Abstract Background Smartphone applications that use artificial intelligence (AI) for skin cancer diagnosis may assist in early detection. However, prospective studies assessing real-world performance remain scarce. Objectives This independent prospective study evaluated the diagnostic accuracy of a widely used skin cancer detection application and the effect of photographic conditions in a user-representative cohort of patients consulting for lesions of concern. Methods Between 1 February 2021 and 30 June 2023, participants presenting at an early-access consultation with a lesion of concern were consecutively enrolled. Following dermatological assessment, each lesion was photographed using the application. The application’s convolutional neural network (CNN) generates a binary risk output and advice. A teledermatology review was performed in a subset of cases. The diagnostic accuracy of the CNN combined with teledermatology review was compared with final clinical or histopathological diagnosis. Performance was tested under different photographic conditions (angle, lighting, user) and smartphone models. Results A total of 1,458 participants with 1,904 lesions of concern were included. Of these, 185 (9.7%) were skin cancers, with 32 melanomas. Image capture was unsuccessful in 16.6% of lesions (317/1,904) despite optimal conditions. For successfully captured lesions, the CNN reached a sensitivity of 82.5% and specificity of 76.8% for skin cancer detection. In-application teledermatology review was available for 65.7% of images. Combined CNN and teledermatology review resulted in increased specificity (86.8%(p 0.001)) with a sensitivity of 75.3%. Overall sensitivity in melanocytic lesions was lower than in non-melanocytic lesions (71% versus 76.3%, p 0.001), whereas specificity was higher (90% versus 84.9%, p 0.001). A substudy demonstrated low image-capture success in user hands (28.9%) and variation in diagnostic performance between smartphone models. Conclusions This independent, prospective study evaluated diagnostic performance of a widely used application for skin cancer detection in a user-representative cohort. The findings highlight the importance of independent clinical validation of AI-based healthcare tools in real-world settings. Trial registration ClinicalTrials.gov NCT05246163
Kips et al. (Sun,) studied this question.