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

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05634421
Collaborator
(none)
20
13

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: E-learning

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Training Health Care Professionals in Detecting Basal Cell Carcinoma on Optical Coherence Tomography Using E-learning and Cumulative Sum Analysis
Anticipated Study Start Date :
Dec 1, 2022
Anticipated Primary Completion Date :
Jul 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Dermatologists

Dermatologists who have no experience with OCT.

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

Residents/physicians

Residents/physicians who have no experience with OCT

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

Medical students

Medical students who have no experience with OCT

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

Nurses

Nurses who have no experience with OCT

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

Outcome Measures

Primary Outcome Measures

  1. Achieving and maintaining an acceptable error rate (16%) for BCC detection on OCT [Measured before december 31st 2023]

  2. Number of practice scans needed in order to achieve an acceptable error rate [Measured before december 31st 2023]

  3. Median time that dermatologists and non-dermatologists need to assess OCT scans [Measured before december 31st 2023]

  4. Diagnostic accuracy of newly trained dermatologists and non-dermatologists expressed as sensitivity, specificity, PPV, NPV and DOR. [Measured before december 31st 2023]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Health care provider or medical student
Exclusion Criteria:
  • Previous experience with OCT

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Maastricht University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT05634421
Other Study ID Numbers:
  • 2022-3253
First Posted:
Dec 2, 2022
Last Update Posted:
Dec 2, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Maastricht University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 2, 2022