Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
Positive predictive values of fecal immunochemical tests used in the STOP CRC pragmatic trial
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DOI：
10.1002/cam4.1727
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发表时间：
2018-09-01
期刊：
影响因子：
4
通讯作者：
Coronado, Gloria D.
中科院分区：
文献类型：
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作者：
Nielson, Carrie M.;Petrik, Amanda F.;Coronado, Gloria D.
每年一次的粪便免疫化学检测(FIT)对结直肠癌(CRC)筛查是具有成本效益的。然而，Fit阳性率和阳性预测值(PPV)可能有很大的差异，假阳性(FP)结果增加了结肠镜检查的负担，而没有改善癌症检测。我们的目标是描述在接受结直肠癌筛查的患者中Fit PPV和与FP结果相关的因素。在一项正在进行的邮寄FIT外展的务实临床试验中，诊所推出了三种FIT品牌之一(Insuure、OC-Micro和hemosure)。符合结果为阳性并随访结肠镜检查的患者被纳入本分析(N=1130)。患者的人口统计和病史是从电子健康记录(EHR)中提取的。使用混合效应多变量Logistic回归分析Fit品牌和患者因素与FP结果(即Fit阳性结果，在后续结肠镜检查中未发现晚期肿瘤)的相关性。FIT阳性结果的平均比例从使用OC-Micro测试的中心的8%到血液检查的21%不等。晚期肿瘤的PPV值分别为0.30~0.17(P=0.08)。在多变量调整的模型中，与OC-Micro(OR=2.00，95%CI：0.47-8.56)或保险(OR.=1.72，95%可信区间：0.44~6.68)。女性(OR=1.58，95%CI：1.19~2.10)和结直肠癌病史(OR=2.17，95%CI：1.13~4.15)与FP显著相关。总而言之，FIT阳性因品牌而异，FP结果因EHR提供的患者因素不同而不同。这些结果可以用来最小化FP结果的频率，减少患者的痛苦和结肠镜检查的负担。
Annual fecal immunochemical testing (FIT) is cost-effective for colorectal cancer (CRC) screening. However, FIT positivity rates and positive predictive value (PPV) can vary substantially, with false-positive (FP) results adding to colonoscopy burden without improving cancer detection. Our objective was to describe FIT PPV and the factors associated with FP results among patients undergoing CRC screening. In an ongoing pragmatic clinical trial of mailed-FIT outreach, clinics delivered one of three FIT brands (InSure, OC-Micro, and Hemosure). Patients who had a positive FIT result and a follow-up colonoscopy were included in this analysis (N = 1130). Patients' demographic and medical histories were abstracted from electronic health records (EHR). Associations with a FP result (ie, a positive FIT result with no evidence of advanced neoplasia during follow-up colonoscopy) were evaluated for FIT brand and patient factors using mixed-effects multivariable logistic regression. The mean proportion of FIT-positive results ranged from 8% in centers using the OC-Micro test to 21% for Hemosure. PPVs for advanced neoplasia were 0.30 to 0.17, respectively (P for chi(2) = 0.08). In multivariable-adjusted models, use of Hemosure was associated with greater odds of a FP result than OC-Micro (OR = 2.00, 95% CI: 0.47-8.56) or InSure (OR. = 1.72, 95% CI: 0.44-6.68). However, only female sex (OR = 1.58, 95% CI: 1.19-2.10) and history of a colorectal condition (OR = 2.17, 95% CI: 1.13-4.15) were significantly associated with FP. In conclusion, FIT positivity varied by brand, and FP results differed by patient factors available through the EHR. These results can be used to minimize the frequency of FP results, reducing patient distress and colonoscopy burden.