Journal of Clinical and Translational Science最新文献

{"title":"The research equity and diversity initiative (READI): Changing the face of clinical research through community outreach and engagement.","authors":"Sally Taylor, Stephanie Freel, Lynn Sutton, Kenisha Bethea, Leatrice Martin, Julie McKeel, Matthew Ray, Perusi B Muhigaba, Stella Quenstedt, Amanda McMillan, Taryn Cavanaugh Faulk, Jenifer Allen, Kiah Gaskin, Richard Sloane, Salimah El-Amin, Annie Tsui, Cindy Canty-Dumas, Denise C Snyder, Joseph McClernon, Michelle Lyn, Keisha L Bentley-Edwards, Mina Silberberg, Steven C Grambow, Jessica Sperling, Howard Eisenson, Holly Biola, Wanda Boone, Rachel Galanter, Tracie Locklear, Sharleen Traynor, Seronda Robinson, William Pilkington, L Ebony Boulware, Nadine J Barrett, Susanna Naggie","doi":"10.1017/cts.2025.10085","DOIUrl":"10.1017/cts.2025.10085","url":null,"abstract":"<p><p>Current evidence underscores a need to transform how we do clinical research, shifting from academic-driven priorities to co-led community partnership focused programs, accessible and relevant career pathway programs that expand opportunities for career development, and design of trainings and practices to develop cultural competence among research teams. Failures of equitable research translation contribute to health disparities. Drivers of this failed translation include lack of diversity in both researchers and participants, lack of alignment between research institutions and the communities they serve, and lack of attention to structural sources of inequity and drivers of mistrust for science and research. The Duke University Research Equity and Diversity Initiative (READI) is a program designed to better align clinical research programs with community health priorities through community engagement. Organized around three specific aims, READI-supported programs targeting increased workforce diversity, workforce training in community engagement and cultural competence, inclusive research engagement principles, and development of trustworthy partnerships.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e156"},"PeriodicalIF":2.0,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392350/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956138","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":"Real-world mastery of essential skills in a clinical research coordinator graduate program.","authors":"Erika J Stevens, Ginnette Watkins-Keller, Nancy Reilly, Reynold A Panettieri, Barbara Tafuto","doi":"10.1017/cts.2025.10077","DOIUrl":"10.1017/cts.2025.10077","url":null,"abstract":"<p><p>Rutgers Health, Clinical Research Management (CRM) program with support from New Jersey Alliance for Clinical and Translational Science (NJ ACTS) provide scholarships to establish a \"Clinical Research Experience\" (CRE). The CRE focuses on building an entry-level Clinical Research Coordinator (CRC) workforce. The six-month precepted CRE is embedded in an accelerated master's degree and demonstrates a skill-based approach to developing CRC resources. The CRE structure affiliated site collaboration; competency based curriculum objectives; standardized competency aligned on-boarding; and preceptor-evaluated performance. The experiential education is designed for academic medical centers (AMCs) to foster the development of qualified research coordinators. The CRE model supports \"teach one, see one, do one\" coupled with preceptor-evaluated feedback to cultivate clinical research competency.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e162"},"PeriodicalIF":2.0,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392342/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955886","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":"Expanding the use and interpretation of patient-centric cardiovascular clinical trial endpoints.","authors":"Shelby D Reed, Pishoy Gouda","doi":"10.1017/cts.2025.10054","DOIUrl":"10.1017/cts.2025.10054","url":null,"abstract":"<p><p>Significant improvements have been achieved to enhance the patient-centricity of clinical research, including the development and utilization of novel clinical trial endpoints. These include endpoints that harness outcomes that are important to patients and reflect the patients' lived experiences. This may take the form of utilizing variables such as days alive and out of hospital (DAOH) and quality-of-life adjusted outcomes. The use of composite outcomes can be used to enrich patient-centricity by weighting or ranking events. These approaches have several nuances that should be considered including selecting appropriate events, defining outcomes, how to elicit or construct weights, and whose opinions to consider. After weights have been determined, a variety of approaches exist to combine weights with outcomes and make comparisons between groups. The approaches, including the win ratio, weighted win ratio, desirability of outcome ranking (DOOR), multicriteria decision analysis (MCDA), and variations of time-to-first composite event analyses, have unique advantages and challenges depending on the clinical scenario. While improving patient-centric outcomes is of high importance to multiple stakeholders, more comparative work is needed to characterize the implications of alternative approaches.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e151"},"PeriodicalIF":2.0,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955953","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":"Exploring grant writing coaching and its role in professional development of health equity investigators: A qualitative study.","authors":"Yulia A Levites Strekalova, Selin Kavak, Vanessa Caridad Rodriguez, Sara Midence, Lee S Caplan, Winston Thompson, Muhammed Y Idris, Jonathan Stiles, Priscilla Pemu, Alexander Quarshie, Adriana Baez, Maritza Salazar Campo, Elizabeth Ofili","doi":"10.1017/cts.2025.10080","DOIUrl":"10.1017/cts.2025.10080","url":null,"abstract":"<p><strong>Introduction: </strong>External funding is a critical metric in research career advancement, particularly in biomedical fields. Grant-writing coaching emerges as a strategy in biomedical workforce development. Recognizing disparities in grant success among early-career investigators from underrepresented groups, the National Research Mentoring Network Strategic Empowerment Tailored for Health Equity Investigators (NRMN-SETH) provides grant-writing coaching to support these scholars. This study explores the roles of NRMN-SETH grant-writing coaches in fostering technical skills and social support in a group setting.</p><p><strong>Methods: </strong>This qualitative study employed semi-structured interviews with 16 NIH-funded investigators who served as coaches within the NRMN-SETH program. Data were transcribed, coded, and analyzed using the Framework Method, identifying key roles related to coaching practices.</p><p><strong>Results: </strong>Findings reveal that grant-writing coaching involved personalized guidance, confidence-building, and structured group interactions. Coaches emphasized individualized feedback on grant components and provided iterative guidance. The group-based coaching environment fostered peer support and normalized challenges, creating a collaborative atmosphere conducive to skill-building. Coaches noted the importance of institutional support in enabling participants to engage in the program, though challenges arose in managing participants with varying grant-writing experience.</p><p><strong>Conclusions: </strong>This study highlights the potential of grant-writing coaching to enhance research capacity among underrepresented scholars, offering a structured, supportive approach that complements traditional mentorship. Integrating tailored coaching programs within biomedical workforce development, particularly at minority-serving and low-resourced institutions, may reduce disparities in grant success. Future research could expand on these findings by investigating the long-term career impacts of coaching and testing the effectiveness of peer-led, group-based components in grant-writing success.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e178"},"PeriodicalIF":2.0,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444689/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113380","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 Clinical and Translational Science Award compendium of dissemination and implementation science resource catalogs: Capacity building tools for clinical and translational scientists.","authors":"Lindsay A Lennox, Rachel C Shelton, Catherine L Rohweder, Bethany M Kwan","doi":"10.1017/cts.2025.10087","DOIUrl":"10.1017/cts.2025.10087","url":null,"abstract":"<p><p>This paper describes the development and initial implementation of the Compendium of D&I Catalogs, a tool created by a Clinical and Translational Science Awards (CTSA) consortium working group to streamline navigation of the proliferating online resources, catalogs and interactive tools designed to guide application of dissemination and implementation (D&I) science. The Compendium is a curated, dynamically-updated list of 35 D&I resource catalogs organized into eight categories: comprehensive resources; frameworks, theories, and models; methods and measures; funding; practitioner resources; training; CTSA infrastructure; health equity. Eight CTSA hubs volunteered to serve as \"early adopters\" for the tool and completed an evaluation of its initial implementation. Among these \"early adopters,\" half had implemented the Compendium within their websites, describing the web implementation process as \"easy.\" Remaining \"early adopter\" respondents cited institutional web development capacity concerns and competing priorities as reasons for delayed implementation. All respondents valued the Compendium's dynamic updates. Among implementing sites, roughly two-thirds directly embedded the Compendium into their institutional websites, with the others providing a link to the Compendium. For CTSAs striving to meet the rising demand for D&I expertise and resources, the Compendium of D&I Catalogs represents a simple, low-cost tool to enhance accessibility of D&I capacity-building resources.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e154"},"PeriodicalIF":2.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956166","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":"Team science training for clinical and translational Scientists: An assessment of effectiveness.","authors":"Anne Mook, Verena Knerich, Goldie Komaie, Lisa Cicutto, Jennifer Cross","doi":"10.1017/cts.2025.10088","DOIUrl":"10.1017/cts.2025.10088","url":null,"abstract":"<p><strong>Introduction: </strong>Effective interdisciplinary collaboration is essential for addressing complex clinical and translational research challenges. This paper presents and evaluates a structured team science training program developed by the Colorado Clinical and Translational Sciences Institute (CCTSI), while also introducing and validating a novel assessment tool used to measure changes in key teaming competencies.</p><p><strong>Methods: </strong>We evaluated the effectiveness of this program between 2020 and 2022 using pre- and post-program surveys (<i>N</i> = 221). Our evaluation tool was designed to capture familiarity with teaming concepts and the frequency of applying collaborative practices. Principal component analysis (PCA) was applied to validate the grouping of these competencies, and paired <i>t</i>-tests were used to measure changes over time.</p><p><strong>Results: </strong>PCA revealed three distinct components of team science competencies: Team Planning, Managing a Team, and Interpersonal Relations, all demonstrating strong internal reliability. Participants showed statistically significant improvements (<i>p</i> < 0.05) in all three domains. Gains were robust in Team Planning and Managing a Team, emphasizing structured tools and practices. Although improvement was also observed in Interpersonal Relations, the overall gains were smaller.</p><p><strong>Conclusions: </strong>These findings highlight the self-reported value of Team Science Training programs in CTR settings. The TEAMS instrument described in this manuscript offers a novel approach for CTSAs to evaluate their Team Science training programs. Future applications could include longitudinal tracking and integration metrics to support future program planning, particularly fostering interdisciplinary collaboration and team integration.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e158"},"PeriodicalIF":2.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392353/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144956130","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":"Insights from the trial innovation network's initial consultation process.","authors":"Paul A Harris, Nan Kennedy, Consuelo H Wilkins, Karen Lane, Gordon R Bernard, Jonathan D Casey, Daniel E Ford, Salina P Waddy, Ken L Wiley, Terri L Edwards, Nichol McBee, Dixie D Thompson, Mary Stroud, Emily S Serdoz, Sarah J Nelson, Michelle Jones, Lindsay M Eyzaguirre, Leslie R Boone, Jessica Baird, Colleen E Lawrence, Elizabeth Holthouse, Sarah K Cook, Maeve Tischbein, Natalya Amrine, Tiffany Chen, Jodie Cohen, LaShondra Deyampert, Natalie A Dilts, Delicia Burts, Amna Baig, Joseph G Christodoulou, Mariela Rodriguez, Edgar R Miller, James F Casella, W Andrew Mould, J Michael Dean, Daniel K Benjamin, Harry P Selker, Marisha E Palm, Lori Poole, Jeri S Burr, Sara Hassani, Angeline Nanni, Meghan Hildreth, Daniel F Hanley","doi":"10.1017/cts.2025.10084","DOIUrl":"10.1017/cts.2025.10084","url":null,"abstract":"<p><p>Multicenter clinical trials are essential for evaluating interventions but often face significant challenges in study design, site coordination, participant recruitment, and regulatory compliance. To address these issues, the National Institutes of Health's National Center for Advancing Translational Sciences established the Trial Innovation Network (TIN). The TIN offers a scientific consultation process, providing access to clinical trial and disease experts who provide input and recommendations throughout the trial's duration, at no cost to investigators. This approach aims to improve trial design, accelerate implementation, foster interdisciplinary teamwork, and spur innovations that enhance multicenter trial quality and efficiency. The TIN leverages resources of the Clinical and Translational Science Awards (CTSA) program, complementing local capabilities at the investigator's institution. The Initial Consultation process focuses on the study's scientific premise, design, site development, recruitment and retention strategies, funding feasibility, and other support areas. As of 6/1/2024, the TIN has provided 431 Initial Consultations to increase efficiency and accelerate trial implementation by delivering customized support and tailored recommendations. Across a range of clinical trials, the TIN has developed standardized, streamlined, and adaptable processes. We describe these processes, provide operational metrics, and include a set of lessons learned for consideration by other trial support and innovation networks.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e149"},"PeriodicalIF":2.0,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305380/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742238","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":"Health Equity Leadership and Mentoring (HELM): A health equity-focused early-career development program to promote biomedical workforce diversity.","authors":"Melanie Steiner, Susan A Everson-Rose, April F Mohanty, José E Rodríguez, Molly B Conroy, Michele L Allen, Antonia Apolinário-Wilcoxon, Kolawole S Okuyemi","doi":"10.1017/cts.2025.10083","DOIUrl":"10.1017/cts.2025.10083","url":null,"abstract":"<p><p>Intentionally enhancing and supporting the early careers of individuals from populations underrepresented in science and medicine (URSM) is essential to achieving health equity. The Health Equity Leadership and Mentoring (HELM) Program at the University of Minnesota and the University of Utah is designed to foster academic excellence and build leadership capacity of postdoctoral fellows, clinical fellows, and early-career faculty who identify as URSM and/or who are committed to careers in health equity research and clinical care. HELM models a culture of psychosocial safety to create a sense of belonging and uses evidence-based and culturally aware mentoring and career development strategies with the goal of retaining diverse faculty. HELM proved agile and adaptive during the Covid-19 pandemic and has been successful in states with and without legislation limiting diversity programs. Across the 2 institutions, the HELM program has supported over 200 trainees and early-career faculty through mid-2024. Among HELM participants who joined the program as faculty, 85%-95% have remained in their faculty positions.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e183"},"PeriodicalIF":2.0,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12444691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145113007","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":"Translating implementation science principles and methods to front-line clinicians: The Implementation Science Scholars Program.","authors":"Geoffrey M Curran, Sara J Landes, Taren Massey-Swindle, Benjamin S Teeter, Cynthia L Mosley, Jennifer Naylor, Laura P James","doi":"10.1017/cts.2025.10072","DOIUrl":"10.1017/cts.2025.10072","url":null,"abstract":"<p><p>This article describes the Implementation Science (IS) Scholars Program at the University of Arkansas for Medical Sciences (UAMS). The program's goal is to translate knowledge, approaches, and methods from IS to front-line clinicians in an academic medical center, thereby supporting its goals as a learning health system and promoting a dynamic workforce of IS-informed change leaders. Initiated in 2020, the program is relatively unique in that it attempts to translate concepts and knowledge <i>from</i> IS to clinicians to improve their skills as implementers and change agents. The program is supported by the Translational Research Institute, the UAMS' awardee of the Clinical and Translational Science Award Program. The two-year program provides 20% salary coverage, bespoke didactics, and close mentoring on a Scholar-initiated project to improve care in their clinical context. The program has trained four cohorts of Scholars over the program's initial five years. We describe the program, our evaluation of it thus far, and future plans. The program has contributed to numerous healthcare improvements and served as a gateway to future implementation and other research activities among some Scholars.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e147"},"PeriodicalIF":2.0,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305373/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742239","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":"Perceptions of a comprehensive telehealth intervention in patients with persistently poor type 2 diabetes control.","authors":"Jashalynn German, Madeleine R Eldridge, Lucy Esteve, Anastasia-Stefania Alexopoulos, Connor Drake, Allison Lewinski, Hayden B Bosworth, David Edelman, Karen Steinhauser, Matthew J Crowley","doi":"10.1017/cts.2025.10082","DOIUrl":"10.1017/cts.2025.10082","url":null,"abstract":"<p><strong>Introduction: </strong>To understand participant perspectives on an effective, practical, comprehensive telehealth intervention for persistently poorly controlled diabetes mellitus and examine how its components contributed to improved outcomes, with the goal of informing broader telehealth-based diabetes management strategies.</p><p><strong>Methods: </strong>We conducted semi-structured interviews of a purposive sample of patients and staff in the comprehensive telehealth arm of the Practical Telehealth to Improve Control and Engagement for Patients with Clinic-Refractory Diabetes Mellitus study. Using the lens of patient engagement, we applied directed content analysis to categorize themes across the five components of the intervention.</p><p><strong>Results: </strong>The purposive sample included 19 patients (79% male, 53% Black, varying levels of intervention engagement) and 8 staff. The telemonitoring component was associated with encouragement and motivation among patients; staff found satisfaction in providing metrics of success for participants. For the self-management component, patients saw staff as helpful with problem-solving; staff felt patients were receptive to education. Medication management supported medication adherence and optimization and was acceptable to patients. Diet/activity support motivated behavioral changes among patients. Staff felt that depression support allowed for responsiveness to medical and behavioral factors influencing self-management. Identified areas for improvement included staff time constraints, patient difficulties with taking and transmitting data, and challenges with patient adherence among those with mental health conditions.</p><p><strong>Conclusion: </strong>Findings from this study provide insights that may inform the design, implementation, and scalability of comprehensive telehealth models for diabetes management across diverse healthcare settings.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e153"},"PeriodicalIF":2.0,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12392345/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955944","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}