Base Model
OtherSee arm description.
Other names: Intervention 1
NCT Number: NCT07468357
The goal of this randomized controlled study is to compare the effect of a new, personalized uncertainty-aware decision model (FDM) to a standard image recognition model in improving the diagnostic accuracy while reducing diagnostic uncertainty in experienced dermatologists tasked with differentiating between melanomas, moles and other benign skin lesions. The main question it aims to answer: Is the FDM a feasible method for an improved human AI partnership in which trust is build, misdiagnoses are avoided, and uncertainty is duly introduced or reduced.
The investigators expect to see only a slight increase in collective diagnostic accuracy for both interventions as the the human participants are skilled dermatologist and thus have high accuracies pre-intervention.
The investigators expect to see a higher increase in diagnostic certainty for the FDM intervention compared to the diagnostic certainty in the Base Model intervention.
The investigators expect to see a higher amount of diagnosis changes from incorrect to correct in the FDM group compared to the Base Model group.
The investigators do not expect any learning effect during the study.
Participants will start by answering a series of training cases consisting of images of skin lesions. These are used to train their individual FDM (only for the FDM-intervention group). From here, the participants will be randomized into two arms determining which of the two interventions they are exposed to. The participants will solve each case withouth any intervention first, and this reply will act as a control.
Trial opening soon.
Get NotifiedA detailed description of the FDM is presented in the references.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
See arm description.
Other names: Intervention 1
See arm description
Other names: Final Decision Model, Intervention 2
Time frame: Immediately after the intervention.
Diagnostic accuracy in differentiating between melanoma, nevus, and benign keratosis. Defined as the percentage of correct diagnoses. Ground truth is based on histopathologically verified diagnoses.
Time frame: Immediately after the intervention.
Changes in self-assesed uncertainty ranging from 0 (very uncertain) to 10 (very certain) from pre- to post-intervention.
Time frame: Immediately after the intervention.
The self-assessed uncertainty of cases where the participant has clicked a "would you like to discuss this case with a collegue"-button.
Time frame: Immediately after the intervention.
Time from the start to finish of each case with a split time corresponding to the end of the control phase (the time "Show AI input"-button is clicked).
Contact information is provided by the study sponsor or research team.
Copenhagen Academy for Medical Education and Simulation
Other
The Effect of Human-AI Uncertainty Calibration vs. AI Uncertainty Alone on the Diagnostic Accuracy of Human Experts for Skin Lesions - a Randomized Controlled Trial.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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