RESUMO
BACKGROUND: Clinical decision support systems (CDSS) have the potential to lower the patient mortality and morbidity rates. However, signal artifacts present in physiological data affect the reliability and accuracy of the CDSS. Moreover, patient monitors and other medical devices generate false alarms while processing physiological data, further leading to alarm fatigue because of increased noise levels, staff disruption, and staff desensitization in busy critical care environments. This adversely affects the quality of care at the patient bedside. Hence, artifact detection (AD) algorithms play a crucial role in assessing the quality of physiological data and mitigating the impact of these artifacts. OBJECTIVE: The aim of this study is to evaluate a novel AD framework for integrating AD algorithms with CDSS. We designed the framework with features that support real-time implementation within critical care. In this study, we evaluated the framework and its features in a false alarm reduction study. We developed static framework component models, followed by dynamic framework compositions to formulate four CDSS. We evaluated these formulations using neonatal patient data and validated the six framework features: flexibility, reusability, signal quality indicator standardization, scalability, customizability, and real-time implementation support. METHODS: We developed four exemplar static AD components with standardized requirements and provisions interfaces that facilitate the interoperability of framework components. These AD components were mixed and matched into four different AD compositions to mitigate the artifacts' effects. We developed a novel static clinical event detection component that is integrated with each AD composition to formulate and evaluate a dynamic CDSS for peripheral oxygen saturation (SpO2) alarm generation. This study collected data from 11 patients with diverse pathologies in the neonatal intensive care unit. Collected data streams and corresponding alarms include pulse rate and SpO2 measured from a pulse oximeter (Masimo SET SmartPod) integrated with an Infinity Delta monitor and the heart rate derived from electrocardiography leads attached to a second Infinity Delta monitor. RESULTS: A total of 119 SpO2 alarms were evaluated. The lowest achievable SpO2 false alarm rate was 39%, with a sensitivity of 80%. This demonstrates the framework's utility in identifying the best possible dynamic composition to serve the clinical need for false SpO2 alarm reduction and subsequent alarm fatigue, given the limitations of a small sample size. CONCLUSIONS: The framework features, including reusability, signal quality indicator standardization, scalability, and customizability, allow the evaluation and comparison of novel CDSS formulations. The optimal solution for a CDSS can then be hard-coded and integrated within clinical workflows for real-time implementation. The flexibility to serve different clinical needs and standardized component interoperability of the framework supports the potential for a real-time clinical implementation of AD.