This study aims to provide an initial assessment of the potential impact DERM could have on the number of onward referrals for a face to face dermatologist review and/or biopsy from a teledermatology-based service, and to improve the understanding of the patient pathways that exist.
DERM, an Artificial Intelligence (AI)-based diagnosis support tool, has been shown to be able to accurately identify melanoma, non-melanoma skin cancers (NMSC) and other conditions from historical images of suspicious skin lesions (moles). This study aims to establish whether the use of DERM in the patient pathway could reduce the number of unnecessary referrals to dermatologist review and/or biopsy. Suspicious skin lesions that are due to be photographed for a dermatologist to review, will have two additional photographs taken using a commonly available smart phone camera with and without a specific lens attachment. The images will be analysed by DERM, and the results compared to the clinician's diagnosis (all lesions) and histologically-confirmed diagnosis (any lesion that is biopsied).
Study Type
OBSERVATIONAL
Enrollment
700
AI-based decision support tool
Chelsea and Westminster Hospital
London, United Kingdom
Referral rate
The rate of unnecessary referrals for a face to face dermatologist review for the same detection rate between standard of care and DERM of lesions reviewed by teledermatology or DERM
Time frame: Study completion, on average 5 days
Sensitivity of DERM on biopsied lesions
Sensitivity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Specificity of DERM on biopsied lesions
Specificity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
False positive rate of DERM on biopsied lesions
False positive rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
False negative rate of DERM on biopsied lesions
False negative rate of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Positive predictive value of DERM on biopsied lesions
Positive predictive value of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Number needed to biopsy by DERM on biopsied lesions
Number needed to biopsy by DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
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Time frame: Study completion, on average 5 days
Sensitivity of teledermatologists on biopsied lesions
Sensitivity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Specificity of teledermatologists on biopsied lesions
Specificity of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
False positive rate of teledermatologists on biopsied lesions
False positive rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
False negative rate of teledermatologists on biopsied lesions
False negative rate of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Positive predictive value of teledermatologists on biopsied lesions
Positive predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Negative predictive value of teledermatologists on biopsied lesions
Negative predictive value of teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Number needed to biopsy by teledermatologists on biopsied lesions
Number needed to biopsy by teledermatologists on biopsied lesions, using histopathological confirmed diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Sensitivity of DERM to identify benign conditions
Sensitivity of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Specificity of DERM to identify benign conditions
Specificity of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Time frame: Study completion, on average 5 days
False positive rate of DERM to identify benign conditions
False positive of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Time frame: Study completion, on average 5 days
False negative rate of DERM to identify benign conditions
False negative rate of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Positive predictive value of DERM to identify benign conditions
Positive predictive of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Negative predictive value of DERM to identify benign conditions
Negative predictive value of DERM to identify benign conditions, using clinical diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Number needed to refer by DERM to identify benign conditions
Number needed to refer by DERM to identify benign conditions, using clinical diagnosis as gold-standard
Time frame: Study completion, on average 5 days
Concordance of DERM result with clinical diagnosis
Concordance of DERM result with clinical diagnosis
Time frame: Study completion, on average 5 days
Percent of patients attending teledermatology by referral route
Percentage of patients referred to teledermatology through 2-week wait referral, general referral, direct to teledermatology, routine follow-up (etc) referral routes
Time frame: Study completion, on average 5 days
Time taken from general practitioner (GP) referral to diagnosis
Time taken (days) from GP referral to either histopathology-confirmed or clinical diagnosis
Time frame: Study completion, on average 5 days
Estimated cost impact associated with introducing DERM into the patient pathway
The cost of the number of referrals for face to face dermatologist review and/or biopsy that would have been saved / charged if DERM had been used to decide whether to refer the patient onwards
Time frame: Study completion, on average 5 days
Proportion of images submitted to DERM that cannot be analysed
Proportion of images submitted to DERM that cannot be analysed
Time frame: Study completion, on average 5 days
Patient satisfaction survey
Patient feedback on their experience of the service. Patients will rate whether they agree, or don't agree, with statements that assess their acceptance of having a computer involved in their diagnosis pathway
Time frame: Study completion, on average 5 days