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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

加速 COVID-19 治疗干预和疫苗 (ACTIV) 由美国政府发起,旨在 2020 年快速开发和测试针对 COVID-19 的疫苗和疗法。ACTIV 疗法-临床工作组选择了 ACTIV 试验团队和临床网络,以根据治疗目标和患者群体快速开发和启动主方案。这套临床试验旨在为全球 COVID-19 门诊、住院和重症监护人群的治疗护理提供集体信息。在本报告中,我们重点介绍了临床方案开发和监管审批方面的挑战、策略和解决方案,以记录我们的经验,并为未来类似的医疗紧急情况提出计划。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

加速 COVID-19 治疗干预和疫苗治疗临床工作组成员在 COVID-19 大流行早期发布的经验教训手稿的后续工作中收集了重要建议。他们分享了关于病原体优先排序、临床前治疗测试、主方案设计与实施、药品生产与供应、数据共享和公私合作价值等方面的经验教训,以便为应对未来的大流行提供参考。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) was an extraordinary example of a public-private partnership (PPP) that brought together over thirty organizations and hundreds of individuals to address one of the most pressing global health needs in recent decades. In particular, ACTIV provided a key avenue for testing numerous therapeutics for their potential benefit in treating the SARS-CoV-2 virus or the resulting symptoms of acute COVID-19 infection. Given the speed and scale at which ACTIV designed and implemented master protocols across global networks that it was simultaneously working to create, the PPP can provide valuable lessons for best practices and avoiding pitfalls the next time the world is faced with a global pandemic of a novel pathogen. This report provides a general overview of the ACTIV partnership to set the stage and context for the subsequent articles in this issue that will relay these lessons learned.

加速 COVID-19 治疗干预和疫苗(ACTIV)是公私合作伙伴关系(PPP)的一个杰出范例,它汇集了三十多个组织和数百名个人,以解决近几十年来最紧迫的全球健康需求之一。特别是,ACTIV 为测试多种治疗方法提供了重要途径,以确定这些方法对治疗 SARS-CoV-2 病毒或急性 COVID-19 感染症状的潜在益处。考虑到 ACTIV 在其同时努力创建的全球网络中设计和实施主协议的速度和规模,PPP 可以为下一次全球面临新型病原体大流行时的最佳实践和避免陷阱提供宝贵的经验。本报告对 ACTIV 合作伙伴关系进行了总体概述,为本期后续文章介绍这些经验教训奠定了基础和背景。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

背景:健康的社会决定因素(SDoH),如社会经济和邻里关系,对健康结果有很大影响。然而,目前电子健康记录(EHR)中缺乏标准化的 SDoH 数据,这是研究和医疗质量的一大障碍:我们使用 "SDOH "和 "EHR "医学主题词进行了PubMed搜索,分析了五个领域的文章:1)SDoH 筛查和评估方法;2)SDoH 数据收集和记录;3)使用自然语言处理 (NLP) 提取 SDoH;4)SDoH 数据和健康结果;5)SDoH 驱动的干预措施:在确定的 685 篇文章中,有 324 篇进行了全面审查。主要研究结果包括:实施量身定制的筛查工具、将人口普查和理赔数据联系起来以建立 SDoH 背景档案、从笔记中提取 SDoH 的 NLP 系统、SDoH 与医疗保健利用率和慢性病控制之间的关联以及综合护理管理计划。然而,数据来源、工具和结果之间的差异凸显了标准化的必要性:尽管在确定患者社会需求方面取得了进展,但进一步制定标准、预测模型和协调干预措施对于 SDoH-EHR 整合至关重要。更多的数据库搜索可以加强此次范围界定审查。最终,广泛采集、分析多维 SDoH 数据并将其转化为临床护理对于促进健康公平至关重要。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

来自少数种族和族裔群体的人员在临床试验中的代表性不足,威胁着临床和转化科学的外部有效性,降低了创新成果在实践中的吸收率,并限制了人们获得参与试验的潜在益处。尽管我们努力提高临床试验的多样性,但拉丁裔背景的儿童和成人参与临床试验的比例仍然偏低。质量改进概念、策略和工具在提高临床试验的招募和入组方面展现了前景。为了证明这一前景,我们借鉴了我们团队开展随机临床试验的经验,该试验测试了三种行为干预措施,旨在促进来自资源匮乏社区的拉丁裔父母-婴儿二人组在语言和社会情感技能习得方面的公平性。招募活动是在 COVID-19 大流行期间进行的,因此更加需要采取应对策略和程序。我们采用了 "改进模式 "来实现招募目标。在各个研究阶段,我们采用了以下策略:(1)有意识地组建团队;(2)采用参与式方法设定目标、监督成果、选择变革策略;(3)进行小型迭代测试,为后续工作提供依据。这些策略帮助我们的团队克服了一些障碍。这些策略可以帮助其他研究人员应用质量改进工具,提高少数群体参与临床和转化研究的程度。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-10-09 eCollection Date: 2024-01-01 DOI: 10.1017/cts.2024.564
Sheri Rowland, LaPrincess C Brewer, Lisa G Rosas
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

Enrollment into a prospective cohort study of mother-preterm infant dyads during the COVID-19 pandemic progressed slower than anticipated. Enrollment occurred during the first week after preterm birth, while infants were still hospitalized. We hypothesized that slower enrollment was attributable to mothers testing positive for COVID-19 as hospital policies restricted them from entering the neonatal intensive care unit, thus reducing interactions with research staff. However, only 4.5% of 245 screened mothers tested COVID-19 positive. Only 24.9% of those screened, far fewer than anticipated, were eligible for enrollment. Assumptions about pandemic-related enrollment barriers were not substantiated in this pediatric cohort.

在 COVID-19 大流行期间,一项针对母亲-早产儿二人组的前瞻性队列研究的注册进度比预期的要慢。在早产儿出生后的第一周,当婴儿仍在住院时,研究就开始了。我们假设,由于医院的政策限制母亲进入新生儿重症监护室,从而减少了她们与研究人员的交流,导致 COVID-19 检测呈阳性的母亲入组速度较慢。然而,在 245 名接受筛查的母亲中,只有 4.5% 的母亲 COVID-19 检测呈阳性。只有 24.9% 的筛查对象符合入组条件,远远低于预期。在这个儿科群组中,与大流行相关的注册障碍假设并未得到证实。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

目的:将社区纳入研究可提高研究的质量和相关性,但以公平的方式做到这一点非常复杂。在其他行业中,用于与历史上被边缘化的社区建立联系的新方法可能适用于临床研究领域:为了解决长期存在的差距和挑战,我们召集了一个利益相关者小组,以制定变革理论 (ToC),这是一种结构化的方法,用于从利益相关者那里获取意见,以加强研究的设计、开展和传播。该利益相关者小组由一个大都市地区的黑人居民组成,在 12 个月的时间里,他们按照结构化的月度会议计划,绘制了一张成果图,这是一个正式定义该社区研究和参与方面的模型:结果:利益相关者报告称,在 12 个月的时间里,他们对研究的信任度和参与度有了明显提高,但在健康赋权方面(个人、组织或社区层面)却没有发生变化。通过这一召集过程,制定了一个 ToC 和成果图,重点是在马萨诸塞州波士顿市被认定为黑人、土著人和有色人种 (BIPOC) 的群体与研究人员之间建立双向关系。此外,该小组还开发了一个社区所有权模型,并为研究人员在与黑人、土著和有色人种(BIPOC)社区共同使用 ToC 和成果图时提供了指导原则:结论:在研究人员和社区成员之间建立双向关系的共同所有权模式(如 ToC 和成果图),可以在提高研究的信任度和参与度的同时,提升和扩大基于社区的参与式研究的价值和范围。
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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 Q3 MEDICINE, RESEARCH & EXPERIMENTAL 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

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.

导言:过去二十年来,电子健康记录(EHR)数据网络的扩展大大改善了数据共享的可及性和流程。然而,在满足临床与转化科学奖(CTSA)中心的需求方面还存在差距,尤其是与真实世界数据(RWD)和真实世界证据(RWE)相关的需求:我们采用了一种混合方法来构建全面的需求评估,其中包括(方法:我们采用混合方法构建了全面的需求评估,其中包括:(1)景观背景分析,以了解竞争环境;(2)客户发现,以确定利益相关者和与电子病历数据网络相关的价值主张。方法包括调查、访谈和焦点小组:32 家 CTSA 机构为分析提供了数据。共进行了 54 次访谈和一次焦点小组讨论。我们围绕五个新出现的主题对研究结果进行了综合:(1)CTSA 的细分需求因资源而异;(2)团队科学是成功的关键;(3)数据质量可产生对网络的信任;(4)能力建设因研究人员的职业阶段和 CTSA 的现有资源而异;以及(5)研究人员的需求未得到满足:根据研究结果,像 ENACT 这样的电子病历数据网络要想满足 CTSA 联盟内学术研究中心的期望,就需要考虑填补我们的研究发现的空白:促进团队科学、提高劳动力能力、实现数据治理信任和运行效率,并帮助学习型医疗系统验证、应用和推广证据,以支持质量改进和高价值护理。这些研究结果与美国国立卫生研究院 NCATS 的数据科学战略计划相一致。
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引用次数: 0
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