Journal of Clinical and Translational Science最新文献

OBJECTIVES/GOALS: Community and other stakeholder engagement (CSE) is critical for relevant and equitable clinical research, yet implementation poses challenges. This study delineates the perspectives of scientists and diverse stakeholders regarding facilitators and challenges in CSE, its perceived value, and their recommendations for successful CSE. METHODS/STUDY POPULATION: The Tufts CTSI Pilot Studies Program requires applicants to propose a plan for CSE while implementing the award, including which stakeholders (SHs)—community members, clinicians, and others affected by the research--will be involved and at what stages. This qualitative study assessed the experiences of both Principal Investigators (PIs) and SHs engaged in pilot projects from three cohorts of awardees (2019-21). Recruitment targeted one PI and one SH per project. Semi-structured interviews explored their CSE experiences, including facilitators, challenges, meaningfulness, perceived impact, intent to participate in CSE in future studies, as well as recommendations for funders, research support organizations, and investigators. Inductive consensus-based coding and thematic analysis was employed. RESULTS/ANTICIPATED RESULTS: Fourteen PIs from different pilot projects and a SH from five of these projects participated. Almost all PIs (92%) had over six years of experience, but two-thirds (67%) had little or no experience with CSE. Four SHs self-identified as representatives of community organizations and one as a clinician scientist. CSE was a “win-win” for both PIs and SHs, and all PIs intended to involve SHs in other research studies. Three facilitators were identified as fostering effective CSE (e.g., PI access to CSE expertise while conducting the project), while four challenges hindered it (e.g., limits on SH capacity and CSE funding). SHs advised scientists to build authentic, sustained relationships, and PIs and SHs provided three actionable recommendations for funders and research support organizations to deepen and expand CSE. DISCUSSION/SIGNIFICANCE: Perspectives of scientists and SHs engaged in research projects are vital for expanding and sustaining effective CSE in research. Funders and research support organizations can enhance their strategies for CSE integration in clinical and translational research by incorporating these diverse views to ensure the research achieves maximal impact.

OBJECTIVES/GOALS: The objectives of this workshop were to: (1) provide learners with a space to become aware of and discuss the history of the LGBTQ+ community in medical and public health research; (2) apply frameworks for LGBTQ+ inclusivity in research, inspired by lived experience and multimedia; and (3) assess LGBTQ+ research inclusivity best practices. METHODS/STUDY POPULATION: The CTSC provided the LGBT Community Center of Greater Cleveland (Center) with access to academic resources via an affiliate account and insights on the clinical and translational science research process. Members of the CTSC Research Equity, Accessibility, Diversity, and Inclusion team met regularly with the education and programming team at the Center to review research findings for workshop segments, ideate and provide feedback on activities, and strategize to ensure a psychologically safe virtual environment for learners. Zoom registration was used for workshop registration. An evaluation survey, created by the LGBT Community Center of Greater Cleveland (Center), was deployed by the CTSC to learners after the workshop. Respondents reported that the LGBTQ+ terminology focus was most valuable. RESULTS/ANTICIPATED RESULTS: To maximize investment in and scale theLGBTQ+ Inclusivity For Researchers workshop, the LGBT Community Center of Greater Cleveland offered a shortened version to their Youth Participatory Action Research group and will continue to offer the workshop in their suite of program/educational offerings. The CTSC plans to offer opportunities to co-host the workshop at its hospital system partner institutions, with room to tailor content based on internal LGBT resources (e.g., gender care offered at the institution). We hope to see a remarkable increase in LGBTQ+ identifying researchers, LGBTQ+ participation in research studies and clinical trials, and LGBTQ+ research topics/ideas/questions in response to CTSC pilots, local, national, and global funding opportunities. DISCUSSION/SIGNIFICANCE: LGBTQ+ people are less likely to have a regular health care provider—impeding screening, diagnosis, and treatment. This is reflected in health research where clinical research participation may follow a diagnosis. By providing tools for LGBTQ+ research inclusion, we will catalyze more research with LGBTQ+ people—as researchers and participants.

OBJECTIVES/GOALS: Chronic kidney disease (CKD) impacts 15% of US adults and African American (AA) persons are disproportionately affected with more than 3 times higher risk of kidney failure when compared to Caucasian persons. This study evaluated the physiological and metabolomic effects of increased fruits and vegetables (F&V) on cardio-renal risk factors. METHODS/STUDY POPULATION: This pilot trial used a prospective, 2-group, randomized study design to evaluate a F&V intervention (N=46), where participants received a prescribed amount of fresh, base-producing F&V compared to a wait-list control (WL) condition (N=45). All participants were African American adults (≥18 years), had self-reported hypertension, and had CKD (Stage 1-3) on screening spot-urine microalbumin test. Participants were measured at baseline and 6 weeks post-intervention. Clinical data (i.e., systolic and diastolic blood pressure, lipid panel, hemoglobin A1C, BMI [body mass index], and albumin to creatinine ratio) were collected. Targeted metabolomic quantitative analysis was performed followed by LC-MS/MS and FIA-MS/MS. Linear mixed models evaluated analyte expression and clinical data. RESULTS/ANTICIPATED RESULTS: AA participants (N=91) were aged 58 ± 10.2 years, 66% female, and 54% had incomes ≤$50,000. T-tests compared change scores (baseline to 6-weeks) between groups. The F&V group demonstrated a significant reduction in BMI of -4.7 ± 10.5 kg/m² compared to a 1.9 ± 8.3 kg/m² increase in the WL group, p<.01. Further, the F&V group demonstrated a reduction in total cholesterol of -15.4 ± 58.8 mg/dL compared to a 17.7 ± 68.8 mg/dL increase in the WL group, p<.05. Non-significant reductions in hemoglobin A1c were found in the F&V versus the WL group. Metabolomic analysis indicated significant variation with an increase of suggestive key biomarkers for worse CKD in the WL versus F&V groups at 6-weeks. DISCUSSION/SIGNIFICANCE: Consumption of only 2 cups of F&V via a community-based intervention reduced CVD risk factors in AA adults with CKD and HTN and resulted in molecular/biochemical changes which may improve long-term kidney health. Further investigation may lead to development of cost-effective dietary intervention models to improve CKD outcomes in AA persons.