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

NCT ID: NCT05634421

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Basal Cell Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Dermatologists

Dermatologists who have no experience with OCT.

E-learning

Intervention Type OTHER

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

Residents

Residents who have no experience with OCT

E-learning

Intervention Type OTHER

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

Medical students

Medical students who have no experience with OCT

E-learning

Intervention Type OTHER

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

Nurses

Nurses who have no experience with OCT

E-learning

Intervention Type OTHER

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

Research physicians

E-learning

Intervention Type OTHER

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

Interventions

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E-learning

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Health care provider or medical student

Exclusion Criteria

* Previous experience with OCT
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maastricht UMC+

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

References

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Wolswijk T, Nelemans PJ, Adan F, van Leersum F, Kreiter D, Adams T, van Dorsten S, Mosterd K. Cumulative Sum Analysis-Integrated E-Learning for Differentiation Between Basal Cell Carcinoma and Non-Basal Cell Carcinoma on Optical Coherence Tomography: An Observational Cohort Study. Int J Dermatol. 2025 Oct;64(10):1870-1878. doi: 10.1111/ijd.17918. Epub 2025 Jun 27.

Reference Type DERIVED
PMID: 40579737 (View on PubMed)

Other Identifiers

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2022-3253

Identifier Type: -

Identifier Source: org_study_id

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