INTRODUCTION: An artificial intelligence as a medical device (AIaMD), built on convolutional neural networks, has demonstrated high sensitivity for melanoma. To be of clinical value, it needs to safely reduce referral rates. The primary objective of this study was to demonstrate that the AIaMD had a higher rate of correctly classifying ...
INTRODUCTION: An artificial intelligence as a medical device (AIaMD), built on convolutional neural networks, has demonstrated high sensitivity for melanoma. To be of clinical value, it needs to safely reduce referral rates. The primary objective of this study was to demonstrate that the AIaMD had a higher rate of correctly classifying lesions that did not need to be referred for biopsy or urgent face-to-face dermatologist review, compared to teledermatology standard of care (SoC), while achieving the same sensitivity to detect malignancy. Secondary endpoints included the sensitivity, specificity, positive and negative predictive values, and number needed to biopsy to identify one case of melanoma or squamous cell carcinoma (SCC) by both the AIaMD and SoC. METHODS: This prospective, single-centre, single-arm, masked, non-inferiority, adaptive, group sequential design trial recruited patients referred to a teledermatology cancer pathway (clinicaltrials.gov NCT04123678). Additional dermoscopic images of each suspicious lesion were taken using a smartphone with a dermoscopic lens attachment. The images were assessed independently by a consultant dermatologist and the AIaMD. The outputs were compared with the final histological or clinical diagnosis. RESULTS: A total of 700 patients with 867 lesions were recruited, of which 622 participants with 789 lesions were included in the per-protocol (PP) population. In total, 63.3% of PP participants were female; 89.0% identified as white, and the median age was 51 (range 18-95); and all Fitzpatrick skin types were represented including 25/622 (4.0%) type IV-VI skin. A total of 67 malignant lesions were identified, including 8 diagnosed as melanoma. The AIaMD sensitivity was set at 91 and 92.5%, to match the literature-defined clinician sensitivity (91.46%) as closely as possible. In both settings, the AIaMD identified had a significantly higher rate of identifying lesions that did not need a biopsy or urgent referral compared to SoC (p-value = 0.001) with comparable sensitivity for skin cancer. DISCUSSION: The AIaMD identified significantly more lesions that did not need to be referred for biopsy or urgent face-to-face dermatologist review, compared to teledermatologists. This has the potential to reduce the burden of unnecessary referrals when used as part of a teledermatology service.
