National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
P95 Pharmacovigilance and Epidemiology Services, Leuven, Belgium.
Pharmacoepidemiol Drug Saf. 2018 Jul;27(7):724-730. doi: 10.1002/pds.4419. Epub 2018 Mar 24.
Composite disease burden measures such as disability-adjusted life-years (DALY) have been widely used to quantify the population-level health impact of disease or injury, but application has been limited for the estimation of the burden of adverse events following immunization. Our objective was to assess the feasibility of adapting the DALY approach for estimating adverse event burden.
We developed a practical methodological framework, explicitly describing all steps involved: acquisition of relative or absolute risks and background event incidence rates, selection of disability weights and durations, and computation of the years lived with disability (YLD) measure, with appropriate estimation of uncertainty. We present a worked example, in which YLD is computed for 3 recognized adverse reactions following 3 childhood vaccination types, based on background incidence rates and relative/absolute risks retrieved from the literature.
YLD provided extra insight into the health impact of an adverse event over presentation of incidence rates only, as severity and duration are additionally incorporated. As well as providing guidance for the deployment of DALY methodology in the context of adverse events associated with vaccination, we also identified where data limitations potentially occur.
Burden of disease methodology can be applied to estimate the health burden of adverse events following vaccination in a systematic way. As with all burden of disease studies, interpretation of the estimates must consider the quality and accuracy of the data sources contributing to the DALY computation.
复合疾病负担指标,如伤残调整生命年(DALY),已广泛用于量化疾病或伤害对人群健康的影响,但由于不良事件的负担估算应用有限,该指标的应用受到限制。我们的目的是评估为估算不良事件负担而调整 DALY 方法的可行性。
我们开发了一个实用的方法学框架,明确描述了所有涉及的步骤:获取相对或绝对风险和背景事件发生率、选择残疾权重和持续时间,以及计算伤残生命年(YLD)指标,并适当估计不确定性。我们提供了一个示例,根据文献中检索到的背景发生率和相对/绝对风险,为 3 种儿童疫苗接种类型后的 3 种公认的不良反应计算 YLD。
YLD 提供了对不良事件健康影响的额外见解,因为它还纳入了严重程度和持续时间。除了为疫苗接种相关不良事件中 DALY 方法的部署提供指导外,我们还确定了数据限制可能出现的地方。
疾病负担方法可用于系统地估计疫苗接种后不良事件的健康负担。与所有疾病负担研究一样,对估计值的解释必须考虑到对 DALY 计算有贡献的数据来源的质量和准确性。