Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays - LungAnalysis (LuAna): LuAna Stepped Wedge Trial

What this Trial Is About

Researchers are evaluating the use of artificial intelligence (AI) as a tool to support doctors in detecting abnormalities on chest X-rays of adults with respiratory complaints. This trial compares AI-supported diagnosis to diagnosis made by doctors alone, aiming to see if AI increases the rate of finding relevant lung issues. The study follows a cluster-randomized stepped wedge design and seeks to validate the AI tool, called LuAna, across a diverse public health population to improve diagnostic accuracy and healthcare efficiency. The trial uses the LuAna app, which provides feedback on lung findings after chest X-ray images are included in the system. The study involves multiple centers where chest X-rays taken during respiratory symptoms or follow-up are analyzed with and without AI support. The AI tool is applied to images from any X-ray machine that include at least one frontal chest view. The trial excludes certain chest X-rays like those related to trauma or technical limitations. Participants will have their chest X-rays reviewed with the assistance of the LuAna app to identify findings such as consolidation, lung injury, pleural effusion, pneumothorax, cardiomegaly, and lung edema. Researchers will measure the detection rate of these findings over about one year. The study includes ongoing monitoring of image quality and diagnostic feedback, aiming to enhance the safety and confidence of doctors while potentially reducing diagnostic errors. The overall participation period aligns with the study timeline, ending in December 2026.

Evaluation of the Efficacy of Diagnostic Support Algorithms in Chest X-rays- LuAna Trial