Over-Detection of Melanoma-Suspect Lesions by a CE-Certified Smartphone App: Performance in Comparison to Dermatologists, 2D and 3D Convolutional Neural Networks in a Prospective Data Set of 1204 Pigmented Skin Lesions Involving Patients’ Perception

SIMPLE SUMMARY: Early detection and resection of cutaneous melanoma are crucial for a good prognosis. However, visual distinction of early melanomas from benign nevi remains challenging. New artificial intelligence-based approaches for risk stratification of pigmented skin lesions provide screening methods for laypersons with increasing use of smartphone applications (apps). Our study aims to prospectively investigate the diagnostic accuracy of a CE-certified smartphone app, SkinVision(®), in melanoma recognition. Based on classification into three different risk scores, the app provides a recommendation to consult a dermatologist. In addition, both patients’ and dermatologists’ perspectives towards AI-based mobile health apps were evaluated. We observed that the app classified a significantly higher number of lesions as high-risk than dermatologists, which would have led to a clinically harmful number of unnecessary excisions. The diagnostic performance of the app in dichotomous classification of 1204 pigmented skin lesions (risk classification for nevus vs. melanoma) remained below advertised rates with low sensitivity (41.3–83.3%) and specificity (60.0–82.9%). The confidence in the app was low among both patients and dermatologists, and no patient favored an assessment by the app alone. Although smartphone apps are a potential medium for increasing awareness of melanoma screening in the lay population, they should be evaluated for certification with prospective real-world evidence. ABSTRACT: The exponential increase in algorithm-based mobile health (mHealth) applications (apps) for melanoma screening is a reaction to a growing market. However, the performance of available apps remains to be investigated. In this prospective study, we investigated the diagnostic accuracy of a class 1 CE-certified smartphone app in melanoma risk stratification and its patient and dermatologist satisfaction. Pigmented skin lesions ≥ 3 mm and any suspicious smaller lesions were assessed by the smartphone app SkinVision(®) (SkinVision(®) B.V., Amsterdam, the Netherlands, App-Version 6.8.1), 2D FotoFinder ATBM(®) master (FotoFinder ATBM(®) Systems GmbH, Bad Birnbach, Germany, Version 3.3.1.0), 3D Vectra(®) WB360 (Canfield Scientific, Parsippany, NJ, USA, Version 4.7.1) total body photography (TBP) devices, and dermatologists. The high-risk score of the smartphone app was compared with the two gold standards: histological diagnosis, or if not available, the combination of dermatologists’, 2D and 3D risk assessments. A total of 1204 lesions among 114 patients (mean age 59 years; 51% females (55 patients at high-risk for developing a melanoma, 59 melanoma patients)) were included. The smartphone app’s sensitivity, specificity, and area under the receiver operating characteristics (AUROC) varied between 41.3–83.3%, 60.0–82.9%, and 0.62–0.72% according to two study-defined reference standards. Additionally, all patients and dermatologists completed a newly created questionnaire for preference and trust of screening type. The smartphone app was rated as trustworthy by 36% (20/55) of patients at high-risk for melanoma, 49% (29/59) of melanoma patients, and 8.8% (10/114) of dermatologists. Most of the patients rated the 2D TBP imaging (93% (51/55) resp. 88% (52/59)) and the 3D TBP imaging (91% (50/55) resp. 90% (53/59)) as trustworthy. A skin cancer screening by combination of dermatologist and smartphone app was favored by only 1.8% (1/55) resp. 3.4% (2/59) of the patients; no patient preferred an assessment by a smartphone app alone. The diagnostic accuracy in clinical practice was not as reliable as previously advertised and the satisfaction with smartphone apps for melanoma risk stratification was scarce. MHealth apps might be a potential medium to increase awareness for melanoma screening in the lay population, but healthcare professionals and users should be alerted to the potential harm of over-detection and poor performance. In conclusion, we suggest further robust evidence-based evaluation before including market-approved apps in self-examination for public health benefits.