A community-informed recruitment plan template to increase recruitment of racial and ethnic groups historically excluded and underrepresented in clinical research.

INTRODUCTION: Engaging communities in research planning and implementation can enhance recruitment and retention (R&R) of racial and ethnic groups historically excluded and underrepresented in clinical research; however, most studies do not use community-informed approaches. This paper describes the formative research process used to design a Community-Informed Recruitment Plan Template for racial and ethnic groups historically excluded and underrepresented in clinical research. METHODS: Using an existing R&R template as a starting point, we iteratively developed and refined the community-informed template through a 3-phase process to achieve cultural-appropriateness. Phase 1 included a literature review, 34 community engagement (CE) studios to review recommendations, community advisory board (CAB) review, and survey data from minority recruitment experts. Phase 2 involved integration of content into existing R&R template. Phase 3 was a final review and revision using input of the CAB and researchers' panel. Survey data collected in Phase 1 were analyzed using descriptives (i.e., frequencies and percentages). Open-ended survey responses were analyzed using inductive, qualitative thematic analysis. RESULTS: The final 8-section template can help develop effective grant or proposal language where study R&R plans are requested. They include: 1) Recruitment Strategy; 2) A Stakeholder Communication Plan; 3) Evidence of Recruitment Feasibility; 4) Recruitment and Retention Team; 5) Recruitment and Retention Methods; 6) Recruitment and Retention Timeline; 7) Evaluation; and 8) Budget. CONCLUSIONS: Incorporating multiple perspectives into this formative research process enhances the cultural appropriateness of this community-informed R&R template to help research teams achieve R&R goals for individuals historically excluded and underrepresented in clinical research.

A multiperspective on the broad dissemination of research findings to past research participants and the community-at-large.

Dissemination of research findings to past research participants and the community-at-large is a critical element to improving health outcomes, yet it is often overlooked by researchers. Few studies have explored how to provide study findings to the community, and no studies have investigated how community members can be involved in this process. This study explored views on the broad dissemination of research findings to community members and the role of the community in the dissemination process. We conducted a comparative analysis from the perspective of researchers, community members, and program officers (POs) from national health research funding agencies. Semistructured interviews were conducted with community members (African American, N = 10; Latino, N = 10), academic researchers (N = 10), and POs (N = 5). Thematic analysis was utilized in which codes and themes were created. One cross-cutting theme was identified, Views on Disseminating Research Findings to Communities. There were three additional themes identified among community members, five among researchers, and four among POs. All groups perceived the value of dissemination to communities as meaningful and ethical. Groups differed in their perceptions of prioritization of dissemination audiences. This study highlighted consensus on the value of broad dissemination to the community-at-large and identified areas of insufficiency in the translational research continuum that could be expanded or improved to ensure targeted groups receive the intended benefits of positive research findings. The long-term benefit of disseminating findings to the community-at-large is increased acceptability of interventions and reduced mistrust in research and researchers.

Design and implementation of a massive open online course on enhancing the recruitment of minorities in clinical trials - Faster Together.

BACKGROUND: Racial and ethnic minorities are often underrepresented in clinical trials, threatening the generalizability of trial results. Several factors may contribute to underrepresentation of minorities in clinical trials, including lack of training for researchers and staff on the importance of diversity in clinical trials and effective strategies for recruiting and retaining minority populations. METHODS: Applying community engaged research principles, we developed a massive open online course (MOOC) to help research team members develop knowledge and skills to enhance the recruitment of minorities in clinical trials. A transdisciplinary working group, consisting of clinical researchers, community engagement specialists, minority clinical trial recruitment and retention educators and specialists, and knowledge management information scientists, was formed to develop an evidence-based curriculum. Feedback from the Recruitment Innovation Center Community Advisory Board was incorporated to help finalize the curriculum. The course was implemented in Coursera, an online learning platform offering MOOCs. A bootstrap paired sample t-test was used to compare pre- and post-assessments of knowledge, attitudes, and intentions as it relates to minority recruitment. RESULTS: The final course, entitled Faster Together, was divided into eight 1-h modules. Each module included video presentations, reading assignments, and quizzes. After 10 months, 382 individuals enrolled in the course, 105 participants completed the pre-test, and 14 participants completed the post-test. Participants' knowledge scores were higher with an increase in the mean number of correct answers from 15.4 (95% CI:12.1-18.7) on the pre-test to 18.7 (95% CI:17.42-20.2) on the post-test. All post-test respondents (n = 14) indicated that the course improved their professional knowledge, and 71.4% of respondents indicated that they were very likely to make changes to their recruitment practices. CONCLUSIONS: Faster Together, a massive open online course, is an acceptable, accessible approach to educating research teams on minority recruitment in clinical trials. Preliminary evidence indicates the course increased knowledge on how to recruit minorities into clinical trials and could promote change in their recruitment practices.

Streamlining the institutional review board process in pragmatic randomized clinical trials: challenges and lessons learned from the Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-Term Effectiveness (ADAPTABLE) trial.

BACKGROUND: New considerations during the ethical review processes may emerge from innovative, yet unfamiliar operational methods enabled in pragmatic randomized controlled trials (RCT), potentially making institutional review board (IRB) evaluation more complex. In this manuscript, key components of the pragmatic "Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-term Effectiveness (ADAPTABLE)" randomized trial that required a reappraisal of the IRB submission, review, and approval processes are discussed. MAIN TEXT: ADAPTABLE is a pragmatic, multicenter, open-label RCT evaluating the comparative effectiveness of two doses of aspirin widely used for secondary prevention (81 mg and 325 mg) in 15,000 patients with an established history of atherosclerotic cardiovascular disease. The electronic informed consent form is completed online by the participants at the time of enrollment, and endpoint ascertainment is conducted through queries of electronic health records. IRB challenges encountered regarding centralized IRB evaluation, electronic informed consent, patient engagement, and risk determination in ADAPTABLE are described in this manuscript. The experience of ADAPTABLE encapsulates how pragmatic protocol components intended to facilitate the study conduct have been tempered by unexpected, yet justified concerns raised by local IRBs. How the lessons learned can be applied to future similar pragmatic trials is delineated. CONCLUSION: Development of engaging communication channels between IRB and study personnel in pragmatic randomized trials as early as at the time of protocol design allows to reduce issues with IRB approval. Integrations of the lessons learned in ADAPTABLE regarding the IRB process for centralized IRBs, informed consent, patient engagement, and risk determination can be emulated and will be instrumental in future pragmatic studies.

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.

A REDCap-based model for electronic consent (eConsent): Moving toward a more personalized consent.

INTRODUCTION: The updated common rule, for human subjects research, requires that consents "begin with a 'concise and focused' presentation of the key information that will most likely help someone make a decision about whether to participate in a study" (Menikoff, Kaneshiro, Pritchard. The New England Journal of Medicine. 2017; 376(7): 613-615.). We utilized a community-engaged technology development approach to inform feature options within the REDCap software platform centered around collection and storage of electronic consent (eConsent) to address issues of transparency, clinical trial efficiency, and regulatory compliance for informed consent (Harris, et al. Journal of Biomedical Informatics 2009; 42(2): 377-381.). eConsent may also improve recruitment and retention in clinical research studies by addressing: (1) barriers for accessing rural populations by facilitating remote consent and (2) cultural and literacy barriers by including optional explanatory material (e.g., defining terms by hovering over them with the cursor) or the choice of displaying different videos/images based on participant's race, ethnicity, or educational level (Phillippi, et al. Journal of Obstetric, Gynecologic, & Neonatal Nursing. 2018; 47(4): 529-534.). METHODS: We developed and pilot tested our eConsent framework to provide a personalized consent experience whereby users are guided through a consent document that utilizes avatars, contextual glossary information supplements, and videos, to facilitate communication of information. RESULTS: The eConsent framework includes a portfolio of eight features, reviewed by community stakeholders, and tested at two academic medical centers. CONCLUSIONS: Early adoption and utilization of this eConsent framework have demonstrated acceptability. Next steps will emphasize testing efficacy of features to improve participant engagement with the consent process.

Engagement of community stakeholders to develop a framework to guide research dissemination to communities.

BACKGROUND: Dissemination of research findings to past study participants and the community-at-large is important. Yet, a standardized process for research dissemination is needed to report results to the community. OBJECTIVE: We developed a framework and strategies to guide community-academic partnerships in community-targeted, dissemination efforts. METHODS: From 2017 to 2019, a community-academic partnership was formed in Nashville, Tennessee, and iteratively developed a framework and strategies for research dissemination using cognitive interviews. A deductive, constant comparative analysis was conducted on interview responses to examine framework and strategy content. Feedback was used to finalize the framework and strategies for the evaluation. Using existing data, the framework's utility was evaluated in seven town hall meetings (n = 117). Bivariate analyses determined its effect on community members' trust and willingness to participate in research using pre- and post-surveys. Evaluation results were used to finalize the framework. RESULTS: The Community-Engaged Research Dissemination (CERD) framework has two phases. Phase one is a preliminary planning phase with two steps, and phase two is the four-step dissemination process. There are five standards to be upheld conducting these phases. We provide competencies for each component. Three feasible, culturally adapted strategies were developed as exemplars to disseminate research findings. Using pre- and post-surveys for intervention evaluation, there was a significant difference in trust in medical research and researchers (P = .006) and willingness to participate in research (P = .013). DISCUSSION AND CONCLUSION: The CERD framework can potentially standardize the process and compare the effect of dissemination efforts on the community's trust and willingness to participate in research.

Implementation and Evaluation of a Dual-Track Research Training Program for Community Members and Community-Based Organizations.

BACKGROUND: It is a public health priority to increase community research participation to improve health outcomes and eliminate health disparities. There is a need for effective research training programs that build community stakeholders' capacity to engage as equitable partners. OBJECTIVES: To describe the collaborative process of implementing and evaluating a dual-track community research training program-Meharry Vanderbilt Community Engaged Research Core-Community Research Training Program (MVC-CRT) Program-and present participant evaluations. METHODS: The MVC-CRT is a six-session community-based organization (CBO) curriculum and a three-session community member (CM) curriculum, based on needs identified by various community stakeholders, that was piloted in 2016. Immediately post-training, an outcome evaluation (surveys) was used to measure trainees' confidence relative to 30 learning objectives for the combined training sessions (e.g., Introduction to research), satisfaction in preparing them for research roles, and impact on research activities (e.g., building sustainable partnerships). 2 and 3 months after training, a process evaluation (focus groups) was used to assess each session's flow, materials, group discussions, and facilitators. RESULTS: Trainees' immediate post-training confidence increased or remained the same across 26 of 30 learning objectives. Two to 3 months after training, trainees reported sustained confidence, perceived increased knowledge, and increased intentions to engage in or improve research activities. All participants were satisfied with the program and felt better prepared for research roles. CONCLUSIONS: Tailored community research training may result in positive outcomes that can ultimately increase community capacity to be equitable partners in research in support of efforts to improve health outcomes and eliminate health disparities.

Patient Stories Can Make a Difference in Patient-Centered Research Design.

Amid increasing interest in improving the patient-centeredness of research, new forms of engagement are emerging that enable researchers to get input from community members on research goals, methods, and implementation. This input often includes stories, which are useful for understanding lived experiences of illness and encounters with health care organizations, and for locating these experiences within larger meta-narratives of specific communities. We analyzed the stories in transcripts of 13 Community Engagement Studios and identified 4 major functions that the stories served in the sessions. Major functions included: (1) establishing mutual understanding, (2) adding expansion and depth, (3) characterizing abstract concepts, and (4) providing context for experience, with the latter being the most frequent. We assert that stories can serve to better communicate the complex contexts of patient experiences, helping to align research priorities and research design with community interests, leading to more patient-centered innovations in clinical practice.

Advancing Community-Engaged Research through Partnership Development: Overcoming Challenges Voiced by Community-Academic Partners.

BACKGROUND: Community-engaged research (CEnR) is a promising approach to translate research into practice. The Meharry-Vanderbilt Community Engaged Research Core (CERC) was established to support academic-community partnerships with the goal of improving community health. A successful mini-grant program has been used to foster academic community partnerships. We describe the process of developing, implementing, and sustaining a grant program and discuss how the program has informed our CEnR activities. METHODS: Grant applications are solicited twice per year. Submission guidelines align with typical procedures. However, considerable guidance and support for applicants are provided. If necessary. Grant funds are awarded directly to the community partner. RESULTS: The CERC has awarded nearly $250,000 to support academic-community research partnerships. Both community and academic partners reported that the opportunity was beneficial and enriched their work. CONCLUSIONS: Resources provided by our mini-grant program enhance the development and sustainability of CEnR partnerships.

Community advisory boards: Experiences and common practices of clinical and translational science award programs.

Community advisory boards (CABs) are a valuable strategy for engaging and partnering with communities in research. Eighty-nine percent of Clinical and Translational Science Awardees (CTSA) responding to a 2011 survey reported having a CAB. CTSAs' experiences with CABs are valuable for informing future practice. This study was conducted to describe common CAB implementation practices among CTSAs; document perceived benefits, challenges, and contributions; and examine their progress toward desirable outcomes. A cross-CTSA collaborative team collected survey data from respondents representing academic and/or community members affiliated with CTSAs with CABs. Data representing 44 CTSAs with CABs were analyzed using descriptive statistics. A majority of respondents reported practices reflecting respect for CAB members' expertise and input such as compensation (75%), advisory purview beyond their CTSA's Community Engagement program (88%), and influence over CAB operations. Three-quarters provide members with orientation and training on roles and responsibilities and 89% reported evaluating their CAB. Almost all respondents indicated their CTSA incorporates the feedback of their CABs to some degree; over half do so a lot or completely. This study profiles practices that inform CTSAs implementing a CAB and provide an evaluative benchmark for those with existing CABs.

A taxonomy of impacts on clinical and translational research from community stakeholder engagement.

BACKGROUND: Community engagement is increasingly recognized as a valuable tool in clinical and translational research; however, the impact of engagement is not fully understood. No standard nomenclature yet exists to clearly define how research changes when community stakeholders are engaged across the research spectrum. This severely limits our ability to assess the value of community engagement in research. To address this gap, we developed a taxonomy for characterizing and classifying changes in research due to community engagement. METHODS: Using an iterative process, we (a) identified areas of potential impact associated with community engagement from author experience, (b) categorized these in taxonomic bins based on research stages, (c) conducted semi-structured interviews with researchers and community stakeholders, (d) validated the codebook in a sample dataset and (e) refined the taxonomy based on the validation. Community stakeholders were involved in every step of the process including as members of the primary study team. RESULTS: The final taxonomy catalogues changes into eleven domains corresponding to research phases. Each domain includes 2-4 dimensions depicting concepts within the domain's scope and, within each dimension, 2-10 elements labelling activities through which community engagement could change research. CONCLUSIONS: Community engagement has great potential to enhance clinical and translational research. This taxonomy provides a common vocabulary and framework for understanding the impact of community engagement and suggests metrics for assessing the value of community engagement in research.

Development and validation of the Person-Centeredness of Research Scale.

AIM: Person-centeredness shifts the focus of healthcare and research to the needs and priorities of patients and communities, and may improve health outcomes. There are no instruments available, however, with which we can assess the degree to which research is indeed person-centered. Our aim was to develop and validate a quantitative instrument to rate person-centeredness of research. MATERIALS & METHODS: Scale development and validation entailed a multistep approach that led to the seven-item Person Centeredness of Research Scale (PCoR Scale) that uses a 5-point Likert rating scale. The scale was validated using ratings of the Patient-Centered Outcomes Research Institute-funded research abstracts or abstracts submitted to a translational science meeting. RESULTS: Psychometric properties of the PCoR Scale showed high internal consistency (α = 0.96). All seven items were highly correlated with the total score (rs range from 0.63 to 0.90). An exploratory factor analysis demonstrated that all of the items loaded on a single factor, explaining 80% of the variance. The Patient-Centered Outcomes Research Institute-funded research abstracts had a mean PCoR Scale score of 6.52 (±8.01) that was significantly higher than the abstracts submitted to the translational science meeting (-2.56 (±9.18); t = 8.09; p < 0.0001). Inter-rater reliability in the validation of the revised instrument was high (Intraclass Correlation Coefficient [ICC](group1) = 0.89; ICC(group2) = 0.95). CONCLUSION: This brief, quantitative rating scale is the first to assess the main constructs that describe person-centeredness of research products. The PCoR Scale can be used to assess person-centeredness in research products; for example, by funders evaluating proposals, data networks evaluating data requests or researchers evaluating their research designs.

A Multilevel Approach to Stakeholder Engagement in the Formulation of a Clinical Data Research Network.

OBJECTIVES: To ensure meaningful engagement of stakeholders (patients, clinicians, and communities) in developing the Mid-South Clinical Data Research Network (MS-CDRN), we implemented a comprehensive, multilevel approach: (1) identify barriers to involving stakeholders in governance, network design, and implementation; (2) engage stakeholders in priority setting and research topic generation; (3) develop strategies to fully integrate stakeholders in CDRN governance and oversight; and (4) solicit guidance on patient-centered tools and strategies for recruiting research participants. METHODS: We engaged stakeholders: (1) as integral research team members; (2) on oversight and advisory committees; (3) as consultants (using Community Engagement Studios); and (4) through interviews and surveys. We recruited stakeholders from community health centers, churches, barbershops, health fairs, a volunteer registry, and a patient portal. We prioritized recruitment from populations often underrepresented in research. RESULTS: During the first 18 months, we engaged 5670 stakeholders in developing the MS-CDRN. These were research team members and on governance committees (N=10), consultants (N=58), survey respondents (N=5543), and interviewees (N=59). Stakeholders identified important barriers and facilitators to engagement, developed stakeholder-informed policies, provided feedback on priority topics and research questions, and developed an intake process for data requests and interventional studies that included reviewing for appropriate patient-centeredness, patient engagement, and dissemination. DISCUSSION: Multilevel stakeholder engagement is a novel systematic approach to developing a meaningful patient-centered and patient-engaged research program. This approach allows ongoing input from highly engaged stakeholders while leveraging focused input from larger, more diverse groups to enhance the patient-centeredness of research and increase relevance to broader audiences.

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.

Comprehensive strategy for capturing and integrating community input into community research training curricula.

INTRODUCTION: Community stakeholders often participate in community research training curricula development. There is limited information describing how their input informs curricula. This paper describes input solicitation methods, input received, and examples of its integration. METHODS: From June 2014 to June 2016, community members (CMs) and community-based organizations (CBOs) guided curricula development tailored for CMs and CBOs, respectively. Engagement methods included a strategic planning retreat, surveys, a listening session, workgroup meetings, and community engagement studios. Descriptive statistics were used to summarize survey input. For other methods, input was extracted and compiled from facilitator notes. RESULTS: CMs (n = 37) and CBOs (n = 83) providing input included patients and caregivers and advocacy, community service, and faith-based organizations, respectively. The major feedback categories were training topic priorities, format (e.g., face-to-face vs. online), logistics (e.g., training frequency), and compensation (e.g., appro-priateness). Input directly guided design of CBO and CM curricula (e.g., additional time devoted to specific topics based on feedback) or helped to finalize logistics. CONCLUSIONS: Multiple quantitative and qualitative methods can be used to elicit input from community stakeholders to inform the development of community research training curricula. This input is essential for the development of training curricula that are culturally relevant and acceptable.

Enhancing translational researchers' ability to collaborate with community stakeholders: Lessons from the Community Engagement Studio.

Community engagement is considered essential to effectively translate research into practice and is increasingly recognized as a key to successful clinical trial recruitment. Challenges to engaging community stakeholders in research persist and new methods are needed to facilitate meaningful stakeholder involvement. The Community Engagement Studio (CE Studio), a consultative model, has been used at every stage of the research process. Best practices drawn from the model could inform other methods of engagement. Using a mixed-methods approach that included evaluation surveys, impact surveys and interviews, we assessed the CE Studio program. We analyzed data from 75 CE Studios; 65 researchers and 591 community members completed surveys and 10 researchers completed interviews. Surveys indicate that 100% of researchers would request a CE Studio in the future, and 99.3% of community members would participate in a CE Studio again. We identified 6 practices to enhance community engagement in clinical and translational research: early input, researcher coaching, researcher humility, balancing power, neutral facilitator, and preparation of community stakeholders. These best practices may enhance the quality of existing community engagement approaches and improve the effectiveness of translational researchers' efforts to engage community stakeholders in their work.

Needs, Priorities, and Recommendations for Engaging Underrepresented Populations in Clinical Research: A Community Perspective.

Engaging underrepresented groups in outcomes research is a public health priority for reducing health and health care disparities; yet, engaging these groups is challenging. Failure to involve these underrepresented populations in research further exacerbates these disparities. This article presents the health and research priorities of diverse groups of underrepresented populations in biomedical research, their concerns for participating in research, and strategies to engage them in their healthcare and research studies. Eleven community listening sessions, ranging from 7 to 13 community members each (N = 117), representing racial/ethnic minority, economically disadvantaged (e.g., uninsured), and hearing impaired communities. We used an inductive, qualitative content analysis approach to analyze the data for emerging themes. We identified the following themes: Uncertainties of underrepresented populations regarding research participation; Ineffective communication about research opportunities and research findings; Research on primary care and prevention are priorities for underrepresented populations in research; and Research teams need training in cultural competence and humility. Underrepresented groups provided research priorities, concerns, and strategies to engage them in their healthcare and in research studies. Findings from this study could facilitate improvement of research participation among underrepresented groups, ultimately reducing health disparities and improving quality of life among groups commonly omitted from research recruitment and participation.

Community Engagement Studios: A Structured Approach to Obtaining Meaningful Input From Stakeholders to Inform Research.

PROBLEM: Engaging communities in research increases its relevance and may speed the translation of discoveries into improved health outcomes. Many researchers lack training to effectively engage stakeholders, whereas academic institutions lack infrastructure to support community engagement. APPROACH: In 2009, the Meharry-Vanderbilt Community-Engaged Research Core began testing new approaches for community engagement, which led to the development of the Community Engagement Studio (CE Studio). This structured program facilitates project-specific input from community and patient stakeholders to enhance research design, implementation, and dissemination. Developers used a team approach to recruit and train stakeholders, prepare researchers to engage with stakeholders, and facilitate an in-person meeting with both. OUTCOMES: The research core has implemented 28 CE Studios that engaged 152 community stakeholders. Participating researchers, representing a broad range of faculty ranks and disciplines, reported that input from stakeholders was valuable and that the CE Studio helped determine project feasibility and enhanced research design and implementation. Stakeholders found the CE Studio to be an acceptable method of engagement and reported a better understanding of research in general. A tool kit was developed to replicate this model and to disseminate this approach. NEXT STEPS: The research core will collect data to better understand the impact of CE Studios on research proposal submissions, funding, research outcomes, patient and stakeholder engagement in projects, and dissemination of results. They will also collect data to determine whether CE Studios increase patient-centered approaches in research and whether stakeholders who participate have more trust and willingness to participate in research.