Clinical trial NCT06080711: AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy
Official title: AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Skin Cancer
Melanoma
Keywords: melanoma
artificial intelligence
AI augmentation
deep learning
teledermatoscopy
dermatoscopy
skin cancer
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Medical University of Vienna
name: Stockholm School of Economics
First posted: 2023-10-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: In this study an artificial intelligence (AI) tool for skin cancer diagnosis is implemented in a teleldermatoscopy platform. The aim is to study the effects on clinician diagnostic accuracy, management decisions, and confidence. Furthermore, this prospective randomized study investigates the role of human factors in determining clinician reliance on AI tools and the consequent accuracy in a real-world setting.

Detailed description: Deep-learning algorithms can potentially benefit many areas in healthcare, including the diagnosis of skin cancer using teledermatoscopy. However, there is a dearth of clinical, prospective research on human-AI interaction in diagnostic tasks that take human factors into account.

In this study we will examine the impact of such factors in a real-world setting where we integrate an algorithm in an existing teledermatoscopy platform that is used clinically at a tertiary hospital in Sweden. We will investigate what impact various implementations of AI tool output in relation to human factors have on diagnostic accuracy and management decisions.

Study subjects are recruited at the Department of Dermatology at Karolinska University Hospital and will be asked to rate prospective teledermatoscopic consults with and without AI-support. Each consult will be randomized into one of three workflows with or without one pre-defined implementation of the AI tool. Study subjects are also asked to complete two surveys with demographic information and questions relating to various human factors. Patients participating in the study will be diagnosed outside the study prior to inclusion without any involvement of an AI tool, notably by two experienced dermatologists who do not participate as study subjects.

Eligibility criteria: Inclusion Criteria:

* Licensed physician
* Working at a dermatology clinic
* Sufficient knowledge in Swedish
* Written consent to participate

Exclusion Criteria:

* No experience of using dermatoscopy
* Does not wish to participate
* Incomplete answers
* Physicians that are involved in the patients' clinical care relating to the teledermoscopical consult

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: 1 year
measure: Accuracy of management decisions
timeFrame: 1 year
measure: Tendency to change initial diagnosis or management decision
timeFrame: 1 year
measure: Self-reported confidence in diagnosis and management decisions
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
Study officials:
References: