Westwood Marie, Lang Shona, Armstrong Nigel, van Turenhout Sietze, Cubiella Joaquín, Stirk Lisa, Ramos Isaac Corro, Luyendijk Marianne, Zaim Remziye, Kleijnen Jos, Fraser Callum G
Kleijnen Systematic Reviews Ltd, Unit 6, Escrick Business Park, Riccall Road, Escrick, York, YO19 6FD, UK.
University Medical Centre, De Boelelaan 1117, 1081HV, Amsterdam, Netherlands.
BMC Med. 2017 Oct 24;15(1):189. doi: 10.1186/s12916-017-0944-z.
This study has attempted to assess the effectiveness of quantitative faecal immunochemical tests (FIT) for triage of people presenting with lower abdominal symptoms, where a referral to secondary care for investigation of suspected colorectal cancer (CRC) is being considered, particularly when the 2-week criteria are not met.
We conducted a systematic review following published guidelines for systematic reviews of diagnostic tests. Twenty-one resources were searched up until March 2016. Summary estimates were calculated using a bivariate model or a random-effects logistic regression model.
Nine studies are included in this review. One additional study, included in our systematic review, was provided as 'academic in confidence' and cannot be described herein. When FIT was based on a single faecal sample and a cut-off of 10 μg Hb/g faeces, sensitivity estimates indicated that a negative result using either the OC-Sensor or HM-JACKarc may be adequate to rule out nearly all CRC; the summary estimate of sensitivity for the OC-Sensor was 92.1% (95% confidence interval, CI 86.9-95.3%), based on four studies (n = 4091 participants, 176 with CRC), and the only study of HM-JACKarc to assess the 10 μg Hb/g faeces cut-off (n = 507 participants, 11 with CRC) reported a sensitivity of 100% (95% CI 71.5-100%). The corresponding specificity estimates were 85.8% (95% CI 78.3-91.0%) and 76.6% (95% CI 72.6-80.3%), respectively. When the diagnostic criterion was changed to include lower grades of neoplasia, i.e. the target condition included higher risk adenoma (HRA) as well as CRC, the rule-out performance of both FIT assays was reduced.
There is evidence to suggest that triage using FIT at a cut-off around 10 μg Hb/g faeces has the potential to correctly rule out CRC and avoid colonoscopy in 75-80% of symptomatic patients.
PROSPERO 42016037723.
本研究旨在评估定量粪便免疫化学检测（FIT）对出现下腹部症状患者进行分流的有效性，这些患者正考虑因疑似结直肠癌（CRC）而转诊至二级医疗机构进行检查，特别是在未满足两周标准的情况下。
我们按照已发表的诊断试验系统评价指南进行了一项系统评价。截至2016年3月，检索了21种资源。使用双变量模型或随机效应逻辑回归模型计算汇总估计值。
本评价纳入了9项研究。我们的系统评价中纳入的另一项研究作为“学术保密”提供，在此无法描述。当FIT基于单个粪便样本且临界值为10μg血红蛋白/克粪便时，敏感性估计表明，使用OC-Sensor或HM-JACKarc检测得到的阴性结果可能足以排除几乎所有的CRC；基于四项研究（n = 4091名参与者，176例CRC患者），OC-Sensor敏感性的汇总估计值为92.1%（95%置信区间，CI 86.9 - 95.3%），唯一一项评估10μg血红蛋白/克粪便临界值的HM-JACKarc研究（n = 507名参与者，11例CRC患者）报告的敏感性为100%（95%CI 71.5 - 100%）。相应的特异性估计值分别为85.8%（95%CI 78.3 - 91.0%）和76.6%（95%CI 72.6 - 80.3%）。当诊断标准改变为包括较低级别的肿瘤，即目标疾病包括高级别腺瘤（HRA）以及CRC时，两种FIT检测的排除性能均降低。
有证据表明，使用临界值约为10μg血红蛋白/克粪便的FIT进行分流，有可能在75 - 80%的有症状患者中正确排除CRC并避免结肠镜检查。
PROSPERO 42016037723
