Clin Chem Lab Med. 2014 Jun;52(6):889-97. doi: 10.1515/cclm-2013-0708.
Appropriateness of tumor markers (TMs) has been retrospectively studied in limited patients' series, matching the requests to clinical records. Methods to monitor appropriateness suitable for use on a large scale are required. This study aims to establish and validate an innovative model to estimate appropriateness based on the comparison between the number of TMs requested and the expected requests inferred from epidemiological data.
The number of CA15.3, CA19.9 and CA125 requests theoretically expected according to the epidemiology of malignancies in a known geographic area (2 Italian regions) was compared with the number of TMs actually requested - the surveyed requests projected on a regional scale - during a given time span (1 year). The expected number of requests was calculated comparing TMs recommended by guidelines in different clinical scenarios with the prevalence or incidence figures of the examined diseases (carcinomas of breast, pancreas and biliary tract, ovary and endometrium).
Suitability of the model was demonstrated with the analysis of 1,891,070 TM requests surveyed in 66 laboratories from Veneto and Tuscany regions. The percentage difference over the total of expected TMs (delta%) ranged from -6.9% for CA15.3 to +1022.6% for CA19.9 in Veneto and from +35.7% for CA15.3 to +1842.6% for CA19.9 in Tuscany.
The presented model was effective in demonstrating higher than expected TM request rates, possibly associated with inappropriate use. Moreover, it can be applied on a large scale survey setting since it circumvents the unavailability of clinical information on test orders.
肿瘤标志物(TMs)的适宜性已在有限的患者系列中进行了回顾性研究,与临床记录的要求相匹配。需要寻找适合大规模使用的监测适宜性的方法。本研究旨在建立和验证一种创新模型,该模型基于通过比较请求的 TM 数量与从流行病学数据推断出的预期请求数量来估计适宜性。
根据已知地理区域(意大利的两个地区)恶性肿瘤的流行病学数据,比较了 CA15.3、CA19.9 和 CA125 请求的理论预期数量与在给定时间段(1 年)内实际请求的 TM 数量——调查请求在区域范围内的投影。通过比较不同临床情况下指南推荐的 TM 与所研究疾病(乳腺癌、胰腺和胆道癌、卵巢和子宫内膜癌)的患病率或发病率数据,计算出预期请求数量。
该模型通过对来自威尼托和托斯卡纳地区的 66 个实验室的 1891070 个 TM 请求进行分析得到了验证。在威尼托,实际请求与预期请求的总差异百分比(delta%)范围从 CA15.3 的-6.9%到 CA19.9 的+1022.6%,而在托斯卡纳,CA15.3 的差异百分比为+35.7%到 CA19.9 的+1842.6%。
所提出的模型在证明高于预期的 TM 请求率方面非常有效,这可能与不适当的使用有关。此外,由于它规避了测试订单临床信息不可用的问题,因此可以应用于大规模调查环境中。