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":"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":"Health impacts of a remotely delivered prolonged nightly fasting intervention in stressed adults with memory decline and obesity: A nationwide randomized controlled pilot trial - ADDENDUM.","authors":"Dara L James, Chung Jung Mun, Linda K Larkey, Edward Ofori, Nanako A Hawley, Kate Alperin, David E Vance, Dorothy D Sears","doi":"10.1017/cts.2024.693","DOIUrl":"https://doi.org/10.1017/cts.2024.693","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e3"},"PeriodicalIF":2.1,"publicationDate":"2025-01-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11736289/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143006282","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 changing demographics and severity in hospitalized patients across COVID-19 variants: A national cohort study.","authors":"Priyanka Parajuli, Lara A C Phipps, Roy Sabo, Rasha Alsaadawi, Amanda Robinson, Evan French, Richard K Sterling","doi":"10.1017/cts.2024.1166","DOIUrl":"10.1017/cts.2024.1166","url":null,"abstract":"<p><strong>Introduction: </strong>The respiratory syndrome coronavirus (SARS-CoV-2) has undergone genetic evolution and led to variants of concern that vary in transmissibility and clinical severity.</p><p><strong>Methods: </strong>This retrospective cohort analysis studied 232,364 hospitalized COVID-19-positive patients in the National COVID Cohort Collaborative [April 27, 2020 and June 25, 2022]. The primary outcomes were to compare demographics and need for mechanical ventilation and 30-day mortality across variants including Alpha (B.1.1.7), Delta (B.1.617.2), and Omicron (B.1.1.529).</p><p><strong>Results: </strong>The severity of SARS-CoV-2 decreased in the omicron-subsequent wave with decreased utilization of mechanical ventilation and decreased 30-day mortality among patients with comorbidities like diabetes mellitus, obesity, and liver disease. Although with each subsequent wave, the sex distribution remained equal and constant, there was an increase in rates of diabetes, liver disease, and respiratory disease amongst patients hospitalized with COVID-19 over the COVID waves despite the decreasing 30-day mortality and mechanical ventilation.</p><p><strong>Conclusions: </strong>Despite changes in demographics over time, more recent COVID waves were associated with decreasing severity and mortality. These observations will help guide specific and effective resource allocation and patient care.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e22"},"PeriodicalIF":2.1,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255758","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 pilot randomized controlled trial of the iPeer2Peer program in adolescents with sickle cell disease: A mixed method study.","authors":"Lauren Kelenc, Brittany Wiles, Fareha Nishat, Chitra Lalloo, Anya Nair, Craig Eling, Melanie Kirby-Allen, Ewurabena Simpson, Roona Sinha, Richard Ward, William T Zempsky, Sara Ahola Kohut, Jennifer N Stinson","doi":"10.1017/cts.2024.1170","DOIUrl":"10.1017/cts.2024.1170","url":null,"abstract":"<p><strong>Background and objectives: </strong>Sickle cell disease (SCD) is hallmarked by recurrent episodes of severe acute pain and the risk for chronic pain. Remote peer support programs have been shown to effectively improve health outcomes for many chronic conditions. The objective of this study was to examine the feasibility and acceptability of an online peer mentoring program (iPeer2Peer program) for adolescents with SCD.</p><p><strong>Method: </strong>A waitlist pilot randomized controlled trial was conducted. Adolescents randomized to the intervention group were matched with trained peer mentors (19-25 years; successfully managing their SCD), consisting of up to 10 sessions of approximately 30-min video calls over a 15-week period. The control group received standard care. The primary outcomes were rates of accrual, withdrawal, and adherence to iP2P program/protocol, with secondary outcomes identifying topics of mentorship-mentee conversations through qualitative analysis.</p><p><strong>Results: </strong>Twenty-eight participants (14 intervention; 14 control) were randomized to the study (mean age: 14.8 ± 1.7 years; 57% female). Accrual rate was 80% (28/35) and withdrawal rate was 18% (5/28), with 28% (4/14) adhering to the iP2P program; however, 71% (10/14) of adolescents in the intervention completed at least one call. Based on content analysis of 75 mentor-mentee calls, three distinct content categories emerged: impact of SCD, self-management, transitioning to adulthood with SCD, and general topics.</p><p><strong>Conclusion: </strong>The results from this pilot study suggest that the current iteration of the iP2P SCD program lacks feasibility. Future research with the iP2P program can focus improved engagement via personalized mentoring, variable communication avenues, and an emphasis on gender.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e18"},"PeriodicalIF":2.1,"publicationDate":"2025-01-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254765","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":"Erratum: 489 Nasal-derived Extracellular Vesicles (EVs) carry a cargo of antiviral and immunomodulatory molecules - CORRIGENDUM.","authors":"Tiziana Corsello, Teodora Ivanciuc, Yue Qu, Antonella Casola, Roberto P Garofalo","doi":"10.1017/cts.2024.687","DOIUrl":"https://doi.org/10.1017/cts.2024.687","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2023.497.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e226"},"PeriodicalIF":2.1,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11713422/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142971016","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 workforce development and scientific collaboration: A novel resource for biostatistical education.","authors":"Emily Slade, Claudine T Jurkovitz, Shari Messinger, Robert A Oster, Gina-Maria Pomann, Sandra L Taylor, Ann M Brearley","doi":"10.1017/cts.2024.694","DOIUrl":"10.1017/cts.2024.694","url":null,"abstract":"<p><p>A clinical and translational scientist (CTS) often seeks to increase their knowledge of statistical topics to effectively conduct biomedical research studies. A common method for obtaining this knowledge is through existing online educational materials that are suggested by a biostatistical collaborator or identified by the CTS. However, the volume of available educational materials on diverse statistical topics makes the task of identifying high-quality educational resources at an appropriate level challenging and time consuming for CTSs and collaborative biostatisticians. In response to these challenges, the Biostats4You website was created, where existing online educational materials for a variety of statistical topics are vetted to identify those most appropriate for CTSs. In this manuscript, we describe the resource review process, provide information about statistical topics and resources currently available, and make recommendations for how CTSs and collaborative biostatisticians can utilize the Biostats4You website to improve training, mentoring, and collaborative research practices.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e11"},"PeriodicalIF":2.1,"publicationDate":"2025-01-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254938","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":"Biomarkers of racism-based stress injury: A feasibility and correlation study.","authors":"Rachel Wangari Kimani, Jonathan N Tobin, Steven W Cole, Ann Campbell, Erich D Jarvis","doi":"10.1017/cts.2024.683","DOIUrl":"10.1017/cts.2024.683","url":null,"abstract":"<p><strong>Background: </strong>Persistent discrimination and identity threats contribute to adverse health outcomes in minoritized groups, mediated by both structural racism and physiological stress responses.</p><p><strong>Objective: </strong>This study aims to evaluate the feasibility of recruiting African American volunteers for a pilot study of race-based stress, the acceptability of a mindfulness intervention designed to reduce racism-induced stress, and to evaluate preliminary associations between race-based stress and clinical, psychosocial, and biological measures.</p><p><strong>Methods: </strong>A convenience sample of African Americans aged 18-50 from New York City's Tri-state area underwent assessments for racial discrimination using the Everyday Discrimination Scale (EDS) and Race-Based Traumatic Stress Symptom Scale. Mental health was evaluated using validated clinical scales measuring depression, anxiety, stress, resilience, mindfulness, resilience, sleep, interpersonal connection, and coping. Biomarkers were assessed through clinical laboratory tests, allostatic load assessment, and blood gene expression analysis.</p><p><strong>Results: </strong>Twenty participants (12 females, 8 males) completed assessments after consent. Elevated EDS scores were associated with adverse lipid profiles, including higher cholesterol/high-density lipoprotein (HDL) ratios and lower HDL levels, as well as elevated inflammatory markers (NF-kB activity) and reduced antiviral response (interferon response factor). Those with high EDS reported poorer sleep, increased substance use, and lower resilience. Mindfulness was positively associated with coping and resilience but inversely to sleep disturbance. 90% showed interest in a mindfulness intervention targeting racism-induced stress.</p><p><strong>Conclusions: </strong>This study demonstrated an association between discrimination and adverse health effects among African Americans. These findings lay the groundwork for further research to explore the efficacy of mindfulness and other interventions on populations experiencing discrimination.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e23"},"PeriodicalIF":2.1,"publicationDate":"2024-12-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254939","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":"Transforming research recruitment: Leveraging EHR systems and patient portals.","authors":"Megan Schwinne, Edward Woods, Barney Chan, Candace D Speight, Vivian Corry, Neal W Dickert, Gabriel R Najarro","doi":"10.1017/cts.2024.692","DOIUrl":"10.1017/cts.2024.692","url":null,"abstract":"<p><p>Electronic health records and patient portals are increasingly utilized to enhance research recruitment efficiency, yet response patterns across patient groups remain unclear. We examined 10 studies at Emory Healthcare that used these tools to identify and recruit 24,000 patients over 1 year. Response rates were lower among males and Black individuals, though study interest was higher among respondents. Interest was also greater among those with frequent healthcare interactions and lower comorbidity. In a large academic health system, portal-based recruitment offered a streamlined approach to research recruitment and patient engagement, with minor variations across patient characteristics warranting continued study.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e10"},"PeriodicalIF":2.1,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255759","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":"Completion of a standardizable competency-based research training program improves understanding and preparedness for both new and experienced clinical research professionals.","authors":"Lucy Palmer, Sandra E Morones, Heidi T Jacobe, Rhonda Oilepo","doi":"10.1017/cts.2024.690","DOIUrl":"10.1017/cts.2024.690","url":null,"abstract":"<p><p>Clinical research professionals (CRPs) are integral to the academic medical center workforce, research operations, and daily clinical research tasks; however, due to inconsistent training, there is a shortage of qualified CRPs. The Joint Task Force for Clinical Trial Competency created a competency framework for CRPs, which has demonstrated positive results from various institutions, but training programs have been limited in standardization, replicability, and dissemination. To improve this, we designed the University of Texas Southwestern (UTSW) Medical Center Clinical Research Foundations (CRF) training program, which is a competency-based online self-paced CRP training curriculum hosted via the Collaborative Institutional Training Initiative (CITI) portal. We examined feasibility, acceptability, and uptake of the UTSW CRF training on an institutional scale and were pleased to find this curriculum is not only feasible but has high levels of acceptability. Furthermore, faculty, clinicians, and trainees voluntarily completed this training program indicating utility across diverse groups. The UTSW CRF combines the existing CITI training modules with UTSW-created material, providing an optimal balance between generalized clinical research education and institutionally tailored content. We believe the UTSW CRF curriculum could serve as a plug-and-play foundational model for other research centers to tailor according to their audience and institutional needs.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e19"},"PeriodicalIF":2.1,"publicationDate":"2024-12-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143255542","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}