JMIR Publications

ABSTRACT

Background:

Elastic-scattering spectroscopy (ESS) is a non-invasive optical biopsy technique that can distinguish between normal and abnormal tissue in vivo. The handheld device measures ESS spectra of skin lesions and classifies lesions with an output of “Investigate Further” or “Monitor”. The algorithm was trained and validated with over 11,000 spectral scans from over 3,500 skin lesions as well as in an associated clinical study.

Objective:

To establish whether use of a handheld ESS tool can improve detection of skin malignancies by evaluating clinical performance while emulating a real-world telemedicine clinical care setting.

Methods:

The associated clinical study examined an independent test set of 332 lesions in a prospective, multicenter study that compared algorithm performance to biopsy results for diagnosing malignant lesions. Fifty cases were randomly selected from the study database (25 malignant and 25 benign lesions). Device performance on these lesions was 96% sensitivity. High resolution digital images and the patient’s clinical information including prior skin cancer history, risk factors and physical examination results were available for evaluation. 57 Primary Care Physicians participated in this study in two phases, one phase with their standard-of-care diagnostic and the second phase regarding their evaluation with the device output. Physicians were educated on the ESS device before evaluating cases in a random order. Case evaluation included the physician reporting their diagnosis, management decision and confidence level without the device output in the first phase and with the device output in the second phase. Results were evaluated for sensitivity and specificity with confidence intervals.

Results:

The diagnostic sensitivity of the readers with and without the use of the Handheld ESS device increased significantly from 67% (62-72%) to 88% (84% - 92%) (p<0.0001). There was no significant difference in specificity at 40% and 53% (p=0.0516). The management sensitivity of the readers increased significantly with and without the use of the device was 94% (91% - 96%) and 81% (77% - 85%) (p=0.0009), suggesting that use of the device may reduce false negatives by 68%. Specificity was comparable for management decisions (p=0.3558) at 31% compared to 36% without the device.

Conclusions:

The use of the Handheld ESS device significantly improved diagnostic and management sensitivity over standard-of-care, with comparable specificity. While telemedicine has shown promise in many fields, studies have shown that in-person skin evaluation is superior to telemedicine evaluations, however integration with this type of tool has potential to improve early detection.