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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Referral rate
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Referral rate
时间窗: Study completion, on average 5 days
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
次要结局
- Number needed to biopsy by teledermatologists on biopsied lesions(Study completion, on average 5 days)
- Specificity of DERM to identify benign conditions(Study completion, on average 5 days)
- Sensitivity of teledermatologists on biopsied lesions(Study completion, on average 5 days)
- Sensitivity of DERM on biopsied lesions(Study completion, on average 5 days)
- Specificity of DERM on biopsied lesions(Study completion, on average 5 days)
- False positive rate of DERM on biopsied lesions(Study completion, on average 5 days)
- Positive predictive value of DERM on biopsied lesions(Study completion, on average 5 days)
- Positive predictive value of DERM to identify benign conditions(Study completion, on average 5 days)
- Number needed to biopsy by DERM on biopsied lesions(Study completion, on average 5 days)
- Specificity of teledermatologists on biopsied lesions(Study completion, on average 5 days)
- False negative rate of teledermatologists on biopsied lesions(Study completion, on average 5 days)
- Positive predictive value of teledermatologists on biopsied lesions(Study completion, on average 5 days)
- Sensitivity of DERM to identify benign conditions(Study completion, on average 5 days)
- False negative rate of DERM on biopsied lesions(Study completion, on average 5 days)
- False positive rate of teledermatologists on biopsied lesions(Study completion, on average 5 days)
- Negative predictive value of teledermatologists on biopsied lesions(Study completion, on average 5 days)
- Concordance of DERM result with clinical diagnosis(Study completion, on average 5 days)
- Estimated cost impact associated with introducing DERM into the patient pathway(Study completion, on average 5 days)
- False positive rate of DERM to identify benign conditions(Study completion, on average 5 days)
- False negative rate of DERM to identify benign conditions(Study completion, on average 5 days)
- Percent of patients attending teledermatology by referral route(Study completion, on average 5 days)
- Time taken from general practitioner (GP) referral to diagnosis(Study completion, on average 5 days)
- Negative predictive value of DERM to identify benign conditions(Study completion, on average 5 days)
- Number needed to refer by DERM to identify benign conditions(Study completion, on average 5 days)
- Proportion of images submitted to DERM that cannot be analysed(Study completion, on average 5 days)
- Patient satisfaction survey(Study completion, on average 5 days)