Jahn, Anna Sophie, Navarini, Alexander Andreas, Cerminara, Sara Elisa, Kostner, Lisa, Huber, Stephanie Marie, Kunz, Michael; https://orcid.org/0000-0003-4783-5155, Maul, Julia-Tatjana; https://orcid.org/0000-0002-9914-1545, Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, Sommer, Seraina, Neuner, Anja Dominique, Levesque, Mitchell Paul; https://orcid.org/0000-0001-5902-9420, Cheng, Phil Fang; https://orcid.org/0000-0003-2940-006X, Maul, Lara Valeska; https://orcid.org/0000-0001-9202-0073, Jahn, Anna Sophie, Navarini, Alexander Andreas, Cerminara, Sara Elisa, Kostner, Lisa, Huber, Stephanie Marie, Kunz, Michael; https://orcid.org/0000-0003-4783-5155, Maul, Julia-Tatjana; https://orcid.org/0000-0002-9914-1545, Dummer, Reinhard; https://orcid.org/0000-0002-2279-6906, Sommer, Seraina, Neuner, Anja Dominique, Levesque, Mitchell Paul; https://orcid.org/0000-0001-5902-9420, Cheng, Phil Fang; https://orcid.org/0000-0003-2940-006X, and Maul, Lara Valeska; https://orcid.org/0000-0001-9202-0073
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 preferr