Boikos Constantina, Imran Mahrukh, De Lusignan Simon, Ortiz Justin R, Patriarca Peter A, Mansi James A
Seqirus Inc., Kirkland, QC H9H 4M7, Canada.
Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford OX2 6GG, UK.
Vaccines (Basel). 2022 May 6;10(5):727. doi: 10.3390/vaccines10050727.
Real-world evidence (RWE) increasingly informs public health and healthcare decisions worldwide. A large database has been created (“Integrated Dataset”) that integrates primary care electronic medical records with pharmacy and medical claims data on >123 million US patients since 2014. This article describes the components of the Integrated Dataset and evaluates its representativeness to the US population and its potential use in evaluating influenza vaccine effectiveness. Representativeness to the US population (2014−2019) was evaluated by comparison with demographic information from the 2019 US census and the National Ambulatory Medical Care Survey (NAMCS). Variables included in the Integrated Dataset were evaluated against World Health Organization (WHO) defined key and non-critical variables for evaluating influenza vaccine performance. The Integrated Dataset contains a variety of information, including demographic data, patient medical history, diagnoses, immunizations, and prescriptions. Distributions of most age categories and sex were comparable with the US Census and NAMCS populations. The Integrated Dataset was less diverse by race and ethnicity. Additionally, WHO key and non-critical variables for the estimation of influenza vaccine effectiveness are available in the Integrated Dataset. In summary, the Integrated Dataset is generally representative of the US population and contains key variables for the assessment of influenza vaccine effectiveness.
真实世界证据（RWE）越来越多地为全球公共卫生和医疗保健决策提供信息。自2014年以来，已创建了一个大型数据库（“综合数据集”），该数据库将初级保健电子病历与超过1.23亿美国患者的药房和医疗理赔数据整合在一起。本文描述了综合数据集的组成部分，并评估了其对美国人群的代表性以及在评估流感疫苗有效性方面的潜在用途。通过与2019年美国人口普查和国家门诊医疗调查（NAMCS）的人口统计信息进行比较，评估了该综合数据集对美国人群（2014 - 2019年）的代表性。针对世界卫生组织（WHO）定义的评估流感疫苗性能的关键和非关键变量，对综合数据集中包含的变量进行了评估。综合数据集包含各种信息，包括人口统计数据、患者病史、诊断、免疫接种和处方。大多数年龄类别和性别的分布与美国人口普查和NAMCS人群相当。综合数据集在种族和族裔方面的多样性较低。此外，综合数据集中提供了WHO用于估计流感疫苗有效性的关键和非关键变量。总之，综合数据集总体上代表了美国人群，并包含评估流感疫苗有效性的关键变量。
