Clinical Evaluation of Medical Image Synthesis: A Case Study in Wireless Capsule Endoscopy

Sharing retrospectively acquired data is essential for both clinical research and training. Synthetic Data Generation (SDG), using Artificial Intelligence (AI) models, can overcome privacy barriers in sharing clinical data, enabling advancements in medical diagnostics. This study focuses on the clinical evaluation of medical SDG, with a proof-of-concept investigation on diagnosing Inflammatory Bowel Disease (IBD) using Wireless Capsule Endoscopy (WCE) images. The paper contributes by a) presenting a protocol for the systematic evaluation of synthetic images by medical experts and b) applying it to assess TIDE-II, a novel variational autoencoder-based model for high-resolution WCE image synthesis, with a comprehensive qualitative evaluation conducted by 10 international WCE specialists, focusing on image quality, diversity, realism, and clinical decision-making. The results show that TIDE-II generates clinically relevant WCE images, helping to address data scarcity and enhance diagnostic tools. The proposed protocol serves as a reference for future research on medical image-generation techniques.