Journal of Clinical and Translational Science最新文献

Background: Digital tools offer promising solutions to improve eligibility screening, recruitment, and retention in research, particularly in human genetic studies where representative sampling is critical. SMS text messaging has been found effective in population-based survey research, but evidence of its impact on genetic study recruitment - and how it varies by demographics - is limited.

Objective: We examined the effect of tailored SMS messages on enrollment in a population-based genomic screening study. We assessed differences in message open and consent rates across four message types and explored how these outcomes varied by demographic factors.

Methods: Participants were randomized to receive one of four SMS messages emphasizing different social values: generic, individual impact, community impact, or research discoveries. We calculated descriptive statistics for open and consent rates and used generalized linear logistic regression and Pearson's Chi-Square Test to assess demographic differences.

Results: Among 15,977 messages sent, 2.4% were opened (n = 382), and 35.3% of those who opened consented (n = 135). Females were more likely than males to open (3.1% vs. 1.6%) and consent (1.1% vs. 0.5%). Individuals aged 30-39 had the highest open rate (3.4%), and those 40-49 had the highest consent rate (1.6%). Message type was not significantly associated with open or consent rates.

Conclusion: Sociodemographic factors were more predictive of engagement than message content. Tailoring messages by demographic group may improve recruitment in genomic studies. Future research should explore the drivers of participant engagement in digital recruitment strategies.

Background: Numerous efforts are focused on building the clinical and translational research (CTR) workforce. Approaches to evaluate CTR initiatives are varied, and efforts often rely on research project-level outcomes. This article applies an evaluation tool to capture individual-level data.

Objective: The study used a novel Researcher Investment Tool (RIT) to measure researchers' experience as well as perceptions of institutional support, including an analysis based on researcher characteristics. The study also evaluated the RIT based on common measures, including a bibliometric indicator, investigator status, and percent time dedicated to research.

Methods: The RIT was administered to researchers who received funding or targeted research support from a CTR initiative. Mean scores were assessed by RIT section, domains/sub-domains, and for each item. Mean scores per section were compared across researcher characteristics using t-tests, and associations between common measures and average domain scores were tested using linear regression.

Results: Thirty researchers completed all RIT items. RIT domain scores ranged from a high mean of 4.0 for the research skills domain to a low mean of 2.6 for researcher productivity and community engagement domains. Analysis of indicators of commonly used measures across domains suggest that researchers with a higher bibliometric score had more advanced research skills, service to profession, research productivity, and research collaboration (p < .05). New investigators had lower perceptions of institutional support (p < .05).

Conclusions: As an evaluation tool, the RIT captures individual-level data that may help to determine key areas of strength and opportunities for growth of a CTR program.

This report outlines the workflow, challenges, and key roles involved in operationalizing a complex, disruptive, acute clinical trial protocol requiring multidisciplinary collaboration. Yale University School of Medicine and the Neuroscience Intensive Care Unit (NICU) at Yale New Haven Hospital (YNHH) leverage interdisciplinary collaboration to successfully enroll patients into complex clinical trials, including the Biomarker and Edema Attenuation in IntraCerebral Hemorrhage (BEACH) trial (ClinicalTrials.gov identifier: NCT05020535). Successful execution of the BEACH trial relies on five key domains: ensuring patient safety, optimizing screening and enrollment, acquiring pharmacokinetics, identifying signals of efficacy, and adapting to operational challenges. These domains require precise coordination, communication, and adaptability within dynamic patient care environments. By streamlining workflows, all members of the care delivery team and the research team maximize efficiency and optimize patient enrollment while upholding the highest standards of ethical research and patient care. Implementation of the BEACH trial at the Yale research center exemplifies the critical role of interdisciplinary collaboration in clinical research. By integrating research into patient care, the team improves trial efficiency and contributes to innovative treatment strategies for intracerebral hemorrhage. Lessons learned can inform best practices for future acute trials and improve patient outcomes.

Introduction: Recruiting and retaining racial/ethnic minorities in research remains a significant challenge, often due to mistrust in clinical research and cultural misconceptions related to specific conditions. Despite the anonymity provided by technology-based intervention studies, difficulties in participant recruitment and retention in these studies remain. This paper addresses practical issues in recruiting and retaining Asian American breast cancer survivors with pain and depressive symptoms in a technology-based intervention study.

Methods: To identify practical issues in participant recruitment and retention, a content analysis was conducted on all recorded materials, including research diaries of individual research team members, weekly team meeting minutes, and research team members' posts on Microsoft Teams.

Results: Analysis identified six practical issues: (a) strict inclusion/exclusion criteria; (b) multiple stigmas associated with cancer, depressive symptoms, and pain; (c) lack of interest in research participation; (d) closed Asian American communities/groups; (e) frequent technological issues; and (f) potential unauthentic cases.

Conclusion: Addressing these recruitment and retention issues can inform the design of future culturally tailored, technology-based intervention studies for racial and ethnic minority populations.

Introduction: Rural cancer survivors have worse outcomes than their urban counterparts. To improve outcomes, it is essential that rural survivors participate in research, yet they are underrepresented in cancer research. The aim of this study was to assess urban-rural differences in participation in a cancer survivorship survey and differences in mode of participation (mail, online, or phone) by rurality and age.

Methods: We developed a survivorship needs assessment survey and invited cancer survivors to participate by mail, online, or phone. We compared participation between rural and urban invitees and examined differences in mode of participation by rurality and age.

Results: A quarter (25.47%) of invited rural patients and 27.84% of invited urban patients participated in the survivorship study. The probability of participation by urban survivors was approximately 1.09 times higher than for rural survivors (χ ²(1) = 4.31, p = 0.038). Rural survivors were more likely to participate by mail (average difference [Rural-Urban] = 9.64%, p < 0.001), while urban survivors were more likely to participate online (average difference [Urban-Rural] = 8.77%, p < 0.001). As participant age increased, the likelihood of survey participation by mail increased (1.16% per year of age, p < 0.001) while the probability of participating online decreased by 1.20% per year of age (p < 0.001).

Conclusion: To ensure equitable access to research for rural and older cancer survivors, researchers should design studies with a range of participation modes. Non-digital methods, such as mailed paper surveys, appear to promote participation among rural and older survivors.

Over the past decade, several multi-institutional research consortia have formed within the North American pediatric surgical community. In this article, we describe our experience with the creation and implementation of the Eastern Pediatric Surgery Network, a large and comprehensive research consortium designed to produce a wide array of high-quality clinical studies within our subspecialty. In 2020, a vision statement and rules of governance were established at thirteen academic pediatric surgery divisions in the eastern United States. The research consortium was organized based on four major pillars, namely legal ownership of aggregate data, horizontal leadership structure, mandatory participation in adopted studies, and a broad research portfolio that encompasses the full breath of the specialty. Over the past five years, the number of research projects has dramatically expanded over time and includes participation from 24 different medical centers. Despite a lack of dedicated sponsored extramural support for most projects, there have been 28 abstracts presented at national conferences and 12 manuscripts published in peer-reviewed journals. It is our hope that sharing our experience with creating this organization can help to inform others interested in establishing the academic infrastructure to engage in multi-institutional, evidence-based clinical research in other medical specialties and beyond.

Introduction: Scientific teams that are comprised of different types of researchers have higher research productivity, and there is a need for evidence-based methods to improve the biomedical research workforce. Building Up a Biomedical Research Workforce (Building Up) was a multi-center, cluster-randomized, unblinded controlled trial with one intervention arm and one control arm, conducted at 25 United States academic medical centers. The authors tested the hypothesis that participants from backgrounds underrepresented in science who are randomized to the intervention will have greater numbers of peer-reviewed publications and increased Psychological Capital, compared to the control group.

Methods: The study included a 10-month intervention period and follow-up assessments occurring one, two, and three years after the intervention began. The intervention arm received a 10-month intervention with monthly meetings, near-peer mentoring, networking opportunities, and grant- and scientific-writing coursework. Participants in the control arm experienced the usual forms of mentoring, networking, and coursework that their institutions provided.

Results: Of the 220 participants who completed the pre-intervention assessment (98% of all enrolled participants), 71% completed the post-intervention assessment at year 1, 60% at year 2, and 66% at year 3. Individuals in the intervention arm had significantly higher levels of self-efficacy, resilience, and optimism in the three years following the start of the intervention, compared to the control arm.

Discussion: This finding suggests that the Building Up intervention can increase participants' Psychological Capital.

The Duke Research Equity and Diversity Initiative (READI) was established in 2021 to engage Durham and surrounding communities in clinical research and build capacity to promote equitable access to research participation. Within READI, a voucher program was launched with the goals of increasing diverse participation in clinical research, improving community-partnered research, and enhancing community engagement. The vouchers leveraged a stand-alone, community-centered, outpatient research clinic, the Duke Research at Pickett (R@P) facility, which was originally opened to support COVID-19 trials. A formative evaluation of the voucher program was conducted with 3 voucher-awarded teams, READI personnel, and R@P staff. Data included 18 semi-structured interviews (n = 14) over two timepoints (Spring 2023, 2024). A rapid response analysis approach was used. Data indicate that READI voucher-awarded services were useful for voucher teams, with value for supporting community-engaged efforts, making research participation accessible, creating a community-centered and streamlined service facility, and personnel development benefits. Communication and flexibility of support services facilitated program implementation. Challenges occurred in service utilization logistics and incorporating community engagement into research support services. Ultimately, we find that a research support program with embedded community engagement support is feasible; this type of support can be integral in normalizing community-engaged research.