The glucocorticoid receptor (GR) is a key receptor involved in inflammatory responses and is influenced by sex steroids. This study measured GR expression on circulating leukocyte subtypes in males and females.

A total of 23 healthy adults (12 female) participated in this study. GR expression was measured in leukocyte subtypes using flow cytometry. Peripheral blood mononuclear cell (PBMC) gene expression of GR (NR3C1), GR β, TGF-β1 and 2, and glucocorticoid-induced leucine zipper (GILZ) were determined by real-time polymerase chain reaction.

Leukocyte GR was lower in females, particularly in granulocytes, natural killer cells, and peripheral blood mononuclear cells (p≤0.01). GR protein expression was different across leukocyte subtypes, with higher expression in eosinophils compared with granulocytes, T lymphocytes, and natural killer cells (p<0.05). There was higher gene expression of GR β in males (p=0.03).

This is the first study to identify sexual dimorphism in GR expression in healthy adults using flow cytometry. These results may begin to explain the sexual dimorphism seen in many diseases and sex differences in glucocorticoid responsiveness.

A new competency-based job framework was implemented for clinical research professionals at a large, clinical research-intensive academic medical center. This study evaluates the rates of turnover before and after implementation of the new framework. Turnover in this workforce (as with most) is costly; it contributes to wasted dollars and lost productivity since these are highly specialized positions requiring extensive training, regardless of experience in the field.

Trends in employee turnover for 3 years prior to and after the implementation of competency-based job framework for clinical research positions were studied using human resources data. Employee demographics, turnover rates, and comparisons to national statistics are summarized.

Employee turnover within the clinical research professional jobs has decreased from 23% to 16%, a 45% reduction, since the implementation of competency-based job framework.

The new jobs and career ladders, both of which are centered on a competency-based framework, have decreased the overall turnover rate in this employee population. Since little is known about the rates of turnover in clinical research, especially in the academic medical setting, the results of this analysis can provide important insights to other academic medical centers on both employee turnover rate in general and the potential impact of implementing large-scale competency-based job changes.

Electronic health record (EHR) data have emerged as an important resource for population health and clinical research. There have been significant efforts to leverage EHR data for research; however, given data security concerns and the complexity of the data, EHR data are frequently difficult to access and use for clinical studies. We describe the development of a Clinical Research Datamart (CRDM) that was developed to provide well-curated and easily accessible EHR data to Duke University investigators.

The CRDM was designed to (1) contain most of the patient-level data elements needed for research studies; (2) be directly accessible by individuals conducting statistical analyses (including Biostatistics, Epidemiology, and Research Design (BERD) core members); (3) be queried via a code-based system to promote reproducibility and consistency across studies; and (4) utilize a secure protected analytic workspace in which sensitive EHR data can be stored and analyzed. The CRDM utilizes data transformed for the PCORnet data network, and was augmented with additional data tables containing site-specific data elements to provide additional contextual information.

We provide descriptions of ideal use cases and discuss dissemination and evaluation methods, including future work to expand the user base and track the use and impact of this data resource.

The CRDM utilizes resources developed as part of the Clinical and Translational Science Awards (CTSAs) program and could be replicated by other institutions with CTSAs.

Research organizations face challenges in creating infrastructures that cultivates and sustains interdisciplinary team science. The objective of this paper is to identify structural elements of organizations and training that promote team science.

We qualitatively analyzed the National Institutes of Health’s Building Interdisciplinary Research Careers in Women’s Health, K12 using organizational psychology and team science theories to identify organizational design factors for successful team science and training.

Seven key design elements support team science: (1) semiformal meta-organizational structure, (2) shared context and goals, (3) formal evaluation processes, (4) meetings to promote communication, (5) role clarity in mentoring, (6) building interpersonal competencies among faculty and trainees, and (7) designing promotion and tenure and other organizational processes to support interdisciplinary team science.

This application of theory to a long-standing and successful program provides important foundational elements for programs and institutions to consider in promoting team science.

Translating research findings into practice requires understanding how to meet communication and dissemination needs and preferences of intended audiences including past research participants (PSPs) who want, but seldom receive, information on research findings during or after participating in research studies. Most researchers want to let others, including PSP, know about their findings but lack knowledge about how to effectively communicate findings to a lay audience.

We designed a two-phase, mixed methods pilot study to understand experiences, expectations, concerns, preferences, and capacities of researchers and PSP in two age groups (adolescents/young adults (AYA) or older adults) and to test communication prototypes for sharing, receiving, and using information on research study findings.

PSP and researchers agreed that sharing study findings should happen and that doing so could improve participant recruitment and enrollment, use of research findings to improve health and health-care delivery, and build community support for research. Some differences and similarities in communication preferences and message format were identified between PSP groups, reinforcing the best practice of customizing communication channel and messaging. Researchers wanted specific training and/or time and resources to help them prepare messages in formats to meet PSP needs and preferences but were unaware of resources to help them do so.

Our findings offer insight into how to engage both PSP and researchers in the design and use of strategies to share research findings and highlight the need to develop services and support for researchers as they aim to bridge this translational barrier.

Prior to the COVID pandemic, many CTSAs employed face-to-face interactions to conduct most of their community engagement (CE) activities. During the COVID pandemic, such engagement had to be curtailed and alternatives needed to be formulated. In addition, Community Engaged Research (CEnR) teams refocused their efforts to address this public health crisis.

To obtain a general understanding of how CTSAs have conducted CE and CEnR during the COVID pandemic, we invited seven CTSA CE leaders to provide brief field reports of their activities during the pandemic. This included how their approaches to CE and CEnR were modified during the COVID-19 pandemic and key lessons learned.

We found that despite numerous challenges, all seven CTSAs CE cores were able to successfully carry out CE and CEnR. We also found that the fundamental principles of meaningful and authentic stakeholder engagement were of paramount importance during the pandemic. Through virtual approaches, all sites had considerable success in maintaining CE in during the COVID pandemic. They also leveraged existing bi-directional community partnerships to carry out meaningful and impactful research. This included both new COVID CEnR and also innovative approaches to sustain prior non-COVID research.

These findings suggest that academic-community partnerships must be fostered and sustained over the many years so that when such crises emerge, all partners can build on existing trust and mutual respect. The lessons learned and the new tools and approaches developed would be key in addressing any such future public health emergencies.

Research mentor training is a valuable professional development activity. Options for training customization (by delivery mode, dosage, content) are needed to address the many critical attributes of effective mentoring relationships and to support mentors in different institutional settings.

We conducted a pilot randomized controlled trial to evaluate a hybrid mentor training approach consisting of an innovative, 90-minute, self-paced, online module (Optimizing the Practice of Mentoring, OPM) followed by workshops based on the Entering Mentoring (EM) curriculum. Mentors (n = 59) were randomized to intervention or control arms; the control condition was receipt of a two-page mentoring tip sheet. Surveys (pre, post, 3-month follow up) and focus groups assessed training impact (self-appraised knowledge, skills, behavior change) and participants’ perceptions of the blended training model.

The intervention (∼6.5 hours) produced significant improvements in all outcomes, including skills gains on par with those reported previously for the 8-hour EM model. Knowledge gains and intention-to-change mentoring practices were realized after completion of OPM and augmented by the in-person sessions. Mentors valued the synergy of the blended learning format, noting the unique strengths of each modality and specific benefits to completing a foundational online module before in-person engagement.

Findings from this pilot trial support the value of e-learning approaches, both as standalone curricula or as a component of hybrid implementation models, for the professional development of research mentors.

Mentorship is critical for faculty success, satisfaction, and engagement. However, many faculty, particularly underrepresented racial/ethnic (UR) faculty, lack access to high-quality mentoring. In an effort to improve mentoring for all faculty, we developed and implemented a formally structured faculty mentor training program (FMTP) across UC San Diego Health Sciences, which included institutional support, mentorship training, and department/division mentorship programs.

FMTP impact was evaluated using three primary outcome variables: mentoring quality, mentoring behaviors, and institutional climate. Participants’ self-assessed mentoring competencies were measured using validated instruments.

A total of 391 (23%) of Health Sciences faculty participated in FMTP. Participation rate was higher for women than men (30% versus 17%) and highest for UR faculty (39%). FMTP was implemented in 16 of 19 departments. Self-reported mentoring improved for FMTP participants with mentoring quality (p = 0.009) and meeting mentees’ expectations (p = 0.01) continuing to improve for up to 2 years after training. However, participants were unsure if they were meeting UR mentees’ expectations. FMTP participants were significantly more satisfied with mentoring quality (p < 0.001) compared to non-participants, with the greatest increase in satisfaction reported by UR faculty (38–61%). UR faculty reported improved overall morale (51–61%) and a perception that the environment was supportive for UR faculty (48–70%).

The implementation of a system-wide formal structured FMTP was associated with improved faculty satisfaction, quality of mentoring, and institutional climate, especially for UR faculty.

Many institutions are attempting to implement patient-reported outcome (PRO) measures. Because PROs often change clinical workflows significantly for patients and providers, implementation choices can have major impact. While various implementation guides exist, a stepwise list of decision points covering the full implementation process and drawing explicitly on a sociotechnical conceptual framework does not exist.

To facilitate real-world implementation of PROs in electronic health records (EHRs) for use in clinical practice, members of the EHR Access to Seamless Integration of Patient-Reported Outcomes Measurement Information System (PROMIS) Consortium developed structured PRO implementation planning tools. Each institution pilot tested the tools. Joint meetings led to the identification of critical sociotechnical success factors.

Three tools were developed and tested: (1) a PRO Planning Guide summarizes the empirical knowledge and guidance about PRO implementation in routine clinical care; (2) a Decision Log allows decision tracking; and (3) an Implementation Plan Template simplifies creation of a sharable implementation plan. Seven lessons learned during implementation underscore the iterative nature of planning and the importance of the clinician champion, as well as the need to understand aims, manage implementation barriers, minimize disruption, provide ample discussion time, and continuously engage key stakeholders.

Highly structured planning tools, informed by a sociotechnical perspective, enabled the construction of clear, clinic-specific plans. By developing and testing three reusable tools (freely available for immediate use), our project addressed the need for consolidated guidance and created new materials for PRO implementation planning. We identified seven important lessons that, while common to technology implementation, are especially critical in PRO implementation.

Dissemination of results to research participants is largely missing from the practices of most researchers. Few resources exist that describe best practices for disseminating information to this important stakeholder group.

Four focus groups were conducted with a diverse group of individuals. All participants were part of a Patient-Centered Outcomes Research Institute-funded survey study. Focus groups aimed to identify participants’ preferences about receiving research results and their reactions to three different dissemination platforms.

Four focus groups with 37 participants were conducted, including: (1) adults with one comorbidity, at least a college education, and high socioeconomic status (SES); (2) adults with one comorbidity, less than a college education, and lower SES; (3) adults with low health literacy and/or numeracy; and (4) Black or African American adults. Participants discussed their preferences for research results delivery and how each of the platforms met those preferences. This included information needs as they relate to content and scope, including a desire to receive both individual and aggregate results, and study summaries. Email, paper, and website were all popular avenues of presentation. Some desired a written summary, and others preferred videos or visual graphics. Importantly, participants emphasized the desire for having a choice in the timing, frequency, and types of results.

Research participants prefer to receive research results, including study impact and key findings, disseminated to them in an engaging format that allows choice of when and how the information is presented. The results encourage new standards whereby research participants are considered a critical stakeholder group.

The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.

In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.

This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.

We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.