Understanding how to translate research discoveries into solutions for healthcare improvement is a priority of NIH-funded Clinical and Translational Science Awards (CTSA). This study, supported by one CTSA, aims to capture one process of shaping and implementing innovations to advance the timeliness and patient-centeredness of cardiovascular care. Specifically, we sought to understand a partnership between a private digital health startup company, a university innovation lab, and an academic health system’s cardiology program pursuing this goal.

The collaboration proceeded through clear phases to address the questions and challenges: problem definition, exploration and formalization of the partnership, innovation co-creation and pilot test, and scale-up planning. Phases were punctuated by key decisions, such as forming the partnership, negotiating terms of the partnership, iterating form and features of the innovation, and exploring sufficiency of its value-add for scale-up and sustainment. Key implementation concepts were apparent, including implementation strategies (e.g., champions and iterative trialing) and the implementation outcomes of acceptability, sustainment, and scale-up. Participants identified potential risks of collaboration, reflected on their co-creation process, and the value of engaging stakeholders in innovation design. Findings may inform subsequent collaborations between innovators and translational researchers.

We conducted a case study to understand the partnership; characterize the questions they pursued, their decision points, information and data sources; and identify the challenges and risks. Data were collected through a series of four focus groups with members of each partnering organization. A transdisciplinary research team iteratively worked to condense and synthesize data from audio recorded transcripts into a case narrative.

Research career development awards (CDAs) facilitate development of clinician-scientists. This study compared the academic achievements of individuals in a structured institutional “pre-K” CDA program, the Mayo Clinic Kern Scholars program, with individuals who applied for but were not admitted to the Kern program (“Kern applicants”), and awardees of other unstructured internal CDAs.

This was a longitudinal cohort study of clinicians engaged in research at Mayo Clinic between 2010 and 2019. The primary outcome was time to the 15th new peer-reviewed publication after the program start, adjusted for baseline number of publications. Secondarily, we described successful awarding of federal funding by the NIH or VA.

The median (IQR) number of baseline publications was highest among Kern Scholars compared to Kern Applicants or other CDA awardees [16 (12, 29) vs 5 (1, 11) and 8 (5, 16); P < 0.001]. After adjustment for baseline publications, the time to 15th new publication was significantly shorter for Kern Scholars than for the two comparator groups (P<0.001). Similar findings were observed with total new publications within 5 years (P < 0.001), as well as number of new first-/last-author publications within 5 years (P < 0.001). The overall frequency of K-awards, R-awards (or equivalent), or any funding were similar between groups, with the exception of R03 awards, which were significantly more common among Kern Scholars (P = 0.002).

The Kern Scholars program is a successful training model for clinician-scientists that demonstrated comparatively greater acceleration of scholarly productivity than other internal CDA programs.

Many Clinical and Translational Science Awards (CTSAs) focus their energy on operational aspects of running their hub, but may not devote enough energy and resources toward branding and effective communication. However, CTSAs have an important mission when it comes to communicating effectively with their stakeholders through social media. Using framing theory as the underpinning, the purpose of this content analysis is to investigate the ways in which CTSAs use Twitter to communicate with their various stakeholders, the type of content they post, and the type of engagement their tweets garner.

We examined 349 tweets posted from January 2019 to January 2020 from 19 CTSA Twitter accounts (sampled from a total of 35 CTSA accounts). A thematic codebook was generated using tweets randomly chosen from the sample. Content analysis was performed on the entire tweet sample by four coders using the codebook (alpha = 0.89).

CTSAs tweeted the most about events (29.8%), and the least about study recruitment (2.01%). Most tweets included images (59.31%) and hashtags (51.29%), but received little user engagement on the average post (average: 4.38 likes and 1.94 retweets). CTSAs tweeted most from 10 a.m. to 12 p.m. PST and received the most engagement. Most CTSAs had a dedicated person (e.g., manager, coordinator) handling their communications.

Our analysis shows multiple opportunities for CTSAs to engage with stakeholders and the public, as well as standardize and improve their Twitter communications to effectively reach a broader audience.

During the COVID-19 pandemic, some K-12 schools resumed in-person classes with varying degrees of mitigation plans in the fall 2020. Physical distancing and face coverings can minimize SARS-CoV-2 spread, the virus that causes COVID-19. However, no research has focused on adherence to mitigation strategies during school days. Thus, we sought to develop a systematic observation protocol to capture COVID-19 mitigation strategy adherence in school environments: The Systematic Observation of COVID-19 Mitigation (SOCOM).

We extended previously validated and internationally used tools to develop the SOCOM training and implementation protocols to assess physical-distancing and face-covering behaviors. SOCOM was tested in diverse indoor and outdoor settings (classrooms, lunchrooms, physical education [PE], and recess) among diverse schools (elementary, secondary, and special needs).

For the unique metrics of physical-distancing and face-covering behaviors, areas with less activity and a maximum of 10–15 students were more favorable for accurately capturing data. Overall proportion of agreement was high for physical distancing (90.9%), face covering (88.6%), activity type (89.2%), and physical activity level (87.9%). Agreement was lowest during active recess, PE, and observation areas with ≥20 students.

Millions of children throughout the USA are likely to return to school in the months ahead. SOCOM is a relatively inexpensive research tool that can be implemented by schools to determine mitigation strategy adherence and to assess protocols that allow students return to school safely and slow the spread of COVID-19.

Understanding, categorizing, and using implementation science theories, models, and frameworks is a complex undertaking. The issues involved are even more challenging given the large number of frameworks and that some of them evolve significantly over time. As a consequence, researchers and practitioners may be unintentionally mischaracterizing frameworks or basing actions and conclusions on outdated versions of a framework.

This paper addresses how the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework has been described, summarizes how the model has evolved over time, and identifies and corrects several misconceptions.

We address 13 specific areas where misconceptions have been noted concerning the use of RE-AIM and summarize current guidance on these issues. We also discuss key changes to RE-AIM over the past 20 years, including the evolution to Pragmatic Robust Implementation and Sustainability Model, and provide resources for potential users to guide application of the framework.

RE-AIM and many other theories and frameworks have evolved, been misunderstood, and sometimes been misapplied. To some degree, this is inevitable, but we conclude by suggesting some actions that reviewers, framework developers, and those selecting or applying frameworks can do to prevent or alleviate these problems.

Interdisciplinary academic teams perform better when competent in teamwork; however, there is a lack of best practices of how to introduce and facilitate the development of effective learning and functioning within these teams in academic environments.

To close this gap, we tailored, implemented, and evaluated team science training in the year-long Engineering Innovation in Health (EIH) program at the University of Washington (UW), a project-based course in which engineering students across several disciplines partner with health professionals to develop technical solutions to clinical and translational health challenges. EIH faculty from the UW College of Engineering and the Institute of Translational Health Sciences’ (ITHS) Team Science Core codeveloped and delivered team science training sessions and evaluated their impact with biannual surveys. A student cohort was surveyed prior to the implementation of the team science trainings, which served as a baseline.

Survey responses were compared within and between both cohorts (approximately 55 students each Fall Quarter and 30 students each Spring Quarter). Statistically significant improvements in measures of self-efficacy and interpersonal team climate (i.e., psychological safety) were observed within and between teams.

Tailored team science training provided to student-professional teams resulted in measurable improvements in self-efficacy and interpersonal climate both of which are crucial for teamwork and intellectual risk taking. Future research is needed to determine long-term impacts of course participation on individual and team outcomes (e.g., patents, start-ups). Additionally, adaptability of this model to clinical and translational research teams in alternate formats and settings should be tested.

Research demonstrates that children receive twice as much medical radiation from Computed Tomography (CT) scans performed at non-pediatric facilities as equivalent CTs performed at pediatric trauma centers (PTCs). In 2014, AFMC outreach staff educated Emergency Department (ED) staff on appropriate CT imaging utilization to reduce unnecessary medical radiation exposure. We set out to determine the educational campaign’s impact on injured children received radiation dose.

All injured children who underwent CT imaging and were transferred to a Level I PTC during 2010 to 2013 (pre-campaign) and 2015 (post-campaign) were reviewed. Patient demographics, mode of transportation, ED length of stay, scanned body region, injury severity score, and trauma center level were analyzed. Median effective radiation dose (ERD) controlled for each variable, pre-campaign and post-campaign, was compared using Wilcoxon rank sum test.

Three hundred eighty-five children under 17 years were transferred from 45 and 48 hospitals, pre- and post-campaign. Most (43%) transferring hospitals were urban or critical access hospitals (30%). Pre- and post-campaign patient demographics were similar. We analyzed 482 and 398 CT scans pre- and post-campaign. Overall, median ERD significantly decreased from 3.80 to 2.80. Abdominal CT scan ERD declined significantly from 7.2 to 4.13 (P-value 0.03). Head CT scan ERD declined from 3.27 to 2.45 (P-value < 0.0001).

A statewide, CT scan educational campaign contributed to ERD decline (lower dose scans and fewer repeat scans) among transferred injured children seen at PTCs. State-level interventions are feasible and can be effective in changing radiology provider practices.

Human-centered design (HCD) training offers the potential to improve both team processes and products. However, the use of HCD to improve the quality of team science is a relatively recent application, and its benefits and challenges have not been rigorously evaluated. We conducted a qualitative study with health sciences researchers trained in HCD methods. We aimed to determine how researchers applied HCD methods and perceived the benefits and barriers to using HCD on research teams.

We conducted 1-hour, semi-structured interviews with trainees from three training cohorts. Interviews focused on perceptions of the training, subsequent uses of HCD, barriers and facilitators, and perceptions of the utility of HCD to science teams. Data analysis was conducted using Braun and Clarke’s process for thematic analysis.

We interviewed nine faculty and nine staff trained in HCD methods and identified four themes encompassing HCD use, benefits, challenges, and tensions between HCD approaches and academic culture.

Trainees found HCD relevant to research teams for stakeholder engagement, research design, project planning, meeting facilitation, and team management. They also described benefits of HCD in five distinct areas: creativity, egalitarianism, structure, efficiency, and visibility. Our data suggest that HCD has the potential to help researchers work more inclusively and collaboratively on interdisciplinary teams and generate more innovative and impactful science. The application of HCD methods is not without challenges; however, we believe these challenges can be overcome with institutional investment.

Clinical and Translational Science Award Program (CTSA)-funded institutions were charged with developing clinical and translational science programs and transforming clinical research at their institutions. Community engagement (CE) was recognized as a key component and catalyst of that transformation. CE hub capacities for working with communities and translating knowledge into practice have been illustrated through their COVID-19 responses.

CE hub leaders met and discussed their CTSA’s early responses regarding the COVID-19 pandemic. The 2-hour discussion was distilled into themes which were sent to the CE hub leaders with a request for written accounts describing actions taken to engage local partners, communities, and institutions. The written reports form the basis for this compendium.

Eighteen institutions submitted written reports describing activities in relation to six themes: (1) listen to the community and respond to concerns, (2) collect data to understand the impact of COVID-19 on distinct communities and groups, (3) communicate science and address misinformation, (4) collaborate with health departments, (5) engage hubs and underrepresented populations in COVID-19 research, and (6) support our own well-being and that of others.

Bidirectional interactions comprise the foundation of CE, which requires trusted partnerships that sustain communication through a series of activities and goals. The nimble responses to the pandemic substantiate the need for CE programs to maintain the infrastructure necessary to achieve the primary CTSA goals of improving health within and across communities and localities as well as expanding research participation of community members.

Barriers to research participation by racial and ethnic minority group members are multi-factorial, stem from historical social injustices and occur at participant, research team, and research process levels. The informed consent procedure is a key component of the research process and represents an opportunity to address these barriers. This manuscript describes the development of the Strengthening Translational Research in Diverse Enrollment (STRIDE) intervention, which aims to improve research participation by individuals from underrepresented groups.

We used a community-engaged approach to develop an integrated, culturally, and literacy-sensitive, multi-component intervention that addresses barriers to research participation during the informed consent process. This approach involved having Community Investigators participate in intervention development activities and using community engagement studios and other methods to get feedback from community members on intervention components.

The STRIDE intervention has three components: a simulation-based training program directed toward clinical study research assistants that emphasizes cultural competency and communication skills for assisting in the informed consent process, an electronic consent (eConsent) framework designed to improve health-related research material comprehension and relevance, and a “storytelling” intervention in which prior research participants from diverse backgrounds share their experiences delivered via video vignettes during the consent process.

The community engaged development approach resulted in a multi-component intervention that addresses known barriers to research participation and can be integrated into the consent process of research studies. Results of an ongoing study will determine its effectiveness at increasing diversity among research participants.

To study the effectiveness of any educational intervention for faculty requires first that they attend the training. Using attendance as a measure of faculty engagement, this study examined factors associated with the percentage of faculty in divisions of departments of medicine who attended a workshop as part of a multisite study.

Between October 2018 and March 2020, 1675 of 4767 faculty in 120 divisions of 14 departments of medicine attended a 3-hour in-person workshop as part of the Bias Reduction in Internal Medicine (BRIM) initiative. This paper describes the workshop development and study design. The number of faculty per division ranged from 5 to 296. Attendance rates varied from 2.7% to 90.1%. Taking a quality improvement approach, the study team brainstormed factors potentially related to variations in workshop attendance, constructed several division- and institution-level variables, and assessed the significance of factors on workshop attendance with hierarchical linear models.

The following were positively associated with workshop attendance rate: the division head attended the workshop, the BRIM principal investigator gave Medical Grand Rounds, and the percentage of local workshop presenters who completed training. Workshop attendance rates fell when departments identified more than five on-site study leaders.

Factors associated with higher workshop attendance may have increased the perceived status and value of attending the workshop, leading faculty to choose the workshop over other competing demands. For future investigators studying educational interventions that require participation of faculty in clinical departments at multiple sites, this work offers several valuable lessons.

Controlled clinical trials (CCTs) have traditionally been limited to urban academic clinical centers. Implementation of CCTs in rural setting is challenged by lack of resources, the inexperience of patient care team members in CCT conductance and workflow interruption, and global inexperience with remote data monitoring.

We report our experience during the coronavirus disease 2019 (COVID-19) pandemic in activating through remote monitoring a multicenter clinical trial (the Study of Efficacy and Safety of Canakinumab Treatment for cytokine release syndrome (CRS) in Participants with COVID-19-induced Pneumonia [CAN-COVID] trial, ClinicalTrials.gov Identifier: NCT04362813) at a rural satellite hospital, the VCU Health Community Memorial Hospital (VCU-CMH) in South Hill, VA, that is part of the larger VCU Health network, with the lead institution being VCU Health Medical College of Virginia Hospital (VCU-MCV), Richmond, VA. We used the local resources at the facility and remote guidance and oversight from the VCU-MCV resources using a closed-loop communication network. Investigational pharmacy, pathology, and nursing were essential to operate the work in coordination with the lead institution.

Fifty-one patients with COVID-19 were enrolled from May to August 2020, 35 (69%) at VCU-MCV, and 16 (31%) at VCU-CMH. Among the patients enrolled at VCU-CMH, 37.5% were female, 62.5% Black, and had a median age of 60 (interquartile range 56–68) years.

Local decentralization of this trial in our experience gave rural patients access to a novel treatment and also accelerated enrollment and more diverse participants’ representative of the target population.

The use of online platforms for pediatric healthcare research is timely, given the current pandemic. These platforms facilitate trial efficiency integration including electronic consent, randomization, collection of patient/family survey data, delivery of an intervention, and basic data analysis.

We created an online digital platform for a multicenter study that delivered an intervention for sleep disorders to parents of children with autism spectrum disorder (ASD). An advisory parent group provided input. Participants were randomized to receive either a sleep education pamphlet only or the sleep education pamphlet plus three quick-tips sheets and two videos that reinforced the material in the pamphlet (multimedia materials). Three measures – Family Inventory of Sleep Habits (FISH), Children’s Sleep Habits Questionnaire modified for ASD (CSHQ-ASD), and Parenting Sense of Competence (PSOC) – were completed before and after 12 weeks of sleep education.

Enrollment exceeded recruitment goals. Trial efficiency was improved, especially in data entry and automatic notification of participants related to survey completion. Most families commented favorably on the study. While study measures did not improve with treatment in either group (pamphlet or multimedia materials), parents reporting an improvement of ≥3 points in the FISH score showed a significantly improved change in the total CSHQ (P = 0.038).

Our study demonstrates the feasibility of using online research delivery platforms to support studies in ASD, and more broadly, pediatric clinical and translational research. Online platforms may increase participant inclusion in enrollment and increase convenience and safety for participants and study personnel.