Optical Diagnostic Devices For Evaluating Skin Lesions Suspected Of Malignancy

There is interest in noninvasive devices that will improve the diagnosis of malignant skin lesions. One technique is dermatoscopy (dermoscopy, epiluminescence microscopy, in vivo cutaneous microscopy), which enables the clinician to perform direct microscopic examination of diagnostic features in pigmented skin lesions. Another approach is computer-based light imaging systems. These techniques have the potential to improve diagnostic accuracy for suspicious skin lesions and may increase the detection rate of malignant skin lesions and/or reduce the rate of unnecessary biopsies. The evidence for dermatoscopy in patients who have lesions suspicious of melanoma includes a number of diagnostic accuracy studies and several meta-analyses. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The literature suggests that dermatoscopy is more accurate than naked eye examination when used in the expert clinical setting. The available evidence from prospective randomized controlled trials (RCTs) and other studies suggests that dermatoscopy used by specialists may lead to a decrease in the number of benign lesions excised and, when used by primary care physicians, may lead to fewer benign lesions being referred to specialists. The number of studies on the impact of dermatoscopy on patient management and clinical outcomes remains limited. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for computer-based optical diagnostic devices in patients who have lesions suspicious of melanoma includes several prospective diagnostic accuracy studies and a simulation study. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. In the diagnostic accuracy study, 10% of samples were not evaluable and the simulation study had a number of potential biases. There are no studies comparing patient management decisions and health outcomes with and without these devices. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for dermatoscopy in patients who have pigmented lesions being monitored for suspicious changes consists of noncomparative studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The available does not clearly indicate that dermatoscopy results in better patient management decisions. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for computer-based optical diagnostic device in patients who have pigmented lesions being monitored for suspicious changes includes no published studies. Relevant outcomes are overall survival, disease-specific survival, test accuracy, and change in disease status. The evidence is insufficient to determine the effects of the technology on health outcomes. The evidence for dermatoscopy and computer-based optical diagnostic devices in patients who have cancerous skin lesions referred for surgery includes 1 RCT and several observational studies. Relevant outcomes are overall survival, disease-specific survival, and treatment-related morbidity. The single RCT did not report superior outcomes using dermatoscopy compared with visual inspection or curettage. The published studies were all conducted outside of the United States and at least 2 did not use U.S. Food and Drug Administration‒approved devices. None addressed computer-based optical devices. The evidence is insufficient to determine the effects of the technology on health outcomes.