Journal of Clinical and Translational Science最新文献

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.

Medication errors in clinical care and in clinical research are preventable situations requiring quality improvement approaches to mitigate negative safety trends. The "Rights of Medication Administration" framework has existed in hospital and clinic settings for decades to aid clinicians with ensuring medication administration safety for patients. These quality measures such as expanded rights of medication administration, bar coding, and "time outs" have been employed to improve clinical patient safety. In clinical trials, drug accountability standard operating procedures are established standards; however, policies for direct administration of the investigational medical product to the study participant in a trial are lacking. Current administration rights were examined through the lens of clinical research practices, regulations, and case studies leading to proposed revisions for local adaptation. The authors suggest a standard operating procedure for investigational product that includes a "time out" checklist to ensure improved quality study performance and safety for clinical trial participants. This new standard operating procedure considers evolved quality practices suggested in the new "Good Clinical Practice" guidelines, ICH E6 (R3). With safety and quality at the forefront, this newly proposed SOP has been developed for implementation at the local site. Future research is encouraged.

Objective: To provide insights into the motivations, challenges, and preferred methods of contact that influence the recruitment and retention of young adults (YAs) in health research.

Methods: We designed, collected, and analyzed two surveys targeting YAs aged 18-39 years through the Amazon MTurk platform, to assess factors influencing recruitment and retention in health studies. The recruitment survey (n = 477) examined initial engagement motivations, while the retention survey (n = 473) explored factors that sustain long-term participation. Descriptive analyses were stratified by age group and sex.

Results: The recruitment survey indicated that 88% of YAs were willing to participate in health studies, with a preference for online formats (78%). Social media, particularly Facebook (53%), was endorsed as the most common platform for discovering research opportunities. Monetary incentives were reported as the top motivator across all age groups, especially for those aged 35-39 years, with gift cards endorsed as the most appealing to participants aged 18-34. Retention survey results indicated that email (100%) was the most preferred method for maintaining engagement, followed by text messages (78.9%) and social media (62.2%). Text messages (65%), regular updates (56%) and sharing of study results (54%) were identified as key factors for maintaining participant engagement.

Conclusion: Our findings identify that YA participation is driven by a mix of altruistic motivations, such as contributing to the community and research, and personal motivations, including personal health benefits and financial incentives, emphasizing the need for strategies that address both aspects of recruitment and retention motivations.

Introduction: Research ethics consultation services (RECS) provide important ethical guidance to various entities, including investigators and Institutional Review Boards. Established in the late 1980s and influenced by funding requirements from the National Center for Advancing Translational Science, RECS have evolved to address ethical challenges in research. This study aimed to identify key barriers and facilitators affecting the success of RECS, particularly in light of changes in funding and institutional support.

Materials and methods: From a comprehensive list of 55 Clinical and Translational Science Award programs, 20 RECS were purposively sampled for in-depth interviews. Interviews focused on primary functions, accomplishments, barriers, and facilitators of the service. We performed an abductive analysis on transcribed data.

Results: Twenty-two research ethics consultants from 20 institutions participated. Respondents emphasized their services' goal of facilitating ethical research, though many faced barriers such as underutilization and lack of awareness among researchers. Facilitators included institutional support and funding. Support often was contingent on institutional leadership facilitating the service into the university's research enterprise. Participants reported accomplishments, including successful consultations and contributions to institutional policies.

Discussion: Our findings indicate that RECS play a crucial role in supporting ethical research practices, though their effectiveness is often contingent on institutional relationships and funding. Key recommendations include tracking consults, defining consultation outcomes, and fostering the development of new consultants to sustain the field of research ethics.

[This corrects the article DOI: 10.1017/cts.2025.10133.].