Jessica Sperling, Stella Quenstedt, Perusi Muhigaba, F Joseph McClernon, Kristine Glauber, Eman Ghanem, Tarun Saxena, Vonda Rodriguez, Cinthia Sanchez
{"title":"Erratum: 238 The Translational Science Promotion and Research Capacity (T-SPARC) framework: Developing institutional capacity for translational science - CORRIGENDUM.","authors":"Jessica Sperling, Stella Quenstedt, Perusi Muhigaba, F Joseph McClernon, Kristine Glauber, Eman Ghanem, Tarun Saxena, Vonda Rodriguez, Cinthia Sanchez","doi":"10.1017/cts.2025.10093","DOIUrl":"https://doi.org/10.1017/cts.2025.10093","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2024.885.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e143"},"PeriodicalIF":2.0,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305372/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742234","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}
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
{"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}
Geoffrey M Curran, Sara J Landes, Taren Massey-Swindle, Benjamin S Teeter, Cynthia L Mosley, Jennifer Naylor, Laura P James
{"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}
Xiaoqian Zhu, Tariq Shafi, Keith C Norris, Jeannette Simino, Srishti Shrestha, Thomas H Mosley, Michael E Griswold, Seth T Lirette
{"title":"Comparing methods for glomerular filtration rate estimation.","authors":"Xiaoqian Zhu, Tariq Shafi, Keith C Norris, Jeannette Simino, Srishti Shrestha, Thomas H Mosley, Michael E Griswold, Seth T Lirette","doi":"10.1017/cts.2025.10057","DOIUrl":"10.1017/cts.2025.10057","url":null,"abstract":"<p><strong>Background: </strong>The glomerular filtration rate (GFR), estimated from serum creatinine (SCr), is widely used in clinical practice for kidney function assessment, but SCr-based equations are limited by non-GFR determinants and may introduce inaccuracies across racial groups. Few studies have evaluated whether advanced modeling techniques enhance their performance.</p><p><strong>Methods: </strong>Using multivariable fractional polynomials (MFP), generalized additive models (GAM), random forests (RF), and gradient boosted machines (GBM), we developed four SCr-based GFR-estimating equations in a pooled data set from four cohorts (<i>n</i> = 4665). Their performance was compared to that of the refitted linear regression-based 2021 CKD-EPI SCr equation using bias (median difference between measured GFR [mGFR] and estimated GFR [eGFR]), precision, and accuracy metrics (e.g., P10 and P30, percentage of eGFR within 10% and 30% of mGFR, respectively) in a pooled validation data set from three additional cohorts (<i>n</i> = 2215).</p><p><strong>Results: </strong>In the validation data set, the greatest bias and lowest accuracy, were observed in Black individuals for all equations across subgroups defined by race, sex, age, and eGFR. The MFP and GAM equations performed similarly to the refitted CKD-EPI SCr equation, with slight improvements in P10 and P30 in subgroups including Black individuals and females. The GBM and RF equations demonstrated smaller biases, but lower accuracy compared to other equations. Generally, differences among equations were modest overall and across subgroups.</p><p><strong>Conclusions: </strong>Our findings suggest that advanced methods provide limited improvement in SCr-based GFR estimation. Future research should focus on integrating novel biomarkers for GFR estimation and improving the feasibility of GFR measurement.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e148"},"PeriodicalIF":2.0,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742233","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}
Emiliane L Pereira, Thomas E Strayer, Samantha M Harden, Russell E Glasgow, Christina Studts, Paul A Estabrooks, Amy G Huebschmann
{"title":"Improving the usability of online resources to support implementation research and practice: The RE-AIM website use case.","authors":"Emiliane L Pereira, Thomas E Strayer, Samantha M Harden, Russell E Glasgow, Christina Studts, Paul A Estabrooks, Amy G Huebschmann","doi":"10.1017/cts.2025.10070","DOIUrl":"10.1017/cts.2025.10070","url":null,"abstract":"<p><strong>Introduction: </strong>Our overall goal was to enhance the usability and interactivity of the RE-AIM website (re-aim.org) and improve resources to support the application of the RE-AIM framework within the context of dissemination & implementation (D&I) research and practice.</p><p><strong>Methods: </strong>We applied a mixed-methods approach to obtain user feedback from 24 D&I researchers and practitioners. Usability (System Usability Scale) and interactivity (Interactivity Scale) were assessed through validated surveys, at baseline and after two iterative rounds of website modifications (Phase 1 and Phase 2). We also conducted qualitative assessments at each phase.</p><p><strong>Results: </strong>Qualitative baseline and Phase 1 findings indicated a need to simplify organization, enhance information accessibility, provide concrete guidance on applying RE-AIM, and clarify contextual factors related to RE-AIM constructs. After streamlining website and homepage organization, Phase 2 qualitative results suggested improved user navigation experience; users also requested greater interactivity. Modifications included: new interactive planning tool and a video introduction of contextual factors influencing RE-AIM outcomes. Significant improvements were found in the SUS score from baseline to Phase 1(64.2[SD18.7] to 80.8 [SD 12.1] (<i>p</i> < .05) and remained higher in Phase 2(77.1[SD 15] (<i>p</i> = 0.08). Interactivity also improved from baseline to Phase 2(3.5[SD1.2] to 41[0.9], though not statistically significant.</p><p><strong>Conclusion: </strong>User-centered feedback on online resources, as exemplified by this use case example of enhancements to the RE-AIM website, are important in bridging the gap between research and practice, and the revised website should be more accessible and useful to users.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e146"},"PeriodicalIF":2.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305379/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742237","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}
Marissa Stroo, Camila Reyes, Christine Deeter, Stephanie A Freel, Heather Gaudaur, Richard Sloane, Denise C Snyder
{"title":"Trends in turnover and turbulence at a large academic medical center before and during COVID-19: Analyzing structured clinical research professional roles.","authors":"Marissa Stroo, Camila Reyes, Christine Deeter, Stephanie A Freel, Heather Gaudaur, Richard Sloane, Denise C Snyder","doi":"10.1017/cts.2025.10063","DOIUrl":"10.1017/cts.2025.10063","url":null,"abstract":"<p><strong>Introduction: </strong>High workforce turbulence has plagued clinical research, becoming intensified during the COVID-19 pandemic, especially for patient-facing workers. In a time of great uncertainty and risk among healthcare workers, researchers included, the pandemic also brought increased demand for research studies in volume, speed, and complexity, triggering elevated staff turnover. This has posed significant hurdles for employers, especially research sites, where retaining skilled patient-facing clinical research professionals (CRPs) is pivotal for sustaining medical innovation. Lack of job standardization and advancement pathways has been noted to play an important role both in turnover and contributes to the inability to accurately measure workforce trends. To address these factors, Duke University adopted a competency-based job classification system for CRPs in 2016.</p><p><strong>Methods: </strong>Since that adoption of competency-based jobs, employee-level staffing data for all CRPs have been tracked monthly, creating a master data file from September 2016 through June 2024. This study updates previous analyses, evaluating turnover and turbulence rates, and demographic changes in the CRP workforce over this period.</p><p><strong>Results: </strong>Over the last six years, the Duke CRP workforce remained relatively stable. Voluntary turnover rates fluctuated, peaking at 19.1% in FY 2021 during the COVID-19 pandemic, and have steadily declined each year since then.</p><p><strong>Conclusions: </strong>Despite national workforce challenges exacerbated by the pandemic, our data indicate that proactive measures to standardize clinical research jobs and assess the resultant well-defined site-based employee data may have mitigated extremes in workforce turnover at Duke University. Turbulence rates, while stabilizing, signal areas for further study.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e134"},"PeriodicalIF":2.1,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12260974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642719","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}
Phillip A Ianni, Brenda L Eakin, Elias M Samuels, Christine Byks-Jazayeri, Ellen Champagne, Matheos Yosef, Shokoufeh Khalatbari, Vicki L Ellingrod
{"title":"Examining the effect of a non-attendance fee on writing workshop attendance, grant submission, and success rates among K award applicants.","authors":"Phillip A Ianni, Brenda L Eakin, Elias M Samuels, Christine Byks-Jazayeri, Ellen Champagne, Matheos Yosef, Shokoufeh Khalatbari, Vicki L Ellingrod","doi":"10.1017/cts.2025.10079","DOIUrl":"10.1017/cts.2025.10079","url":null,"abstract":"<p><p>In 2009, the University of Michigan's Michigan Institute for Clinical and Health Research developed a three-session K Writing workshop. Beginning in 2016, we implemented a non-attendance fee to encourage attendance across the three sessions. We examined whether this fee improved attendance, increased submission of an NIH K or R grant proposal, and improved success rates. Between 2012 and 2021, 373 participants attended the workshop. After the non-attendance fee was implemented, significantly more participants attended all three sessions of the workshop, and there was a statistical trend suggesting an increase in the success rate, while submission rates remained constant.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e145"},"PeriodicalIF":2.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305375/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742236","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 knowledge into action: Community-centered recommendations from the RADx-UP COVID-19 Equity Evidence Academy virtual conference series.","authors":"Alicia Bilheimer, Blen Mengesha Biru, Enomen Idiagbonya, Cassidy Fox, Renee Leverty, Camille Brown-Lowery, Lori Carter-Edwards","doi":"10.1017/cts.2025.10075","DOIUrl":"10.1017/cts.2025.10075","url":null,"abstract":"<p><p>The Rapid Acceleration of Diagnostics-Underserved Populations' COVID-19 Equity Evidence Academy (RADx-UP EA) was a series of virtual conferences hosted between 2021 and 2023 that assembled community members, researchers, and governmental leaders from across the US to discuss and devise ways to promote equity in COVID-19 testing and vaccination. Using community-engaged methodologies in its design and implementation, this series provided a framework and forum for community and academic partners to engage in collaborative idea generation and consensus building during a public health emergency. The ideas and strategies gained during the EAs were disseminated to inform future research and action related to COVID-19. This conference paper highlights the specific engagement approaches used and the themes and recommendations generated. This model and its findings have broad utility beyond RADx-UP and can be used by researchers and practitioners to inform and advance community-engaged research and practice in diverse public health settings.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e142"},"PeriodicalIF":2.0,"publicationDate":"2025-06-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12305377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144742240","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}
Kimberly McCall, Jewell Dickson-Clayton, Jordin Lane, Keith McGregor, Shellie Layne, Raymond Jones
{"title":"Erratum: 271 Research follow-up: Outcomes/preliminary results - BeFit Toolbox Collaboration: Building empowerment through Fitness program - CORRIGENDUM.","authors":"Kimberly McCall, Jewell Dickson-Clayton, Jordin Lane, Keith McGregor, Shellie Layne, Raymond Jones","doi":"10.1017/cts.2025.10074","DOIUrl":"https://doi.org/10.1017/cts.2025.10074","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2024.914.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e126"},"PeriodicalIF":2.1,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12209957/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144540432","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}
Maggie Padek, Dinesh Pal Mudaranthakam, Sam Pepper, Mary Penne Mays, Shellie D Ellis
{"title":"Building an evaluation infrastructure to capture process and progress within a Clinical and Translational Science Awards hub.","authors":"Maggie Padek, Dinesh Pal Mudaranthakam, Sam Pepper, Mary Penne Mays, Shellie D Ellis","doi":"10.1017/cts.2025.10047","DOIUrl":"10.1017/cts.2025.10047","url":null,"abstract":"<p><p>To improve its management capacity, Frontiers Clinical and Translational Science Institute overhauled its evaluation infrastructure to be comprehensive, efficient, and transparent in demonstrating outputs and outcomes. We built a platform that standardized measures across program areas, integrated continuous improvement processes, and reduced the data entry burden for investigators. Using the Utilization-Focused Evaluation Framework, we created logic models to identify appropriate metrics. We built the evaluation data platform within REDCap to capture requests, events, attendance, and outcomes and to push work processes to Navigators. We initiated a membership model to serve as the backbone of the platform which allowed tailored communication, demographic data capture, and reduced data entry burden. The platform consists of nine REDCap projects across multiple programmatic areas. Using REDCap Dynamic SQL query fields and External Modules, the membership module was integrated into all forms to check and collect membership before service access. Data is synched to a dashboard for tracking outputs and outcomes in real-time. Since the launch of the evaluation platform in Fall 2022, Frontiers has increased its workflow efficiency and streamlined continuous improvement communication. The platform can serve as a model for other hubs to build efficient processes to create comprehensive and transparent evaluation plans.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e136"},"PeriodicalIF":2.1,"publicationDate":"2025-06-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12260981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144642700","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}