Nevus Doctor Clinical Decision Support

Study Overview
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Brief Summary
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The Nevus doctor is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program Nevus doctor is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program Nevus doctor is better than the performance of the GPs.

Detailed Description
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In the trial GPs examine patients who attend a primary health care center. A given PSL is first assessed clinically by the GP and afterwards photographed. A clinical photograph as well as a dermatoscopic photograph is taken, the latter using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program. The performance of Nevus doctor is compared with the GPs' assessment. A dermatologist reviews all cases based on the clinical and dermatoscopic photographs and this assessment serves as the reference standard.

Official Title
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Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma

Conditions
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Nevus, Melanoma

Intervention / Treatment
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* Device: Nevus doctor program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pigmented skin lesion Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nevus doctor program<br>Use of Nevus doctor program to assess the diagnostic category of pigmented skin lesions | Device: Nevus doctor program<br>* The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of correct test results | The computer program tests whether the appearance of a skin lesion is suggestive of skin cancer. There are two possible test outcomes: suspicious or not suspicious. The reference standard is the assessment done by a dermatologist. The number (and percentage) of skin lesions correctly classified as suspicious or not suspicious is reported. Furthermore sensitivity, specificity, positive and negative predictive values are calculated. | Up to 2 weeks from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patterns regarding false test results | All cases with false test results are described in order to identify any pattern that can help to explain the false test result: correlation with specific types of skin lesions, poor image quality, gender and age of the patients. | Up to 2 weeks from enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nevus, Computer-assisted diagnosis, General practice, Dermatoscopy, Melanoma