Journal of Clinical and Translational Science最新文献

{"title":"The Translational Science Benefits Model, a new training tool for demonstrating implementation science impact: A pilot study - ADDENDUM.","authors":"Stephanie Andersen, Annalee Wilson, Todd Combs, Laura Brossart, Julie Heidbreder, Stacey McCrary, Rinad S Beidas, Leopoldo J Cabassa, Erin P Finley, Emma E McGinty, Jonathan Purtle, Lisa Saldana, Enola Proctor, Douglas Luke","doi":"10.1017/cts.2024.643","DOIUrl":"10.1017/cts.2024.643","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"201"},"PeriodicalIF":2.1,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626599/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800164","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":"Creating a plasma coordination center to support COVID-19 outpatient trials across a national network of hospital blood banks.","authors":"Anusha Yarava, Christi Marshall, David E Reichert, Aaron Ye, Preeti Khanal, Sanford H Robbins, Bruce S Sachais, David Oh, Ryan A Metcalf, Kathleen Conry-Cantilena, Karen King, Meredith Reyes, Jill Adamski, Marisa B Marques, Minh-Ha Tran, Elizabeth S Allen, Daniel Pach, Neil Blumberg, Rhonda Hobbs, Tammon Nash, Aarthi G Shenoy, Giselle S Mosnaim, Yuriko Fukuta, Bela Patel, Sonya L Heath, Adam C Levine, Barry R Meisenberg, Shweta Anjan, Moises A Huaman, Janis E Blair, Judith S Currier, James H Paxton, William Rausch, Kevin Oei, Matthew Abinante, Donald N Forthal, Martin S Zand, Seble G Kassaye, Edward R Cachay, Kelly A Gebo, Shmuel Shoham, Arturo Casadevall, Nichol A McBee, Daniel Amirault, Ying Wang, Erica Hopkins, David M Shade, Oliver Layendecker, Sabra L Klein, Han-Sol Park, John S Lee, Patrizio Caturegli, Jay S Raval, Daniel Cruser, Alyssa F Ziman, Jonathan Gerber, Thomas J Gniadek, Evan M Bloch, Aaron A R Tobian, Daniel F Hanley, David J Sullivan, Karen Lane","doi":"10.1017/cts.2024.642","DOIUrl":"10.1017/cts.2024.642","url":null,"abstract":"<p><strong>Introduction: </strong>In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.</p><p><strong>Methods: </strong>A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.</p><p><strong>Results: </strong>We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.</p><p><strong>Conclusion: </strong>The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e200"},"PeriodicalIF":2.1,"publicationDate":"2024-11-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626586/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800927","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":"\"Do they REALLY trust us\"?: Lessons from a volunteer research registry.","authors":"Sylk Sotto-Santiago, Sarah Wiehe, Brenda Hudson, James Slaven, Conor Vinaixa, Rebecca Bruns, Gina Claxton, Lynsey Delp, Dustin Lynch, Sharon Moe","doi":"10.1017/cts.2024.584","DOIUrl":"10.1017/cts.2024.584","url":null,"abstract":"<p><strong>Background: </strong>All IN for Health is a well-established community-academic partnership dedicated to helping improve the lives of Indiana residents by increasing health research literacy and promoting health resources, as well as opportunities to participate in research. It is sponsored by the Indiana Clinical and Translational Science Institute (I-CTSI). The study's purpose was to measure trust in biomedical research and healthcare organizations among research volunteers.</p><p><strong>Methods: </strong>The Relationship of Trust and Research Engagement (RTRE) survey was developed utilizing 3 validated scales. The RTRE consisted of 36 items in a 5-point Likert scale with three open-text questions. We conducted 3 focus groups with a total of 24 individuals ahead of the survey's launch. Recruitment was done through the All IN for Health newsletter. The survey was administered in the summer of 2022.</p><p><strong>Results: </strong>Six hundred and sixty-three individuals participated in the survey. Forty-one percent agreed that doctors do medical research for selfish reasons. Moreover, 50% disagree that patients get the same medical treatment regardless of race/ethnicity. Sixty-seven percent think it is safe to participate in medical research, yet 79% had never been asked to participate. Ten percent believe that researchers select minorities for their most dangerous studies and expose minoritized groups to diseases.</p><p><strong>Conclusion: </strong>The utilization of tools to measure trust will facilitate participant recruitment and will assist institutions and investigators alike in accountability. It is imperative, we work toward understanding our communities' trust in medical research, assessing our own trustworthiness, and critically reflect on the authenticity of our efforts.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e196"},"PeriodicalIF":2.1,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626595/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800512","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: Building Research Capacity at FQHCs: A model of support from the All of Us Research Program - CORRIGENDUM.","authors":"Derek Inokuchi, Heta K Mehta, Jessica M Burke","doi":"10.1017/cts.2024.636","DOIUrl":"10.1017/cts.2024.636","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1017/cts.2023.571.].</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e198"},"PeriodicalIF":2.1,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626578/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800934","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":"Environmental tobacco smoke exposure in a multi-city cohort of children with asthma: Analyzing true exposure and the validity of caregiver survey.","authors":"Katherine McKeon, Derek Werthmann, Rebecca Straubing, Anna Rodriguez, Connie Sosnoff, Benjamin C Blount, Ginger L Chew, Tiina Reponen, Gary Adamkiewicz, Joy Hsu, Felicia A Rabito","doi":"10.1017/cts.2024.581","DOIUrl":"10.1017/cts.2024.581","url":null,"abstract":"<p><strong>Introduction: </strong>The avoidance of asthma triggers, like tobacco smoke, facilitates asthma management. Reliance upon caregiver report of their child's environmental tobacco smoke (ETS) exposure may result in information bias and impaired asthma management. This analysis aimed to characterize the chronicity of ETS exposure, assess the validity of caregiver report of ETS exposure, and investigate the relationship between ETS exposure and asthma attack.</p><p><strong>Methods: </strong>A secondary data analysis was performed on data from a longitudinal study of 162 children aged 7-12 years with asthma living in federally subsidized housing in three US cities (Boston, Cincinnati, and New Orleans). Data were collected at three time points over 1 year.</p><p><strong>Results: </strong>Over 90% of children were exposed to ETS (≥0.25 ng/ml of urine cotinine (UC)). Exposure was consistent over 1 year. Questionnaire data had a sensitivity of 28-34% using UC ≥0.25 ng/ml as the gold standard. High ETS exposure (UC ≥ 30 ng/ml) was significantly associated with asthma attack (aOR 2.97, 0.93-9.52, <i>p</i> = 0.07). Lower levels (UC 0.25-30 ng/ml) were not statistically significant (aOR 1.76, 0.71- 4.38, <i>p</i> = 0.22). No association was found using caregiver-reported ETS exposure.</p><p><strong>Conclusion: </strong>Relying on questionnaire data to assess children's exposure to tobacco smoke may lead to substantial information bias. For children with asthma, incorrect characterization may substantially impact asthma morbidity.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e197"},"PeriodicalIF":2.1,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626568/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800930","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":"Recruitment and retention strategies to promote research engagement among caregivers and their children: A scoping review.","authors":"Tammy E Corr, Alma Jusufagic, James Basting, Catherine Caldwell, Steven King, Aleksandra E Zgierska","doi":"10.1017/cts.2024.624","DOIUrl":"10.1017/cts.2024.624","url":null,"abstract":"<p><p>Long-term health and developmental impact after <i>in utero</i> opioid and other substance exposures is unclear. There is an urgent need for well-designed, prospective, long-term observational studies. The HEALthy Brain and Child Development Study aims to address this need. It will require optimizing recruitment and retention of caregivers and young children in long-term research. Therefore, a scoping review of original research articles, indexed in the PubMed database and published in English between January 1, 2010, and November 23, 2023, was conducted on recruitment and retention strategies of caregiver-child (≤6 years old) dyads in observational, cohort studies. Among 2,902 titles/abstracts reviewed, 37 articles were found eligible. Of those, 29 (78%) addressed recruitment, and 18 (49%) addressed retention. Thirty-four (92%) articles focused on strategies for facilitating recruitment and/or retention, while 18 (49%) described potentially harmful approaches. Recruitment and retention facilitators included face-to-face and regular contact, establishing a relationship with study personnel, use of technology and social platforms, minimizing inconveniences, and promoting incentives. This review demonstrates that numerous factors can affect engagement of caregivers and their children in long-term cohort studies. Better understanding of these factors can inform researchers about optimal approaches to recruitment and retention of caregiver-child dyads in longitudinal research.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e194"},"PeriodicalIF":2.1,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626585/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142801063","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 Conversation with James LaBelle, MD, PhD, Associate Professor of Pediatric Hematology/Oncology/Stem Cell Transplant, University of Chicago.","authors":"","doi":"10.1017/cts.2024.628","DOIUrl":"https://doi.org/10.1017/cts.2024.628","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e193"},"PeriodicalIF":2.1,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626587/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800821","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":"Mixed-methods analysis of personal growth in an equity-centered leadership development program.","authors":"Josephine McKelvy, Chenguang Du, Michelle Song, Tara Carr, Rachel Berthiaume, Giselle Corbie, Claudia Fernandez, Gaurav Dave","doi":"10.1017/cts.2024.597","DOIUrl":"https://doi.org/10.1017/cts.2024.597","url":null,"abstract":"<p><strong>Introduction: </strong>Self-efficacy (or the belief in one's ability to effect change) often moderates the relationship between education, interest, and actions in evaluations of training programs that prepare community-based investigators in the clinical and translational sciences workforce. Such evaluations, however, tend to emphasize individual-level attitudes when there are also community- or organizational-level outcomes impacted.</p><p><strong>Methods: </strong>This study uses a novel sequential, explanatory mixed-methods design to explore multiple levels of self-efficacy (or self-awareness of personal growth in leadership) in the Clinical Scholars program, an equity-centered leadership development program for mid- to later-career healthcare professionals. Our design involves: (1) bivariate correlations and confirmatory factor analysis of self-assessed competencies across all program participants to identify emergent combinations of competencies, which informed (2) more nuanced thematic coding of participants' stories of most significant change in their personal and professional lives, as a result of the program.</p><p><strong>Results: </strong>In unpacking their accounts of personal leadership styles (that aligned with our quantitative analyses of competencies), we found that participants demonstrated multiple competencies simultaneously. Specifically, they employed emotionally intelligent learning and consensus-building dialogue to manage conflict for interpersonal impact. Additionally, they used this combination of skills to unite diverse stakeholders under a shared vision in order to lead and manage organizational change where all colleagues' contributions were valued.</p><p><strong>Conclusion: </strong>Together, these methods extend our understanding of personal growth in leadership as an outcome of the program in terms of individual- and organizational-level impacts, using representative quantitative self-assessments to categorize rich qualitative descriptions.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e175"},"PeriodicalIF":2.1,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604511/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769456","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 Conversation with Nasser Altorki, MD, David B. Skinner, M.D. Professor of Thoracic Surgery, Weill Cornell Medicine.","authors":"","doi":"10.1017/cts.2024.627","DOIUrl":"https://doi.org/10.1017/cts.2024.627","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e192"},"PeriodicalIF":2.1,"publicationDate":"2024-11-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626576/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800824","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":"Examining individual- versus population-level social determinants of health in a cluster randomized trial of health coaches for patients with multiple chronic conditions.","authors":"Mary E Charlson, Martin T Wells, James Hollenberg, Rosio Ramos, Guillerma Maritza Martinez, Martin J Gerard, Andrea Cassells, T J Lin, Ilana Mittleman, Alice Eggleston, Jonathan N Tobin","doi":"10.1017/cts.2024.598","DOIUrl":"10.1017/cts.2024.598","url":null,"abstract":"<p><strong>Introduction: </strong>Social determinants of health (SDOH) are an important contributor to health status and health outcomes. In this analysis, we compare SDOH measured both at the individual and population levels in patients with high comorbidity who receive primary care at Federally Qualified Health Centers in New York and Chicago and enrolled in the Tipping Points trial.</p><p><strong>Methods: </strong>We analyzed individual- and population-level measures of SDOH in 1,488 patients with high comorbidity (Charlson Comorbidity Index ≥ 4) enrolled in Tipping Points. At the individual level, we used a standardized patient-reported questionnaire. At the population level, we employed patient addresses to calculate the Social Deprivation Index (SDI) and Area Deprivation Index. Multivariable regressions were conducted in addition to qualitative feedback from stakeholders.</p><p><strong>Results: </strong>Individual-level SDOH are distinct from population-level measures. Significant component predictors of population SDI are being unhoused, unable to pay for utilities, and difficulty accessing medical transportation. Qualitative findings mirrored these results. High comorbidity patients report significant SDOH challenges at the individual level. Fitting a binomial generalized linear model, the comorbidity score is significantly predicted by the composite individual SDOH index (<i>p</i> < 0.0001) controlling for age and race/ethnicity.</p><p><strong>Conclusions: </strong>Individual- and population-level SDOH measures provide different risk assessments. The use of community-level SDI data is informative in the aggregate but should not be used to identify patients with individual unmet social needs. Health systems should implement a standardized individualized assessment of unmet SDOH needs and build strong, enduring partnerships with community-based organizations that can provide those services.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e191"},"PeriodicalIF":2.1,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11626581/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142800935","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}