Development and Validation of a Traditional Chinese Medicine Constitution-Based Risk Score for Advanced Colorectal Neoplasia in Asymptomatic Chinese Adults

Objective: The objective of this study was to develop and validate an innovative risk-stratification tool that integrates Traditional Chinese Medicine (TCM) constitution with clinical factors to enhance colorectal cancer (CRC) screening among asymptomatic Chinese adults. Methods: Conducted as a multicenter investigation, the study involved the randomization of 1430 asymptomatic participants into a derivation cohort (n=953) for model development and a validation cohort (n=477). Data on demographics, TCM constitution, and colonoscopy results were gathered using the TCM-Asia-Pacific Colorectal Screening (TCM-APCS) Questionnaire. A risk score was constructed through multivariable logistic regression analysis and its performance was assessed using receiver operating characteristic (ROC) analysis. Results: The TCM-APCS model proficiently stratified participants into low-, medium-, and high-risk categories. Among individuals classified within the high-risk group, there was a significantly elevated prevalence of both low-grade adenoma (44.1% compared to 7.3%, p< 0.001) and advanced colorectal neoplasia (17.2% compared to 3.6%, p< 0.001) when contrasted with the low-risk group. The model demonstrated strong discriminatory capability for advanced neoplasia, exhibiting enhanced predictive performance relative to the original Asia-Pacific CRC Screening score. Additionally, at the optimal threshold, the model accurately identified 71.1% of advanced neoplasia cases within the validation cohort. Conclusion: The TCM-APCS score is an effective, validated tool for risk-stratified CRC screening in China, enabling targeted resource allocation and enhanced screening efficiency in resource-constrained settings. Further external validation in diverse populations is warranted. Keywords: traditional Chinese medicine constitution, risk stratification model, colorectal cancer screening, asymptomatic subjects