AI-enabled electrocardiogram alert for potassium imbalance treatment: a pragmatic randomized controlled trial

Figures

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  Fig. 1. CONSORT-AI flow diagram. AIDE alert context: “An ECG from patient X indicates a high risk for hyperkalemia/hypokalemia. The estimated ECG-K+ is X. Please assess patient data to arrange suitable treatment. According to the previous study, you may also need to assess the risk of cardiac events. Please click on the following link to connect the ECG and the result of AI-ECG prediction.” ED emergency department, ECG electrocardiography, AIDE artificial intelligence-enabled dyskalemia using electrocardiogram.

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  Fig. 2. Prospective accuracy of AIDE for estimating blood potassium. This analysis included only ECGs with an associated Lab-K+ collection within 1 hour of the ECG examination (n = 11,547; 5781 in the intervention group and 5766 in the control group), regardless of whether the blood sample was drawn before or after the ECG. Data from patients whose Lab-K+ measurements were obtained >1 hour apart or after treatment were excluded. We combined the intervention and control groups in this analysis. The ROC curve and PRROC curve were used to determine the performance of AIDE for hyperkalemia (Lab-K+ ≥6.0 mmol/L, a and hypokalemia (Lab-K+ ≤3.0 mmol/L, b), respectively. The cutoff points were determined as previously expected to have a positive predictive value of 40%. Scatter plots (c) and Bland–Altman plots (d) were used to compare the Lab-K+ and ECG-K+ values. Red points represent the highest density, followed by yellow, green, light blue, and dark blue. AUC area under the curve, Diff mean difference, r Pearson correlation, MAE mean absolute error, Sens. sensitivity, Spec. specificity, PPV positive predictive value, NPV negative predictive value, PRAUC precision recall curve. Source data are…

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  Fig. 3. Prespecified primary analysis. All the significance tests were based on the Cox proportional hazard mixed effect model. a The overall effect of AIDE intervention on hyperkalemia-related treatment, including drugs (calcium chloride, insulin, potassium binding resin, β2-agonist, loop diuretics, or sodium bicarbonate) and hemodialysis, within 3 hours. b Effect of AI-ECG intervention stratified by AIDE prediction (ECG-hyperkalemia and non-ECG-hyperkalemia). For patients identified as having ECG-hyperkalemia in the intervention group, the corresponding physician received a “pop-up” alert in the hospital information system. Since the prespecified treatments for ECG-hypokalemia differ from those for ECG-hyperkalemia, we combined ECG-hypokalemia and ECG-normal into ECG-non-hyperkalemia in this analysis. We highlighted the difference within 1 and 2 hours. c The overall effect of AIDE intervention on hypokalemia-related treatment, including intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride, within 3 hours. d The effect of AI-ECG intervention stratified by AIDE prediction (ECG-hypokalemia and non-ECG-hypokalemia). For patients identified as having…

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  Fig. 4. Safety outcomes and clinical outcomes stratified by AIDE predictions. The total sample size consisted of 14,989 patients (7506 in the intervention group and 7483 in the control group). Within this cohort, the subgroup sizes were as follows: ECG-hyperkalemia (n = 158), ECG-hypokalemia (n = 364), and ECG-normal (n = 14,467). The error bars denote 95% confidence intervals. All the significance tests were based on the Cox proportional hazard mixed effect model. Each p value was two-sided, with no adjustment for multiple comparisons. a Results for the overall population. b Prespecified subgroup analyses of AI-ECG prediction. The p value for interactions was two-sided, with no adjustment for multiple comparisons. For treatment-induced hypokalemia, we included only events after hyperkalemia-related treatment (calcium chloride, insulin, potassium-binding resin, β2-agonist, loop diuretics, sodium bicarbonate, or hemodialysis). For treatment-induced hyperkalemia, we included only events that occurred after hypokalemia-related treatment (intravenous potassium chloride, oral potassium gluconate, and oral potassium chloride). In the analysis for discharge within 14 days, patients who were not…

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  Fig. 5. Flow diagram of the emergency department workflow. a A flow chart of the emergency department process, starting with the ED visit and triage. Depending on the triage level and symptoms, an ECG may be performed prior to physician assessment. The physician then evaluates the patient and, as appropriate, orders further tests, including potassium measurements. This may lead to additional medical orders and an examination report. b Four examples of different patient timelines for hyperkalemia demonstrate how ECG, laboratory tests, physician assessments, and AI-ECG alerts (AIDE) can occur in different scenarios. Patient 1 undergoes an ECG and laboratory test around the same time, with treatment prior to the laboratory report; Patient 2 receives an ECG and is treated on the basis of the AI-ECG alert prior to laboratory testing; Patient 3 receives an ECG and is treated on the basis of subsequent laboratory testing and reports; Patient 4 undergoes a laboratory test with hyperkalemia and is treated after the AIDE alert.