As clinical trials adopt remote methodologies, there is need to optimize efficiency of remote enrollment. Within a remote clinical trial, we aim to (1) assess if sociodemographic factors differ among those consenting via mail vs. technology-based procedures (e-consent), (2) determine if, among those consenting via mail, a small unconditional monetary reward ($5) increases likelihood of subsequent enrollment, (3) economically evaluate additional cost per additional participant enrolled with $5 reward.

In the parent nationwide randomized clinical trial of adult smokers (N = 638), participants could enroll via mail or e-consent. Logistic regression models assessed relationships between sociodemographics and enrollment via mail (vs e-consent). Mailed consent packets were randomized (1:4) to include $5 unconditional reward or not, and logistic regression modeling examined impact of reward on subsequent enrollment, allowing for a randomized study within a study. Incremental cost-effectiveness ratio analysis estimated additional cost per additional participant enrolled with $5 incentive.

Older age, less education, lower income, and female sex predicted enrolling via mail vs e-consent (p < .05’s). In adjusted model, older age (AOR = 1.02, p = .016) and less education (AOR = 2.23, p < .001) remained predictive of mail enrollment. The $5 incentive (vs none) increased enrollment rate by 9% (AOR = 1.64, p = .007), with estimated cost of additional $59 per additional participant enrolled.

As e-consent methods become more common, they have potential to reach many individuals but with perhaps diminished inclusion across all sociodemographic groups. Provision of an unconditional monetary incentive is possibly a cost-effective mechanism to increase recruitment efficiency for studies employing mail-based consenting procedures.

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.

Integrating social and environmental determinants of health (SEDoH) into enterprise-wide clinical workflows and decision-making is one of the most important and challenging aspects of improving health equity. We engaged domain experts to develop a SEDoH informatics maturity model (SIMM) to help guide organizations to address technical, operational, and policy gaps.

We established a core expert group consisting of developers, informaticists, and subject matter experts to identify different SIMM domains and define maturity levels. The candidate model (v0.9) was evaluated by 15 informaticists at a Center for Data to Health community meeting. After incorporating feedback, a second evaluation round for v1.0 collected feedback and self-assessments from 35 respondents from the National COVID Cohort Collaborative, the Center for Leading Innovation and Collaboration’s Informatics Enterprise Committee, and a publicly available online self-assessment tool.

We developed a SIMM comprising seven maturity levels across five domains: data collection policies, data collection methods and technologies, technology platforms for analysis and visualization, analytics capacity, and operational and strategic impact. The evaluation demonstrated relatively high maturity in analytics and technological capacity, but more moderate maturity in operational and strategic impact among academic medical centers. Changes made to the tool in between rounds improved its ability to discriminate between intermediate maturity levels.

The SIMM can help organizations identify current gaps and next steps in improving SEDoH informatics. Improving the collection and use of SEDoH data is one important component of addressing health inequities.

Physician-scientists have long been in high demand owing to their role as key drivers of biomedical innovation, but their dwindling prevalence in research and medical communities threatens ongoing progress. As the principal avenue for physician-scientist development, combined MD–PhD training programs and NIH-funded Medical Scientist Training Programs (MSTPs) must address all aspects of career development, including grant writing skills.

The NIH F-series grants – the F30 grant in particular – model the NIH format of federal funding, and are thus ideal opportunities to acquire biomedical research grant preparation experience. Therefore, in this report, we describe a curricular model through which predoctoral MSTP students obtain exposure to – and training for – F-series grant conceptualization, writing, and evaluation.

Since the development of these longitudinal courses, we observed trending improvements in student funding success rates, particularly among original submissions, and perceived benefits among participating students.

The Clinical and Translational Science Awards (CTSA) Consortium, a network of academic health care institutions with CTSA hubs, is charged with improving the national clinical and translational research enterprise. The CTSA Consortium and the NIH National Center for Advancing Translational Sciences implemented the Common Metrics Initiative comprised of standardized metrics and a shared performance improvement framework. This article summarizes hubs’ perspectives on its value during the initial implementation.

The value was assessed across 58 hubs. Survey items assessed change in perceived ability to manage performance and advance clinical and translational science. Semi-structured interviews elicited hubs’ perspectives on meaningfulness and value-added of the Common Metrics Initiative and hubs’ recommendations.

Hubs considered their abilities to manage performance to have improved, but there was no change in perceived ability to advance clinical and translational science. The initiative added value by providing a formal structured process, enabling strategic conversations, facilitating improvements in processes, providing an external impetus for improvement, and providing justification for funds invested. Hubs were concerned about the usefulness of the metrics chosen and whether the value-added was sufficient relative to the effort required. Hubs recommended useful benchmarking, disseminating best practices and promoting peer-to-peer learning, and expanding the use of data to inform the initiative.

Implementing Common Metrics and a performance improvement framework yielded concrete short-term benefits, but concerns about usefulness remained, particularly considering the effort required. The Common Metrics Initiative should focus on facilitating cross-hub collaboration around metrics that address high-priority impact areas for individual hubs and the Consortium.

The COVID-19 pandemic had an abrupt impact on patient-oriented research early in the pandemic. CTSA Clinical Research Centers (CRCs) rapidly adapted to this challenge, but the continued impact of later phases of the pandemic on CRC operations is not clear.

An online REDCap survey of CTSA CRCs was developed that covered the first 2 years of the pandemic. The survey focused on impact on CRC functions, mitigation strategies, recovery of CRC activities, CRC contributions to COVID-related research, and potential lessons for future public health emergencies. The survey was sent to CRC directors at 61 CTSA Hubs in May 2022.

Twenty-seven Hubs (44%) responded to the survey. Most CRCs reported greater than 50% declines in inpatient census in the first year of the pandemic, with less severe impacts on outpatient census. CRCs pivoted to support COVID-related research and adopted innovative technology-driven approaches to support clinical research. Census improved in the second year of the pandemic in most CRCs but often remained below pre-pandemic levels, and greater than half of CRCs reported decreased revenue.

CTSA-supported CRCs faced unprecedented challenges at the onset of the COVID-19 pandemic and responded rapidly to support COVID-related research and implement innovative approaches that allowed patient-oriented research activities to resume. However, many CRCs continued to report decreased research activities in the second year of the pandemic, and the long-term effects on CRC operations on finances are not clear. CRCs will likely need to evolve to provide support in nontraditional ways.

Research shows incentives can motivate faculty to increase their engagement in mentoring, despite a myriad of institutional barriers. One such incentive may be the implementation of a university-wide mentor award program to promote a culture of mentorship.

A new mentorship award was created at a research-intensive university and faculty recipients were surveyed to assess their perceptions of the award’s impact on their mentoring practices and career.

Sixty-two percent of awardees (n=21) completed the survey and felt the recognition incentivized them to engage in further mentoring and participate in formal mentorship training. Most awardees referenced the award in their CVs, performance evaluations, and grant proposals. Additionally, they felt the award effectively promoted mentoring among the broader faculty community.

Growth of clinical and translational research depends in part on the mentorship received by early career faculty. Therefore, other research universities may benefit from implementing such awards.

Because a primary focus of Centers of Biomedical Research Excellence (COBRE) is the development of junior-level investigators into competent and successful research scientists, evaluation of their skills, mentoring experiences, and usefulness of COBRE services is paramount to the transition of the Center to a self-sustaining, collaborative, multidisciplinary research environment. A formative evaluation, focused on the processes of a COBRE, was undertaken and is presented here.

Two instruments, one for completion by junior investigators and one for completion by mentors, were developed for the purpose of evaluating this COBRE. Areas of inquiry were relationships between junior investigators and mentors, research self-efficacy, mentee progress, and satisfaction with the COBRE. All eight of the COBRE’s current junior investigators and six of their mentors completed the online questionnaires.

Junior investigators were very positive about mentors and vice versa. Junior investigators were least positive about their progress as academicians and most positive about their abilities to develop collaborations with other scholars/professionals. Mentors felt as though junior investigators could benefit most by increasing the number of publications they had generated.

Activities provided by the CardioPulmonary Vascular Biology (CPVB) COBRE were extremely positive. Junior investigators felt as though the scientific, academic, and professional development opportunities afforded by this COBRE were integral to their success as researchers; however they would like more assistance developing professional networks (i.e., serving on committees of professional societies). Leadership of the CPVB COBRE may consider expanding the role of their advisory committee to ensure these opportunities are provided.

Social determinants of health (SDoH), such as socioeconomics and neighborhoods, strongly influence health outcomes. However, the current state of standardized SDoH data in electronic health records (EHRs) is lacking, a significant barrier to research and care quality.

We conducted a PubMed search using “SDOH” and “EHR” Medical Subject Headings terms, analyzing included articles across five domains: 1) SDoH screening and assessment approaches, 2) SDoH data collection and documentation, 3) Use of natural language processing (NLP) for extracting SDoH, 4) SDoH data and health outcomes, and 5) SDoH-driven interventions.

Of 685 articles identified, 324 underwent full review. Key findings include implementation of tailored screening instruments, census and claims data linkage for contextual SDoH profiles, NLP systems extracting SDoH from notes, associations between SDoH and healthcare utilization and chronic disease control, and integrated care management programs. However, variability across data sources, tools, and outcomes underscores the need for standardization.

Despite progress in identifying patient social needs, further development of standards, predictive models, and coordinated interventions is critical for SDoH-EHR integration. Additional database searches could strengthen this scoping review. Ultimately, widespread capture, analysis, and translation of multidimensional SDoH data into clinical care is essential for promoting health equity.

Shared patient–clinician decision-making is central to choosing between medical treatments. Decision support tools can have an important role to play in these decisions. We developed a decision support tool for deciding between nonsurgical treatment and surgical total knee replacement for patients with severe knee osteoarthritis. The tool aims to provide likely outcomes of alternative treatments based on predictive models using patient-specific characteristics. To make those models relevant to patients with knee osteoarthritis and their clinicians, we involved patients, family members, patient advocates, clinicians, and researchers as stakeholders in creating the models.

Stakeholders were recruited through local arthritis research, advocacy, and clinical organizations. After being provided with brief methodological education sessions, stakeholder views were solicited through quarterly patient or clinician stakeholder panel meetings and incorporated into all aspects of the project.

Participating in each aspect of the research from determining the outcomes of interest to providing input on the design of the user interface displaying outcome predications, 86% (12/14) of stakeholders remained engaged throughout the project. Stakeholder engagement ensured that the prediction models that form the basis of the Knee Osteoarthritis Mathematical Equipoise Tool and its user interface were relevant for patient–clinician shared decision-making.

Methodological research has the opportunity to benefit from stakeholder engagement by ensuring that the perspectives of those most impacted by the results are involved in study design and conduct. While additional planning and investments in maintaining stakeholder knowledge and trust may be needed, they are offset by the valuable insights gained.

Experimental evidence is needed to evaluate interventions that curtail burnout for physical therapists. The goal of this research was to assess the impact of mindfulness-based training (MBT) on the well-being of physical therapists. We hypothesized physical therapists would demonstrate greater work engagement, empathy, and job satisfaction, and lower depression, anxiety, stress, and moral distress following MBT.

Thirteen physical therapists (10 female/3 male; 35.38 ± 9.32 years old) completed this two-arm embedded mixed-methods pilot study. The control group (n = 4) was followed while the intervention group (n = 9) completed six MBT sessions over 3 months. Sessions were assigned a representative topic area (meaning in physical therapy, situational- and self-awareness, compassion fatigue/burnout, implicit biases, establishing boundaries and managing conflict, self-care) with relevant reflective writing, small group discussions, and mindfulness strategies. Non-parametric statistics compared quantitative outcomes across and within groups, and a thematic framework matrix was established by way of qualitative description for data analysis.

Physical therapists in the intervention group had improved pre- to post-scores for work engagement, mental health, and moral distress (p ≤ 0.043). Inability to effect change contributed to compassion fatigue/burnout, whereas difficulty prioritizing self/limited personal time impeded self-care. “I realized how easy it is to get caught up in life and in helping out those around you, you completely forget to take time to check in with how you are doing (Physical Therapist 3).”

Implementing an MBT program demonstrates promise and may benefit the well-being of physical therapists while simultaneously enhancing employee retention and improving patient care.