Journal of Clinical and Translational Science最新文献

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

Introduction: Local context is the most common concern regarding use of a single institutional review board (sIRB). Yet what "local context" constitutes remains underspecified. Developing a shared understanding of the goals of local context review, the categories of information that should be considered, as well as the types of studies for which sIRB review may be inappropriate, are critical for ensuring that sIRB review provides adequate protections for human subjects.

Methods: We conducted a three-round modified Delphi process convening individuals with expertise in the conduct and oversight of multisite research. Delphi surveys explored: (1) the goals of local context review; (2) the types of information that should be considered; and (3) study types that should be exempted from sIRB requirements.

Results: Twenty-one experts participated. Experts agreed that (1) local context review should aim to both protect local participants and ensure compliance and (2) that four types of information should be considered (population/participant-level characteristics; investigator and research team characteristics; institution-level characteristics; and state and local laws). There was less consensus about whether existing processes facilitated adequate consideration of this information. Experts agreed that exemptions from sIRB requirements should be permitted but disagreed about when and in what circumstances.

Conclusion: There is overlapping consensus about both the goals of local context review and the types of information that should be assessed. Future work remains, however, to develop effective processes to best realize the goals of local context review - and do so with appropriate efficiency.

Multi-site and multi-organizational teams are increasingly common in epidemiologic research; however, there is a lack of standards or best practices for achieving success in collaborative research networks in epidemiology. We summarize our experiences and lessons learned from the Diabetes Location, Environmental Attributes, and Disparities (LEAD) Network, a collaborative agreement between the Centers for Disease Control and Prevention and research teams at Drexel University, New York University, Johns Hopkins University and Geisinger, and the University of Alabama at Birmingham. We present a roadmap for success in collaborative epidemiologic research, with recommendations focused on the following areas to maximize efficiency and success in collaborative research agreements: 1) operational and administrative considerations; 2) data access and sharing of sensitive data; 3) aligning network research aims; 4) harmonization of methods and measures; and 5) dissemination of findings. Future collaborations can be informed by our experiences and ultimately dedicate more resources to achieving scientific aims and efficiently disseminating scientific work products.

To evaluate the design of I-Corps@NCATS as a translational scientist training program, we mapped specific elements of the program's content and pedagogy to the characteristics of a translational scientist, as first defined by Gilliland et al. []: systems thinker, process innovator, boundary spanner, team player, and skilled communicator. Using a mixed-methods evaluation, we examined how the I-Corps@NCATS training program, delivered across twenty-two Clinical and Translational Science Award Hubs, impacted the development of these key translational scientist characteristics.

Methods: We developed survey items to assess the characteristics of systems thinker, process innovator, boundary spanner, team player, and skilled communicator. Data were collected from a national sample of 281 participants in the I-Corps@NCATS program. Using post-then-retrospective-pre survey items, participants self-reported their ability to perform skills associated with each of the translational scientist characteristics. Additionally, two open-ended survey questions explored how the program shifted participants' translational orientation, generating 211 comments. These comments were coded through a team-based, iterative process.

Results: Respondents reported the greatest increases in self-assessed abilities related to systems thinking and skilled communication. Participants indicated the highest levels of abilities related to team player and boundary crosser. From the coding of open-ended comments, we identified two additional characteristics of translational scientists: intellectual humility and cognitive flexibility.

Conclusions: Participation in I-Corps@NCATS accelerates translational science in two ways: 1) by teaching the process of scientific translation from research ideas to real-world solutions, and 2) by encouraging growth in the mindset and characteristics of a translational scientist.

Participant representation, including the Good Participatory Practice guidelines, in the design and execution of clinical research can profoundly affect research structure and process. Early in the COVID-19 pandemic, an online registry called the Healthcare Worker Exposure Response and Outcomes (HERO) Registry, was launched to capture the experiences of healthcare workers (HCWs) on the pandemic frontlines. It evolved into a program that distributed COVID-19-related information and connected participants with COVID-19-related research opportunities. Furthermore, a subcommittee of HCWs was created to inform the COVID-19-related clinical research, engagement, and communication efforts. This paper, coauthored by the HERO HCW subcommittee, describes how it was formed, the impact of community participation on the HERO Registry and Research Program, reflections on lessons learned, and implications for future research. Engagement of the HCW Subcommittee resulted in representing their lived experience and ensured that their perspectives as HCWs were incorporated into the HERO Research. The strategies not only supported recruitment and retention efforts but also influenced the HERO research team in framing research questions and data collection pertinent to the participant community. This experience demonstrated the importance of having participants' input as expert advisors to an investigative team in their research efforts during a global health emergency.

Introduction: Translational science rarely addresses the needs of rural communities, perpetuating health inequities. Furthermore, policy and resource allocation reflect this dynamic. Through a partnership between a rural community and a community engagement program, the Rural Health Initiative (RHI) was developed with the goal of building capacity for community-driven translational research in rural settings.

Methods: We describe the process of forming the RHI and selection of a community health priority to motivate the translational research agenda in this particular rural setting. We used a mixed methods approach utilizing literature review, community survey data, and qualitative evaluation of community meeting discussions. Consensus on a final health priority was built through voting and comparison of voting responses across the three RHI counties through Fisher's Exact test.

Results: Four priority topics were identified through literature search, community needs assessment, state/national trend data, and community experts. Priority ranking from a community forum and survey selected the final health priority topic. Healthcare access was selected by all three counties in the RHI community as the most critical health priority to address.

Conclusions: This program highlights the importance of and methods for community involvement in directing the research conducted in their community. Additionally, through this project, guidance was developed to define the role of community engagement programs supporting work led by communities.

There is a growing trend for studies run by academic and nonprofit organizations to have regulatory submission requirements. As a result, there is greater reliance on REDCap, an electronic data capture (EDC) widely used by researchers in these organizations. This paper discusses the development and implementation of the Rapid Validation Process (RVP) developed by the REDCap Consortium, aimed at enhancing regulatory compliance and operational efficiency in response to the dynamic demands of modern clinical research. The RVP introduces a structured validation approach that categorizes REDCap functionalities, develops targeted validation tests, and applies structured and standardized testing syntax. This approach ensures that REDCap can meet regulatory standards while maintaining flexibility to adapt to new challenges. Results from the application of the RVP on recent successive REDCap software version releases illustrate significant improvements in testing efficiency and process optimization, demonstrating the project's success in setting new benchmarks for EDC system validation. The project's community-driven responsibility model fosters collaboration and knowledge sharing and enhances the overall resilience and adaptability of REDCap. As REDCap continues to evolve based on feedback from clinical trialists, the RVP ensures that REDCap remains a reliable and compliant tool, ready to meet regulatory and future operational challenges.

Introduction: Older age significantly increases risk for cognitive decline. A growing number of older adults (≥ 65 years) experience cognitive decline that compromises immediate and/or long-term health. Interventions to mitigate cognitive decline are greatly needed. Intermittent fasting aligned with innate circadian rhythms is associated with health benefits and improved circadian rhythms; here, we explore impacts on cognition and cardiometabolic outcomes.

Methods: We conducted a single-group, pre-/post-pilot study to explore an 8-week prolonged nightly fasting intervention (14 h fasting/night) among adults 65+ years with self-reported memory decline. We explored changes in cognitive function, insomnia, and cardiometabolic risk factors. Intervention engagement/adherence were assessed. The intervention was delivered fully remotely; participants completed their fasting protocol at home and were not required to come into the lab.

Results: In total, 20 individuals signed consent and 18 participants completed the study. Participants were mean age 69.7 years, non-Hispanic White (89%), predominantly female (95%), married (50%), and employed (65%). Paired t-tests indicated an increase in cognitive function (Memory and Attention Phone Screener) (p = 0.02) with a medium effect size (Cohen's d = 0.58) and a decrease in insomnia (Insomnia Severity Index) (p = 0.04) with a medium effect size (Cohen's d = 0.52). Changes in BMI or diet quality were not observed. Engagement (66%-77%) and adherence (70%-100%) were high.

Conclusion: These pilot findings suggest that prolonged nightly fasting, targeted to align food intake with circadian rhythms, may improve cognitive function and sleep among older adults. Fully powered, randomized controlled trials to test the efficacy of this non-pharmacological, low cost-to-burden ratio intervention are needed.

Introduction: The continued momentum toward equity-based, patient/community-engaged research (P/CenR) is pushing health sciences to embrace principles of community-based participatory research. Much of this progress has hinged on individual patient/community-academic partnered research projects and partnerships with minimal institutional support from their academic health institutions.

Methods: We partnered with three academic health institutions and used mixed methods (i.e., institution-wide survey (n = 99); qualitative interviews with institutional leadership (n = 11); and focus group discussions (6 focus groups with patients and community members (n = 22); and researchers and research staff (n = 9)) to gain a deeper understanding of the institutional context.

Results: Five key themes emerged that were supported by quantitative data. First, the global pandemic and national events highlighting social injustices sparked a focus on health equity in academic institutions; however, (theme 2) such a focus did not always translate to support for P/CenR nor align with institutional reputation. Only 52% of academics and 79% of community partners believed that the institution is acting on the commitment to health equity (Χ² = 6.466, p < 0.05). Third, institutional structures created power imbalances and community mistrust which were identified as key barriers to P/CenR. Fourth, participants reported that institutional resources and investments are necessary for recruitment and retention of community-engaged researchers. Finally, despite challenges, participants were motivated to transform current paradigms of research and noted that accountability, communication, and training were key facilitators.

Conclusions: Triangulating findings from this mixed-methods study revealed critical barriers which provide important targets for interventions to improving supportive policies and practices toward equity-based P/CenR.