Culturally adapted diabetes self-management education (DSME) programs are effective in improving glycemic control and diabetes outcomes among minority populations, but data on program costs and cost-effectiveness are limited. This study aimed to assess the cost and cost-effectiveness of a culturally adapted DSME (adapted DSME) compared to a standard DSME model among Marshallese adults with type 2 diabetes (T2D).

Retrospective cost and cost-effectiveness analyses (CEA) were conducted using data from the community-based trial, conducted between May 2015 and May 2018. We applied an activity-based costing approach to quantify the implementation resources. The CEA was performed using an incremental implementation cost-effectiveness ratio (ICER) measure, expressed as costs for additional unit change in hemoglobin A1c (HbA1c) over 12 months between adapted DSME and standard DSME. We further estimated the replication costs for the adapted DSME for implementation in other settings. The analysis was conducted from a community implementation perspective with a one-year time horizon.

Total program costs were $1,227 per participant for the adapted DSME and $122 per participant for the standard DSME. The ICER was $1434 per additional unit reduction in HbA1c. Replication costs for the adapted DSME were estimated at $125,473 (range: $62,737–$188,210).

The culturally adapted DSME has been shown to be effective in managing T2D and may serve as a cost-effective lifestyle intervention for Marshallese individuals beyond the trial period. Future research should assess its broader economic and health impacts.

Recruitment and retention of populations with limited prior participation in clinical trials remains a challenge. Thus, an increased understanding of the complex factors that impede or facilitate recruitment and retention is needed. Adapting the Systems Engineering Initiative for Patient Safety (SEIPS), we developed the Systems Engineering Initiative for Participant-Centric Research (SEIPR) framework that researchers can use to develop, implement, and evaluate interventions to increase trial participation.

We performed a non-systematic literature review using the digital databases PubMed and Google Scholar to determine factors facilitating and impeding involvement of populations with limited prior participation in clinical trials. From this literature, we developed the SEIPR framework by applying it to the context of recruitment and retention.

We organized key obstacles and evidence-based solutions into five framework components: Person, Tasks and Tools, Technology, Physical Environment, and Organizational Conditions. Common obstacles included lack of awareness of active trials by participants and healthcare providers, patient’s distance from trial centers, lack of access to traditional advertising technology, and mistrust towards investigators, among others. Solutions included promotional strategies appropriate to the regional or social context, decentralizing trials, providing communication technology to participants, partnering with trusted members from the participant’s community and primary care team, using local connections and community centers, financial incentives, and transportation solutions.

The SEIPR framework presents a promising tool for investigators interested in increasing participant breadth in clinical trials. Future research is needed to explore real-world applications and assess its effectiveness in recruiting and retaining broad populations.

Person-centered care that honors individual preferences can improve the well-being of nursing home (NH) residents with Alzheimer’s disease and related dementias (ADRD). However, preferences such as going outside independently are often restricted due to perceived safety risks. There is a critical need for strategies that help NH staff balance safety concerns with residents’ autonomy.

We developed the Decision-making In aGing and demeNtIa for autonomy (DIGNITY) intervention using the Community-Engaged Intervention Mapping (CEIM) Model. This multilevel, theory informed program was codesigned with NH stakeholders to support shared decision-making and promote preference-congruent dementia care.

A total of 53 stakeholders participated in focus groups and engagement sessions. Feedback informed six key refinements to the DIGNITY program: manual formatting, communication strategies, staff role delineation, addressing resident decision-making capacity, and identifying implementation barriers and facilitators. The final intervention includes a structured manual, decision-making tools, and a training and coaching program to support NH staff in honoring resident preferences while managing perceived risks.

DIGNITY is a novel, stakeholder-informed intervention designed to support preference-based dementia care in rural NHs. Future research should assess its feasibility, acceptability, and impact on staff attitudes and resident outcomes.

The impact of guideline-directed medical therapy (GDMT) has not fully translated to decreases in the disproportionate rates of hospitalization and lengths of stay in African Americans with congestive heart failure (CHF). GDMT is optimized by registered nurses (RNs) and their use of clinical information. Yet, there are no instruments for measuring the influence of clinical information use and nursing care. The study assessed an instrument’s ability to measure the influence of RN performance of social, technical, and socio-technical care tasks on length of stay in the CHF hospitalizations of African Americans.

A sample of 200 RNs, who cared for 5060 African Americans with 14,123 heart failure hospitalizations, were surveyed. Descriptive statistics, Cronbach’s alpha, and a generalized linear regression assessed the instrument’s reliability and predictive validity.

The Cronbach’s alpha was 0.95 (95% CI: 0.94–0.96). The corrected item-total correlations for the 22 items ranged from 0.44 to 0.80. For an increase of one to four points per item in a RN’s performance, the estimated reductions in the patient’s length of stay were 3.34% (6.11,0.5), 6.58% (11.84,1), 9.70% (17.22,1.49), and 12.72% (22.28,1.99), respectively (P = 0.004).

Increases in a RN’s performance of social, technical, and socio-technical care tasks were significantly associated with clinically meaningful decreases in their patients’ length of stay. The instrument has strong potential for addressing the disproportionate impact of CHF by measuring and tailoring interventions to optimize nursing care and the use of clinical information in the provision and receipt of GDMT.

Opportunities for face-to-face interaction between sponsor-side clinical research associates (CRAs) and site-side clinical research coordinators (CRCs) have decreased with remote and risk-based monitoring, potentially impeding communication and mutual understanding – key determinants of team functioning. Accordingly, we implemented a reciprocal on-site training to enhance CRA-CRC mutual understanding and evaluated its impact.

Seventeen sponsor staff, including 11 CRAs, joined an 8-hour hospital tour with CRC-guided process simulations and discussion; conversely, 14 hospital staff, including 11 CRCs, attended a 4-hour sponsor-office visit with system demonstrations and discussion. Self-assessed understanding of counterpart workflows and impressions of the counterpart group were rated pre- and post-training on 5-point Likert scales. Free-text feedback underwent text-mining analysis. Behavioral change was surveyed 6 months later.

CRAs improved on all 9 understanding items (e.g. “flow of daily medical practice:” median score 2.0 vs. 4.0, pre- and post-training, respectively, p < 0.0001); CRCs improved on 4 of 5. Positive impressions increased and negative impressions decreased in both groups (e.g. “bright atmosphere:” median 3.0 vs. 5.0 for CRAs, p = 0.0002; 3.0 vs. 5.0 for CRCs, p = 0.0044). Text-mining revealed the specific content participants learned, which included keywords reflecting this training’s objective of enhancing mutual understanding. At 6 months, 70% of CRAs and 88% of CRCs reported changes in their work behavior.

A brief, reciprocal, on-site training improved CRA–CRC mutual understanding and perceptions, with sustained self-reported behavioral changes in work practices. From a team science perspective, such practical training may strengthen sponsor-site communication and collaboration.

Community engagement that emphasizes shared leadership is essential in clinical and translational science, and language, naming, and framing have the potential to shape power dynamics. This study explored how renaming and restructuring a Community Advisory Board (CAB) into a Community Leadership Board (CLB) could strengthen a trauma-informed network of care (TINoC) by elevating community power, cultural responsiveness, and equitable participation.

Guided by the Trauma and Resilience Informed Research Principles and Practice(TRIRPP) framework, we established a paid CLB in Yolo County, California, composed of six individuals who identified as members of groups underrepresented in science. We reviewed timesheets and TINoC products and conducted an inductive thematic analysis of meeting minutes to determine the CLB’s main areas of influence.

The CLB met 25 times over two years, provided iterative feedback on more than a dozen educational materials, clinical workflows, trauma-informed trainings, and communication strategies, and co-presented at community meetings. Eight recurring areas of influence were identified: trauma-informed ACE screening, accessibility, workflow feasibility, community- and patient-centered feedback, health communication, participant compensation, engagement, and post-screening navigation. CLB members highlighted gaps not identified by the academic and community members of the TINoC, including translation accuracy, time allowed for ACE screening, and ensuring voluntary patient participation.

Renaming the CLB as a “leadership” body signaled a shift in accountability, deepened engagement, and underscored how naming practices can drive more equitable translational research. Virtual-only meetings potentially limited the representativeness of the CLB; however, results suggest naming is a critical component of trauma-informed community-engaged research(CEnR).

Decentralized trial designs can improve accessibility and continuity of research participation by enabling remote data collection. This manuscript describes our team’s experiences with remote data collection to identify acute asthma exacerbations in a clinical study as well as practical insights that support the continued optimization of remote methodologies.

In this 12-month observational study, adolescents aged 12–21 years with persistent asthma and ≥1 exacerbation in the prior 24 months completed an initial in-person visit followed by monthly virtual visits. Participants used home spirometry, app-based symptom tracking, smart inhalers to monitor lung function and short-acting beta agonist (SABA) use, and self-collection of nasal epithelial lining fluid (NELF) samples. Exacerbations were defined a priori by symptom/SABA thresholds or ≥20% FEV1 decline.

Forty participants enrolled; 73% completed all visits. Median adherence to performance of daily spirometry and symptom surveys was 44% and 38%, respectively. Seventy-eight percent experienced ≥1 exacerbation. Of 132 alerts, 80% represented true exacerbations, primarily due to ≥20% FEV1 decline; erroneous alerts were linked to software errors and poor spirometry technique. Sixty-six NELF sample sets were collected and 50 were analyzed. Cytokine concentrations did not differ significantly between clinic-collected and self-collected samples. Technical challenges included device connectivity issues, erroneous alerts, and shipping delays.

Decentralized study designs with remote data collection requires further study as a means of conducting clinical research in asthma that increases participant accessibility, representation and generalizability of trial results. This approach presents numerous challenges and requires further optimization to address adherence, technical complexity, and staff burden while maintaining scientific rigor.

Strategies to improve accrual and reduce barriers to cancer clinical trials participation are critical for the advancement and implementation of new treatments and processes to improve cancer patient outcomes. While researchers have identified several barriers to accrual from the perspective of health care providers and patients, mechanisms to address and alleviate these concerns are needed to increase participation and interest in clinical trials.

A focus group of 9 people with lived experience of a cancer diagnosis were accrued randomly and provided with a hands-on research experience and educational resources about clinical trials, followed by a focused group discussion to capture perspectives and/or experiences with clinical trials. Focus groups were transcribed and analyzed via Braun & Clarke’s 6-phase reflexive thematic analysis.

Five key themes were identified as important to increase clinical trial accrual. These included a patient-centered approach, easily digestible educational resources, a personalized understanding of motivating factors, local outreach, and transparency on outcomes and progress of the work. Qualitative input also identified methods that could positively influence accrual rates.

Providing participants with opportunities to see first-hand how research works and data are used was noted as an overwhelmingly positive experience that could improve clinical trial accrual rates. This work confirms several previous findings with respect to patient identified barriers to participation in clinical trials and provides support and a framework for development of knowledge translation strategies to increase awareness and knowledge of the importance of clinical research to improve health outcomes for cancer patients.

Recruitment for rare disease studies is challenging due to small eligible populations. Traditional clinical research management systems often lack tools to track recruitment contacts prior to enrollment. The NET-PRO study, focused on neuroendocrine tumors (NETs), implemented a participation monitoring system to enhance recruitment efficiency and representativeness.

NET-PRO is a multicenter cohort study of 2538 adults diagnosed with gastroenteropancreatic (GEP) or lung NETs between January 2018 and September 2024. Recruitment occurred from January 2022 to February 2025 across 14 U.S. medical centers. Sites used flexible recruitment methods (email, mail, phone, in-clinic) and tracked contacts using REDCap-based tools. Participant characteristics were analyzed by enrollment mode (online or mail) and recruitment difficulty (number of contacts required prior to enrollment) using standardized mean differences, chi-square tests, and ANOVA.

Of 9279 contacted patients, 2675 consented (28.8%) and 2538 enrolled (27.4%). Most enrolled online (83.2%), while 16.8% enrolled by mail. Mail respondents were older, had lower education and income, and more comorbidities. Among those enrolled, recruitment difficulty was associated with older age, lower education and income, but not comorbidity. Over half of the most difficult-to-recruit participants enrolled online. Contact methods varied by attempt, with email dominating early contacts and phone/mail used more in later attempts.

A participation monitoring tool supported flexible, multimodal recruitment and improved sample representativeness in a rare cancer study. Tracking recruitment contacts enabled adaptive strategies and may reduce bias in observational research by enabling better outreach to harder-to-reach populations.