Validation of prostate-specific antigen laboratory values recorded in Surveillance, Epidemiology, and End Results registries.
Validation of prostate-specific antigen laboratory values recorded in Surveillance, Epidemiology, and End Results registries.
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作者：
National Cancer Institute Surveillance, Epidemiology, and End Results Prostate-Specific Antigen Working Group;Adamo MP;Boten JA;Coyle LM;Cronin KA;Lam CJ;Negoita S;Penberthy L;Stevens JL;Ward KC
研究人员使用中央癌症登记处收集的前列腺特异性抗原（PSA）值来评估肿瘤的潜在侵袭性临床疾病。一项收集PSA值的独立研究表明，与隐含小数点相关的错误率较高（18%）。为了评价监测、流行病学和最终结果（SEER）计划中的错误率，对所有SEER登记研究中记录的PSA值进行了全面审查。对SEER登记研究中符合条件的前列腺癌病例的合并PSA值进行了审查，并与摘要记录的文本文件进行了比较。确定了四种类型的分类错误：隐含的小数点错误，抽象或编码实现错误，非重大错误，以及与“未知”值相关的变化。共审查了2012年诊断的50，277例前列腺癌病例。大约94.15%的病例没有有意义的变化（85.85%正确，5.58%无显著变化<1 ng/mL，2.80%无临床变化）。大约5.70%的病例发生了有意义的变化（1.93%由于隐含的小数点错误，1.54%由于摘要或编码错误，2.23%由于与未知类别相关的错误）。在最初的50，277例病例中，只有419例（0.83%）由于校正的PSA值导致疾病分期发生变化。在当前的验证研究中，隐含的小数错误率仅为所有病例的1.93%，有意义的错误率为5.81%。SEER中错误率较低的原因可能是由于中央登记中心正在进行严格的质量控制和视觉编辑过程。SEER项目目前正在审查和纠正2004年的PSA值，并将在公共使用研究文件中重新发布这些数据。Cancer 2017;123：697-703.© 2016美国癌症协会。研究人员使用中央癌症登记处收集的前列腺特异性抗原（PSA）值来评估肿瘤的潜在侵袭性临床疾病。本研究描述了对2012年前列腺癌病例的所有监测、流行病学和最终结果登记研究中记录的PSA实验室检查值的全面审查，以及审查和纠正PSA实验室检查值的拟议机制。
Researchers have used prostate‐specific antigen (PSA) values collected by central cancer registries to evaluate tumors for potential aggressive clinical disease. An independent study collecting PSA values suggested a high error rate (18%) related to implied decimal points. To evaluate the error rate in the Surveillance, Epidemiology, and End Results (SEER) program, a comprehensive review of PSA values recorded across all SEER registries was performed. Consolidated PSA values for eligible prostate cancer cases in SEER registries were reviewed and compared with text documentation from abstracted records. Four types of classification errors were identified: implied decimal point errors, abstraction or coding implementation errors, nonsignificant errors, and changes related to “unknown” values. A total of 50,277 prostate cancer cases diagnosed in 2012 were reviewed. Approximately 94.15% of cases did not have meaningful changes (85.85% correct, 5.58% with a nonsignificant change of <1 ng/mL, and 2.80% with no clinical change). Approximately 5.70% of cases had meaningful changes (1.93% due to implied decimal point errors, 1.54% due to abstract or coding errors, and 2.23% due to errors related to unknown categories). Only 419 of the original 50,277 cases (0.83%) resulted in a change in disease stage due to a corrected PSA value. The implied decimal error rate was only 1.93% of all cases in the current validation study, with a meaningful error rate of 5.81%. The reasons for the lower error rate in SEER are likely due to ongoing and rigorous quality control and visual editing processes by the central registries. The SEER program currently is reviewing and correcting PSA values back to 2004 and will re‐release these data in the public use research file. Cancer 2017;123:697–703. © 2016 American Cancer Society. Researchers have used prostate‐specific antigen (PSA) values collected by central cancer registries to evaluate tumors for potential aggressive clinical disease. The current study describes the comprehensive review of PSA laboratory values recorded across all Surveillance, Epidemiology, and End Results registries for 2012 prostate cancer cases and the proposed mechanism for reviewing and correcting PSA laboratory values.