S1791 Validating Calibration of an Artificial Intelligence Assessment of Endoscopic Severity in Ulcerative Colitis

Abstract

Introduction: Regulatory guidance recommends the endoscopy subscore as the index to assess the endoscopic component of the primary endpoint in ulcerative colitis (UC) trials. Inter-reader variability in assessments may impact the reliability of trial results. Currently, there is no metric in place to assess the certainty by which a reader is assigning an endoscopy subscore. Machine learning (ML) provides an opportunity to assess the endoscopy subscore and provide a measurement of its certainty in a standardized manner. Artificial Intelligence Assessment of Endoscopic Severity (AI-ES) accurately assesses the endoscopy subscore. The objective of this study is to evaluate the calibration of AI-ES - how well its predicted probabilities reflect true likelihoods - to assess the reliability of its measurement of certainty in endoscopy subscore assessments in UC trials. Methods: AI-ES is a deep learning algorithm that assesses the endoscopy subscore in UC endoscopic videos. AI-ES measures probability for the 4 ordinal endoscopy subscore classes. The endoscopy subscore with the highest probability is assigned as the final score by AI-ES. We assessed calibration on a holdout test set of 639 videos (∼25%) from the Phase 3 induction trial for mirikizumab in UC (NCT03518086). Videos had a 2 + 1 centrally read endoscopy subscore, randomly selected from week 0 and 12 with a distribution of endoscopic severity similar to the overall study population. Calibration plots were generated across endoscopy subscore classes with probabilities grouped into septiles (∼100 videos per group) for primary analysis and deciles for confirmation. Brier scores, ranging from 0 (perfect calibration) to 1 (worst calibration), were calculated, with values <0.25 considered informative. Results: AI-ES demonstrated strong calibration, with Brier scores below <0.25 for each endoscopy subscore (0: 0.037, 1: 0.082, 2: 0.162, 3: 0.112). The Brier score for evaluation of endoscopic improvement (0,1 vs 2,3) also showed excellent calibration (0.066). Findings were consistent when assessing probabilities by deciles. Conclusion: Whereas data on the certainty of human readers in endoscopy subscore assessments are elusive, AI-ES is calibrated across all endoscopy subscore classes, providing reliable data on score probabilities. This novel measurement of certainty by AI-ES added to the score assessment may enable novel AI-based multi-reader or consensus workflows in trials, potentially improving the reliability of UC endpoint assessments.

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