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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关联。

Handling With Vaccine Type Missing Data in a Dynamic Cohort to Assess the Link Between Time-Varying Vaccination and an Autoimmune Disease.

机构信息

Division of Pharmacoepidemiology and Pharmacovigilance, Spanish Agency of Medicines and Medical Devices (AEMPS), Madrid, Spain.

Department of Computer Science, Applied Mathematics and Statistics, University of Girona, Girona, Spain.

出版信息

Pharmacoepidemiol Drug Saf. 2024 Dec;33(12):e70060. doi: 10.1002/pds.70060.

Abstract

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.

摘要

目的

患者健康记录中可能缺失所接种疫苗的类型信息。我们旨在应用一种简单策略,基于多个因素,对缺失的人乳头瘤病毒(HPV)疫苗类型进行推断,以研究其与甲状腺炎的相关性。

方法

本队列研究纳入了西班牙健康记录(BIFAP)中的女孩数据。随访时间分为非暴露组、暴露组和暴露后组。疫苗类型通过基于与首剂缺失和记录值均相关的(非)临床因素、混杂因素和结局的单随机推断来获得。推断后估计了 HR。作为次要分析,将这些结果与其他策略进行了比较:仅使用记录了疫苗类型的女孩(完整病例;CC)和所有女孩,包括未记录缺失类别的类型的女孩(MiCat)。

结果

构建了 388411 名女孩的 808201 个观察值。在剩余的 35%进行推断的 153924 名接种疫苗的女孩中,有 2.84%进行了疫苗接种。确定了 15 个与 HPV 疫苗类型缺失和值相关的因素和 4 个混杂因素进行推断。在 MiCat 中,二价和四价疫苗的 HR 高估分别可达 10%和低估 10%,而在 CC 中分别高估 24%和低估 3%。

结论

在我们的示例中,确定了与 HPV 疫苗类型缺失和值相关的多个因素,提示缺失不完全随机。因此,CC 和 MiCat 可能会导致估计值出现偏差。使用这些因素进行推断,使随机缺失的假设更合理。该策略简单、高效,可轻松应用于药物流行病学中的时间变化暴露分析。

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