Journal of Clinical and Translational Science最新文献

Background: Academic-community research partnerships focusing on addressing the social determinants of health and reducing health disparities have grown substantially in the last three decades. Early-stage investigators (ESIs), however, are less likely to receive grant funding from organizations like the National Institutes of Health, and we know little about the facilitators and barriers they face on their career journeys or the best ways to support them and their community research partnerships. This study examines ESIs' experiences with a program that funded and supported their community-partnered pilot health disparities research.

Methods: Fourteen ESIs from five cohorts of pilot investigators participated in in-depth focus groups between April 2020 and February 2024. Two reviewers independently identified significant quotes and created codes. Thematic analysis was used to develop relevant themes.

Results: The overarching theme was that the program was a launch pad for the ESIs' research careers. Four distinct sub-themes contributing to the launch pad theme were: (1) ESI Growth & Adaptation; (2) Community and Support; (3) The Value of Collaboration and Partnership; (4) Need for Effective Mentorship. The results suggest the program offered ESIs and community partners substantial, unique support and resources, but challenges remained.

Conclusions: Future programs helping ESIs who conduct community-engaged research to launch their research careers should consider implementing tailored support while offering strategies to eliminate or reduce institutional barriers, including strengthening mentoring.

In healthcare and medical research, advisory boards are now commonplace, but most boards consist of a relatively homogenous, geographically collocated group, often demonstrating demographic imbalance. It is crucial to include individuals from diverse backgrounds on community advisory boards for healthcare and medical research to address ongoing health disparities and ensure studies are more culturally competent so that we can achieve more inclusive representation. We conducted purposeful recruitment to attract a demographically diverse group of community members across the United States (U.S.) to partner with the All of Us Research Program to inform our strategies including program recruitment, engagement, retention, and incentives. Recruitment of a diverse group of advisors and purposeful community building has created a psychologically safe environment where members openly share their opinions, thoughts, and perspectives to shape various aspects of this ambitious, nationwide research program.

NIH/NIGMS-funded IDeA-Clinical and Translational Research (CTR) networks seek to expand translational research infrastructure to support research that has at its endpoints measurable clinical, public health, technological, or economic benefits. This retrospective case study followed 14 projects that received Pilot funding from the Great Plains IDeA-CTR (GP IDeA-CTR) at the University of Nebraska Medical Center. It focuses on the impact of pilot funding and GP IDeA-CTR resources on subsequent clinical and translational research. Metrics include extramural awards, lessons learned that relate to clinical and translational research infrastructure, and demonstrated and potential benefits using the Translational Science Benefits Model (TSBM).

Introduction: Over the last couple of decades, there has been a growing awareness of the value of community-engaged research (CEnR). Simultaneously, many academic institutions have established centralized support for CEnR. For example, dozens of academic medical centers in the United States receive National Institutes of Health (NIH)-funded Clinical and Translational Science Awards (CTSAs) and have embedded community engagement programs (CE) whose primary expertise and mission is to advance CEnR at their institutions.

Methods: As part of a larger interview study aiming to learn more about how institutional CE programs and HRPPs work together, we analyzed interviews with CE program leaders at academic medical centers that receive funding from the NIH CTSA program to identify barriers and strategies to conducting CEnR at their institutions, primarily focusing on the relationships with Institutional Review Boards (IRBs).

Results: We identified three categories in the interviews: barriers and strategies vis-à-vis IRBs to address 1) CE/IRB relationships; 2) Understanding issues; and 3) Structural and resource issues.

Conclusions: CTSA CE program leaders have experience implementing solutions to common barriers to IRB review faced by CEnR researchers. The barriers they face in these three categories and the strategies they use to overcome them can provide helpful insights to others who hope to facilitate CEnR research at their institutions.

Introduction: The respiratory syndrome coronavirus (SARS-CoV-2) has undergone genetic evolution and led to variants of concern that vary in transmissibility and clinical severity.

Methods: This retrospective cohort analysis studied 232,364 hospitalized COVID-19-positive patients in the National COVID Cohort Collaborative [April 27, 2020 and June 25, 2022]. The primary outcomes were to compare demographics and need for mechanical ventilation and 30-day mortality across variants including Alpha (B.1.1.7), Delta (B.1.617.2), and Omicron (B.1.1.529).

Results: The severity of SARS-CoV-2 decreased in the omicron-subsequent wave with decreased utilization of mechanical ventilation and decreased 30-day mortality among patients with comorbidities like diabetes mellitus, obesity, and liver disease. Although with each subsequent wave, the sex distribution remained equal and constant, there was an increase in rates of diabetes, liver disease, and respiratory disease amongst patients hospitalized with COVID-19 over the COVID waves despite the decreasing 30-day mortality and mechanical ventilation.

Conclusions: Despite changes in demographics over time, more recent COVID waves were associated with decreasing severity and mortality. These observations will help guide specific and effective resource allocation and patient care.

Introduction: Children continue to be an underrepresented population in research and clinical trials due to difficulties encountered in recruitment, assenting, and retention processes. "Sofia Learns About Research" is a children's activity book that introduces youth to clinical research and basic elements of clinical trials.

Methods: Development of the activity book began in 2016, with publication of the first paper version in 2017 and an online version adapted for computer and tablet users in 2019. In 2019, we developed internal review board-approved pre/post surveys with five statements (written at ≤ 3^rd-grade level) reflecting key concepts covered in the book. Participants were asked to indicate whether they agreed, disagreed, or were not sure about each of the statements and if they would ever want to be part of a research study. Preliminary analyses included descriptive statistics and cross-tabulations with chi squares.

Results: Despite delays in dissemination and outreach due to the COVID-19 pandemic, we obtained feedback from over 170 diverse persons across a spectrum of communities and community partners. After book exposure, more participants knew that both children and parents have to assent/consent and that participants can withdraw from a study at any time.

Conclusions: The book is an important advocacy tool with a long-term aim of increasing children's knowledge and awareness about clinical research, ultimately leading to enhanced participation in clinical research and trials.

Background and objectives: Sickle cell disease (SCD) is hallmarked by recurrent episodes of severe acute pain and the risk for chronic pain. Remote peer support programs have been shown to effectively improve health outcomes for many chronic conditions. The objective of this study was to examine the feasibility and acceptability of an online peer mentoring program (iPeer2Peer program) for adolescents with SCD.

Method: A waitlist pilot randomized controlled trial was conducted. Adolescents randomized to the intervention group were matched with trained peer mentors (19-25 years; successfully managing their SCD), consisting of up to 10 sessions of approximately 30-min video calls over a 15-week period. The control group received standard care. The primary outcomes were rates of accrual, withdrawal, and adherence to iP2P program/protocol, with secondary outcomes identifying topics of mentorship-mentee conversations through qualitative analysis.

Results: Twenty-eight participants (14 intervention; 14 control) were randomized to the study (mean age: 14.8 ± 1.7 years; 57% female). Accrual rate was 80% (28/35) and withdrawal rate was 18% (5/28), with 28% (4/14) adhering to the iP2P program; however, 71% (10/14) of adolescents in the intervention completed at least one call. Based on content analysis of 75 mentor-mentee calls, three distinct content categories emerged: impact of SCD, self-management, transitioning to adulthood with SCD, and general topics.

Conclusion: The results from this pilot study suggest that the current iteration of the iP2P SCD program lacks feasibility. Future research with the iP2P program can focus improved engagement via personalized mentoring, variable communication avenues, and an emphasis on gender.

[This corrects the article DOI: 10.1017/cts.2023.497.].