Department of Urology, Stanford University, Stanford, California.
Department of Urology, University of California-Los Angeles, Los Angeles, California; Veterans Administration Greater Los Angeles Healthcare System, Los Angeles, California.
J Urol. 2018 Sep;200(3):541-548. doi: 10.1016/j.juro.2018.03.127. Epub 2018 Apr 6.
We sought to characterize the effects of prostate specific antigen registry errors on clinical research by comparing cohorts based on cancer registry prostate specific antigen values with those based directly on results in the electronic health record.
We defined sample cohorts of men with prostate cancer using data from the Veterans Health Administration, including those with a prostate specific antigen value less than 4.0, 4.0 to 10.0, 10.0 to 20.0 and 20.0 to 98.0 ng/ml, respectively. We compared the composition of each cohort and overall patient survival when using prostate specific antigen values from the Veteran Affairs Central Cancer Registry vs the gold standard electronic health record laboratory file results.
There was limited agreement among cohorts when defined by cancer registry prostate specific antigen values vs the laboratory file of the electronic health record. The least agreement of 58% was seen in patients with prostate specific antigen less than 4.0 ng/ml and greatest agreement of 89% was noted among patients with prostate specific antigen between 4.0 and 10.0 ng/ml. In each cohort patients assigned to a cohort based only on the cancer registry prostate specific antigen value had significantly different overall survival when compared with patients assigned based on registry and laboratory file prostate specific antigen values.
Cohorts based exclusively on cancer registry prostate specific antigen values may have high rates of misclassification that can introduce concerning differences in key characteristics and result in measurable differences in clinical outcomes.
我们旨在通过比较基于癌症登记处前列腺特异性抗原值的队列和直接基于电子健康记录结果的队列，来描述前列腺特异性抗原登记错误对临床研究的影响。
我们使用退伍军人事务部的数据，定义了前列腺癌患者的样本队列，包括前列腺特异性抗原值分别小于 4.0、4.0 至 10.0、10.0 至 20.0 和 20.0 至 98.0ng/ml 的患者。我们比较了每个队列的构成以及使用退伍军人事务部中央癌症登记处的前列腺特异性抗原值与黄金标准电子健康记录实验室文件结果时的总体患者生存率。
当根据癌症登记处前列腺特异性抗原值与电子健康记录的实验室文件定义队列时，队列之间的一致性有限。前列腺特异性抗原值小于 4.0ng/ml 的患者中一致性最低为 58%，前列腺特异性抗原值在 4.0 至 10.0ng/ml 之间的患者中一致性最高为 89%。在每个队列中，仅根据癌症登记处前列腺特异性抗原值分配给队列的患者与根据登记处和实验室文件前列腺特异性抗原值分配的患者相比，总体生存率存在显著差异。
完全基于癌症登记处前列腺特异性抗原值的队列可能存在较高的分类错误率，这可能导致关键特征存在令人担忧的差异，并导致临床结果出现可衡量的差异。
