Nevus Doctor Clinical Decision Support for GPs

Nevus or Melanoma? Nevus Doctor - Computer Aided Clinical Decision Support in Primary Health Care

The study investigates if a computer-based clinical decision support tool for skin cancer may improve the diagnostic accuracy of general practitioners (GPs). The aim of the program is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious skin lesions that need biopsy or referral to specialist health care for further assessment. Half of the physicians in the trial will have the clinical decision support tool available during consultations, while the other half has no such tool available. We hypothesize that general practitioners using the clinical decision support tool will have a higher number of correct classifications of skin lesions compared to doctors without the tool.

Study Overview

• Status: Completed
• Conditions: Melanoma (Skin); Actinic Keratoses; Non-melanoma Skin Cancer
• Intervention / Treatment: Diagnostic test: Nevus doctor clinical decision support

Detailed Description

General practitioners (GPs) examine patients who attend a primary health care center. In the intervention group the computer-based clinical decision support tool "Nevus doctor" in a first step assists doctors in the process of selecting skin lesions that are suggestive of cancer. In the next step a given skin lesion is photographed using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program "Nevus doctor" and a preliminary result is presented. Finally the GP reviews the result and assesses the clinical significance of the output by using guidelines presented by "Nevus doctor". The patient is subsequently referred to a dermatologist and a complete skin examination is performed. The assessment of the dermatologist serves as the gold standard.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Troms
    • Tromsø, Troms, Norway, 9038
      • University Hospital of North-Norway

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients concerned about one or several skin lesion(s)
• Patients with any other condition if doctor has observed a skin lesion suspicious for skin cancer (incl. actinic keratosis)

Exclusion Criteria:

• Patients not able to give consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nevus doctor clinical decision support; The GPs have access to the clinical decision support tool "Nevus doctor".	Diagnostic test: Nevus doctor clinical decision support; The computer program analyzes dermatoscopic images. The output is an estimate of the risk of the skin lesion representing skin cancer. The decision support tool helps the doctor to assess the significance of the computer output by taking into account clinical information.
No Intervention: Control; The GPs have no access to the clinical decision support tool "Nevus Doctor".

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic classification of suspicious skin lesions	Skin lesions selected by the GP are classified into three classes: 1 Not suspicious for skin cancer, 2 Somewhat suspicious for skin cancer, 3 Very suspicious for skin cancer. The reference standard is the specialist's classification. The number of correct classifications are counted. Sensitivity and specificity scores are calculated.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin lesions not classified by GPs	Skin lesions that were not selected by the GP but were later classified by the specialist to be suspicious for skin cancer or very suspicious for skin cancer are counted.	Up to 3 months
Biopsies and excisions	Skin lesions biopsied or excised by the GP are counted.	Up to 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
User experience	The GPs are asked to answer a questionnaire to assess the user experiences of operating the clinical decision support tool.	Up to 12 months.

Collaborators and Investigators

• Sponsor: University Hospital of North Norway
• Investigators: Principal Investigator: Thomas Schopf, PhD, University Hospital of North Norway

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2018
• Primary Completion (Actual): December 12, 2019
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: August 8, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 6, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Precancerous Conditions; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Melanoma; Keratosis, Actinic; Keratosis
• Other Study ID Numbers: 2013/1793

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No