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AI-Augmented Skin Cancer Diagnosis in Teledermatoscopy (AIDMel)

K

Karolinska University Hospital

Status

Invitation-only

Conditions

Melanoma
Skin Cancer

Treatments

Other: AI assistance

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

30 participants in 3 patient groups

Workflow 1
No Intervention group
Description:
Standard of care
Workflow 2
Experimental group
Description:
Consult with AI assistance
Treatment:
Other: AI assistance
Workflow 3
Experimental group
Description:
First workflow 1, then workflow 2
Treatment:
Other: AI assistance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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