DERM Health Economics Study

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma; Non-melanoma Skin Cancer
• Intervention / Treatment: Device: Deep Ensemble for the Recognition of Malignancy (DERM)

Detailed Description

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 (Actual): 700

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SW10 9NH
    • Chelsea And Westminster Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients attending Medical Photography for imaging of at least 1 suspicious skin lesion. Patients may have been referred to the teledermatology service or for imaging for monitoring purposes from the dermatology clinic or for virtual teledermatology review.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

All; 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); AI-based decision support tool

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Skin Analytics Limited
• Collaborators: Innovate UK

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Actual): August 5, 2021
• Study Completion (Actual): August 6, 2021

Study Registration Dates

• First Submitted: October 9, 2019
• First Submitted That Met QC Criteria: October 9, 2019
• First Posted (Actual): October 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2021
• Last Update Submitted That Met QC Criteria: August 12, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Skin Neoplasms
• Other Study ID Numbers: DERM-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Research to improve or test the performance of DERM only allowed in consent

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No