Dermoscopy Augmented Histology Trial

Study Overview
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Brief Summary
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Background: Melanoma mortality remains almost stable with a 0.2-1.5% increase annually despite rapid growth in reported melanoma incidence of 2.5-8.6% per year. Part of this discrepancy could be explained by overdiagnosis of melanoma, which may be as high as 54%. Histopathology is considered the gold standard diagnosis for melanocytic lesions despite only a moderately good intra- and inter-rater reliability. A possible explanation of why the inter-rater reliability is suboptimal could be that pathologists are inexperienced, extra cautious, or lack sufficient information needed for a reliable diagnosis.It has been hypothesized that the horizontal overview of a lesion through dermoscopy combined with clinical information on a given tumor, enables the generation of a tentative diagnosis that the pathologists can use to actively search for signs of pathology. Former research shows that clinicians' competence in dermoscopy can be improved by a short learning intervention, but that these skills aren't sustainable Aim: The aim of this study is to examine how acquired basic skills in dermoscopy of pigmented lesions and access to clinical images of a lesion, affect pathologists' confidence, accuracy and inter-rater reliability when interpreting melanocytic lesions.

Detailed Description
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Method: Preparative phase: Case database Lesion data will be collected from patients during the period between 02.11.2020 and 22.01.2021 at the Department of Plastic Surgery, Herlev Hospital. Requirements for eligibility are: The patient is referred through the clinical cancer pathways for melanoma The lesion is excised upon evaluation by the plastic surgeon. An internal investigation has shown that approximately ⅓ of all melanocytic lesions referred in the clinical cancer pathway are melanomas (in situ and invasive). Patients will receive oral and written information about the project and be asked to sign a consent form before participation. Participation will not affect the treatment, diagnostics, or follow-up of included patients. Upon consent the following information will be collected for each lesion: Clinical image Dermoscopic image Patients´ CPR-number (personal ID-number) Gender and age of the patient Location of skin tumor (3D avatar) Medical history (congenital nevi, pregnant patient, how long has it been present, appearance change, symptoms, former melanoma, family history of melanoma, sun exposure within the last six months) As soon as the lesions have been prepared for pathological examination, a representative slide (including pathognomic features) for each skin lesion will be chosen by an experienced dermatopathologist. This slide will subsequently be digitized and coupled to the remaining information (dermoscopic and clinical image, tumor location, gender, age, lesion information, etc.). Thereafter the CPR number is deleted, rendering the case anonymous. Each case will be stored in a database under a random anonymous ID number. Web-based IT-platform In order to maximize patient participation and the number of pathologists that can be included in the study, the investigators will develop an IT platform for the trial. The platform will enable the following features: Sign-in Automated randomization Login Case presentation Diagnosis of cases Tracking The IT platform: The diagnostic options will be based on the standardized MPATH-Dx formula (participants will be introduced to this before participation) used in former studies on inter-rater reliability. Subsequent to diagnosing the lesion, participating pathologists will rate their confidence in the chosen diagnosis on a 5-step Likert scale. Participants will be grouped by department or affiliation center in order to enable post-hoc cluster analyses and continuous status reports during the study. The tracking feature will enable search pattern analysis including time per diagnosis and percentage of time spent looking at the histology slide and dermoscopy photo. Saliency heat maps will be developed that enable visualization of classical search patterns (both global and feature specific) in both study groups. Executive phase: General pathologists and dermatopathologists from Denmark, Australia and other countries will be enrolled between 1.09.2021 and 1.10.2021. All participants will be sent an email informing them about the trial and the handling of their data before signing a digital consent. Upon inclusion each enrolled pathologist will be asked to fill out a digital sign-in form with the following variables: Name E-mail address (including verification) Age Gender Subspecialization (general pathologist or dermatopathologist) Number of years interpreting skin lesions Caseload from melanocytic lesions per month Percentage of caseload from melanocytic lesions Number of second opinion assessments per month Number of second opinion referrals per month Former training in dermoscopy (yes/no) Perceived relevance of dermoscopic images during histopathological evaluation on a 5-step Likert scale Following the sign-in, all participants will be asked to answer a dermoscopy test consisting of 20 formerly validated test items. Then they will be automatically stratified by level of dermatopathological experience and randomized (allocation ratio 1:1) to either the intervention or control group. Participants in the intervention group will receive immediate access to a previously developed digital (tablet or smartphone) educational platform in dermoscopy of melanocytic lesions and then answer the dermoscopy test again, before diagnosing the lesions in this study. Participants in the control group will not be given access to the learning intervention but will diagnose the lesions from this study immediately after sign up and dermoscopy test. Each participant will be asked to assess a minimum of 50 cases within 14 days, preferably all 200 cases. Statistics: The accuracy will be measured as the number of correct answers divided by the total number of answers. Consensus agreement among pathologists with a caseload of more than 60 melanocytic lesions per month and at least 10 years of experience will be used as the gold standard. Inter-rater reliability will be measured using generalizability theory that allows calculations in nested and unbalanced designs. Mean time spent per diagnosis and diagnostic confidence during 1st evaluation will be compared between the study groups using independent t-tests. A post hoc ANOVA will compare time spent per diagnosis and confidence of pathologists grouped by time spent training in dermoscopy.

Official Title
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Correlation Between Dermoscopy Training of Pathologists and Improvement of Histopathological Interpretation of Skin Lesions

Conditions
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Melanoma, Pigmented Lesions

Intervention / Treatment
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* Other: DermLoop Learn


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologists are required to work at a specialized skin department Doctors must be registered authorized health personnel Exclusion Criteria: Doctors that have previously received access to the DermLoop Learn educational intervention
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trial. Pathologists are randomized to either the control group or det intervention, allocation ratio 1:1.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention<br>Access to DermLoop Learn IT platform | Other: DermLoop Learn<br>* DermLoop Learn is our AI augmented digital educational platform with case training on a library of 18,000+ benign and malignant skin lesion as well as written learning modules for the most common skin lesion diagnosis.<br>|
| No Intervention: Control group<br>No access to DermLoop Learn | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inter-rater reliability | Comparison of the pathologists interpretation/diagnosis of each case. | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent/case | Comparing time spent per case (overall) and time spent on each image (clinical, dermoscopic, histopathological) with the interpretation of the case e.g. the diagnosis. | 2 months |