Journal of Clinical and Translational Science最新文献

{"title":"Operationalizing a complex acute clinical trial: Lessons from the BEACH study.","authors":"Gracey Sorensen, Will Remillard, Maia Schlechter, Michael Kampp, Cailin Whisler Brady, Kaley Kildahl, Andrew Mould, Wendy Ziai, Karen Lane, Linda J Van Eldik, Ashley Distasio, Jing Lu, Lauren H Sansing, Daniel F Hanley, Jessica Magid-Bernstein","doi":"10.1017/cts.2025.10152","DOIUrl":"10.1017/cts.2025.10152","url":null,"abstract":"<p><p>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.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e215"},"PeriodicalIF":2.0,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12485565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212747","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":"Practical issues in recruiting and retaining Asian American breast cancer survivors in a technology-based intervention study: A discussion paper.","authors":"Wonshik Chee, Seulgi Ryu, Jianing Quan, Dongmi Kim, Eun-Ok Im","doi":"10.1017/cts.2025.10132","DOIUrl":"10.1017/cts.2025.10132","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Addressing these recruitment and retention issues can inform the design of future culturally tailored, technology-based intervention studies for racial and ethnic minority populations.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e198"},"PeriodicalIF":2.0,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444715/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113268","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":"A conversation with Kevin Gibbs, MD, associate professor, Wake Forest University School of Medicine.","authors":"","doi":"10.1017/cts.2025.10135","DOIUrl":"https://doi.org/10.1017/cts.2025.10135","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e197"},"PeriodicalIF":2.0,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444685/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113402","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 perceptions of point-of-care-technologies: Results from a nationwide survey of healthcare professionals.","authors":"Trevor Vigeant, Reilly Riddell, Bernard Ofosuhene, Grace White, Matheus Montenario, Ziyue Wang, Taylor Orwig, Heaven Y Tatere, Bryan Buchholz, Denise Dunlap, David D McManus, Ayorkor Gaba, Nathaniel Hafer","doi":"10.1017/cts.2025.10149","DOIUrl":"10.1017/cts.2025.10149","url":null,"abstract":"<p><strong>Background/objective: </strong>Point-of-care technologies (POCTs) have grown increasingly prevalent in clinical and at-home settings, offering various rapid diagnostic capabilities. This study presents findings from a nationwide survey conducted between November 2023 and January 2024, capturing clinician perceptions of POCTs.</p><p><strong>Methods: </strong>The survey was distributed via email to healthcare professionals through academic and industry listservs and through LinkedIn posts. A total of 159 responses were analyzed.</p><p><strong>Results: </strong>Core priorities, including accuracy, ease of use, and availability, remain consistently valued over the years. However, several perceived benefits, including continuous patient monitoring, diagnostic certainty, and patient management exhibited significant declines in agreement compared to previous years. Despite this, clinician perceptions of POCTs' abilities to enhance patient-provider communication remained stable. Evolving concerns may reflect heightened expectations and greater scrutiny as these technologies become commonplace. Agreement that POCTs may undermine clinical expertise increases, while concerns related to reimbursement and usability decline. Pilot questions related to artificial intelligence (AI) and machine learning (ML) indicated moderate openness to adopting AI-enhanced POCTs, particularly with tools offering novel clinical insights.</p><p><strong>Conclusions: </strong>While POCTs continue to be an asset in clinical settings, the findings of this study suggest a shift in provider attitudes toward a more neutral standpoint. Limitations include a low response rate, self-selection, and missing demographic data from a subset of participants. Future surveys will further integrate AI/ML-related questions while prioritizing broader demographic and geographic reach.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e207"},"PeriodicalIF":2.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12485566/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145212733","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":"An impending crisis for the translational science pipeline: The dire impact of proposed NIH budget cuts on early-career researchers.","authors":"Niranjan S Karnik, Vicki L Ellingrod, Emma Anne Meagher","doi":"10.1017/cts.2025.10129","DOIUrl":"10.1017/cts.2025.10129","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e196"},"PeriodicalIF":2.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444700/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113432","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":"Efforts to evaluate translational science's impact on biomedicine and society should incorporate Science and Technology Studies (STS).","authors":"Stephen Molldrem, Jacob D Moses, Emma Tumilty, Peyton Swanson, Jeffrey S Farroni, Elise M R Smith","doi":"10.1017/cts.2025.10120","DOIUrl":"10.1017/cts.2025.10120","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e191"},"PeriodicalIF":2.0,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444701/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113395","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":"A case series on TNF-α inhibitors for APS- induced high-risk pregnancies.","authors":"Ran An, Xiaolei Wang, Ligui Xiong, Yanqi Yang, Peiling Li","doi":"10.1017/cts.2025.10097","DOIUrl":"10.1017/cts.2025.10097","url":null,"abstract":"<p><p>We deliberated a case report of seven cases to investigate whether inhibitors of tumor necrosis factor-α (TNF-) could reduce pregnancy dangers caused by antiphospholipid syndrome (APS). Patient 1 was diagnosed with NC-OAPS and Hashimoto, Patient 3 was with SN-APS and Hashimoto, Patient 2, 3, 4 were with SN-APS, Patient 5 and 6 were with OAPS, and Patient 7 was with OAPS and PCOS. Patient 4 took the longest period to report the disappearance of symptoms (7 days), followed by patients 1 and 5, and lastly, 2, 3, 6 and 7; after treatment, TNF-α decreased to varying degrees in 7 patients, among which Patient 1, 3, 6, 7 reached the ideal level (< 8.1) and Patient 5 reached the highest level (123.04); Patient 6 and 7 were ongoing pregnancies. The fetuses were born to the desired gestational age except the fetus from Patient 1. A total of 5 patients underwent cesarean delivery. The average height of the newborns was 48.20 cm and the average weight was 2.50 kg. The Apgar scores ranged between 8 and 10. The ongoing pregnancies as a limitation of the dataset. Collectively, we found that TNF-α Inhibitors could prolong gestational period.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e186"},"PeriodicalIF":2.0,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444713/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113351","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":"Partial waiver of consent to overcome translational science barriers in neonatal clinical research.","authors":"Megha Sharma, Sarah E Diamond, Jenna Chancellor, Simon Chung, Andrew W Brown, D Micah Hester, Laura P James, Mario Schootman, Peter M Mourani, Sherry E Courtney","doi":"10.1017/cts.2025.10122","DOIUrl":"10.1017/cts.2025.10122","url":null,"abstract":"<p><p>Prospective consent in neonatal research poses significant challenges, particularly during urgent, time-sensitive clinical windows of study enrollment. This is especially true at referral centers for large geographic regions. A partial waiver of consent offers a potential translational science approach to enhance access to research participation in critically ill neonates. We compared enrollment rates in a study evaluating pulse oximetry accuracy across neonates with varying skin pigmentation before and after implementing a partial waiver of consent. Overall enrollment increased significantly without creating a racial disparity in enrollment, thereby improving generalizability and efficiency in neonatal clinical research.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e202"},"PeriodicalIF":2.0,"publicationDate":"2025-08-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12454670/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137741","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":"Development and validation of natural language processing algorithms in the national ENACT network.","authors":"Yanshan Wang, Jordan Hilsman, Chenyu Li, Michele Morris, Paul M Heider, Sunyang Fu, Min Ji Kwak, Andrew Wen, Joseph R Applegate, Liwei Wang, Elmer Bernstam, Hongfang Liu, Jack Chang, Daniel R Harris, Alexandria Corbeau, Darren Henderson, John Osborne, Richard E Kennedy, Nelly-Estefanie Garduno-Rapp, Justin F Rousseau, Chao Yan, You Chen, Mayur B Patel, Tyler J Murphy, Bradley A Malin, Chan Mi Park, Jungwei W Fan, Sunghwan Sohn, Sandeep Pagali, Yifan Peng, Aman Pathak, Yonghui Wu, Zongqi Xia, Salvatore Loguercio, Steven E Reis, Shyam Visweswaran","doi":"10.1017/cts.2025.10116","DOIUrl":"10.1017/cts.2025.10116","url":null,"abstract":"<p><strong>Objective: </strong>Electronic Health Record (EHR) data are critical for advancing translational research and AI technologies. The ENACT network offers access to structured EHR data across 57 CTSA hubs. However, substantial information is contained in clinical narratives, requiring natural language processing (NLP) for research. The ENACT NLP Working Group was formed to make NLP-derived clinical information accessible and queryable across the network.</p><p><strong>Methods: </strong>We established the ENACT NLP Working Group with 13 sites selected based on criteria including clinical notes access, IT infrastructure, NLP expertise, and institutional support. We divided sites into five focus groups targeting clinical tasks within disease contexts. Each focus group consisted of two development sites and two validation sites. We extended the ENACT ontology to standardize NLP-derived data and conducted multisite evaluations using the Open Health Natural Language Processing (OHNLP) Toolkit.</p><p><strong>Results: </strong>The working group achieved 100% site retention and deployed NLP infrastructure across all sites. We developed and validated NLP algorithms for rare disease phenotyping, social determinants of health, opioid use disorder, sleep phenotyping, and delirium phenotyping. Performance varied across sites (F1 scores 0.53-0.96), highlighting data heterogeneity impacts. We extended the ENACT common data model and ontology to incorporate NLP-derived data while maintaining Shared Health Research Informatics NEtwork (SHRINE) compatibility.</p><p><strong>Conclusion: </strong>This demonstrates feasibility of deploying NLP infrastructure across large, federated networks. The focus group approach proved more practical than general-purpose approaches. Key lessons include the challenge of data heterogeneity and importance of collaborative governance. This work also provides a foundation that other networks can build on to implement NLP capabilities for translational research.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e199"},"PeriodicalIF":2.0,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444719/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113358","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":"The 10-year anniversary of the dissemination and implementation models in health interactive webtool: History, refinement, use, and guidance.","authors":"Borsika A Rabin, Bryan Ford, Rachel G Tabak, Rebekah Gomes, Kera N Swanson, Sara Malone, Maggie Padek Kalman, Ross C Brownson, Russell E Glasgow","doi":"10.1017/cts.2025.10128","DOIUrl":"10.1017/cts.2025.10128","url":null,"abstract":"<p><p>Theories, models, and frameworks (TMFs) are essential tools in dissemination and implementation (D&I) research, yet selecting and applying the most appropriate TMF is routinely a challenge, particularly for those new to the field. To address this need, we developed the <i>Dissemination and Implementation Models in Health</i> webtool (www.dissemination-implementation.org) a free, interactive, and evolving online resource designed to support the thoughtful use of D&I TMFs across all phases of research and practice - from planning through assessment. Created through a multi-institutional collaboration and refined using human-centered design, the webtool includes features such as logic model development, D&I TMF selection and comparison, guidance on combining and adapting models, strategies for application, and linkages to measurement tools. Since its initial release in 2014, the webtool has expanded to include over 110 D&I TMFs and new thematic content areas, including a section dedicated to health equity. It can be used in D&I trainings, proposal development, consultations, and academic coursework. Usage analytics and community feedback reflect ongoing relevance, utility, and evolving needs. The webtool continues to address a significant gap in D&I infrastructure by guiding users in selecting and operationalizing D&I TMFs, ultimately supporting more rigorous, context-sensitive translational research and practice.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e195"},"PeriodicalIF":2.0,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444696/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113318","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}