Abstract
Background: Access to dermatologists is limited in parts of the US, making primary care clinicians (PCCs) integral for early detection of skin cancers. A handheld device using elastic scattering spectroscopy (ESS) was developed to aid PCCs in their clinical assessment of skin lesions.
Methods: In this prospective study, 3 PCCs evaluated skin lesions reported by patients as concerning and scanned each lesion with the handheld ESS device. The comparison was pathology results or a 3-dermatologist panel examining high resolution dermatoscopic and clinical images. PCCs reported their diagnosis, management decision, and confidence level for each lesion. Evaluation of results included sensitivity, specificity, negative predictive value (NPV), positive predictive value (PPV), and Area Under the Curve (AUC).
Results: A total of 155 patients and 178 lesions were included in the final analysis. The most commonly patient-reported concerning feature was “new or changing lesion” (91.6%). Device diagnostic sensitivity and specificity were 90.0% and 60.7%, respectively, based on biopsy result or dermatologist panel reference standard; comparatively, PCC sensitivity was 40.0% and 84.8% specificity without the use of the device. Device NPV was 98.9%, and device PPV was 13.6%. The device recommended patient referral to dermatology with 88.2% concordance with the dermatologist panel. AUC for the device and PCCs were 0.815 and 0.643, respectively.
Conclusions: The use of the ESS device by PCCs can improve diagnostic and management sensitivity for select malignant skin lesions by correctly classifying most benign lesions of patient concern. This may increase skin cancer detection while improving access to specialist care.
