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

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).

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.

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.

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

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.

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.

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.

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.

We conducted a scoping review of peer-reviewed literature to describe the nature and extent of reporting on the involvement of stakeholders in early-stage translational research.

We conducted two literature searches in six databases, screened records and full-text articles, and abstracted and analyzed data from included publications. The literature searches yielded unduplicated 2,894 records. After screening, 13 articles were included.

Our review of the literature yielded rare reports of engagement in early-stage translational research. Half of included articles reported on engagement with patients, clinicians, and researchers while fewer that one in three reported on engagement with policymakers, industry, and insurers. One in four reported engagement in the publication’s acknowledgments but not in the main text. More than half drew unmeasured conclusions about the outcomes of engagement.

Our definition of early-stage translation pointed to a specific set of peer-reviewed research; our findings indicate a reporting gap and not necessarily a gap in practice. By addressing four themes–developing a shared language, identifying frameworks and principles, creating a repository of resources, and establishing a research agenda, research leaders can develop new insights about how to engage communities in early-stage translational research.

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.

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.

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.

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.

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.

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).

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.

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.

Managing clinical trials is a complex process requiring careful integration of human, technology, compliance, and operations for success. We collaborated with experts to develop a multi-axial Clinical Trials Management Ecosystem (CTME) maturity model (MM) to help institutions identify best practices for CTME capabilities.

A working group of research informaticists was established. An online session on maturity models was hosted, followed by a review of the candidate domain axes and finalization of the axes. Next, maturity level attributes were defined for min/max levels (level 1 and level 5) for each axis of the CTME MM, followed by the intermediate levels. A REDCap survey comprising the model’s statements was then created, and a subset of working group members tested the model by completing it at their respective institutions. The finalized survey was distributed to all working group members.

We developed a CTME MM comprising five maturity levels across 11 axes: study management, regulatory and audit management, financial management, investigational product management, subject identification and recruitment, subject management, data, reporting analytics & dashboard, system integration and interfaces, staff training & personnel management, and organizational maturity and culture. Informaticists at 22 Clinical and Translational Science Award hubs and one other organization self-assessed their institutional CTME maturity. Respondents reported relatively high maturity for study management and investigational product management. The reporting analytics & dashboard axis was the least mature.

The CTME MM provides a framework to research organizations to evaluate their current clinical trials management maturity across 11 axes and identify areas for future growth.

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.

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.

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.

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.

Preoperative anxiety is a common phenomenon affecting 60–80% of surgical patients, with potential implications for surgical outcomes. Despite its prevalence, there remains a lack of consensus on its precise effects and optimal management strategies.

This meta-analysis aimed to synthesize current evidence on the impact of preoperative anxiety on various surgical outcomes, including anesthetic and analgesic requirements, delirium, recovery times, and pain.

We conducted a comprehensive literature search and meta-analysis of studies examining the relationship between preoperative anxiety and surgical outcomes. Standardized mean differences (SMD), correlation (COR), and odds ratios (OR) with 95% confidence intervals were calculated.

Our analysis revealed significant associations between preoperative anxiety and increased anesthetic requirements (SMD = 0.67, 95% CI: 0.32–1.01) and analgesic requirements (SMD = 0.89, 95% CI: 0.65–1.12). Preoperative anxiety was associated with postoperative delirium in adults (OR = 1.90, 95% CI: 1.11–3.26), unlike the pediatric population. Preoperative anxiety was associated with prolonged time to reach Modified Aldrete Score of 9 (SMD = 0.79, 95% CI: 0.50–1.07) and extubation time (SMD = 0.89, 95% CI: 0.58–1.21). Preoperative anxiety was positively correlated with propofol consumption (STAI-S COR = 0.35, 95%CI: 0.15–0.55). No significant association between preoperative anxiety and postoperative pain was found.

This meta-analysis provides evidence for the wide-ranging effects of preoperative anxiety on surgical outcomes. The findings emphasize the need for routine preoperative anxiety screening and the development of targeted interventions. Future research should focus on long-term impacts and the effectiveness of various anxiety management strategies.

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.

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 ≤ 3rd-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.

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.

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.