Colonoscopy and fecal immunochemical testing versus usual care in diagnostic colorectal cancer screening: the SCREESCO randomized controlled trial.

Guidelines recommend screening in individuals aged 50-75 years using colonoscopy or FIT, and many screening programs use one-sample biennial FIT.

指南建议在50-75岁个体中使用结肠镜检查或FIT进行筛查，并且许多筛查项目使用每两年一次的一次性样本FIT。

Here we compare incidenceof diagnosed CRCs and gastrointestinal and cardiovascular events between screening and usual care during the diagnostic phase of the SCREESCO trial. A randomized block method (no masking) assigned 278,280 individuals aged 60 years to once-only colonoscopy, 2 rounds of two-stool FIT with a low cutoff (10 μg g-1 feces) or usual care (control group) in a ratio of 1:6 for colonoscopy versus control and 1:2 for FIT versus control.

在此，我们比较了SCREESCO试验诊断阶段筛查组与常规护理组之间诊断出的结直肠癌(CRCs)以及胃肠道和心血管事件的发生率。采用随机区组方法（无盲法）将278,280名60岁及以上的个体随机分配到一次性的结肠镜检查组、两轮两次粪便免疫化学试验（FIT）低截止值（10 μg g-1粪便）组或常规护理（对照组），结肠镜检查组与对照组的比例为1:6，FIT组与对照组的比例为1:2。

In the analysis, 31,113 individuals were in the primary colonoscopy arm and 60,267 were in the FIT arm, and there were 186,671 primary colonoscopy controls, of whom 120,521 were also controls for comparison with the FIT arm.

在分析中，有31,113名个体在主要结肠镜检查组，60,267名在FIT组，有186,671名主要结肠镜检查对照组，其中120,521名也是与FIT组进行比较的对照组。

After a median follow-up of 4.8 years, the incidencerate of CRC was 107.9 in the colonoscopy arm and 99.9 in controls per 100,000 person-years (incidencerate ratio (IRR): 1.08, 95% confidence interval(CI): 0.91-1.28) and 96.0 in the FIT arm and 103.9 in controls (IRR: 0.92, 95% CI: 0.81-1.05).

中位随访4.8年后，结肠镜组的结直肠癌（CRC）发病率为每10万人年107.9，对照组为99.9（发病率比（IRR）：1.08，95%置信区间（CI）：0.91-1.28），而粪便免疫化学试验（FIT）组为96.0，对照组为103.9（IRR：0.92，95% CI：0.81-1.05）。

Rates of stage I-II CRC were higher in the colonoscopy arm (IRR: 1.38, 95% CI: 1.09-1.74) and in the FIT arm (IRR: 1.19, 95% CI: 0.99-1.43) versus controls.

I-II期结直肠癌的发病率在结肠镜组（发病率比（IRR）：1.38，95%置信区间（CI）：1.09-1.74）和FIT组（IRR：1.19，95% CI：0.99-1.43）中均高于对照组。

Rates of cardiovascular and gastrointestinal events were slightly higher in the intervention arms during the first year and were subsequently more similar to controls.

干预组在第一年的心血管和胃肠道事件发生率略高，随后与对照组更为相似。

Our findings of an increase in CRC detection implies a benefit of screening while the increase in adverse events suggests some initial harm.

我们发现结直肠癌（CRC）检测率的增加意味着筛查的好处，而不良事件的增加则暗示了一些初始的伤害。

ClinicalTrials.gov: NCT02078804 .

ClinicalTrials.gov: NCT02078804 .