汇集健康记录数据如何改善流感研究?

Challenge

Vaccines for COVID-19 have significantly decreased morbidity and mortality among those infected, yet more work is needed to fully understand how well they work for different groups of people, 在不同的现实世界条件下, 并了解更多的症状, outcomes, 以及这种疾病的并发症.

要回答这些问题, the 美国疾病控制与预防中心 established the VISION Vaccine Effectiveness (VE) Network—leveraging existing virtual networks, including the VISION influenza (flu) network to swiftly integrate data from 9 medical systems across the U.S.:

• Baylor Scott & White Health (Texas)
• 哥伦比亚大学欧文医学中心(纽约)
• 明尼苏达州儿童
• 健康伙伴(明尼苏达州和威斯康星州)
• Intermountain Healthcare(犹他州)
• 凯撒永久西北公司(俄勒冈州和华盛顿州)
• 注册律师协会(印第安纳州)
• 科罗拉多大学
• 范德比尔特大学医学中心(田纳西州)

需要一个由熟练的流行病学家组成的大型数据管理团队, biostatisticians, and IT specialists, able to develop and use advanced data collection and analysis tools and multimode processes, CDC于2020年选择趣赢平台作为VISION数据协调中心. The project demands collaboration with the VISION network of clinical sites and partners to harmonize a common protocol and data management system to expeditiously and continuously collect data on vaccinations, testing, 以及类似covid -19的疾病. 趣赢平台为衡量COVID-19疫苗的有效性提供分析支持, which informs public health policies designed to protect the public from the ravages of these diseases.

Solution

To address key questions about COVID-19 vaccine effectiveness and the clinical epidemiology of COVID-19 by sociodemographic status and among high-risk groups, 趣赢平台 established collaborative relationships with 9 health systems and partner research organizations to collect data on COVID-19-related medical outcomes in outpatient, urgent care, emergency department, 医院环境.

We developed a common protocol for harmonized data collection across sites; coordinated approval of the study protocol and data dictionary by a common institutional review board (趣赢平台’s IRB); and constructed a research data platform for site data collection.

9个卫生系统提供阴性检测设计数据(每两周一次), 对于站点的子集, cohort data (monthly) from electronic health records (EHRs) and vaccine registries related to SARS-CoV-2 testing, COVID-19接种疫苗, 与covid -19相关的医疗事件, and severe outcomes. 网站收集人口统计信息, 临床特点, discharge diagnoses, SARS-CoV-2 testing, and vaccination status of individuals with a COVID-19-like illness associated medical event.

数据通过安全的数据管道从站点发送到趣赢平台. We then conduct quality checks and combine the data into an analytic dataset with additional derived variables (such as underlying medical conditions, 这是根据每次就诊的出院诊断来定义的). 这些数据集每两周发送给疾病预防控制中心. 这一两周一次的时间表对于通报主要公共卫生政策至关重要, 比如加强建议, 资源分配. Our project staff work with site staff to facilitate accurate and complete reporting of testing, vaccination, 医疗接触数据. 趣赢平台的工作人员还将跨平台和跨站点的数据进行组合, 进行数据清理和质量控制, 生成分析数据集, 并带头进行分析, including vaccine effectiveness (VE) of COVID in immunocompromised populations and pregnant people, waning COVID VE, 不同SARS-CoV-2变异时期的VE, and, more recently, influenza (flu) VE.

趣赢平台使用基于机器学习的方法和复杂的分析(例如.g.(梯度增强回归树)，以帮助CDC更多地了解疫苗诱导的免疫. 通过使用亚马逊网络服务(AWS), we are able to capture and harmonize data in a central database and have instituted procedures for quality assurance and control. 我们的工作人员开发了自己的R包来分析数据, 并管理一个共享的Git存储库，用于中央代码分发和再现.

Results

趣赢平台’s research is broadening CDC’s knowledge about real-world effectiveness of COVID-19 and flu vaccines among different populations, 包括免疫功能低下的人. It is also contributing to CDC’s understanding of the signs and symptoms associated with COVID-19 illness; who is receiving each vaccine; and how different groups of people respond to it. These studies are providing CDC with the critical intelligence it needs to develop recommendations about how Americans can protect themselves from both diseases.

Importantly, 如果出现其他病原体, VISION’s structure will be able to leverage the platform to quickly conduct studies of those diseases and assess the level of protection afforded by any vaccines developed to combat them.

Since 2020, 韦斯特迅速得出的疫苗有效性估计已经通知了疾病预防控制中心, 免疫做法咨询委员会, 美国食品和药物管理局, and White House stakeholders as they consider next steps in safeguarding the public against both flu and COVID-19. 这些数据也发表在十几个高影响力的出版物上, 以及各大新闻媒体的报道.