The impact of a SmartPhone applicatiOn for skin cancer risk assessmenT on the healthcare system (SPOT-study): A randomized controlled trial.

Background: Recently, deep learning algorithms have been integrated into smartphone applications that allow risk assessments of skin lesions to be performed at home by people in the general population. The SkinVision app (SVA) is a CE marked class 1 medical device that uses a machine learning algorithm to classify a skin lesion as low or high risk. Based on this classification, users can be advised to visit a doctor when the lesion is at high risk of skin cancer. The SVA is reimbursed by multiple healthcare insurances in Europe, including the Netherlands. Although previous studies have tested the accuracy of the SVA, the impact of smartphone-based skin cancer risk assessments on health care systems is unknown.

Objective: In this prospective randomized study, we will study the effects of the SVA on healthcare consumption in the Netherlands on a population-wide level.

Methods: In this randomized controlled trial, all customers (+/-200.000) of DSW aged >18 years will be invited to participate. After randomization, the intervention group will be offered to use the SVA at no extra costs for the duration of one year. After this year the control group will receive access to the SVA for the period of one year. Both groups will enter a passive follow-up for 2 years after the use of the SVA. Data will be collected on the incidence of (pre)malignant and benign skin lesions through Palga and on the incidence of claims from the DSW database.

Our hypothesis is that the incidence of skin cancer and (pre)malignant diagnosis and related healthcare claims will be higher in the intervention group compared to the control group, while the incidence for benign tumor related claims will be lower in the intervention group compared to the control group.

The first year of the study will be an active comparison phase in which the intervention group will have access to the SVA and the control group will receive the current standard of healthcare. One year after the start of the study the control group will also get access to the SVA for a year. Both groups will enter a passive follow-up phase after one year of using the SVA. In this period, data will be collected on the incidence of skin malignancies, benign skin lesions and pre-malignancies through Palga. Additionally data on claims will be collected from the database of DSW.

The intervention group will be offered to use the SkinVision app for free, for a duration of one year. After this year the control group will receive access to the SVA for the period of one year. Both groups will enter a passive follow-up for 2 years after the use of the SVA.