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Background  Diagnostic decision making, especially in emergency departments, is a highly complex cognitive process that involves uncertainty and susceptibility to errors. A combination of factors, including patient factors (eg, history, behaviors, complexity, and comorbidity), provider-care team factors (eg, cognitive load and information gathering and synthesis), and system factors (eg, health information technology, crowding, shift-based work, and interruptions) may contribute to diagnostic errors. Using electronic triggers to identify records of patients with certain patterns of care, such as escalation of care, has been useful to screen for diagnostic errors. Once errors are identified, sophisticated data analytics and machine learning techniques can be applied to existing electronic health record (EHR) data sets to shed light on potential risk factors influencing diagnostic decision making.    Objective  This study aims to identify variables associated with diagnostic errors in emergency departments using large-scale EHR data and machine learning techniques.    Methods  This study plans to use trigger algorithms within EHR data repositories to generate a large data set of records that are labeled  trigger-positive  or  trigger-negative,  depending on whether they meet certain criteria. Samples from both data sets will be validated using medical record reviews, upon which we expect to find a higher number of diagnostic safety events in the trigger-positive subset. Machine learning will be used to evaluate relationships between certain patient factors, provider-care team factors, and system-level risk factors and diagnostic safety signals in the statistically matched groups of trigger-positive and trigger-negative charts.    Results  This federally funded study was approved by the institutional review board of 2 academic medical centers with affiliated community hospitals. Trigger queries are being developed at both organizations, and sample cohorts will be labeled using the triggers. Machine learning techniques such as association rule mining, chi-square automated interaction detection, and classification and regression trees will be used to discover important variables that could be incorporated within future clinical decision support systems to help identify and reduce risks that contribute to diagnostic errors.    Conclusions  The use of large EHR data sets and machine learning to investigate risk factors (related to the patient, provider-care team, and system-level) in the diagnostic process may help create future mechanisms for monitoring diagnostic safety.    International Registered Report Identifier (IRRID)  DERR1-10.2196/24642

Monitoring Diagnostic Safety Risks in Emergency Departments: Protocol for a Machine Learning Study