A Human-Centered AI Framework for Efficient Labelling of ECGs from Drug Safety Trials.

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Abstract

Drug safety trials require substantial ECG labelling like, in thorough QT studies, measurements of the QT interval, whose prolongation is a biomarker of proarrhythmic risk. The traditional method of manually measuring the QT interval is time-consuming and error-prone. Studies have demonstrated the potential of deep learning (DL)-based methods to automate this task but expert validation of these computerized measurements remains of paramount importance, particularly for abnormal ECG recordings. In this paper, we propose a highly automated framework that combines such a DL-based QT estimator with human expertise. The framework consists of 3 key components: (1) automated QT measurement with uncertainty quantification (2) expert review of a few DL-based measurements, mostly those with high model uncertainty and (3) recalibration of the unreviewed measurements based on the expert-validated data. We assess its effectiveness on 3 drug safety trials and show that it can significantly reduce effort required for ECG labelling-in our experiments only 10% of the data were reviewed per trial-while maintaining high levels of QT accuracy. Our study thus demonstrates the possibility of productive human-machine collaboration in ECG analysis without any compromise on the reliability of subsequent clinical interpretations.