Aligning clinical research ethics with community-engaged and participatory research in the United States.

The professional role in ethical review of research in which boards review proposed research involving human beings continues to evolve. The scholarly literature on institutional review boards in academic centers of the United States, at which a majority of the community engaged and participatory research emanates and is reviewed, suggests the need to implement changes in board education, the infrastructure supporting review, and the accountability of review. The recommendations for change advanced in this perspective involve enhancing reviewer knowledge of local community contexts and developing an infrastructure that supports engagement in and dialogue among individuals involved in community-academic research to inform ethical review and the assessment of review outcomes. Additionally, recommendations regarding putting an institutional infrastructure in place are advanced in order to sustain community engaged and participatory research. The infrastructure can also support the collection and review of outcome data as the foundation of accountability. The recommendations outlined intend to improve clinical research ethics reviews of community-engaged and participatory research.

The impact of COVID-19 on disease epidemiology, family dynamics, and social justice in Minnesota: All that you cannot see.

Objective: The COVID-19 pandemic presented a challenge to established seed grant funding mechanisms aimed at fostering collaboration in child health research between investigators at the University of Minnesota (UMN) and Children's Hospitals and Clinics of Minnesota (Children's MN). We created a "rapid response," small grant program to catalyze collaborations in child health COVID-19 research. In this paper, we describe the projects funded by this mechanism and metrics of their success. Methods: Using seed funds from the UMN Clinical and Translational Science Institute, the UMN Medical School Department of Pediatrics, and the Children's Minnesota Research Institute, a rapid response request for applications (RFAs) was issued based on the stipulations that the proposal had to: 1) consist of a clear, synergistic partnership between co-PIs from the academic and community settings; and 2) that the proposal addressed an area of knowledge deficit relevant to child health engendered by the COVID-19 pandemic. Results: Grant applications submitted in response to this RFA segregated into three categories: family fragility and disruption exacerbated by COVID-19; knowledge gaps about COVID-19 disease in children; and optimizing pediatric care in the setting of COVID-19 pandemic restrictions. A series of virtual workshops presented research results to the pediatric community. Several manuscripts and extramural funding awards underscored the success of the program. Conclusions: A "rapid response" seed funding mechanism enabled nascent academic-community research partnerships during the COVID-19 pandemic. In the context of the rapidly evolving landscape of COVID-19, flexible seed grant programs can be useful in addressing unmet needs in pediatric health.

Exploring theoretical mechanisms of community-engaged research: a multilevel cross-sectional national study of structural and relational practices in community-academic partnerships.

BACKGROUND: Community-Based Participatory Research (CBPR) is often used to address health inequities due to structural racism. However, much of the existing literature emphasizes relationships and synergy rather than structural components of CBPR. This study introduces and tests new theoretical mechanisms of the CBPR Conceptual Model to address this limitation. METHODS: Three-stage online cross-sectional survey administered from 2016 to 2018 with 165 community-engaged research projects identified through federal databases or training grants. Participants (N = 453) were principal investigators and project team members (both academic and community partners) who provided project-level details and perceived contexts, processes, and outcomes. Data were analyzed through structural equation modeling and fuzzy-set qualitative comparison analysis. RESULTS: Commitment to Collective Empowerment was a key mediating variable between context and intervention activities. Synergy and Community Engagement in Research Actions were mediating variables between context/partnership process and outcomes. Collective Empowerment was most strongly aligned with Synergy, while higher levels of Structural Governance and lower levels of Relationships were most consistent with higher Community Engagement in Research Actions. CONCLUSIONS: The CBPR Conceptual Model identifies key theoretical mechanisms for explaining health equity and health outcomes in community-academic partnerships. The scholarly literature's preoccupation with synergy and relationships overlooks two promising practices-Structural Governance and Collective Empowerment-that interact from contexts through mechanisms to influence outcomes. These results also expand expectations beyond a "one size fits all" for reliably producing positive outcomes.

Science Cafés and Local Dissemination: Fulfilling the Responsibilities of Community-Engaged Research.

This report describes a Science Café innovation, using an interpreter to translate remarks and engage three underserved Minnesota communities. It also illustrates how translational research can emphasize community benefit by combining longer-term knowledge production goals with shorter-term goals such as developing materials that are responsive to community health literacy needs.

A compendium of community engagement responses to the COVID-19 pandemic.

INTRODUCTION: Clinical and Translational Science Award Program (CTSA)-funded institutions were charged with developing clinical and translational science programs and transforming clinical research at their institutions. Community engagement (CE) was recognized as a key component and catalyst of that transformation. CE hub capacities for working with communities and translating knowledge into practice have been illustrated through their COVID-19 responses. METHODS: CE hub leaders met and discussed their CTSA's early responses regarding the COVID-19 pandemic. The 2-hour discussion was distilled into themes which were sent to the CE hub leaders with a request for written accounts describing actions taken to engage local partners, communities, and institutions. The written reports form the basis for this compendium. RESULTS: Eighteen institutions submitted written reports describing activities in relation to six themes: (1) listen to the community and respond to concerns, (2) collect data to understand the impact of COVID-19 on distinct communities and groups, (3) communicate science and address misinformation, (4) collaborate with health departments, (5) engage hubs and underrepresented populations in COVID-19 research, and (6) support our own well-being and that of others. CONCLUSIONS: Bidirectional interactions comprise the foundation of CE, which requires trusted partnerships that sustain communication through a series of activities and goals. The nimble responses to the pandemic substantiate the need for CE programs to maintain the infrastructure necessary to achieve the primary CTSA goals of improving health within and across communities and localities as well as expanding research participation of community members.

Feasibility of a virtual Facebook community platform for engagement on health research.

INTRODUCTION: Community engagement is important for advancing Clinical and Translational Science (CTS), but face-to-face engagement has limited reach and scale. We examined the feasibility of a novel virtual Facebook community platform for public engagement on health research statewide in Minnesota. METHODS: The Facebook platform, MN Research Link, was evaluated from June 19, 2019 to June 30, 2020. Facebook advertisements and boosts were used to recruit followers. Content, based on prior formative work, included health research information and interactive postings (e.g., live interviews with researchers). Standard metrics obtained from Facebook analytics included participation (followers), content reach (views), and engagement (likes, shares, comments, clicks). RESULTS: During the 12-month period, we acquired 1406 followers (31% rural residents), with a retention of followers of 99.7%. Mean number of views per month was 9379.83 (Mdn = 2791, range 724-41,510). Engagement metrics indicated a mean of 535.2 likes, shares, comments, and/or clicks per month (Mdn = 296.5, range 55-1535). The page continued to acquire new followers, but a slight decrease in engagement was observed in the final months after state COVID-19 mitigation strategies were implemented. CONCLUSION: As the complexity of CTS continues to grow, along with social distancing measures resulting from the COVID-19 pandemic, the availability of virtual digital platforms to reach and engage community stakeholders in conversations about health and research has increasing importance. Preliminary findings from this program evaluation indicate that a Facebook community platform is feasible to engage Minnesota residents in conversations around health and research topics. Future work will evaluate its potential for reach, scale, and sustainability.

Low-dose aspirin for primary prevention of cardiovascular disease: Trends in use patterns among African American adults in Minnesota, 2015-2019.

Cardiovascular disease (CVD) disproportionately affects African Americans. Aspirin has long been recommended to reduce cardiovascular events. However, national guideline changes in 2016 limited the aspirin recommended population and several clinical trials questioning the utility of primary prevention aspirin were published in 2018. In light of the recent guidelines and study findings, we investigated primary prevention aspirin use among urban African American adults. Using three cross-sectional surveys, we collected data from self-identified African Americans with no CVD in 2015, 2017 and 2019, querying information on CVD risk factors, health behaviors and beliefs, and aspirin use. Poisson regression modeling was used to estimate age- and risk-factor adjusted aspirin prevalence, trends and associations. A total of 1491 African Americans adults, ages 45-79, were included in this analysis; 61% were women. There was no change in age- and risk factor-adjusted aspirin use over the 3 surveys for women (37%, 34% and 35% respectively) or men (27%, 25%, 30% respectively). However, fewer participants believed aspirin was helpful in 2019 compared to 2015-75% versus 84% (p < 0.001). Aspirin discussions with a health care practitioner were highly associated with aspirin use (adjusted RR 2.97, 95% CI 2.49-3.54) and aspirin use was 2.56 times higher (adjusted RR 95% CI 2.17-3.03) in respondents who agreed that people close to them thought they should take aspirin compared with those who disagreed or did not know. Despite major changes in national guidelines, overall primary prevention aspirin use did not significantly change in these African American samples from 2015 to 2019.

Collaboration and Context in the Design of Community-Engaged Research Training.

Collaboration between academic researchers and community members, clinicians, and organizations is valued at all levels of the program development process in community-engaged health research (CEnR). This descriptive study examined a convenience sample of 30 projects addressing training in CEnR methods and strategies within the Clinical and Translational Science Awards (CTSA) consortium. Projects were selected from among posters presented at an annual community engagement conference over a 3-year period. Study goals were to learn more about how community participation in the design process affected selection of training topics, how distinct community settings influenced the selection of training formats, and the role of evaluation in preparing training participants to pursue future health research programming. Results indicated (1) a modest increase in training topics that reflected community health priorities as a result of community (as well as academic) participation at the program design stage, (2) a wide range of community-based settings for CEnR training programs, and (3) the majority of respondents conducted evaluations, which led in turn to revisions in the curricula for future training sessions. Practice and research implications are that the collaboration displayed by academic community teams around CEnR training should be traced to see if this participatory practice transfers to the design of health promotion programs. Second, collaborative training design tenets, community formats and settings, and evaluation strategies should be disseminated throughout the CTSA network and beyond. Third, common evaluative metrics and indicators of success for CEnR training programs should be identified across CTSA institutions.

Engagement science: The core of dissemination, implementation, and translational research science.

Stakeholder engagement is acknowledged as central to dissemination and implementation (D&I) of research that generates and answers new clinical and health service research questions. There is both benefit and risk in conducting stakeholder engagement. Done wrong, it can damage trust and adversely impact study results, outcomes, and reputations. Done correctly with sensitivity, inclusion, and respect, it can significantly facilitate improvements in research prioritization, communication, design, recruitment strategies, and ultimately provide results useful to improve population and individual health. There is a recognized science of stakeholder engagement, but a general lack of knowledge that matches its strategies and approaches to particular populations of interest based on history and characteristics. This article reviews stakeholder engagement, provides several examples of its application across the range of translational research, and recommends that Clinical Translational Science Awards, with their unique geographical, systems, and historical characteristics, actively participate in deepening our understanding of stakeholder engagement science and methods within implementation and dissemination research. These recommendations include (a) development of an inventory of successful stakeholder engagement strategies; (b) coordination and intentionally testing a variety of stakeholder engagement strategies; (c) tool kit development; and (d) identification of fundamental motivators and logic models for stakeholder engagement to help align stakeholders and researchers.

Engage for Equity: The Role of Trust and Synergy in Community-Based Participatory Research.

Community-based participatory research (CBPR) partnerships exist as complex, dynamic relationships that incorporate shared decision that supports trust development between communities and academics. Within CBPR, the interest in understanding the concept of trust has grown with the realization that, without trust, CBPR relationships fracture. A barrier to monitoring the trust health of a partnership is the lack of a shared operationalization of the concept, its antecedents, and measurement tools. To address these barriers, a six-category trust typology was created as a developmental theory of trust progress. To advance the theory, this article reports on the quantitative structural elements of the trust typology, identifies variability in trust correlates, and creates an empirical foundation for the trust types. Using Engage for Equity data, trust covariates included measures of synergy, CBPR principles, participation, and influence. Structural equation models were used to assess associations between trust types and the latent constructs measured by the items in each measure. The findings demonstrate that the six trust types generally operate on a continuum. Specifically, it does appear that trust deficit, role-based trust, functional trust, proxy trust, and reflective trust are on a single continuum from low to high. Scale scores for reflective trust and proxy trust were consistently and statistically significantly higher than those for functional trust, role-based, neutral, and trust deficit. These results support the construct validity of the trust typology as representing "higher levels" of trust phases. Due to the dynamic nature of partnerships, regular monitoring of partnership trust types can serve as a proxy for partnership functioning.

The Effects of a Multicomponent Colorectal Cancer Screening Intervention on Knowledge, Recommendation, and Screening among Underserved Populations.

This trial tested a multicomponent intervention to increase colorectal cancer (CRC) screening among underserved patients. Participants were randomized to: (1) physician + patient intervention, (2) physician-only intervention, or (3) usual care (UC). Study outcomes included patient knowledge, physician recommendation of CRC screening, and screening completion via colonoscopy or stool tests. Among 538 participants, those exposed to the physician + patient intervention had significantly increased knowledge over patients in physician-only (p=.0008) or UC arms (p=.0003). However, there were no statistically significant differences in completion of CRC screening, with 10%, 20%, and 16% of UC, physician-only, and physician + patient participants screened, respectively. In UC, all completed screenings were colonoscopy, whereas in the physician-only and physician + patient arms, 39% and 46% of completed tests were via stool test, respectively. The multicomponent intervention did not increase overall CRC screening, yet results underscore the need to provide patients options for completing CRC screening.

Use of a Geographic Information System to create treatment groups for group-randomized community trials: The Minnesota Heart Health Program.

BACKGROUND: Group-randomized trials of communities often rely on the convenience of pre-existing administrative divisions, such as school district boundaries or census entities, to divide the study area into intervention and control sites. However, these boundaries may include substantial heterogeneity between regions, introducing unmeasured confounding variables. This challenge can be addressed by the creation of exchangeable intervention and control territories that are equally weighted by pertinent socio-demographic characteristics. The present study used territory design software as a novel approach to partitioning study areas for The Minnesota Heart Health Program's "Ask about Aspirin" Initiative. METHODS: Twenty-four territories were created to be similar in terms of age, sex, and educational attainment, as factors known to modify aspirin use. To promote ease of intervention administration, the shape and spread of the territories were controlled. Means of the variables used in balancing the territories were assessed as well as other factors that were not used in the balancing process. RESULTS: The analysis demonstrated that demographic characteristics did not differ significantly between the intervention and control territories created by the territory design software. CONCLUSIONS: The creation of exchangeable territories diminishes geographically based impact on outcomes following community interventions in group-randomized trials. The method used to identify comparable geographical units may be applied to a wide range of population-based health intervention trials. TRIAL REGISTRATION: National Institutes of Health (Clinical Trials.gov), Identifier: NCT02607917 . Registered on 16 November 2015.

An observational study of a clinical guideline implementation project in primary care.

Explorations of workflow development within primary care allow us to understand initial steps in the pace of knowledge and practice acclimatization within clinics. This study describes use of practice facilitation as an implementation strategy to communicate shared project goals and monitor and support refinement of practice behavior. This study engaged eight health care organizations, including 55 primary care practices, ≈380 clinicians, and ≈620 nursing and support staff in a guideline implementation project regarding United States Preventive Services Task Force use of aspirin recommendations for primary prevention of cardiovascular events.

Public feedback on a proposed statewide virtual translational research community.

INTRODUCTION: Researchers have explored using the internet and social media to recruit participants to specific research projects. Less systematic work has been done to inform the engagement of large populations in virtual communities to advance clinical and translational science. We report on our first step to use social media to engage Minnesota residents by studying the willingness of participants to engage in a virtual (Facebook) community about the concepts of health and health-related research. METHODS: Data were collected at the 2018 Minnesota State Fair using a cross-sectional, 46-item survey with assessment including sociodemographics and willingness to engage in a Facebook group for health-related research. Quantitative analysis included univariate, bivariate, and multivariate analyses. Content analysis was used to generate themes from open-ended survey responses. RESULTS: Five hundred people completed the survey; after data cleaning, 418 participant responses informed this report. A majority were younger than age 50 (73%), female (66%), and married/partnered (54%). Overall, 46% of participants agreed/strongly agreed they are willing to join the Facebook group. Multivariate logistic regression identified social media use over the past 6 months as the sole variable independently associated with willingness to join the Facebook group (once a day vs. never or rarely OR = 1.82 (0.86, 3.88), several hours a day vs. never or rarely OR = 2.17 (1.17, 4.02, overall p-value 0.048). CONCLUSION: Facebook holds potential for reaching a broader community, democratizing access to and engagement with clinical and translational research. Social media infrastructure and content could be disseminated to other institutions with Clinical and Translational Science Awards.

Defining and Measuring Community Engagement and Community-Engaged Research: Clinical and Translational Science Institutional Practices.

BACKGROUND: The institutions that comprise the Clinical and Translational Science Award (CTSA) consortium and the National Center for Advancing Translational Sciences continue to explore and develop community-engaged research strategies and to study the role of community academic partnerships in advancing the science of community engagement. OBJECTIVES: To explore CTSA institutions in relation to an Institute of Medicine recommendation that community engagement occur in all stages of translational research and be defined and evaluated consistently. METHODS: A sequential multimethods study starting with an online pilot survey followed by survey respondents and site informant interviews. A revised survey was sent to the community engagement and evaluation leads at each CTSA institution, requesting a single institutional response about the definitions, indicators, and metrics of community engagement and community-engaged research. RESULTS: A plurality of CTSA institutions selected the definition of community engagement from the Principles of Community Engagement. Although claiming unique institutional priorities create barriers to developing shared metrics, responses indicate an overall lack of attention to the development and deployment of metrics to assess community engagement in and contributions to research. CONCLUSIONS: Although definitions of community engagement differ among CTSAs, there seem to be more similarities than differences in the indicators and measures tracked and reported on across all definitions, perhaps owing to commonalities among program infrastructures and goals. Metrics will likely need to be specific to translational research stages. The assessment of community engagement within translational science will require increased institutional commitment.

An exploratory study of Clinical and Translational Science Award community-engaged research training programs.

BACKGROUND: The Clinical and Translational Science Award (CTSA) institutions are increasing development of training programs in community-engaged research (CEnR) to support translational science. METHODS: This study sampled posters at CTSA national meetings to identify CEnR training approaches, topics, and outcomes. RESULTS: Qualitative analysis of 30 posters revealed training topics and outcomes focused primarily on CEnR capacity building, overcoming barriers, systems change, and sustainability. CONCLUSION: Further research should focus on development and results of CTSA CEnR training program metrics.

A Retrospective on the Vision for Progress in Community Health Partnerships: Research, Education, and Action.

The organizers founded Progress in Community Health Partnerships with a commitment to improving our understanding of community-based participatory research (CBPR) and its use in community-academic/institutional health partnerships. Following Rogers's Diffusion of Innovations, they reasoned that expanded adoption would occur through academic and community partner recognition of CBPR's relative advantage over previous approaches; its compatibility with the values, past experience and needs of potential adopters; its ease of understanding and use; its capacity for experimentation and refinement; and its production of observable results. We now assess the journal's progress toward realizing the vision, as well as issues and problems the organizers identified. We map the journal's content over its first decade onto the initial vision by examining the record of submissions and publications across the eight types of articles and the journal's record of rejections and publications. In remembering that Rogers's study of innovations requires both technical and social change, we discuss the difference between understanding how to do something and actually putting an innovation into action that becomes standard practice at both individual and systemic levels. We observe that the large number of Original Research and Works-in-Progress/Lessons Learned manuscripts, submitted and published, reflect traditional expectations for faculty research productivity. We suggest that sustainability, which rated of lower importance within the initial vision, has gained in importance among community and academic partners; however, it will gain added attention only with changed university expectations of researchers. We further suggest that the study of partnerships involved in researching and improving public health should be expanded beyond the current focus on CBPR.

Using the TRANSLATE Framework to Support Practice Transformation: Perspectives of a Practice Facilitator.

BACKGROUND: In 2008, the Minnesota Department of Health (MDH) awarded Statewide Health Improvement Partnership (SHIP) funding to community health boards (CHBs), directing them to partner with schools, worksites, communities, and health care to address obesity and tobacco use/exposure. METHODS: Each CHB selected one of two health care strategies: implement obesity and healthy lifestyle guidelines or connect clinics to community resources. The CHB in rural west-central Minnesota chose to champion clinical guideline implementation, assigning one of its own county-level public health nurses the role of practice facilitator (PF). This decision set the stage for a novel community partnership between public health, clinical guideline developers, and local providers of relevant clinical services. LESSONS LEARNED: This community perspective describes how the PF organized support for clinical guideline implementation using the TRANSLATE framework, and explores the capacity of the TRANSLATE framework to accommodate particularities of clinical partners that is necessary in working to transform evidence-based knowledge into real-world practice.