Julius Global Health, University Medical Center Utrecht, Heidelberglaan 100, the Netherlands; VACCINE.GRID, Basel, Switzerland VACCINE.GRID, Spitalstrasse 33, Basel, Switzerland; P-95, Leuven, Belgium Koning Leopold III laan, 1, 3001 Heverlee, Belgium.
Sciensano, Rue Juliette Wytsmanstraat 14, 1050 Brussels, Belgium.
Vaccine. 2020 Dec 22;38 Suppl 2:B8-B21. doi: 10.1016/j.vaccine.2020.01.100. Epub 2020 Feb 12.
The public-private ADVANCE consortium (Accelerated development of vaccine benefit-risk collaboration in Europe) aimed to assess if electronic healthcare databases can provide fit-for purpose data for collaborative, distributed studies and monitoring of vaccine coverage, benefits and risks of vaccines.
To evaluate if European healthcare databases can be used to estimate vaccine coverage, benefit and/or risk using pertussis-containing vaccines as an example.
Characterisation was conducted using open-source Java-based (Jerboa) software and R scripts. We obtained: (i) The general characteristics of the database and data source (meta-data) and (ii) a detailed description of the database population (size, representatively of age/sex of national population, rounding of birth dates, delay between birth and database entry), vaccinations (number of vaccine doses, recording of doses, pattern of doses by age and coverage) and events of interest (diagnosis codes, incidence rates). A total of nine databases (primary care, regional/national record linkage) provided data on events (pertussis, pneumonia, death, fever, convulsions, injection site reactions, hypotonic hypo-responsive episode, persistent crying) and vaccines (acellular pertussis and whole cell pertussis) related to the pertussis proof of concept studies.
The databases contained data for a total population of 44 million individuals. Seven databases had recorded doses of vaccines. The pertussis coverage estimates were similar to those reported by the World Health Organisation (WHO). Incidence rates of events were comparable in magnitude and age-distribution between databases with the same characteristics. Several conditions (persistent crying and somnolence) were not captured by the databases for which outcomes were restricted to hospital discharge diagnoses.
The database characterisation programs and workflows allowed for an efficient, transparent and standardised description and verification of electronic healthcare databases which may participate in pertussis vaccine coverage, benefit and risk studies. This approach is ready to be used for other vaccines/events to create readiness for participation in other vaccine related studies.
公共-私营 ADVANCE 联盟（在欧洲加速疫苗效益-风险合作的发展）旨在评估电子医疗保健数据库是否可以提供适合合作、分布式研究以及监测疫苗接种率、疫苗效益和风险的数据。
以含百日咳疫苗为例，评估欧洲医疗保健数据库是否可用于估计疫苗接种率、效益和/或风险。
使用开源的基于 Java 的（Jerboa）软件和 R 脚本进行特征描述。我们获得了：（i）数据库和数据源（元数据）的一般特征；（ii）数据库人群的详细描述（规模、代表全国人口的年龄/性别、出生日期的四舍五入、出生日期与数据库输入之间的延迟）、疫苗接种（疫苗剂量数、剂量记录、按年龄和覆盖率的剂量模式）和感兴趣的事件（诊断代码、发病率）。共有九个数据库（初级保健、区域/国家记录链接）提供了与百日咳概念验证研究相关的事件（百日咳、肺炎、死亡、发热、惊厥、注射部位反应、低张性低反应发作、持续哭泣）和疫苗（无细胞百日咳和全细胞百日咳）的数据。
这些数据库包含了 4400 万人的总人口数据。七个数据库记录了疫苗剂量。百日咳疫苗接种率估计与世界卫生组织（WHO）报告的相似。具有相同特征的数据库中，事件的发病率在幅度和年龄分布上相似。数据库未捕捉到一些情况（持续哭泣和嗜睡），这些情况的结果仅限于出院诊断。
数据库特征描述程序和工作流程允许对电子医疗保健数据库进行高效、透明和标准化的描述和验证，这些数据库可能参与百日咳疫苗接种率、效益和风险研究。这种方法已准备好用于其他疫苗/事件，为参与其他疫苗相关研究做好准备。
