Using Artificial Intelligence As a Diagnostic Decision Support Tool in Skin Disease: Protocol for an Observational Prospective Cohort Study

Background Dermatological conditions are a relevant health problem. Each person has an average of 1.6 skin diseases per year, and consultations for skin pathology represent 20% of the total annual visits to primary care and around 35% are referred to a dermatology specialist. Machine learning (ML) models can be a good tool to help primary care professionals, as it can analyze and optimize complex sets of data. In addition, ML models are increasingly being applied to dermatology as a diagnostic decision support tool using image analysis, especially for skin cancer detection and classification. Objective This study aims to perform a prospective validation of an image analysis ML model as a diagnostic decision support tool for the diagnosis of dermatological conditions. Methods In this prospective study, 100 consecutive patients who visit a participant general practitioner (GP) with a skin problem in central Catalonia were recruited. Data collection was planned to last 7 months. Anonymized pictures of skin diseases were taken and introduced to the ML model interface (capable of screening for 44 different skin diseases), which returned the top 5 diagnoses by probability. The same image was also sent as a teledermatology consultation following the current stablished workflow. The GP, ML model, and dermatologist’s assessments will be compared to calculate the precision, sensitivity, specificity, and accuracy of the ML model. The results will be represented globally and individually for each skin disease class using a confusion matrix and one-versus-all methodology. The time taken to make the diagnosis will also be taken into consideration. Results Patient recruitment began in June 2021 and lasted for 5 months. Currently, all patients have been recruited and the images have been shown to the GPs and dermatologists. The analysis of the results has already started. Conclusions This study will provide information about ML models’ effectiveness and limitations. External testing is essential for regulating these diagnostic systems to deploy ML models in a primary care practice setting.