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COLOFIT:利用年龄、性别、粪便免疫化学检测和血液检测优化有症状患者结直肠癌诊断的模型开发及内部-外部验证

COLOFIT: Development and Internal-External Validation of Models Using Age, Sex, Faecal Immunochemical and Blood Tests to Optimise Diagnosis of Colorectal Cancer in Symptomatic Patients.

作者信息

Crooks C J, West J, Jones J, Hamilton W, Bailey S E R, Abel G, Banerjea A, Rees C J, Tamm A, Nicholson B D, Benton S C, Hunt N, Humes D J

机构信息

Gastrointestinal and Liver Theme, National Institute for Health Research (NIHR) Nottingham Biomedical Research Centre (BRC), Nottingham University Hospitals NHS Trust and the University of Nottingham, School of Medicine, Queen's Medical Centre, Nottingham, UK.

Translational Medical Sciences, School of Medicine, University of Nottingham, Nottingham, UK.

出版信息

Aliment Pharmacol Ther. 2025 Mar;61(5):852-864. doi: 10.1111/apt.18459. Epub 2025 Jan 7.

DOI:10.1111/apt.18459
PMID:39764729
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11825929/
Abstract

BACKGROUND

Colorectal cancer (CRC) is the third most common cancer in the United Kingdom and the second largest cause of cancer death.

AIM

To develop and validate a model using available information at the time of faecal immunochemical testing (FIT) in primary care to improve selection of symptomatic patients for CRC investigations.

METHODS

We included all adults (≥ 18 years) referred to Nottingham University Hospitals NHS Trust between 2018 and 2022 with symptoms of suspected CRC who had a FIT. Predicted 1-year CRC diagnosis were calculated, and externally validated, using Cox proportional hazards modelling with selected multiple fractional polynomial transformations for age, faecal haemoglobin concentration (f-Hb) value, mean corpuscular volume (MCV), platelet count and sex.

RESULTS

At a CRC risk threshold of 0.6% (equivalent to f-Hb = 10 μg Hb/g (μg/g)) overall performance of the validated model across age strata using Harrell's C index was ≥ 0.91% (overall C-statistic 93%, 95% CI 92%-95%) with acceptable calibration. Using this model yields similar numbers of detected and missed cancers, but requires ~20% fewer investigations than a f-Hb ≥ 10 μg/g strategy. For approximately 100,000 people per year with symptoms of suspected CRC, we predict it might save > 4500 colonoscopies with no evidence that more cancers would be missed if we used our model compared to using FIT f-Hb ≥ 10 μg/g.

CONCLUSIONS

Including age, sex, MCV, platelets and f-Hb in a survival analysis model to predict the risk of CRC yields greater diagnostic utility than a simple binary cut off f-Hb ≥ 10 μg/g.

摘要

背景

结直肠癌(CRC)是英国第三大常见癌症,也是癌症死亡的第二大原因。

目的

利用初级保健中粪便免疫化学检测(FIT)时的现有信息开发并验证一种模型,以改善有症状患者进行CRC检查的选择。

方法

我们纳入了2018年至2022年间转诊至诺丁汉大学医院国民保健服务信托基金的所有有疑似CRC症状且进行了FIT的成年人(≥18岁)。使用Cox比例风险模型并对年龄、粪便血红蛋白浓度(f-Hb)值、平均红细胞体积(MCV)、血小板计数和性别进行选定的多重分数多项式变换,计算并外部验证预测的1年CRC诊断率。

结果

在CRC风险阈值为0.6%(相当于f-Hb = 10μg Hb/g(μg/g))时,使用Harrell's C指数在各年龄层验证模型的总体性能≥0.91%(总体C统计量93%,95%CI 92%-95%),校准可接受。使用该模型检测到的癌症数量和漏诊的癌症数量相似,但与f-Hb≥10μg/g策略相比,所需检查减少约20%。对于每年约100,000名有疑似CRC症状的人,我们预测与使用FIT f-Hb≥10μg/g相比,使用我们的模型可能节省>4500次结肠镜检查,且没有证据表明会漏诊更多癌症。

结论

在生存分析模型中纳入年龄、性别、MCV、血小板和f-Hb来预测CRC风险,比简单的二元临界值f-Hb≥10μg/g具有更大的诊断效用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f1ff/11825929/8fa7bc54ad8b/APT-61-852-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f1ff/11825929/8fa7bc54ad8b/APT-61-852-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f1ff/11825929/8fa7bc54ad8b/APT-61-852-g001.jpg

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