Midcareer is a critical transition point for biomedical research faculty and a common dropout point from an NIH-funded career. We report a study to assess the efficacy of a group peer mentoring program for diverse biomedical researchers in academic medicine, seeking to improve vitality, career advancement, and cross-cultural competence.

We conducted a stratified randomized controlled trial with a waitlist control group involving 40 purposefully diverse early midcareer research faculty from 16 states who had a first-time NIH R01 (or equivalent) award, a K training grant, or a similar major grant. The yearlong intervention (2 to 3 days quarterly) consisted of facilitated, structured, group peer mentoring. Main study aims were to enhance faculty vitality, self-efficacy in achieving research success, career advancement, mentoring others, and cultural awareness and appreciation of diversity in the workplace.

Compared to the control group, the intervention group’s increased vitality did not reach statistical significance (P = 0.20), but perceived change in vitality was 1.47 standard deviations higher (D = 1.47, P = 0.03). Self-efficacy for career advancement was higher in the intervention group (D = 0.41, P = 0.05) as was self-efficacy for research (D = 0.57, P = 0.02). The intervention group also valued diversity higher (D = 0.46, P = 0.02), had higher cognitive empathy (D = 0.85, P = 0.03), higher anti-sexism/racism skills (D = 0.71, P = 0.01), and higher self-efficacy in mentoring others (D = 1.14, P = 0.007).

The mentoring intervention resulted in meaningful change in important dimensions and skills among a national sample of diverse early midcareer biomedical faculty. This mentoring program holds promise for addressing the urgencies of sustaining faculty vitality and cross-cultural competence.

Self-efficacy (or the belief in one’s ability to effect change) often moderates the relationship between education, interest, and actions in evaluations of training programs that prepare community-based investigators in the clinical and translational sciences workforce. Such evaluations, however, tend to emphasize individual-level attitudes when there are also community- or organizational-level outcomes impacted. Methods: This study uses a novel sequential, explanatory mixed-methods design to explore multiple levels of self-efficacy (or self-awareness of personal growth in leadership) in the Clinical Scholars program, an equity-centered leadership development program for mid- to later-career healthcare professionals. Our design involves: (1) bivariate correlations and confirmatory factor analysis of self-assessed competencies across all program participants to identify emergent combinations of competencies, which informed (2) more nuanced thematic coding of participants’ stories of most significant change in their personal and professional lives, as a result of the program. Results: In unpacking their accounts of personal leadership styles (that aligned with our quantitative analyses of competencies), we found that participants demonstrated multiple competencies simultaneously. Specifically, they employed emotionally intelligent learning and consensus-building dialogue to manage conflict for interpersonal impact. Additionally, they used this combination of skills to unite diverse stakeholders under a shared vision in order to lead and manage organizational change where all colleagues’ contributions were valued. Conclusion: Together, these methods extend our understanding of personal growth in leadership as an outcome of the program in terms of individual- and organizational-level impacts, using representative quantitative self-assessments to categorize rich qualitative descriptions.

With persistent incidence, incomplete vaccination rates, confounding respiratory illnesses, and few therapeutic interventions available, COVID-19 continues to be a burden on the pediatric population. During a surge, it is difficult for hospitals to direct limited healthcare resources effectively. While the overwhelming majority of pediatric infections are mild, there have been life-threatening exceptions that illuminated the need to proactively identify pediatric patients at risk of severe COVID-19 and other respiratory infectious diseases. However, a nationwide capability for developing validated computational tools to identify pediatric patients at risk using real-world data does not exist.

HHS ASPR BARDA sought, through the power of competition in a challenge, to create computational models to address two clinically important questions using the National COVID Cohort Collaborative: (1) Of pediatric patients who test positive for COVID-19 in an outpatient setting, who are at risk for hospitalization? (2) Of pediatric patients who test positive for COVID-19 and are hospitalized, who are at risk for needing mechanical ventilation or cardiovascular interventions?

This challenge was the first, multi-agency, coordinated computational challenge carried out by the federal government as a response to a public health emergency. Fifty-five computational models were evaluated across both tasks and two winners and three honorable mentions were selected.

This challenge serves as a framework for how the government, research communities, and large data repositories can be brought together to source solutions when resources are strapped during a pandemic.

Clinical trials are a critical step in the meaningful translation of biomedical discoveries into effective diagnostic and therapeutic interventions. Quality by design (QbD) is a framework for embedding quality into the design, conduct, and monitoring of clinical trials. Here we report the feasibility and acceptability of a process for implementing QbD in clinical research at an academic health center via multidisciplinary design studios aimed at identifying and prioritizing critical to quality (CTQ) factors.

The Clinical Trial Transformation Initiative’s Principles Document served as a guide to identify and categorize key CTQ factors, defined as elements of a clinical trial that are critical to patient safety and data integrity. Individual trials were reviewed in CTQ design studios (CTQ-DS) and the feasibility and acceptability of this intervention was examined through post-meeting interviews and surveys.

Eight clinical research protocols underwent the QbD evaluation process. The protocols ranged from multicenter randomized clinical trials to nonrandomized investigator-initiated studies. A developmental evaluation informed the iterative refinement of the CTQ-DS process, and post-meeting surveys revealed that CTQ-DS were highly valued by principal investigators (PIs) and resulted in multiple protocol changes.

The present study demonstrated that QbD principles can be implemented to inform the design and conduct of clinical research at an academic health center using multidisciplinary design studios aimed at identifying and prioritizing CTQ elements. This approach was well received by the participants including study PIs. Future research will need to evaluate the effectiveness of this approach in improving the quality of clinical research.

Clinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication.

We analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis.

Our analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran’s Administration purview and specific staff in charge of a protocol's review.

We have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.

Zinc and copper are trace elements that have important roles in the function of the immune system. We aimed to compare serum zinc and copper levels in neonates with and without neonatal sepsis.

This case–control study examined 54 newborns with sepsis and 54 matched healthy controls admitted to the neonatal intensive care unit of Children’s Hospital, Bandar Abbas, Iran. Neonates with the diagnosis of sepsis were regarded as cases and those admitted for other reasons were regarded as controls. Maternal and neonatal serum zinc and copper were measured on admission. Copper, zinc, and copper/zinc ratio differences between case and control groups were analyzed.

Neonatal zinc levels were significantly lower in the sepsis group versus controls (88.65 ± 40.64 vs 143.48 ± 69.57μg/dL, p < 0.001). Sepsis group mothers had lower zinc (66.04 vs 83.37μg/dL, p = 0.008) and copper (124.09 vs 157.74μg/dL, p < 0.001). Neonatal copper levels were slightly lower in the sepsis group. Copper/zinc ratio was significantly higher in the sepsis group (p < 0.001). In the sepsis group, the interval to the resolution of sepsis symptoms was significantly shorter in neonates with excess compared to sufficient copper levels (P = 0.023).

Serum copper and zinc levels have an important role in the immune system’s response to the infection. Neonatal serum copper at levels higher than normal can lead to significantly shorter hospital stay. Also, higher Cu/Zn ratios can be found in neonatal sepsis, suggesting the potential utility of this index in the diagnosis of sepsis.

Latinx populations are underrepresented in clinical research. Asking Latinx research participants about their research experiences, barriers, and facilitators could help to improve research participation for these populations.

The Salud Estres y Resilencia (SER) Hispano cohort study is a longitudinal cohort study of young adult Latinx immigrants whose design and conduct were tailored for their study population. We administered the Research Participant Perception Survey (RPPS) to SER Hispano participants to assess their experiences in the study. We describe overall results from the RPPS and compare results of surveys administered to SER Hispano participants via email versus telephone.

Of 340 participants who were contacted with the RPPS, 142 (42%) responded. Among respondents, 53 (37%) responded by initial email contact; and 89 (63%) responded by subsequent phone contact. The majority of respondents were between 35 and 44 years of age (54%), female (76%), and of Cuban origin (50%). Overall, research participants expressed high satisfaction with their research experience; 84% stated that they would “definitely” recommend research participation to friends and family, with no significant difference by method of survey administration (P = 0.45). The most common factor that was chosen that would influence future research participation was having summary results of the research shared with them (72%).

We found that culturally tailored studies can be good experiences for Latinx research participants; and we found that use of the RPPS can be administered successfully, particularly when administered by more than one method, including telephone, to evaluate and to improve research experiences for this population.