Journal of Clinical and Translational Science最新文献

{"title":"Using technology to increase reach and optimize consent experience for a large-scale research program.","authors":"Emma Coen, Daniel P Judge, Samantha Norman, John T Clark, Andrew Cates, Randolph Thornhill, Kelly Hunt, Lori McMahon, Leslie Lenert, Caitlin G Allen","doi":"10.1017/cts.2024.640","DOIUrl":"10.1017/cts.2024.640","url":null,"abstract":"<p><p>The consent process for research studies can be burdensome for potential participants due to complex information and lengthy consent forms. This pragmatic study aimed to improve the consent experience and evaluate its impact on participant decision making, study knowledge, and satisfaction with the In Our DNA SC program, a population-based genomic screening initiative. We compared two consent procedures: standard consent (SC) involving a PDF document and enhanced consent (EC) incorporating a pictograph and true or false questions. Decision-making control, study knowledge, satisfaction, and time to consent were assessed. We analyzed data for 109 individuals who completed the SC and 96 who completed the EC. Results indicated strong decision-making control and high levels of knowledge and satisfaction in both groups. While no significant differences were found between the two groups, the EC experience took longer for participants to complete. Future modifications include incorporating video modules and launching a Spanish version of the consent experience. Overall, this study contributes to the growing literature on consent improvements and highlights the need to assess salient components and explore participant preferences for receiving consent information.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e15"},"PeriodicalIF":2.1,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255760","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":"Engaging stakeholders to strengthen support for community-engaged research at Stanford School of Medicine: An institutional assessment and action planning approach.","authors":"Patricia Rodriguez Espinosa, Anisha I Patel, Starla Gay, Ysabel Duron, Alyce S Adams, Nina Wallerstein, Ruth O'Hara, Lisa G Rosas","doi":"10.1017/cts.2025.8","DOIUrl":"10.1017/cts.2025.8","url":null,"abstract":"<p><strong>Introduction: </strong>Despite the central role that patient and community engagement plays in translational science and health equity research, there remain significant institutional barriers for researchers and their community partners to engage in this work meaningfully and sustainably. The goal of this paper is to describe the process and outcomes of Engage for Equity PLUS at Stanford School of Medicine, which was aimed at understanding and addressing institutional barriers and facilitators for community-engaged research (CEnR).</p><p><strong>Methods: </strong>A Stanford champion team of four faculty and two community partners worked with the University of New Mexico team to conduct two workshops (<i>n</i> = 26), focus groups (<i>n</i> = 2), interviews with leaders (<i>n</i> = 4), and an Institutional Multi-Stakeholder Survey (<i>n</i> = 35). These data were employed for action planning to identify strategies to build institutional support for CEnR.</p><p><strong>Results: </strong>Findings revealed several key institutional barriers to CEnR, such as the need to modify organizational policies and practices to expedite and simplify CEnR administration, silos in collaboration, and the need for capacity building. Facilitators included several offices devoted to and engaging in innovative CEnR efforts. Based on these findings, action planning resulted in three priorities: 1) Addressing IRB barriers, 2) Addressing barriers in post-award policies and procedures, and 3) Increasing training in CEnR within Stanford and for community partners.</p><p><strong>Conclusions: </strong>Addressing institutional barriers is critical for Academic Medical Centers and their partners to meaningfully and sustainably engage in CEnR. The Engage for Equity PLUS process offers a roadmap for Academic Medical Centers with translational science and health equity goals.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e36"},"PeriodicalIF":2.1,"publicationDate":"2025-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883597/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573049","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":"Bioethical and critical consciousness in clinical translational neuroscience.","authors":"Angela Fang, Riana Elyse Anderson, Sierra Carter, Kristen Eckstrand, Kean J Hsu, Shawn Jones, Maria Kryza-Lacombe, Andrew Peckham, Greg J Siegle, Lucina Q Uddin, Mariann Weierich, Mary L Woody, Judy Illes","doi":"10.1017/cts.2025.5","DOIUrl":"10.1017/cts.2025.5","url":null,"abstract":"<p><p>Clinical translational neuroscience (CTN) is positioned to generate novel discoveries for advancing treatments for mental health disorders, but it is held back today by the siloing of bioethical considerations from critical consciousness. In this article, we suggest that bioethical and critical consciousness can be paired to intersect with structures of power within which science and clinical practice are conducted. We examine barriers to the adoption of neuroscience findings in mental health from this perspective, especially in the context of current collective attention to widespread disparities in the access to and outcomes of mental health services, lack of representation of marginalized populations in the relevant sectors of the workforce, and the importance of knowledge that draws upon multicultural perspectives. We provide 10 actionable solutions to confront these barriers in CTN research, as informed by existing frameworks such as structural competency, adaptive calibration models, and community-based participatory research. By integrating critical consciousness with bioethical considerations, we believe that practitioners will be better positioned to benefit from cutting-edge research in the biological and social sciences than in the past, alert to biases and equipped to mitigate them, and poised to shepherd in a robust generation of future translational therapies and practitioners.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e37"},"PeriodicalIF":2.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883569/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573013","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":"Testing the feasibility of a digital storytelling intervention combined with heart rate variability biofeedback in hematopoietic cell transplant patients.","authors":"Sunny W Kim, Dara L James, Rachel E Koffer, Lakshmi Nair, Raheleh Bahrami, Lihong Ou, Veena Fauble, Nandita Khera, Linda K Larkey","doi":"10.1017/cts.2024.619","DOIUrl":"10.1017/cts.2024.619","url":null,"abstract":"<p><p>This pilot 2-week, randomized controlled trial examined integrating digital storytelling (DST) with heart rate variability biofeedback (HRVB) to enhance psycho-emotional well-being of hematopoietic cell transplantation (HCT) patients. HCT patients (<i>N</i> = 25; <i>M</i> _age = 51.9 years) were randomly assigned: (1) DST + HRVB intervention, or (2) DST-only control. Both groups viewed four emotionally-rich digital stories. The DST + HRVB group practiced HRVB at home for ten minutes/day. DST + HRVB participants decreased anger, depression, fatigue (<i>d</i> = 0.53) and increased emotional processing (<i>d</i> = 0.20), and HRV-assessed autonomic nervous system balance (3.5 vs. 0.9). This study supports feasibility of integrating DST with HRVB, and effect sizes indicate superiority of combining DST with HRVB.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e35"},"PeriodicalIF":2.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883578/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573141","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 maturity model for Clinical Trials Management Ecosystem.","authors":"Shruti Sehgal, E Chris Pua, Svetlana Rojevsky, Michael J Becich, Joshua Fehrmann, Boyd M Knosp, Adam Wilcox, Jeffery C Talbert, Catherine K Craven, Justin Starren","doi":"10.1017/cts.2024.1168","DOIUrl":"10.1017/cts.2024.1168","url":null,"abstract":"<p><strong>Introduction: </strong>Managing clinical trials is a complex process requiring careful integration of human, technology, compliance, and operations for success. We collaborated with experts to develop a multi-axial Clinical Trials Management Ecosystem (CTME) maturity model (MM) to help institutions identify best practices for CTME capabilities.</p><p><strong>Methods: </strong>A working group of research informaticists was established. An online session on maturity models was hosted, followed by a review of the candidate domain axes and finalization of the axes. Next, maturity level attributes were defined for min/max levels (level 1 and level 5) for each axis of the CTME MM, followed by the intermediate levels. A REDCap survey comprising the model's statements was then created, and a subset of working group members tested the model by completing it at their respective institutions. The finalized survey was distributed to all working group members.</p><p><strong>Results: </strong>We developed a CTME MM comprising five maturity levels across 11 axes: study management, regulatory and audit management, financial management, investigational product management, subject identification and recruitment, subject management, data, reporting analytics & dashboard, system integration and interfaces, staff training & personnel management, and organizational maturity and culture. Informaticists at 22 Clinical and Translational Science Award hubs and one other organization self-assessed their institutional CTME maturity. Respondents reported relatively high maturity for study management and investigational product management. The reporting analytics & dashboard axis was the least mature.</p><p><strong>Conclusion: </strong>The CTME MM provides a framework to research organizations to evaluate their current clinical trials management maturity across 11 axes and identify areas for future growth.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e28"},"PeriodicalIF":2.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883580/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573011","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":"Collaborating with and enabling diverse communities to address health inequities: The experiences of a community engagement and outreach team.","authors":"Reimund Serafica, Lorraine S Evangelista, Tony Ward, Jeffery Peterson, Joseph Guerrero Lopez, Julie Lucero, Esther Erdei, Kathryn L Braun, Andrea Bersamin, Jenifer Thomas, J D Wulfhorst, Cheryl Jorcyk, Rebecca Palacios, Judith Owens-Manley, Elizabeth Fore, Ann Bertagnolli, Chelsea Bellon, Francisco S Sy","doi":"10.1017/cts.2025.7","DOIUrl":"10.1017/cts.2025.7","url":null,"abstract":"<p><p>The Mountain West Clinical and Translational Infrastructure Network Community Engagement and Outreach (CEO) Core has fostered academic-community engagement since 2018. States historically receiving lower levels of NIH funding are characterized by significantly higher proportions of rural and remote populations, as well as uniquely elevated percentages of Native American/Alaska Native and Native Hawaiian/Pacific Islander populations compared to most other states. This case study highlights the Core's efforts in advancing community-engaged research. Key initiatives included forming a CEO Core Steering Committee to recruit interdisciplinary investigators, establishing regional community advisory boards to identify research priorities, and creating a Resource Library and Training Portal for stakeholders. The Core also collaborated with other Cores to provide training, mentorship, and funding for community-engaged research. Despite these achievements, geographical and cultural diversity presented engagement challenges. Regular meetings between investigators and stakeholders ensured bidirectional communication and aligned goals. The Core transformed transactional engagement into meaningful collaboration, emphasizing the need for interdisciplinary teams who understand community needs. Future goals include training academic teams, clinical providers, and community members, empowering early-stage investigators to share findings with partners, leveraging health records for research, and developing strategies to protect investigators' time.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e38"},"PeriodicalIF":2.1,"publicationDate":"2025-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883566/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573043","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":"Evaluating translational science knowledge gains following an online short course for a general scientific audience.","authors":"Amanda L Vogel, Shadab F Hussain, Jessica M Faupel-Badger","doi":"10.1017/cts.2024.585","DOIUrl":"10.1017/cts.2024.585","url":null,"abstract":"<p><strong>Purpose: </strong>The translational science workforce requires preparation in both core skills for biomedical research and competencies for advancing progress along the translational pipeline. Delivering this content in a highly accessible manner will help expand and diversify the workforce.</p><p><strong>Methods: </strong>The NCATS Education Branch offers online case study-based courses in translational science for a general scientific audience. The branch updated its course in preclinical translational science with additional content aligned with the NCATS Translational Science Principles, which characterize effective approaches to advance translation. The updated course was offered in 2021 and 2022. The branch also revised the course evaluation to capture knowledge change aligned with the NCATS Translational Science Principles.</p><p><strong>Results: </strong>Of 106 students, 88 completed baseline or endpoint surveys, with 48 completing both. Most found the online format (<i>n</i> = 48; 91%) and case study approach (<i>n</i> = 48; 91%) effective. There was a statistically significant increase in knowledge related to the Translational Science Principles (<i>p < 0.001</i>). Survey items with the highest endpoint scores reflected the principles on creativity and innovation, efficiency, cross-disciplinary team science, and boundary-crossing collaborations. Findings highlighted the effectiveness of pairing a case study with lectures that offer generalizable strategies aligned with the translational science principles. Students reported the course helped them learn about the trajectory of a drug discovery and development initiative, where their own work fit in, and scientific and operational approaches to apply in their own work.</p><p><strong>Conclusions: </strong>This online case study-based course was effective in teaching generalizable principles for translational science to students with varied scientific backgrounds.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e16"},"PeriodicalIF":2.1,"publicationDate":"2025-01-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255598","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":"Promoting inclusion in COVID-19 research for diverse Hispanic/Latino(x) populations: Recommendations from the RADx® Underserved Populations Hispanic/Latino/Latinx working group.","authors":"Rosa M Gonzalez-Guarda, Edna Acosta-Perez, Cristina Adames, Rocio Bailey, Luis Carvajal-Carmona, Jenni Detwiler, Linda K Ko, Hailey Leiva, Kathleen Page, Antoinette Schoenthaler","doi":"10.1017/cts.2024.600","DOIUrl":"10.1017/cts.2024.600","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e31"},"PeriodicalIF":2.1,"publicationDate":"2025-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883567/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573109","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":"Preoperative anxiety and its impact on surgical outcomes: A systematic review and meta-analysis.","authors":"Mohamed A Shebl, Eman Toraih, Menna Shebl, Ahmed Mosaad Tolba, Parisa Ahmed, Harshdeep Singh Banga, Mohab Orz, Mahmoud Tammam, Keroles Saadalla, Mohamed Elsayed, Mennatallah Kamal, Mohamed Abdulla, Ahmed Ibrahim Eldessouky, Yousef Tarek Moustafa, Omar Ahmed Mohamed, Hani Aiash","doi":"10.1017/cts.2025.6","DOIUrl":"10.1017/cts.2025.6","url":null,"abstract":"<p><strong>Background: </strong>Preoperative anxiety is a common phenomenon affecting 60-80% of surgical patients, with potential implications for surgical outcomes. Despite its prevalence, there remains a lack of consensus on its precise effects and optimal management strategies.</p><p><strong>Objective: </strong>This meta-analysis aimed to synthesize current evidence on the impact of preoperative anxiety on various surgical outcomes, including anesthetic and analgesic requirements, delirium, recovery times, and pain.</p><p><strong>Methods: </strong>We conducted a comprehensive literature search and meta-analysis of studies examining the relationship between preoperative anxiety and surgical outcomes. Standardized mean differences (SMD), correlation (COR), and odds ratios (OR) with 95% confidence intervals were calculated.</p><p><strong>Results: </strong>Our analysis revealed significant associations between preoperative anxiety and increased anesthetic requirements (SMD = 0.67, 95% CI: 0.32-1.01) and analgesic requirements (SMD = 0.89, 95% CI: 0.65-1.12). Preoperative anxiety was associated with postoperative delirium in adults (OR = 1.90, 95% CI: 1.11-3.26), unlike the pediatric population. Preoperative anxiety was associated with prolonged time to reach Modified Aldrete Score of 9 (SMD = 0.79, 95% CI: 0.50-1.07) and extubation time (SMD = 0.89, 95% CI: 0.58-1.21). Preoperative anxiety was positively correlated with propofol consumption (STAI-S COR = 0.35, 95%CI: 0.15-0.55). No significant association between preoperative anxiety and postoperative pain was found.</p><p><strong>Conclusions: </strong>This meta-analysis provides evidence for the wide-ranging effects of preoperative anxiety on surgical outcomes. The findings emphasize the need for routine preoperative anxiety screening and the development of targeted interventions. Future research should focus on long-term impacts and the effectiveness of various anxiety management strategies.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e33"},"PeriodicalIF":2.1,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573072","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":"Recommendations for interdisciplinary research collaboration for early career dissemination and implementation researchers: A multi-phase study.","authors":"Hannah G Lane, Sallie D Allgood, Julie Schexnayder, Hayden B Bosworth, Ana A Baumann, Allison A Lewinski","doi":"10.1017/cts.2024.684","DOIUrl":"10.1017/cts.2024.684","url":null,"abstract":"<p><strong>Introduction: </strong>Dissemination and implementation (D&I) scientists are key members of collaborative, interdisciplinary clinical and translational research teams. Yet, early career D&I researchers (ECRs) have few guidelines for cultivating productive research collaborations. We developed recommendations for ECRs in D&I when serving as collaborators or co-investigators.</p><p><strong>Methods: </strong>We employed a consensus-building approach: (1) group discussions to identify 3 areas of interest: \"Marketing yourself\" (describing your value to non-D&I collaborators), \"Collaboration considerations<i>\"</i> (contributions during proposal development), and \"Responsibilities following project initiation\" (defining your role throughout projects); (2) first survey and focus groups to iteratively rank/refine sub-domains within each area; (3) second survey and expert input on clarity/content of sub-domains; and (4) iterative development of key recommendations.</p><p><strong>Results: </strong>Forty-four D&I researchers completed the first survey, 12 of whom attended one of three focus groups. Twenty-nine D&I researchers completed the second survey (<i>n</i> = 29) and 10 experts provided input. We identified 25 recommendations. Findings suggest unique collaboration strengths (e.g, partnership-building) and challenges (e.g., unclear link to career milestones) for ECR D&I researchers, and underscore the value of ongoing training and mentorship for ECRs and the need to intersect collaborative D&I efforts with health equity principles.</p><p><strong>Conclusions: </strong>Research collaborations are essential in clinical and translational research. We identified recommendations for D&I ECRs to be productive research collaborators, including training and support needs for the field. Findings suggest an opportunity to examine research collaboration needs among early career D&I scientists, and provide guidance on how to successfully provide mentorship and integrate health equity principles into collaborative research.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e39"},"PeriodicalIF":2.1,"publicationDate":"2025-01-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11883575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143573117","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}