Journal of Clinical and Translational Science最新文献

Introduction: Recruitment of participants into research studies remains a major concern for investigators. Using clinical teams to identify potentially eligible patients can present a significant barrier. To overcome this, we implemented a process for using our patient portal, called MyChart, as a new institutional recruitment option utilizing our electronic health record's existing functionality.

Methods: To streamline the institutional approval process, we established a working group comprised of representatives from human subject protection, information technology, and privacy and vetted our process with many stakeholder groups. Our specific process for study approval is described and started with a consultation with our recruitment and retention function funded through our Clinical and Translational Science Award.

Results: The time from consultation to the first message(s) sent ranged from 84 to 442 days and declined slightly over time. The overall patient response rate to MyChart messages about available research studies was 23% with one third of those saying they were interested in learning more. The response rate for Black and Hispanic patients was about 50% that of White patients.

Conclusions: Many different types of studies from any medical specialty successfully identified interested patients using this option. Study teams needed support in defining appropriate inclusion/exclusion criteria to identify the relevant population in the electronic health records and they needed assistance writing study descriptions in plain language. Using MyChart for recruitment addressed a critical barrier and opened up the opportunity to provide a full recruitment consultation to identify additional recruitment channels the study teams would not have considered otherwise.

This paper explores the development of the Dissemination and Implementation Science Collaborative (DISC) at the Medical University of South Carolina, established through the Clinical and Translational Science Award program. DISC aims to accelerate clinical and translational science by providing training, mentorship, and collaboration opportunities in dissemination and implementation (D&I) science. Through DISC, investigators, trainees, and community partners are equipped with the knowledge and skills to conduct D&I research and translate findings into practice, particularly in South Carolina's public health and healthcare landscape. We describe efforts to achieve the major overarching aims of DISC, which include conducting scientific workforce training, providing mentorship and consultation, and advancing methods and processes for D&I research. By sharing DISC experiences, successes, and challenges, this paper aims to support the growth of D&I research and capacity-building programs, fostering collaboration and shared resources in the field.

Background: Social determinants of health (SDoH), such as socioeconomics and neighborhoods, strongly influence health outcomes. However, the current state of standardized SDoH data in electronic health records (EHRs) is lacking, a significant barrier to research and care quality.

Methods: We conducted a PubMed search using "SDOH" and "EHR" Medical Subject Headings terms, analyzing included articles across five domains: 1) SDoH screening and assessment approaches, 2) SDoH data collection and documentation, 3) Use of natural language processing (NLP) for extracting SDoH, 4) SDoH data and health outcomes, and 5) SDoH-driven interventions.

Results: Of 685 articles identified, 324 underwent full review. Key findings include implementation of tailored screening instruments, census and claims data linkage for contextual SDoH profiles, NLP systems extracting SDoH from notes, associations between SDoH and healthcare utilization and chronic disease control, and integrated care management programs. However, variability across data sources, tools, and outcomes underscores the need for standardization.

Discussion: Despite progress in identifying patient social needs, further development of standards, predictive models, and coordinated interventions is critical for SDoH-EHR integration. Additional database searches could strengthen this scoping review. Ultimately, widespread capture, analysis, and translation of multidimensional SDoH data into clinical care is essential for promoting health equity.

Introduction: Community health workers (CHWs) stand as critical frontline agents within the Brazilian healthcare system. In this qualitative study, we examined the impact of a community-based behavioral change intervention spearheaded by CHWs.

Methods: The intervention focused on promoting healthy behaviors - physical activity, nutrition, and emotional well-being - among individuals aged 50 and older living in a rural community in Brazil. The intervention was designed, implemented, and evaluated in close collaboration with CHWs and local administrators. The implementation of the intervention unfolded in two waves, each lasting 12 months. Interviews with CHWs, health administrators, and intervention participants conducted at post-intervention and 6-year follow-up centered on CHWs as delivery agents and examined the implementation of the intervention in primary care contexts around adoption, implementation, and long-term maintenance.

Results: Inductive analysis revealed four themes that highlight CHWs' motivation to take active roles in health promotion and overcoming challenges such as unfamiliarity with new roles or limited training. In addition, enhanced community bonds, job satisfaction, and trust in CHWs gained through the intervention, empowered CHWs to realize their potential and importance. Another important area relates to the CHWs' ability to leverage their deep community ties and cultural insights to enhance the intervention's significance. CHWs' participation in the program also led to personal benefits and self-care practices, setting an example for the community they serve.

Conclusions: This study underscores the positive impact of a community-based intervention led by CHWs. Such programs have the potential for nationwide dissemination, leveraging the CHWs' widespread presence and deep community integration.

Underrepresentation of people from racial and ethnic minoritized groups in clinical trials threatens external validity of clinical and translational science, diminishes uptake of innovations into practice, and restricts access to the potential benefits of participation. Despite efforts to increase diversity in clinical trials, children and adults from Latino backgrounds remain underrepresented. Quality improvement concepts, strategies, and tools demonstrate promise in enhancing recruitment and enrollment in clinical trials. To demonstrate this promise, we draw upon our team's experience conducting a randomized clinical trial that tests three behavioral interventions designed to promote equity in language and social-emotional skill acquisition among Latino parent-infant dyads from under-resourced communities. The recruitment activities took place during the COVID-19 pandemic, which intensified the need for responsive strategies and procedures. We used the Model for Improvement to achieve our recruitment goals. Across study stages, we engaged strategies such as (1) intentional team formation, (2) participatory approaches to setting goals, monitoring achievement, selecting change strategies, and (3) small iterative tests that informed additional efforts. These strategies helped our team overcome several barriers. These strategies may help other researchers apply quality improvement tools to increase participation in clinical and translational research among people from minoritized groups.

Background: Researchers generally do an excellent job tracking the scientific impacts of their scholarship in ways that are relevant for academia (e.g., publications, grants) but too often neglect to focus on broader impacts on population health and equity. The National Cancer Institute's Implementation Science Centers in Cancer Control (ISC3) includes 7 P50 Centers that are interested in broad measures of impact. We provide an overview of the approach underway within the ISC3 consortium to identify health and social impacts.

Methods: ISC3 adapted and applied the Translational Science Benefits Model (TSBM) to identify the impact on the discipline of D&I science and to consider dissemination and implementation (D&I) impacts in the four original TSBM domains: (1) clinical; (2) community; (3) economic; and (4) policy. To collect data from all Centers, we: (1) co-developed a set of detailed impact indicators with examples; (2) created a data collection template; and (3) summarized the impact data from each center.

Results: Based on data from 48 ISC3 pilot studies, cores, or consortium activities, we identified 84 distinct benefits. The most common impacts were shown for implementation science (43%), community (28%), and clinical (18%). Frequent audiences included primary care providers, public health practitioners, and community partners. ISC3 members highlighted the need for product feedback, and storytelling assistance to advance impact.

Conclusions: The ISC3 consortium is using a participatory approach to successfully apply the TSBM, thus seeking to maximize the real-world impacts of D&I science. The D&I field needs to prioritize ways to more fully document and communicate societal impacts.

Enrollment into a prospective cohort study of mother-preterm infant dyads during the COVID-19 pandemic progressed slower than anticipated. Enrollment occurred during the first week after preterm birth, while infants were still hospitalized. We hypothesized that slower enrollment was attributable to mothers testing positive for COVID-19 as hospital policies restricted them from entering the neonatal intensive care unit, thus reducing interactions with research staff. However, only 4.5% of 245 screened mothers tested COVID-19 positive. Only 24.9% of those screened, far fewer than anticipated, were eligible for enrollment. Assumptions about pandemic-related enrollment barriers were not substantiated in this pediatric cohort.

Purpose: Community inclusion in research may increase the quality and relevance of research, but doing so in an equitable way is complex. Novel approaches used to build engagement with historically marginalized communities in other sectors may have relevance in the clinical research sector.

Method: To address long-standing gaps and challenges, a stakeholder group was convened to develop a theory of change (ToC), a structured method for obtaining input from stakeholders to enhance the design, conduct, and dissemination of research. The stakeholder group, comprised of Black residents within a metropolitan area, followed a structured monthly meeting schedule for 12 months to produce an outcome map, a model that formally defines aspects of research and engagement for this community.

Results: Stakeholders reported significant improvements in trust in and engagement with research over the 12-month period, but not changes in health empowerment (individual, organizational, or community level). Through this convening process, a ToC and outcome map were developed with the focus of building bidirectional relationships between groups identifying as Black, Indigenous, and People of Color (BIPOC) and researchers in Boston, MA. Additionally, the group developed a community ownership model and guidelines for researchers to adhere to when utilizing the ToC and outcome map with BIPOC communities.

Conclusion: Co-ownership of models to develop bidirectional relationships between researchers and community members, such as the ToC and outcome map, may advance and further the value and reach of community-based participatory research while increasing levels of trust and engagement in research.

Introduction: The expansion of electronic health record (EHR) data networks over the last two decades has significantly improved the accessibility and processes around data sharing. However, there lies a gap in meeting the needs of Clinical and Translational Science Award (CTSA) hubs, particularly related to real-world data (RWD) and real-world evidence (RWE).

Methods: We adopted a mixed-methods approach to construct a comprehensive needs assessment that included: (1) A Landscape Context analysis to understand the competitive environment; and (2) Customer Discovery to identify stakeholders and the value proposition related to EHR data networks. Methods included surveys, interviews, and a focus group.

Results: Thirty-two CTSA institutions contributed data for analysis. Fifty-four interviews and one focus group were conducted. The synthesis of our findings pivots around five emergent themes: (1) CTSA segmentation needs vary according to resources; (2) Team science is key for success; (3) Quality of data generates trust in the network; (4) Capacity building is defined differently by researcher career stage and CTSA existing resources; and (5) Researchers' unmet needs.

Conclusions: Based on the results, EHR data networks like ENACT that would like to meet the expectations of academic research centers within the CTSA consortium need to consider filling the gaps identified by our study: foster team science, improve workforce capacity, achieve data governance trust and efficiency of operation, and aid Learning Health Systems with validating, applying, and scaling the evidence to support quality improvement and high-value care. These findings align with the NIH NCATS Strategic Plan for Data Science.