DERM Health Economics Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Impact of an Artificial Intelligence Platform (DERM) on the Healthcare Resource Utilisation (HRU) Needed to Diagnose Skin Cancer When Used as Part of a United Kingdom-based Teledermatology Service

Conditions
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Melanoma, Non-melanoma Skin Cancer

Intervention / Treatment
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* Device: Deep Ensemble for the Recognition of Malignancy (DERM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is willing and able to give informed consent for participation in the study, Male or Female, aged 18 years or above, Has at least one suspicious skin lesion which is being photographed as part of Standard of Care (SoC), In the Investigators opinion, able and willing to comply with all study requirements. Exclusion Criteria: Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All<br>Patients attending a Medical Photography facility with at least 1 suspicious skin lesion will be approached to participate in the study. Participants will have an additional macro and dermoscopic image of each suspicious skin lesions suitable for photography. Photographs will be taken by a healthcare professional using an iPhone XR smart phone camera with a DL1 dermoscopic lens attachment. The images will be encrypted and electronically transmitted to Skin Analytics' cloud servers for analysis by DERM. The suspected diagnosis determined by DERM will be compared with dermatologist review and histologically confirmed diagnosis, where obtained. Healthcare resource utilization information and patient satisfaction data will also be collected | Device: Deep Ensemble for the Recognition of Malignancy (DERM)<br>* AI-based decision support tool<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Study completion, on average 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of DERM on biopsied lesions | Sensitivity of DERM on biopsied lesions, using histopathological confirmed diagnosis as gold-standard | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Study completion, on average 5 days | 
| Concordance of DERM result with clinical diagnosis | Concordance of DERM result with clinical diagnosis | 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 | 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 | 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 | 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 | 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 | Study completion, on average 5 days |