跳至主要内容
临床试验/NCT04576416
NCT04576416已完成不适用

Artificial Intelligence Augmented Training of Danish General Practitioners in Skin Cancer Diagnostics - A Randomized Superiority Clinical Trial

Herlev Hospital2 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
115
试验地点
2
主要终点
Change in diagnostic accuracy

研究概览

简要总结

Background:

The worldwide incidence of skin cancer has been rising for 50 years, in particular the incidence of malignant melanoma has increased approx. 2-7% annually and is the most common cancer amongst Danes aged 15-34. Currently there is a significant amount of misdiagnosis of skin cancer and mole cancer. Our aim is to improve general practitioners' diagnostic skills and accuracy of skin and mole cancer.

Research questions:

In a population of Danish General Practitioners (GPs) what is the dose/response effect of hours spent with an educational platform that offers AI augmented training and clinical feedback on their diagnostic accuracy and accurate clinical management (treatment, dismissal, referral)? Does access to an educational platform that offers AI augmented training and clinical feedback increase the number of malignant skin lesions referred by Danish GPs without simultaneously increasing the number of incorrect benign referrals? Can the participating GPs clinical accuracy be predicted from the MCQ-score by comparing their quiz answers and diagnostic accuracy on their registered lesions with their score on the MCQ?

Method:

90 Danish GPs will at baseline, 1 month and end of trial answer a Multiple Choice Questionnaire (MCQ). There is no change to current clinical practice, but all participating doctors will be asked to register a clinical picture and a dermoscopic image as well as basic information about the lesion and patient (age, gender, location and diagnosis) of all skin lesions examined due to a suspicion for non-melanoma or melanoma skin cancer, raised by the GP or patient.

GPs in the intervention group are besides the registration application (R-app) given access to an AI augmented training and clinical feedback through an educational smartphone app (E-app). Within the E-app the doctor can access quizzes on a library of 10,000+ skin lesions, written articles about the 40 most common skin lesions, and a clinical feedback module that gives the GP feedback on their registered skin lesions.

Feedback on skin lesions with the registered clinical management of referred/excised/biopsied will be provided continuously by independent experts in skin cancer diagnostics (>10 years of experience) through a web-based review system developed by our group. Feedback on the remaining registered cases are withheld until the end of the study period. This is done to simulate a realistic clinical setting during the study.

详细描述

Statistics and Results Using data from the E-app, scores on the MCQs and the diagnostic accuracy of the GP's a dose/response relationship is calculated, in order to answer the research questions posed above.

Aim The aim of this project is to investigate the dose/response effect on GPs' proficiency from AI augmented training and clinical feedback in skin cancer diagnostics. This project will examine how much training is needed before the GPs' ability to diagnose and correctly refer skin cancer is affected.

Research Questions In a population of Danish GPs what is the dose/response effect of hours spent with an educational platform that offers AI augmented training and clinical feedback on their diagnostic accuracy and accurate clinical management (treatment, dismissal, referral)?

Does access to an educational platform that offers AI augmented training and clinical feedback increase the number of malignant skin lesions referred by Danish general practitioners without simultaneously increasing the number of incorrect benign referrals? Can the participating GPs clinical accuracy be predicted from the MCQ-score by comparing their quiz answers and diagnostic accuracy on their registered lesions with their score on the MCQ?

Design This stratified superiority RCT will include 90 GPs in Denmark. The study period is five months. Three months of active intervention, then two months of post intervention observation period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Participating doctors are either given access to an AI augmented digital educational platform or not. During the study period, both doctors of the intervention and control arm are registering skin lesions they encounter in their daily practice.

The expert dermatologists that evaluate the registered skin lesions are unaware of the registering doctors allocation.

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in diagnostic accuracy

时间窗: Participants are assessed over a period of 5 months.

The change in diagnostic accuracy is measured as percentage of correctly diagnosed skin lesions.

Time spent on educational materials

时间窗: Participants are assessed over a period of 5 months.

The participants time spend with the digital educational platform is measured by the platform.

Benign/Malignant Ratio

时间窗: Participants are assessed over a period of 5 months.

All registered lesions will be evaluated by a expert dermatologist. Using the expert opinion as golden standard a ratio of the benign and malignant skin lesions forwarded by the General Practitioner is calculated.

次要结局

  • Multiple-Choice-Questionnaire predictability of diagnostic accuracy(Participants are assessed over a period of 5 months.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gustav Gede Nervil

Principal Investigator

Herlev Hospital

研究点 (2)

Loading locations...

相似试验