Journal of Clinical and Translational Science最新文献

{"title":"Prediction of α-synuclein seed amplification assay positivity in remotely followed <i>LRRK2</i> G2019S carriers using a validated data-driven model.","authors":"Ruth B Schneider, Peggy Auinger, Charles S Venuto","doi":"10.1017/cts.2026.10756","DOIUrl":"10.1017/cts.2026.10756","url":null,"abstract":"<p><p>The α-synuclein seed amplification assay (SAA) is a biomarker for Parkinson's disease (PD) but requires cerebrospinal fluid. We applied a validated model to predict α-synuclein SAA+ using remotely collected data in LRRK2 G2019S carriers. VALOR-PD participants completed at-home olfactory and autonomic assessments. SAA+ probabilities for manifest and non-manifest carriers at baseline and month 36 visits were estimated. Baseline SAA+ mean probability was 0.57 (manifest) and 0.28 (non-manifest). Over three years, SAA+ mean probabilities increased in manifest (0.66, p = 0.014) and non-manifest carriers (0.38, p < 0.001), paralleling olfactory declines. Remotely collected data may be used to approximate SAA classification.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e101"},"PeriodicalIF":2.7,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13312348/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148352118","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":"Are you still engaged? Leveraging the LMS to support engagement in asynchronous courses.","authors":"Damian N Di Florio, Kristina B Nelson, Ryan C Jimison, Ross A Dierkhising, Carmen J Silvano, Felicity T Enders","doi":"10.1017/cts.2026.10752","DOIUrl":"10.1017/cts.2026.10752","url":null,"abstract":"<p><strong>Introduction: </strong>Asynchronous online courses are plagued with the challenge of engaging students consistently. Behavioral interventions, such as bottlenecks (enforced deadlines) and nudges (automated reminders), may modulate behaviors that lead to engagement and can now be easily applied and measured in a Learning Management System (LMS).</p><p><strong>Methods: </strong>This study included three groups of three asynchronous online courses each over three academic quarters. Two distinct behavioral interventions, bottlenecks and nudges, were implemented to increase engagement with the course compared to non-intervention controls.</p><p><strong>Results: </strong>The results showed that behavioral intervention tools increase student engagement with course materials by measures of increased student access to the course and reduced time to quiz completion. However, there was no significant impact in grades across the three groups.</p><p><strong>Conclusion: </strong>The use of nudges and bottlenecks as behavioral interventions to increase engagement in asynchronous courses for Clinical and Translational Science Education is recommended as part of best practice in course design with the same or similar structure.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e99"},"PeriodicalIF":2.7,"publicationDate":"2026-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13312351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148352077","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":"Erratum: \"Being treated as the expert:\" A blueprint for a community advisory board approach to elevate the voice of people with living experience with substance use in academic research - ERRATUM.","authors":"Trevor Moffitt, Bryson Henson, April Young, Sharon L Walsh, Rachel Vickers-Smith, Junior Cruz, Jeremy Byard, Brook West, Amanda Fallin-Bennett","doi":"10.1017/cts.2026.10750","DOIUrl":"10.1017/cts.2026.10750","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2026.10242.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e82"},"PeriodicalIF":2.7,"publicationDate":"2026-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13184648/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147981881","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":"Systematic review of approaches to informed consent in recent high-impact clinical trials.","authors":"Caleigh Propes, Jonathan D Casey, Matthew W Semler, Stephanie C DeMasi, Amelia L Muhs, Edward T Qian, Kevin P Seitz, Stephanie Morain","doi":"10.1017/cts.2026.10751","DOIUrl":"10.1017/cts.2026.10751","url":null,"abstract":"<p><p>The U.S. Food and Drug Administration (FDA) recently harmonized its regulatory criteria for waivers and alterations of informed consent with the U.S. Common Rule. We conducted a systematic review of clinical trials in the two highest-impact clinical journals in the U.S. to better understand practice-changing trials that are being conducted in the U.S. without prospective written informed consent. One in ten trials in our sample were conducted without prospective written informed consent. Such trials accounted for 93.1% of patient-subjects in our sample, enrolling nearly 3 million individuals. Further guidance would support socially valuable research while ensuring appropriate oversight.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e94"},"PeriodicalIF":2.7,"publicationDate":"2026-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13247783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148217377","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":"Evolving roles of Data Coordinating Centers in multisite research: Challenges and adaptations from a rapid scoping review.","authors":"Yunxi Zhang, Lincy Lal, Soeun Kim, John Michael Swint, David T Mauger, Aimee Merchlinski, Paula A Valencia, Beth R Holmes, Brenda Phillips, Kendall Thomas Baab, Vernon M Chinchilli","doi":"10.1017/cts.2026.10755","DOIUrl":"10.1017/cts.2026.10755","url":null,"abstract":"<p><p>Data Coordinating Centers (DCCs) play essential roles in multisite clinical and translational research, ensuring consistent protocol implementation, data integrity, and regulatory compliance across geographically and organizationally diverse sites. As study design, regulatory, and technological complexity have evolved, DCC responsibilities have expanded beyond data coordination. This rapid scoping review maps published experiences from academic DCCs to address two questions: (i) What key organizational and operational challenges have been reported? (ii) What solutions and emerging technologies have been adopted in response? We conducted a rapid scoping review in accordance with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). We searched the peer-reviewed literature (2010-2025) using PubMed, Scopus, and the Web of Science Core Collection. Fifteen reports describing 16 DCCs were included in this review. DCCs faced recurring challenges related to infrastructure development, multisite coordination, regulatory governance, data heterogeneity, and workforce development. Reported adaptations include homegrown modular infrastructure solutions, standardized workflows, streamlined proactive regulatory processes, and workforce investments. By synthesizing evidence on DCC challenges and adaptations, this review provides practical guidance to help DCCs enhance operational feasibility and uphold scientific integrity in multisite clinical and translational research.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e92"},"PeriodicalIF":2.7,"publicationDate":"2026-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13237188/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199099","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":"Findings and recommendations from a root cause analysis of a clinical trial randomization error.","authors":"Muayad Hamidi, Omar Abbaas, Pavan Bhatraju, Subrata Debnath, Jonathan Gelfond, Joel E Michalek, Karen Nijland, Jeannette Watterson, Melanie Zuniga Rapp, Jason Bates, Susanne Schmidt, Kumar Sharma, Laura Aubree Shay, Hung-da Wan, Meredith Zozus","doi":"10.1017/cts.2026.10749","DOIUrl":"10.1017/cts.2026.10749","url":null,"abstract":"<p><strong>Introduction: </strong>Participants in NIH-funded multicenter clinical trial received the compound opposite to the randomization intention. We report the problem, subsequent root cause analysis (RCA) and corrective and preventative action (CAPA).</p><p><strong>Methods: </strong>The RCA was independently facilitated to identify study-level causes of the problem. Results were reviewed by institutional research administration leaders to identify institution-level causes and formulate corresponding CAPA. Both culminated in consensus.</p><p><strong>Results: </strong>The resulting causal chain consisted of two physical causes, two study-level system causes, and two institution-level system causes for which two institution-level CAPAs were formulated by institutional leadership. The CAPAs established institutional procedures for independent verification of critical processes, their specification, and their planned control on high-risk studies.</p><p><strong>Conclusions: </strong>Lack of study-level procedural infrastructure jeopardized a multicenter study led by our institution. Lack of institutional infrastructure supporting identification of critical study processes, risks to them, and appropriate controls enabled the problem to occur. Studies conducted in settings lacking institutional or study-level procedural infrastructure are susceptible to similar problems. Adding the needed institutional processes to support identification of critical study processes, risks to them, and appropriate controls required reprioritizing existing resources.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e93"},"PeriodicalIF":2.7,"publicationDate":"2026-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13247789/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148217348","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":"Steps toward developing an algorithm to facilitate recognition of translational science.","authors":"Paul J Martin, Brian E Saelens, Theodore Johnson, Mark Harniss, Tumaini R Coker, Erin Abu-Rish Blakeney, Nina Isoherranen, Tong Sun, Nisha Bansal, Stephanie J Lee, John Amory, Naomi Kaku, Melissa Vaught","doi":"10.1017/cts.2026.10753","DOIUrl":"10.1017/cts.2026.10753","url":null,"abstract":"<p><strong>Introduction: </strong>In preparing for our Clinical and Translational Science Award (CTSA) UM1 application, we recognized the need to develop a shared understanding of the distinctions between translational science (TS) and translational research (TR). We describe our efforts to develop and evaluate the reliability of a concise instrument that investigators and reviewers could use to distinguish between TS and TR.</p><p><strong>Methods: </strong>Groups of faculty and staff individually reviewed published translational studies to determine whether the project involved TS and, separately, TR. One group (<i>n</i> = 10) first reviewed 14 publications with limited guidance; the same group and a second group (<i>n</i> = 9) then reviewed another set of 14 publications guided by a detailed algorithm. We used kappa statistics to measure agreement in the determinations of TS and TR for each publication.</p><p><strong>Results: </strong>The overall kappa coefficients in the three sets of TS determinations (two by the first group and one by the second group) were 0.61, 0.33, and 0.18, respectively. The overall kappa coefficients in the three sets of TR determinations were 0.26, 0.11, and 0.40, respectively. The median kappa coefficients for all 42 determinations were 0.39 for TS and 0.22 for TR, both indicating only fair agreement. We found no evidence that the algorithm helped to improve agreement rates.</p><p><strong>Conclusion: </strong>Our results show gaps in understanding the distinction between TS and TR among CTSA hub faculty and staff. We discuss some reasons for this gap and propose ways that could improve the recognition of TS and TR.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e100"},"PeriodicalIF":2.7,"publicationDate":"2026-05-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13312354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148352089","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":"Barriers and facilitators to participant recruitment and retention among black adults in a mobile health intervention to control hypertension (MI-BP): A mixed methods study.","authors":"Analay Perez, Katee Dawood, Reema Kadri, Rachelle Muladore, Alexandria Degner, Dongru Chen, Dara Harris, Phillip Levy, Lorraine R Buis, Timothy C Guetterman","doi":"10.1017/cts.2026.10738","DOIUrl":"10.1017/cts.2026.10738","url":null,"abstract":"<p><strong>Introduction: </strong>There are growing efforts to recruit and retain individuals from various populations in clinical trials to increase trial representativeness. Nonetheless, these challenges can hamper the development of clinical trials, contributing to increased inequities. This study explored the barriers and facilitators of participating in a mobile health trial designed to improve blood pressure (BP) among Blacks with uncontrolled hypertension from underserved communities.</p><p><strong>Methods: </strong>Participants were recruited from a larger mHealth clinical trial, MI-BP, across emergency departments, mobile health units, and community-based settings. We conducted an explanatory sequential mixed methods design to quantitatively examine participants' experiences with the MI-BP trial including satisfaction and reasons for dropping out. The qualitative semi-structured interviews expanded on participant experiences based on the quantitative results. Quantitative and qualitative results were integrated to provide a more comprehensive understanding.</p><p><strong>Results: </strong>Fifty-two participants completed the survey and a subset of 22 were interviewed. There were no statistically significant differences on reasons for joining the MI-BP study regardless of study completion. Participants were generally motivated to learn about ways to improve their BP, with many noting positive experiences, including completers and non-completers. Some who dropped out indicated meeting their goal of lowering their BP. Despite a robust consent process, some in the non-completer group reported not understanding certain components of the study compared to the completer group. Additional barriers included concerns over adverse effects and missing worktime.</p><p><strong>Conclusion: </strong>Findings illuminate the barriers and facilitators participants encountered in the MI-BP trial and provides considerations for reducing barriers among this population.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e95"},"PeriodicalIF":2.7,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13247782/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148217158","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":"Community feedback sessions: An adaptation of the community engagement studio model to enhance scalability.","authors":"Simone C Frank, Alicia Bilheimer, Nixola Datta, Mary E Grewe, Eseohe Aikhuele, Khadeejatul-Kubraa A Lawal, Michael D Kappelman","doi":"10.1017/cts.2026.10745","DOIUrl":"10.1017/cts.2026.10745","url":null,"abstract":"<p><strong>Introduction: </strong>The Community Engagement (CE) Studio is an established approach for integrating community and patient perspectives into research. Despite its widespread implementation, little information is available about how this model has been adapted across institutions to accommodate varying resources and capacities.</p><p><strong>Methods: </strong>The Patient and Community Engagement in Research (PaCER) Program at UNC-Chapel Hill modified the CE Studio model - with adaptations to recruitment, onboarding, virtual delivery, compensation, and session planning - resulting in the development of a new Community Feedback Session (CFS) service. This adaptation yielded a scalable model that requires fewer resources, supports capacity-building within research teams, and leverages technology. We then evaluated the CFS approach via surveys distributed to CFS attendees and researchers.</p><p><strong>Results: </strong>Between January 2022 and August 2025, we conducted 46 CFSs across 19 projects engaging 302 attendees; 149 attendees and 34 researchers completed evaluation surveys. Of these, 99% of attendees indicated they would participate again, and 97% of researchers rated the CFS service as Good or Excellent and recommended it to colleagues. Respondents appreciated the structure, facilitation, composition, and size of the sessions, and many had no suggestions for improvement. Researchers described changes they made to projects based on feedback received during CFSs, including amending study protocols, altering intervention content and delivery modalities, and revising a variety of study-related materials.</p><p><strong>Conclusions: </strong>Evaluation data support the acceptability, feasibility, and utility of the CFS approach, indicating that this modified and scalable service accomplishes researcher goals, informs research in an impactful way, and provides value to partners.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e91"},"PeriodicalIF":2.7,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13237187/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199180","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":"Advancing translational science through biostatistics, epidemiology, and research design consultations: A multi-perspective evaluation of the Georgia CTSA BERD program.","authors":"Gaurav Rajgopal, Nicole Llewellyn, John Hanfelt, Julia Wrobel, Eric Nehl","doi":"10.1017/cts.2026.10748","DOIUrl":"10.1017/cts.2026.10748","url":null,"abstract":"<p><p>A multi-perspective evaluation of a Biostatistics, Epidemiology, and Research Design (BERD) program was conducted within an NIH Clinical and Translational Science Awards hub. The program provides individual and group consultations, an educational forum event, and pilot and conference grants. Surveys from consultants and consultees following 62 BERD consultations spanning one year across four institutions assessed satisfaction, effectiveness, and expectations. Respondents expressed strong satisfaction, intent to recommend consultations, and many noted that the support strengthened their study design and grant preparation. Consultants highlighted the need for additional BERD resources to strengthen pre-consultations guidance, sustained follow-up, and mentoring for early-career investigators.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"10 1","pages":"e89"},"PeriodicalIF":2.7,"publicationDate":"2026-05-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13237171/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148199138","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}