Journal of Clinical and Translational Science最新文献

{"title":"Qualitative assessment of proposed visual key information pages for informed consent.","authors":"Krista E Cooksey, Eliana Goldstein, Clara Lee, Jessica Mozersky, Kimberly A Kaphingst, Victor Catalan Gallegos, Mary C Politi","doi":"10.1017/cts.2024.662","DOIUrl":"10.1017/cts.2024.662","url":null,"abstract":"<p><strong>Introduction: </strong>The 2018 Common Rule revision intended to improve informed consent by recommending a concise key information (KI) section, yet provided little guidance about how to describe KI. We developed innovative, visual KI templates with attention to health literacy and visual design principles. We explored end users' attitudes, beliefs, and institutional policies that could affect implementing visual KI pages.</p><p><strong>Materials and methods: </strong>From October 2023 to April 2024, we conducted semi-structured interviews with principal investigators, research staff, and Institutional Review Board (IRB) personnel, including those in oversight/management, and community partners. Forty participants from three academic institutions (in the Midwest, Southeast, and Mountain West) viewed example KI pages and completed interviews. We coded written transcripts inductively and deductively based on the capability, opportunity, and motivation to change behavior (COM-B) framework. Data were analyzed using content analysis and organized thematically.</p><p><strong>Results: </strong>Participants responded positively to the visual KI examples. They discussed potential benefits, including improving information processing and understanding of study procedures, diversity in research, trust in research, and study workflow. They also described potential challenges to consider before widespread implementation: IRBs' interpretations of federal guidelines, possible impacts on IRB submission processes, the effort/skill required to develop visuals, and difficulty succinctly communicating study risks. There was no consensus about when to use visual KI during consent, and some wondered if they were feasible for all study types.</p><p><strong>Discussion: </strong>Visual KI offers a promising solution to long-standing informed consent challenges. Future work can explore resources and training to address challenges and promote widespread use.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e218"},"PeriodicalIF":2.1,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11713442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949730","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 review of reported stakeholder engagement in early-stage translational research.","authors":"Thomas W Concannon, Marguerite Fenwood Hughes, Amy E LaVertu, Jonathan Garlick, Alice M Rushforth","doi":"10.1017/cts.2024.620","DOIUrl":"10.1017/cts.2024.620","url":null,"abstract":"<p><strong>Background: </strong>We conducted a scoping review of peer-reviewed literature to describe the nature and extent of reporting on the involvement of stakeholders in early-stage translational research.</p><p><strong>Methods and results: </strong>We conducted two literature searches in six databases, screened records and full-text articles, and abstracted and analyzed data from included publications. The literature searches yielded unduplicated 2,894 records. After screening, 13 articles were included.</p><p><strong>Findings: </strong>Our review of the literature yielded rare reports of engagement in early-stage translational research. Half of included articles reported on engagement with patients, clinicians, and researchers while fewer that one in three reported on engagement with policymakers, industry, and insurers. One in four reported engagement in the publication's acknowledgments but not in the main text. More than half drew unmeasured conclusions about the outcomes of engagement.</p><p><strong>Interpretation: </strong>Our definition of early-stage translation pointed to a specific set of peer-reviewed research; our findings indicate a reporting gap and not necessarily a gap in practice. By addressing four themes-developing a shared language, identifying frameworks and principles, creating a repository of resources, and establishing a research agenda, research leaders can develop new insights about how to engage communities in early-stage translational research.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"9 1","pages":"e24"},"PeriodicalIF":2.1,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11795857/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254766","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":"Pilot training for clinical research professionals in using empathy to recognize and respond to implicit bias in research recruitment and retention.","authors":"Jennifer Adams, Cristina M Gonzalez, Colleen Gillespie, James Holahan, Maura Minsky, Suchismita Datta, Rosario Medina, Amin Yakubov, Kimberly Byrnes, Miriam A Bredella","doi":"10.1017/cts.2024.618","DOIUrl":"10.1017/cts.2024.618","url":null,"abstract":"<p><p>Recruiting and retaining research participants is challenging because it often requires overcoming structural barriers and addressing how histories of mistrust and individuals' lived experiences affect their research engagement. We describe a pilot workshop designed to educate clinical research professionals on using empathy skills to recognize and mitigate bias to improve recruitment and retention. In a post-workshop survey (22/31 participants completed), 94% agreed the workshop helped them practice perspective-taking, recognize implicit bias, and identify opportunities for empathy. Participants reported increased confidence in key recruitment and retention skills (<i>p</i> < 0.05). Future studies will evaluate whether this translates into improved recruitment.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e209"},"PeriodicalIF":2.1,"publicationDate":"2024-11-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11713438/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949725","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":"Facilitating multidisciplinary working groups in translational research: Strategies to promote cross-center collaboration and sustain the Cancer Center Cessation Initiative Consortium.","authors":"Mara Minion, Betsy Rolland","doi":"10.1017/cts.2024.653","DOIUrl":"10.1017/cts.2024.653","url":null,"abstract":"<p><p>As funding for large translational research consortia increases across the National Institutes of Health (NIH), focused working groups provide an opportunity to leverage the power of unique networks to conduct high-impact science and offer a strategy for building collaborative infrastructure to sustain networks long-term. This sustainment leverages the existing NIH investments, amplifying the impact and creating conditions for future innovative translational research. However, few resources exist that detail practical strategies for establishing and sustaining working groups in consortia. Here, we describe how the Coordinating Center for the National Cancer Institute-funded Cancer Center Cessation Initiative (C3I) utilized principles derived from the Science of Team Science to develop replicable strategies for building and sustaining an effective working group-led consortium. These strategies include continually engaging community members in strategic planning, prioritizing diversity in leadership and membership, creating multi-level opportunities for leadership and participation, providing intensive community management and facilitation, and incentivizing projects that support the consortium sustainment. When assessing the impact of these interventions through qualitative exit interviews, four key themes emerged: through the C3I working group consortium, members co-created new dissemination products, gained new insights and innovations, enhanced local program implementation, and invested in cross-network collaboration to support sustained engagement in the initiative.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e216"},"PeriodicalIF":2.1,"publicationDate":"2024-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11713431/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949677","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 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":"Health impacts of a remotely delivered prolonged nightly fasting intervention in stressed adults with memory decline and obesity: A nationwide randomized controlled pilot trial.","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.2024.651","DOIUrl":"10.1017/cts.2024.651","url":null,"abstract":"<p><strong>Objective/goals: </strong>Cognitive decline is intricately linked to various factors such as obesity, stress, poor sleep, and circadian rhythm misalignment, which are interrelated in their impact on cognitive health. Irregular food-intake timing further compounds these issues. The practice of prolonged nightly fasting (PNF) may help synchronize food intake with circadian rhythms, potentially mitigating adverse effects of cognitive decline and associated factors.</p><p><strong>Methods: </strong>A pilot nationwide, remotely delivered, 2-arm randomized controlled trial was conducted to assess the 8-week outcomes of cognition, stress, and sleep, after a PNF intervention (14-hr nightly fast, 6 nights/week, no calories after 8 pm) compared to a health education (HED) control condition. Participants were living with memory decline, stress, and obesity and had weekly check-in calls to report fasting times (PNF) or content feedback (HED).</p><p><strong>Results: </strong>Participants were enrolled from 37 states in the US; <i>N</i> = 58, 86% women, 71% white, 93% non-Latinx, mean (SD) age 50.1 (5.1) years and BMI 35.6 (3.6) kg/m². No group differences existed at baseline. Linear mixed-effects models were used to compare outcome change differences between groups. Compared to the HED control, the PNF intervention was associated with improved sleep quality (<i>B</i> = -2.52; <i>SE</i> = 0.90; <i>95% CI</i> -4.30--0.74; <i>p</i> = 0.006). Perceived stress and everyday cognition significantly changed over time (<i>p</i> < 0.02), without significant difference by group.</p><p><strong>Discussion: </strong>Changing food intake timing to exclude nighttime eating and promote a fasting period may help individuals living with obesity, memory decline, and stress to improve their sleep. Improved sleep quality may lead to additional health benefits.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e215"},"PeriodicalIF":2.1,"publicationDate":"2024-11-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11713440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949754","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}