Journal of Clinical and Translational Science最新文献

Background and purpose: Federally Qualified Health Centers (FQHC) are critically important in addressing the unmet healthcare needs of individuals impacted by poverty. We used implementation science frameworks to advance understanding of perceived and actual facilitators and barriers to a novel asthma intervention before initiating a FQHC practice-based clinical trial.

Methods: Interviews with clinicians and administrators explored pre-implementation trial considerations. Transcripts were inductively coded using conventional content analysis.

Results: Sixteen administrators and/or clinicians (88% female; mean age 49 ± 12.21; 44% Black race; 25% Hispanic ethnicity) from four FQHCs participated. Themes included (1) multi-level factors making successful implementation more or less likely, (2) pandemic-specific concerns with implications for current healthcare delivery challenges, and (3) unintended implementation consequences.

Conclusions: Participants were optimistic about the likelihood of successful intervention implementation if challenges were recognized and managed. Combined with other planned assessments, this data may provide a more comprehensive evaluation of clinical trial implementation in FQHCs.

Introduction: Children's Advocacy Centers (CACs) use multidisciplinary teams to respond to child abuse allegations. These fluid teams can benefit from team training to enhance team functioning and performance and strengthen the workforce, but they need guidance and resources to support the implementation of team training.

Methods: We conducted a cluster-randomized hybrid effectiveness-implementation trial to test the effectiveness of team training and evaluate a self-guided implementation process. Six rural CACs (N = 172 team members) were randomized to TeamTRACS (Team Training in Roles, Awareness, Communication, & Support; n = 4) or a waitlist comparison (n = 2). Simultaneous mixed methods evaluated the effectiveness of TeamTRACS (QUAN + qual) and the implementation process (quan + QUAL).

Results: Reactions to TeamTRACS were positive (mean ratings > 4.5 on 1-5 scale), and TeamTRACS significantly increased teamwork knowledge (estimated marginal means = 80% vs. 75% [intent-to-treat]; 85% vs. 76% [training attendance]). There were no effects on skill use or work-related outcomes. Changes in team-level outcomes were small and inconsistent; one TeamTRACS team made substantial improvements. Reactions to self-guided implementation were positive (mean ratings > 4 on 1-5 scale). However, only one team completed the implementation process. Challenges included difficulty forming and maintaining a change team, turnover and understaffing, and competing priorities and a short timeframe.

Conclusions: Overall, TeamTRACS and its self-guided implementation process were positively received. Incomplete implementation may have limited TeamTRACS' effectiveness. Longer timeframes and external support may improve the implementation of team training in low-resource settings.

Rural primary care providers report increasing rates of professional burnout, which can further exacerbate rural provider shortages and health disparities. From 2023 to 2025, the Project ECHO team at Penn State University developed and delivered an educational rural health telementoring program, collaboratively with stakeholders, to disseminate guideline-concordant care to rural primary care clinicians. The program focused on key rural topics and created a professional learning community aimed at decreasing participant burnout. Self-reported results of the pilot program's participants (n = 106) demonstrate increased knowledge (p < .001) and reduced professional isolation. Future programing will expand data collection to explore longer-term impact.

Introduction: In Indiana, Black women had 12% higher cervical cancer incidence, and 21% higher mortality compared to White women during the years 2008-2017. Human Papillomavirus (HPV) self-sampling delivered by community health workers (CHW) has demonstrated potential to increase cervical cancer screening rates among at-risk populations. This study aims to understand patient attitudes toward HPV self-sampling and CHW-delivered screening.

Methods: We conducted a cross-sectional online survey among patients from three Planned Parenthood clinics in Lake County, IN, which has one of the highest cervical cancer mortality rates in Indiana. Patients' willingness to self-sample and to receive health education and services related to cervical cancer screening from CHWs was analyzed using logistic regression.

Results: In the final sample (N = 140), the largest proportions of respondents were below age 30 (54.3%), aware of cervical cancer (78.6%), up to date on cervical cancer screening (84.3%), had no prior self-sampling experience (53.6%) and were aware of CHWs (52.1%). Multivariable logistic regression analyses showed Black patients had higher odds of being willing to: self-sample at home (aOR = 3.749, 95% CI = 1.619-8.681), receive health education from CHWs (aOR = 4.952, 95% CI = 2.124-11.548), and receive health services from CHWs (aOR = 3.305, 95% CI = 1.479-7.388) compared to White patients.

Conclusion: Our results showed Black patients had higher willingness for HPV self-sampling and CHW delivery of cervical cancer screening services. Study findings can be used to inform future CHW-led interventions for outreach, education, and delivery of self-sampling interventions to increase cervical cancer screening rates among Black women in underserved areas.

Research participants should be informed of genetic test results that could impact their health, particularly when they have expressed interest in receiving such information. Furthermore, the return of genetic test results is essential to improve trust, transparency, and health equity. However, investigators often encounter barriers in returning genetic test results to research participants. We examined genomic research at a large, research-intensive medical school and found less than 6% of protocols included plans to return results to participants. This study describes our development of protocols for returning primary and secondary genetic test results and implementation of a Genomic Return of Results (gROR) service. This arose through a collaboration with experts in community engagement, genetics, and pathology to consider consent adequacy, analytical/clinical validity, and clinical utility when returning results. The gROR service reduces investigator burden and provides participants with genetic information and guidance to address any potential health risks. Genetic results are returned by a genetic counselor at no cost to participants or their family. Investigator costs are subsidized to incentivize the delivery of actionable genetic test results to research participants. Our approach prioritizes transparency, accessibility, and informed decision-making, thereby promoting equitable sharing of genetic knowledge and personalized healthcare interventions.

Objective: To compare healthcare survey response rates using two widely utilized recruitment methods: email and the electronic health record (EHR) patient portal.

Materials and methods: Adults with a prior history of any bariatric surgery were randomly assigned (1:1) to receive a survey invitation via email or through the EHR patient portal. A second reminder was sent using the same method. A third invitation used a crossover approach, switching to the alternate method. We compared survey completion rates, changes in research preference status, and time to survey completion. Predictors of response were assessed using multivariable logistic regression.

Results: The email group had a 9.9% response rate after the first invitation and 6.5% after the second. The EHR portal group had 8.4% and 4.5% response rates, respectively. Following crossover, the third invitation yielded a 4.4% response for those switched to the EHR portal and 7.5% for those switched to email. The EHR portal group was 27% less likely to complete the survey compared to the email group. Respondents were more likely to be female, non-Hispanic, White, have a recent healthcare encounter, and have recently logged into the portal. Median time to completion was under 24 hours in both groups, with over two-thirds of responses received on the day of or the day after the invitation. A change in research preference status was observed in 2.5% of email and 4.0% of portal participants.

Discussion and conclusion: Email-based recruitment yielded higher response rates than EHR portal-based recruitment, with most responses occurring shortly after invitation.

Despite representing 18% of the world's population and 20% of the disease burden, only an estimated 2% of global clinical trials include at least one study site in Africa. This underscores the critical need for continued research on how to overcome clinical trial challenges on the continent. In countries with established reputations for clinical trials, Contract Research Organizations (CROs) play a vital role, accounting for half of the research workforce and effectively managing clinical trials for pharmaceutical, biotechnology, and medical device companies. In contrast, the potential of CROs in Africa's clinical trials ecosystem remains largely unexplored. This narrative review discusses the challenges, opportunities, best practices, emerging trends, and prospects of clinical trials in Africa. Major challenges in clinical trial implementation in Africa stem from gaps in financial and human resources, infrastructure, and regulatory systems, while opportunities are linked to Africa's large population, genetic diversity, disease burden, lower operating costs, positive economic outlook, and growing interest from global health and research players. Emerging trends, such as the decentralization of clinical trials and conducting trials during public health emergencies, offer promising avenues for maintaining research continuity. Ultimately, the paper proposes a context-specific framework, aimed at maximizing the effectiveness of CROs in the continent's clinical trials ecosystem.

The quality by design (QbD) framework holds promise for improving success rates for completion of clinical studies, which often fail to complete on time. Initially used in manufacturing, the framework is now frequently applied to clinical trials to anticipate risks and avoid challenges that impact study completion or the credibility of results. The Southern California Clinical and Translational Science Institute created and implemented a program based on QbD to increase the success of research studies, including clinical trials and other study designs, being conducted by scholars in our Mentored Career Development Program and awardees in our Pilot Grant Programs. The program's three components are QbD Design Studios, project management, and team science support. The overall goal is to increase study quality and efficiency, thereby improving study completion success rates and, ultimately, driving innovations in healthcare and public health. The current article describes QbD program elements in detail, along with preliminary results from initial implementation, approaches for evaluating the program's implementation and impact on study success, and plans to disseminate the program widely.