Effect of Teledermoscopic Triage on Clinical Management of Skin Lesions Suspected of Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Triage Values
研究概览
简要总结
The goal of this study is to estimate the triage values, efficiency and safety of tele-dermoscopic triage of skin lesions suspected of melanoma. The main question[s] it aims to answer are:
- What is the rate of correct patient management by a single, 2, 3 and 5 dermatologists.
- What is the consequence for the patients if teledermoscopic triage is implemented, in termes of missed melanomas and reduced unnecessary excisions/biopsies.
Retrospectively included patients will have their skin lesions re-examined by setups of 1, 2, 3 and 5 tele-dermoscopists who will assign a tentative diagnosis and a recommended clinical action.
The investigators will compare the rate of correct patient management between the different setups.
详细描述
Background The incidence of melanoma has been increasing in Denmark for decades [1]. With an age-standardized rate of 29.7 per 100.000 citizens, Denmark has the third highest melanoma rate in the world, and the highest rate for women (33.6) [2].
The excision rate in Danish departments of plastic surgery is close to 100%, although only 46% of referred patients have a malignant tumour [3].
To combat this over-treatment, the patient should be triaged by an expert in evaluation of skin tumours as early as possible, who, to a higher degree, could be able to distinguish between benign and malignant skin lesions and dismiss patients with benign lesions without a biopsy.
This triage should therefore be made by subspecialized dermatologists with expertise regarding diagnosing melanocytic skin lesions.
Teledermoscopy has a high sensitivity equal to face-to-face examination [8], and images taken in the primary care setting and at the hospital have been found to be of comparable quality [9], enabling an accurate assessment of images acquired in the primary care setting.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referred to the Department of Plastic Surgery at Herlev Hospital because of suspicion of melanoma
- •Clinical and dermoscopic images registered in Dermloop
- •Histopathological diagnosis available for the lesion
排除标准
- •The patient's images cannot be anonymized adequately
结局指标
主要结局
Triage Values
时间窗: Immediately after all participants have completed the evaluations
Recommended clinical action, correct vs incorrect. Each teledermatologist will recommend a clinical action for each patient case. We evaluate the correctness of this recommended clinical action (in binary classification of correct vs incorrect) by a list of pre-defined "best practice management rules" for each diagnosis.
次要结局
- Diagnostic Values(Immediately after all participants have completed the evaluations)
研究者
Gustav Gede Nervil
Principal Investigator
Herlev Hospital