Katsoula Anastasia, Paschos Paschalis, Haidich Anna-Bettina, Tsapas Apostolos, Giouleme Olga
Second Propedeutic Medical Department, Aristotle University of Thessaloniki, Thessaloniki, Greece.
Clinical Research and Evidence-Based Medicine Unit, Aristotle University of Thessaloniki, Thessaloniki, Greece.
JAMA Intern Med. 2017 Aug 1;177(8):1110-1118. doi: 10.1001/jamainternmed.2017.2309.
The potential role of the fecal immunochemical test (FIT) for screening patients at increased risk for colorectal cancer (CRC) has not yet been elucidated.
To assess the diagnostic accuracy of FIT for CRC or advanced neoplasia (AN) in asymptomatic patients at above-average risk.
MEDLINE, EMBASE, Cochrane Library, and gray literature sources through August 2016.
Diagnostic studies evaluating the accuracy of FIT for CRC or AN in patients with a personal or familial history of CRC using colonoscopy as the reference standard.
Two authors (A.K. and P.P.) independently extracted data and evaluated study quality using the Quality Assessment of Diagnostic Accuracy Studies-2 tool, and evaluated the quality of the body of evidence by means of GRADE (Grading of Recommendations Assessment, Development, and Evaluation). Hierarchical models were used to synthesize available evidence.
The primary outcome was the diagnostic performance of FIT for detecting CRC or AN.
We included 12 studies (6204 participants). Seven studies were deemed at high or unclear risk of bias. The average sensitivity of FIT for CRC was 93% (95% CI, 53%-99%), and the average specificity was 91% (95% CI, 89%-92%), yielding a positive likelihood ratio (LR+) of 10.30 (CI 7.7-13.9) and a negative likelihood ratio (LR-) of 0.08 (95% CI, 0.01-0.75) (GRADE: very low). The average sensitivity of FIT for AN was 48% (95% CI, 39%-57%); and the average specificity was 93% (95% CI, 91%-94%), yielding an LR+ of 6.55 (95% CI, 5.0-8.5) and an LR- of 0.57 (95% CI, 0.48-0.67) (GRADE: very low). Subgroup analyses indicated that FIT cutoff values between 15- and 25-μg/g feces provided the best combination of sensitivity and specificity for the diagnosis of CRC (93% and 94%, respectively). Quantitative and 1-sample FIT showed adequate test performance, but data on other FIT brands and multiple samples were insufficient.
The FIT has high overall diagnostic accuracy for CRC but moderate accuracy for AN in patients at above-average personal or familial risk. Heterogeneity and wide confidence intervals limit the trustworthiness of our findings.
粪便免疫化学检测（FIT）在筛查结直肠癌（CRC）风险增加患者中的潜在作用尚未阐明。
评估FIT对风险高于平均水平的无症状患者CRC或进展期肿瘤（AN）的诊断准确性。
截至2016年8月的MEDLINE、EMBASE、Cochrane图书馆及灰色文献来源。
以结肠镜检查为参考标准，评估FIT对有CRC个人或家族史患者CRC或AN诊断准确性的诊断研究。
两位作者（A.K.和P.P.）独立提取数据，并使用诊断准确性研究质量评估-2工具评估研究质量，通过GRADE（推荐分级评估、制定和评价）评估证据体质量。采用分层模型合成现有证据。
主要结局为FIT检测CRC或AN的诊断性能。
我们纳入了12项研究（6204名参与者）。7项研究被认为存在高或不明确的偏倚风险。FIT对CRC的平均敏感性为93%（95%CI，53%-99%），平均特异性为91%（95%CI，89%-92%），阳性似然比（LR+）为10.30（CI 7.7-13.9），阴性似然比（LR-）为0.08（95%CI，0.01-0.75）（GRADE：极低）。FIT对AN的平均敏感性为48%（95%CI，39%-57%）；平均特异性为93%（95%CI，91%-94%），LR+为6.55（95%CI，5.0-8.5），LR-为0.57（95%CI，0.48-0.67）（GRADE：极低）。亚组分析表明，粪便中FIT临界值在15至25μg/g之间对CRC诊断的敏感性和特异性组合最佳（分别为93%和94%）。定量和单样本FIT显示出足够的检测性能，但关于其他FIT品牌和多个样本的数据不足。
对于个人或家族风险高于平均水平的患者，FIT对CRC总体诊断准确性高，但对AN诊断准确性中等。异质性和宽泛的置信区间限制了我们研究结果的可信度。
