Journal of Clinical and Translational Science最新文献

A clinical and translational scientist (CTS) often seeks to increase their knowledge of statistical topics to effectively conduct biomedical research studies. A common method for obtaining this knowledge is through existing online educational materials that are suggested by a biostatistical collaborator or identified by the CTS. However, the volume of available educational materials on diverse statistical topics makes the task of identifying high-quality educational resources at an appropriate level challenging and time consuming for CTSs and collaborative biostatisticians. In response to these challenges, the Biostats4You website was created, where existing online educational materials for a variety of statistical topics are vetted to identify those most appropriate for CTSs. In this manuscript, we describe the resource review process, provide information about statistical topics and resources currently available, and make recommendations for how CTSs and collaborative biostatisticians can utilize the Biostats4You website to improve training, mentoring, and collaborative research practices.

Background: Persistent discrimination and identity threats contribute to adverse health outcomes in minoritized groups, mediated by both structural racism and physiological stress responses.

Objective: This study aims to evaluate the feasibility of recruiting African American volunteers for a pilot study of race-based stress, the acceptability of a mindfulness intervention designed to reduce racism-induced stress, and to evaluate preliminary associations between race-based stress and clinical, psychosocial, and biological measures.

Methods: A convenience sample of African Americans aged 18-50 from New York City's Tri-state area underwent assessments for racial discrimination using the Everyday Discrimination Scale (EDS) and Race-Based Traumatic Stress Symptom Scale. Mental health was evaluated using validated clinical scales measuring depression, anxiety, stress, resilience, mindfulness, resilience, sleep, interpersonal connection, and coping. Biomarkers were assessed through clinical laboratory tests, allostatic load assessment, and blood gene expression analysis.

Results: Twenty participants (12 females, 8 males) completed assessments after consent. Elevated EDS scores were associated with adverse lipid profiles, including higher cholesterol/high-density lipoprotein (HDL) ratios and lower HDL levels, as well as elevated inflammatory markers (NF-kB activity) and reduced antiviral response (interferon response factor). Those with high EDS reported poorer sleep, increased substance use, and lower resilience. Mindfulness was positively associated with coping and resilience but inversely to sleep disturbance. 90% showed interest in a mindfulness intervention targeting racism-induced stress.

Conclusions: This study demonstrated an association between discrimination and adverse health effects among African Americans. These findings lay the groundwork for further research to explore the efficacy of mindfulness and other interventions on populations experiencing discrimination.

Electronic health records and patient portals are increasingly utilized to enhance research recruitment efficiency, yet response patterns across patient groups remain unclear. We examined 10 studies at Emory Healthcare that used these tools to identify and recruit 24,000 patients over 1 year. Response rates were lower among males and Black individuals, though study interest was higher among respondents. Interest was also greater among those with frequent healthcare interactions and lower comorbidity. In a large academic health system, portal-based recruitment offered a streamlined approach to research recruitment and patient engagement, with minor variations across patient characteristics warranting continued study.

Clinical research professionals (CRPs) are integral to the academic medical center workforce, research operations, and daily clinical research tasks; however, due to inconsistent training, there is a shortage of qualified CRPs. The Joint Task Force for Clinical Trial Competency created a competency framework for CRPs, which has demonstrated positive results from various institutions, but training programs have been limited in standardization, replicability, and dissemination. To improve this, we designed the University of Texas Southwestern (UTSW) Medical Center Clinical Research Foundations (CRF) training program, which is a competency-based online self-paced CRP training curriculum hosted via the Collaborative Institutional Training Initiative (CITI) portal. We examined feasibility, acceptability, and uptake of the UTSW CRF training on an institutional scale and were pleased to find this curriculum is not only feasible but has high levels of acceptability. Furthermore, faculty, clinicians, and trainees voluntarily completed this training program indicating utility across diverse groups. The UTSW CRF combines the existing CITI training modules with UTSW-created material, providing an optimal balance between generalized clinical research education and institutionally tailored content. We believe the UTSW CRF curriculum could serve as a plug-and-play foundational model for other research centers to tailor according to their audience and institutional needs.

Introduction: Evidence-based interventions (EBIs) exist to increase colorectal cancer (CRC) screening, but implementation remains slow in federally qualified health centers (FQHCs). Assessing organizational readiness can improve EBI implementation outcomes, but no studies have quantitatively examined the relation between organizational readiness subcomponents and implementation outcomes. This study examines associations between readiness subcomponents and CRC screening EBI implementation outcomes in FQHCs.

Methods: We used data from an ongoing parent study to develop an organizational readiness measure using the R = MC² heuristic. We conducted descriptive and cross-sectional analyses using FQHC clinic (n = 57) data across three states. A clinic contact completed a survey about clinic characteristics and then distributed an EBI-specific survey to clinic staff containing readiness and implementation questions about Community Guide EBIs (e.g., patient reminders). Pearson correlations assessed bivariate associations between readiness variables and implementation outcomes. We then computed multivariable linear associations between readiness variables and implementation outcomes while controlling for clinic-level variables. One-way analysis of variance tested group differences in readiness subcomponent mean scores using EBI implementation responses.

Results: Respondents' most common job type was medical assistant, and the most frequently implemented EBIs were provider or patient reminders. Organizational structure was associated with implementing patient reminders. Clinics reporting inconsistent implementation had lower organizational structure scores than clinics planning or fully implementing patient reminders.

Conclusion: This study guides researchers in prioritizing organizational structure and selecting specific implementation strategies to improve this construct to implement CRC screening-related EBIs. Future research should examine these associations using a larger sample size to explore additional relations between organizational readiness and implementation outcomes.

The Students Participating as Ambassadors for Research in Kentucky (SPARK) program provides novel health equity research training and targeted mentorship for undergraduates, particularly those from groups underrepresented in the biomedical and behavioral research and workforce. SPARK aims to address inadequate diversity in the medical and scientific research fields by providing comprehensive research mentorship and skill-building. Unlike most existing research training programs that are brief, focus on laboratory research, or are limited to graduate students and junior faculty, SPARK delivers a 16-month intensive behavioral and population health science training, equipping students with needed tools to conceptualize, plan, execute, and analyze their own health equity research study. Trainees complete didactic coursework on health equity, study design and proposal development, data analysis, and ethics. Students receive a stipend and research expenses, and multiple mentors guide them in creating original research projects for which they serve as Principal Investigator. Students disseminate their findings annually at an academic research conference as a capstone. Evaluation data from the first three cohorts suggest SPARK has been pivotal in preparing students for graduate studies and research careers in health equity and behavioral and population health sciences, providing strong support for further investments in similar undergraduate research training models.

Extant literature reveals how patients of marginalized social identities, socioeconomic status (SES), and medical experiences - especially patients of color and older adults - are underrepresented in cancer clinical trials (CCTs). Emerging evidence increasingly indicates CCT underrepresentation among patients of lower SES or rural origin, sexual and gender minorities, and patients with comorbid disability. This review applies an intersectional perspective to characterizing CCT representativeness across race and ethnicity, age, sexual and gender identity, SES, and disability. Four databases were systematically queried for articles addressing CCT participation inequities across these marginalizing indicators, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. One hundred one articles were included in a qualitative evaluation of CCT representativeness within each target population in the context of their intersectional impacts on participation. Findings corroborate strong evidence of CCT underrepresentation among patients of color, older age, lower SES, rural origin, and comorbid disabling conditions while highlighting systemic limitations in data available to characterize representativeness. Results emphasize how observed inequities interactively manifest through the compounding effects of minoritized social identity, inequitable economic conditions, and marginalizing medical experiences. Recommendations are discussed to more accurately quantify CCT participation inequities across underserved cancer populations and understand their underpinning mechanisms.

The Implementation Science Centers in Cancer Control (ISC3) initiative, funded by the National Cancer Institute, called for the development of implementation laboratories to bolster implementation science, create research-ready environments, and expedite adoption and implementation of evidence-based interventions (EBIs) into practice. The Building Research in Implementation and Dissemination to close Gaps and achieve Equity in Cancer Control (BRIDGE-C2) Center is one of seven ISC3 centers. BRIDGE-C2 aims to identify strategies to improve implementation of cancer prevention EBIs and conduct research / develop pragmatic methods to tailor, enhance, and support the adoption and sustainability of these strategies; advance implementation science; and build capacity and training opportunities. Since its inception, the BRIDGE-C2 Center has been conducting research and training activities to advance knowledge on how to effectively implement strategies to improve cancer prevention EBIs in primary care clinics serving socioeconomically disadvantaged patients. The translational science benefits model (TSBM) provides a useful framework for organizing a description of the BRIDGE-C2 Center's activities. In this paper, we describe examples of BRIDGE-C2 activities and the specific impact indicators within each relevant domain/subdomain of the TSBM, demonstrating that a single activity or project has multiple impacts on methods and capacity building, clinical domains, and community health.

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.

Introduction: Community advisory boards (CABs) are a promising approach for strengthening patient and partner voices in community health center (CHC) evidence-based decision-making. This paper aims to describe how CHCs used CABs during the COVID-19 pandemic to improve the reach of testing among populations experiencing health disparities and identify transferable lessons for future implementation.

Methods: This mixed methods study integrates brief quantitative surveys of community engagement (N = 20) and one-on-one qualitative interviews (N = 13) of staff and community partners engaged in CHC CABs with a cost analysis and qualitative feedback from CHC staff participating in an online learning community (N = 17).

Results: Community partners and staff engaged in the CHC CABs reported high ratings of engagement, with all mean ratings of community engagement principles above a 4 ("very good" or "often") out of 5. Qualitative findings provided a more in-depth understanding of experiences serving on the CHC CAB and highlighted how engagement principles such as trust and mutual respect were reflected in CAB practices. We developed a CHC CAB toolkit with strategies for governance and prioritization, cost estimates to ensure sustainment, guidance on integrating quality improvement expertise, testimonies from community members on the benefits of joining, and template agendas and facilitator training to ensure meeting success.

Conclusion: In alignment with the Translational Science Benefits Model, this study expands research impact through comprehensive mixed methods measurement of community engagement and by transforming findings into an action-orientated guide for CHCs to implement CABs to guide evidence-based decision-making for community and public health impact.