Journal of Clinical and Translational Science最新文献

{"title":"Implementation and evaluation of a group peer mentoring and leadership development program for research faculty in academic medicine.","authors":"Linda H Pololi, Janet T Civian, Mark Brimhall-Vargas, Vasilia Vasiliou, Arthur T Evans, Kacy Ninteau, Lisa A Cooper, Brian T Gibbs, Robert T Brennan","doi":"10.1017/cts.2025.37","DOIUrl":"10.1017/cts.2025.37","url":null,"abstract":"<p><strong>Introduction: </strong>Research faculty often experience poor mentoring, low vitality, and burnout. We report on our logic model inputs, activities, measurable outcomes, and impact of a novel mentoring intervention for biomedical research faculty: the <i>C-Change Mentoring & Leadership Institute</i>. We present a) a detailed description of the curriculum and process, b) evaluation of the program's mentoring effectiveness from the perspective of participants, and c) documentation of mentoring correlated with key positive outcomes.</p><p><strong>Methods: </strong>A yearlong facilitated group peer mentoring program that convened quarterly in person was conducted twice (2020-2022) as part of an NIH-funded randomized controlled study. The culture change intervention aimed to increase faculty vitality, career advancement, and cross-cultural competence through structured career planning and learning of skills essential for advancement and leadership in academic medicine. Participants were 40 midcareer MD and PhD research faculty, half women, and half underrepresented by race or ethnicity from 27 US medical schools.</p><p><strong>Results: </strong>Participants highly rated their mentoring received at the Institute. Extent of effective mentoring experienced correlated strongly with the measurable outcomes of enhanced vitality, self-efficacy in career advancement, research and work-life integration, feelings of inclusion in the program, valuing diversity, and skills for addressing inequity.</p><p><strong>Conclusions: </strong>The mentoring model fully included men and women and historically underrepresented persons in medicine and minimized problems of power, gender, race, and ethnicity discordance. The intervention successfully addressed the urgencies of sustaining faculty vitality, developing faculty careers, facilitating cross-cultural engagement and inclusion, and contributing to cultivating cultures of inclusive excellence in academic medicine.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e63"},"PeriodicalIF":2.1,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975773/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811483","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":"Best practices for clinical trials data harmonization and sharing on NHLBI bioData catalyst (BDC) learned from CONNECTS network COVID-19 studies.","authors":"Jeran K Stratford, Huaqin Helen Pan, Alex Mainor, Edvin Music, Joshua Froess, Alex C Cheng, Alexandra Weissman, David T Huang, Elizabeth C Oelsner, Sonia M Thomas","doi":"10.1017/cts.2025.52","DOIUrl":"10.1017/cts.2025.52","url":null,"abstract":"<p><p>The need for collaborative and transparent sharing of COVID-19 clinical trial and large-scale observational study data to accelerate scientific discovery and inform clinical practice is critical. Responsible data-sharing requires addressing challenges associated with data privacy and confidentiality, data linkage, data quality, variable harmonization, data formats, and comprehensive metadata documentation to produce a high-quality, contextually rich, findable, accessible, interoperable, and reusable (FAIR) dataset. This communication explores the experiences and lessons learned from sharing National Heart Lung and Blood Institute (NHLBI) COVID-19 clinical trial (including adaptive platform trials) and cohort study datasets through the NHLBI BioData Catalyst® (BDC) ecosystem, focusing on the challenges and successes of harmonizing these datasets for broader research use. Our findings highlight the importance of establishing standardized data formats, adopting common data elements and creating and maintaining robust data governance structures that address common challenges (i.e., data privacy and data-sharing limitations resulting from informed consent). These efforts resulted in a set of comprehensive and interoperable datasets from 5 clinical trials and 13 cohort studies that will enable downstream reuse in analyses and collaborations. The principles and strategies outlined, derived through experience with consortia data, can lay the groundwork for advancing collaborative and efficient data sharing.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e87"},"PeriodicalIF":2.1,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083401/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093820","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":"EHRchitect: An open-source software tool for medical event sequences data extraction from Electronic Health Records.","authors":"Kostiantyn Botnar, Justin T Nguen, Madison G Farnsworth, George Golovko, Kamil Khanipov","doi":"10.1017/cts.2025.55","DOIUrl":"10.1017/cts.2025.55","url":null,"abstract":"<p><strong>Background: </strong>Electronic Health Records (EHR) analysis is pivotal in advancing medical research. Numerous real-world EHR data providers offer data access through exported datasets. While enabling profound research possibilities, exported EHR data requires quality control and restructuring for meaningful analysis. Challenges arise in medical events (e.g., diagnoses or procedures) sequence analysis, which provides critical insights into conditions, treatments, and outcomes progression. Identifying causal relationships, patterns, and trends requires a more complex approach to data mining and preparation.</p><p><strong>Methods: </strong>This paper introduces EHRchitect - an application written in Python that addresses the quality control challenges by automating dataset transformation, facilitating the creation of a clean, formatted, and optimized MySQL database (DB), and sequential data extraction according to the user's configuration.</p><p><strong>Results: </strong>The tool creates a clean, formatted, and optimized DB, enabling medical event sequence data extraction according to users' study configuration. Event sequences encompass patients' medical events in specified orders and time intervals. The extracted data are presented as distributed Parquet files, incorporating events, event transitions, patient metadata, and events metadata. The concurrent approach allows effortless scaling for multi-processor systems.</p><p><strong>Conclusion: </strong>EHRchitect streamlines the processing of large EHR datasets for research purposes. It facilitates extracting sequential event-based data, offering a highly flexible framework for configuring event and timeline parameters. The tool delivers temporal characteristics, patient demographics, and event metadata to support comprehensive analysis. The developed tool significantly reduces the time required for dataset acquisition and preparation by automating data quality control and simplifying event extraction.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e79"},"PeriodicalIF":2.1,"publicationDate":"2025-03-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12086738/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144101903","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 of a job satisfaction measure for clinical research professionals: A mixed methods approach.","authors":"Jacqueline M Knapke, John Kues, Spencer K Harris, Denise C Snyder, Stephanie A Freel, Harini Pallerla, Jessica Fritter, Angela Mendell, Carolynn T Jones","doi":"10.1017/cts.2025.34","DOIUrl":"10.1017/cts.2025.34","url":null,"abstract":"<p><strong>Background: </strong>Clinical research professionals (CRPs) are essential members of research teams serving in multiple job roles. However, recent turnover rates have reached crisis proportions, negatively impacting clinical trial metrics. Gaining an understanding of job satisfaction factors among CRPs working at academic medical centers (AMCs) can provide insights into retention efforts.</p><p><strong>Materials/methods: </strong>A survey instrument was developed to measure key factors related to CRP job satisfaction and retention. The survey included 47 rating items in addition to demographic questions. An open-text question solicited respondents to provide their top three factors for job satisfaction. The survey was distributed through listservs of three large AMCs. Here, we present a factor analysis of the instrument and quantitative and qualitative results of the subsequent survey.</p><p><strong>Results: </strong>A total of 484 CRPs responded to the survey. A principal components analysis with Varimax rotation was performed on the 47 rating items. The analysis resulted in seven key factors and the survey instrument was reduced to 25 rating items. Self-efficacy and pride in work were top ranked in the quantitative results; work complexity and stress and salary and benefits were top ranked in the qualitative findings. Opportunities for education and professional development were also themes in the qualitative data.</p><p><strong>Discussion: </strong>This study addresses the need for a tool to measure job satisfaction of CRPs. This tool may be useful for additional validation studies and research to measure the effectiveness of improvement initiatives to address CRP job satisfaction and retention.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e55"},"PeriodicalIF":2.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975783/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811551","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 social determinants of health research and practice: Data, tools, and implementation.","authors":"Chenyu Li, Jingchuan Guo, Jiang Bian, Michael J Becich","doi":"10.1017/cts.2024.657","DOIUrl":"10.1017/cts.2024.657","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e58"},"PeriodicalIF":2.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975782/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811367","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":"Integrating mRNA vaccines into the attitudes toward genomics and precision medicine scale: A validation study with a sample of 4939 adults in the USA.","authors":"Jenine K Harris, Erin D Solomon, Kari Baldwin, Lauren L Baker, Eu Gene Chin, James M DuBois","doi":"10.1017/cts.2025.38","DOIUrl":"10.1017/cts.2025.38","url":null,"abstract":"<p><p>The attitudes toward genomics and precision medicine (AGPM) measure examines attitudes toward activities such as genetic testing, gene editing, and biobanking. This is a useful tool for research on the ethical, legal, and social implications of genomics, a major program within the National Institutes of Health. We updated the AGPM to explore controversies over mRNA vaccines. This brief report examines the factor structure of the updated AGPM using a sample of 4939 adults in the USA. The updated AGPM's seven factors include health benefits, knowledge benefits, and concerns about the sacredness of life, privacy, gene editing, mRNA vaccines, and social justice.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e60"},"PeriodicalIF":2.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975789/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811491","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":"Contextualizing barriers and facilitators to scaling community-engaged research transformation at a historically black medical school.","authors":"Tabia Henry Akintobi, Rhonda Holliday, LaShawn Hoffman, Latrice Rollins, Yvette Daniels, Howard Grant, Melissa Kottke","doi":"10.1017/cts.2025.32","DOIUrl":"10.1017/cts.2025.32","url":null,"abstract":"<p><strong>Introduction: </strong>Morehouse School of Medicine (MSM) embodies an applied definition of community engagement advanced over four decades. The increased demand for community collaboration requires attention to the <i>institutional contexts</i> supporting community-engaged research. MSM partnered with the University of New Mexico Center for Participatory Research for the Engage for Equity (E2) PLUS Project to assess, ideate, and consider existing and recommended institutional supports for community-engaged research.</p><p><strong>Methods: </strong>MSM assembled a community-campus Champion Team. The team coordinated virtual workshops with 18 community and academic research partners, facilitated four interviews of executive leaders and two focus groups (researchers/research staff and patients/community members, respectively) moderated by UNM-CPR. Analyses of the transcripts were conducted using an inductive and deductive process. Once the themes were identified, the qualitative summaries were shared with the Champion Team to verify and discuss implications for action and institutional improvements.</p><p><strong>Results: </strong>Institutional strengths and opportunities for systemic change were aligned with equity indicators (power and control, decision-making, and influence) and contextual factors (history, trust, and relationship building) of The continuum of community engagement in research. Institutional advances include community-engagement added as the fourth pillar of the institution's strategic plan. Action strategies include 1) development a research navigation system to address community-campus research partnership administrative challenges and 2) an academy to build the capacities of community/patient partners to <i>independently</i> acquire, manage, and sustain grants and negotiate equity in dissemination of research.</p><p><strong>Conclusions: </strong>MSM has leveraged E2 PLUS to identify systems improvements necessary to ensure that community/patient-centered research and partnerships are amplified and sustained.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e57"},"PeriodicalIF":2.1,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975764/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811533","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 importance of the integration of community engagement with biomedical informatics when assessing social determinants of health.","authors":"Linda B Cottler","doi":"10.1017/cts.2025.15","DOIUrl":"10.1017/cts.2025.15","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e53"},"PeriodicalIF":2.1,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11975772/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143811617","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":"Building and implementation of a common infrastructure for specimen and data storage at an academic medical center.","authors":"Donna A Santillan, Laura S Jacobus, Michael D Henry, George J Weiner, Patricia L Winokur, Boyd M Knosp, Heath A Davis","doi":"10.1017/cts.2025.43","DOIUrl":"10.1017/cts.2025.43","url":null,"abstract":"<p><p>Precision or \"Personalized Medicine\" and \"Big Data\" are growing trends in the biomedical research community and highlight an increased focus on access to larger datasets to effectively explore disease processes at the molecular level versus the previously common one-size-fits all approach. This focus necessitated a local transition from independent lab and siloed projects to a single software application utilizing a common ontology to create access to data from multiple repositories. Use of a common system has allowed for increased ease of collaboration and access to quality biospecimens that are extensively annotated with clinical, molecular, and patient associated data. The software needed to function at an enterprise level while continuing to allow investigators the autonomy and security access they desire. To identify a solution, a working group comprised of representation from independent repositories and areas of research focus across departments was established and responsible for review and implementation of an enterprise-wide biospecimen management system. Central to this process was the creation of a unified vocabulary across all repositories, including consensus around source of truth, standardized field definitions, and shared terminology.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e76"},"PeriodicalIF":2.1,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083205/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093920","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":"Engage for equity plus: Transforming academic health centers to sustain patient/community engaged research structures, policies, and practices.","authors":"Shannon Sanchez-Youngman, Belkis Jacquez, Prajakta Adsul, Elizabeth Dickson, Tabia Henry Akintobi, LaShawn Hoffman, Lisa G Rosas, Starla Gay, Jason A Mendoza, Diane Mapes, John Oetzel, Donald Nease, Nina Wallerstein","doi":"10.1017/cts.2025.51","DOIUrl":"10.1017/cts.2025.51","url":null,"abstract":"<p><strong>Introduction: </strong>Community-based participatory research (CBPR) and patient/ community engaged research (P/CEnR) are shown to be effective approaches that improve health inequities, particularly among disadvantaged populations. While the science of CBPR demonstrates promising partnering practices that lead to effective interventions, there are institutional and structural barriers to creating and sustaining patient/community research within academic health centers (AHCs). As the field matures, there is a growing need to enhance patient/community leadership so that communities can set their own research agendas and priorities.</p><p><strong>Methods: </strong>Engage for Equity PLUS sought to address these challenges by implementing an engagement intervention aimed at transforming AHCs through supporting champion teams of academic, community, and patient partners to strengthen research infrastructures for P/CEnR. This paper uses a qualitative, case study analysis to describe how E2PLUS enabled champion teams at Stanford School of Medicine, Fred Hutchinson/University of Washington Cancer Consortium, and Morehouse School of Medicine to pursue institutional change strategies through coaching, workshops, contextual data analysis, and a community of practice.</p><p><strong>Results: </strong>This paper describes key themes of how E2Plus helped identify targets of change by a) using institutional data collection as core to generating critical consciousness of contextual conditions; b) implementing feasible E2PLUS strategies to leverage conditions for catalyzing a champion team for advocacy and achievable actions; c) identifying the critical role of patients/community members in stimulating change; and d) the role of continual collective reflection.</p><p><strong>Conclusion: </strong>We discuss the overall implications for E2 PLUS for other AHCs working toward sustainable community/patient engaged research policies and practices.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e80"},"PeriodicalIF":2.1,"publicationDate":"2025-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12083203/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144093925","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}