Azienda USL Umbria 1 Perugia, Laboratorio Unico di Screening, Perugia, Italy.
Centre for Research into Cancer Prevention and Screening, University of Dundee School of Medicine, Dundee, UK.
Gut. 2018 Mar;67(3):485-496. doi: 10.1136/gutjnl-2016-312716. Epub 2016 Dec 14.
To compare acceptability and diagnostic accuracy of a recently available faecal immunochemical test (FIT) system (HM-JACKarc) with the FIT routinely used in an established screening programme (OC-Sensor).
Randomised controlled trial (ISRCTN20086618) within a population-based colorectal cancer (CRC) screening programme. Subjects eligible for invitation in the Umbria Region (Italy) programme were randomised (ratio 1:1) to be screened using one of the FIT systems.
Screening uptake among the 48 888 invitees was the same for both systems among subjects invited in the first round and higher with OC-Sensor than with HM-JACKarc (relative risk (RR): 1.03; 95% CI 1.02 to 1.04) among those invited in subsequent rounds. Positivity rate (PR) was similar with OC-Sensor (6.5%) as with HM-JACKarc (6.2%) among subjects performing their first FIT screening and higher with OC-Sensor (5.6%, RR: 1.25, 95% CI 1.12 to 1.40) than with HM-JACKarc (4.4%) among those screened in previous rounds. Positive predictive value (PPV) (OC-Sensor: 25.9%, HM-JACKarc: 25.6%) and detection rate (DR) (OC-Sensor: 1.40%; HM-JACKarc: 1.42%) for advanced neoplasia (AN: CRC + advanced adenoma) were similar among subjects performing their first FIT screening. The differences in the AN PPV (OC-Sensor: 20.3%, HM-JACKarc: 22.6%) and DR (OC-Sensor: 0.96%, HM-JACKarc: 0.83%) among those screened in previous rounds were not statistically significant. The number needed to scope to detect one AN was 3.9 (95% CI 5.8 to 2.9) and 3.9 (95% CI 5.5 to 2.9) at first and 4.9 (95% CI 5.8 to 4.2) and 4.4 (95% CI 5.3 to 3.7) at subsequent screening, with OC-Sensor and HM-JACKarc, respectively.
Our results suggest that acceptability and diagnostic performance of HM-JACKarc and of OC-Sensor systems are similar in a screening setting.
ISRCTN20086618; Results.
比较一种新的粪便免疫化学检测（FIT）系统（HM-JACKarc）与常规用于既定筛查计划的 FIT（OC-Sensor）的可接受性和诊断准确性。
在基于人群的结直肠癌（CRC）筛查计划中进行的随机对照试验（ISRCTN20086618）。乌姆比亚地区（意大利）计划中符合邀请条件的受试者被随机（比例为 1:1）使用一种 FIT 系统进行筛查。
在第一轮邀请的受试者中，两种系统的筛查参与率相同，而在随后的几轮邀请中，OC-Sensor 的参与率高于 HM-JACKarc（相对风险（RR）：1.03；95%置信区间 1.02 至 1.04）。在进行首次 FIT 筛查的受试者中，OC-Sensor 的阳性率（PR）与 HM-JACKarc 相似（6.5%），而在之前几轮筛查中，OC-Sensor 的 PR 更高（5.6%，RR：1.25，95%置信区间 1.12 至 1.40）。在进行首次 FIT 筛查的受试者中，OC-Sensor 和 HM-JACKarc 的阳性预测值（PPV）（OC-Sensor：25.9%，HM-JACKarc：25.6%）和检出率（DR）（OC-Sensor：1.40%；HM-JACKarc：1.42%）均相似。在之前几轮筛查中，AN 的 PPV（OC-Sensor：20.3%，HM-JACKarc：22.6%）和 DR（OC-Sensor：0.96%，HM-JACKarc：0.83%）的差异无统计学意义。OC-Sensor 和 HM-JACKarc 分别检测到一个 AN 的需要进行内镜检查的数量为 3.9（95%置信区间 5.8 至 2.9）和 3.9（95%置信区间 5.5 至 2.9），以及 4.9（95%置信区间 5.8 至 4.2）和 4.4（95%置信区间 5.3 至 3.7）。
我们的结果表明，在筛查环境中，HM-JACKarc 和 OC-Sensor 系统的可接受性和诊断性能相似。
ISRCTN20086618；结果。
