Estimating influenza vaccine effectiveness among older adults using an integrated administrative database and the implications of potential bias: A population-based cohort study in Japan.

Ayu Kasamatsu, Yuichiro Yahata, Wakaba Fukushima, Hirofumi Sakamoto, Kaori Tanaka, Miwa Takigawa, Kaori Izu, Yuko Nishino, Motoi Suzuki, Hajime Kamiya
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Abstract

Background: Japan lacks an established framework for routine seasonal influenza vaccine effectiveness (SIVE) assessment at the national and municipal levels. This study aimed to estimate SIVE among older adults using an innovative population-based administrative database linking medical fee claims data with vaccination records, while also exploring its potential bias.

Methods: In this retrospective population-based cohort study, we assessed SIVE against medically attended influenza during the 2017/18 season among older adults aged ≥65 years in a Japanese city. A Cox proportional hazards model was used to estimate hazard rate ratios, treating vaccination status as time-dependent. To explore potential biases, multivariate logistic regression analysis was used to investigate the association between vaccination status and acute respiratory infection (ARI) diagnosis and trauma/injury during the non-influenza season.

Results: This study included 82 % (n = 110,892) of the city's older adult population, with 39.7 % vaccination coverage. The estimated SIVE was 2.9 % (95 % confidence interval: -6.2-11.2), showing no statistical significance. Similarly, subgroup analyses by age and comorbidities revealed no significant protective effect of SIVE. In the non-season analysis, adjusted odds ratios of vaccination were significantly higher for ARI [1.3 (1.3-1.4)] and trauma/injury [1.2 (1.1-1.2)]. However, no significance was observed for hospitalizations with these diagnoses, which include severe conditions less associated with healthcare-seeking behaviors [0.9 (0.8-1.1) and 0.8 (0.6-1.0), respectively].

Conclusions: No significant SIVE was observed during the 2017/18 season. Our real-world observational study, based on medical fee claims data, indicates a potential underestimation of SIVE owing to bias related to healthcare-seeking behaviors.

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利用综合行政数据库估算老年人接种流感疫苗的效果以及潜在偏差的影响:日本一项基于人群的队列研究。
背景:日本在国家和市级层面缺乏常规季节性流感疫苗有效性(SIVE)评估的既定框架。本研究旨在利用一个创新的基于人口的行政数据库,将医疗费用报销数据与疫苗接种记录联系起来,对老年人的 SIVE 进行评估,同时探讨其潜在的偏差:在这项以人群为基础的回顾性队列研究中,我们评估了日本某市年龄≥65岁的老年人在2017/18年流感季节接种流感疫苗的SIVE情况。我们采用 Cox 比例危险模型来估算危险率比,并将疫苗接种状况视为时间依赖因素。为了探究潜在的偏差,研究人员采用了多变量逻辑回归分析来研究疫苗接种情况与非流感季节急性呼吸道感染(ARI)诊断和外伤/损伤之间的关系:这项研究包括该市 82% 的老年人口(n = 110,892 人),疫苗接种覆盖率为 39.7%。估计 SIVE 为 2.9 %(95 % 置信区间:-6.2-11.2),无统计学意义。同样,按年龄和合并症进行的亚组分析显示,SIVE 没有显著的保护作用。在非季节分析中,急性呼吸道感染[1.3 (1.3-1.4)]和创伤/受伤[1.2 (1.1-1.2)]的调整后接种几率比明显更高。然而,对于因这些诊断而住院的情况(包括与寻求医疗保健行为不太相关的严重情况),没有观察到明显的差异[分别为 0.9 (0.8-1.1) 和 0.8 (0.6-1.0)]:2017/18赛季未观察到明显的SIVE。我们基于医疗费用报销数据的真实世界观察研究表明,由于与寻求医疗保健行为相关的偏差,SIVE可能被低估。
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