An evaluation of the impact of missing deaths on overall survival analyses of advanced non-small cell lung cancer patients conducted in an electronic health records database
An evaluation of the impact of missing deaths on overall survival analyses of advanced non-small cell lung cancer patients conducted in an electronic health records database
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DOI：
10.1002/pds.4758
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发表时间：
2019-05-01
影响因子：
2.6
通讯作者：
Capra, William B.
中科院分区：
文献类型：
--
作者：
Carrigan, Gillis;Whipple, Samuel;Capra, William B.
目的：本研究的目的是评估缺失的死亡数据对生存分析的影响进行肿瘤EHR派生database.Methods：这项研究是使用熨斗健康肿瘤数据库和国家死亡指数（NDI）作为金标准。在晚期非小细胞肺癌（aNSCLC）患者中评估了三种分析框架：中位总生存期[mOS]），在EHR衍生数据库中进行的相对风险估计，以及比较使用金标准死亡率数据的实验组与仅来自EHR衍生数据库的对照组的“外部对照组”分析。将EHR衍生数据库（91%敏感性）和外部对照组分析中获得的风险比（HR）与两组均使用金标准死亡率数据进行扩增时的结果进行比较。上述分析重复使用模拟较低的死亡率的敏感性，以了解更极端的水平失踪deaths.Results的影响：偏差在mOS范围从适度（0.6-0.9月）。在EHR衍生的队列中，当通过模拟产生较低的敏感性（3.3-9.7个月）时，敏感性（91%）为实质性。总体而言，与使用金标准数据源获得的HR相比，在比较分析中观察到EHR衍生队列的HR存在微小差异。当只有一个治疗臂受到估计偏差，偏差是稍微更明显，但大幅增加时，较低的灵敏度simulated.Conclusions：生存分析的影响是最小的高死亡率的敏感性，只有适度的影响与外部控制臂应用程序。
Purpose: The aim of this study was to assess the impact of missing death data on survival analyses conducted in an oncology EHR-derived database.Methods: The study was conducted using the Flatiron Health oncology database and the National Death Index (NDI) as a gold standard. Three analytic frameworks were evaluated in advanced non-small cell lung cancer (aNSCLC) patients: median overall survival [mOS]), relative risk estimates conducted within the EHR-derived database, and "external control arm" analyses comparing an experimental group augmented with mortality data from the gold standard to a control group from the EHR-derived database only. The hazard ratios (HRs) obtained within the EHR-derived database (91% sensitivity) and the external control arm analyses, were compared with results when both groups were augmented with mortality data from the gold standard. The above analyses were repeated using simulated lower mortality sensitivities to understand the impact of more extreme levels of missing deaths.Results: Bias in mOS ranged from modest (0.6-0.9 mos.) in the EHR-derived cohort with (91% sensitivity) to substantial when lower sensitivities were generated through simulation (3.3-9.7 mos.). Overall, small differences were observed in the HRs for the EHR-derived cohort across comparative analyses when compared with HRs obtained using the gold standard data source. When only one treatment arm was subject to estimation bias, the bias was slightly more pronounced, but increased substantially when lower sensitivities were simulated.Conclusions: The impact on survival analysis is minimal with high mortality sensitivity with only modest impact associated within external control arm applications.