Department of Preventive Medicine, Faculty of Medicine, Saga University.
Department of Pediatrics, Faculty of Medicine, Saga University.
J Epidemiol. 2019 Aug 5;29(8):282-287. doi: 10.2188/jea.JE20180054. Epub 2018 Oct 20.
Selection of test-negative controls takes less time and costs less than traditional control selection for evaluating vaccine effectiveness (VE). Here, rotavirus VE was evaluated using hospital controls and compared with test-negative controls to determine whether using the latter can substitute for the former.
We recorded gastroenteritis in children from 2 months to 2 years of age at six medical facilities in Saga City between January 4th and May 31st, 2014. Stools from all identified acute gastroenteritis patients were tested for rotavirus using immunochromatography. Rotavirus gastroenteritis (RVGE) cases had test-positive stool, whereas test-negative controls had gastroenteritis but no rotavirus infection; hospital controls were outpatients visiting the same facility for indications other than gastroenteritis. Vaccination status was verified by inspecting maternal and child health records, and demographic data were obtained from a questionnaire completed by the patients' guardians or from the medical records. Unconditional logistic regression analysis was used to adjust for possible confounding factors.
Sixty-four RVGE cases, 260 test-negative controls, and 589 hospital controls were enrolled. The characteristics of the two control groups, including RV vaccination history, were similar. The RVGE cases were more likely to have used daycare services than children from either of the two control groups. The VE against RVGE estimated using hospital controls was 86.6% (95% confidence interval [CI], 55.9-96.0%), very similar to the VE using test-negative controls (84.9% [95% CI, 49.6-95.5%]).
The estimated VE using test-negative controls and hospital controls is similar. Therefore, test-negative controls are considered appropriate for establishing VE.
与传统的对照选择方法相比，选择阴性测试对照评估疫苗效果（VE）所需的时间更短，成本更低。在这里，我们使用医院对照评估轮状病毒 VE，并与阴性测试对照进行比较，以确定后者是否可以替代前者。
我们记录了 2014 年 1 月 4 日至 5 月 31 日在佐贺市的六家医疗机构中 2 个月至 2 岁儿童的肠胃炎情况。使用免疫层析法对所有确诊为急性肠胃炎的患者的粪便进行轮状病毒检测。轮状病毒肠胃炎（RVGE）病例的粪便检测为阳性，而阴性测试对照则患有肠胃炎但没有轮状病毒感染；医院对照是因非肠胃炎原因就诊于同一医疗机构的门诊患者。通过检查母婴健康记录来核实疫苗接种情况，通过患者监护人填写的问卷或从病历中获取人口统计学数据。采用非条件逻辑回归分析调整可能的混杂因素。
纳入了 64 例 RVGE 病例、260 例阴性测试对照和 589 例医院对照。两组对照的特征相似，包括 RV 疫苗接种史。RVGE 病例更有可能使用日托服务，而不是来自任何一组对照的儿童。使用医院对照估计的 RVGE 对 RVGE 的保护率为 86.6%（95%置信区间[CI]，55.9-96.0%），与使用阴性测试对照（84.9%[95%CI，49.6-95.5%]）非常相似。
使用阴性测试对照和医院对照估计的 VE 相似。因此，阴性测试对照被认为适合建立 VE。
