Journal of Clinical and Translational Science最新文献

Introduction: Operationalizing multi-site Community Engagement (CE) Studios to inform a research program is valuable for researchers. We describe the process and outcomes of hosting three CE Studios with Community Experts aged 65 years or older with chronic conditions and care partners of older adults. Experts gave feedback about processes for testing the feasibility, efficacy, effectiveness, and implementation of audio recording clinic visits and sharing recordings with patients who have multimorbidity and their care partners.

Methods: The CE Cores of the Clinical and Translational Science Awards Programs at three academic health science centers created a joint CE Studio guide. Studios were conducted iteratively by site. Following receipt of the final reports, responses were compared to find themes, similarities, and differences on four topics in addition to overall commentary: Recruitment and Retention, Study Protocol, Study Reminders and Frequency, and Recording Technology.

Results: Eighteen older adults and care partners in three states provided valuable feedback to inform multi-site trials. Feedback influenced multiple aspects of trials in process or subsequently funded. Experts provided critique on the wording of study invitations, information sheets, and reminders to engage in study procedures. Experts were concerned for participants being disappointed by randomization to a control arm and advised how investigators should prepare to address that.

Conclusions: Multi-site CE Studios should be consecutive, so each team can learn from the previous teams. Using the CES Toolkit ensures that final reports were easily comparable and utilized to develop a research program that now includes three federally funded clinical trials.

Evaluation of benefits beyond quantitative academic outputs is essential in determining translational research value. We used the Translational Science Benefits Model (TSBM) to examine the impact of the QUARTET USA trial using 30 benefits across 4 domains: Clinical, Community, Economic, and Policy. We found that the QUARTET USA trial demonstrated impact in six areas within the Clinical, and Community domains and had potential impact in two additional areas within the Community and Economic domains. Use of the TSBM supports the value of the QUARTET USA trial, which can be used as a template for future cardiovascular trials.

Introduction: Essential trace elements and micronutrients are critical in eliciting an effective immune response to combat sepsis, with selenium being particularly noteworthy. The objective of this investigation is to analyze and the levels of serum selenium in neonates within sepsis and control groups.

Methodology: In 2023, a case-control study was carried out involving 66 hospitalized infants - 33 diagnosed with sepsis forming the case group and 33 free from sepsis constituting the control group - along with their mothers, at Children's and Shariati Hospitals in Bandar Abbas. The serum selenium concentrations (expressed in micrograms per deciliter) were quantified utilizing atomic absorption spectrometry. Subsequently, the data were processed and analyzed using IBM SPSS statistical software, version 22.

Results: The average serum selenium level in neonates with sepsis (42.06 ± 20.40 µg/dL) was notably lower compared to the control group (55.61 ± 20.33 µg/dL), a difference that was statistically significant (p-value = 0.009). The levels of serum selenium were comparable between neonates and mothers across both study groups.

Conclusion: The findings of this research indicate that selenium levels in the sepsis group were reduced compared to the control group, despite similar selenium levels in the mothers and neonates in both groups, suggesting that sepsis could be associated with a decrease in selenium levels.

Efficient evidence generation to assess the clinical and economic impact of medical therapies is critical amid rising healthcare costs and aging populations. However, drug development and clinical trials remain far too expensive and inefficient for all stakeholders. On October 25-26, 2023, the Duke Clinical Research Institute brought together leaders from academia, industry, government agencies, patient advocacy, and nonprofit organizations to explore how different entities and influencers in drug development and healthcare can realign incentive structures to efficiently accelerate evidence generation that addresses the highest public health needs. Prominent themes surfaced, including competing research priorities and incentives, inadequate representation of patient population in clinical trials, opportunities to better leverage existing technology and infrastructure in trial design, and a need for heightened transparency and accountability in research practices. The group determined that together these elements contribute to an inefficient and costly clinical research enterprise, amplifying disparities in population health and sustaining gaps in evidence that impede advancements in equitable healthcare delivery and outcomes. The goal of addressing the identified challenges is to ultimately make clinical trials faster, more inclusive, and more efficient across diverse communities and settings.

Research studies involving human subjects require collection of and reporting on demographic data related to race and ethnicity. However, existing practices lack standardized guidelines, leading to misrepresentation and biased inferences and conclusions for underrepresented populations in research studies. For instance, sometimes there is a misconception that self-reported racial or ethnic identity may be treated as a biological variable with underlying genetic implications, overlooking its role as a social construct reflecting lived experiences of specific populations. In this manuscript, we use the We All Count data equity framework, which organizes data projects across seven stages: Funding, Motivation, Project Design, Data Collection, Analysis, Reporting, and Communication. Focusing on data collection and analysis, we use examples - both real and hypothetical - to review common practice and provide critiques and alternative recommendations. Through these examples and recommendations, we hope to provide the reader with some ideas and a starting point as they consider embedding a lens of justice, equity, diversity, and inclusivity from research conception to dissemination of findings.

Background: West Virginia is a rural state with high rates of type 2 diabetes (T2DM) and prediabetes. The Diabetes Prevention and Management (DPM) program was a health coach (HC)-led, 12-month community-based lifestyle intervention.

Objective: The study examined the impact of the DPM program on changes in glycosylated hemoglobin (A1C) and weight over twelve months among rural adults with diabetes and prediabetes. Program feasibility and acceptability were also explored.

Methods: An explanatory sequential quantitative and qualitative one-group study design was used to gain insight into the pre- and 12-month changes to health behavior and clinical outcomes. Trained HCs delivered the educational sessions and provided weekly health coaching feedback. Assessments included demographics, clinical, anthropometric, and qualitative focus groups. Participants included 94 obese adults with diabetes (63%) and prediabetes (37%). Twenty-two participated in three focus groups.

Results: Average attendance was 13.7 ± 6.1 out of 22 sessions. Mean weight loss was 4.4 ± 11.5 lbs at twelve months and clinical improvement in A1C (0.4%) was noted among T2DM adults. Program retention (82%) was higher among older participants and those with poor glycemic control. While all participants connected to a trained HC, only 72% had regular weekly health coaching. Participants reported overall acceptability and satisfaction with the program and limited barriers to program engagement.

Conclusion: Our findings suggest that it is feasible to implement an HC-led DPM program in rural communities and improve A1C in T2DM adults. Trained HCs have the potential to be integrated with healthcare teams in rural regions of the United States.

Scholarly activity is a key component of most residency programmes. To establish fundamental research skills and fill gaps within training curricula, we developed an online, asynchronous set of modules called Research 101 to introduce trainees to various topics that are germane to the conduct of research and evaluated its effectiveness in resident research education. Research 101 was utilised by residents at One Brooklyn Health in Brooklyn, NY. Resident knowledge, confidence, and satisfaction were assessed using pre- and post-module surveys with 5-point Likert scaled questions, open-ended text responses, and a multiple-choice quiz. Pre-module survey results indicated that residents were most confident with the Aligning expectations, Introduction to research, and Study design and data analysis basics modules and least confident with the Submitting an Institutional Review Board protocol and Presenting your summer research modules. Post-module survey responses demonstrated increased learning compared to pre-module results for all modules and learning objectives (p < 0.0001). "This module met my needs" was endorsed 91.4% of the time. The median score for the final quiz that consisted of 25 multiple-choice questions was 23. Thematic analysis of open-ended post-module survey responses identified multiple strengths and opportunities for improvement in course content and instructional methods. These data demonstrate that residents benefit from completion of Research 101, as post-module survey scores were significantly higher than pre-module survey scores for all modules and questions, final quiz scores were high, and open-ended responses highlighted opportunities for additional resident learning.

Background: The Centers for Disease Control and Prevention (CDC)-funded Cancer Prevention and Control Research Network (CPCRN) has been a leader in cancer-related dissemination & implementation (D&I) science. Given increased demand for D&I research, the CPCRN Scholars Program launched in 2021 to expand the number of practitioners, researchers, and trainees proficient in cancer D&I science methods.

Methods: The evaluation was informed by a logic model and data collected through electronic surveys. Through an application process (baseline survey), we assessed scholars' competencies in D&I science domains/subdomains, collected demographic data, and asked scholars to share proposed project ideas. We distributed an exit survey one month after program completion to assess scholars' experience and engagement with the program and changes in D&I competencies. A follow-up survey was administered to alumni nine months post-program to measure their continued network engagement, accomplishments, and skills.

Results: Three cohorts completed the program, consisting of 20, 17, and 25 scholars in Years 1-3, respectively. There was a significant increase in the total D&I competency scores for all three cohorts for 4 overarching domains and 43 subdomains (M_Pre = 1.38 M_Post = 1.89). Differences were greatest for the domain of Practice-Based Considerations (0.50 mean difference) and Theory & Analysis (0.47 mean difference). Alumni surveys revealed that scholars appreciated access to D&I-focused webinars, toolkits, and training resources. 80% remain engaged with CPCRN workgroups and investigators.

Conclusions: Program evaluation with scholars and alumni helped with ongoing quality assurance, introspection, and iterative program adaptation to meet scholars' needs. This approach is recommended for large-scale capacity-building training programs.

Introduction: Latinx populations are underrepresented in clinical research. Asking Latinx research participants about their research experiences, barriers, and facilitators could help to improve research participation for these populations.

Methods: The Salud Estres y Resilencia (SER) Hispano cohort study is a longitudinal cohort study of young adult Latinx immigrants whose design and conduct were tailored for their study population. We administered the Research Participant Perception Survey (RPPS) to SER Hispano participants to assess their experiences in the study. We describe overall results from the RPPS and compare results of surveys administered to SER Hispano participants via email versus telephone.

Results: Of 340 participants who were contacted with the RPPS, 142 (42%) responded. Among respondents, 53 (37%) responded by initial email contact; and 89 (63%) responded by subsequent phone contact. The majority of respondents were between 35 and 44 years of age (54%), female (76%), and of Cuban origin (50%). Overall, research participants expressed high satisfaction with their research experience; 84% stated that they would "definitely" recommend research participation to friends and family, with no significant difference by method of survey administration (P = 0.45). The most common factor that was chosen that would influence future research participation was having summary results of the research shared with them (72%).

Conclusion: We found that culturally tailored studies can be good experiences for Latinx research participants; and we found that use of the RPPS can be administered successfully, particularly when administered by more than one method, including telephone, to evaluate and to improve research experiences for this population.

Introduction: More than 5 million children in the United States experience food insecurity (FI), yet little guidance exists regarding screening for FI. A prediction model of FI could be useful for healthcare systems and practices working to identify and address children with FI. Our objective was to predict FI using demographic, geographic, medical, and historic unmet health-related social needs data available within most electronic health records.

Methods: This was a retrospective longitudinal cohort study of children evaluated in an academic pediatric primary care clinic and screened at least once for FI between January 2017 and August 2021. American Community Survey Data provided additional insight into neighborhood-level information such as home ownership and poverty level. Household FI was screened using two validated questions. Various combinations of predictor variables and modeling approaches, including logistic regression, random forest, and gradient-boosted machine, were used to build and validate prediction models.

Results: A total of 25,214 encounters from 8521 unique patients were included, with FI present in 3820 (15%) encounters. Logistic regression with a 12-month look-back using census block group neighborhood variables showed the best performance in the test set (C-statistic 0.70, positive predictive value 0.92), had superior C-statistics to both random forest (0.65, p < 0.01) and gradient boosted machine (0.68, p = 0.01), and showed the best calibration. Results were nearly unchanged when coding missing data as a category.

Conclusions: Although our models could predict FI, further work is needed to develop a more robust prediction model for pediatric FI.