结直肠癌（CRC）的发病率一直在增加。结肠镜检查仍然是早期诊断的金标准方法，但单独使用结肠镜检查作为大规模筛查方法是不现实的。本研究旨在探讨将粪便免疫化学检测（FIT）和高危因素问卷（HRFQ）与结肠镜检查相结合是否可以提高大规模结直肠癌筛查的成本效益。第一阶段结合 FIT 和 HRFQ 以及结肠镜检查的结直肠癌筛查方案第二阶段于2007-2015年在50个乡镇开展。 40-74岁的居民有资格参加这项免费筛查。共有160~210（76.12%）名参与者完成第一阶段筛查，28~679（17.90%）名参与者被定义为阳性，其中21~715（75.72%）名参与者完成结肠镜检查并纳入最终分析。结果随访至 2020 年。第一和第二筛选阶段的合规性分别为 76.12% 和 75.72%。筛查共检出结直肠癌252例、腺瘤4033例、晚期肿瘤1234例、总肿瘤病例5534例。 FIT 人群中 CRC、腺瘤、晚期肿瘤和总肿瘤的阳性预测值分别高于 HRFQ 人群。 FIT 和 HRFQ 中分别发现肿瘤病例总数的 64.60% 和 43.42%（两者均为 8.02%）。 HRFQ和FIT联合检测的结直肠肿瘤和CRC病例总数分别增加了55.08%和40.00%，且增幅高于HRFQ。结合 HRFQ 和 FIT 的每个肿瘤的检测成本 < 5331 美元，而单独使用 FIT 和 HRFQ 的成本分别 < 4570 美元和 5380 美元。将 FIT 和 HRFQ 与结肠镜检查相结合可提高大规模 CRC 筛查计划的成本效益。该方案可推荐给大多数人群，特别是人口密度高、医生/人口比例低的国家和地区。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。

Colorectal cancer (CRC) incidence has been increasing. Colonoscopy is still a gold standard method for its early diagnosis but using colonoscopy alone as a mass screening method is unrealistic. This study is to investigate whether combining fecal immunochemical test (FIT) and high-risk-factors questionnaire (HRFQ) with colonoscopy improve the cost-effectiveness of a mass CRC screening.CRC screening protocol combining FITs and HRFQ in the first stage and colonoscopy in the second stage was used in 50 villages/towns in 2007-2015. Residents aged 40-74 years were eligible for this free screening. A total of 160 210 (76.12%) participants completed first-stage screening, and 28 679 (17.90%) participants were defined as positive, among which 21 715 (75.72%) participants completed colonoscopy and were included in the final analysis. Outcomes were followed up until 2020.The compliance was 76.12% and 75.72% in the first and second screening stage, respectively. A total of 252 CRC, 4033 adenoma, 1234 advanced neoplasm, and 5534 total neoplasm cases were detected in the screening. The positive predictive values of CRC, adenoma, advanced neoplasm, and total neoplasm were higher in FITs+ than those in the HRFQ+ population, respectively. A total of 64.60% and 43.42% total neoplasm cases were found in FITs+ and HRFQ+ (8.02% for both), respectively. The total colorectal neoplasm and CRC cases detected by combining HRFQ and FITs increased by 55.08% and 40.00%, respectively, and their increases were higher compared to HRFQ. The detection cost per any neoplasm by combining HRFQ and FITs was <$5331, while that by FITs and HRFQ alone was <$4570 and $5380, respectively.Combining FITs and HRFQ with colonoscopy improve the cost-effectiveness of a mass CRC screening program. This protocol can be recommended for most populations, especially those in the countries and areas with high population density and low physician/population ratio.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.