Differential misclassification between self-reported status and official HPV vaccination records in Japan: Implications for evaluating vaccine safety and effectiveness
Differential misclassification between self-reported status and official HPV vaccination records in Japan: Implications for evaluating vaccine safety and effectiveness
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DOI：
10.1016/j.pvr.2018.05.002
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发表时间：
2018-12-01
影响因子：
3.2
通讯作者：
Enomoto, Takayuki
中科院分区：
文献类型：
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作者：
Yamaguchi, Manako;Sekine, Masayuki;Enomoto, Takayuki
日本没有国家疫苗登记处，大约1700个市政当局独立管理免疫记录。2013年6月，在未经证实的媒体关于接种后不良事件的报道后，暂停了对人乳头状瘤病毒(HPV)疫苗的积极建议，尽管没有提出疫苗安全信号。此外，暂停后发表的评估HPV疫苗安全性和有效性的研究主要是基于自我报告的信息。我们的目的是检查自我报告的疫苗接种状况与市政官方记录的准确性。参与者是20-22岁的女性，她们在新泻市接受宫颈筛查。根据自我报告问卷和市政记录，在1230名合格登记者中，疫苗接种率(定义为任何剂量)分别为75.0%和77.2%。阳性预测值(PPV)为87.7%，阴性预测值(NPV)为54.5%，敏感性为85.2%，特异性为59.8%。自我报告信息效度中等(Kappa统计量=0.44，95%可信区间0.37~0.50)。这一点再加上较低的净现值，可能会导致对有效性和安全性的估计减少。需要建立一种更可靠的方法，如全国HPV疫苗登记，以评估日本的HPV免疫状况。
Japan has no national vaccine registry and approximately 1700 municipalities manage the immunization records independently. In June 2013, proactive recommendations for the human papillomavirus (HPV) vaccine were suspended after unconfirmed reports of adverse events following immunization in the media, despite no vaccine safety signal having been raised. Furthermore, studies assessing HPV vaccine safety and effectiveness published post suspension are predominantly based on self-reported information. Our aim was to examine the accuracy of self-reported vaccination status compared with official municipal records. Participants were women aged 20-22 yrs, who were attending for cervical screening in Niigata city. Among the 1230 eligible registrants, vaccine uptake, defined as any dose, was 75.0% and 77.2% according to a self-reported questionnaire and municipal records, respectively. The accuracy rate of self-reported information was as follows: positive predictive value (PPV) was 87.7%; negative predictive value (NPV) was 54.5%; sensitivity was 85.2%; and specificity was 59.8%. The validity of self-reported information was only moderate (Kappa statistic = 0.44, 95% confidence interval 0.37-0.50). This combined with the low NPV may lead to reduced estimation of effectiveness and safety. A more reliable method, such as a national HPV vaccine registry, needs to be established for assessing HPV immunization status in Japan.