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Completed

NCT Number: NCT05634421

Training Health Care Professional in Detecting BCC on OCT Using E-learning and CUSUM-analysis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maastricht UMC+

Maastricht, Limburg, 6229HX, Netherlands

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Health care provider or medical student

Exclusion criteria

  • Previous experience with OCT

Treatment and study plan

e-learning

Other

The E-learning is under development at the department of Dermatology from MUMC+.

Primary outcomes

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

    Time frame: Measured before december 31st 2023

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

    Time frame: Measured before december 31st 2023

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

    Time frame: Measured before december 31st 2023

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

    Time frame: Measured before december 31st 2023

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 2, 2022
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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