Clinical trial design
CAD, lung volume deterioration
CAD
To test H2, we used the AI-PROBE-2 protocol with The clinical trial took place at HOSP-TM, between 21 February 2022 and 15 March 2022., where physicians were already using Rayscape, a commercial CAD system for COVID-19 volumetric quantification. The Rayscape CAD system is an existing medical device that complies with the European Economic Area regulations, it adheres to the quality management standard ISO 13485 and has obtained the CE mark. For the entire period of the study, Rayscape version v2-1.286-1.415-2.262, launched in January 2022, was used, which showed the AI analysis in the form of coloured delineated volumes along with a percentage of total lung volume deterioration, similar to standard clinical practice at the hospital. The AI analysed all CT studies in real-time and sent the analysis to the PACS. Half of the studies received the AI analysis, and the other half received the disclaimer. Aside from the disclaimer message of lacking the AI assistance in the controls during the development of the study, the radiologists did not receive any other instructions.The allocation process was performed programmatically, in real-time, by Rayscape’s Dicom Server using the default pseudorandom number generator of Python 3.8