Brenner Hermann, Qian Jing, Werner Simone
Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.
Division of Preventive Oncology, German Cancer Research Center (DKFZ) and National Center for Tumor Diseases (NCT), Heidelberg, Germany.
Clin Epidemiol. 2018 Apr 5;10:381-389. doi: 10.2147/CLEP.S155548. eCollection 2018.
Fecal immunochemical tests (FITs) for hemoglobin in stool are increasingly used for colorectal cancer screening. Reported sensitivities and specificities have strongly varied between studies, but it is unclear to what extent such variation reflects differences between tests or between study population characteristics. We aimed to evaluate the key parameters of FIT performance for detecting advanced neoplasia (AN) according to sex and age.
Sex- and age-specific sensitivity, specificity, positive predictive values (PPVs) and negative predictive values (NPVs) for detecting AN of a quantitative FIT (FOB Gold®) were evaluated among 3211 men and women aged 50-79 years who underwent screening colonoscopy in Germany.
At the cutoff recommended by the manufacturer (17 µg hemoglobin/g feces), sensitivity was higher (51.2% versus 34.7%, =0.004) and specificity was lower (91.0% versus 94.8%, <0.001) among 65-79 year-old participants compared with 50-64 year-old participants. PPVs and NPVs did not differ significantly between age groups. However, higher NPVs were observed among women compared with men (94.7% versus 92.5%, =0.015). Specificity was also higher among women compared with men (94.7% versus 92.3%, =0.007), while there was only a little variation in sensitivity (40.3% versus 41.8%, =0.789) according to sex. In joint stratification by both factors, sensitivity ranged from 34.1% (95% CI 24.2%-45.2%) in 50-64 year-old women to 51.4% (95% CI 39.3%-63.3%) in 65-79 year-old men (=0.029). The observed age and sex differences were highly consistent across a wide range of alternative cutoffs from 10 to 50 µg hemoglobin/g feces.
There are major differences in diagnostic performance parameters according to sex and age, which should receive careful attention in the interpretation and comparison of results of FIT-based colorectal cancer screening studies.
粪便免疫化学检测（FITs）用于检测粪便中的血红蛋白，越来越多地被用于结直肠癌筛查。不同研究报告的敏感度和特异度差异很大，但尚不清楚这种差异在多大程度上反映了检测方法之间的差异或研究人群特征之间的差异。我们旨在评估根据性别和年龄，FIT检测进展期肿瘤（AN）的关键性能参数。
在德国3211名年龄在50 - 79岁接受结肠镜筛查的男性和女性中，评估定量FIT（FOB Gold®）检测AN的性别和年龄特异性敏感度、特异度、阳性预测值（PPV）和阴性预测值（NPV）。
在制造商推荐的临界值（17μg血红蛋白/克粪便）下，与50 - 64岁的参与者相比，65 - 79岁的参与者敏感度更高（51.2%对34.7%，P = 0.004），特异度更低（91.0%对94.8%，P < 0.001）。各年龄组的PPV和NPV没有显著差异。然而，女性的NPV高于男性（94.7%对92.5%，P = 0.015）。女性的特异度也高于男性（94.7%对92.3%，P = 0.007），而根据性别，敏感度只有轻微差异（40.3%对41.8%，P = 0.789）。在两个因素的联合分层中，敏感度范围从50 - 64岁女性的34.1%（95%CI 24.2% - 45.2%）到65 - 79岁男性的51.4%（95%CI 39.3% - 63.3%）（P = 0.029）。在10至50μg血红蛋白/克粪便的广泛替代临界值范围内，观察到的年龄和性别差异高度一致。
根据性别和年龄，诊断性能参数存在重大差异，这在基于FIT的结直肠癌筛查研究结果的解释和比较中应予以仔细关注。
