Abstract:Accurate assessment of disease severity from endoscopy videos in ulcerative colitis (UC) is crucial for evaluating drug efficacy in clinical trials. Severity is often measured by the Mayo Endoscopic Subscore (MES) and Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score. However, expert MES/UCEIS annotation is time-consuming and susceptible to inter-rater variability, factors addressable by automation. Automation attempts with frame-level labels face challenges in fully-supervised solutions due to the prevalence of video-level labels in clinical trials. CNN-based weakly-supervised models (WSL) with end-to-end (e2e) training lack generalization to new disease scores and ignore spatio-temporal information crucial for accurate scoring. To address these limitations, we propose "Arges", a deep learning framework that utilizes a transformer with positional encoding to incorporate spatio-temporal information from frame features to estimate disease severity scores in endoscopy video. Extracted features are derived from a foundation model (ArgesFM), pre-trained on a large diverse dataset from multiple clinical trials (61M frames, 3927 videos). We evaluate four UC disease severity scores, including MES and three UCEIS component scores. Test set evaluation indicates significant improvements, with F1 scores increasing by 4.1% for MES and 18.8%, 6.6%, 3.8% for the three UCEIS component scores compared to state-of-the-art methods. Prospective validation on previously unseen clinical trial data further demonstrates the model's successful generalization.
Abstract:Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by relapsing inflammation of the large intestine. The severity of UC is often represented by the Mayo Endoscopic Subscore (MES) which quantifies mucosal disease activity from endoscopy videos. In clinical trials, an endoscopy video is assigned an MES based upon the most severe disease activity observed in the video. For this reason, severe inflammation spread throughout the colon will receive the same MES as an otherwise healthy colon with severe inflammation restricted to a small, localized segment. Therefore, the extent of disease activity throughout the large intestine, and overall response to treatment, may not be completely captured by the MES. In this work, we aim to automatically estimate UC severity for each frame in an endoscopy video to provide a higher resolution assessment of disease activity throughout the colon. Because annotating severity at the frame-level is expensive, labor-intensive, and highly subjective, we propose a novel weakly supervised, ordinal classification method to estimate frame severity from video MES labels alone. Using clinical trial data, we first achieved 0.92 and 0.90 AUC for predicting mucosal healing and remission of UC, respectively. Then, for severity estimation, we demonstrate that our models achieve substantial Cohen's Kappa agreement with ground truth MES labels, comparable to the inter-rater agreement of expert clinicians. These findings indicate that our framework could serve as a foundation for novel clinical endpoints, based on a more localized scoring system, to better evaluate UC drug efficacy in clinical trials.