Maternal mortality rates in the USA remain high, with persistent racial and socioeconomic disparities. We identified 207,016 hospital admissions for pregnant women in Maryland, from 2017 to 2019. Logistic regression was used to identity factors associated with maternal death. The health outcome for black women was more prone to give rise to maternal mortality than for white women. Our study revealed numerous racial and age discrepancies in gestational health outcomes, which opioid use disorder exacerbated. Our findings elaborate on the importance of identifying the drivers of adverse pregnancy outcomes, to help inform policy, and resource allocations.

Observational studies are notoriously susceptible to bias, and parallel-group randomized trials are important to identify the best overall treatment for eligible patients. Yet, such trials can be expected to be a misleading indicator of the best treatment for some subgroups or individual patients. In selected circumstances, patients can be treated in n-of-1 trials to address the inherent heterogeneity of treatment response in clinical populations. Such trials help to accomplish the ultimate goal of all biomedical research, to optimize the care of individual patients.

In recent years, there have been concerted efforts to better recruit, support, and retain diverse faculty, staff, and trainees in academic medicine. However, many institutions lack comprehensive and strategic plans to provide support to retain and recruit individuals from historically underrepresented groups. In this article, we itemize specific mechanisms through which institutions can support diverse individuals with the goal of improving inclusion and belonging in the workforce to better reflect the diversity of the intended patient and research participant population.

Enterprise data warehouses for research (EDW4R) is a critical component of National Institutes of Health Clinical and Translational Science Award (CTSA) hubs. EDW4R operations have unique needs that require specialized skills and collaborations across multiple domains which limit the ability to apply existing models of information technology (IT) performance. Because of this uniqueness, we developed a new EDW4R maturity model based on prior qualitative study of operational practices for supporting EDW4Rs at CTSA hubs. In a pilot study, respondents from fifteen CTSA hubs completed the novel EDW4R maturity index survey by rating 33 maturity statements across 6 categories using a 5-point Likert scale. Of the six categories, respondents rated workforce as most mature (4.17 [3.67–4.42]) and relationship with enterprise IT as the least mature (3.00 [2.80–3.80]). Our pilot of a novel maturity index shows a baseline quantitative measure of EDW4R functions across fifteen CTSA hubs. The maturity index may be useful to faculty and staff currently leading an EDW4R by creating opportunities to explore the index in local context and comparison to other institutions.

COVID-19 has widened the existing digital divide, especially for people from socially and economically deprived communities. We describe a program evaluation using a community participatory approach to develop self-reported items of patient experience with technology inclusive of digital access and literacy. The feedback received from Community Advisory Boards and Community Engagement Studio members led to the evaluation and refinement of the individual items. The community-based participatory approach highlighted in our paper to develop these items could serve as a model for other screening tool development for enhancing equity and inclusiveness in clinical care and research.

Funding agencies are increasingly seeking team-based approaches to tackling complex research questions, but there is a need to mobilize translational teams and create shared visions and strategic action plans long before specific funding opportunities are considered or even released. This is particularly evident for teams who want to pursue large-scale grants, where cross-disciplinary synergy is often required. In response, we created Research Jams, which are engaging yet structured brainstorming sessions that bring together groups for the first time to collectively generate novel research ideas, critically map the future of initiatives, prioritize opportunities and next steps, and build community. Research Jams leveraged various aspects of design thinking, including divergence and convergence, visual thinking, and amplifying diversity. We piloted seven Research Jams for a collective 129 researchers, staff, and partners across 50 University of Michigan units and external organizations. Feedback was overwhelmingly positive, with the vast majority of survey respondents indicating that the sessions were helpful for surfacing shared ideas or visions and that opportunities emerged they would like to pursue. Research Jams were ideal for cross-disciplinary groups who wanted to collaboratively ideate and strategize around complex problems in translational research. Importantly, these models have the potential for implementation with groups in any disciplinary domain who want to spur collaborations to address challenging problems. Our ultimate goal is for Research Jams to be the first intervention within a comprehensive support pathway that extends from early brainstorming all the way to grant submission.

Obtaining informed consent is a fundamental and ethical practice within human subjects’ research. Informed consent forms (ICFs) include a large amount of information, much of which may be unfamiliar to research subjects, and the revised Common Rule resulted in several required additions to that language. As limited health literacy impacts many potential subjects, efforts should be made to optimize subjects’ ability to read and understand ICFs. In this brief report, we describe an assessment of ICFs at an academic medical center to evaluate longitudinal changes in readability with the introduction and update of a plain language ICF template.

ABSTRACT IMPACT: Understanding the needs and barriers or facilitators to participation in research, especially among minority communities is critical not only for COVID-19 research but also for future clinical and translational research and health disparities studies. OBJECTIVES/GOALS: The overall goal of this project is to enhance education, awareness, access, and inclusion of underserved communities across Florida in COVID-19 research, especially among Black and Hispanic minority groups that are disproportionately affected by COVID-19. METHODS/STUDY POPULATION: Through strategic partnership among five academic institutions and community-based organizations across the state of Florida, the FL-CEAL team will implement focus groups and surveys in minority communities in Florida to gauge the awareness and understanding of COVID-19, and the barriers and facilitators for participation in COVID-19 research studies. These communities include but are not limited to Latinx and Black populations in South and Central Florida, and Black communities in North Florida. The outcomes will help shape strategies for outreach and dissemination activities and minority recruitment plans to promote participation of minorities into vaccine and therapeutic trials. RESULTS/ANTICIPATED RESULTS: An estimated 75-125 participants will be recruited for focus groups. Four focus groups with minority communities have been conducted and the results are being analyzed. A common Community-Based Needs Assessment survey is being finalized and will be deployed across the 11 states that are part of the national CEAL consortium. Community Health Workers are being engaged to support outreach and dissemination to educate targeted communities on COVID-19 research and the importance of participation in COVID trials. To date, 243 CHWs and 880 community members have been engaged. Minority participation in COVID-19 vaccine trials at University of Miami has been higher than the national average. DISCUSSION/SIGNIFICANCE OF FINDINGS: The FL-CEAL Alliance has successfully demonstrated a coordinated effort to engage minority communities affected by COVID. Through strategic geographic partnerships, FL-CEAL will positively impact minority communities throughout the state that has one of the most diverse populations in the nation.

Despite increasing attention to the importance of diverse research participants, success across the translational research spectrum remains limited. To assess investigator and research team training needs, we conducted a web-based survey exploring barriers in knowledge and practice. Respondents (n = 279) included those affiliated with the University of Wisconsin Institute for Clinical and Translational Research (ICTR). Although all respondents reported an abstract belief in the importance of diversity, factors associated with higher levels of best practices knowledge and implementation included: (1) use of federal funding; (2) having fewer years of experience; (3) recruiting healthy participants; and (4) having recruitment training.

Implementation assessment plans are crucial for clinical trials to achieve their full potential. Without a proactive plan to implement trial results, it can take decades for one-fifth of effective interventions to be adopted into routine care settings. The Veterans Health Administration Office of Research and Development is undergoing a systematic transformation to embed implementation planning in research protocols through the Cooperative Studies Program, its flagship clinical research program. This manuscript has two objectives: 1) to introduce an Implementation Planning Assessment (IPA) Tool that any clinical trialist may use to facilitate post-trial implementation of interventions found to be effective and 2) to provide a case study demonstrating the IPA Tool’s use. The IPA Tool encourages study designers to initially consider rigorous data collection to maximize acceptability of the intervention by end-users. It also helps identify and prepare potential interested parties at local and national leadership levels to ensure, upon trial completion, interventions can be integrated into programs, technologies, and policies in a sustainable way. The IPA Tool can alleviate some of the overwhelming nature of implementation science by providing a practical guide based on implementation science principles for researchers desiring to scale up and spread effective, clinical trial-tested interventions to benefit patients.

The National Center for Advancing Translational Sciences has called for more comprehensive research with priority populations to reduce disparities and for the development of additional resources to assist researchers in implementing these recommendations. Here we report the development and initial evaluation of five Priority Populations Toolkits, which are resources developed by the University of Illinois Center for Clinical and Translational Science to meet these goals. Three aims guide the content: increasing knowledge, facilitating communication, and improving research design. Materials were curated from scientific literature reviews and Internet searches and revised iteratively. Analytics and user surveys provide information about usage. In 22 months, 387 unique users accessed the toolkits. The top reason for usage was to improve research recruitment. Comprehensive toolkits for working with priority populations show promising potential for increasing knowledge and readiness to work with underrepresented populations. Further toolkit development and evaluation of effectiveness are warranted.

The success rate for translation of newly engineered medical technologies into clinical practice is low. Traversing the “translational valleys of death” requires a high level of knowledge of the complex landscape of technical, ethical, regulatory, and commercialization challenges along a multi-agency path of approvals. The Indiana Clinical and Translational Sciences Institute developed a program targeted at increasing that success rate through comprehensive training, education, and resourcing. The Medical Technology Advance Program (MTAP) provides technical, educational, and consultative assistance to investigators that leverages partnerships with experts in the health products industry to speed progress toward clinical implementation. The training, resourcing, and guidance are integrated through the entire journey of medical technology translation. Investigators are supported through a set of courses that cover bioethics, ethical engineering, preclinical and clinical study design, regulatory submissions, entrepreneurship, and commercialization. In addition to the integrated technical and educational resources, program experts provide direct consultation for planning each phase along the life cycle of translation. Since 2008, nearly 200 investigators have gained assistance from MTAP resulting in over 100 publications and patents. This support via medicine–engineering–industry partnership provides a unique and novel opportunity to expedite new medical technologies into clinical and product implementation.