This study evaluates the impact of a novel computer-aided prognostic prediction tool for colorectal liver metastases (CRLM) on clinician performance. Colorectal cancer is a leading cause of cancer-related mortality worldwide, with 20-30% of patients presenting synchronous liver metastases, which are associated with poor prognosis and high postoperative recurrence rates. Simultaneous resection of primary tumor and liver metastases is a preferred treatment for selected patients but outcomes vary significantly. The latest web-based tool uses Random Forest models integrating demographic, clinical, laboratory, and genetic data to predict postoperative recurrence and mortality specifically for CRLM patients undergoing simultaneous resection. This multiple-reader, multiple-case (MRMC) study will assess 12 physicians who will predict 1-, 3-, and 5-year recurrence and mortality risks in 166 retrospective cases, with and without the tool's aid, separated by a washout period. The primary focus is to determine whether the tool improves prediction accuracy for 3-year postoperative mortality, measured by AUC-ROC. Secondary and exploratory endpoints include other time points, sensitivity, specificity, inter-rater reliability, decision-making confidence, and evaluation time. By enabling individualized risk assessment, this tool aims to support optimized clinical decision-making and tailored treatment strategies for CRLM patients undergoing simultaneous resection.
≥ 18 years old
confirmation of histologically diagnosed liver metastases of colorectal adenocarcinoma
receiving colorectal resection with simultaneous liver resection.
presence of other malignancies
absence of follow-up data
patients who were followed up postoperatively for less than 5 years and had no occurrences of death.
This reader study involves 12 physicians (4 junior, 4 mid-level, 4 senior) from the Surgical Oncology Department of the Digestive Tract. All readers will receive standardized training on accessing patient data through the medical record system and completing the questionnaire. The study includes 166 colorectal liver metastases (CRLM) patients who underwent simultaneous colorectal and liver resection. Inclusion criteria: age ≥18 years, histologically confirmed colorectal adenocarcinoma liver metastases, and simultaneous resection. Exclusion criteria: presence of other malignancies, lack of follow-up data, or postoperative follow-up less than 5 years without death occurrence.
Cohort
Prospective
Not listed
AUCs: Area Under the Receiver Operating Characteristic Curve (AUC-ROC)
The comparative accuracy of model aided versus unaided risk prediction of post-operative 3-year mortality assessed by readers. Under model aided condition, prediction model will estimate the overall survival (OS) rate at Year 3 for each individual patient. OS was defined as the time from the date of simultaneous resection to death due to any cause. Patients without death were censored at their last known alive date. The mortality data were retrospectively collected and the event status were known. Patients were followed up to approximately 120 months after simultaneous resection.
AUCs: Area Under the Receiver Operating Characteristic Curve (AUC-ROC)
The comparative accuracy of model aided versus unaided risk prediction of post-operative 1-year recurrence, 3-year recurrence, 5-year recurrence, 1-year mortality, and 5-year mortality made by readers. PFS was defined as the time from the date of simultaneous colorectal and liver resection to first documented disease progression or death due to any cause, whichever occurs first. Patients without PFS event were censored at their last assessment follow-up. OS was defined as the time from the date of simultaneous resection to death due to any cause. Patients without death were censored at their last known alive date. Patients were followed up to approximately 120 months after simultaneous resection.
Sensitivity: the ratio of true positives to total (actual) positives.
To evaluate aided versus unaided with respect to (improved) sensitivity for prediction of post-operative 1-year, 3-year, and 5-year recurrence and mortality made by readers.
Specificity: the ratio of true negatives to total (actual) negatives.
To evaluate aided versus unaided with respect to (improved) specificity for prediction of post-operative 1-year, 3-year, and 5-year recurrence and mortality made by readers.
Inter-rater reliability: the consistency of ratings made by readers on the cases
To evaluate aided versus unaided with respect to (improved) inter-rater reliability for rating on the likelihood of post-operative 1-year, 3-year, and 5-year recurrence and mortality made by readers.
Inter-rater reliability: the consistency of ratings made by readers on the cases
To evaluate aided versus unaided with respect to inter-rater reliability for readers' recommendation on initiating surgical treatment; To evaluate aided versus unaided with respect to inter-rater reliability for readers' recommendation on the timing of the first post-surgery follow-up.
Decision-making confidence: confidence of a reader in completing the evaluation for a case
To evaluate aided versus unaided with respect to (improve) decision-making confidence in predicting the disease progression and making recommendation for a case. The general confidence on prediction model in pre and post study will also be evaluated.
Decision-making time: duration of a reader in completing the evaluation for a case
To evaluate aided versus unaided with respect to (reduced) decision-making time in completing a case evaluation.
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