Enhancing Diagnostic Precision in Primary Care: A Multireader Multicase (MRMC) Study of an AI-Powered Handheld...

Skin cancer is the most common cancer faced by adults in the United States. Melanoma, while a less common subtype of skin cancer compared to basal cell and squamous cell carcinomas, is associated with greater rates of metastases, mortality, and morbidity, and its rate of incidence is projected to increase. Primary care physicians (PCPs) can play an important role in skin cancer detection and in the decision to refer a patient to a dermatologist. Technologies such as the elastic scattering spectroscopy (ESS) device (DermaSensor, Inc.), a handheld, noninvasive assistive tool, may help in the evaluation of a skin growth and improve appropriate referral decision making.

A total of 50 malignant and 50 benign lesions were assessed by each of the 118 physicians (board-certified internal and family medicine physicians), yielding 5,900 malignant and benign lesion assessments without the device and 5,900 with the ESS device. Physicians were also surveyed regarding their confidence in their management decision.

The study met the primary endpoint; the area under the receiver operating characteristic (AUROC) of the PCPs aided with the device was 0.671 (95% confidence interval [CI]: 0.611-0.732) compared with the AUROC unaided by the device of 0.630 (95% CI: 0.582-0.678), a significant increase (p=0.036). When asked whether the device would provide value to their decision making, 91.5% of respondents either agreed or strongly agreed.

The ESS device improved PCP accuracy in managing lesions suggestive of melanoma and increased their sensitivity for all skin cancers and melanoma. Participating internal medicine and family medicine physicians reported increased confidence in their assessments with the device. The ESS device can improve PCP decision making when managing lesions suggestive of melanoma.