To quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations.

Over 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies.

Staffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process.

Understanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.

Increasing interest in real-world evidence has fueled the development of study designs incorporating real-world data (RWD). Using the Causal Roadmap, we specify three designs to evaluate the difference in risk of major adverse cardiovascular events (MACE) with oral semaglutide versus standard-of-care: (1) the actual sequence of non-inferiority and superiority randomized controlled trials (RCTs), (2) a single RCT, and (3) a hybrid randomized-external data study.

The hybrid design considers integration of the PIONEER 6 RCT with RWD controls using the experiment-selector cross-validated targeted maximum likelihood estimator. We evaluate 95% confidence interval coverage, power, and average patient time during which participants would be precluded from receiving a glucagon-like peptide-1 receptor agonist (GLP1-RA) for each design using simulations. Finally, we estimate the effect of oral semaglutide on MACE for the hybrid PIONEER 6-RWD analysis.

In simulations, Designs 1 and 2 performed similarly. The tradeoff between decreased coverage and patient time without the possibility of a GLP1-RA for Designs 1 and 3 depended on the simulated bias. In real data analysis using Design 3, external controls were integrated in 84% of cross-validation folds, resulting in an estimated risk difference of –1.53%-points (95% CI –2.75%-points to –0.30%-points).

The Causal Roadmap helps investigators to minimize potential bias in studies using RWD and to quantify tradeoffs between study designs. The simulation results help to interpret the level of evidence provided by the real data analysis in support of the superiority of oral semaglutide versus standard-of-care for cardiovascular risk reduction.

The field of dissemination and implementation science has the potential to narrow the translational research-to-practice gap and improve the use of evidence-based practices (EBPs) within community-based settings. Yet, foundational research related to dissemination efforts, such as understanding researcher attitudes, practices, and the determinants to sharing research findings, is lacking within extant literature.

A sequential explanatory (QUAN $$ \to $$ qual) mixed methods design was used to examine 85 academic researchers’ perspectives and self-reported dissemination methods used to share research outcomes with community stakeholders to better understand researcher’s usual dissemination practices (referred to as dissemination-as-usual). Quantitative surveys collected researcher demographic data, attitudes toward dissemination efforts, and dissemination strategy use.

Multiple linear regression examined predictors of the quantity of dissemination strategies utilized by researchers, finding that years since earning their degree, time spent disseminating, and the number of reasons for engaging in dissemination efforts predicted greater numbers of dissemination strategies utilized by researchers. Individual, semi-structured interviews with a subset of researchers (n = 18) expanded upon quantitative findings, identifying barriers and facilitators to their dissemination efforts. Data strands were integrated using a joint display, and the Dissemination of Research model guided data interpretation. More established researchers experienced fewer barriers and more facilitators to support their use of a variety of dissemination strategies to share findings with community stakeholders. However, researchers reported needing specific training, institutional support, and/or dedicated time to plan and enact dissemination strategies.

The necessary first step in research translation is the dissemination of research evidence, and understanding dissemination-as-usual can identify areas of need to advance translational science.

Community stakeholders often participate in community research training curricula development. There is limited information describing how their input informs curricula. This paper describes input solicitation methods, input received, and examples of its integration.

From June 2014 to June 2016, community members (CMs) and community-based organizations (CBOs) guided curricula development tailored for CMs and CBOs, respectively. Engagement methods included a strategic planning retreat, surveys, a listening session, workgroup meetings, and community engagement studios. Descriptive statistics were used to summarize survey input. For other methods, input was extracted and compiled from facilitator notes.

CMs (n=37) and CBOs (n=83) providing input included patients and caregivers and advocacy, community service, and faith-based organizations, respectively. The major feedback categories were training topic priorities, format (e.g., face-to-face vs. online), logistics (e.g., training frequency), and compensation (e.g., appropriateness). Input directly guided design of CBO and CM curricula (e.g., additional time devoted to specific topics based on feedback) or helped to finalize logistics.

Multiple quantitative and qualitative methods can be used to elicit input from community stakeholders to inform the development of community research training curricula. This input is essential for the development of training curricula that are culturally relevant and acceptable.

The Clinical and Translational Science Awards (CTSA) Consortium, about 60 National Institutes of Health (NIH)-supported CTSA hubs at academic health care institutions nationwide, is charged with improving the clinical and translational research enterprise. Together with the NIH National Center for Advancing Translational Sciences (NCATS), the Consortium implemented Common Metrics and a shared performance improvement framework.

Initial implementation across hubs was assessed using quantitative and qualitative methods over a 19-month period. The primary outcome was implementation of three Common Metrics and the performance improvement framework. Challenges and facilitators were elicited.

Among 59 hubs with data, all began implementing Common Metrics, but about one-third had completed all activities for three metrics within the study period. The vast majority of hubs computed metric results and undertook activities to understand performance. Differences in completion appeared in developing and carrying out performance improvement plans. Seven key factors affected progress: hub size and resources, hub prior experience with performance management, alignment of local context with needs of the Common Metrics implementation, hub authority in the local institutional structure, hub engagement (including CTSA Principal Investigator involvement), stakeholder engagement, and attending training and coaching.

Implementing Common Metrics and performance improvement in a large network of research-focused organizations proved feasible but required substantial time and resources. Considerable heterogeneity across hubs in data systems, existing processes and personnel, organizational structures, and local priorities of home institutions created disparate experiences across hubs. Future metric-based performance management initiatives across heterogeneous local contexts should anticipate and account for these types of differences.

The Institute of Translational Health Sciences (ITHS) promotes and supports translational research collaboration between clinicians, communities, and investigators across the five-state Washington, Wyoming, Alaska, Montana, and Idaho (WWAMI) region. The ITHS has developed a collaborative regional clinical research network, the Northwest Participant & Clinical Interactions Network (NW PCI), involving 12 diverse clinical health systems and academic institutions.

This descriptive article details NW PCI’s development, infrastructure and governance, tools, characteristics, and initial outcomes.

Regional NW PCI sites are conducting largely industry-sponsored studies; they are interested in including more grant-funded research. Regional NW PCI sites had over 1,240 open studies involving over 6700 patients in 2016. NW PCI trials are largely industry-sponsored; NW PCI sites are interested in including more grant-funded research. In its first three years, the NW PCI Coordinating Center facilitated regional sites’ participation in 34 new grant and contract applications across diverse topics.

The NW PCI model supports the goals of the developing CTSA Trial Innovation Network by increasing access to cutting-edge research across the Northwestern U.S., by supporting investigators seeking diverse populations, including those with rare diseases, for their research studies, and by providing settings to test implementation and dissemination of effective interventions.

Studies examining the role of geographic factors in coronavirus disease-2019 (COVID-19) epidemiology among rural populations are lacking.

Our study is a population-based longitudinal study based on rural residents in four southeast Minnesota counties from March through October 2020. We used a kernel density estimation approach to identify hotspots for COVID-19 cases. Temporal trends of cases and testing were examined by generating a series of hotspot maps during the study period. Household/individual-level socioeconomic status (SES) was measured using the HOUSES index and examined for association between identified hotspots and SES.

During the study period, 24,243 of 90,975 residents (26.6%) were tested for COVID-19 at least once; 1498 (6.2%) of these tested positive. Compared to other rural residents, hotspot residents were overall younger (median age: 40.5 vs 43.2), more likely to be minorities (10.7% vs 9.7%), and of higher SES (lowest HOUSES [SES] quadrant: 14.6% vs 18.7%). Hotspots accounted for 30.1% of cases (14.5% of population) for rural cities and 60.8% of cases (27.1% of population) for townships. Lower SES and minority households were primarily affected early in the pandemic and higher SES and non-minority households affected later.

In rural areas of these four counties in Minnesota, geographic factors (hotspots) play a significant role in the overall burden of COVID-19 with associated racial/ethnic and SES disparities, of which pattern differed by the timing of the pandemic (earlier in pandemic vs later). The study results could more precisely guide community outreach efforts (e.g., public health education, testing/tracing, and vaccine roll out) to those residing in hotspots.

We evaluate a CTSA program hub by applying bibliometrics, social network analysis (SNA), and altmetrics and examine the changes in research productivity, citation impact, research collaboration, and CTSA-supported research topics since our pilot study in 2017.

The sampled data included North Carolina Translational and Clinical Science Institute (NC TraCS)-supported publications produced between September 2008 and March 2021. We applied measures and metrics from bibliometrics, SNA, and altmetrics to the dataset. In addition, we analyzed research topics and correlations between different metrics.

1154 NC TraCS-supported publications generated over 53,560 citation counts by April 2021. The average cites per year and the relative citation ratio (RCR) mean of these publications improved from 33 and 2.26 in 2017 to 48 and 2.58 in 2021. The number of involved UNC units in the most published authors’ collaboration network increased from 7 (2017) to 10 (2021). NC TraCS-supported co-authorship involved 61 NC organizations. PlumX metrics identified articles with the highest altmetrics scores. About 96% NC TraCS-supported publications have above the average SciVal Topic Prominence Percentile; the average approximate potential to translate of the included publication was 54.2%; and 177 publications addressed health disparity issues. Bibliometric measures (e.g., citation counts, RCR) and PlumX metrics (i.e., Citations, Captures, and Social-Media) are positively correlated (p < .05).

Bibliometrics, SNA, and altmetrics offer distinctive but related perspectives to examine CTSA research performance and longitudinal growth, especially at the individual program hub level. These perspectives can help CTSAs build program foci.

Interventions to address social needs in clinical settings can improve child and family health outcomes. Electronic health record (EHR) tools are available to support these interventions but are infrequently used. This mixed-methods study sought to identify approaches for implementing social needs interventions using an existing EHR module in pediatric primary care.

We conducted focus groups and interviews with providers and staff (n = 30) and workflow assessments (n = 48) at four pediatric clinics. Providers and staff completed measures assessing the acceptability, appropriateness, and feasibility of social needs interventions. The Consolidated Framework for Implementation Research guided the study. A hybrid deductive-inductive approach was used to analyze qualitative data.

Median scores (range 1–5) for acceptability (4.9) and appropriateness (5.0) were higher than feasibility (3.9). Perceived barriers to implementation related to duplicative processes, parent disclosure, and staffing limitations. Facilitators included the relative advantage of the EHR module compared to existing documentation practices, importance of addressing social needs, and compatibility with clinic culture and workflow. Self-administered screening was seen as inappropriate for sensitive topics. Strategies identified included providing resource lists, integrating social needs assessments with existing screening questionnaires, and reducing duplicative documentation.

This study offers insight into the implementation of EHR-based social needs interventions and identifies strategies to promote intervention uptake. Findings highlight the need to design interventions that are feasible to implement in real-world settings. Future work should focus on integrating multiple stakeholder perspectives to inform the development of EHR tools and clinical workflows to support social needs interventions.

To enhance enrollment into randomized clinical trials (RCTs), we proposed electronic health record-based clinical decision support for patient–clinician shared decision-making about care and RCT enrollment, based on “mathematical equipoise.”

As an example, we created the Knee Osteoarthritis Mathematical Equipoise Tool (KOMET) to determine the presence of patient-specific equipoise between treatments for the choice between total knee replacement (TKR) and nonsurgical treatment of advanced knee osteoarthritis.

With input from patients and clinicians about important pain and physical function treatment outcomes, we created a database from non-RCT sources of knee osteoarthritis outcomes. We then developed multivariable linear regression models that predict 1-year individual-patient knee pain and physical function outcomes for TKR and for nonsurgical treatment. These predictions allowed detecting mathematical equipoise between these two options for patients eligible for TKR. Decision support software was developed to graphically illustrate, for a given patient, the degree of overlap of pain and functional outcomes between the treatments and was pilot tested for usability, responsiveness, and as support for shared decision-making.

The KOMET predictive regression model for knee pain had four patient-specific variables, and an r2 value of 0.32, and the model for physical functioning included six patient-specific variables, and an r2 of 0.34. These models were incorporated into prototype KOMET decision support software and pilot tested in clinics, and were generally well received.

Use of predictive models and mathematical equipoise may help discern patient-specific equipoise to support shared decision-making for selecting between alternative treatments and considering enrollment into an RCT.