Real-world data privacy is a complex yet underexplored topic. To date, few studies have reported adult perspectives around real-world data privacy and willingness to share real-world data with researchers.

Relevant survey items were identified in the literature, adapted and pilot tested among a small convenience sample, and finalized for distribution. The survey was distributed electronically in April 2021 among adults (≥18 years of age) registered in ResearchMatch (www.researchmatch.org). Microsoft Excel was used to assess descriptive statistics across demographical items and four privacy-related items.

Of 402 completed responses received, half of respondents (∼50%) expressed willingness to share their prescription history data and music streaming data with researchers and unwillingness to share real-world data from several other sources. Most (53–93%) of participants expressed concern with five statements reflecting the sharing and use of their digital data online. Most participants (71–75%) agreed with four statements focused on individual measures taken to protect their personal privacy and disagreed (77–85%) with two statements centered on not being concerned about sharing or 3rd party access to their personal data online.

Our observations indicate an important yet unmet need to further explore and address real-world data privacy concerns among US adults engaging as prospective research participants.

This study describes attitudes towards diversity, equity, and inclusion (DEI) among members of the Clinical and Translational Science Awards (CTSA) Program. It also explores associations between program members’ roles and their perceived importance of and commitment to improving DEI and assesses the link between perceived importance of and commitment to improving DEI. Lastly, it ascertains barriers and priorities concerning health equity research, workforce development, CTSA consortium leadership, and clinical trials participation among respondents.

A survey was administered to registrants of the virtual CTSA Program 2020 Fall Meeting. Respondents reported their roles, perceived importance of and commitment to improving DEI. Bivariate cross-tabulations and structural equation modeling examined associations between respondents’ roles, perceived importance of DEI, and commitment to improving DEI. Grounded theory was used to code and analyze open-ended questions.

Among 796 registrants, 231 individuals completed the survey. DEI was “extremely important” among 72.7 percent of respondents and lowest among UL1 PIs (66.7%). Being “extremely committed” to improving DEI was reported by 56.3 percent of respondents and lowest among “other staff” (49.6%). Perceived importance of DEI was positively associated with commitment to improve DEI. Institutional and CTSA Commitment, Support, and Prioritization of DEI represented a key theme for improving DEI among respondents.

Clinical and translational science organizations must take bold steps to transform individual perceptions of DEI into commitment and commitment into action. Institutions must set visionary objectives spanning leadership, training, research, and clinical trials research to meet the promise and benefits of a diverse NIH-supported workforce.

The Food and Drug Administration (FDA) reviews safety, efficacy, and the quality of medical devices through its regulatory process. The FDA Safety and Innovation Act (FDASIA) of 2012 was aimed at accelerating the regulatory process for medical devices.

The purpose of our study was to (1) quantify characteristics of pivotal clinical trials (PCTs) supporting the premarket approval of endovascular medical devices and (2) analyze trends over the last two decades in light of the FDASIA.

We surveyed the study designs of endovascular devices with PCTs from the US FDA pre-market approval medical devices database. The effect of FDASIA on key design parameters (e.g., randomization, masking, and number of enrolled patients) was estimated using an interrupted time series analysis (segmented regression).

We identified 117 devices between 2000–2018. FDASIA was associated with a decrease in double blinding (p < 0.0001) and a decrease in historical comparators (p < 0.0001).

Our results reveal an overall trend of decreased regulatory requirements as it relates to clinical trial characteristics, but a compensatory increased rate of post-approval across device classes. Furthermore, there was an emphasis on proving equivalence or non-inferiority rather than more use of active comparators in clinical trials. Medical device stakeholders, notably clinicians, must be aware of the shifting regulatory landscape in order to play an active role in promoting patient safety.

Little is known about strategies to implement new critical care practices in response to COVID-19. Moreover, the association between differing implementation climates and COVID-19 clinical outcomes has not been examined. The purpose of this study was to evaluate the relationship between implementation determinants and COVID-19 mortality rates.

We used mixed methods guided by the Consolidated Framework for Implementation Research (CFIR). Semi-structured qualitative interviews were conducted with critical care leaders and analyzed to rate the influence of CFIR constructs on the implementation of new care practices. Qualitative and quantitative comparisons of CFIR construct ratings were performed between hospital groups with low- versus high-mortality rates.

We found associations between various implementation factors and clinical outcomes of critically ill COVID-19 patients. Three CFIR constructs (implementation climate, leadership engagement, and engaging staff) had both qualitative and statistically significant quantitative correlations with mortality outcomes. An implementation climate governed by a trial-and-error approach was correlated with high COVID-19 mortality, while leadership engagement and engaging staff were correlated with low mortality. Another three constructs (needs of patient; organizational incentives and rewards; and engaging implementation leaders) were qualitatively different across mortality outcome groups, but these differences were not statistically significant.

Improving clinical outcomes during future public health emergencies will require reducing identified barriers associated with high mortality and harnessing salient facilitators associated with low mortality. Our findings suggest that collaborative and engaged leadership styles that promote the integration of new yet evidence-based critical care practices best support COVID-19 patients and contribute to lower mortality.

This study describes a needs assessment of clinical and translational research (CTR) scientists at a large, distributed, School of Medicine within a public university and affiliated clinics.

We performed an Exploratory Conversion Mixed-Methods analysis using a quantitative survey and qualitative interviews with CTR scientists across the training continuum, from early-career scholars, mid-career mentors, and senior administrators at the University of Wisconsin and Marshfield Clinics. Qualitative findings were confirmed using epistemic network analysis (ENA). A survey was distributed to CTR scientists in training.

Analyses supported that early-career and senior-career scientists have unique needs. Scientists who identified as non-White or female reported needs that differed from White male scientists. Scientists expressed the needs for educational training in CTR, for institutional support of career development, and trainings for building stronger relationships with community stakeholders. The tension between meeting tenure clocks and building deep community connections was particularly meaningful for scholars who identified as under-represented, including based on race, gender, and discipline.

This study yielded clear differences in support needs between scientists based upon their years in research and diversity of identities. The validation of qualitative findings, through quantification with ENA, enables robust identification of unique needs of CTR investigators. It is critically important to the future of CTR that scientists are provided with supports throughout the career. Delivery of that support in efficient and timely ways improves scientific outcomes. Advocacy at the level of the institution for under-represented scientists is of utmost importance.

Studies that measure environmental exposures in biological samples frequently provide participants their results. In contrast, studies using personal air monitors do not typically provide participants their monitoring results. The objective of this study was to engage adolescents who completed personal air sampling and their caregivers to develop understandable and actionable report-back documents containing the results of their personal air sampling.

Adolescents and their caregivers who previously completed personal air sampling participated in focus groups to guide the development of report-back materials. We conducted thematic analyses of focus group data to guide the design of the report-back document and convened experts in community engagement, reporting study results, and human subjects research to provide feedback. Final revisions to the report-back document were made based on follow-up focus group feedback.

Focus groups identified critical components of an air-monitoring report-back document to include an overview of the pollutant being measured, a comparison of individual personal sampling data to the overall study population, a guide to interpreting results, visualization of individual data, and additional information on pollution sources, health risks, and exposure reduction strategies. Participants also indicated their desire to receive study results in an electronic and interactive format. The final report-back document was electronic and included background information, participants’ results presented using interactive maps and figures, and additional material regarding pollution sources.

Studies using personal air monitoring technology should provide research participants their results in an understandable and meaningful way to empower participants with increased knowledge to guide exposure reduction strategies.

A growing number of biomedical doctoral graduates are entering the biotechnology and industry workforce, though most lack training in business practice. Entrepreneurs can benefit from venture creation and commercialization training that is largely absent from standard biomedical educational curricula. The NYU Biomedical Entrepreneurship Educational Program (BEEP) seeks to fill this training gap to prepare and motivate biomedical entrepreneurs to develop an entrepreneurial skill set, thus accelerating the pace of innovation in technology and business ventures.

The NYU BEEP Model was developed and implemented with funding from NIDDK and NCATS. The program consists of a core introductory course, topic-based interdisciplinary workshops, venture challenges, on-line modules, and mentorship from experts. Here, we evaluate the efficacy of the core, introductory course, “Foundations of Biomedical Startups,” through the use of pre/post-course surveys and free-response answers.

After 2 years, 153 participants (26% doctoral students, 23% post-doctoral PhDs, 20% faculty, 16% research staff, 15% other) have completed the course. Evaluation data show self-assessed knowledge gain in all domains. The percentage of students rating themselves as either “competent” or “on the way to being an expert” in all areas was significantly higher post-course (P < 0.05). In each content area, the percentages of participants rating themselves as “very interested” increased post-course. 95% of those surveyed reported the course met its objectives, and 95% reported a higher likelihood of pursuing commercialization of discoveries post-course.

NYU BEEP can serve as a model to develop similar curricula/programs to enhance entrepreneurial activity of early-stage researchers.

Behavioral health treatment disparities by race and ethnicity are well documented across the criminal legal system. Despite criminal legal settings such as drug treatment courts (DTCs) increasingly adopting evidence-based programs (EBPs) to improve care, there is a dearth of research identifying strategies to advance equitable implementation of EBPs and reduce racial/ethnic treatment disparities. This paper describes an innovative approach to identify community- and provider-generated strategies to support equitable implementation of an evidence-based co-occurring mental health and substance use disorder intervention, called Maintaining Independence and Sobriety through Systems Integration, Outreach and Networking-Criminal Justice (MISSION-CJ), in DTCs.

Guided by the Health Equity Implementation Framework, qualitative interviews and surveys will assess factors facilitating and hindering equitable implementation of MISSION-CJ in DTCs among 30 Black/African American and/or Hispanic/Latino persons served and providers. Concept mapping with sixty Black/African American and/or Hispanic/Latino persons served and providers will gather community- and provider-generated strategies to address identified barriers. Finally, an advisory board will offer iterative feedback on the data to guide toolkit development and inform equitable implementation of MISSION-CJ within DTCs.

The paper illustrates a protocol of a study based in community-engaged research and implementation science to understand multilevel drivers of racial/ethnic disparities in co-occurring disorder treatment and identify opportunities for intervention and improvements within criminal legal settings.

The goal of the Patient-Centered Outcomes Research Partnership was to prepare health care professionals and researchers to conduct patient-centered outcomes and comparative effectiveness research (CER). Substantial evidence gaps, heterogeneous health care systems, and decision-making challenges in the USA underscore the need for evidence-based strategies.

We engaged five community-based health care organizations that serve diverse and underrepresented patient populations from Hawai’i to Minnesota. Each partner nominated two in-house scholars to participate in the 2-year program. The program focused on seven competencies pertinent to patient-centered outcomes and CER. It combined in-person and experiential learning with asynchronous, online education, and created adaptive, pragmatic learning opportunities and a Summer Institute. Metrics included the Clinical Research Appraisal Inventory (CRAI), a tool designed to assess research self-efficacy and clinical research skills across 10 domains.

We trained 31 scholars in 3 cohorts. Mean scores in nine domains of the CRAI improved; greater improvement was observed from the beginning to the midpoint than from the midpoint to conclusion of the program. Across all three cohorts, mean scores on 52 items (100%) increased (p ≤ 0.01), and 91% of scholars reported the program improved their skills moderately/significantly. Satisfaction with the program was high (91%).

Investigators that conduct patient-centered outcomes and CER must know how to collaborate with regional health care systems to identify priorities; pose questions; design, conduct, and disseminate observational and experimental research; and transform knowledge into practical clinical applications. Training programs such as ours can facilitate such collaborations.