This study will evaluate the performance of specialist physicians in interpreting normal electrocardiograms (ECGs) with and without the assistance of an artificial intelligence (AI) neural network. The primary aim is to determine whether AI support affects the rate of false-positive interpretations of normal tracings. Secondary aims include evaluating the time required for interpretation, the sensitivity for detecting abnormalities, and the effect on false positives in ECGs with major abnormalities according to the Minnesota Code system. All ECGs in the sample will be reviewed by a panel of three specialists, to determine the reference classification.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
710
Neural network-based AI software that analyzes ECG tracings and provides a classification as normal suggestion to the interpreting specialist.
Manual interpretation of ECGs by specialists without AI support, following standard diagnostic procedures
Precision (Positive Predictive Value) for detection of normal ECG tracings
Precision (Positive Predictive Value) of detecting normal ECG by the physician or physician+model compared against the reference standard defined by a panel of three specialists. Precision (Positive Predictive Value) is defined by the number of true positive normal cases divided by all positive predictions.
Time frame: One week
Sensitivity, Specificity, Negative Predictive Value, and F1 score for detection of normal ECG tracings
Accuracy evaluated by Sensitivity, Specificity, Negative Predictive Value, and F1 score of normal ECGs correctly identified by the physician or physician+model, in relation to a reference standard defined by a panel of three specialists.
Time frame: One week
ECGs with major abnormalities incorrectly classified as normal
Ratio of ECGs with major abnormalities according to the Minnesota Code system among those incorrectly classified as normal by the physician or physician+model, in relation to a reference standard defined by a panel of three specialists.
Time frame: One week
Time of analysis for normal cases (seconds per case)
Time required by the physician, or physician+model, to interpret normal ECGs, measured in seconds per case; the reference standard of normal cases defined by a panel of three specialists.
Time frame: One week
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