Nevus Doctor Clinical Decision Support
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Nevus Doctor Clinical Decision Support Program for Pigmented Skin Lesions and Melanoma|
- Number of correct test results [ Time Frame: Up to 2 weeks from enrollment ] [ Designated as safety issue: No ]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.
- Patterns regarding false test results [ Time Frame: Up to 2 weeks from enrollment ] [ Designated as safety issue: No ]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.
- User-friendliness [ Time Frame: 6-8 months after enrollment ] [ Designated as safety issue: No ]Participating GPs are invited to interviews
|Study Start Date:||October 2014|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Experimental: Nevus doctor program
Use of Nevus doctor program to assess the diagnostic category of pigmented skin lesions
Device: Nevus doctor program
The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02012751
|Contact: Thomas R Schopf, MD PhDfirstname.lastname@example.org|
|Kirkenes, Finnmark, Norway, 9915|
|Principal Investigator: Drude Bratlien, MD|
|Principal Investigator:||Thomas R Schopf, Ph.D.||University Hospital North-Norway|