Ortiz-de-Lejarazu Leonardo Raúl, Díez Domingo Javier, de Miguel Ángel Gil, Martinón Torres Federico, Margüello Esther Redondo, López-Belmonte Claver Juan Luis, Palomo-Jiménez Paloma I, Farré Avellà J Manel, Abellán Perpiñán José María
Centro Nacional de Gripe de Valladolid, GISRS (Global Influenza Surveillance and Response System), Valladolid, Spain.
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO), Valencia, Spain.
BMC Infect Dis. 2025 Feb 1;25(1):152. doi: 10.1186/s12879-025-10442-3.
Influenza is a seasonal infection with a huge impact on morbidity and mortality in older adults, for whom vaccination is recommended. New influenza vaccines for this population have been introduced in Spain in the past 5 years, and a number of cost-effectiveness analyses (CEA) have been published to aid healthcare decision-making. The objective of this study was to assess possible sources of uncertainty in the CEAs of influenza vaccines for the older adults in Spain.
A systematic review was performed to identify Spanish CEAs published since 2016. Potential sources of structural, methodologic and parametric uncertainty in CEA results were systematically analysed using the TRansparent Uncertainty ASsessmenT (TRUST) Tool, quality assessment checklists, and the WHO guidance on economic evaluations of influenza vaccine strategies. The primary sources of efficacy/effectiveness were analysed in depth to ascertain whether they could support the conclusions of the respective CEAs.
Seven CEAs were included. Overall, they were designed and performed in accordance with the applicable guidelines; however, some critical sources of uncertainty were detected, mainly: (1) the choice and use of efficacy/effectiveness data (real-world single season studies, meta-analyses including studies with high risk of bias and/or high heterogeneity with biased interpretation); (2) use of fewer than 5 seasons to estimate influenza burden; (3) generalized use of influenza-like illness data to estimate effectiveness and burden, among others.
Seemingly well-designed studies may conceal important sources of uncertainty that affect the results. This must be taken into account when interpreting results to support decision-making.
流感是一种季节性感染疾病,对老年人的发病率和死亡率有巨大影响,建议这部分人群接种疫苗。在过去5年里,西班牙已引入针对该人群的新型流感疫苗,并且已发表了多项成本效益分析(CEA)以辅助医疗决策。本研究的目的是评估西班牙老年人流感疫苗CEA中可能存在的不确定性来源。
进行了一项系统综述,以识别自2016年以来发表的西班牙CEA。使用透明不确定性评估(TRUST)工具、质量评估清单以及世界卫生组织关于流感疫苗策略经济评估的指南,系统分析了CEA结果中结构、方法和参数不确定性的潜在来源。对疗效/有效性的主要来源进行了深入分析,以确定它们是否能支持各自CEA的结论。
纳入了7项CEA。总体而言,它们是按照适用指南设计和实施的;然而,发现了一些关键不确定性来源,主要包括:(1)疗效/有效性数据的选择和使用(真实世界单季研究、包含偏倚风险高和/或异质性高且解释有偏倚的研究的荟萃分析);(2)使用少于5个季节的数据来估计流感负担;(3)普遍使用流感样疾病数据来估计有效性和负担等。
看似设计良好的研究可能掩盖影响结果的重要不确定性来源。在解释结果以支持决策时必须考虑到这一点。