Abstract
Present-day practice of primary healthcare is both one of the most rewarding as well as one of the most challenging aspects of modern medicine. The seemingly endless expansion of new practice guidelines, new diagnoses, complex treatments, and an aging population with compounding comorbidities is faced with ever-decreasing time allotments for physician-patient interactions and access to specialty care. Thus, there is a constantly growing demand for primary care providers to manage more, in less time and at minimal cost. From the standpoint of the most common malignancy in humans, regular skin exams intended for skin cancer screening are the most cost-effective means for skin cancer prevention/interception. However, visual inspection of the skin is highly dependent on clinician experience and often triggers further workup of slightly irregular lesions (dermatology consultation or skin biopsy) that may not be necessary. Considering the limited access to dermatology specialty care, delays in workup completion with skin biopsies are commonplace. Therefore, it is not surprising that over the past several years, there has been an emergence of several point-of-care devices intended to assist physicians in the assessment of suspicious skin lesions and improve the specificity and sensitivity of cancer detection, improving/narrowing the selection of patients that benefit from further work-up. Presented herein are two studies conducted in a primary care setting demonstrating the clinical utility of an elastic scattering spectroscopy (ESS) device as an aid to clinical examination for skin cancer screening. (DermaSensor) Both studies, albeit different in design and scope, come to the same conclusion, supporting the use of the hand-held ESS device by primary care providers as an aid in the selection of patients whose suspicious skin lesions may require additional evaluation and skin biopsy. The DERM-SUCCESS study was a blinded, prospective multicenter clinical study that enrolled patients in whom primary care physicians (PCPs) suspected skin malignancy. The lesions were assessed by physical exam and scanned with the DermaSensor device, followed by biopsy. The diagnostic performance of the device was assessed. As reported, of 1579 skin lesions, 14.2% were skin cancer (224). Device sensitivity was 95% CI [91.7%-97.6%] overall, with an impressive negative predictive value of 96.6%. The device misclassified a skin lesion and recommended “monitor” rather than “investigate further” in 4 cases of keratinocyte carcinomas and 4 melanomas (0.5% of lesions). The device was easy to use at the point-of-care, with excellent performance as a screening tool. In the second study, the authors took images of 100 skin lesions and their clinical histories from DERM-SUCCESS patients (50 aided with device output and 50 unaided), and asked 108 PCPs to provide a diagnosis, management decision and level of confidence without and then subsequently with device output. The study revealed a significant increase in diagnostic sensitivity using the DermaSensor device from 71.1% to 81.7% (P = .0085). Using the device, PCPs reported an increase in their high confidence in management decisions from 36.8% to 53.4%. Notably, 21.2% of benign skin lesions that the PCPs referred for further evaluation were deemed unnecessary when aided by the device. These data all support the positive impact of the DermaSensor device and ESS as a useful tool for primary care assessment of skin lesions. This is an excellent example of technological advances improving the quality and cost efficiency of healthcare.