Abstract：
To evaluate the positive predictive value (PPV) of an endometrial cancer case finding algorithm using International Classification of Disease 10th revision Clinical Modification (ICD-10-CM) diagnosis codes from US insurance claims for implementation in a planned post-marketing safety study. Two algorithm variants were evaluated.
Provisional incident endometrial cancer cases were identified from 2016 through 2020 among women aged ≥50 years. One algorithm variant used diagnosis codes for malignant neoplasms of uterine sites (C54.x), excluding C54.2 (malignant neoplasm of myometrium); the other used only C54.1 (malignant neoplasm of endometrium). A random sample of medical records of recent incident provisional cases (2018-2020) was requested for adjudication. Confirmed cases showed biopsy evidence of endometrial cancer, documentation of cancer staging, or hysterectomy following diagnosis. We estimated the PPV of the variants with 95% confidence intervals (CI) excluding cases that had insufficient information.
Of 294 provisional cases adjudicated, 85% were from outpatient settings (n = 249). Mean age at diagnosis was 69.3 years. Among the 294 adjudicated cases (identified with the broader algorithm variant), the same 223 were confirmed endometrial cancer cases by both algorithm variants. The PPV (95% CI) for the broader algorithm variant was 84.2% (79.2% and 88.3%), and for the variant using only C54.1 was 85.8% (80.9% and 89.8%).
We developed and validated an algorithm using ICD-10-CM diagnosis codes to identify endometrial cancer cases in health insurance claims with a sufficiently high PPV to use in a planned post-marketing safety study.
Provisional incident endometrial cancer cases were identified from 2016 through 2020 among women aged ≥50 years. One algorithm variant used diagnosis codes for malignant neoplasms of uterine sites (C54.x), excluding C54.2 (malignant neoplasm of myometrium); the other used only C54.1 (malignant neoplasm of endometrium). A random sample of medical records of recent incident provisional cases (2018-2020) was requested for adjudication. Confirmed cases showed biopsy evidence of endometrial cancer, documentation of cancer staging, or hysterectomy following diagnosis. We estimated the PPV of the variants with 95% confidence intervals (CI) excluding cases that had insufficient information.
Of 294 provisional cases adjudicated, 85% were from outpatient settings (n = 249). Mean age at diagnosis was 69.3 years. Among the 294 adjudicated cases (identified with the broader algorithm variant), the same 223 were confirmed endometrial cancer cases by both algorithm variants. The PPV (95% CI) for the broader algorithm variant was 84.2% (79.2% and 88.3%), and for the variant using only C54.1 was 85.8% (80.9% and 89.8%).
We developed and validated an algorithm using ICD-10-CM diagnosis codes to identify endometrial cancer cases in health insurance claims with a sufficiently high PPV to use in a planned post-marketing safety study.
摘要：
目的：评估子宫内膜癌病例发现算法的阳性预测值（PPV），该算法使用来自美国保险索赔的国际疾病分类第10次修订临床修改（ICD-10-CM）诊断代码，以在计划的上市后安全性研究中实施。评估了两种算法变体。
方法：从2016年到2020年，在≥50岁的女性中发现了临时发生的子宫内膜癌病例。一种算法变体使用了子宫部位恶性肿瘤的诊断代码（C54。x),排除C54.2（子宫肌层恶性肿瘤）；另一个仅使用C54.1（子宫内膜恶性肿瘤）。要求对近期事件临时病例（2018-2020年）的病历进行随机抽样裁定。确诊病例显示子宫内膜癌的活检证据，癌症分期的文献，或诊断后子宫切除术。我们用95%置信区间(CI)估计了变异体的PPV,不包括信息不足的病例。
结果：在裁定的294起临时案件中，85%来自门诊（n=249）。诊断时的平均年龄为69.3岁。在294起判决的案件中(用更广泛的算法变体确定)，通过两种算法变体确认了同样的223例子宫内膜癌病例.更广泛的算法变体的PPV（95％CI）为84.2％（79.2％和88.3％），对于仅使用C54.1的变体，为85.8％（80.9％和89.8％）。
结论：我们开发并验证了一种使用ICD-10-CM诊断代码的算法，以识别具有足够高PPV的健康保险索赔中的子宫内膜癌病例，用于计划的上市后安全性研究。
方法：从2016年到2020年，在≥50岁的女性中发现了临时发生的子宫内膜癌病例。一种算法变体使用了子宫部位恶性肿瘤的诊断代码（C54。x),排除C54.2（子宫肌层恶性肿瘤）；另一个仅使用C54.1（子宫内膜恶性肿瘤）。要求对近期事件临时病例（2018-2020年）的病历进行随机抽样裁定。确诊病例显示子宫内膜癌的活检证据，癌症分期的文献，或诊断后子宫切除术。我们用95%置信区间(CI)估计了变异体的PPV,不包括信息不足的病例。
结果：在裁定的294起临时案件中，85%来自门诊（n=249）。诊断时的平均年龄为69.3岁。在294起判决的案件中(用更广泛的算法变体确定)，通过两种算法变体确认了同样的223例子宫内膜癌病例.更广泛的算法变体的PPV（95％CI）为84.2％（79.2％和88.3％），对于仅使用C54.1的变体，为85.8％（80.9％和89.8％）。
结论：我们开发并验证了一种使用ICD-10-CM诊断代码的算法，以识别具有足够高PPV的健康保险索赔中的子宫内膜癌病例，用于计划的上市后安全性研究。
