Evaluation of autoimmune safety signal in observational vaccine safety studies
Evaluation of autoimmune safety signal in observational vaccine safety studies
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DOI：
10.4161/hv.21268
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发表时间：
2012-09-01
影响因子：
4.8
通讯作者：
Jacobsen, Steven
中科院分区：
文献类型：
--
作者：
Chao, Chun;Jacobsen, Steven
自身免疫安全性评价是疫苗上市后安全性评价的重要组成部分。最近，我们发表了一项关于女性四价人乳头瘤病毒疫苗的大型观察性安全性研究的结果。从这项研究中，基于两个大型的管理式医疗机构，我们已经获得了一些经验数据，可能会被证明是有用的设计未来的疫苗安全性研究在管理式医疗环境。对于自身免疫性疾病，疫苗安全性研究的一个主要挑战是确定与疫苗接种时间相关的真实事件病例。我们发现，对病历的专家病例审查是基于电子健康记录的自身免疫安全性研究不可或缺的组成部分。病例识别还应扩大，在适用的情况下，除了疾病特异性ICD-9诊断代码外，还应包括使用实验室检查结果或其他相关措施。此外，我们建议平行使用安全性信号评价（涉及更常见疾病的模式评价）和相当罕见疾病的统计学比较。最后，我们建议进行一项伴随的疫苗摄取研究，以了解特定研究人群中的潜在选择偏倚和混杂，这些研究应通过数据收集和分析技术加以解决。
Autoimmune safety evaluation is an important component of post-licensure vaccine safety evaluation. Recently, we published the findings from a large observational safety study of the quadrivalent human papillomavirus vaccine in females. From this study, based on two large managed care organizations, we have obtained some empirical data that may prove useful for the design of future vaccine safety studies within a managed care environment. For autoimmune conditions, a major challenge in vaccine safety study is to determine true incident cases in relation to the timing of vaccination. We found expert case review of medical records an indispensable component for autoimmune safety studies based on electronic health records. Case identification should also be expanded to include the use of laboratory test results or other relevant measures in addition to the disease specific ICD-9 diagnosis codes, when applicable. Furthermore, we recommend the parallel use of both safety signal evaluation that involves pattern evaluation for conditions that are more common, and statistical comparisons for conditions that are rather rare. Finally, we recommend an accompanying vaccine uptake study to understand the potential selection bias and confounding in a given study population that should be addressed with data collection and analytical techniques.