Obtaining complete and accurate information in recruitment registries is essential for matching potential participants to research studies for which they qualify. Since electronic health record (EHR) systems are required to make patient data available to external systems, an interface between EHRs and recruitment registries may improve accuracy and completeness of volunteers’ profiles. We tested this hypothesis on ResearchMatch (RM), a disease- and institution-neutral recruitment registry with 1357 studies across 255 institutions.

We developed an interface where volunteers signing up for RM can authorize transfer of demographic data, medical conditions, and medications from the EHR into a registration form. We obtained feedback from a panel of community members to determine acceptability of the planned integration. We then developed the EHR interface and performed an evaluation study of 100 patients to determine whether RM profiles generated with EHR-assisted adjudication included more conditions and medications than those without the EHR connection.

Community member feedback revealed that members of the public were willing to authenticate into the EHR from RM with proper messaging about choice and privacy. The evaluation study showed that out of 100 participants, 75 included more conditions and 69 included more medications in RM profiles completed with the EHR connection than those without. Participants also completed the EHR-connected profiles in 16 fewer seconds than non-EHR-connected profiles.

The EHR to RM integration could lead to more complete profiles, less participant burden, and better study matches for many of the over 148,000 volunteers who participate in ResearchMatch.

A Health Equity Task Force (HETF) of members from seven Centers funded by the National Cancer Institute’s (NCI) Implementation Science in Cancer Control Centers (ISC3) network sought to identify case examples of how Centers were applying a focus on health equity in implementation science to inform future research and capacity-building efforts.

HETF members at each ISC3 collected information on how health equity was conceptualized, operationalized, and addressed in initial research and capacity-building efforts across the seven ISC3 Centers funded in 2019–2020. Each Center completed a questionnaire assessing five health equity domains central to implementation science (e.g., community engagement; implementation science theories, models, and frameworks (TMFs); and engaging underrepresented scholars). Data generated illustrative examples from these five domains.

Centers reported a range of approaches focusing on health equity in implementation research and capacity-building efforts, including (1) engaging diverse community partners/settings in making decisions about research priorities and projects; (2) applying health equity within a single TMF applied across projects or various TMFs used in specific projects; (3) evaluating health equity in operationalizing and measuring health and implementation outcomes; (4) building capacity for health equity-focused implementation science among trainees, early career scholars, and partnering organizations; and (5) leveraging varying levels of institutional resources and efforts to engage, include, and support underrepresented scholars.

Examples of approaches to integrating health equity across the ISC3 network can inform other investigators and centers’ efforts to build capacity and infrastructure to support growth and expansion of health equity-focused implementation science.

The role of lay health workers in data collection for clinical and translational research studies is not well described. We explored lay health workers as data collectors in clinical and translational research studies. We also present several methods for examining their work, i.e., qualitative interviews, fidelity checklists, and rates of unusable/missing data.

We conducted 2 randomized, controlled trials that employed lay health research personnel (LHR) who were employed by community-based organizations. In one study, n = 3 Latina LHRs worked with n = 107 Latino diabetic participants. In another study, n = 6 LHR worked with n = 188 Cambodian American refugees with depression. We investigated proficiency in biological, behavioral, and psychosocial home-based data collection conducted by LHR. We also conducted in-depth interviews with lay LHR to explore their experience in this research role. Finally, we described the training, supervision, and collaboration for LHR to be successful in their research role.

Independent observers reported a very high degree of fidelity to technical data collection protocols (>95%) and low rates of missing/unusable data (1.5%–11%). Qualitative results show that trust, training, communication, and supervision are key and that LHR report feeling empowered by their role. LHR training included various content areas over several weeks with special attention to LHR and participant safety. Training and supervision from both the academic researchers and the staff at the community-based organizations were necessary and had to be well-coordinated.

Carefully selected, trained, and supervised LHRs can collect sophisticated data for community-based clinical and translational research.

Health systems have many incentives to screen patients for health-related social needs (HRSNs) due to growing evidence that social determinants of health impact outcomes and a new regulatory context that requires health equity measures. This study describes the experience of one large urban health system in scaling HRSN screening by implementing improvement strategies over five years, from 2018 to 2023.

In 2018, the health system adapted a 10-item HRSN screening tool from a widely used, validated instrument. Implementation strategies aimed to foster screening were retrospectively reviewed and categorized according to the Expert Recommendations for Implementing Change (ERIC) study. Statistical process control methods were utilized to determine whether implementation strategies contributed to improvements in HRSN screening activities.

There were 280,757 HRSN screens administered across 311 clinical teams in the health system between April 2018 and March 2023. Implementation strategies linked to increased screening included integrating screening within an online patient portal (ERIC strategy: involve patients/consumers and family members), expansion to discrete clinical teams (ERIC strategy: change service sites), providing data feedback loops (ERIC strategy: facilitate relay of clinical data to providers), and deploying Community Health Workers to address HRSNs (ERIC strategy: create new clinical teams).

Implementation strategies designed to promote efficiency, foster universal screening, link patients to resources, and provide clinical teams with an easy-to-integrate tool appear to have the greatest impact on HRSN screening uptake. Sustained increases in screening demonstrate the cumulative effects of implementation strategies and the health system’s commitment toward universal screening.

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 goal of this pilot study was to identify changes associated with completion of a unique six-week hand exercise program in persons with carpometacarpal osteoarthritis.

Twenty-four individuals, aged 55–80, with doctor-diagnosed carpometacarpal osteoarthritis participated in the study. Movement data from standard clinical motions and complex multi-planar motions were obtained using a motion capture system at three-time points: an initial visit, after two weeks of hand exercises, and after completion of the six-week exercise program.

This exercise program produced trends of improvement in complex multi-planar motions. Specifically, joint angle changes were seen during opposition and the formation of an “okay sign” that was included as part of the exercise program.

Through the use of motion capture, changes were identified in thumb joint function after exercise. Specifically, motions associated with the more complex multi-planar tasks showed changes in individual joint contributions following the six-week exercise intervention. The results suggest that further exploration of this exercise program, particularly the inclusion of complex multi-planar tasks during osteoarthritis treatment and associated evaluations, should be considered in future clinical studies.

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.

The pediatric medical device development (PMDD) process is highly complex, beset by a variety of financial, technical, medical, and regulatory barriers. Startup company innovators and academic investigators often struggle with accessing specialized knowledge relating to regulatory requirements, product development, research, and marketing strategies.

The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) conducted an educational needs assessment to understand knowledge gaps and inform our educational strategy.

We surveyed a total of 49 medical device startups and 52 academic investigators. Electronic surveys were developed for each group on Qualtrics and focused on manufacturing, regulatory, research, commercialization, and funding. Descriptive statistics were used.

A larger proportion of academic investigator respondents had a clinical background compared to the startup respondents (45% vs. 22%). The biggest barriers for academic investigators were understanding regulatory and safety requirements testing (52%) and finding and obtaining non-dilutive funding was the most difficult (54%). Among startups, understanding clinical research methods and requirements was the biggest barrier (79%).

Startup companies and academic investigators have similar, but not identical, educational needs to better understand the PMD development process. Investigators need more support in identifying funding sources, while startup companies identified an increased need for education on research regulatory topics. These findings can help guide curriculum development as well as opportunities for partnerships between academia and startups.

Despite the intuitive attractiveness of bringing research to participants rather than making them come to central study sites, widespread decentralized enrollment has not been common in clinical trials.

The need for clinical research in the context of the COVID-19 pandemic, along with innovations in technology, led us to use a decentralized trial approach in our Phase 2 COVID-19 trial. We used real-time acquisition and transmission of health-related data using home-based monitoring devices and mobile applications to assess outcomes. This approach not only avoids spreading COVID-19 but it also can support inclusion of participants in more diverse socioeconomic circumstances and in rural settings.

Our team developed and deployed a decentralized trial platform to support patient engagement and adverse event reporting. Clinicians, engineers, and informaticians on our research team developed a Clinical-Trial-in-a-Box tool to optimally collect and analyze data from multiple decentralized platforms.

Applying the decentralized model in Long COVID, using digital health technology and personal devices integrated with our telehealth platform, we share the lessons learned from our work, along with challenges and future possibilities.

The Institute of Translational Health Sciences (Clinical and Translational Science Awards Program hub) developed a program coined Community Voices to invite communities to submit project ideas and be matched with academic researchers. We describe formative research to understand community and academic researcher perspectives on how the program could facilitate collaborations addressing community priorities.

We conducted four focus groups with 31 community-based organization (CBO) representatives and 11 semi-structured interviews with academic researchers in the Washington, Wyoming, Alaska, Montana, and Idaho regions. Questions included the appeal of Community Voices to engage community and academic partners, potential program usefulness, and Community Voices’ potential role in building community–academic partnerships. We used an inductive, constant comparison approach to code transcripts and thematic analysis to generate themes.

Most CBO representatives were female (87.1%) and Hispanic/Latino (61.3%). Most academic researchers had a PhD (63.6%) and worked at a university (81.8%). The themes were: (1) community–academic partnerships built on trust will offer mutual benefit, (2) community-initiated project ideas should prioritize community needs, (3) matchmaking will accelerate connections but should not replace time to foster partnership, (4) Community Voices should go beyond matchmaking and provide ongoing support/training, and (5) fostering effective communication is key to partnership success.

Community Voices is a novel, bidirectional community engagement program model that advances current practices of prioritizing researchers’ project ideas. This community-driven program may shift the future direction of community engagement practices where prioritizing community’s ideas becomes the norm of community–academic partnerships in clinical and translational science.