Background:Colon capsule endoscopy (CCE) or panenteric capsule endoscopy (PCE) offers a promising, non-invasive diagnostic approach for patients with iron deficiency anaemia (IDA). However, high rates of conversion to conventional colonoscopy (CCC) following capsule procedures reduce cost-effectiveness and patient satisfaction. Optimising the faecal immunochemical test (FIT) threshold may improve patient stratification and reduce unnecessary conversions in future applications within the IDA diagnostic pathway.Methods:The CLEAR IDA study was a multicentre, retrospective observational study conducted across four UK hospitals. Data were collected over a six-month study period and included patients referred via the two-week-wait (2WW) cancer pathway for iron deficiency, with or without anaemia, over a 12-month timeframe. Colonoscopy findings were analysed and extrapolated using NHS England’s CCE-to-colonoscopy referral criteria to assess the predictive value of FIT for colorectal cancer (CRC), polyp burden, and CCC using ROC curve analysis. The optimal FIT threshold was identified through three complementary approaches: threshold-based analysis, decision curve analysis, and cost–benefit modelling.Results:A total of 1531 patients were analysed; only 1.6% underwent small bowel capsule endoscopy. The diagnostic accuracy (AUC) of FIT for predicting CRC, polypoidal lesions, and CCC was 0.78, 0.58, and 0.69, respectively. Threshold-based analysis identified FIT = 15 µg/g as the lowest level at which CCC rates significantly increased (p= 0.02; OR = 1.87; 95% CI: 1.07–3.14). Decision curve analysis showed a maximum net benefit at FIT = 17.6 µg/g, while cost–benefit modelling identified 9 µg/g as the most cost-effective. Raising the threshold to 10 µg/g resulted in a net loss of GBP –294.4 per patient. An optimal cost-effective FIT threshold range was identified between 10 and 17.6 µg/g. The threshold selection should be tailored to local service capacity and resource availability.Conclusions:While FIT alone is an imperfect triage tool, optimising thresholds between 10 and 17 µg/g may enhance cost-effectiveness and guide appropriate PCE use in IDA.
背景：结肠胶囊内镜（CCE）或全消化道胶囊内镜（PCE）为缺铁性贫血（IDA）患者提供了一种前景广阔的无创诊断方法。然而，胶囊检查后较高的传统结肠镜（CCC）转诊率降低了成本效益和患者满意度。优化粪便免疫化学检测（FIT）阈值可改善患者分层，减少未来在IDA诊断路径中不必要的转诊。 方法：CLEAR IDA研究是一项在英国四家医院开展的多中心回顾性观察研究。数据收集期为六个月，纳入通过两周紧急癌症转诊路径（2WW）转诊的缺铁伴或不伴贫血患者，时间跨度为12个月。通过分析结肠镜检查结果，并应用英国国家医疗服务体系（NHS England）的CCE转诊结肠镜标准，采用ROC曲线分析评估FIT对结直肠癌（CRC）、息肉负荷及CCC的预测价值。通过阈值分析、决策曲线分析和成本效益模型三种互补方法确定最佳FIT阈值。 结果：共分析1531例患者，仅1.6%接受了小肠胶囊内镜检查。FIT预测CRC、息肉样病变和CCC的诊断准确度（AUC）分别为0.78、0.58和0.69。阈值分析显示FIT=15 µg/g是CCC率显著升高的最低阈值（p=0.02；OR=1.87；95% CI：1.07–3.14）。决策曲线分析显示FIT=17.6 µg/g时净获益最大，而成本效益模型确定9 µg/g为最具成本效益的阈值。将阈值提高至10 µg/g会导致每例患者净损失294.4英镑。最终确定10–17.6 µg/g为最具成本效益的FIT阈值区间，具体阈值选择需根据当地服务能力和资源可用性进行调整。 结论：虽然FIT单独作为分诊工具并不完美，但将阈值优化至10–17 µg/g区间可提升成本效益，并指导IDA患者合理使用PCE。
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