Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients.
Development and external validation of a faecal immunochemical test-based prediction model for colorectal cancer detection in symptomatic patients.
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DOI：
10.1186/s12916-016-0668-5
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发表时间：
2016-08-31
期刊：
影响因子：
9.3
通讯作者：
COLONPREDICT study investigators
中科院分区：
文献类型：
--
作者：
Cubiella J;Vega P;Salve M;Díaz-Ondina M;Alves MT;Quintero E;Álvarez-Sánchez V;Fernández-Bañares F;Boadas J;Campo R;Bujanda L;Clofent J;Ferrandez Á;Torrealba L;Piñol V;Rodríguez-Alcalde D;Hernández V;Fernández-Seara J;COLONPREDICT study investigators
基于现有生物标志物的结直肠癌风险预测模型可提高结直肠癌的诊断率。我们的目的是开发一个基于临床和实验室变量的结直肠癌预测模型COLONPREDICT，并与NICE转诊标准进行比较，并进行外部验证。这项前瞻性横断面研究包括衍生队列中2012年3月至2013年9月和验证队列中2014年3月至2015年3月期间连续接受结肠镜检查的胃肠道症状患者。在派生队列中，我们评估了症状和NICE转诊标准，并在进行肛门直肠检查和结肠镜检查之前测定了粪便血红蛋白和钙保护素、血液血红蛋白和血清癌胚抗原的水平。用多因素Logistic回归分析建立以结直肠癌检出为主要结果的诊断准确率模型。我们纳入了派生队列中的1572名患者和验证队列中的1481名患者，其CRC患病率分别为13.6%和9.1%。最终的预测模型包括11个变量：年龄(年)(优势比[OR]1.04，95%可信区间[CI]1.02~1.06)，男性(OR 2.2，95%CI 1.5~3.4)，粪便血红蛋白≥20μg/g(OR 17.0，95%CI 10.0~28.6)，血血红蛋白和Lt；10 ng/dL(OR4.8，95%CI 2.2-10.3)，血中血红蛋白10-12 ng/dL(OR 1.8，95%CI 1.1-3.0)，癌胚抗原≥3 ng/mL(OR 4.5，95%CI 3.0-6.8)，乙酰水杨酸治疗(OR 0.4，95%CI 0.2-0.7)，既往结肠镜检查(OR 0.1，95%CI 0.06-0.2)，直肠肿块(OR 14.8，95%CI 5.3~41.0)、肛门直肠良性病变(OR 0.3，95%CI 0.2~0.4)、直肠出血(OR 2.2，95%CI 1.4~3.4)、排便习惯改变(OR 1.7，95%CI 1.1~2.5)。曲线下面积(AUC)为0.92(95%可信区间0.91~0.94)，高于NICE推荐标准(AUC0.59，95%可信区间0.55~0.63；p <； 0.001)。根据敏感度分别为90%(5.6)和99%(3.5)的阈值，我们将派生队列分为三个风险组：高(队列的30.9%，阳性预测值[PPV]40.7%，95%CI 36.7-45.9%)，中等(29.5%，PPV 4.4%，95%CI 2.8-6.8%)和低(39.5%，PPV 0.2%，95%CI 0.0-1.1%)。在验证队列中，判别能力相同(AUC0.92，95%可信区间0.90-0.94；p = 0.7)。COLONPREDICT是一种用于CRC检测的高精度预测模型。本文的在线版本(doi：10.1186/s12916-0160668-5)包含补充材料，授权用户可以使用。
Risk prediction models for colorectal cancer (CRC) detection in symptomatic patients based on available biomarkers may improve CRC diagnosis. Our aim was to develop, compare with the NICE referral criteria and externally validate a CRC prediction model, COLONPREDICT, based on clinical and laboratory variables. This prospective cross-sectional study included consecutive patients with gastrointestinal symptoms referred for colonoscopy between March 2012 and September 2013 in a derivation cohort and between March 2014 and March 2015 in a validation cohort. In the derivation cohort, we assessed symptoms and the NICE referral criteria, and determined levels of faecal haemoglobin and calprotectin, blood haemoglobin, and serum carcinoembryonic antigen before performing an anorectal examination and a colonoscopy. A multivariate logistic regression analysis was used to develop the model with diagnostic accuracy with CRC detection as the main outcome. We included 1572 patients in the derivation cohort and 1481 in the validation cohorts, with a 13.6 % and 9.1 % CRC prevalence respectively. The final prediction model included 11 variables: age (years) (odds ratio [OR] 1.04, 95 % confidence interval [CI] 1.02–1.06), male gender (OR 2.2, 95 % CI 1.5–3.4), faecal haemoglobin ≥20 μg/g (OR 17.0, 95 % CI 10.0–28.6), blood haemoglobin <10 g/dL (OR 4.8, 95 % CI 2.2–10.3), blood haemoglobin 10–12 g/dL (OR 1.8, 95 % CI 1.1–3.0), carcinoembryonic antigen ≥3 ng/mL (OR 4.5, 95 % CI 3.0–6.8), acetylsalicylic acid treatment (OR 0.4, 95 % CI 0.2–0.7), previous colonoscopy (OR 0.1, 95 % CI 0.06–0.2), rectal mass (OR 14.8, 95 % CI 5.3–41.0), benign anorectal lesion (OR 0.3, 95 % CI 0.2–0.4), rectal bleeding (OR 2.2, 95 % CI 1.4–3.4) and change in bowel habit (OR 1.7, 95 % CI 1.1–2.5). The area under the curve (AUC) was 0.92 (95 % CI 0.91–0.94), higher than the NICE referral criteria (AUC 0.59, 95 % CI 0.55–0.63; p < 0.001). On the basis of the thresholds with 90 % (5.6) and 99 % (3.5) sensitivity, we divided the derivation cohort into three risk groups for CRC detection: high (30.9 % of the cohort, positive predictive value [PPV] 40.7 %, 95 % CI 36.7–45.9 %), intermediate (29.5 %, PPV 4.4 %, 95 % CI 2.8–6.8 %) and low (39.5 %, PPV 0.2 %, 95 % CI 0.0–1.1 %). The discriminatory ability was equivalent in the validation cohort (AUC 0.92, 95 % CI 0.90–0.94; p = 0.7). COLONPREDICT is a highly accurate prediction model for CRC detection. The online version of this article (doi:10.1186/s12916-016-0668-5) contains supplementary material, which is available to authorized users.
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DOI：
10.1056/nejmoa1301969
发表时间：
2013-09-19
期刊：
The New England journal of medicine
影响因子：
--
作者：
Nishihara R;Wu K;Lochhead P;Morikawa T;Liao X;Qian ZR;Inamura K;Kim SA;Kuchiba A;Yamauchi M;Imamura Y;Willett WC;Rosner BA;Fuchs CS;Giovannucci E;Ogino S;Chan AT
通讯作者：
Chan AT
影响因子：
2.4
作者：
Williams TG;Cubiella J;Griffin SJ;Walter FM;Usher-Smith JA
通讯作者：
Usher-Smith JA
影响因子：
9.3
作者：
Atkin, W. S.;Valori, R.;Pox, C.
通讯作者：
Pox, C.
影响因子：
168.9
作者：
Lozano, Rafael;Naghavi, Mohsen;Murray, Christopher J. L.
通讯作者：
Murray, Christopher J. L.
影响因子：
7.7
作者：
Rex, Douglas K.;Schoenfeld, Philip S.;Weinberg, David S.
通讯作者：
Weinberg, David S.