health Promot Pract. 2006; 7(3): 312–323. 22. Eder M, Carter-Edwards L, Hurd T, Rumala B, and Wallerstein N. A logic model for community engagement within the clinical and translational science awards consortium: can we measure what we model? Acad Med. 2013; 88(10): 1430–1436. 23. Tunis SR, Benner J, McClellan M. Comparative Effectiveness Research: Policy, context, methods development and research infrastructure. Stat Med. 2010; 29: 1963–1976. 24. Constas MA. Qualitative analysis as a public event: The documentation of category development procedures. Am Educ Res J. 1992; 29: 253–256. 25. Carter SM, Little M. Justifying knowledge, justifying methods, taking action: epistemologies, methodologies and methods in qualitative research. Qual Health Res. 2007; 17: 1316–1328.
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Keywords: community engagement, comparative effectiveness, translational research Introduction
There is growing, mutual recognition that some interdependence between researchers, including the Community Engagement in Research (CEnR) and Comparative Effectiveness Research (CER) disciplines, will produce mutual benefits.1–8 Support for collaborative research comes from the US Institute of Medicine (IOM),1 National Institutes of Health’s National Center for Advancing Translational Research (NIH NCATS),2,3 and appropriations for the Patient Centered Outcomes Research Institute (PCORI).4 The healthcare and health research enterprise includes stakeholders who collectively strive to reach the goal of expedited scientific discovery that will lead to improvements in efficiency, quality, and health outcomes. The success of these efforts ultimately stands with the engagement and acceptance of individual patients and the larger population comprised of varying communities. CEnR and CER experts are essential conduits for accomplishing this goal as they directly interact with these groups but at the same time have distinct sets of needs that must be addressed before synergy and collaboration can be achieved.5–8 These issues motivated the Clinical and Translational Science Institute of Southeast Wisconsin (CTSI)9 to host a CEnR-CER Bridge Building Day that initiated dialogue and gain understanding from local experts and challenged workshop participants to explore questions about each disciplines’ attributes and needs. This paper describes what was learned from the participants, similar challenges, and diverging areas of priority, and suggests next steps for operationalization. The paper’s aim is to clarify a vision and strategies for adopting and applying these approaches in community and healthcare settings. Background
The United States has established a growing foundation for translation of scientific discoveries into the community. The NIH
continues to support public health engagement and translational science.1–3,8,10 The IOM recently recommended that academic medical centers with Clinical Translational Science Awards (CTSAs) ensure community engagement through “active and substantive … participation in priority setting and decision making across all phases of clinical and translational research.”1 “Bench to bedside to curbside”10 describes a continuum of inclusivity and bi-directionality11 fostering collaboration with researchers and communities.3 Interdisciplinary approaches among basic scientists, clinical investigators, and community engaged researchers will “accelerated discoveries toward better health”1 and the “Triple Aim” of healthcare reform: improving the experience of care and population health and reducing costs12 while including communities in the process. Aforementioned federal investments and the national consortium of CTSAs support the concept of bridging CEnR and CER to enhance research overall. Definitions and Need
Despite progress in supporting scientific discovery, adoption of healthcare recommendations by the community remains a challenge. Gaps exists for quality and efficiency of US healthcare, particularly among populations with the greatest needs. All researchers (bench, clinical, CER, and CEnR) have the responsibility of advancing their fields while assuring relevance and importance to patients, communities, and policy makers. Researchers must actively engage stakeholders in all stages of research.1–8,10,13 The most clear and current roadmap for researchers to accomplish such a task in a conscientious, mutualistic manner is through research that is genuinely community engaged.6,8,10,13 Institutional complexities in infrastructure, policy, curriculum, and other support mechanisms limit researchers’ capacity to be dedicated to such efforts.13
Department of Family and Community Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA; 2Department of Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA; 3Institute for Health and Society, Medical College of Wisconsin, Milwaukee, Wisconsin, USA. 1
Correspondence: Anne Kissack ([email protected]) DOI: 10.1111/cts.12236
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Community Engagement in Research (CEnR) 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 or focus. It is a core element of any research effort involving communities which requires academic members to become part of the community and community members to become part of the research team, thereby creating a unique working and learning environment before, during, and after the research.6 Comparative Effectiveness Research (CER) is the conduct and synthesis of systematic research comparing different interventions and strategies to prevent, diagnose, treat, and monitor health conditions. The purpose of this research is to inform patients, providers, and decision makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. To provide this information, comparative effectiveness research must assess a comprehensive array of health-related outcomes for diverse patient populations. Defined interventions compared may include medications, procedures, medical and assistive devices and technologies, behavioral change strategies, and delivery system interventions. This research necessitates the development, expansion, and use of a variety of data sources and methods to assess comparative effectiveness.23 Table 1. Definitions for Community Engagement in Research and Comparative Effectiveness Research.
CEnR dominant case examples
CER dominant case examples
1. Can CER inform CEnR in measuring and improving treatment fidelity with research team members as well as controlling intervention delivery in a nonclinical/lab setting?
1. How can CER engage all members of a community without obscuring the impact of the intervention while still gaining the approval for the validity of the intervention?
2. Can CER inform CEnR in improving management of knowledge and consistency of data when facing high research staff turnover?
2. How can a CER study make outcomes be of relevancy and importance to its stakeholders?
Table 2. Examples of questions for workgroup discussion.
Philosophical and practical differences between CEnR and CER complicate translation and interdisciplinary research. A central focus of CEnR is to prioritize social change and reduce health inequities5,8,13,14 arising from individual, sociological, economic, and environmental issues too complex for a single solution.14–18 CEnR embraces a comprehensive approach to human health by applying the principles of community-based participatory research.15,19,21 Proponents of CEnR support systematic community participation to optimize research relevance and impact.21,22 In comparison, the design of CER focuses attention on evidence relevant to the expressed needs of patients, healthcare professionals, and other key decision makers across diverse settings to make informed healthcare decisions.20,23 In the CER framework, knowledge and practicality of clinical care comes from evidence about benefits, risks, and costs for different patient or clinician populations.20,23 CER strategically focuses on a practical comparison of two or more health interventions to determine what works best for which patients and populations.20,23 Practitioners of CER believe that developing and disseminating better evidence on which treatments work best is part of the healthcare reform solution.22 CEnR and CER researchers will be more effective through collaboration. CER practitioners seek to implement practice changes that follow from an improved understanding of “best” approaches to treating common conditions. They confront a need to obtain buy-in from communities to successfully translate efficacious interventions from clinical trials to widespread practice. Those who support CEnR seek to develop novel programs or interventions to address common health issues in collaboration with communities. They confront the need to demonstrate outcomes that support the validity of their approach over a variety of alternatives. Despite major differences between CER and CEnR—differences of philosophies, approaches, and aims—both value stakeholder engagement in their research and both see significant potential in collaboration in order to improve WWW.CTSJOURNAL.COM
the health of communities. Of concern, is that the differences in research approaches could limit capacity to collaborate or create unintended, negative consequences on the communities they seek to benefit. Workshop Description
The CTSI9 invited workshop participants from its multiple institutional consortia. A large scope in practitioner type was desired including faculty and staff from disciplines including CEnR; CER; clinical researchers; population and public health; medicine, nursing, biomedical, informatics, and technology. Members of community-based organizations involved in community–academic partnerships participated. The all-day interactive format used case examples to foster dialogue on problems and needs related to either CER or CEnR. The format was intended to drive discussions on how disciplines can work together. Table 1 states the definitions for CEnR and CER utilized for participants’ reference. Two CER and two CEnR cases were authored by workgroup leaders. Cases were designed to generate multidirectional dialogue. The composition of four case discussion workgroups was predesignated to balance representation from community members, CEnR, and CER including a composite of participants by field of study and appointment type. Facilitated workgroups used the cases to develop and begin to categorize a broad set of needs and problems and to discuss collaborative solutions and practical next steps. Table 2 lists questions from which the facilitators could choose to aid discussion. Program Outcomes
The workshop convened a diverse set of participants from four academic institutions and twelve other organizations. Detailed notes of the discussions produced feedback from workgroup participants that helped to frame similar and difference challenges in CEnR and CER as well as generalizable themes and priority areas. Table 3 is a brief summary of workgroup feedback. VOLUME 8 • ISSUE 2
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Similar challenges 1. Study design 2. Study population 3. Regulation 4. Funding and sustainability Challenges with diverging priority areas Community Engagement in Research (CEnR)
Comparative Effectiveness Research (CER)
1. Policy implications relate to social issues in the community
Policy implications relate to healthcare and multiple stakeholders
2. Dissemination traditionally is in the form of sharing results with community based organizations and the general citizenry
Dissemination traditionally is in the form of published results from research that is intended for clinical or healthcare settings to adopt
3. Engagement is with communities as stakeholders
Engagement focuses on multiple stakeholders
Table 3. CEnR–CER bridge day case study workgroup feedback on similar and different challenges.
Education
1. Support building capacity at community-based organizations to become more engaged and active in CEnR and CER. 2. Support opportunities for community-based organizations and academic researchers to network and discuss current research news, trends, and opportunities.
Research
1. Support the discovery of shared local interests and need among investigators and community-based resources. 2. Support a comprehensive, collaborative enterprise of investigators for transdisciplinary projects utilizing a compliment of CEnR and CER methods and approaches.
Policy
1. Expand support through institutional change that better enables CEnR–CER collaboration by allowing for sustainability and capacity among both community and academic partners.
Table 4. Summary of next step recommendations from workshop participants.
Workshop participants generated a wealth of information for next step recommendations based on their knowledge of existing resources available and in response to the conversations occurring throughout the day. Table 4 outlines a distinct set of actions proposed for establishing stronger relationships in CEnR– CER locally. Over 100 comments as suggested next steps were categorized into specific theme areas relevant to research paradigm and process.24 Figures 1 and 2 in the discussion section identify common critical areas and topics for debate between CEnR and CER to evolve assumptions and practices for interdisciplinary work. The authors made this distinction to avoid addressing more specific points on engaging stakeholders and communities, which have been so clearly described in a recent commentary by Burke et al.8 Discussion
This CEnR–CER workshop explored obstacles and assets for closing gaps in application of these research approaches in both community and healthcare settings. Rather than establishing specific hypotheses or consensus on practice changes, this opportunity began to lay groundwork to establish a common place for local CEnR and CER colleagues to discuss problems together. It was an effective way to initially understand one another’s perspectives and increase collective knowledge. Ultimately and of high relevance, we discovered that despite the fact that differences exist between CER and CEnR, these are a matter of degree rather than in stark contrast to one another. Although case example discussions produced several key findings in relation to their distinct topic, more issues were 162
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crosscutting regardless of the focus area. Knowledge of the generalizability of issues also lends itself to deeper investigation of the overlap, discrepancies, and priority of shared need for more enthusiastic, engaged dialogue. Figure 1 is a detailed portrayal of the data that were gathered from the shared dialogue of participants broken into Community Engagement in Research A and Comparative Effectiveness Research B. It is within the intersection that a set of congruent, pervasive themes overlap C; methodology or study design, engagement or study population, institutional review boards, funding and sustainability, dissemination, and policy implications. The Venn diagram within the figure suggests that the symmetric difference of the two sets is less than their intersection. Upon further exploration of these themes, those involved in the process specified diverging issues within the themes and thus created different priorities (CEnR Priority Impact Areas D and CER Priority Impact Areas E). This information can be utilized as a springboard for CTSAs to support discussions and future interdisciplinary research. The particular principles and priorities by which CEnR has as a foundation for community–academic partnerships and the approach to conducting research could appear limiting in scientific methods or rigor to CER.13 For this particular example, one may ask questions such as “How far will a CEnR investigator deviate from a community partner’s priority in order to assist in creating a comparator for a CER project?” or “If a CER investigator wants a community as a stakeholder early in developing a research question, how willing are they to structure a research study that develops a solution rather than compares existing resources?” Thoughtful reflection and discussion between WWW.CTSJOURNAL.COM
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Figure 1. Overlapping challenges and the diverging priority areas of impact shared among workshop participants during four, facilitated case study examples led by local Community Engagement in Research and Comparative Effectiveness Research practitioners.
investigators and their limitations, convictions, commitment, and perceptions are important exchanges to support health improvement and discovery. These discussions may include each researcher’s understanding of how they and others in their field justify knowledge through their research from theory to assumptions, best practices, and research approaches to obtaining evidence.13,25 Using participant feedback, we identified potential questions for dialogue to align transdisciplinary work among CEnR– CER. Because our participants were only beginning to develop relationships, at this point in time, our intentions do not extend past mutual exploration into specific recommendations for practice change actions. Figure 2 includes major underpinnings for research and differentiates questions within each category.25 We have defined the categories in the following way: • Assumptions: Investigators can share, debate, and explore what they value and assume for developing questions they think would lead to the most impactful answers. • Dialect: A general understanding of shared and different definitions, taxonomy, and ontology between fields and concepts can be important to identify throughout the process of learning each other’s foundational aspects of research. • Best practices: Those working in two different areas of research can examine why and how they proceed with inquiry and experimentation. Discipline-based best practices, personal experiences, and world views or constructs will be foundational. Gaining a deeper understanding of another researcher’s ways of thinking that influence the aims, objectives and design of their research could increase trust and establish a starting point for approaching a similar interest area or question. • Obtaining evidence: CEnR and CER have a variety of methods for conducting research. Sharing more about how their WWW.CTSJOURNAL.COM
protocols are designed for sampling, what are considered comparators, data collection, tools for measurement and statistical methods could benefit both practices as well as transdisciplinary efforts. The stage of practical applications of collaborative thinking is pivotal for continued learning and growing between CEnR– CER. Within the conference planning group, CEnR and CER investigators continue to share research interests and are eager to develop foundations for future funded research. More examples of where these two domains practice together are needed. The lessons and guidance from such pioneers will help to direct another generation that can follow similar paths. Examples should justify the blending of CEnR–CER as a useful effort that brings highly impactful benefits to community health and demonstrates effective outcomes. Otherwise, community-based organizations and citizens will not engage and establish trust in the process or protocol. Some questions to gauge progress of working together are: • Can or does collaboration among CEnR and CER form shared assumptions? • Can investigators approach a research question and implement a study with adoption of the others’ practices and processes? What of these are distinct and what can be shared? • Can a deeper understanding of the issue be reached by working in collaboration between the two orientations? • What of research paradigms are new, necessary to concede in collaborative work, or shared for the advantage and science of the others’ discipline? Community members and academics regularly attend CTSI-sponsored conferences and thus we have been successful in gaining leadership from community-based organizations and VOLUME 8 • ISSUE 2
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Figure 2. Critical discussions for CEnR–CER bridge building. Based on findings from this workshop, this figure is a revision of a seminal publication by Carter and Little25 (original in italic). It includes key areas of inquiry supported by our findings, leading to future research that may more closely align CEnR and CER.
general citizenry who have an interest in research. Dialogue was not only between CEnR and CER researchers but also among and between communities. This conference demonstrated that community played a dual role—one as key contributors and the other as necessary connectors. Key moments occurred during the workshop when community input assisted in bridging CEnR and CER investigators around a solution or similarity. They identified organizational and service population needs as well as their perspectives on approaches to research and practicality of methods in a community setting. Rather than having a bidirectional exchange, these contributions from the community representation created a circular loop. Next Steps
Proximally, our CTSA must find ways to bridge between differences and enable greater collaboration based on the workshop participant’s very specific next step suggestions. Support is needed in areas of education, research, and policy. 164
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Our CTSI 9 must now maintain and monitor interactions between participants to assess evolution of new CEnR–CER transdisciplinary efforts. Distally, other CTSAs can join in addressing next steps outlined in this paper as well as foster future discussions through developing focus and action around themes and priority impact areas identified in Figure 1. One example may be making determinations on blending methodologies to enhance CEnR and CER metrics and outcomes. Finally, CTSAs could find and pose questions to key stakeholders regarding research that uses community–academic partnerships or comparative effectiveness as an approach, but which require skill or knowledge from the both disciplines. While more work needs to be done in the area of converging CER and CEnR, the results of this workshop provide support for discovering new ways for individuals from seemingly different points of view to work together. This effort established groundwork for approaching collaboration through dialogue and shared learning. Demonstration is the next challenge. While federal and institutional supports along with grassroots demands for authentic WWW.CTSJOURNAL.COM
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engagement continue to push researchers and community on the cutting edge of individual and population health, stronger ties and a significant common ground in conjunction with the appropriate supports will successfully align assets and innovate to solve challenges and improve outcomes. Acknowledgments
This project has been funded in in part with federal funds from the National Center for Research Resources (NCRR), the National Center for Advancing Translational Sciences (NCATS), and the National Institutes of Health (NIH) through the Clinical and Translational Science Award Program through funding for the Clinical and Translational Science Institute of Southeast Wisconsin (#8UL1TR000055). Support was also provided through the Advancing a Healthier Wisconsin Research and Education Initiative Fund, a component of the Advancing a Healthier Wisconsin endowment at the Medical College of Wisconsin (#5520190). The Medical College of Wisconsin institutional review board approved the research component of this article. The views in this article are those of the authors—and not of their institutions or funding agencies. References
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