Journal of Clinical and Translational Science最新文献

{"title":"Opportunities amid complexities in returning genetic results to black precision medicine research participants: Interview themes in context with open <i>all of us</i> data.","authors":"Rachele M Hendricks-Sturrup, Nora Emmott, Maryam Nafie, Stephanie Argetsinger, Lauren Edgar, Tracey Johnson-Glover, Kurt D Christensen","doi":"10.1017/cts.2025.67","DOIUrl":"10.1017/cts.2025.67","url":null,"abstract":"<p><strong>Objective: </strong>We sought to describe perspectives among Black nursing professionals and community leaders regarding the return of genetic test results, and place perspectives into context with aggregated findings in the <i>All of Us</i> Research Program's Data Browser.</p><p><strong>Methods: </strong>Semi-structured, virtual interviews were held with adults (≥18 years of age) self-identifying as Black. A 2-step thematic analysis process was used to assess interviewee perspectives with (sub)themes identified in the literature across two topics: drug/medication response and hereditary disease risk. Themes were placed into context with Data Browser content, focusing on genes and their respective alleles with frequencies ≥0.10 in African ancestry populations in <i>All of Us</i>.</p><p><strong>Results: </strong>Interviewee perspectives aligned with previously identified major themes in the literature (motivations to engage or disengage; integrating research and care), with five (5) subthemes emerging across major themes. Seven (7) alleles were observed with frequencies ≥0.10 for three (3) pharmacogenomic (PGx) biomarkers in the Data Browser for African ancestry populations: <i>CYP2C19</i> (SNV, 10-94761900-C-T; SNV,10-94775367-A-G; SNV 10-94781859-G-A), <i>DPYD</i> (SNV, 1-97883329-A-G; SNV, 1-97515839-T-C), <i>UGT1A1</i> (insertion, 2-233760233-C-CAT; SNV, 2-233757136-G-A). Four (4) alleles were observed with frequencies ≥0.10 for three (3) genes implicated in hereditary disease risk, two of which contemporaneously hold PGx implications for African ancestry populations: <i>CACNA1S</i> (PGx, SNV, 1-201112815-C-T; SNV, 1-201110107-C-T), <i>SCN5A</i> (no PGx, SNV, 3-38603929-T-C), <i>TP53</i> (PGx, SNV, 17-7676154-G-C).</p><p><strong>Conclusions: </strong>Our findings convey important clinical and translational science considerations for individuals and community leaders of African ancestry and researchers seeking reputable, publicly available information to understand, communicate, and act on genomic findings.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e89"},"PeriodicalIF":2.1,"publicationDate":"2025-04-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110520","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementation and impact of a diversity supplement repository.","authors":"Maryam Gholami, Eva Kintzer, Mitchell Wong, Davey Smith, Colin Depp","doi":"10.1017/cts.2025.70","DOIUrl":"10.1017/cts.2025.70","url":null,"abstract":"<p><p>The National Institutes of Health (NIH) diversity supplements represent an opportunity to enhance diversity in the biomedical research workforce. Despite their potential impact, practical barriers prevent effective use of these resources. The Altman Clinical and Translational Research Institute (ACTRI) at the University of California San Diego (UCSD) developed and implemented of an institutional repository and support system to improve diversity supplement applications. The centralized repository and support system incorporated three strategies: (1) a secure web-based repository housing successful examples of supplements, (2) match making for diversity supplements and mentors, and (3) web-based resources for potential applicants. The repository was implemented in June 2021 and includes 51 supplement samples across 14 divisions of NIH as of November 2024. The repository has been accessed by 51 potential applicants since implementation in 2021. Few investigators have requested match making. Early indicators show a doubling in diversity supplement applications compared to pre-implementation period at UCSD. We outlined our approach to addressing some of the barriers in diversity supplement applications, which could provide a model for other institutions. Pending solutions to some of the lessons learned, coordinated efforts aimed at diversity supplements could be a practical approach toward a more diverse biomedical research workforce.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e85"},"PeriodicalIF":2.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083204/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093929","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"<i>Narratives of Discovery</i> as a catalyst for translational science education and training.","authors":"Leah G Pope, Daichi Shimbo, Harold A Pincus, Muredach P Reilly, Rita Charon","doi":"10.1017/cts.2025.60","DOIUrl":"10.1017/cts.2025.60","url":null,"abstract":"<p><p>New education and training opportunities are critical for the development of a diverse and highly skilled translational science workforce. In this special communication, the authors consider how <i>Narratives of Discovery</i>, an initiative to interview leading scientists about the sources of their creativity, can serve as a novel translational science teaching tool. Reporting on a project to map translational science principles onto nine <i>Narratives of Discovery</i> conducted to date, the authors demonstrate how translational science principles are manifested in the career trajectories of these scientists and propose that the narratives can serve as a formative model for trainees. Findings from systematic coding of the <i>Narratives of Discovery</i> suggest that the narrative format is particularly well suited to highlight translational science principles not well-addressed by existing education opportunities, including what it means for scientists to be creative and innovative, use bold and rigorous approaches, and prioritize diversity, equity, inclusion, and accessibility. Offering excerpts from the published <i>Narratives of Discovery</i> and quotations from the scientists themselves, the authors aim to create space for continued conversation about how to best crystallize the concepts of translational science and advance translational science education and training initiatives.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e94"},"PeriodicalIF":2.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Toolkit for adapting community engagement studios to effectively engage older adults in research.","authors":"Shaye A Kerper, Janelle C Christensen, Steven M Albert","doi":"10.1017/cts.2025.66","DOIUrl":"10.1017/cts.2025.66","url":null,"abstract":"<p><p>Older adults have largely been excluded from health research despite bearing a disproportionate disease burden. The Community Engagement Studio (CES) model, initially developed at Vanderbilt University in 2009, allows potential research participants to help shape research to promote greater inclusion. The University of Pittsburgh adapted the CES model for older adults (OA-CES). Tailored specifically to older adults, OA-CES addresses underrepresentation in research by gathering valuable feedback that allows investigators to make research more accessible and relevant to older people. An OA-CES toolkit will help in adapting the model in other research areas to close the gap in research inclusion.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e90"},"PeriodicalIF":2.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089849/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110613","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characterization of terminated and withdrawn clinical trials for the treatment and prevention of oral mucositis.","authors":"Alex Reznik, Stephen Sonis, Alessandro Villa","doi":"10.1017/cts.2025.65","DOIUrl":"10.1017/cts.2025.65","url":null,"abstract":"<p><strong>Purpose: </strong>Oral mucositis (OM) is a significant complication of cytotoxic cancer therapy and has no effective therapies. Unfortunately, the termination rate of clinical trials (CTs) testing potential OM interventions remains high. Here, we compared the characteristics of failed trials and matched completed trials to identify common features, which might inform better study design.</p><p><strong>Methods: </strong>CTs for the prevention/treatment of OM were identified using <i>ClinicalTrials.gov</i>. Failed (terminated or withdrawn) trials were evaluated for phase, type of cancer treatment (radiotherapy, chemotherapy, or chemo-radiotherapy), subject accrual, study type, number of clinical sites, intervention type, inclusion criteria, sponsor type, and reason(s) for failure. A secondary analysis of completed OM CTs that were individually matched to failed trials based on indication and phase or intervention type served as a control.</p><p><strong>Results: </strong>Failed OM CTs were more likely to have academic sponsorship (45.7% vs. 39.1%), nonrandomized design (19.6% vs. 4.3%), and lower mean subject accrual (27.8 subjects vs. 101.4 subjects) compared to completed trials. The leading reason for termination was recruitment/enrollment (37.9%). Recruitment/enrollment and safety/efficacy accounted for failure in 84.6% of phase II trials.</p><p><strong>Conclusion: </strong>Contrary to general CTs where safety/efficacy concerns predominate, our results suggest OM-related trial failures are associated with a broader list of challenges including recruitment/enrollment, funding/sponsorship, and investigator/site issues. OM CTs demand aggressive planning, funding, and careful selection of trial sites and sponsorship to assure timely subject recruitment and reduce the risk for early termination and withdrawal.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e86"},"PeriodicalIF":2.1,"publicationDate":"2025-04-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083202/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perspective integration capability: A valid and reliable measurement instrument for assessing knowledge integration readiness in interdisciplinary collaborations.","authors":"Maritza Salazar Campo, Theresa K Lant","doi":"10.1017/cts.2025.54","DOIUrl":"10.1017/cts.2025.54","url":null,"abstract":"<p><strong>Background: </strong>Work in science, medicine, and engineering increasingly relies on collaborations among diverse experts to solve complex problems. Despite the importance of interprofessional training and practice to enhance collaboration and knowledge integration, there is a lack of a conceptually meaningful, valid, and reliable measure of individual capacity for interdisciplinary knowledge integration. This study contributes a conceptual framework and empirical tool to facilitate both research and practice of interdisciplinary collaborations.</p><p><strong>Methods: </strong>We conduct a three-phase, five-study investigation to develop and validate a measure of individual perspective integration capability (PIC), which assesses individual willingness and ability to integrate knowledge with others during collaborative work. Phase 1 includes item generation and reduction in three studies using different samples of respondents. Phase 2 demonstrates convergent and discriminant validity with conceptually related and unrelated constructs, using a separate sample of respondents. Phase 3 tests criterion-related validity and mediation by examining the multilevel relationships between PIC and key antecedents and outcomes, using data from a unique sample of research scientists in interdisciplinary medical research teams.</p><p><strong>Results: </strong>Across the three phases of our study, the results demonstrate support for the PIC instrument's factor structure, reliability, and validity. We also demonstrated that the PIC construct has important implications for individuals engaged in interdisciplinary collaborations.</p><p><strong>Conclusions: </strong>Having a conceptually meaningful, valid, reliable, and easily administered survey instrument will facilitate further study of interdisciplinary collaboration, and the development and evaluation of integration efforts of teams engaged in convergent and translational initiatives.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e93"},"PeriodicalIF":2.1,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110597","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Feasibility of deploying community health workers to assist with health-related social needs and hypertension in community care clinics.","authors":"Brian Robusto, Iris Cheng, Rohan Mahabaleshwarkar, Jessica McCutcheon, Nancy Denizard-Thompson, Sara R Kinny, Selina Quinones, Henry Bundy, Yhenneko J Taylor, Deepak Palakshappa","doi":"10.1017/cts.2025.53","DOIUrl":"10.1017/cts.2025.53","url":null,"abstract":"<p><p>We conducted a pilot study of implementing community health workers (CHWs) to assist patients with hypertension and social needs. As part of clinical care, patients identified as having an unmet need were referred to a CHW. We evaluated changes in blood pressure and needs among 35 patients and conducted interviews to understand participants' experiences. Participants had a mean age of 54.1 years and 29 were Black. Twenty-six completed follow-up. Blood pressure and social needs improved from baseline to 6 months. Participants reported being accepting of CHWs, but also challenges with establishing a relationship with a CHW and being unclear about their role.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e81"},"PeriodicalIF":2.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083196/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Investigating research study participant compensation practices at a California academic and research institution.","authors":"Mariam Carson, Paula Fleisher, Rana Barar, Li Zhang, Elizabeth Tioupine, Hilary Seligman","doi":"10.1017/cts.2025.57","DOIUrl":"10.1017/cts.2025.57","url":null,"abstract":"<p><strong>Introduction: </strong>While providing compensation for participation in research studies is common, there is an ongoing debate surrounding compensation models and how they can be equitably applied. This work attempts to better understand the landscape of research compensation by evaluating factors associated with compensation of research study participants across instiutional review board (IRB)-approved studies at a single academic institution in California.</p><p><strong>Methods: </strong>We extracted all IRB applications for social, behavioral, educational, and public policy research studies between January 1, 2019, and December 31, 2021, at the University of California, San Francisco. Compensation amounts, time estimates for participation, and location of study activities (hybrid, remote, in-person) were extracted from free text entries in the IRB application and reorganized into discrete variables. Multivariable logistic regression was used to assess factors associated with receiving payment after adjusting for time.</p><p><strong>Results: </strong>We analyzed 403 unique IRB applications. Studies held at public hospitals and clinics were more likely to provide compensation to study participants, whereas studies held at the university hospitals and clinics were less likely to provide compensation. Unfunded studies also were less likely to provide compensation to research study participants. While participants that were classified as \"economically/educationally disadvantaged\" and \"unable to read, speak, or understand English\" within the institution's IRB application were more likely to receive compensation, those that had \"diminished capacity to consent\" were less likely to receive compensation.</p><p><strong>Conclusions: </strong>While there are multiple frameworks for compensation, there is still significant variability in compensation strategies. Institutions should center equity in considering standardized approaches to compensation for research participation.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e103"},"PeriodicalIF":2.1,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12089853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144110455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics of research review boards in the context of community-academic settings: A scoping review.","authors":"Katarzyna Wilczek, Ashley Nordsletten, Patricia Piechowski, Luther Evans, Sharon Saddler, Ella Greene-Moton, Susan Woolford, Polly Y Gipson Allen, Jodyn E Platt","doi":"10.1017/cts.2025.50","DOIUrl":"10.1017/cts.2025.50","url":null,"abstract":"<p><p>Community advisory boards (CABs) have traditionally been formed in the context of discrete projects and served to support community protections within the confines of the associated investigation(s). However, as funding bodies increasingly prioritize health equity, CABs have shifted - evolving into long-running organizations with broader scope and value. An emerging cornerstone of these project-independent boards (PICABs) has been the formation of \"Research Review Boards\" (RRBs). While unified in their goal of promoting community protection and representation in health research, it is unknown to what degree RRBs differ on key features including membership, leadership, service reach, and - crucially - impact. A scoping review was conducted according to PRISMA-ScR guidelines to analyze current practices for RRBs. Of screened articles (<i>n</i>= 1878), 25 were included, corresponding to 24 unique RRBs. Findings indicated overlaps in the stated missions, funding structures, and processes of most RRBs. Differences in membership composition, location, service-reach, leadership structures, evaluation procedures, and perceived impact were evident. Where data is available, RRBs receive positive endorsement from both internal members and external users. Standardization of evaluation procedures is needed to fully quantify impact. Additional challenges to sustainability, communication, and conflicts (e.g., of interest, commitment, and power differentials) merit further consideration.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e82"},"PeriodicalIF":2.1,"publicationDate":"2025-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083201/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093921","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Decentralized subject recruitment for a prospective community surveillance system: The influence of social determinants of health on inclusion of minorities in research.","authors":"Paul Takahashi, Chung-Il Wi, Robert Pignolo, Wendelyn Bosch, Katherine King, Euijung Ryu, Traci Natoli, Kathy Ihrke, Matthew Spiten, Lisa Speiser, Brandon Hidaka, Young Juhn","doi":"10.1017/cts.2025.18","DOIUrl":"10.1017/cts.2025.18","url":null,"abstract":"<p><strong>Background/objective: </strong>Decentralized research has many advantages; however, little is known about the representativeness of a source population in decentralized studies. We recruited participants aged 18-64 years from four states from June to December 2022 for a prospective cohort study to assess viral epidemiology. Our aim was to determine the association between age, gender, race/ethnicity, rurality, and socioeconomic status (SES) on study participation in a decentralized prospective cohort study.</p><p><strong>Methods: </strong>We consented 9,286 participants from 231,099 (4.0%) adults with the mean age of 45.6 years (±12.0). We used an electronic decentralized approach for recruitment. Consented participants were more likely to be non-Hispanic White, female, older, urban residents, have more health conditions, and possessed higher socioeconomic status (SES) compared to those non-consented.</p><p><strong>Results: </strong>We observed an interaction between SES and race-ethnicity on the odds of consent (<i>P</i> = 0.006). Specifically, SES did not affect non-Hispanic white participation rates(OR 1.24 95% CI 1.16 - 1.32] for the highest SES quartile compared to those with the lowest SES quartile) as much as it did participants combined across the other races (OR 1.73; 95% CI 1.45 - 2.98]).</p><p><strong>Conclusion: </strong>The relationship between SES and consent rates might be disproportionately greater in historically disadvantaged groups, compared to non-Hispanic White. It suggests that instead of focusing on enrollment of specific minority groups in research, there is value in future research exploring and addressing the diversity of barriers to trials within minority groups. Our study highlights that decentralized studies need to address social determinants of health, especially in under-resourced populations.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e104"},"PeriodicalIF":2.1,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12100557/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144142662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}