VISION疫苗有效性网络:为什么它成功了

随着新型冠状病毒肺炎大流行的紧急阶段过去, 人们越来越有兴趣了解为什么VISION疫苗有效性(VE)网络, 由美国疾病控制与预防中心(CDC)于2020年发起, succeeded in guiding vaccine policy decisions and providing vital information to the American public when other similarly focused initiatives fell short. 了解是什么促成了这个由9个美国人组成的协作“虚拟网络”.S. 医疗系统, 由韦斯特协调, 能够快速及时的交货, 关于不同人群疫苗有效性(VE)的可靠数据, 在不同的现实世界条件下, and deepen knowledge about 新型冠状病毒肺炎’s outcomes and complications is critical to helping us fight other pathogens should they emerge.

在整个项目过程中, VISION网络发表了超过25篇论文, 无论是在同行评议的期刊上还是在疾控中心的期刊上 发病率和死亡率周报(MMWR). These publications served to update the scientific community about the effectiveness of the 新型冠状病毒肺炎 vaccines and to provide policymakers with data to inform decisionmaking. 在一个特别高产的时期，该网络在不到一年的时间里发表了14篇手稿. The following figure shows all the different publication efforts that were occurring simultaneously during this period.

寻求对VISION网络成功的洞察, 趣赢平台 turned to those on the frontlines of this work—the Principal Investigators (PIs) at the 9 医疗系统 engaged in the VISION Network—as well as the director of the VISION project, 韦斯特的莎拉·鲍尔报道, 镜头分割, MS, 英里每小时, 副总裁兼首席科学/流行病学顾问.

两年多了, the PIs oversaw their organizations’ rapid extraction of data from electronic health records (EHRs) and vaccine registries related to SARS-CoV-2 testing, 新型冠状病毒肺炎接种疫苗, clinical characteristics and discharge diagnoses from COVID-like-illness-associated medical events, 以及患者的人口统计信息. This was possible because of decades of investment by collaborating institutions into their data systems so they were ready to provide high-quality data during the pandemic.  

一旦聚集, 数据被安全地转移到韦斯特, which conducted quality checks and combined the data into analytic datasets with additional derived variables (such as underlying medical conditions). The data were then delivered biweekly to CDC to inform key policies to protect Americans and establish resource allocations. 向趣赢平台提交数据的9个站点是:

• 贝勒·斯科特和怀特健康公司(德克萨斯州)
• 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)

什么促成了网络的成功?

pi对这个问题的回答指向了swift, 优质连续道岔, 真实的数据, 患者样本广泛而多样, 疾控中心的领导和韦斯特迅速扩大行动的能力, 协调网站的输出, 并为站点提供持续的技术和分析支持. 具体来说，他们和其他参与该项目的人员描述了以下因素.

及时、高质量的真实世界数据

“VISION’s comprehensive collection of standardized data from geographically diverse health care systems is one of the major factors…,VISION PI说。 Malini B的. DeSilva, MD, 英里每小时, Research Investigator and Travel and Tropical Medicine Physician at HealthPartners. 通过使用这些标准化数据, the network was able to utilize a test-negative study design to provide 新型冠状病毒肺炎 VE estimates in a timely manner.” She added that eliminating the need for chart reviews to capture the information from patients who tested positive or negative for SARS-CoV-2 enabled “faster analyses,，这有助于指导政策决策.

指向趣赢平台的支持，VISION PI Manjusha Gaglani, 黑带大师, FAAP, FIDSA, FPIDS, Director of the Center for Research in Vaccines and Infections (CRVI) at Baylor Scott and White Health, 德州, remarked that it was “趣赢平台’s great coordination with timely updates to the data dictionary and regular communication to provide timely feedback to sites [that led to] improvement in data quality.”

Toan C. Ong，博士，VISION PI和 科罗拉多大学安舒茨医学院副教授, 评论说“尽管有很多挑战, VISION网站从未停止过提高数据质量的努力, 要么通过内部数据探索活动，要么通过与其他站点的外部协作.”

VISION Project Director Ball said by developing a common protocol for harmonized data collection and procedures across sites and implementing an innovative data management system, 韦斯特能够提供真实世界的数据和证据.

“Supplying the government with timely data was essential to its understanding of the early epidemiology of the disease, 高危人群的VE, 当VE正在减弱时——所有这些都是制定政策决策所必需的,鲍尔说.

不同的样本群体

难道不是因为多样化人群的大样本量吗, 就不可能对不同人群的新型冠状病毒肺炎 VE提出关键问题, 德西尔瓦说. 与此呼应的是， VISION PI Anupam Kharbanda, MD, MSc, 明尼苏达儿童医院临床副总裁兼重症监护服务主任, 补充说，这种多样性-“无论是在年龄方面, 地理位置, and racial make-up”—stemming from the collaboration of geographically diverse health systems—contributed to VISION’s success.

协作、韧性和奉献

“VISION [was] the most demanding and fast-paced project that I’ve ever been involved in,” said Ong. “然而，我们在科罗拉多州的团队和VISION网站的所有其他团队都很有弹性, 专用的, 并且迎接挑战……响应[提供]数据和科学专业知识的需求.

“We had a talented team that stayed focused and worked tirelessly to rapidly analyze SARS-CoV-2 vaccine effectiveness data and disseminate results…,加格拉尼说.

“Credit goes to CDC for encouraging us to collaborate with subject matter experts and leaders in epidemiology, 传染病, 以及我们合作网站的数据科学,鲍尔说.

疾控中心的领导

CDC的领导无疑是网络成功的一个因素，Ong说. 对此进行阐述, Ong explained that CDC’s “decisive actions and support steered the project team in the right direction in response to the emergency of the pandemic. 疾控中心的领导是一流的，”他大声说道. “Together with the 趣赢平台 team…CDC colleagues always tried their absolute best to clearly define the objectives, 数据需求, 数据定义.”

韦斯特的模范支持

他说:“趣赢平台作为数据协调中心的重要性怎么强调都不为过。. (韦斯特)团队……在技术和科学上提供了出色而坚定的支持. 由于专业，事情进展顺利，及时, 礼貌, 以及团队的能力.”

韦斯特团队愿意提出重要的研究问题, 探索不同的分析方法, 并找到创新的解决方案，推动流行病学和VE科学向前发展,加格拉尼指出.

“Our collaborative work contributed to CDC’s understanding of the disease and the effectiveness of the vaccines,鲍尔说. “重要的是，我们的研究有助于降低新型冠状病毒肺炎的发病率和死亡率.”