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This study was registered at the German Clinical Trial Register (DRKS-Study-ID: DRKS00013570; https://www.drks.de/drks_web/).

The results of our study suggest that an elaborated follow-up schedule in cutaneous melanoma is suitable for the early detection of second primary melanomas and early recurrences. The intensity of clinical and technical examinations can be reduced during follow-up of patients in the primary tumor stages and may be intensified in locoregional disease. Recommendations for an effective follow-up strategy are outlined.

IMPORTANCE Deep learning convolutional neural networks (CNNs) have shown a performance at the level of dermatologists in the diagnosis of melanoma. Accordingly, further exploring the potential limitations of CNN technology before broadly applying it is of special interest. OBJECTIVE To investigate the association between gentian violet surgical skin markings in dermoscopic images and the diagnostic performance of a CNN approved for use as a medical device in the European market. DESIGN AND SETTING A cross-sectional analysis was conducted from August 1, 2018, to November 30, 2018, using a CNN architecture trained with more than 120 000 dermoscopic images of skin neoplasms and corresponding diagnoses. The association of gentian violet skin markings in dermoscopic images with the performance of the CNN was investigated in 3 image sets of 130 melanocytic lesions each (107 benign nevi, 23 melanomas). EXPOSURES The same lesions were sequentially imaged with and without the application of a gentian violet surgical skin marker and then evaluated by the CNN for their probability of being a melanoma. In addition, the markings were removed by manually cropping the dermoscopic images to focus on the melanocytic lesion. MAIN OUTCOMES AND MEASURES Sensitivity, specificity, and area under the curve (AUC) of the receiver operating characteristic (ROC) curve for the CNN's diagnostic classification in unmarked, marked, and cropped images. RESULTS In all, 130 melanocytic lesions (107 benign nevi and 23 melanomas) were imaged. In unmarked lesions, the CNN achieved a sensitivity of 95.7% (95% CI, 79%-99.2%) and a specificity of 84.1% (95% CI, 76.0%-89.8%). The ROC AUC was 0.969. In marked lesions, an increase in melanoma probability scores was observed that resulted in a sensitivity of 100% (95% CI, 85.7%-100%) and a significantly reduced specificity of 45.8% (95% CI, 36.7%-55.2%, P < .001). The ROC AUC was 0.922. Cropping images led to the highest sensitivity of 100% (95% CI, 85.7%-100%), specificity of 97.2% (95% CI, 92.1%-99.0%), and ROC AUC of 0.993. Heat maps created by vanilla gradient descent backpropagation indicated that the blue markings were associated with the increased false-positive rate. CONCLUSIONS AND RELEVANCE This study's findings suggest that skin markings significantly interfered with the CNN's correct diagnosis of nevi by increasing the melanoma probability scores and consequently the false-positive rate. A predominance of skin markings in melanoma training images may have induced the CNN's association of markings with a melanoma diagnosis. Accordingly, these findings suggest that skin markings should be avoided in dermoscopic images intended for analysis by a CNN. TRIAL REGISTRATION German Clinical Trial Register (DRKS) Identifier: DRKS00013570

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