Journal of Clinical and Translational Science最新文献

{"title":"The Spanish translation, adaptation, and validation of a Community-Engaged Research survey and a pragmatic short version: Encuesta Comunitaria and FUERTES.","authors":"Patricia Rodriguez Espinosa, Juan M Peña, Carlos Devia, Blake Boursaw, Magdalena Avila, Diana Rudametkin, Sergio Aguilar-Gaxiola, Margarita Alegria, Lourdes E Soto de Laurido, Edna Acosta Pérez, Nina Wallerstein","doi":"10.1017/cts.2024.613","DOIUrl":"10.1017/cts.2024.613","url":null,"abstract":"<p><strong>Introduction: </strong>Community-Engaged Research (CEnR) and Community-Based Participatory Research (CBPR) require validated measures and metrics for evaluating research partnerships and outcomes. There is a need to adapt and translate existing measures for practical use with diverse and non-English-speaking communities. This paper describes the Spanish translation and adaptation of Engage for Equity's Community Engagement Survey (E² CES), a nationally validated and empirically-supported CEnR evaluation tool, into the full-length \"<i>Encuesta Comunitaria</i>,\" and a pragmatic shorter version \"<i>Fortaleciendo y Uniendo EsfueRzos Transdisciplinarios para Equidad de Salud</i>\" (FUERTES).</p><p><strong>Methods: </strong>Community and academic partners from the mainland US, Puerto Rico, and Nicaragua participated in translating and adapting E² CES, preserving content validity, psychometric properties, and importance to stakeholders of items, scales, and CBPR constructs (contexts, partnership processes, intervention and research actions, and outcomes). Internal consistency was assessed using Cronbach's alpha and convergent validity was assessed via a correlation matrix among scales.</p><p><strong>Results: </strong><i>Encuesta Comunitaria</i> respondents (<i>N</i> = 57) self-identified as primarily Latinos/as/x (97%), female (74%), and academics (61%). Cronbach's alpha values ranged from 0.72 to 0.88 for items in the context domain to 0.90-0.92 for items in the intervention/research domain. Correlations were found as expected among subscales, with the strongest relationships found for subscales within the same CBPR domain. Results informed the creation of FUERTES.</p><p><strong>Conclusions: </strong><i>Encuenta Comunitaria</i> and FUERTES offer CEnR/CBPR practitioners two validated instruments for assessing their research partnering practices, and outcomes. Moreover, FUERTES meets the need for shorter pragmatic tools. These measures can further strengthen CEnR/CBPR involving Latino/a/x communities within the US, Latin America, and globally.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e165"},"PeriodicalIF":2.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604499/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769472","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":"Clinical researchers' insights on key data for eligibility screening in clinical studies.","authors":"Betina Idnay, Emily R Gordon, Aubrey S Johnson, Jordan G Nestor, Karen Marder, Chunhua Weng","doi":"10.1017/cts.2024.617","DOIUrl":"https://doi.org/10.1017/cts.2024.617","url":null,"abstract":"<p><strong>Introduction: </strong>Clinical research is critical for healthcare advancement, but participant recruitment remains challenging. Clinical research professionals (CRPs; e.g., clinical research coordinator, research assistant) perform eligibility prescreening, ensuring adherence to study criteria while upholding scientific and ethical standards. This study investigates the key information CRP prioritizes during eligibility prescreening, providing insights to optimize data standardization, and recruitment approaches.</p><p><strong>Methods: </strong>We conducted a freelisting survey targeting 150 CRPs from diverse domains (i.e., neurological disorders, rare diseases, and other diseases) where they listed essential information they look for from medical records, participant/caregiver inquiries, and discussions with principal investigators to determine a potential participant's research eligibility. We calculated the salience scores of listed items using Anthropac, followed by a two-level analytic procedure to classify and thematically categorize the data.</p><p><strong>Results: </strong>The majority of participants were female (81%), identified as White (44%) and as non-Hispanic (64.5%). The first-level analysis universally emphasized age, medication list, and medical history across all domains. The second-level analysis illuminated domain-specific approaches in information retrieval: for instance, history of present illness was notably significant in neurological disorders during participant and principal investigator inquiries, while research participation was distinctly salient in potential participant inquiries within the rare disease domain.</p><p><strong>Conclusion: </strong>This study unveils the intricacies of eligibility prescreening, with both universal and domain-specific methods observed. Variations in data use across domains suggest the need for tailored prescreening in clinical research. Incorporating these insights into CRP training and refining prescreening tools, combined with an ethical, participant-focused approach, can advance eligibility prescreening practices.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e167"},"PeriodicalIF":2.1,"publicationDate":"2024-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769481","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 future is now: Using the lessons learned from the ACTIV COVID-19 therapeutics trials to create an inclusive and efficient clinical trials enterprise.","authors":"Stacey J Adam, Sarah E Dunsmore, Lisa H Merck, Sarah W Read, Yves Rosenberg","doi":"10.1017/cts.2024.622","DOIUrl":"10.1017/cts.2024.622","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e148"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523011/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545790","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 statistical design and analysis of pandemic platform trials: Implications for the future.","authors":"Christopher J Lindsell, Matthew Shotwell, Kevin J Anstrom, Scott Berry, Erica Brittain, Frank E Harrell, Nancy Geller, Birgit Grund, Michael D Hughes, Prasanna Jagannathan, Eric Leifer, Carlee B Moser, Karen L Price, Michael Proschan, Thomas Stewart, Sonia Thomas, Giota Touloumi, Lisa LaVange","doi":"10.1017/cts.2024.514","DOIUrl":"10.1017/cts.2024.514","url":null,"abstract":"<p><p>The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Cross-Trial Statistics Group gathered lessons learned from statisticians responsible for the design and analysis of the 11 ACTIV therapeutic master protocols to inform contemporary trial design as well as preparation for a future pandemic. The ACTIV master protocols were designed to rapidly assess what treatments might save lives, keep people out of the hospital, and help them feel better faster. Study teams initially worked without knowledge of the natural history of disease and thus without key information for design decisions. Moreover, the science of platform trial design was in its infancy. Here, we discuss the statistical design choices made and the adaptations forced by the changing pandemic context. Lessons around critical aspects of trial design are summarized, and recommendations are made for the organization of master protocols in the future.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e155"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142636100","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 communities in therapeutics clinical research during pandemics: Experiences and lessons from the ACTIV COVID-19 therapeutics research initiative.","authors":"David A Wohl, Stacey J Adam, Kevin W Gibbs, Ari L Moskowitz, Thomas L Ortel, Upinder Singh, Nikolaus Jilg, Teresa H Evering, William A Fischer, Babafemi O Taiwo, Eric S Daar, Christopher J Lindsell, Susanna Naggie, Russell L Rothman, Sarah E Dunsmore, M Patricia McAdams, Julia Vail, Dushyantha Jayaweera","doi":"10.1017/cts.2024.561","DOIUrl":"10.1017/cts.2024.561","url":null,"abstract":"<p><p>This manuscript addresses a critical topic: navigating complexities of conducting clinical trials during a pandemic. Central to this discussion is engaging communities to ensure diverse participation. The manuscript elucidates deliberate strategies employed to recruit minority communities with poor social drivers of health for participation in COVID-19 trials. The paper adopts a descriptive approach, eschewing analysis of data-driven efficacy of these efforts, and instead provides a comprehensive account of strategies utilized. The Accelerate COVID-19 Treatment Interventions and Vaccines (ACTIV) public-private partnership launched early in the COVID-19 pandemic to develop clinical trials to advance SARS-CoV-2 treatments. In this paper, ACTIV investigators share challenges in conducting research during an evolving pandemic and approaches selected to engage communities when traditional strategies were infeasible. Lessons from this experience include importance of community representatives' involvement early in study design and implementation and integration of well-developed public outreach and communication strategies with trial launch. Centralization and coordination of outreach will allow for efficient use of resources and the sharing of best practices. Insights gleaned from the ACTIV program, as outlined in this paper, shed light on effective strategies for involving communities in treatment trials amidst rapidly evolving public health emergencies. This underscores critical importance of community engagement initiatives well in advance of the pandemic.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e156"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557280/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621440","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":"ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic.","authors":"Maryam Keshtkar-Jahromi, Kevin J Anstrom, Christina Barkauskas, Samuel M Brown, Eric S Daar, William Fischer, Kevin W Gibbs, Elizabeth S Higgs, Michael D Hughes, Prasanna Jagannathan, Lisa LaVange, Christopher J Lindsell, Seema U Nayak, Roger Paredes, Mahesh Parmar, Ithan D Peltan, Michael Proschan, Matthew S Shotwell, David M Vock, Tammy Yokum, Stacey J Adam","doi":"10.1017/cts.2024.1","DOIUrl":"10.1017/cts.2024.1","url":null,"abstract":"<p><p>Accelerating COVID-19 Treatment Interventions and Vaccines (ACTIV) was initiated by the US government to rapidly develop and test vaccines and therapeutics against COVID-19 in 2020. The ACTIV Therapeutics-Clinical Working Group selected ACTIV trial teams and clinical networks to expeditiously develop and launch master protocols based on therapeutic targets and patient populations. The suite of clinical trials was designed to collectively inform therapeutic care for COVID-19 outpatient, inpatient, and intensive care populations globally. In this report, we highlight challenges, strategies, and solutions around clinical protocol development and regulatory approval to document our experience and propose plans for future similar healthcare emergencies.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e151"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142550067","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":"Return of individual research results to participants with and at risk for Parkinson's disease.","authors":"Samantha E Lettenberger, Emily A Hartman, Kali Tam, Peggy Auinger, Meghan E Pawlik, Renee Wilson, Elizabeth T Banda, Blanca Valdovinos, Daniel Kinel, Roy N Alcalay, E Ray Dorsey, Lucy Norcliffe-Kaufmann, Saloni Sharma, Robert G Holloway, Ruth B Schneider","doi":"10.1017/cts.2024.616","DOIUrl":"https://doi.org/10.1017/cts.2024.616","url":null,"abstract":"<p><p>In a prospective, remote natural history study of 277 individuals with (60) and genetically at risk for (217) Parkinson's disease (PD), we examined interest in the return of individual research results (IRRs) and compared characteristics of those who opted for versus against the return of IRRs. Most (<i>n</i> = 180, 65%) requested sharing of IRRs with either a primary care provider, neurologist, or themselves. Among individuals without PD, those who requested sharing of IRRs with a clinician reported more motor symptoms than those who did not request any sharing (mean (SD) 2.2 (4.0) versus 0.7 (1.5)). Participant interest in the return of IRRs is strong.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e164"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11604507/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142769471","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":"Preparing better: Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) therapeutics trials lessons learned: A call to the future.","authors":"Stacey J Adam, Timothy G Buchman, Judith S Currier, Ruxandra Draghia-Akli, Josh P Fessel, Elizabeth S Higgs, Eric A Hughes, Lisa LaVange, Joseph P Menetski, Sarah W Read, Yves Rosenberg, Randall Tressler","doi":"10.1017/cts.2024.178","DOIUrl":"10.1017/cts.2024.178","url":null,"abstract":"<p><p>The Accelerating COVID-19 Therapeutic Interventions and Vaccines Therapeutic-Clinical Working Group members gathered critical recommendations in follow-up to lessons learned manuscripts released earlier in the COVID-19 pandemic. Lessons around agent prioritization, preclinical therapeutics testing, master protocol design and implementation, drug manufacturing and supply, data sharing, and public-private partnership value are shared to inform responses to future pandemics.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e150"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523022/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545787","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":"Lessons learned from the conduct of inpatient clinical trials in a pandemic.","authors":"Jane A O'Halloran, Jeremy R Beitler, Lucy K Chung, Mamta K Jain, Akram Khan, Lisa H Merck, Ahmad Mourad, Minn A Oh, Shweta Sharma, Tammy Yokum, Seema U Nayak","doi":"10.1017/cts.2024.483","DOIUrl":"10.1017/cts.2024.483","url":null,"abstract":"<p><strong>Background: </strong>The COVID-19 pandemic amplified known challenges associated with the conduct of inpatient clinical trials, while also introducing new ones that needed to be addressed.</p><p><strong>Methods: </strong>Stakeholders based in the United States who participated in the conduct of inpatient therapeutic trials for the treatment of COVID-19 as part of the Accelerating COVID-19 Therapeutic Interventions and Vaccines program identified challenges experienced in the conduct of these trials through a series of meeting to discuss and identify common themes. In addition, innovations developed to address these challenges and other potential solutions that may be utilized in future pandemics were highlighted.</p><p><strong>Results: </strong>Six thematic challenges including infection control considerations, the interplay between provision of clinical care and research, competing clinical trials, arduous consenting procedures, onerous procedural requirements, and participant recruitment including achieving representation of diverse populations were identified and are discussed here.</p><p><strong>Conclusions: </strong>Consideration of the lessons learned and recommendation outlined here may allow for more efficient conduct of inpatient clinical trials in future pandemics.</p>","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e154"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557273/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621354","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":"Lessons learned from COVID-19 to overcome challenges in conducting outpatient clinical trials to find safe and effective therapeutics for the next infectious pandemic.","authors":"Minn A Oh, Judith Currier, Akram Khan, Eleftherios Mylonakis, Matthew Newell, Rachel Bender Ignacio, Nick Jilg, Basmah Safdar, Lisa H Merck, Davey M Smith","doi":"10.1017/cts.2024.607","DOIUrl":"10.1017/cts.2024.607","url":null,"abstract":"","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":"8 1","pages":"e153"},"PeriodicalIF":2.1,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11557272/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142621352","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}