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临床试验/NCT07231016
NCT07231016已完成不适用

The Protective Effect of Influenza Vaccine for Vulnerable Population

Taipei Medical University Hospital1 个研究点 分布在 1 个国家目标入组 561,566 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
561,566
试验地点
1
主要终点
post-fracture 30-day mortality

研究概览

简要总结

Background: Both influenza and bone fractures are significant contributors to morbidity and mortality among older adults. This study evaluated the associations between influenza vaccination (IV) and adverse outcomes following fracture-related hospitalizations in elderly individuals.

Methods: A retrospective cohort study was conducted utilizing data from a health insurance database in Taiwan. The study included 561,566 individuals aged 65 years and older who were hospitalized for fractures between 2009 and 2020. Patients were stratified according to whether they had received an IV within the 12 months preceding their fracture event. Propensity score matching was employed between the vaccinated and unvaccinated groups. Multivariate logistic regression models were used to estimate adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for postfracture infectious complications and 30-day mortality associated with prior IV.

详细描述

A nested retrospective cohort design was adopted to evaluate the influence of IVs on clinical outcomes following fracture-related hospitalizations. The analysis drew upon a nationwide, dynamic cohort comprising more than 23 million insured individuals. From this population, we identified 561,566 patients aged 65 years and older who were admitted for fracture treatment between 2009 and 2020. Among them, 213,381 individuals had received an IV within the 12 months prior to admission, whereas 348,185 had not.

To mitigate potential confounding, we applied 1:1 propensity score matching, pairing each vaccinated patient with a nonvaccinated counterpart. The matching criteria included demographic characteristics (age, sex), socioeconomic status (low-income designation), fracture type, comorbidities (documented within the previous 24 months), emergency department visits, and hospital admissions during the 12 months preceding the fracture event.

The primary outcomes were assessed within 30 days postadmission and included the occurrence of pneumonia, septicemia, urinary tract infections, intensive care, hospital length of stay, total medical expenditure, and 30-day mortality. Postfracture infectious complications were identified through physician-coded diagnoses during the index hospitalization or in subsequent inpatient and outpatient claims within 30 days. To avoid confounding due to preexisting infections, individuals with documented cases of pneumonia or septicemia within the six months before fractures were excluded from the analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
20 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with fracture hospitalization who aged more than 65 years

排除标准

  • People had no fracture hospitalization and people aged lower than 65 years

结局指标

主要结局

post-fracture 30-day mortality

时间窗: 30-day period after fracture hospitalization

We calculated the mortality after fracture hospitalization within 30-day period.

mortality after fracture

时间窗: 30-day period after fracture hospitalization

30-day mortality after fracture hospitalization

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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