AI Augmented Training for Skin Specialists

Summary

Participation Requirements

Description

Design: This study is a superiority trial designed as a stratified international multicenter randomized controlled trial of doctors in highly specialized centers that diagnose and/or treat skin- and mole cancer. Stratification and randomization Eligible participants will be stratified based on gende...

Design: This study is a superiority trial designed as a stratified international multicenter randomized controlled trial of doctors in highly specialized centers that diagnose and/or treat skin- and mole cancer. Stratification and randomization Eligible participants will be stratified based on gender, results on the pre-test, age, type of clinic and self-reported years of experience diagnosing skin lesions, before being randomized (allocation ratio 3:1) into either the intervention or control group. Intervention: The intervention group is given access to a digital educational smartphone app (E-app) developed by the research group, are asked to register all skin lesions seen with the registration app (R-App) also developed by the research group, and will be given clinical feedback on every registered skin lesion. Participants in the control group are asked from day one to register all skin lesions with the R-App, but their clinical feedback and their access to the E-App is delayed for 30 days. The delayed educational intervention of the control group serves as a baseline to show the natural development of diagnostic accuracy. Feedback on removed/biopsied skin lesions is given directly from the pathologist. Feedback un-biopsied skin lesions will be provided by a minimum of 4 independent experts in skin cancer diagnostics ( >10 years of experience) through a web-based review system developed by our group, as in a previous study designed by the same group. Statistics: The average increase in diagnostic accuracy for the population of participating GPs as an effect of the hours spent with the E-App is calculated using Generalized Estimating Equations (GEE). As benign lesions can be excised/treated for other reasons than suspicion of malignancy we will analyse correctly diagnosed benign lesions treated for different reasons (cosmetic or functional complaints etc.) separately. We expect a majority of registered lesions to be benign, despite most of the patients already having been seen by GPs before referral. For our statistical analysis we will use a clinically conservative estimated average of 12502 lesions (11 doctors, 7 departments, 5 lesions per day each and a 50% registration rate). Ethical considerations: Patient participation contains no immediate strain or discomfort for the patient, and no change to current clinical practice, as dermoscopic evaluation is part of the clinical examination of skin lesions. The images captured are stored safely and anonymously with no risk for the patient. With the current low diagnostic accuracy of young doctors the educational nature of the intervention justifies the study for the sake of all future patients with skin lesions that are less likely to be misdiagnosed. Educational interventions on doctors do not require approval by The National Committee on Health Research Ethics in Denmark. However ethical considerations have been made and the project is in concordance with the Helsinki Declaration II.

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