Adequate equitable recruitment of underrepresented groups in clinical research and trials is a national problem and remains a daunting challenge to translating research discoveries into effective healthcare practices. Engagement, recruitment, and retention (ER&R) training programs for Clinical Research Professionals (CRPs) often focus on policies and regulations. Although some training on the importance of diversity and inclusion in clinical research participation has recently been developed, there remains a need for training that couples critical equity, diversity, and inclusion (EDI) concepts with skill development in effective recruitment and retention strategies, regulations, and best practices.

We developed the ER&R Certificate program as a holistic approach to provide Duke University CRPs the opportunity to build competency in gap areas and to increase comfort in championing equitable partnerships with clinical research participants. The thirteen core and elective courses include blended learning elements, such as e-learning and wiki journaling prompts, to facilitate meaningful discussions. Pre- and post-assessments administered to CRP program participants and their managers assessed program impact on CRP skills in ER&R tasks and comfort in equitable, diverse, and inclusive engagement of clinical research participants.

Results from the first two cohorts indicate that CRPs perceived growth in their own comfort with program learning objectives, especially those centered on participant partnership and EDI principles, and most managers witnessed growth in competence and responsibility for ER&R-related tasks. Results suggest value in offering CRPs robust training programs that integrate EDI and ER&R training.

Team development and idea generation are key intertwined steps in translational science that need a framework to accommodate unstructured, participatory interactions. To this end, we introduced Un-Meetings to the Clinical and Translational Science Awards (CTSA) Program, innovative events that facilitate cross-disciplinary idea generation and informal discussions between translational scientists, policy makers, community members, advocates, and public health professionals. Here we describe a mixed methods study to characterize the conceptual diversity and clusterization of ideas generated through an Opioid Crisis Un-Meeting.

An Un-Meeting targeting translation science approaches to the opioid crisis were hosted at the University of Rochester Center for Leading Innovation and Collaboration (CLIC). We used semantic analysis and conceptual mapping of keywords to analyze how attendee-led idea generation sessions identified topics for breakout discussions.

One hundred and two individuals from 40 institutions proposed 150 unique ideas that were grouped into 23 breakout sessions. Network analysis showed that diverse pools of experts were bridged by topics addressing the complexities of the opioid crisis. Two clusters emerged: (1) systems, contexts, and community engagement, and (2) technologies, innovations, and treatment advancements.

The cross-disciplinary nature of topic areas that bridge across thematic communities provide opportunities for CTSA programs to engage and support development of diverse translational teams. Potential opportunities for team building include technological advancements of opioid prevention, treatment, surveillance, systems approaches, and studies focusing on special populations and health disparities. The analysis method here may be useful in identifying naturally emerging teams of experts and community gaps when addressing large problems.

Text message-delivered interventions for chronic disease self-management have potential to reduce health disparities, yet limited research has explored implementing these interventions into clinical care. We partnered with safety net clinics to evaluate a texting intervention for type 2 diabetes called REACH (Rapid Encouragement/Education And Communications for Health) in a randomized controlled trial. Following evaluation, we explored potential implementation determinants and recommended implementation strategies.

We interviewed clinic staff (n = 14) and a subset of intervention participants (n = 36) to ask about REACH’s implementation potential. Using the Consolidated Framework for Implementation Research (CFIR) as an organizing framework, we coded transcripts and used thematic analysis to derive implementation barriers and facilitators. We integrated the CFIR-ERIC (Expert Recommendations for Implementing Change) Matching Tool, interview feedback, and the literature to recommend implementation strategies.

Implementation facilitators included low complexity, strong evidence and quality, available clinic resources, the need for a program to support diabetes self-management, and strong fit between REACH and both the clinics’ existing workflows and patients’ needs and resources. The barriers included REACH only being available in English, a lack of interoperability with electronic health record systems, patients’ concerns about diabetes stigma, limited funding, and high staff turnover. Categories of recommended implementation strategies included training and education, offering flexibility and adaptation, evaluating key processes, and securing funding.

Text message-delivered interventions have strong potential for integration in low-resource settings as a supplement to care. Pursuing implementation can ensure patients benefit from these innovations and help close the research to practice gap.

Justice-involved women from rural Appalachia face significant barriers to the utilization of evidence-based HIV prevention interventions in spite of high rates of injection drug use and risky sexual practices. Adapting evidence-based practices to incorporate the cultural uniqueness of the target population is needed in order to advance translational and clinical science in this area. This study provides a descriptive overview of indicators of feasibility and acceptability of an adapted version of the National Institute on Drug Abuse Standard HIV prevention intervention for delivery using Facebook through a small randomized controlled pilot study with rural Appalachian women.

Study methods include the random selection of rural Appalachian women from two local jails, screening for study eligibility, baseline data collection, random assignment to study interventions, and follow-up in the community three months post-release.

Results indicate that the feasibility of the approach was supported through study enrollment of the target population who reported regular Facebook use and HIV risk behaviors including drug use and sex. Acceptability of the intervention was demonstrated through enrollment in the study intervention, engagement in the intervention through Facebook, and indicators of HIV/HCV knowledge.

Study findings contribute to the critical and unmet need to advance translational science on the delivery of evidence-based prevention interventions in real-world rural Appalachian settings to understudied, vulnerable individuals who are often overlooked in targeted prevention efforts.

To identify the informatics educational needs of clinical and translational research professionals whose primary focus is not informatics.

Informatics and data science skills are essential for the full spectrum of translational research, and an increased understanding of informatics issues on the part of translational researchers can alleviate the demand for informaticians and enable more productive collaborations when informaticians are involved. Identifying the level of interest in different topics among various types of of translational researchers will help set priorities for development and dissemination of informatics education.

We surveyed clinical and translational science researchers in Clinical and Translational Science Award (CTSA) programs about their educational needs and preferences.

Researchers from 23 out of the 62 CTSA hubs responded to the survey. 67% of respondents across roles and topics expressed interest in learning about informatics topics. There was high interest in all 30 topics included in the survey, with some variation in interest depending on the role of the respondents.

Our data support the need to advance training in clinical and biomedical informatics. As the complexity and use of information technology and data science in research studies grows, informaticians will continue to be a limited resource for research collaboration, education, and training. An increased understanding of informatics issues across translational research teams can alleviate this burden and allow for more productive collaborations. To inform a roadmap for informatics education for research professionals, we suggest strategies to use the results of this needs assessment to develop future informatics education.

Gait, balance, and cognitive impairment make travel cumbersome for People with Parkinson’s disease (PwPD). About 75% of PwPD cared for at the University of Arkansas for Medical Sciences’ Movement Disorders Clinic reside in medically underserved areas (MUAs). Validated remote evaluations could help improve their access to care. Our goal was to explore the feasibility of telemedicine research visits for the evaluation of multi-modal function in PwPD in a rural state.

In-home telemedicine research visits were performed in PwPD. Motor and non-motor disease features were evaluated and quantified by trained personnel, digital survey instruments for self-assessments, digital voice recordings, and scanned and digitized Archimedes spiral drawings. Participant’s MUA residence was determined after evaluations were completed.

Twenty of the fifty PwPD enrolled resided in MUAs. The groups were well matched for disease duration, modified motor UPDRS, and Montreal Cognitive assessment scores but MUA participants were younger. Ninety-two percent were satisfied with their visit, and 61% were more likely to participate in future telemedicine research. MUA participants traveled longer distances, with higher travel costs, lower income, and education level. While 50% of MUA participants reported self-reliance for in-person visits, 85% reported self-reliance for the telemedicine visit. We rated audio-video quality highly in approximately 60% of visits in both groups. There was good correlation with prior in-person research assessments in a subset of participants.

In-home research visits for PwPD in MUAs are feasible and could help improve access to care and research participation in these traditionally underrepresented populations.

The science of team science (SciTS) is an emerging research area that studies the processes and outcomes of team-based research. A well-established conceptual framework and appropriate methodology for examining the effectiveness of team science are critically important for promoting and advancing collaborative and interdisciplinary research. Although many instruments have been developed and used in the SciTS field, psychometric evidence has not been routinely assessed or reported for these scales. In addition, commonly used psychometric methods were mainly limited to internal consistency and factor analysis. To fill the gaps, this study introduces a framework based on Rasch measurement theory for creating and evaluating measures for team sciences.

We illustrate the application of Rasch measurement theory through the creation of valid measures to evaluate the processes of interdisciplinary scientific teams. Data were collected from 16 interdisciplinary teams through a university-wide initiative for promoting interdisciplinary team collaboration. Psychometric evidence based on a many-facet Rasch model was obtained for assessing the quality of the measures.

The interdisciplinary teams differed in their clarity measures. Significant differences were also found between gender groups, racial groups, and academic ranks. We reported the reliability of measures and identified items that do not fit the model and may present potential threat to validity and fairness of SciTS measures.

This study shows the great potential of using Rasch measurement theory for developing and evaluating SciTS measures. Applying Rasch measurement theory produces objective measures that are comparable across individuals, interdisciplinary teams, institutions, time, and various demographic groups.

The COVID-19 pandemic accelerated a trend for clinical and translational community-engaged research in adapting to an increasingly virtual landscape. This requires a framework for engagement distinct from in-person research and program activities. We reflect on four case studies of community engagement activities that inform a conceptual framework to better integrate the virtual format into community-engaged research reflecting key tenets of health equity and antiracist praxis.

Four projects were selected by community-engaged research stakeholders for an in-depth review based on how much the virtual transition impacted activities such as planning, recruitment, and data collection for each project. Transitions to virtual engagement were assessed across ten areas in which community engagement has been demonstrated to make a positive impact.

Our analysis suggests a conceptual evaluation framework in which the ten community engagement areas cluster into four interrelated domains: (1) development, design, and delivery; (2) partnership and trust building; (3) implementation and change; and (4) ethics and equity.

The domains in this conceptual framework describe critical elements of community engaged research and programs consistent with recommendations for health equity informed meaningful community engagement from the National Academy of Medicine. The conceptual framework and case studies can be used for evaluation and to develop guidelines for clinical and translational researchers utilizing the virtual format in community-engaged research.

Community Health Workers and Promotoras (CHW/Ps) are valued for their role in helping to engage community members in research. CHW/Ps have traditionally received variable training in research fundamentals, including importance and promotion of research rigor to establish consistency in the methods used over time. Research best practices training exists for research professionals, but no standard training is provided as part of the CHW/P job role. To develop this CHW/P research best practices training, our team engaged English- and Spanish-speaking CHW/Ps to watch an early version of an online module and to examine perceptions of the relevance of such a training and optimal delivery methods.

Six virtual focus group discussions were conducted (three in English and three in Spanish) across different US geographic regions with currently employed CHW/Ps.

Forty CHW/Ps participated (95% female, mean age 44 years, 58% identifying as Hispanic/Latino). Four themes emerged: relevance of training, benefits of providing a certificate of completion, flexible training delivery modalities, and peer-led training.

With participation from representatives of the intended learner group of CHW/Ps, our team found that CHW/Ps valued learning about research best practices. They perceived culturally- and linguistically appropriate health research training to be highly relevant to their role, particularly for communicating key information to community members about their participation in health research. Additionally, participants provided input on effective dissemination of the training including the benefit of having proof of course completion, involvement of peer trainers, and value of providing the option to participate in online training.

Clinical research staff play a critical role in recruiting families for pediatric research, but their views are not well described. We aimed to describe how pediatric research staff build trusting research relationships with patients and their families.

We interviewed research staff at one pediatric research institution and its affiliated academic medical center between November 2020 and February 2021. Staff were eligible if they conducted participant recruitment, consent, and/or enrollment for clinical research. We developed our semi-structured interview guide based on a framework for trusting researcher-community partnerships.

We interviewed 28 research staff, with a median age of 28 years (range 22–50) and a median of 5 years of experience (range 1–29). Interviewees identified factors relevant to relationship building across three levels: the individual staff member, the relational interaction with the family, and the institutional or other structural backdrop. Individual factors included how staff developed recruitment skills, their perceived roles, and their personal motivations. Relational factors spanned four stages of recruitment: before the approach, forming an initial connection with a family, building the connection, and following up. Structural factors were related to access and diversity, clinical interactions, and the COVID-19 pandemic.

Research staff discussed tensions and supports with various actors, challenges with the integration of research and clinical care, the importance of voluntariness for building trust, and multiple contributors to inequities in research. These findings reveal the importance of ensuring research staff have a voice in institutional policies and are supported to advocate for patients and families.