School of Oral Hygiene, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.
Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
Cancer Epidemiol Biomarkers Prev. 2018 Jun;27(6):704-709. doi: 10.1158/1055-9965.EPI-17-0387. Epub 2018 Mar 28.
Despite age and sex differences in fecal hemoglobin (f-Hb) concentrations, most fecal immunochemical test (FIT) screening programs use population-average cut-points for test positivity. The impact of age/sex-specific threshold on FIT accuracy and colonoscopy demand for colorectal cancer screening are unknown. Using data from 723,113 participants enrolled in a Taiwanese population-based colorectal cancer screening with single FIT between 2004 and 2009, sensitivity and specificity were estimated for various f-Hb thresholds for test positivity. This included estimates based on a "universal" threshold, receiver-operating-characteristic curve-derived threshold, targeted sensitivity, targeted false-positive rate, and a colonoscopy-capacity-adjusted method integrating colonoscopy workload with and without age/sex adjustments. Optimal age/sex-specific thresholds were found to be equal to or lower than the universal 20 μg Hb/g threshold. For older males, a higher threshold (24 μg Hb/g) was identified using a 5% false-positive rate. Importantly, a nonlinear relationship was observed between sensitivity and colonoscopy workload with workload rising disproportionately to sensitivity at 16 μg Hb/g. At this "colonoscopy-capacity-adjusted" threshold, the test positivity (colonoscopy workload) was 4.67% and sensitivity was 79.5%, compared with a lower 4.0% workload and a lower 78.7% sensitivity using 20 μg Hb/g. When constrained on capacity, age/sex-adjusted estimates were generally lower. However, optimizing age/-sex-adjusted thresholds increased colonoscopy demand across models by 17% or greater compared with a universal threshold. Age/sex-specific thresholds improve FIT accuracy with modest increases in colonoscopy demand. Colonoscopy-capacity-adjusted and age/sex-specific f-Hb thresholds may be useful in optimizing individual screening programs based on detection accuracy, population characteristics, and clinical capacity. .
尽管粪便血红蛋白（f-Hb）浓度在年龄和性别上存在差异，但大多数粪便免疫化学检测（FIT）筛查计划仍使用人群平均切点来判断检测阳性。年龄/性别特异性阈值对 FIT 准确性和结肠镜检查在结直肠癌筛查中的需求的影响尚不清楚。本研究使用了 2004 年至 2009 年期间参加台湾基于人群的结直肠癌筛查且仅接受单次 FIT 的 723113 名参与者的数据，针对各种 f-Hb 检测阳性切点，估计了检测的敏感性和特异性。这包括基于“通用”切点、受试者工作特征曲线（ROC）衍生切点、靶向敏感性、靶向假阳性率以及一种结肠镜检查能力调整方法的估计，该方法将结肠镜检查工作量与是否进行年龄/性别调整相结合。研究发现，最佳的年龄/性别特异性切点等于或低于通用的 20μg Hb/g 切点。对于年龄较大的男性，使用 5%的假阳性率，确定了更高的 24μg Hb/g 切点。重要的是，在敏感性和结肠镜检查工作量之间观察到了非线性关系，在 16μg Hb/g 时，工作量的增加不成比例地高于敏感性。在这个“结肠镜检查能力调整”切点下，检测阳性率（结肠镜检查工作量）为 4.67%，敏感性为 79.5%，而使用 20μg Hb/g 时，工作量为 4.0%，敏感性为 78.7%。在受能力限制时，年龄/性别调整后的估计值通常较低。然而，与通用阈值相比，优化年龄/性别调整后的切点使结肠镜检查需求增加了 17%或更多。年龄/性别特异性切点可提高 FIT 的准确性，同时适度增加结肠镜检查的需求。结肠镜检查能力调整和年龄/性别特异性 f-Hb 切点可能有助于根据检测准确性、人群特征和临床能力优化个体筛查计划。
