Defining key barriers to the development of a well-trained clinical research professional (CRP) workforce is an essential first step in identifying solutions for successful CRP onboarding, training, and competency development, which will enhance quality across the clinical and translational research enterprise. This study aimed to summarize barriers and best practices at academic medical centers related to effective CRP onboarding, training, professional development, identify challenges with the assessment of and mentoring for CRP competency growth, and describe opportunities to improve training and professionalization for the CRP career pathway.

Qualitative data from a series of Un-Meeting breakout sessions and open-text survey questions were analyzed to explore the complex issues involved when developing high-quality onboarding and continuing education opportunities for CRPs at academic medical centers.

Results suggest there are several barriers to training the CRP workforce, including balancing foundational onboarding with role-based training, managing logistical challenges and institutional contexts, identifying/enlisting institutional champions, assessing competency, and providing high-quality mentorship. Several of these themes are interrelated. Two universal threads present throughout all themes are the need for effective communication and the need to improve professionalization of the CRP career pathway.

Few institutions have solved all the issues related to training a competent and adaptable CRP workforce, although some have addressed one or more. We applied a socio-technical lens to illustrate our findings and the need for NCATS-funded academic medical centers to work collaboratively within and across institutions to overcome training barriers and support a vital, well-qualified workforce and present several exemplars from the field to help attain this goal.

There is a need for education activities in translational science (TS) that focus on teaching key principles, concepts, and approaches to effectively overcome common scientific and operational bottlenecks in the translational process. Delivering this content to the broad range of individuals interested in advancing translation will help to both expand and develop the TS workforce. Rigorous evaluations will build the evidence base for effective educational approaches for varied audiences.

In 2020, the National Center for Advancing Translational Sciences offered an online case study-based course in TS for students across education and career stages. The course evaluation used baseline and endpoint student surveys to assess satisfaction with the course and impacts of participation on knowledge and attitudes relevant to TS and professional goals.

Of 112 students, 100 completed baseline and/or endpoint surveys, with 66 completing both. Most found the online format (n = 59, 83%) and case study approach (n = 62, 87%) moderately or very effective. There were statistically significant increases in TS knowledge (P < .001) and positive attitudes about team science in translational research (TR) (P < .001). Students reported the course increased their skills and knowledge in cross-disciplinary team science, the process of preclinical and clinical TR, and how their work fits into the translational spectrum, and increased their interest in scientific approaches used in the case study and careers in TS, TR, or team science.

This online case study-based course effectively conveyed TS concepts to students from a range of backgrounds and enhanced their professional interests related to course content.

Dietary approach to stop hypertension (DASH) diet reduces blood pressure (BP) as effectively as one antihypertensive drug, yet its mechanism of action was never fully characterized.

We designed a translational inpatient trial to elucidate the biological pathway leading from nutritional change, through hormonal response, reversal of urine electrolytes ratio, to BP reduction.

A single-center open-label interventional trial. Volunteers were admitted for 14 days, transitioning from an American-style diet to DASH diet. Vital signs, blood, and urine samples were collected daily. Participants completed two 24-hour ambulatory BP measurements (ABPM) and two 24-hour urine collections on days 1 and 10. Nine volunteers completed the protocol. During inpatient stay, serum aldosterone increased from day 0 (mean 8.3 ± 5.0) to day 5 (mean 17.8 ± 5.8) after intervention and decreased on day 11 (mean 11.5 ± 4.7) despite continuous exposure to the same diet (p-value = 0.002). Urine electrolyte ratio ([Na]/[K]) decreased significantly from a mean of 3.5 to 1.16 on day 4 (p < 0.001). BP by 24-hour ABPM decreased by a mean of 3.7 mmHg systolic BP and 2.3 mmHg diastolic BP from day 1 to 10.

Shifting from a high-sodium/low-potassium diet to the opposite composition leads to aldosterone increase and paradoxical BP reduction. Urine electrolyte ratio reflects nutritional changes and should guide clinicians in assessing adherence to lifestyle modification.

The COVID-19 pandemic presented a challenge to established seed grant funding mechanisms aimed at fostering collaboration in child health research between investigators at the University of Minnesota (UMN) and Children’s Hospitals and Clinics of Minnesota (Children’s MN). We created a “rapid response,” small grant program to catalyze collaborations in child health COVID-19 research. In this paper, we describe the projects funded by this mechanism and metrics of their success.

Using seed funds from the UMN Clinical and Translational Science Institute, the UMN Medical School Department of Pediatrics, and the Children’s Minnesota Research Institute, a rapid response request for applications (RFAs) was issued based on the stipulations that the proposal had to: 1) consist of a clear, synergistic partnership between co-PIs from the academic and community settings; and 2) that the proposal addressed an area of knowledge deficit relevant to child health engendered by the COVID-19 pandemic.

Grant applications submitted in response to this RFA segregated into three categories: family fragility and disruption exacerbated by COVID-19; knowledge gaps about COVID-19 disease in children; and optimizing pediatric care in the setting of COVID-19 pandemic restrictions. A series of virtual workshops presented research results to the pediatric community. Several manuscripts and extramural funding awards underscored the success of the program.

A “rapid response” seed funding mechanism enabled nascent academic-community research partnerships during the COVID-19 pandemic. In the context of the rapidly evolving landscape of COVID-19, flexible seed grant programs can be useful in addressing unmet needs in pediatric health.

Following inception in 2005 as a multiregional practice-based research network (PBRN), the “National Dental PBRN” expanded nationwide in 2012, and in 2019 implemented additional organizational changes. The objectives are to: (1) describe the new structure and function of the network; and (2) quantify its scientific productivity since 2005.

A national Administrative and Resource Center is based in Alabama; regional and specialty nodes are based in Alabama, Florida, Illinois, Minnesota, Oregon, New York, and Texas. A Network Coordinating Center is based in Oregon. Studies are funded via investigator-initiated grants. Scientific productivity is assessed using specific metrics, including the Relative Citation Ratio.

To date, 58 studies have been completed or are in data collection or development. These studies have investigated a broad range of topics using a wide variety of study designs. Of the studies that have completed enrollment, 70,665 patients were enrolled, as were 19,827 practitioners (some participated in multiple studies), plus electronic records for 790,493 patients in two data-only studies. To date, these studies have led to 193 peer-reviewed scientific publications in 62 different journals. The mean (1.40) Relative Citation Ratio of Network publications connotes a greater-than-average influence in their fields.

These metrics demonstrate that the PBRN research context can successfully engage practitioners and patients from diverse settings nationally with a high and sustained level of scientific productivity. This infrastructure has enabled clinical scientists in oral health and nonoral health topics and provided additional recruitment venues outside of the typical academic health center research context.

We created a COVID-19 Research Patient and Community Advisory Board (PCAB) to provide patient and community input into clinical and translational research studies. The purpose of this article is to describe the PCAB creation, implementation, and evaluation.

We identified PCAB members who had participated in previous stakeholder engaged activities at our institution and invited their participation. We created a systematic consultation process where researchers could submit plain language research summaries and questions for the PCAB. A facilitated 1-hour virtual consultation was then held where PCAB members provided feedback. We assessed satisfaction of PCAB members and researchers who received consultations using surveys. We also reviewed video recordings of PCAB consultations and reflections from team meetings to identify key lessons learned.

Twenty-seven PCAB members took part in 23 consultation sessions. Twenty-two completed an evaluation survey (81% response rate). Most members agreed or strongly agreed their opinions were valued (86%), it was a productive use of time (86%) and were satisfied (86%). Nineteen researchers completed an evaluation survey (83% response rate). Researchers reported positive experiences of working with the PCAB. Additional insights include limited funding in COVID-19 research for equitable community engagement, deficiencies in researcher communication skills, and a lack of cultural humility incorporated into study activities.

PCAB members provided recommendations that maximized the patient-centeredness and health equity focus of COVID-19 research. The detailed description of the process of developing, implementing, and evaluating our PCAB can be used as a template for others wishing to replicate this engagement model.

Community-based organizations (CBOs) are well-positioned to incorporate research evidence, local expertise, and contextual factors to address health inequities. However, insufficient capacity limits use of evidence-based interventions (EBIs) in these settings. Capacity-building implementation strategies are popular, but a lack of standard models and validated measures hinders progress in the field. To advance the literature, we conducted a comprehensive scoping review.

With a reference librarian, we executed a comprehensive search strategy of PubMed/Medline, Web of Science Core Collection, and EBSCO Global Health. We included articles that addressed implementation science, capacity-building, and CBOs. Of 5527 articles, 99 met our inclusion criteria, and we extracted data using a double-coding process

Of the 99 articles, 47% defined capacity explicitly, 31% defined it indirectly, and 21% did not define it. Common concepts in definitions were skills, knowledge/expertise, and resources. Of the 57 articles with quantitative analysis, 48 (82%) measured capacity, and 11 (23%) offered psychometric data for the capacity measures. Of the 99 studies, 40% focused exclusively on populations experiencing inequities and 22% included those populations to some extent. The bulk of the studies came from high-income countries.

Implementation scientists should 1) be explicit about models and definitions of capacity and strategies for building capacity, 2) specify expected multi-level implementation outcomes, 3) develop and use validated measures for quantitative work, and 4) integrate equity considerations into the conceptualization and measurement of capacity-building efforts. With these refinements, we can ensure that the necessary supports reach CBO practitioners and critical partners for addressing health inequities.

The main objective of this study was to report stress and anxiety levels during the COVID-19 pandemic on early- to mid-career women researchers in healthcare sciences research and determine the associated factors.

A 50-item self-administered internet questionnaire was developed using a mix of Likert-type scales and open-ended response questions. The survey was distributed June 10–August 3, 2020. Anxiety and stress as well as personal/family demands were assessed through validated measures (Patient Reported Outcomes Measurement Information System [PROMIS]-Anxiety Short Form and Perceived Stress Scale [PSS]) and open-ended responses.

One hundred and fifty-one early-career women in healthcare sciences research completed the survey; mean respondent age was 37.3 ± 5.2 years; and all had a college degree or higher, 50.3% holding a PhD and 35.8% MD. Race and ethnicity were reported in 128; the majority were White (74.0%). One-third (31.2%) reported being “very much” concerned about reaching their research productivity goals and 30.1% were “very much” concerned about academic promotion and tenure. Fifty percent reported a “moderate” PROMIS anxiety score and 72.1% reported a “moderate” PSS score. For the open-ended responses, 65.6% reported a worry about their professional goals because of the COVID-19 pandemic. Major concerns revolved around finances, childcare, and job security.

Throughout the pandemic, early- and mid-career women in healthcare sciences research have reported moderate to high overall stress, anxiety, and worries. These concerns appear related to household settings, additional responsibilities, financial concerns, and reduced research productivity. Institutions and funding agencies should take these concerns into consideration and offer support.

Startup companies in the healthcare sector often fail because they lack sufficient entrepreneurial, regulatory, and business development expertise. Maturity models provide useful frameworks to assess the state of business elements more systematically than heuristic assessments. However, previous models were developed primarily to characterize the business state of larger nonmedical companies. A maturity index designed specifically for startup companies in the medical product sector could help to identify areas in which targeted interventions could assist business development.

A novel MedTech Startup Maturity Index (SMI) was developed by a collaborative team of academic and industry experts and refined through feedback from external stakeholders. Pediatric medical device startups associated with the West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) were scored and ranked according to the SMI following semi-structured interviews. The CTIP executive team independently ranked the maturity of each company based on their extensive experiences with the same companies.

SMI scores for 16 companies ranged from 1.2 to 3.8 out of 4. These scores were well aligned with heuristic CTIP rankings for 14 out of 16 companies, reflected by strong correlations between the two datasets (Spearman’s rho = 0.721, P = 0.002, and Kendall’s tau-b = 0.526, P = 0.006).

The SMI yields maturity scores that correlate well with expert rankings but can be assessed without prior company knowledge and can identify specific areas of concern more systematically. Further research is required to generalize and validate the SMI as a pre-/post-evaluation tool.

Implementation Science (IS) is a complex and rapidly evolving discipline, posing challenges for educators. We developed, implemented, and evaluated a novel, pragmatic approach to teach IS.

Getting To Implementation (GTI)-Teach was developed as a seven-step educational model to guide students through the process of developing, conducting, and sustaining an IS research project. During the four-week online course, students applied the steps to self-selected implementation problems. Students were invited to complete two online post-course surveys to assess course satisfaction and self-reported changes in IS knowledge and relevance of GTI-Teach Steps to their work. Results were summarized using descriptive statistics; self-reported post-course changes in IS knowledge were compared using paired t-tests.

GTI-Teach was developed to include seven Steps: 1. Define the implementation problem; 2. Conceptualize the problem; 3. Prioritize implementation barriers and facilitators; 4. Select and tailor implementation strategies; 5. Design an implementation study; 6. Evaluate implementation; 7. Sustain implementation. Thirteen students, ranging in experience from medical students to full professors, enrolled in and completed the first GTI-Teach course. Of the seven students (54%) completing an end-of course survey, six (86%) were very satisfied with the course. Ten students (77%) responded to the tailored, 6-month post-course follow-up survey. They retrospectively reported a significant increase in their knowledge across all steps of GTI-Teach (1.3–1.8 points on a 5-point Likert scale) and rated each of the Steps as highly relevant to their work.

GTI-Teach is a seven-step model for teaching IS fundamentals that students reported increased their knowledge and was relevant to their work.