Journal of Clinical and Translational Science最新文献

Introduction: Declining participant engagement threatens human subjects research. Participant feedback systems (PFS) may combat this decline by empowering participants to evaluate their research experiences and share that feedback with researchers to identify targets for improvement. PFS signal that participant experiences are prioritized, making the request for feedback itself an intervention. PFS design work remains largely confined to clinical research. This exploratory study investigates the design parameters of extending PFS to nonclinical research. We conducted focus groups with nonclinical stakeholders: Experienced research participants (ERP) and research team members (RTM).

Methods: ERP focus groups were organized by affinity (LGBTQIA+, BIPOC, persons with disabilities, neurodivergent, and a general group). RTM focus groups were organized by unit within the University of Michigan. Transcripts were analyzed using inductive thematic analysis.

Results: Ten focus groups (ERP: 5, n = 25; RTM: 5, n = 26) identified key PFS design considerations: (1) motivations for feedback, (2) feedback collection, and (3) feedback delivery. ERP and RTM collectively preferred anonymous web-based surveys with six potential topic areas: communication, respect, being valued, receiving value, burden, and safety. Feedback delivery faced two key design tensions: balancing institutional standardization with study-specific insights and aligning leadership's preference for high-level summaries with frontline staff's need for detailed, real-time feedback.

Conclusion: Expanding PFS to nonclinical research requires balancing centralization and study-specific flexibility. While centralization enhances consistency, the diversity of nonclinical studies necessitates adaptable implementation. A hybrid model is proposed to optimize feasibility. Future research should refine and test this model.

Introduction: Distinguishing viral versus bacterial lower respiratory tract infection (LRTI) is challenging. We previously developed a rapid, host response-based test (Biomeme HR-B/V assay) using peripheral blood samples to identify viral versus bacterial infection. We assessed the performance of this assay when using nasopharyngeal (NP) samples.

Methods: Patients with LRTI were enrolled, and a NP swab sample was run using the HR-B/V assay (assessing 24 gene targets) on the Franklin^TM platform. The performance of the prior classifier at identifying viral versus bacterial infection was assessed. A novel predictive model was generated for NP samples using the same 24 targets. Results were validated using external datasets with nasal/NP RNA sequence data.

Results: Nineteen patients (median age 62 years, 52.1% male) were included. When using the prior HR-B/V classifier on NP samples of 19 patients with LRTI (12 viral, 7 bacterial), the area under the receiver operator curve (AUC) for viral versus bacterial infection was 0.786 (0.524-1), with accuracy 0.79 (95% CI 0.57-0.91), positive percent agreement (PPA) 0.43 (95% CI 0.16-0.75), and negative percent agreement (NPA) 1.00 (95% CI 0.76-1). The novel model had AUC 0.881 (95% CI 0.726-1), accuracy 0.84 (95% CI 0.62-0.94), PPA 0.86 (95% CI 0.49-0.97), and NPA 0.83 (95% CI 0.55-0.95) for bacterial infection. Validation in two external datasets showed AUC of 0.932 (95% CI 0.90-0.96) and 0.915 (95% CI 0.88-0.95).

Conclusions: We show that host response in the nasopharynx can distinguish viral versus bacterial LRTI. These findings need to be replicated in larger cohorts with diverse LRTI etiologies.

Introduction: Community engagement (CE) is essential in Clinical and Translational Science (CTS), yet its evaluation remains inconsistent and often lacks standardization. The RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) offers a promising structure for evaluating CE efforts, but its application in dynamic, community-based contexts is often limited by data variability and implementation complexity.

Methods: We developed and applied a seven-step, structured, and replicable approach to operationalizing RE-AIM for program evaluation. This method includes the use of tailored RE-AIM subdomains, standardized scoring systems, and visual analytics through Net Effects Diagrams.

Results: We applied this framework to our community-based health education workshops delivered in English and Spanish across Los Angeles, using participant surveys and facilitator feedback data. The operationalized framework enabled consistent assessment and comparison between language groups. Spanish-language workshops outperformed English-language workshops (ELWs) in measures of attendance, participant satisfaction, and short-term effectiveness. Visualizations using Net Effects Diagrams facilitated collaboration among stakeholders to interpret program outputs and outcomes, supporting actionable insights for program adaptation. Differences between workshop groups will inform changes to recruitment and content delivery strategies in ELWs.

Conclusions: This approach offers a transparent, scalable, and context-sensitive method for assessing CE programs. It supports data-driven decision-making, continuous program improvement, and stakeholder engagement. While developed for CE initiatives, the method is broadly adaptable to other community and public health programs. Future efforts will include expanded outcome tracking, integration into dashboards, and dissemination as a toolkit for broader adoption within and beyond the CTS Award network.

In January 2023, the South Carolina Science Writing Initiative for Trainees (SC-SWIFT), an internship in the College of Graduate Studies at the Medical University of South Carolina, began offering tiered digital badges in science communications. The badges' purpose was to encourage graduate students and postdoctoral fellows to engage in extracurricular science writing opportunities available through SC-SWIFT and to document acquired communications skills for employers. The badges have been well received, with 18 interns earning the beginner badge in the first two years of the program. In March 2025, SC-SWIFT queried 25 interns who had earned a beginner badge or completed half the requirements for doing so in 2023-2024 to gauge how important they considered the badges to their engagement in science communications and how valuable they would be in a job search. All 14 respondents found the badges important in engaging them in science communications, and 86% either strongly agreed or agreed that digital badges would be an asset when job searching. Eleven of 12 respondents (92%) thought that their confidence in telling their own research story had increased. These initial results suggest that digital badges could be useful tools for documenting science communications skills acquired during extracurricular, experiential learning.

Background: Community health centers (CHCs) and those most burdened by disease are important partners in setting research agendas to address the needs of people who are medically underserved.

Objectives: Identify and prioritize health equity-focused research priorities using a collaborative approach to community engagement of key informants.

Methods: We used five stepwise phases from January 2021 to February 2023 to formulate and prioritize a set of health equity-focused research topics among CHC staff (leaders, clinicians), their key advisors (patients and community members), and researchers from academic medical centers in California. Phases included: (1) community advisory board formation, (2) key informant identification, (3) individual/small group interview guide development and administration, (4) initial health equity-focused topic categorization, and (5) in-person meeting with community advisors for final topic prioritization using nominal group technique.

Results: Twenty individual or small group interviews were completed with 44 diverse participants, along with engagement from our community advisory board, which resulted in an initial list of 11 health equity-focused research topics. Ninety advisors including diverse community members, CHC staff/leaders, and researchers prioritized six overarching research topics. Final prioritized health-equity focused research topics include addressing mental health challenges, improving public's trust in healthcare and science, healthcare delivery models to increase access and utilization, build and sustain an anti-racist healthcare system, strategies and interventions to address health misinformation, and continuing and sustaining polices based on lessons learned from COVID-19.

Conclusions: Results offer future direction for community-engaged research agendas to advance health equity among medically underserved and vulnerable patient populations.

[This corrects the article DOI: 10.1017/cts.2025.55.].

Introduction: While evaluation approaches for community-academic research groups are established, few tools exist for academic institutional advisory groups across multi-core centers and research, education, and clinical care missions. Institutional advisory group evaluation should consider group processes and their impact on community-centered outcomes. This study describes the community-engaged development of a mixed-method evaluation approach to address this gap and presents pilot outcomes across an NIH-funded center.

Methods: We utilized a Community of Practice model to co-develop a survey with 14 community and academic representatives of four advisory groups. The final survey included five categories of group process and four categories of outcomes. Storytelling sessions with community partners explored areas where the survey identified discrepancies in perspectives between community and academic team members, as well as areas with lower scores.

Results: Nine community and 14 academic (staff and faculty) partners completed the survey. Respondents positively assessed group process outcomes (shared values, leadership, community-centeredness, and decision-making), and slightly less positive assessments of institutional outcomes. Storytelling sessions confirmed the overall satisfaction of community partners but highlighted actionable concerns within power-sharing, decision-making, funding equity, and trust-building.

Conclusions: The results of this equity-centered evaluation suggest the utility and importance of participatory, mixed-methods approaches to evaluating community-academic institutional advisory groups.

Decentralized clinical trials (DCTs) have the potential to increase pace and reach of recruitment as well as to improve sample representation, compared to traditional in-person clinical trials. However, concerns linger regarding data integrity in DCTs due to threats of fraud and sampling bias. The purpose of this report is to describe two tools that we have developed and successfully implemented to combat these threats. Cheatblocker and QuotaConfig are two external modules that we have made publicly available within the REDCap data capture system to target fraud and sampling bias, respectively. We describe the modules, present two case examples in which we used the modules successfully, and discuss the potential impact of tools such as these on data integrity in DCTs. We situate this discussion within the broader landscape of translational science wherein we strive to improve research rigor and efficiency to maximize public health benefit.

Background: Operational roadblocks and organizational delays in multicenter clinical trials have been evident for decades, with the start-up cycle being especially notorious for setbacks. To address these challenges and improve multicenter clinical trial execution, we developed an accelerated start-up (ASU) management strategy - a structured site onboarding approach based on lean management principles.

Methods: Three elements were integrated into the strategy: a standardized workflow, a dedicated site navigator (SN), and an electronic tracking system. We examined the range, central tendencies, and distribution of site activation times among differing combinations of these three elements. To determine how these combinations affected individual start-up milestones, we fit mixed models to compare percent achievement of predetermined milestone benchmarks and time to completion.

Results: Thirteen consecutive trials (n = 308 site activations) employed three distinct combinations of the three ASU elements. Trials using all three elements (n = 6) had 160 total site activations in a median of 133 days. Three trials without the SN element had 52 total site activations in a median of 191 days. Four trials without the standardized workflow element had 96 total site activations in a median of 277 days. Significant differences between combinations included times to sIRB submission (p = 0.004), training/certificates completion (p = 0.03), and site activation (p = 0.003). Results suggest sites activated faster and achieved predetermined benchmarks for every milestone more often when three elements were employed.

Conclusion: This sample trial start-up data supports that sites can meet ambitious timelines, underscoring the strategy's potential to streamline workflows and improve site team performance.