eMERGE Phase IV Clinical Center at Partners HealthCare

Partners HealthCare 的 eMERGE IV 期临床中心

• 批准号: 10230561
• 负责人: ELIZABETH W KARLSON
• 金额: $ 88.31万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-06 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10230561
• 关键词: Address; Affect; Algorithms; Back; COVID-19; COVID-19 pandemic; Clinical; Code; Complex; Computer software; Data; Data Aggregation; Data Analyses; Data Collection; Disease; Electronic Health Record; Generations; Guidelines; Healthcare; Hospitals; Informatics; Intelligence; International; Life; Neuraxis; Patients; Phase; Policy Maker; Public Health; Pythons; Research; Rest; Running; Site; Trust; Update; Validation; Visualization; Work; clinical center; clinical research site; data quality; data visualization; health care delivery; informatics infrastructure; novel; phase 2 testing; research and development; statistics; tool; web site

The Coronavirus Disease 2019 (COVID-19) pandemic has caught the world off guard, reshaping ways of life, the economy, and healthcare delivery. Data in electronic health records (EHRs) should be widely available to study COVID-19 but have not yet been effectively shared across clinical sites, with public health agencies, or with policy makers. There are several large, national and international projects to build informatics infrastructure to analyze the EHR data of patients with COVID-19. However, aggregating data from multiple EHRs only works if you can trust the final results. This means being able to go back to each site and talk to the people who know the data best, to understand the local clinical guidelines, coding practices, data quality problems, and other factors that affect the data. In March, 2020, we launched an international effort called the Consortium for Clinical Characterization of COVID-19 by EHR (4CE). It brings together more than 100 informatics experts, statisticians, and ICU doctors from around the world. The novel aspect of 4CE is that we recognize the complexities of EHR data and the need to directly involve the local data experts, not only in the data collection, but also in the development of research questions and the data analyses. We try to move fast, believing that early intelligence is worth more than complete intelligence later. To do this, we avoid roadblocks that typically slow down informatics projects, such as building or installing new software, or the regulatory hurdles involved in sharing patient-level data. Instead, we ask participating sites to run analyses locally, using simple existing tools, like SQL, R, and Python scripts, and only share aggregate counts and statistics centrally with the rest of the 4CE consortium. We review and validate the data as a group, identify and fix data quality problems, and ask sites to repeat the analyses until everything is right. Through multiple cycles of data verification, we iteratively clean up the data and gain confidence that the findings we are seeing are real. Because we can do this quickly, we go from research question to results in just a few weeks. This proposed project will “productize” the 4CE approach, through three Specific Aims: (1) Transition 4CE to “Phase 2”, where sites will begin more complex local analyses. We will develop Phase 2 analysis scripts; update our data upload, validation, and visualization websites; and, test the Phase 2 scripts at three sites before expanding to the rest of the consortium. (2) Demonstrate and evaluate 4CE through two use cases. We will refine and validate an algorithm for identifying COVID-19 patients with “severe” disease and use 4CE to characterize central nervous system complications in COVID-19. (3) Develop a plan for integrating with complementary efforts and long-term sustainability. As part of this, we will create a guide that shows sites how to use 4CE data extracts and quality checks to support other COVID-19 informatics projects, including the generation of OMOP files.

2019年冠状病毒病（Covid-19）大流行使世界措手不及，重塑生活方式， 经济和医疗保健提供。电子健康记录中的数据（EHR）应广泛使用 研究COVID-19，但尚未在临床站点，公共卫生机构或 与政策制定者。有几个大型国家和国际项目来建立信息基础设施 分析COVID-19患者的EHR数据。但是，来自多个EHR的数据仅有效 如果您可以相信最终结果。这意味着能够回到每个站点并与认识的人交谈 最佳数据，了解本地临床准则，编码实践，数据质量问题以及其他 影响数据的因素。 2020年3月，我们发起了一个名为临床财团的国际努力 EHR（4CE）对COVID-19的表征。它汇集了100多位信息专家，统计学家， 和世界各地的ICU医生。 4CE的新颖方面是我们认识到EHR的复杂性 数据和需要直接涉及本地数据专家的需求，不仅是数据收集，而且还参与了 开发研究问题和数据分析。我们试图快速移动，相信早期的情报 以后是完整的智能的价值。为此，我们避免了通常放慢速度的障碍 信息信息项目，例如构建或安装新软件，或共享涉及的监管障碍 患者级数据。相反，我们要求参与网站在本地进行分析，并使用简单的现有工具，例如 SQL，R和Python脚本，仅与4CE的其余部分共享汇总计数和统计数据 财团。我们审查并验证数据小组，识别和解决数据质量问题，并要求网站 重复分析，直到一切都正确。通过多个数据验证循环，我们迭代清理 数据并获得了我们看到的发现是真实的信心。因为我们可以快速这样做，所以我们去 从研究问题到结果仅几周。这个拟议的项目将“生产” 4CE方法， 通过三个特定的目的：（1）向“ 2阶段”过渡4CE，在那里站点将开始更复杂的本地分析。 我们将开发2阶段分析脚本；更新我们的数据上传，验证和可视化网站；和， 在扩展到其余的财团之前，在三个站点上测试2阶段脚本。 （2）演示和 通过两种用例评估4CE。我们将完善并验证用于识别Covid-19患者的算法 患有“严重”疾病，并使用4CE表征COVID-19的中枢神经系统并发症。 （3） 制定一项计划与完善工作和长期可持续性融为一体。作为其中的一部分，我们将 创建指南，以显示网站如何使用4CE数据提取和质量检查来支持其他Covid-19 信息项目，包括生成OMOP文件。