Incremental Value of Traditional Chinese Medicine Features in Two-Stage Pre-Endoscopic Prediction

Background and rationale. Colonoscopy remains essential for diagnosing ulcerative colitis (UC) and related colorectal inflammatory or neoplastic conditions, but pre-endoscopic risk stratification may help prioritize evaluation. Machine-learning models based on Western clinical and laboratory variables have been developed for sequential triage. Whether structured TCM features provide incremental value beyond a Western-only strategy is less clear and is the focus of this record (TCM-PREDICT).

Study design. Multicenter, observational, retrospective diagnostic modeling study with model development and external validation. No investigational drug, device, or care pathway is assigned by the protocol.

Modeling framework.

Two parallel strategies share the same two-stage prediction structure and are compared using matched algorithm indices where applicable:

Western-only strategy: candidate predictors limited to Western demographic, clinical, and laboratory variables.

TCM-integrated strategy: Western variables plus rule-structured TCM features collected in routine integrative practice.

Stage 1 addresses separation of a lower-risk / functional-predominant pathway from an inflammatory-neoplastic pathway.

Stage 2 addresses separation of UC from other inflammatory or neoplastic conditions within the higher-risk pathway.

Analysis overview (high level). Primary emphasis is strategy-level incremental value (TCM-integrated versus Western-only), summarized across internal validation, external validation, and decision-curve analysis. Feature-level interpretation for the TCM-integrated models (e.g., SHAP-based importance of TCM variables) is secondary and explanatory. Subgroup summaries (e.g., by center or age band) may be reported descriptively.

Data and participants. De-identified clinical records from participating centers are used under institutional approvals. Eligibility, sample size, outcomes, and calendar dates are specified in the corresponding registry fields and should not be repeated here at length.

Patient care implications. Findings are intended for research on pre-endoscopic prediction and triage. Models are not a substitute for endoscopy or clinical decision-making.

Inclusion criteria

Adults aged 18 years or older Patients evaluated in participating centers with clinical records suitable for pre-endoscopic risk assessment related to colorectal inflammatory or functional bowel conditions Underwent colonoscopy (or had a colonoscopy-confirmed final diagnosis) allowing assignment to the study diagnostic labels used in the two-stage framework Stage 1-eligible diagnoses classifiable as either a functional-predominant pathway (e.g., irritable bowel syndrome / related functional presentations as defined in the protocol) or an inflammatory-neoplastic pathway (ulcerative colitis, Crohn disease, indeterminate colitis, or colorectal neoplasia as defined in the protocol) For Stage 2 analyses: patients within the inflammatory-neoplastic pathway classifiable as ulcerative colitis versus other inflammatory or neoplastic conditions (Crohn disease, indeterminate colitis, or colorectal neoplasia) Availability of required Western clinical and laboratory predictors for model development or validation For TCM-integrated analyses: availability of protocol-defined structured Traditional Chinese Medicine (TCM) features Ability to assign the record to the development cohort or an independent external-validation cohort according to the protocol center rules

Exclusion criteria

Age younger than 18 years Missing or unverifiable final diagnostic label required for Stage 1 and/or Stage 2 Missing key predictors required by the Western-only and/or TCM-integrated modeling pipelines (per protocol variable lists) Diagnosis outside the predefined Stage 1 / Stage 2 label sets and not mappable under protocol rules Duplicate or overlapping records for the same patient encounter after de-duplication Records excluded by pre-specified data-quality or center-specific protocol rules (e.g., incomplete critical clinical documentation)