Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule.
Assessing misclassification of vaccination status: Implications for studies of the safety of the childhood immunization schedule.
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DOI：
10.1016/j.vaccine.2017.02.058
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发表时间：
2017-04-04
期刊：
影响因子：
5.5
通讯作者：
McNeil MM
中科院分区：
文献类型：
--
作者：
Daley MF;Glanz JM;Newcomer SR;Jackson ML;Groom HC;Lugg MM;McLean HQ;Klein NP;Weintraub ES;McNeil MM
为了解决公众对儿童免疫接种计划安全性的担忧，医学研究所建议进行观察性研究，比较完全接种疫苗的儿童与因父母选择而接种疫苗不足的儿童的不良健康结果。疫苗接种状态的错误分类可能会使这些研究产生偏差。评估疫苗安全数据链（VSD）中疫苗接种状态错误分类的风险。一项回顾性队列研究分三个阶段进行。在第1阶段，使用电子健康记录（EHR）数据来识别出生后前24个月内可能由于父母选择而导致的疫苗接种不足模式。在第二阶段，人工审查了疫苗接种不足儿童记录的随机样本。在第三阶段，对父母进行了单独的调查，以评估EHR数据是否准确反映了他们孩子的疫苗接种状况。在6个VSD研究中心进行了第1和第2阶段，在1个研究中心进行了第3阶段。研究队列包括2004年至2012年出生的361，901名儿童。到24个月大时，（54.8%）完全接种疫苗，没有延误，84，698（23.4%）经历了延迟，但在24个月大时完全接种，4865（1.3%）未接种疫苗，3789人（1.0%）延迟开始接种直至≤4月龄，4781（1.3%）有一致的疫苗限制（每次访视≤2次疫苗），其余65，519例（18.1%）缺失疫苗系列或剂量。当EHR数据中存在疫苗拒绝的诊断代码时，就诊记录确认疫苗拒绝是近100%抽样记录的疫苗接种不足的原因。家长调查证实了这些发现。接种疫苗不足的儿童的父母比完全接种疫苗的儿童的父母更有可能报告访问替代医疗提供者。使用基于EHR的疫苗数据和诊断代码，可以识别由于父母选择而接种不足的特定儿童群体，其接种状态错误分类的可能性相对较低。
To address public concern about the safety of the childhood immunization schedule, the Institute of Medicine recommended observational studies comparing adverse health outcomes of fully vaccinated children to children under-vaccinated due to parental choice. Misclassification of vaccination status could bias such studies. To assess risk of misclassification of vaccination status within the Vaccine Safety Datalink (VSD). A retrospective cohort study was conducted in three phases. In phase 1, electronic health record (EHR) data were used to identify patterns of under-vaccination during the first 24 months of life potentially due to parental choice. In phase 2, a random sample of records of under-vaccinated children was manually reviewed. In phase 3, a separate sample of parents were surveyed to assess whether EHR data accurately reflected their child’s vaccination status. Phases 1 and 2 were conducted at 6 VSD sites, phase 3 at 1 site. The study cohort included 361,901 children born 2004 through 2012. By 24 months of age, 198,249 (54.8%) were fully vaccinated with no delays, 84,698 (23.4%) experienced delays but were fully vaccinated by 24 months of age, 4865 (1.3%) received no vaccines, 3789 (1.0%) delayed starting vaccination until ≤4 months of age, 4781 (1.3%) had consistent vaccine-limiting (≤2 vaccines per visit), and the remaining 65,519 (18.1%) were missing vaccine series or doses. When a diagnosis code for vaccine refusal was present in EHR data, encounter notes confirmed vaccine refusal as the reason for under-vaccination for nearly 100% of sampled records. Parent surveys confirmed these findings. Parents of under-vaccinated children were more likely to report visiting an alternative medical provider than parents of fully vaccinated children. Specific groups of children, under-vaccinated due to parental choice, can be identified with relatively low likelihood of misclassification of vaccination status using EHR-based vaccine data and diagnosis codes.
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