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临床试验/NCT05634421
NCT05634421已完成不适用

Training Health Care Professionals in Detecting Basal Cell Carcinoma on Optical Coherence Tomography Using E-learning and Cumulative Sum Analysis

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年12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
40
试验地点
1
主要终点
Number of practice scans needed in order to achieve an acceptable error rate

研究概览

简要总结

In this study, various health care professionals will follow an E-learning module in which BCC detection on OCT is explained. Thereafter, the participants will test their skill by assessing OCT-scans. Their performance will be monitored using cumulative-sum analysis. After completion, newly trained OCT assessors will test their diagnostic accuracy for BCC detection on OCT in a exploratory study. The trainability, amount of required training and diagnostic accuracy will be compared between dermatologist and non-dermatologists.

详细描述

Accurate detection of BCC on OCT requires substantial training and for future implementation of OCT, many OCT assessors need to be trained. Cumulative-sum analysis (CUSUM-analysis) can be used to objectify the competence of OCT assessors and has been previously used to monitor the competence of OCT assessors. Hence CUSUM-analysis may be valuable in training new assessors. A consensus statement from 2021 states that OCT scans should be acquired and interpreted by dermatologists. But this consensus is challenged by various studies in which OCT assessors were non-dermatologists. All non-dermatologist OCT assessors achieved high diagnostic accuracy. In addition, as diagnosis, treatment and follow-up of BCC patients constitute a substantial proportion of the workload of dermatologists, the question arises whether the acquisition of OCT scans and the subsequent assessment thereof could be outsourced to non-dermatologists. This could reduce the workload of the dermatologist, shorten waiting lists and potentially reduce costs.

In an E-learning dermatologists and non-dermatologists will learn about BCC features on OCT as described by Hussain et al. In this E-learning they will learn how to systematically examine an OCT-scan and detect BCC features. They will also be informed on common pitfalls in BCC detection. Thereafter they will start a CUSUM-module containing 400 OCT-scans (50% BCC vs. 50% non-BCC) to monitor cumulative successes and failures in diagnostic assessments. The competence of OCT assessors can be objectified using preset acceptable (16%) and unacceptable error rates (25%). The error rate is defined as the sum of false negative and false positive diagnoses divided by the total number of assessed OCT scans. For all OCT scans, the histologically verified diagnosis based on punch or excision biopsy is available. The OCT assessor will practice until an acceptable performance rate is achieved and maintained (over 50 scans). A secondary objective will be to explore the diagnostic accuracy in terms of sensitivity and specificity. Once an acceptable performance rate is achieved and maintained, assessors will assess a new cohort of 100 OCT scans (50% BCC and 50% non-BCC). Their level of suspicion for BCC will be expressed on a 5-point Likert-Scale. Diagnostic parameters will be compared between dermatologists and non-dermatologists.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Health care provider or medical student

排除标准

  • Previous experience with OCT

结局指标

主要结局

Number of practice scans needed in order to achieve an acceptable error rate

时间窗: Measured before december 31st 2023

Achieving and maintaining an acceptable error rate (16%) for BCC detection on OCT

时间窗: Measured before december 31st 2023

Median time that dermatologists and non-dermatologists need to assess OCT scans

时间窗: Measured before december 31st 2023

Diagnostic accuracy of newly trained dermatologists and non-dermatologists expressed as sensitivity, specificity, PPV, NPV and DOR.

时间窗: Measured before december 31st 2023

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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