The partnership between a research community engagement team (CE Team) and a community advisory board (CAB) formed the basis for bidirectional communication in developing resources for participant recruitment in a DNA integrity study. Engaging with a minoritized community, this partnership focused on respect, accessibility, and expanded engagement.

A ten-member CAB, working in two groups defined by meeting time convenience, provided insight and feedback to the CE Team in the creation of recruitment and consent materials, via an iterative design process in which one CAB group reviewed and enhanced materials, and the second group tested and refined them further. The continuous analysis of CE Team notes from CAB meetings captured information needed both for materials refinement and implementation of CAB-suggested activities.

The partnership resulted in the co-creation of recruitment and consent materials that facilitated the enrollment of 191 individuals into the study. The CAB encouraged and assisted in expanded engagement inclusive of community leaders. This broader engagement provided information about the DNA integrity study to community decision-makers as well as responded to questions and concerns about the research. The bidirectional communication between the CAB and the CE Team encouraged the researchers to consider topics and research interests related to the current study but also responsive to community concerns.

The CAB helped the CE Team develop a better understanding of the language of partnership and respect. In this way, the partnership opened doors for expanded community engagement and effective communication with potential study participants.

In 2017, the Michigan Institute for Clinical and Health Research (MICHR) and community partners in Flint, Michigan collaborated to launch a research funding program and evaluate the dynamics of those research partnerships receiving funding. While validated assessments for community-engaged research (CEnR) partnerships were available, the study team found none sufficiently relevant to conducting CEnR in the context of the work. MICHR faculty and staff along with community partners living and working in Flint used a community-based participatory research (CBPR) approach to develop and administer a locally relevant assessment of CEnR partnerships that were active in Flint in 2019 and 2021.

Surveys were administered each year to over a dozen partnerships funded by MICHR to evaluate how community and academic partners assessed the dynamics and impact of their study teams over time.

The results suggest that partners believed that their partnerships were engaging and highly impactful. Although many substantive differences between community and academic partners’ perceptions over time were identified, the most notable regarded the financial management of the partnerships.

This work contributes to the field of translational science by evaluating how the financial management of community-engaged health research partnerships in a locally relevant context of Flint can be associated with these teams’ scientific productivity and impact with national implications for CEnR. This work presents evaluation methods which can be used by clinical and translational research centers that strive to implement and measure their use of CBPR approaches.

More complex research questions are being posed in early-phase oncology clinical trials, necessitating design strategies tailored to contemporary study objectives. This paper describes the proposed design of a Phase I trial concurrently evaluating the safety of a hematopoietic progenitor kinase-1 inhibitor (Agent A) as a single agent and in combination with an anti-PD-1 agent in patients with advanced malignancies. The study’s primary objective was to concurrently determine the maximum tolerated dose (MTD) of Agent A with and without anti-PD-1 therapy among seven possible study dose levels.

Our solution to this challenge was to apply a continual reassessment method shift model to meet the research objectives of the study.

The application of this method is described herein, and a simulation study of the design’s operating characteristics is conducted. This work was developed through collaboration and mentoring between the authors at the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO) annual AACR/ASCO Methods in Clinical Cancer Research Workshop.

The aim of this manuscript is to highlight examples of novel design applications as a means of augmenting the implementation of innovative designs in the future and to demonstrate the flexibility of adaptive designs in satisfying modern design conditions. Although the design is presented using an investigation of Agent A with and without anti-PD-1 therapy as an illustrative example, the approach described is not specific to these agents and could be applied to other concurrent monotherapy and combination therapy studies with well-defined binary safety endpoints.

To identify associations between demographics, social determinants of health, health conditions, and reported history of insomnia. A cross-sectional study including 11,960 adult community members recruited through HealthStreet, a community outreach program at University of Florida.

Health assessments were conducted via interviews. Participants reported their demographic background, level of social support, history of health conditions, and insomnia. Logistic regression was used to understand associations between risk factors and history of insomnia.

The prevalence of self-reported insomnia was 27.3%. Adults aged ≥ 65 years (OR = 1.16) and women (OR = 1.18) reported higher rates of insomnia than their counterparts. Black/African American individuals reported lower rates of insomnia (OR = 0.72) than White individuals. Individuals with food insecurity (OR = 1.53), a military history (OR = 1.30), lower social support (OR = 1.24), living alone (OR = 1.14), anxiety (OR = 2.33), cardiometabolic disease (OR = 1.58), and attention-deficit hyperactivity disorder (ADHD) (OR = 1.44) were significantly more likely to endorse insomnia compared with their counterparts. Depression (OR = 2.57) had the strongest association with insomnia.

This study provides evidence regarding who is at greater risk for insomnia among a large community-based sample. Our findings highlight the importance of screening for insomnia, particularly among patients who experience food insecurity, are military veterans, have anxiety, depression, ADHD, or cardiometabolic disease, as well as those who live alone or have lower levels of social support. Future public health campaigns should provide education on insomnia symptoms, treatments, and evidenced-based sleep-promotion strategies.

Electronic health record (EHR) data have many quality problems that may affect the outcome of research results and decision support systems. Many methods have been used to evaluate EHR data quality. However, there has yet to be a consensus on the best practice. We used a rule-based approach to assess the variability of EHR data quality across multiple healthcare systems.

To quantify data quality concerns across healthcare systems in a PCORnet Clinical Research Network, we used a previously tested rule-based framework tailored to the PCORnet Common Data Model to perform data quality assessment at 13 clinical sites across eight states. Results were compared with the current PCORnet data curation process to explore the differences between both methods. Additional analyses of testosterone therapy prescribing were used to explore clinical care variability and quality.

The framework detected discrepancies across sites, revealing evident data quality variability between sites. The detailed requirements encoded the rules captured additional data errors with a specificity that aids in remediation of technical errors compared to the current PCORnet data curation process. Other rules designed to detect logical and clinical inconsistencies may also support clinical care variability and quality programs.

Rule-based EHR data quality methods quantify significant discrepancies across all sites. Medication and laboratory sources are causes of data errors.

To assess the proportion of inpatients who received guideline-concordant antibiotics for community-acquired bacterial pneumonia (CABP) in special populations of the All of Us database.

CABP contributes significantly to healthcare burden worldwide. The American Thoracic Society and Infectious Disease Society of America jointly published guidelines for the treatment of CABP. Guideline-concordant antibiotics for CABP are associated with better patient and cost outcomes.

This was a retrospective cohort study of patients with pneumonia (n = 1608; SNOMED 233604007) from 10/1/2018 to 1/01/22 in the All of Us database. Cases were excluded for treatment setting other than inpatient, prior (within 90 days) pneumonia, receipt of intravenous antibiotics, respiratory isolation of methicillin-resistant Staphylococcus aureus (MRSA) or Pseudomonas aeruginosa, and/or other non-community-acquired types of pneumonia. Patients were grouped based on patient age, sex, race, and ethnicity. The proportion of patients on guideline-concordant therapy was compared within groups using chi-square statistics. Significant associations were assessed using multivariate logistic regression models.

A total of 1608 cases were included, and 45% of these patients received guideline-concordant antibiotics. Non-Hispanic White (NHW) patients vs. Black patients were associated with a 36% higher likelihood for receiving guideline-concordant antibiotics (adjusted OR, 1.36; 95% CI 1.02–1.81), whereas NHW vs. Hispanic patients were associated with a 34% lower likelihood for receiving guideline-concordant antibiotics (aOR 0.66; 0.48–0.91).

Black patients with CABP in the All of Us database were less likely to receive guideline-concordant antibiotics, and Hispanic patients were more likely to receive guideline-concordant antibiotics, than NHW patients.

Nearly 70% of faculty experience very high levels of stress. Integrative Nurse Coaching (INC) can help by assisting clients in establishing goals and embarking on new lifestyle behaviors that help to decrease perceived stress, achieve work life integration, and enhance life satisfaction. Our goal was to evaluate a faculty coaching and fellowship program to support faculty well-being while developing innovation competency.

We employed an INC paradigm to coach five faculty to build confidence and competence in innovation and enhance well-being. We offered monthly group and individual coaching and used a qualitative research thematic analysis to determine themes important for the fellow and group experiences, identify outcomes, and create recommendations for the future.

We identified the following themes as outcomes for our program: (1) enhanced connection, comradery, and support; (2) increased confidence and competence in navigating academia; (3) shift from a fixed mindset to an innovation mindset; and (4) increased ability to identify and manage stress and burnout. Fellows also experienced a shift from focusing on individual needs to addressing the needs of the community at the college.

Nurse coaching is an effective strategy to address faculty stress and burnout. Additional research is needed to evaluate the Innovation for Well-being faculty fellowship program and its impact on the academic community.

High writing self-efficacy and self-regulation are tied to publication and grant submission. Writers with these attributes are more productive. We investigated whether participating in a Shut Up & Write!®-style intervention (SUAW) would produce statistically significant gains in writing self-efficacy and self-regulation when comparing pre-post-participation surveys.

Forty-seven medical students, TL1/KL2, and early-career faculty from across the USA expressed interest in participating, with 37 completing the pre-survey. We conducted (on Zoom) a 12-week SUAW series and measured the effect using a pre-post survey adapted from the Writer Self-Perception Scale. Paired t-tests (α = 0.05) were conducted on three subscales to test for significant differences between pre- and post-test means. The subscales reflected writing attitudes, writing strategies, and avoiding writing distractions. Subscales showed acceptable internal consistency with Cronbach’s alphas of 0.80, 0.71, and 0.72, respectively.

Twenty-seven participants attended at least one session. Of these, 81% presented as female, and 60% were from NIH-defined Underrepresented Backgrounds and/or were from Minority-Serving Institutions. Twenty-four completed both the pre- and post-surveys. Sixty percent previously participated in an activity similar to SUAW. We found significant improvements in writing attitudes (p = 0.020) and writing strategies (p = 0.041) for those who previously participated. For those who had not previously participated, we found improved writing strategies (p = 0.002). Eighty percent were very satisfied/satisfied with SUAW.

Researchers have tied writing self-efficacy and self-regulation to timely publication and grant submission. We found significant gains in self-efficacy and self-regulation, suggesting that participation in a SUAW-style intervention may increase writing productivity.