在动态队列中处理疫苗类型缺失数据,以评估时变疫苗接种与自身免疫性疾病之间的联系。

IF 2.4 4区 医学 Q3 PHARMACOLOGY & PHARMACY Pharmacoepidemiology and Drug Safety Pub Date : 2024-12-01 DOI:10.1002/pds.70060
Belén Castillo-Cano, Marc Comas-Cufí, Elisa Martín-Merino
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引用次数: 0

摘要

目的在患者的健康记录中,可能会缺少有关接种疫苗类型的信息。我们的目的是根据几个因素采用一种简单的策略,在缺失时估算接种过的人乳头瘤病毒(HPV)疫苗的类型,以研究其与甲状腺炎的关系:这项队列研究包括西班牙女孩的健康记录(BIFAP)。随访时间分为未暴露、暴露和暴露后。疫苗类型是根据与两者相关的(非)临床因素、第一剂的缺失值和记录值、混杂因素和结果,通过单一随机估算获得的。HRs在估算后得出。作为辅助分析,这些结果与其他策略进行了比较:仅使用记录有疫苗类型的女孩(完整病例;CC)和所有女孩,包括没有类型记录的缺失类别女孩(MiCat):结果:共对 388 411 名女童进行了 808 201 次观察。在 153 924 名接种过疫苗的女孩中,2.84% 的女孩进行了疫苗接种,剩余 35% 的女孩进行了估算。在估算中确定了 15 个相关因素和 4 个混杂因素。在 MiCat 中,二价和四价的 HR 分别高估了 10%和 10%,而在 CC 中分别高估了 24%和 3%:在我们的例子中,发现了与HPV疫苗类型相关的多个因素,这些因素的缺失和数值表明缺失并非完全随机。因此,CC 和 MiCat 可能会使估计值出现偏差。这些因素被用于估算,使随机缺失假设更加可信。该策略简单、高效,可轻松应用于药物流行病学中的时变暴露分析。
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Handling With Vaccine Type Missing Data in a Dynamic Cohort to Assess the Link Between Time-Varying Vaccination and an Autoimmune Disease.

Objective: The information about the type of vaccine administrated may be missing in patients' health records. We aimed to apply a simple strategy, based on several factors, to impute, when missing, the type of administrated human papillomavirus (HPV) vaccines to study its association with thyroiditis.

Methods: The cohort study included Spanish health records (BIFAP) of girls. Follow-up time was divided into non-exposed, exposed, and post-exposed. The vaccine type was obtained through a single stochastic imputation based on (non)clinical factors associated with both, missing and recorded values of 1st dose, confounders and outcome. HRs were estimated after imputation. As a secondary analysis, these were compared to other strategies: using only girls with vaccine type recorded (complete cases; CC) and all girls, including those without type recorded in a missing category (MiCat).

Results: A total of 808 201 observations for 388 411 girls were built. Vaccination type was carried out in 2.84% of 153 924 vaccinated girls remaining 35% for imputation. Fifteen factors associated and four confounders were identified for the imputation. HR departed by up to 10% overestimation for bi- and 10% underestimation for quadri- valent in the MiCat, whilst 24% and 3% respectively in the CC.

Conclusions: In our example, multiple factors associated with HPV vaccine type missing and values were identified suggesting missing not completely at random. Thus, CC and MiCat could bias the estimates. Those factors were used for imputation, doing more plausible the missing at random assumption. This strategy was simple, efficient and can be easily applied to analyses time-varying exposure in pharmacoepidemiology.

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来源期刊
CiteScore
4.80
自引率
7.70%
发文量
173
审稿时长
3 months
期刊介绍: The aim of Pharmacoepidemiology and Drug Safety is to provide an international forum for the communication and evaluation of data, methods and opinion in the discipline of pharmacoepidemiology. The Journal publishes peer-reviewed reports of original research, invited reviews and a variety of guest editorials and commentaries embracing scientific, medical, statistical, legal and economic aspects of pharmacoepidemiology and post-marketing surveillance of drug safety. Appropriate material in these categories may also be considered for publication as a Brief Report. Particular areas of interest include: design, analysis, results, and interpretation of studies looking at the benefit or safety of specific pharmaceuticals, biologics, or medical devices, including studies in pharmacovigilance, postmarketing surveillance, pharmacoeconomics, patient safety, molecular pharmacoepidemiology, or any other study within the broad field of pharmacoepidemiology; comparative effectiveness research relating to pharmaceuticals, biologics, and medical devices. Comparative effectiveness research is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition, as these methods are truly used in the real world; methodologic contributions of relevance to pharmacoepidemiology, whether original contributions, reviews of existing methods, or tutorials for how to apply the methods of pharmacoepidemiology; assessments of harm versus benefit in drug therapy; patterns of drug utilization; relationships between pharmacoepidemiology and the formulation and interpretation of regulatory guidelines; evaluations of risk management plans and programmes relating to pharmaceuticals, biologics and medical devices.
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