Objective To estimate the predictive role of faecal haemoglobin (f-Hb) concentration among subjects with faecal immunochemical test (FIT) results below the positivity cut-off for the subsequent risk of advanced neoplasia (AN: colorectal cancer—CRC—or advanced adenoma). Design Prospective cohort of subjects aged 50–69 years, undergoing their first FIT between 1 January 2004 and 31 December 2010 in four population-based programmes in Italy. Methods All programmes adopted the same analytical procedure (OC Sensor, Eiken Japan), performed every 2 years, on a single sample, with the same positivity cut-off (20 µg Hb/g faeces). We assessed the AN risk at subsequent exams, the cumulative AN detection rate (DR) over the 4-year period following the second FIT and the interval CRC (IC) risk following two negative FITs by cumulative amount of f-Hb concentration over two consecutive negative FITs, using multivariable logistic regression models and the Kaplan-Meier method. Results The cumulative probability of a positive FIT result over the subsequent two rounds ranged between 7.8% (95% CI 7.5 to 8.2) for subjects with undetectable f-Hb at the initial two tests (50% of the screenees) and 48.4% (95% CI 44.0 to 53.0) among those (0.7% of the screenees) with a cumulative f-Hb concentration ≥20 µg/g faeces. The corresponding figures for cumulative DR were: 1.4% (95% CI 1.3 to 1.6) and 25.5% (95% CI 21.4 to 30.2) for AN; 0.17% (95% CI 0.12 to 0.23) and 4.5% (95% CI 2.8 to 7.1) for CRC. IC risk was also associated with cumulative f-Hb levels. Conclusion The association of cumulative f-Hb concentration with subsequent AN and IC risk may allow to design tailored strategies to optimise the utilisation of endoscopy resources: subjects with cumulative f-Hb concentration ≥20 µg/g faeces over two negative tests could be referred immediately for total colonoscopy (TC), while screening interval might be extended for those with undetectable f-Hb.

中文翻译：

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FIT 结果为阴性的受试者的粪便血红蛋白浓度与随后几轮肿瘤的检出率相关：意大利基于人群的筛查项目背景下的一项前瞻性研究

目的 评估粪便免疫化学测试 (FIT) 结果低于阳性临界值的受试者粪便血红蛋白 (f-Hb) 浓度对后续晚期肿瘤形成（AN：结直肠癌 - CRC - 或晚期腺瘤）风险的预测作用. 2004 年 1 月 1 日至 2010 年 12 月 31 日期间在意大利的四个基于人群的项目中，设计了 50-69 岁受试者的前瞻性队列。方法 所有程序都采用相同的分析程序（OC Sensor，Eiken Japan），每 2 年对单个样品进行一次，具有相同的阳性临界值（20 µg Hb/g 粪便）。我们在随后的检查中评估了 AN 风险，第二次 FIT 后 4 年的累积 AN 检测率 (DR) 和两次负 FIT 后的间隔 CRC (IC) 风险，通过两次连续负 FIT 的 f-Hb 浓度累积量，使用多变量逻辑回归模型和Kaplan-Meier 方法。结果 对于在最初的两次测试中检测不到 f-Hb 的受试者（50% 的筛查者）和 48.4%（95%），随后两轮 FIT 结果阳性的累积概率介于 7.8%（95% CI 7.5 至 8.2）之间。 % CI 44.0 至 53.0）在那些（0.7% 的筛选者）中累积 f-Hb 浓度 ≥ 20 µg/g 粪便。累积 DR 的相应数字为：AN 为 1.4%（95% CI 1.3 至 1.6）和 25.5%（95% CI 21.4 至 30.2）；CRC 为 0.17%（95% CI 0.12 至 0.23）和 4.5%（95% CI 2.8 至 7.1）。IC 风险还与累积 f-Hb 水平相关。结论 累积 f-Hb 浓度与随后的 AN 和 IC 风险的关联可能允许设计定制的策略来优化内窥镜资源的利用：在两次阴性测试中累积 f-Hb 浓度≥20 µg/g 粪便的受试者可以立即转诊对于全结肠镜检查 (TC)，而对于 f-Hb 检测不到的患者，筛查间隔可能会延长。