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

ABSTRACT Background Artificial intelligence (AI)-based mobile health (mHealth) smartphone apps for skin cancer detection are increasingly available to the general population, but their impact on care is unclear. Methods The SPOT study is an investigator-initiated and -designed, unblinded, randomized controlled trial. Participants from a Dutch non-profit health insurance living in and around region Rotterdam the Netherlands, were recruited between August and December 2021. Participants were randomly assigned (3:2) to either free access to an AI-based mHealth app for skin cancer risk detection or care-as-usual. The primary endpoint was the difference in healthcare consumption for (pre)malignant and benign skin lesions at 12-months follow-up in the intention-to-treat population. Secondary endpoints included differences in the proportion of surgical interventions, overall use of dermatological care, and costs. Findings Among the 19,009 participants, the incidence of claims for (pre)malignant skin lesions was 2·8-fold higher than among non-responders. Within the group of study participants, the skin cancer incidence was higher among the intervention group compared to the control group at 12 months follow-up (2·7% (n=305) vs. 2·3% (n=171); risk difference (RD) 0·4% (95% confidence interval (CI) -0·07 to 0·85), p = 0·10), though this difference was not statistically significant. Furthermore, participants in the intervention group had significantly more claims for benign skin lesions (3·9% (n=443) vs. 2·6% (n=198), RD 1·3 (95% CI 0·7 to 1·7), p < 0·001), underwent more surgical interventions, and had higher mean costs per participant (€63 (95% CI 58 to -67), vs. €47 (41 to -52); p