Bayesian statistical approaches are extensively used in new statistical methods but have not been adopted at the same rate in clinical and translational (C&T) research. The goal of this paper is to accelerate the transition of new methods into practice by improving the C&T researcher’s ability to gain confidence in interpreting and implementing Bayesian analyses.

We developed a Bayesian data analysis plan and implemented that plan for a two-arm clinical trial comparing the effectiveness of a new opioid in reducing time to discharge from the post-operative anesthesia unit and nerve block usage in surgery. Through this application, we offer a brief tutorial on Bayesian methods and exhibit how to apply four Bayesian statistical packages from STATA, SAS, and RStan to conduct linear and logistic regression analyses in clinical research.

The analysis results in our application were robust to statistical package and consistent across a wide range of prior distributions. STATA was the most approachable package for linear regression but was more limited in the models that could be fitted and easily summarized. SAS and R offered more straightforward documentation and data management for the posteriors. They also offered direct programming of the likelihood making them more easily extendable to complex problems.

Bayesian analysis is now accessible to a broad range of data analysts and should be considered in more C&T research analyses. This will allow C&T research teams the ability to adopt and interpret Bayesian methodology in more complex problems where Bayesian approaches are often needed.

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.

There is an increasing recognition of the benefits of sustained community engagement (CE) that accrue to academic health centers and the communities they serve. However, the success and sustainability of CE projects rely on the efforts of individual faculty, learners, and community members, for whom CE efforts are typically added to their professional and personal priorities and responsibilities. This competition for time and resources between priorities and CE can discourage academic medical faculty from participating in CE activities. The Stacked Community Engagement model is proposed to synergize or “stack” responsibilities and goals onto the scaffolding of CE projects.

We examined the literature and expert CE practitioner opinion to identify the challenges faced by community-engaged academic faculty and the key characteristics of CE projects that successfully align and integrate with the priorities of faculty, learners, and community members. We synthesized this information to develop the conceptual Stacked CE model for developing CE academic medical faculty, then illustrated the model in heterogeneous CE programs to explore its generalizability, validity, and robustness.

The Stacked CE model, when applied to a specific nutrition education program (The Food Doctors) and outreach program (StreetLife Communities), provided a practical framework for examining the sustained success of a partnership between Medical College of Wisconsin faculty and medical students and the community.

The Stacked CE model is a meaningful framework for developing community-engaged academic medical faculty. By identifying overlap and integrating CE into professional activities with intention, CE practitioners can benefit from the deeper connections and sustainability.

The objective of this study was to systematically assess the literature regarding postnatal healthcare utilization and barriers/facilitators of healthcare in neonatal abstinence syndrome (NAS) children.

A systematic search was performed in PubMed, Cochrane Database of Systematic Reviews, PsychINFO, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science to identify peer-reviewed research. Eligible studies were peer-reviewed articles reporting on broad aspects of primary and specialty healthcare utilization and access in NAS children. Three investigators independently reviewed all articles and extracted data. Study bias was assessed using the Newcastle–Ottawa Assessment Scale and the National Institute of Health Study Quality Assessment Tool.

This review identified 14 articles that met criteria. NAS children have poorer outpatient appointment adherence and have a higher rate of being lost to follow-up. These children have overall poorer health indicated by a significantly higher risk of ER visits, hospital readmission, and early childhood mortality compared with non-NAS infants. Intensive multidisciplinary support provided through outpatient weaning programs facilitates healthcare utilization and could serve as a model that could be applied to other healthcare fields to improve the health among this population.

This review investigated the difficulties in accessing outpatient care as well as the utilization of such care for NAS infants. NAS infants tend to have decreased access to and utilization of outpatient healthcare following hospital birth discharge. Outpatient weaning programs have proven to be effective; however, these programs require intensive resources and care coordination that has yet to be implemented into other healthcare areas for NAS children.

In 2015, the University of Pittsburgh partnered with several Minority Serving Institutions to develop the Leading Emerging and Diverse Scientists to Success (LEADS) Program. LEADS was designed to provide skills development, mentoring, and networking support to early career underrepresented faculty.

LEADS included three components: skills training (e.g., grant and manuscript writing and team science), mentoring, and networking opportunities. Scholars completed a pre- and post-test survey and an annual alumni survey that included measures on burnout, motivation, leadership, professionalism, mentoring, job and career satisfaction, networking, and an assessment of their research self-efficacy.

Scholars demonstrated a significant increase in their research self-efficacy having completed all the modules (t = 6.12; P < 0.001). Collectively, LEADS scholars submitted 73 grants and secured 46 grants for a 63% success rate. Most scholars either agreed or strongly agreed that their mentor was effective in helping to develop their research skills (65%) and provided effective counseling (56%). Scholars did experience increased burnout with 50% feeling burned out at the exit survey (t = 1.42; P = 0.16) and 58% reporting feelings of burnout at the most recent survey in 2020 (t = 3.96; P < 0.001).

Our findings support the claim that participation in LEADS enhanced critical research skills, provided networking and mentoring opportunities, and contributed to research productivity for scientists from underrepresented backgrounds.

Research participation during undergraduate years has a powerful influence on career selection and attitudes toward scientific research. Most undergraduate research programs in academic health centers are oriented toward basic research or address a particular disease focus or research discipline. Undergraduate research programs that expose students to clinical and translational research may alter student perceptions about research and influence career selection.

We developed an undergraduate summer research curriculum, anchored upon a clinical and translational research study developed to address a common unmet needs in neonatal nurseries (e.g., assessment of neonatal opioid withdrawal syndrome). Program topics reflected the cross-disciplinary expertise that contributed to the development of this “bedside to bench” study, including opioid addiction, vulnerable populations, research ethics, statistics, data collection and management, assay development, analytical laboratory analysis, and pharmacokinetics. The curriculum was delivered through three offerings over 12 months, using Zoom video-conferencing due to restrictions imposed by the COVID-19 pandemic.

Nine students participated in the program. Two-thirds reported the course enhanced their understanding of clinical and translational research. Over three-quarters reported the curriculum topics were very good or excellent. In open-ended questions, students reported that the cross-disciplinary nature of the curriculum was the strongest aspect of the program.

The curriculum could be readily adapted by other Clinical and Translational Science Award programs seeking to provide clinical and translational research-oriented programs to undergraduate students. Application of cross-disciplinary research approaches to a specific clinical and translational research question provides students with relevant examples of translational research and translational science.

We aimed to improve the research consenting process by developing and evaluating simplified consent forms.

Four templates written at the eighth-tenth grade reading level were developed and trialed by a group of experts in clinical research, health literacy, national regulatory requirements, and end users. Researchers from protocols which had received expedited review were surveyed at 2 time points regarding their use and assessment of the templates.

At baseline 18/86 (20.9%) responding researchers had heard of the templates and 5 (5.8%) reported that they had used them; 2 years later, 54.2% (32/59) had heard of the templates and 87.5% (28/32) had used them (p<0.001).

Consent form templates may be one mechanism to improve patient comprehension of research protocols as well as efficiency of the review process, but require considerable time for development and implementation, and one key to their success is involvement and support from the IRB and technical staff.

The COVID-19 pandemic’s need for life-saving treatments and a "warp speed" vaccine challenged the National Institutes of Health’s Clinical and Translational Science Award (CTSA) recipients to improve their methods and processes in conducting clinical research. While CTSA recipient, New Jersey Alliance for Clinical and Translational Science (NJ ACTS), responded to this call to action with significant clinical research milestones, a comprehensive understanding of regulatory metrics during the COVID-19 pandemic is uncertain. The objective of this research is to identify, compare, and contrast metrics that illustrate the effectiveness of NJ ACTS’s research mobilization efforts during COVID-19.

Data were collected from the Institutional Review Board (IRB), the Clinical Research Units (CRUs), and the Office of Research and Sponsored Programs (ORSP). IRB data detailed the volume and types of protocols approved and turnaround time (TAT) for approval in 2020 vs. 2019. CRU data examined study metrics of adult and pediatric clinical trials across 2018-2020. ORSP data documented awards received in 2019 and 2020

Analysis revealed a 95% increase in IRB-approved studies in 2020, with a significant decrease in TAT for COVID-19 studies. All CRUs observed a median 5.2-fold increase in the enrollment of adult and pediatric participants for COVID-19-related research. Study income was 106% and 196% greater than 2019 and 2018, respectively, with more than half funded through federal sponsors and 89% for COVID-19 trials. ORSP data revealed that 9% of awards and 26% of 2020 funding were COVID-19 studies.

This study demonstrates that NJACTS effectively responded to challenges posed by the pandemic

Failure to achieve accrual goals is a common problem in health-related research. Electronic health records represent a promising resource, offering the ability to identify a precisely defined cohort of patients who meet inclusion/exclusion criteria. However, challenges associated with the recruitment process remain and institutional policies vary.

We interviewed researchers, institutional review board chairs, and primary care physicians in North Carolina and Tennessee. Questions focused on strategies for initiating contact with potentially eligible patients, as well as recruitment letters asking recipients to opt in versus opt out of further communication.

When we asked about initiating contact with prospective participants, qualitative themes included trust, credibility, and established relationships; research efficiency and validity; privacy and autonomy; the intersection between research and clinical care; and disruption to physician–researcher and physician–patient relationships. All interviewees said it was acceptable for researchers to contact patients through their physicians; most said it was acceptable for researchers to contact patients directly. Over half chose contact through physicians as more appropriate. Regarding recruitment letters, qualitative themes included the quality of the participant pool; privacy and control; research efficiency and representativeness; and patients’ opportunity to make their own decisions. All interviewees said asking recipients to opt in to further communication was acceptable; nearly all said opt out was acceptable. Similar proportions chose each approach as more appropriate.

Comparing these results to our previous research with patients reveals potential differences in stakeholder perspectives. We offer suggestions for developing balanced approaches that respect patients and facilitate the advancement of science.

We evaluate a CTSA program hub by applying bibliometrics, social network analysis (SNA), and altmetrics and examine the changes in research productivity, citation impact, research collaboration, and CTSA-supported research topics since our pilot study in 2017.

The sampled data included North Carolina Translational and Clinical Science Institute (NC TraCS)-supported publications produced between September 2008 and March 2021. We applied measures and metrics from bibliometrics, SNA, and altmetrics to the dataset. In addition, we analyzed research topics and correlations between different metrics.

1154 NC TraCS-supported publications generated over 53,560 citation counts by April 2021. The average cites per year and the relative citation ratio (RCR) mean of these publications improved from 33 and 2.26 in 2017 to 48 and 2.58 in 2021. The number of involved UNC units in the most published authors’ collaboration network increased from 7 (2017) to 10 (2021). NC TraCS-supported co-authorship involved 61 NC organizations. PlumX metrics identified articles with the highest altmetrics scores. About 96% NC TraCS-supported publications have above the average SciVal Topic Prominence Percentile; the average approximate potential to translate of the included publication was 54.2%; and 177 publications addressed health disparity issues. Bibliometric measures (e.g., citation counts, RCR) and PlumX metrics (i.e., Citations, Captures, and Social-Media) are positively correlated (p < .05).

Bibliometrics, SNA, and altmetrics offer distinctive but related perspectives to examine CTSA research performance and longitudinal growth, especially at the individual program hub level. These perspectives can help CTSAs build program foci.