Division of Epidemiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, TN, USA.
Department of Health Policy, Vanderbilt University Medical Center, Nashville, TN, USA.
JNCI Cancer Spectr. 2020 Dec 30;5(1). doi: 10.1093/jncics/pkaa112. eCollection 2021 Feb.
Human papillomavirus vaccine (HPV) impact on cervical precancer (cervical intraepithelial neoplasia grades 2+ [CIN2+]) is observable sooner than impact on cancer. Biopsy-confirmed CIN2+ is not included in most US cancer registries. Billing codes could provide surrogate metrics; however, the International Classification of Diseases, ninth (ICD-9) to tenth (ICD-10) transition disrupts trends. We built, validated, and compared claims-based models to identify CIN2+ events in both ICD eras.
A database of Davidson County (Nashville), Tennessee, pathology-confirmed CIN2+ from the HPV Vaccine Impact Monitoring Project (HPV-IMPACT) provided gold standard events. Using Tennessee Medicaid 2008-2017, cervical diagnostic procedures (N = 8549) among Davidson County women aged 18-39 years were randomly split into 60% training and 40% testing sets. Relevant diagnosis, procedure, and screening codes were used to build models from CIN2+ tissue diagnosis codes alone, least absolute shrinkage and selection operator (LASSO), and random forest. Model-classified index events were counted to estimate incident events.
HPV-IMPACT identified 983 incident CIN2+ events. Models identified 1007 (LASSO), 1245 (CIN2+ tissue diagnosis codes alone), and 957 (random forest) incident events. LASSO performed well in ICD-9 and ICD-10 eras: 77.3% (95% confidence interval [CI] = 72.5% to 81.5%) vs 81.1% (95% CI = 71.5% to 88.6%) sensitivity, 93.0% (95% CI = 91.9% to 94.0%) vs 90.2% (95% CI = 87.2% to 92.7%) specificity, 61.3% (95% CI = 56.6% to 65.8%) vs 60.3% (95% CI = 51.0% to 69.1%) positive predictive value, 96.6% (95% CI = 95.8% to 97.3%) vs 96.3% (95% CI = 94.1% to 97.8%) negative predictive value, 91.0% (95% CI = 89.9% to 92.1%) vs 88.8% (95% CI = 85.9% to 91.2%) accuracy, and 85.1% (95% CI = 82.9% to 87.4%) vs 85.6% (95% CI = 81.4% to 89.9%) C-indices, respectively; performance did not statistically significantly differ between eras (95% confidence intervals all overlapped).
Results confirmed model utility with good performance across both ICD eras for CIN2+ surveillance. Validated claims-based models may be used in future CIN2+ trend analyses to estimate HPV vaccine impact where population-based biopsies are unavailable.
人乳头瘤病毒（HPV）疫苗对宫颈癌前病变（宫颈上皮内瘤变 2 级及以上[CIN2+]）的影响比癌症更早可见。大多数美国癌症登记处并不包括活检证实的 CIN2+。计费代码可以提供替代指标；然而，国际疾病分类第 9 版（ICD-9）到第 10 版（ICD-10）的过渡扰乱了趋势。我们建立、验证并比较了基于索赔的模型，以在两个 ICD 时代识别 CIN2+事件。
田纳西州戴维森县（纳什维尔）HPV 疫苗影响监测项目（HPV-IMPACT）的病理学证实的 CIN2+数据库提供了黄金标准事件。利用田纳西州医疗补助计划 2008-2017 年的数据，对年龄在 18-39 岁的戴维森县妇女的宫颈诊断程序（N=8549）进行了随机分组，60%用于训练，40%用于测试。使用相关的诊断、程序和筛查代码，仅从 CIN2+组织诊断代码、最小绝对收缩和选择算子（LASSO）和随机森林构建模型。对模型分类的索引事件进行计数，以估计发病事件。
HPV-IMPACT 确定了 983 例 CIN2+发病事件。模型确定了 1007 例（LASSO）、1245 例（CIN2+组织诊断代码）和 957 例（随机森林）发病事件。LASSO 在 ICD-9 和 ICD-10 时代表现良好：77.3%（95%置信区间[CI]为 72.5%至 81.5%）与 81.1%（95%CI=71.5%至 88.6%）敏感性，93.0%（95%CI=91.9%至 94.0%）与 90.2%（95%CI=87.2%至 92.7%）特异性，61.3%（95%CI=56.6%至 65.8%）与 60.3%（95%CI=51.0%至 69.1%）阳性预测值，96.6%（95%CI=95.8%至 97.3%）与 96.3%（95%CI=94.1%至 97.8%）阴性预测值，91.0%（95%CI=89.9%至 92.1%）与 88.8%（95%CI=85.9%至 91.2%）准确率，以及 85.1%（95%CI=82.9%至 87.4%）与 85.6%（95%CI=81.4%至 89.9%）C 指数，分别；两个时代之间的性能没有统计学上的显著差异（95%置信区间均重叠）。
结果证实了模型在两个 ICD 时代的 CIN2+监测中的良好性能。经过验证的基于索赔的模型可用于未来 CIN2+趋势分析，以在无法获得人群活检的情况下估计 HPV 疫苗的影响。
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