Study outcomes
polyp, polyps, diminutive polyps, colorectal polyps, adenomas
HYPERPLASTIC POLYPS, SENSITIVITY, SECONDARY, COLORECTAL POLYPS, ADENOMAS
The primary outcome of the study was the comparison of accuracy in the optical diagnosis of diminutive colorectal polyps between the POLAR system and endoscopists (neoplastic [adenomas and SSLs] vs. non-neoplastic [hyperplastic polyps (HPPs)]) during the clinical validation (phase 2). Accuracy was defined as the percentage of correctly predicted optical diagnoses of the POLAR system or the endoscopists compared with the reference standard histopathology. For the calculation of the primary outcome, adenomas and SSLs were combined in the neoplastic category, and HPPs constituted the non-neoplastic category. There were multiple secondary outcomes in the study. 1) Sensitivity, specificity, negative predictive value (NPV), and positive predictive value [PPV] of the optical diagnosis of diminutive polyps were compared between the POLAR system and the endoscopists; different subgroup analyses were also performed (neoplastic vs. non-neoplastic and adenomas vs. SSL vs. HPPs). 2) Diagnostic accuracy was compared in a subgroup analysis for only high-confidence assessments. 3) The pooled NPV for neoplastic histology in the rectosigmoid and the surveillance interval agreement based on optical diagnosis of diminutive polyps with high confidence were compared between the POLAR system and endoscopists, respectively. Other secondary outcomes were the computation time of the POLAR system to diagnose a polyp, the number of images required for the POLAR system to diagnose a polyp, and the proportion of polyps in which POLAR was able to provide an optical diagnosis (i. e. success rate). Additional exploratory outcomes were: 1) the diagnostic accuracy of optical diagnosis of diminutive polyps if endoscopists were assisted by the POLAR system; 2) the evaluation of factors associated with accurate optical diagnosis of the POLAR system.