This paper presents the principles of implementing register-based cohort studies as currently applied for real-time estimation of influenza vaccine effectiveness in Finland. All required information is retrieved from computerised national registers and deterministically linked via the unique personal identity code assigned to each Finnish resident. The study cohorts comprise large subpopulations eligible for a free seasonal influenza vaccination as part of the National Vaccination Programme. The primary outcome is laboratory-confirmed influenza. Each study subject is taken to be at risk of experiencing the outcome from the onset of the influenza season until the first of the following three events occurs: outcome, loss to follow up or end of season. Seasonal influenza vaccination is viewed as time-dependent exposure. Accordingly, each subject may contribute unvaccinated and vaccinated person-time during their time at risk. The vaccine effectiveness is estimated as one minus the influenza incidence rate ratio comparing the vaccinated with the unvaccinated within the study cohorts. Data collection in register-based research is an almost fully automated process. The effort, resources and the time spent in the field are relatively small compared to other observational study designs. This advantage is pivotal when vaccine effectiveness estimates are needed in real time. The paper outlines possible limitations of register-based cohort studies. It also addresses the need to explore how national and subnational registers available in the Nordic countries and elsewhere can be utilised in vaccine effectiveness research to guide decision making and to improve individual health as well as public health.

译文

本文介绍了实施基于注册的队列研究的原则,该原则目前用于芬兰流感疫苗有效性的实时估计。所有必需的信息都从计算机化的国家登记册中检索,并通过分配给每个芬兰居民的唯一个人身份代码确定地链接。作为国家疫苗接种计划的一部分,研究队列包括符合免费季节性流感疫苗接种条件的大亚群。主要结果是实验室确认的流感。从流感季节开始,直到发生以下三个事件中的第一个,每个研究对象都有经历结果的风险: 结果,随访损失或季节结束。季节性流感疫苗接种被视为时间依赖性暴露。因此,每个受试者可能会在其处于危险中的时间内贡献未接种疫苗和接种疫苗的时间。疫苗有效性估计为1减去流感发病率比率,比较研究队列中接种疫苗和未接种疫苗的比率。基于寄存器的研究中的数据收集是一个几乎完全自动化的过程。与其他观察性研究设计相比,在该领域花费的精力,资源和时间相对较小。当需要实时评估疫苗有效性时,这一优势至关重要。本文概述了基于注册的队列研究的可能局限性。它还解决了探索如何在疫苗有效性研究中利用北欧国家和其他地方的国家和国家以下登记册的需求,以指导决策并改善个人健康和公共卫生。

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