Division of General Medicine, Departments of Internal Medicine and Health Management and Policy, University of Michigan, Ann Arbor, Michigan, USA.
Exact Sciences Corporation, Madison, Wisconsin, USA.
Popul Health Manag. 2023 Aug;26(4):239-245. doi: 10.1089/pop.2023.0037. Epub 2023 Jul 19.
The Centers for Medicare & Medicaid Services (CMS) recommend covering blood-based tests meeting proposed minimum performance thresholds for colorectal cancer (CRC) screening. Outcomes were compared between currently available stool-based screening tests and a hypothetical blood-based test meeting CMS minimum thresholds. Using the Colorectal Cancer and Adenoma Incidence and Mortality Microsimulation Model (CRC-AIM), outcomes were simulated for average-risk individuals screened between ages 45 and 75 years with triennial multitarget stool DNA (mt-sDNA), annual fecal immunochemical test (FIT), and annual fecal occult blood test (FOBT). Per CMS guidance, blood-based CRC screening was modeled triennially, with 74% CRC sensitivity and 90% specificity. Although not specified by CMS, adenoma sensitivity was set between 10% and 20%. Published adenoma and CRC sensitivity and specificity were used for stool-based tests. Adherence was set at (1) 100%, (2) 30%-70%, in 10% increments, and (3) real-world rates for stool-based tests (mt-sDNA = 65.6%; FIT = 42.6%; FOBT = 34.4%). Assuming perfect adherence, a blood-based test produced ≥19 lower life-years gained (LYG) than stool-based strategies. At the best-case scenario for blood-based tests (100% adherence and 20% adenoma sensitivity), mt-sDNA at real-world adherence achieved more LYG (287.2 vs. 297.1, respectively) with 14% fewer colonoscopies. At 100% blood-based test adherence and real-world mt-sDNA and FIT adherence, the blood-based test would require advanced adenoma sensitivity of 30% to reach the LYG of mt-sDNA (297.1) and ∼15% sensitivity to reach the LYG of FIT (258.9). This model suggests that blood-based tests with CMS minimally acceptable CRC sensitivity and low advanced adenoma sensitivity will frequently yield inferior outcomes to stool-based testing across a wide range of adherence assumptions.
美国医疗保险和医疗补助服务中心（CMS）建议覆盖符合结直肠癌（CRC）筛查提议最低性能阈值的基于血液的检测。比较了当前可用的基于粪便的筛查测试和符合 CMS 最低阈值的假设基于血液的测试的结果。使用结直肠癌和腺瘤发生率和死亡率微模拟模型（CRC-AIM），对 45 至 75 岁年龄组进行筛查的平均风险个体的结果进行了模拟，采用三联粪便 DNA（mt-sDNA）、每年粪便免疫化学检测（FIT）和每年粪便潜血检测（FOBT）。根据 CMS 的指导，每三年对基于血液的 CRC 筛查进行建模，CRC 灵敏度为 74%，特异性为 90%。虽然 CMS 没有具体说明，但腺瘤灵敏度设定在 10%至 20%之间。基于粪便的测试使用发表的腺瘤和 CRC 灵敏度和特异性。坚持率设定为（1）100%，（2）30%-70%，每 10%递增，（3）基于粪便的测试的实际坚持率（mt-sDNA=65.6%；FIT=42.6%；FOBT=34.4%）。假设完全坚持，基于血液的测试产生的寿命年获益（LYG）比基于粪便的策略至少低 19 个。在基于血液的测试的最佳情况下（100%坚持和 20%的腺瘤灵敏度），在实际坚持率下的 mt-sDNA 实现了更多的 LYG（分别为 287.2 和 297.1），结肠镜检查减少了 14%。在 100%基于血液的测试坚持率和实际的 mt-sDNA 和 FIT 坚持率下，基于血液的测试需要 30%的高级腺瘤灵敏度才能达到 mt-sDNA 的 LYG（297.1），约 15%的灵敏度才能达到 FIT 的 LYG（258.9）。该模型表明，基于血液的测试具有 CMS 可接受的最低 CRC 灵敏度和低高级腺瘤灵敏度，在广泛的坚持假设下，通常会产生比基于粪便的测试更差的结果。
