Abstract:Machine learning (ML) in medicine has transitioned from research to concrete applications aimed at supporting several medical purposes like therapy selection, monitoring and treatment. Acceptance and effective adoption by clinicians and patients, as well as regulatory approval, require evidence of trustworthiness. A major factor for the development of trustworthy AI is the quantification of data quality for AI model training and testing. We have recently proposed the METRIC-framework for systematically evaluating the suitability (fit-for-purpose) of data for medical ML for a given task. Here, we operationalize this theoretical framework by introducing a collection of data quality metrics - the metric library - for practically measuring data quality dimensions. For each metric, we provide a metric card with the most important information, including definition, applicability, examples, pitfalls and recommendations, to support the understanding and implementation of these metrics. Furthermore, we discuss strategies and provide decision trees for choosing an appropriate set of data quality metrics from the metric library given specific use cases. We demonstrate the impact of our approach exemplarily on the PTB-XL ECG-dataset. This is a first step to enable fit-for-purpose evaluation of training and test data in practice as the base for establishing trustworthy AI in medicine.
Abstract:We introduce a novel wearable textile-garment featuring an innovative electrode placement aimed at minimizing noise and motion artifacts, thereby enhancing signal fidelity in Electrocardiography (ECG) recordings. We present a comprehensive, sex-balanced evaluation involving 15 healthy males and 15 healthy female participants to ensure the device's suitability across anatomical and physiological variations. The assessment framework encompasses distinct evaluation approaches: quantitative signal quality indices to objectively benchmark device performance; rhythm-based analyzes of physiological parameters such as heart rate and heart rate variability; machine learning classification tasks to assess application-relevant predictive utility; morphological analysis of ECG features including amplitude and interval parameters; and investigations of the effects of electrode projection angle given by the textile / body shape, with all analyzes stratified by sex to elucidate sex-specific influences. Evaluations were conducted across various activity phases representing real-world conditions. The results demonstrate that the textile system achieves signal quality highly concordant with reference devices in both rhythm and morphological analyses, exhibits robust classification performance, and enables identification of key sex-specific determinants affecting signal acquisition. These findings underscore the practical viability of textile-based ECG garments for physiological monitoring as well as psychophysiological state detection. Moreover, we identify the importance of incorporating sex-specific design considerations to ensure equitable and reliable cardiac diagnostics in wearable health technologies.