Kern David M, Barron John J, Wu Bingcao, Ganetsky Alex, Willey Vincent J, Quimbo Ralph A, Fisch Michael J, Singer Joseph, Nguyen Ann, Mamtani Ronac
Health Economics and Outcomes Research, HealthCore, Inc, Wilmington, DE.
Department of Pharmacy, Hospital of the University of Pennsylvania, Philadelphia, PA.
Pragmat Obs Res. 2017 Aug 26;8:149-155. doi: 10.2147/POR.S140579. eCollection 2017.
Data from a Cancer Care Quality Program are directly integrated with administrative claims data to provide a level of clinical detail not available in claims-based studies, and referred to as the HealthCore Integrated Research Environment (HIRE)-Oncology data. This study evaluated the validity of the HIRE-Oncology data compared with medical records of breast, lung, and colorectal cancer patients.
Data elements included cancer type, stage, histology (lung only), and biomarkers. A sample of 300 breast, 200 lung, and 200 colorectal cancer patients within the HIRE-Oncology data were identified for medical record review. Statistical measures of validity (agreement, positive predictive value [PPV], negative predictive value [NPV], sensitivity, specificity) were used to compare clinical information between data sources, with medical record data considered the gold standard.
All 300 breast cancer records reviewed were confirmed breast cancer, while 197 lung and 197 colorectal records were confirmed (PPV =0.99 for each). The agreement of disease stage was 85% for breast, 90% for lung, and 94% for colorectal cancer. The agreement of lung cancer histology (small cell vs non-small cell) was 97%. Agreement of progesterone receptor, estrogen receptor, and human epidermal growth factor receptor 2 status biomarkers in breast cancer was 92%, 97%, and 92%, respectively; epidermal growth factor receptor and anaplastic lymphoma kinase agreement in lung was 97% and 92%, respectively; and agreement of KRAS status in colorectal cancer was 95%. Measures of PPV, NPV, sensitivity, and specificity showed similarly strong evidence of validity.
Good agreement between the HIRE-Oncology data and medical records supports the validity of these data for research.
癌症护理质量项目的数据与行政索赔数据直接整合，以提供基于索赔的研究中无法获得的临床细节水平，这些数据被称为HealthCore综合研究环境（HIRE）-肿瘤学数据。本研究评估了HIRE-肿瘤学数据与乳腺癌、肺癌和结直肠癌患者病历相比的有效性。
数据元素包括癌症类型、分期、组织学（仅适用于肺癌）和生物标志物。在HIRE-肿瘤学数据中确定了300例乳腺癌、200例肺癌和200例结直肠癌患者的样本进行病历审查。使用有效性的统计指标（一致性、阳性预测值[PPV]、阴性预测值[NPV]、敏感性、特异性）来比较数据源之间的临床信息，将病历数据视为金标准。
审查的所有300例乳腺癌记录均确诊为乳腺癌，而197例肺癌和197例结直肠癌记录得到确诊（每种癌症的PPV = 0.99）。疾病分期的一致性在乳腺癌中为85%，在肺癌中为90%，在结直肠癌中为94%。肺癌组织学（小细胞与非小细胞）的一致性为97%。乳腺癌中孕激素受体、雌激素受体和人表皮生长因子受体2状态生物标志物的一致性分别为92%、97%和92%；肺癌中表皮生长因子受体和间变性淋巴瘤激酶的一致性分别为97%和92%；结直肠癌中KRAS状态的一致性为95%。PPV、NPV、敏感性和特异性指标显示出同样有力的有效性证据。
HIRE-肿瘤学数据与病历之间的良好一致性支持了这些数据用于研究的有效性。
