Prior studies indicate greater disease burden for obesity among rural compared with urban residents but no differences for mood disorder based on geographic location. Recent attention has focused on the need to examine regional rural–urban disparities in disease burden. We focused on mood disorders and obesity prevalence within three southeastern Minnesota counties served by the Mayo Clinic Center for Translational Science Award, in Rochester, Minnesota, as these were top priorities identified in community health needs assessments.

Cross-sectional study to assess the association of rural–urban locality on 5-year (2009–2014) prevalence of mood disorder and obesity obtained using the Rochester Epidemiological Project medical records linkage system, among subjects residing in three mixed rural–urban counties on April 1, 2014. Multivariable analyses adjusted for demographics, socioeconomic status using an individual housing-based measure, and counties.

The study cohort (percent rural location) included 91,202 (15%) for Olmsted, 10,197 (51%) in Dodge, and 10,184 (57%) in Wabasha counties. On multivariate analysis, 5-year prevalence of mood disorders and obesity was significantly greater for urban compared with rural residents, after adjusting for confounders; odds ratios (95% confidence intervals): 1.21 (1.17–1.26), P < 0.001, and 1.05 (1.01–1.10), P = 0.016, respectively. Observed effects were not modified in additional models adjusted for health care utilization (HCU; ≥1 general medical examination visit and flu vaccination).

Rural–urban health disparities for burden of mood disorders and obesity are independent of socioeconomic status and HCU in a Midwestern community. It is important to assess potential regional heterogeneity of rural–urban disparities on health outcomes.

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.

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.

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).

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.

Scientific quality and feasibility are part of ethics review by Institutional Review Boards (IRBs). Scientific Review Committees (SRCs) were proposed to facilitate this assessment by the Clinical and Translational Science Award (CTSA) SRC Consensus Group. This study assessed SRC feasibility and impact at CTSA-affiliated academic health centers (AHCs).

SRC implementation at 10 AHCs was assessed pre/post-intervention using quantitative and qualitative methods. Pre-intervention, four AHCs had no SRC, and six had at least one SRC needing modifications to better align with Consensus Group recommendations.

Facilitators of successful SRC implementation included broad-based communication, an external motivator, senior-level support, and committed SRC reviewers. Barriers included limited resources and staffing, variable local mandates, limited SRC authority, lack of anticipated benefit, and operational challenges. Research protocol quality did not differ significantly between study periods, but respondents suggested positive effects. During intervention, median total review duration did not lengthen for the 40% of protocols approved within 3 weeks. For the 60% under review after 3 weeks, review was lengthened primarily due to longer IRB review for SRC-reviewed protocols. Site interviews recommended designing locally effective SRC processes, building buy-in by communication or by mandate, allowing time for planning and sharing best practices, and connecting SRC and IRB procedures.

The CTSA SRC Consensus Group recommendations appear feasible. Although not conclusive in this relatively short initial implementation, sites perceived positive impact by SRCs on study quality. Optimal benefit will require local or federal mandate for implementation, adapting processes to local contexts, and employing SRC stipulations.

To examine research participants’ levels of satisfaction and perceptions and aid researchers to better engage research volunteers from all racial and ethnic populations in clinical trials. A participant satisfaction survey was developed that focused on three domains to reflect satisfaction with delivery of care, environment, and center operations. In addition, the survey contained open-ended questions to reflect overall experiences and perceptions. Two hundred and seventy-eight participants (55% African American and 29% non-Hispanic Whites) with an average age of 52 years completed the survey.

The results indicated that the majority of the participants rated their satisfaction very highly across all domains. Ninety percent stated they were very satisfied/satisfied or very strongly agreed/agreed in the three domains. Obtaining high-quality care/access to health care professionals (60%), learning more about their illness/disease (60%), and helping others (57%) were noted as important factors in choosing to participate in a trial. Regarding overall experience, majority of respondents stated that friendliness, expertise of staff, learning more about their disease, and contributing to science were important. Further, financial compensation was not a primary motivation for participation. A majority of participants stated that they would participate in future studies and would recommend a friend or a family member to participate in clinical trials.

The findings indicate that the degree of satisfaction with the research staff and with the specific trial itself are important determinants for enrolling, completing a study, and for participating in future trials.

The National Institute of Health has mandated good clinical practice (GCP) training for all clinical research investigators and professionals. We developed a GCP game using the Kaizen-Education platform. The GCP Kaizen game was designed to help clinical research professionals immerse themselves into applying International Conference on Harmonization GCP (R2) guidelines in the clinical research setting through case-based questions.

Students were invited to participate in the GCP Kaizen game as part of their 100% online academic Masters during the Spring 2019 semester. The structure of the game consisted of 75 original multiple choice and 25 repeated questions stemming from fictitious vignettes that were distributed across 10 weeks. Each question presented a teachable rationale after the answers were submitted. At the end of the game, a satisfaction survey was issued to collect player satisfaction data on the game platform, content, experience as well as perceptions of GCP learning and future GCP concept application.

There were 71 total players who participated and answered at least one question. Of those, 53 (75%) answered all 100 questions. The game had a high Cronbach’s alpha, and item analyses provided information on question quality, thus assisting us in future quality edits before re-testing and wider dissemination.

The GCP Kaizen game provides an alternative method for mandated GCP training using principles of gamification. It proved to be a reliable and an effective educational method with high player satisfaction.

The Clinical and Translational Science Award (CTSA) Program is a Consortium of nearly 60 academic medical research centers across the USA and a natural network for evaluating the spread and uptake of translational research innovation across the Consortium.

Dissemination of the Accrual to Clinical Trials (ACT) Network, a federated clinical informatics data network for population-based cohort discovery, began January 2018 across the Consortium. Diffusion of innovation theory guided dissemination design and evaluation. Mixed-methods assessed the spread and uptake across the Consortium through July 1, 2019 (n = 48 CTSAs). Methods included prospective time activity tracking (Kaplan–Meier curves), and survey and qualitative interviews.

Within 18 months, nearly 80% of CTSAs had joined the data network and two-thirds of CTSAs achieving technical readiness had initiated launch to local clinical investigators. Over 10,000 ACT Network queries are projected for 2019; and by 2020, nearly all CTSAs will have joined the network. Median time-from-technical-readiness-to-local-launch was 154 days (interquartile range: 87–225 days]. Quality improvement processes reduced time-to-launch by 35.2% (64 days, p = 0.0036). Lessons learned include: (1) conceptualize dissemination as two-stage adoption demonstrating value for both CTSA hub service providers and clinical investigators; (2) include institutional trial into dissemination strategies so CTSA hubs can refine internal workflows and gather local user feedback endorsement; (3) embrace designing-for-dissemination during technology development; and (4) sustain adaptive dissemination and customer relationship management to keep CTSA hubs and users engaged.

Scale-up and spread of the ACT Network provides lessons learned for others disseminating innovation across the CTSA Consortium. The Network is primed for embedded implementation research.

Scientific endeavors are increasingly carried out by teams of scientists. While there is growing literature on factors associated with effective science teams, little is known about processes that facilitate the success of dissemination and implementation (D&I) teams studying the uptake of healthcare innovations. This study aimed to identify strategies used by D&I scientists to promote team science.

Using a nominal group technique, a sample of 27 D&I scholars responded to the question, “What strategies have you or others used to promote team science?” Participants were asked to individually respond and then discuss within a small group to determine the group’s top three strategies. Through a facilitated consensus discussion with the full sample, a rank-ordered list of three strategies was determined.

A total of 126 individual responses (M = 9; SD = 4.88) were submitted. Through small group discussion, six groups ranked their top three strategies to promote team science. The final ranked list of strategies determined by the full sample included: (1) developing and maintaining clear expectations, (2) promoting and modeling effective communication, and (3) establishing shared goals and a mission of the work to be accomplished.

Because of its goal of translating knowledge to practice, D&I research necessitates the use of team science. The top strategies are in line with those found to be effective for teams in other fields and hold promise for improving D&I team cohesion and innovation, which may ultimately accelerate the translation of health innovations and the improvement of care quality and outcomes.

Research participation by members of racial or ethnic minority groups continues to be less than optimum resulting in difficulties to generalization of research findings. Community-engaged research that relies on a community health worker (CHW) model has been found effective in building trust in the community, thereby motivating people to participate in health research. The Sentinel Network study aimed at testing the feasibility of utilizing the CHW model to link community members to appropriate health research studies at each of the research sites.

The study was conducted at six Clinical and Translational Science Award institutions (N = 2371) across the country; 733 (30.9%) of the participants were from the University of Florida, 525 (22.0%) were from Washington University in St. Louis, 421 (17.8%) were from the University of California, Davis, 288 (12.1%) were from the University of Michigan, Ann Arbor, 250 (10.5%) were from Rochester, and 154 (6.5%) from Albert Einstein College of Medicine. Trained CHWs from each of these sites conducted regular community outreach where they administered a Health Needs Assessment, provided medical and social referrals, and linked to eligible research studies at each of those sites. A 30-day follow-up assessment was developed to track utilization of services satisfaction with the services and research study participation.

A large majority of people, especially African Americans, expressed willingness to participate in research studies. The top two health concerns reported by participants were hypertension and diabetes.

Findings on the rate of navigation and enrollment in research from this study indicate the effectiveness of a hybrid CHW service and research model of directly engaging community members to encourage people to participate in research.

Audits play a critical role in maintaining the integrity of observational cohort data. While previous work has validated the audit process, sending trained auditors to sites (“travel-audits”) can be costly. We investigate the efficacy of training sites to conduct “self-audits.”

In 2017, eight research groups in the Caribbean, Central, and South America network for HIV Epidemiology each audited a subset of their patient records randomly selected by the data coordinating center at Vanderbilt. Designated investigators at each site compared abstracted research data to the original clinical source documents and captured audit findings electronically. Additionally, two Vanderbilt investigators performed on-site travel-audits at three randomly selected sites (one adult and two pediatric) in late summer 2017.

Self- and travel-auditors, respectively, reported that 93% and 92% of 8919 data entries, captured across 28 unique clinical variables on 65 patients, were entered correctly. Across all entries, 8409 (94%) received the same assessment from self- and travel-auditors (7988 correct and 421 incorrect). Of 421 entries mutually assessed as “incorrect,” 304 (82%) were corrected by both self- and travel-auditors and 250 of these (72%) received the same corrections. Reason for changing antiretroviral therapy (ART) regimen, ART end date, viral load value, CD4%, and HIV diagnosis date had the most mismatched corrections.

With similar overall error rates, findings suggest that data audits conducted by trained local investigators could provide an alternative to on-site audits by external auditors to ensure continued data quality. However, discrepancies observed between corrections illustrate challenges in determining correct values even with audits.

Opioids are more commonly prescribed for chronic pain in rural settings in the USA, yet little is known about how the rural context influences efforts to improve opioid medication management.

The Six Building Blocks is an evidence-based program that guides primary care practices in making system-based improvements in managing patients using long-term opioid therapy. It was implemented at 6 rural and rural-serving organizations with 20 clinic locations over a 15-month period. To gain further insight about their experience with implementing the program, interviews and focus groups were conducted with staff and clinicians at the six organizations at the end of the 15 months and transcribed. Team members used a template analysis approach, a form of qualitative thematic analysis, to code these data for barriers, facilitators, and corresponding subcodes.

Facilitators to making systems-based changes in opioid management within a rural practice context included a desire to help patients and their community, external pressures to make changes in opioid management, a desire to reduce workplace stress, external support for the clinic, supportive clinic leadership, and receptivity of patients. Barriers to making changes included competing demands on clinicians and staff, a culture of clinician autonomy, inadequate data systems, and a lack of patient resources in rural areas.

The barriers and facilitators identified here point to potentially unique determinants of practice that should be considered when addressing opioid prescribing for chronic pain in the rural setting.

Dissemination and implementation (D&I) science is not a formal element of the Clinical Translational Science Award (CTSA) Program, and D&I science activities across the CTSA Consortium are largely unknown.

The CTSA Dissemination, Implementation, and Knowledge Translation Working Group surveyed CTSA leaders to explore D&I science-related activities, barriers, and needed supports, then conducted univariate and qualitative analyses of the data.

Out of 67 CTSA leaders, 55.2% responded. CTSAs reported directly funding D&I programs (54.1%), training (51.4%), and projects (59.5%). Indirect support (e.g., promoted by CTSA without direct funding) for D&I activities was higher – programs (70.3%), training (64.9%), and projects (54.1%). Top barriers included funding (39.4%), limited D&I science faculty (30.3%), and lack of D&I science understanding (27.3%). Respondents (63.4%) noted the importance of D&I training and recommended coordination of D&I activities across CTSAs hubs (33.3%).

These findings should guide CTSA leadership in efforts to raise awareness and advance the role of D&I science in improving population health.

In order to tackle the challenge of efficiently meeting clinical research accrual goals, many Clinical and Translational Science Award (CTSA) recipients have developed recruitment support mechanisms and resources to help investigators successfully recruit study participants. Disseminating recruitment best practices and developing collaborations between institutions can help strengthen recruitment capabilities and methodologies currently utilized by researchers.

To discover what recruitment resources and mechanisms CTSAs are using, the CTSA Recruitment and Retention working group developed an electronic survey, which was distributed to CTSAs between May and July 2019. The survey contained over 50 multiple choice and short answer questions, with 40 of the 64 CTSA institutions completing the survey. Institutions reported on registries, feasibility assessment tools, clinical trial listings, experience recruiting special populations, program operations and evaluation, workforce education, social media use, and other recruitment resources.

All respondents currently utilize some form of a volunteer registry; over 80% of the CTSAs provide investigators with recruitment consultations, feasibility assessments, study listings, and electronic health record (EHR) utilization; 73% assist with study materials; 47% offer social media assistance. Many institutions reported success in recruiting patients and healthy volunteers, but difficulty in recruiting special populations such as non-English-speaking persons and rural populations. Additional recruitment tools included use of the EHR to facilitate recruitment, use of registries, and use of social media to engage participants.

Areas of opportunity or growth include the development of innovative solutions in the areas of social media advertising, identification of participants from special populations, and research volunteer engagement.

NIH Clinical and Translational Science Awards (CTSAs) include KL2 mentored career development awards for faculty commencing clinical and translational research. A survey of KL2 leaders revealed program practices, curricular elements and compelling data about scholar characteristics and outcomes.

We conducted a literature review, framed the survey construct, and obtained input from across the CTSA consortium. A REDCap survey was emailed in fall 2016 to 61 active programs.

Fifty-five programs (90.2%) responded. Respondents had been funded from 3 to 11 years, including 22 “mature” hubs funded for ≥8 years. Program cohort sizes were 56% “small”, 22% “medium”, and 22% “large.” Hubs offer extensive competency-aligned training opportunities relevant to clinical and translational research, including graduate degrees, mentorship, and grant-writing. Seventy-two percent of hubs report parallel “KL2-equivalent” career development programs. All hubs share their training and facilitate intermingling with other early stage investigators. A total of 1,517 KL2 scholars were funded. KL2 awardees are diverse in their disciplines, research projects, and representation; 54% are female and 12% self-identified as underrepresented in biomedical research. Eighty-seven percent of scholars have 2–3 mentors and are currently supported for 2–3 years. Seventy-eight percent of alumni remain at CTSA institutions in translational science. The most common form of NIH support following scholars’ KL2 award is an individual career development award.

The KL2 is a unique career development award, shaped by competency-aligned training opportunities and interdisciplinary mentorship that inform translational research pathways. Tracking both traditional and novel outcomes of KL2 scholars is essential to capture their career trajectories and impact on health.

Implementation of genome-scale sequencing in clinical care has significant challenges: the technology is highly dimensional with many kinds of potential results, results interpretation and delivery require expertise and coordination across multiple medical specialties, clinical utility may be uncertain, and there may be broader familial or societal implications beyond the individual participant. Transdisciplinary consortia and collaborative team science are well poised to address these challenges. However, understanding the complex web of organizational, institutional, physical, environmental, technologic, and other political and societal factors that influence the effectiveness of consortia is understudied. We describe our experience working in the Clinical Sequencing Evidence-Generating Research (CSER) consortium, a multi-institutional translational genomics consortium.

A key aspect of the CSER consortium was the juxtaposition of site-specific measures with the need to identify consensus measures related to clinical utility and to create a core set of harmonized measures. During this harmonization process, we sought to minimize participant burden, accommodate project-specific choices, and use validated measures that allow data sharing.

Identifying platforms to ensure swift communication between teams and management of materials and data were essential to our harmonization efforts. Funding agencies can help consortia by clarifying key study design elements across projects during the proposal preparation phase and by providing a framework for data sharing data across participating projects.

In summary, time and resources must be devoted to developing and implementing collaborative practices as preparatory work at the beginning of project timelines to improve the effectiveness of research consortia.

The purpose of this article is to describe the process of developing and implementing a transdisciplinary community-based research center, the Center for Health Equity Research (CHER) Chicago, to offer a model for designing and implementing research centers that aim to address structural causes of health inequality.

Scholars from diverse backgrounds and disciplines formed a multidisciplinary team for the Center and adopted the structural violence framework as the organizing conceptual model. All Center activities were based on community partnership. The Center activities were organized within three cores: administrative, investigator development, and community engagement and dissemination cores. The key activities during the first year were to develop a pilot grant program for early-stage investigators (ESIs) and to establish community partnership mechanisms.

CHER provided more than 60 consultations for ESIs, which resulted in 31 pilot applications over the three application cycles. Over 200 academic and community partners attended the community symposium and discussed community priority. Some challenges encountered were to improve communication among investigators, to clarify roles and responsibilities of the three cores, and to build consensus on the definition and operationalization of the concept of structural violence.

There is an increasing need for local hubs to facilitate transdisciplinary collaboration and community engagement to effectively address health inequity. Building consensus around a shared vision among partners is a difficult and yet important step toward achieving equity.