EIS provides high-sensitivity melanoma diagnosis vs histopathologic confirmation from biopsies, with 1 study showing a 96.6% sensitivity rating, detecting 256 of 265 melanomas.4 The EIS device, by measuring differences in electrical resistance between benign and cancerous cells, outputs a simple integer score ranging from 0 to 10 associated with the likelihood of the lesion being a melanoma.8 Based on data from the Nevisense pivotal trial,4 Nevisense reports that scores of 0 to 3 carry a negative predictive value of 99% for melanoma, whereas scores of 4 to 10 signify increasingly greater positive predictive values from 7% to 61%.
We aimed to assess whether EIS may be beneficial to PCPs by comparing the accuracy of clinical decision-making for PSLs based on visual examination alone with that based on concurrent visual and EIS evaluation.
METHODS
A questionnaire was distributed via email to 142 clinicians at clinics affiliated with either of 2 organizations delivering care to the New York City area through a network of community health centers: the Institute for Family Health (IFH) and the Community Healthcare Network (CHN). Of these recipients, 72 were affiliated with IFH across 27 community health centers and 70 were affiliated with CHN across 14 community health centers. Recipients were physicians and nurse practitioners (NPs) practicing at primary health care facilities.
Survey instrument. The first section of the survey instrument (APPENDIX) solicited demographic information and explained how to apply the EIS scores for diagnostic decision-making. The second featured images of 12 randomly selected, histologically confirmed, and EIS-evaluated PSLs from a previously published prospective blinded trial of 2416 lesions.4 The Institutional Review Board of the Icahn School of Medicine at Mount Sinai reviewed and approved the study and survey instrument.
Clinical images of these lesions, comprising 4 melanocytic nevi, 4 dysplastic nevi (including 3 mild-moderately dysplastic and 1 severely dysplastic nevus), and 4 melanomas, were first presented to respondents with 2 tasks: (1) rate on a scale of 1 to 5 their likelihood to biopsy or refer this lesion to a dermatologist (1: not likely; 5: extremely likely); and (2) select what they expect the pathology results to be: melanocytic nevus, dysplastic nevus, or malignant melanoma. Subsequently, respondents repeated the assessments after being presented with the EIS score for the same lesion in conjunction with the clinical image.
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