Melanoma, Nevus
Conditions
Keywords
Computer-assisted diagnosis, General practice, Dermatoscopy, Melanoma, Nevus
Brief summary
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
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.
Interventions
DEVICENevus doctor program
The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.
Sponsors
University of Tromso
The Research Council of Norway
University Hospital of North Norway
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pigmented skin lesion
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of correct test results | Up to 2 weeks from enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patterns regarding false test results | Up to 2 weeks from enrollment | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| User-friendliness | 6-8 months after enrollment | Participating GPs are invited to interviews |
Countries
Norway
Outcome results
None listed