Journal of Clinical and Translational Science最新文献

The future is now: Using the lessons learned from the ACTIV COVID-19 therapeutics trials to create an inclusive and efficient clinical trials enterprise. 未来就是现在：利用从 ACTIV COVID-19 疗法试验中汲取的经验教训，创建一个包容、高效的临床试验企业。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.622

Stacey J Adam, Sarah E Dunsmore, Lisa H Merck, Sarah W Read, Yves Rosenberg

引用次数: 0

ACTIV trials: Lessons learned in trial design in the setting of an emergent pandemic. ACTIV 试验：在突发大流行病背景下设计试验的经验教训。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.1

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

{"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":"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.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"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}

引用次数: 0

Preparing better: Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) therapeutics trials lessons learned: A call to the future. 做更好的准备：加速 COVID-19 治疗干预和疫苗（ACTIV）治疗试验的经验教训：对未来的呼唤。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.178

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

引用次数: 0

Overview of ACTIV trial-specific lessons learned. ACTIV 试验的具体经验教训概述。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-15 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2023.698

Ruxandra Draghia-Akli, Sarah W Read, Eric A Hughes

引用次数: 0

Realizing the potential of social determinants data in EHR systems: A scoping review of approaches for screening, linkage, extraction, analysis, and interventions. 发挥电子病历系统中社会决定因素数据的潜力：对筛选、链接、提取、分析和干预方法的范围审查。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-10 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.571

Chenyu Li, Danielle L Mowery, Xiaomeng Ma, Rui Yang, Ugurcan Vurgun, Sy Hwang, Hayoung K Donnelly, Harsh Bandhey, Yalini Senathirajah, Shyam Visweswaran, Eugene M Sadhu, Zohaib Akhtar, Emily Getzen, Philip J Freda, Qi Long, Michael J Becich

{"title":"Realizing the potential of social determinants data in EHR systems: A scoping review of approaches for screening, linkage, extraction, analysis, and interventions.","authors":"Chenyu Li, Danielle L Mowery, Xiaomeng Ma, Rui Yang, Ugurcan Vurgun, Sy Hwang, Hayoung K Donnelly, Harsh Bandhey, Yalini Senathirajah, Shyam Visweswaran, Eugene M Sadhu, Zohaib Akhtar, Emily Getzen, Philip J Freda, Qi Long, Michael J Becich","doi":"10.1017/cts.2024.571","DOIUrl":"10.1017/cts.2024.571","url":null,"abstract":"Background: Social determinants of health (SDoH), such as socioeconomics and neighborhoods, strongly influence health outcomes. However, the current state of standardized SDoH data in electronic health records (EHRs) is lacking, a significant barrier to research and care quality.Methods: We conducted a PubMed search using \"SDOH\" and \"EHR\" Medical Subject Headings terms, analyzing included articles across five domains: 1) SDoH screening and assessment approaches, 2) SDoH data collection and documentation, 3) Use of natural language processing (NLP) for extracting SDoH, 4) SDoH data and health outcomes, and 5) SDoH-driven interventions.Results: Of 685 articles identified, 324 underwent full review. Key findings include implementation of tailored screening instruments, census and claims data linkage for contextual SDoH profiles, NLP systems extracting SDoH from notes, associations between SDoH and healthcare utilization and chronic disease control, and integrated care management programs. However, variability across data sources, tools, and outcomes underscores the need for standardization.Discussion: Despite progress in identifying patient social needs, further development of standards, predictive models, and coordinated interventions is critical for SDoH-EHR integration. Additional database searches could strengthen this scoping review. Ultimately, widespread capture, analysis, and translation of multidimensional SDoH data into clinical care is essential for promoting health equity.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523026/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545788","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}

引用次数: 0

The application of quality improvement concepts, strategies, and tools to enhance participation in clinical trials among Latino families. 应用质量改进概念、策略和工具，提高拉丁裔家庭对临床试验的参与度。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-10 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.557

Keanaan Malke, Jennifer R Hemler, Daniel Lima, Pablo Colon, Caroline Mendoza, Naomy Azcona, Katie A Devine, Thomas I Mackie, Usha Ramachandran, Darlene Forbes, Michael Lucas, Shawna V Hudson, Manuel E Jimenez

{"title":"The application of quality improvement concepts, strategies, and tools to enhance participation in clinical trials among Latino families.","authors":"Keanaan Malke, Jennifer R Hemler, Daniel Lima, Pablo Colon, Caroline Mendoza, Naomy Azcona, Katie A Devine, Thomas I Mackie, Usha Ramachandran, Darlene Forbes, Michael Lucas, Shawna V Hudson, Manuel E Jimenez","doi":"10.1017/cts.2024.557","DOIUrl":"10.1017/cts.2024.557","url":null,"abstract":"Underrepresentation of people from racial and ethnic minoritized groups in clinical trials threatens external validity of clinical and translational science, diminishes uptake of innovations into practice, and restricts access to the potential benefits of participation. Despite efforts to increase diversity in clinical trials, children and adults from Latino backgrounds remain underrepresented. Quality improvement concepts, strategies, and tools demonstrate promise in enhancing recruitment and enrollment in clinical trials. To demonstrate this promise, we draw upon our team's experience conducting a randomized clinical trial that tests three behavioral interventions designed to promote equity in language and social-emotional skill acquisition among Latino parent-infant dyads from under-resourced communities. The recruitment activities took place during the COVID-19 pandemic, which intensified the need for responsive strategies and procedures. We used the Model for Improvement to achieve our recruitment goals. Across study stages, we engaged strategies such as (1) intentional team formation, (2) participatory approaches to setting goals, monitoring achievement, selecting change strategies, and (3) small iterative tests that informed additional efforts. These strategies helped our team overcome several barriers. These strategies may help other researchers apply quality improvement tools to increase participation in clinical and translational research among people from minoritized groups.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-10-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545789","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}

引用次数: 0

Digital health equity - A call to action for clinical and translational scientists. 数字健康公平--呼吁临床和转化科学家采取行动。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-09 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.564

Sheri Rowland, LaPrincess C Brewer, Lisa G Rosas

引用次数: 0

Misperception of maternal COVID-19 test status as a barrier to recruitment for an observational cohort study of mother-preterm infant dyads. 对母体 COVID-19 检测状况的误解是早产儿母婴二人组观察性队列研究招募的障碍。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-08 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.572

Anne L Smazal, Alison E Almgren-Bell, Jonah M Silverglade, Lauren B Bonner, Ann Dozier, Linda Van Horn, Jami Josefson, Daniel T Robinson

引用次数: 0

A novel approach to research engagement: Developing a targeted theory of change with Black and African-American stakeholders. 研究参与的新方法：与黑人和非裔美国人利益相关者共同制定有针对性的变革理论。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-07 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.610

Helen Hemley, Juliana M Ison, Marissa Reynolds, Tiffany Pham, Jonathan D Jackson

{"title":"A novel approach to research engagement: Developing a targeted theory of change with Black and African-American stakeholders.","authors":"Helen Hemley, Juliana M Ison, Marissa Reynolds, Tiffany Pham, Jonathan D Jackson","doi":"10.1017/cts.2024.610","DOIUrl":"10.1017/cts.2024.610","url":null,"abstract":"Purpose: Community inclusion in research may increase the quality and relevance of research, but doing so in an equitable way is complex. Novel approaches used to build engagement with historically marginalized communities in other sectors may have relevance in the clinical research sector.Method: To address long-standing gaps and challenges, a stakeholder group was convened to develop a theory of change (ToC), a structured method for obtaining input from stakeholders to enhance the design, conduct, and dissemination of research. The stakeholder group, comprised of Black residents within a metropolitan area, followed a structured monthly meeting schedule for 12 months to produce an outcome map, a model that formally defines aspects of research and engagement for this community.Results: Stakeholders reported significant improvements in trust in and engagement with research over the 12-month period, but not changes in health empowerment (individual, organizational, or community level). Through this convening process, a ToC and outcome map were developed with the focus of building bidirectional relationships between groups identifying as Black, Indigenous, and People of Color (BIPOC) and researchers in Boston, MA. Additionally, the group developed a community ownership model and guidelines for researchers to adhere to when utilizing the ToC and outcome map with BIPOC communities.Conclusion: Co-ownership of models to develop bidirectional relationships between researchers and community members, such as the ToC and outcome map, may advance and further the value and reach of community-based participatory research while increasing levels of trust and engagement in research.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523009/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545772","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}

引用次数: 0

A national unmet needs assessment for CTSA-affiliated electronic health record data networks: A customer discovery approach. 针对 CTSA 附属电子健康记录数据网络的全国性未满足需求评估：客户发现方法。

IF 2.1

Journal of Clinical and Translational Science Pub Date : 2024-10-03 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.609

Nallely Mora, Madeline Mehall, Lindsay A Lennox, Harold A Pincus, David Charron, Elaine H Morrato

{"title":"A national unmet needs assessment for CTSA-affiliated electronic health record data networks: A customer discovery approach.","authors":"Nallely Mora, Madeline Mehall, Lindsay A Lennox, Harold A Pincus, David Charron, Elaine H Morrato","doi":"10.1017/cts.2024.609","DOIUrl":"10.1017/cts.2024.609","url":null,"abstract":"Introduction: The expansion of electronic health record (EHR) data networks over the last two decades has significantly improved the accessibility and processes around data sharing. However, there lies a gap in meeting the needs of Clinical and Translational Science Award (CTSA) hubs, particularly related to real-world data (RWD) and real-world evidence (RWE).Methods: We adopted a mixed-methods approach to construct a comprehensive needs assessment that included: (1) A Landscape Context analysis to understand the competitive environment; and (2) Customer Discovery to identify stakeholders and the value proposition related to EHR data networks. Methods included surveys, interviews, and a focus group.Results: Thirty-two CTSA institutions contributed data for analysis. Fifty-four interviews and one focus group were conducted. The synthesis of our findings pivots around five emergent themes: (1) CTSA segmentation needs vary according to resources; (2) Team science is key for success; (3) Quality of data generates trust in the network; (4) Capacity building is defined differently by researcher career stage and CTSA existing resources; and (5) Researchers' unmet needs.Conclusions: Based on the results, EHR data networks like ENACT that would like to meet the expectations of academic research centers within the CTSA consortium need to consider filling the gaps identified by our study: foster team science, improve workforce capacity, achieve data governance trust and efficiency of operation, and aid Learning Health Systems with validating, applying, and scaling the evidence to support quality improvement and high-value care. These findings align with the NIH NCATS Strategic Plan for Data Science.","PeriodicalId":15529,"journal":{"name":"Journal of Clinical and Translational Science","volume":null,"pages":null},"PeriodicalIF":2.1,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11523010/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142545771","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}

引用次数: 0