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A handheld tool improved skin cancer detection in primary care, increasing diagnostic sensitivity to 96.3% compared to 83.9% without the device.
Use of a handheld tool in primary care settings could help improve the detection and management of skin cancer, according to a new study.
Results of the study suggest the tool, a handheld elastic scattering spectroscopy (ESS), had a 96.3% sensitivity for detecting skin cancer compared to 83.9% sensitivity observed among primary care providers not using the device.
“The ESS device has high sensitivity for detecting skin cancer when compared to gold standard dermatopathology. Additionally, use of the ESS device by PCPs significantly improved diagnostic and management sensitivity, with clinically acceptable decreases in associated specificities,” investigators wrote.
The first line of defense and detection for many forms of chronic illness, primary care also sits in a prime position for early intervention and detection of skin cancers, particularly when the number of US citizens outnumber dermatologist at a ratio of 100,000 to 1.10. With this in mind, identification and implementation of strategies to optimize detection have been highlighted as key avenues for intervention.
The current research endeavor, which was presented at Maui Derm NP+PA Fall 2024 by Stephen P Merry, MD, a consultant and associate professor of Family Medicine at the Mayo Clinic, was designed as a 2-part study, with the first part aimed at validating the performance of a handheld ESS device and to evaluate whether device availability improved detection and management of skin cancer in primary care settings among patients aged 40 years and older. With this in mind, investigators designed a blinded, prospective, multicenter clinical validation study to be conducted within 22 primary care study sites across the US and Australia.
From the study sites, investigators enrolled a total of 867 patients with 1372 lesions suggestive of skin cancer for the study. Per study protocol, lesions were first assessed by primary care investigators and then scanned with the ESS device. Of note, investigators pointed out suspicious skin lesions received standard of care treatment and all lesions enrolled underwent biopsy.
Following completion of this portion of the study, investigators conducted an accompanying utility study with 108 primary care providers evaluating a series of 44 skin lesion cases, with a subset that would be randomly selected from the validation study to match the breakdown of lesions in the clinical study. For the purpose of analysis, investigators collected diagnoses, management decisions, and level of confidence with and without device results.
Upon analysis, results indicated the device sensitivity measured at 96.3% for detecting high-risk lesions, with a specificity of 20.3% compared to 83.9% sensitivity for primary care providers for clinically suspicious lesions. Investigators noted noninferiority testing suggested the device performance was 90%, which is similar to the published sensitivity of dermatologists (P <.0001).
Analysis of data form the utility study suggested management and diagnostic sensitivity of primary care providers increased significantly (from 83.6% to 95.9% [P <.05] and 73.3% to 88.3% [P<.05], respectively) with the device. Investigators highlighted use of the device was also associated with reductions in specificity for diagnosis (58.1% to 53.1%) and referrals (41.5% to 32.6%). Additionally, investigators pointed out use of the device was associated with an increase in area under the curve from 0.704 to 0.800 as well as an increase in confidence surrounding management decision among primary care providers from 36.8% to 53.4%.
“These findings suggest use of the ESS device has the potential to improve PCP skin cancer detection as well as their confidence in skin lesion evaluation and management,” investigators concluded.
References:
Merry SP, Agresta T, Severing EV, et al. Can a Handheld Elastic Scattering Spectroscopy Device Aid Primary Care Physicians in Detection and Management of Skin Cancer? Presented at: Maui Derm NP+PA Fall 2024. Nashville, TN. September 15-18, 2024.