Yamaguchi Manako, Sekine Masayuki, Kudo Risa, Adachi Sosuke, Ueda Yutaka, Miyagi Etsuko, Hara Megumi, Hanley Sharon J B, Enomoto Takayuki
Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Department of Obstetrics and Gynecology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Papillomavirus Res. 2018 Dec;6:6-10. doi: 10.1016/j.pvr.2018.05.002. Epub 2018 May 25.
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.
日本没有全国性的疫苗登记系统,约1700个自治市独立管理免疫记录。2013年6月,在媒体未经证实报道了接种疫苗后的不良事件后,人乳头瘤病毒(HPV)疫苗的主动推荐被暂停,尽管当时并未出现疫苗安全信号。此外,在暂停推荐后发表的评估HPV疫苗安全性和有效性的研究主要基于自我报告信息。我们的目的是将自我报告的疫苗接种状况与官方自治市记录进行比较,以检验其准确性。研究对象为新潟市20至22岁参加宫颈癌筛查的女性。在1230名符合条件的登记者中,根据自我报告问卷和自治市记录,任何一剂次疫苗的接种率分别为75.0%和77.2%。自我报告信息的准确率如下:阳性预测值(PPV)为87.7%;阴性预测值(NPV)为54.5%;灵敏度为85.2%;特异度为59.8%。自我报告信息的效度仅为中等(Kappa统计量 = 0.44,95%置信区间0.37 - 0.50)。这与较低的阴性预测值相结合,可能会导致对有效性和安全性的估计降低。在日本,需要建立一种更可靠的方法,如全国性的HPV疫苗登记系统,来评估HPV免疫状况。