Pediatric multi-parameter monitors use different alarm thresholds and algorithms than adult modes.
the verdict
INSUFFICIENT LEANING
refutedsupported
the weight of evidence
3 sources for · 0 against
Available literature discusses pediatric alarm thresholds and patient-specific algorithm adaptations separately, but provides only partial support regarding multi-parameter monitors.
Background: Using machine learning to combine wrist accelerometer (ACM) and electrodermal activity (EDA) has been shown effective to detect primarily and secondarily generalized tonic-clonic seizures, here termed as convulsive seizures (CS). A prospective study was conducted for the FDA clearance of an ACM and EDA-based CS-detection device based on a predefined machine learning algorithm. Here we present its performance on pediatric and adult patients in epilepsy monitoring units (EMUs). Methods: Patients diagnosed with epilepsy participated in a prospective multi-center clinical study. Three board-certified neurologists independently labeled CS from video-EEG. The Detection Algorithm was evaluated in terms of Sensitivity and false alarm rate per 24 h-worn (FAR) on all the data and on only periods of rest. Performance were analyzed also applying the Detection Algorithm offline, with a less sensitive but more specific parameters configuration (“Active mode”). Results: Data from 152 patients (429 days) were used for performance evaluation (85 pediatric aged 6–20 years, and 67 adult aged 21–63 years). Thirty-six patients (18 pediatric) experienced a total of 66 CS (35 pediatric). The Sensitivity (corrected for clustered data) was 0.92, with a 95% confidence interval (CI) of [0.85-1.00] for the pediatric population, not significantly different (p > 0.05) from the adult population's Sensitivity (0.94, CI: [0.89–1.00]). The FAR on the pediatric population was 1.26 (CI: [0.87–1.73]), higher (p < 0.001) than in the adult population (0.57, CI: [0.36–0.81]). Using the Active mode, the FAR decreased by 68% while reducing Sensitivity to 0.95 across the population. During rest periods, the FAR's were 0 for all patients, lower than during activity periods (p < 0.001). Conclusions: Performance complies with FDA's requirements of a lower bound of CI for Sensitivity higher than 0.7 and of a FAR lower than 2, for both age groups. The pediatric FAR was higher than the adult FAR, likel
The Detection Algorithm was evaluated in terms of Sensitivity and false alarm rate per 24 h-worn (FAR) on all the data and on only periods of rest. Performance were analyzed also applying the Detection Algorithm offline, with a less sensitive but more specific parameters configuration (“Active mode”). Results: Data from 152 patients (429 days) were used for performance evaluation (85 pediatric aged 6–20 years, and 67 adult aged 21–63 years). Thirty-six patients (18 pediatric) experienced a total of 66 CS (35 pediatric).
The Sensitivity (corrected for clustered data) was 0.92, with a 95% confidence interval (CI) of [0.85-1.00] for the pediatric population, not significantly different ( p > 0.05) from the adult population's Sensitivity (0.94, CI: [0.89–1.00]). The FAR on the pediatric population was 1.26 (CI: [0.87–1.73]), higher ( p < 0.001) than in the adult population (0.57, CI: [0.36–0.81]). Using the Active mode, the FAR decreased by 68% while reducing Sensitivity to 0.95 across the
Conclusions: Performance complies with FDA's requirements of a lower bound of CI for Sensitivity higher than 0.7 and of a FAR lower than 2, for both age groups. The pediatric FAR was higher than the adult FAR, likely due to higher pediatric activity. The high Sensitivity and precision (having no false alarms) during sleep might help mitigate SUDEP risk by summoning caregiver intervention. The Active mode may be advantageous for some patients, reducing the impact of the FAR on daily life. Future work will examine the performance and usability outside of EMUs.
In section Performance Analysis, the performance metrics are presented for the two different operating points, with a particular emphasis on the FDA-cleared mode. The performance analyses are presented over three groupings of the test data: for all the patients, for pediatric ( 6 – 20 ), and for adult patients (21+). Finally, we present the performance of the seizure detection system during rest, as computed by the automated rest detection algorithm, and show the results for all three groupings. Statistical Tests Specific statistical tests were performed to establish whether different populations (pediatric vs. adult groups) and behavioral or environmental conditions (rest vs.
(B) Precision-Recall (PR) curve with 95% confidence intervals (dotted lines). (C) Sensitivity (violet) and FAR (yellow) curves with 95% confidence intervals (dotted lines). All curves were obtained by varying the operating point of the Detection Algorithm. Two operating points are highlighted in each curve, corresponding to “FDA-cleared” mode (blue circles) and “Active” mode (green circles). Figure 4 shows the detected CS and the FAR for each patient in the Test Cohort, grouped according to the operating point of the Detection Algorithm and the age group. In the Active mode, most patients experienced no false alarms (72 and 63% for pediatric and adult patients, respectively, had FAR = 0).
In the FDA-cleared mode, an individual FAR of 0 was experienced by 47 and 46% for pediatric and adult patients, respectively. Figure 4 (A) Number of CS (gray) and the number of detected CS for each of the 36 patients experiencing CS, grouped according to the operating point of the Detection Algorithm and the age group. (B) Distribution of the individual FAR for the “FDA-cleared” mode. (C) Distribution of the individual FAR for the “Active” mode.
This work further contributes to the field detailed analyses examining performance differences between pediatric and adult patients, between rest and active conditions, and using two different operating modes of the automated algorithm (both defined a priori during the previous training phase of the Detection Algorithm and fixed and frozen before applying them to the test data here). To the authors' knowledge, these types of analyses are novel and provide an expanded understanding of the capabilities and potential shortcoming of the wearable multimodal system under investigation.
Bedside monitors are intended as a safety net in patient care, but their management in the inpatient setting is a significant patient safety concern. The low precision of vital sign alarm systems leads to clinical staff becoming desensitized to the sound of the alarm, a phenomenon known as alarm fatigue. Alarm fatigue has been shown to increase response time to alarms or result in alarms being ignored altogether and has negative consequences for patient safety. We present methods to establish personalized thresholds for heart rate and respiratory rate alarms. These thresholds are first chosen based on patient characteristics available at the time of admission and are then adapted to incorporate vital signs observed in the first 2 hours of monitoring. We demonstrate that the adapted thresholds are similar to those chosen by clinicians for individual patients and would result in fewer alarms than the currently used age-based thresholds. Personalized vital sign alarm thresholds can help to alleviate the problem of alarm fatigue in an inpatient setting while ensuring that all critical vital signs are detected.
1846 bii Biomedical Informatics Insights Biomed Inform Insights SAGE Publications PMC6330722 6330722 6330722 30675101 10.1177/1178222618818478 Incorporating Observed Physiological Data to Personalize Pediatric Vital Sign Alarm Thresholds Poole Sarah 1 Shah Nigam 1 ✉ 1 Stanford Center for Biomedical Informatics Research, Stanford University, Stanford, CA, USA ✉ Nigam Shah, Stanford Center for Biomedical Informatics Research, Stanford University, MSOB, 1265 Welch Road, Stanford, CA 94305, USA.
This study focuses on addressing alarm fatigue in a pediatric population, as the change in vital signs with age results in higher inter-patient variation compared to the adult population. 17 , 20 Research has shown that the default heart rate alarm thresholds in a pediatric hospital often fall near the 50th percentile of heart rate values observed in the population, 18 , 21 causing alarms to be triggered for over half of the observed heart rates for some patients. Our previous work used nurse-charted vital sign data to choose population-specific vital sign alarm thresholds.
(B) The heart rate values that would trigger an alarm if the observed 1st and 99th percentiles of heart rate are used as alarm thresholds. The shaded regions are those that would trigger alarms. Many fewer alarms would sound under this model, and alarms would be triggered for different thresholds for each patient. This study aims to address vital sign alarm fatigue by finding personalized alarm thresholds for heart rate and respiratory rate alarms. Models are trained to find vital sign alarm thresholds on a patient-by-patient basis, rather than using patient groups.
The personalized thresholds are initially built using data available at admission and are adjusted after observation of the patient’s own vital signs over a 2-hour period. A method to evaluate the resulting patient-specific alarm thresholds is also introduced. We identify alarms that had a setting chosen by a physician specifically for the patient of interest and use these alarm settings as the best available standard against which to evaluate our proposed thresholds. Methods Data Two main sources of data were used for this study.
(2) V S 1 % = e − 2 . 3263 σ + μ (3) V S 99 % = e 2 . 3264 σ + μ Model structure Modeling the change in expected vital signs with age is an important component of building personalized alarm thresholds. We use loess models to capture the non-linear variation in the mean and the variance of the vital signs with age. The output of the loess models is then used as input to Bayesian additive regression tree (BART) models, along with additional demographic (age, weight, gender, ethnicity, and race) and diagnostic features (DRG and hospital department).
Once the patient has had their vital signs monitored for 2 hours, we have additional data to inform the expected distribution of vital signs. This 2-hour period length was chosen to give enough time for the patient’s condition to begin to stabilize after being admitted, while still
The parameters defining the posterior distribution can then be calculated using the following equations. A tilde is used to indicate the updated parameters of the distribution. (8) μ d a t a = 1 n d a t a ∑ i = 1 n d a t a V S i (9) σ d a t a 2 = 1 n n e w ∑ i = 1 n n e w ( V S i − μ d a t a ) 2 (10) α ~ = α ^ n n e w 2 (11) β ~ = β ^ + σ ^ d a t a 2 n d a t a 2 + n d a t a n 0 ( μ d a t a − μ ^ ) 2 2 ( n d a t a + n 0 ) (12) σ ~ 2 = β ~ ( α ~ − 1 ) (13) μ ~ = n d a t a μ d a t a n d a t a + n 0 + n 0 μ ^ n d a t a + n 0 We can then use equations (2) and ( 3 ) to obtain the new suggested alarm thresholds from these updated estimates of the distribution mean and variance.
Note that only alarms that were actually historically triggered are part of this analysis. The dashed lines show the total number of alarms that were triggered. The alarms making up this analysis span a 3.5-year period. Discussion The aim of this study was to find personalized vital sign alarm thresholds for hospitalized pediatric patients without requiring input from clinical staff. One of the challenges to achieving this aim was determining an appropriate target for these thresholds. Due to the lack of a large set of labeled alarms to use in training a model, we needed to use the patient’s observed vital signs to choose targets for the threshold values.
Conclusions In conclusion, this study describes methods to choose personalized heart rate and respiratory rate alarm thresholds for pediatric inpatients. These thresholds are initially chosen based on patient characteristics available at admission and are adapted to incorporate vital signs observed over the first 2 hours of vital sign monitoring. The resulting adapted thresholds are similar to physician-selected thresholds and result in fewer alarms than the currently used thresholds.
Epilepsy affects over 50 million people worldwide, yet automated seizure detection systems either achieve moderate sensitivity with excessive false alarms or rely on uninterpretable deep networks. This study presents a patient-independent EEG-based seizure detection framework that achieved zero false alarms in 24 h with 95% sensitivity in a retrospective evaluation on a CHB-MIT pediatric cohort (<i>n</i> = 6 seizure-positive patients). The pipeline extracts 27 time-, frequency-, and nonlinear-domain features from 5 s windows and trains five ensemble classifiers (XGBoost, CatBoost, LightGBM, Extra Trees, Random Forest) using strict leave-one-subject-out cross-validation. All models achieved segment-level AUC ≥ 0.99. Under zero-false-alarm constraints, XGBoost attained perfect specificity with 0.922 sensitivity. SHAP and LIME analyses suggested candidate EEG biomarkers that appear consistent with known ictal signatures, including temporo-parietal theta-band power, amplitude variability (IQR, RMS), and Hjorth activity. External validation on the Siena Scalp EEG Database (12 adult patients, 37 seizures) demonstrated cross-dataset generalization with 95% event-level sensitivity (Extra Trees) and AUC of 0.86 (Random Forest). Temporal lobe channels dominated feature importance in both datasets, confirming consistent biomarker identification across pediatric and adult populations. These findings demonstrate that calibrated gradient-boosted ensembles using interpretable EEG features achieve clinically safe seizure detection with cross-dataset generalizability.
Cross-dataset external validation: The framework generalized to the Siena Scalp EEG Database, an independent adult focal epilepsy cohort, achieving 95% event-level sensitivity (Extra Trees) and AUC of 0.86 (Random Forest). Temporal lobe features (T3, T4, and T6 skewness and theta-band power) dominated SHAP rankings in both datasets, demonstrating that the identified biomarkers generalize across pediatric and adult populations with different recording equipment and clinical protocols.
[ 19 ] examined dataset limitations, noting the dominance of the CHB–MIT corpus and the gap between benchmark performance and real-world applicability. These reviews highlight the need for interpretable, patient-generalizable
This system can continuously monitor EEG for 24 h or longer without spurious alarms, a prerequisite for deployment in intensive care and ambulatory environments. This supports Hypothesis H 3 : calibrated gradient-boosted ensembles deliver clinically safe, patient-independent seizure detection. 4.8. External Validation on Siena Dataset To evaluate cross-dataset generalization, the trained ensemble classifiers were applied to the Siena Scalp EEG Database using identical preprocessing and feature extraction pipelines. Table 15 summarizes model performance across 12 adult patients with focal epilepsy under LOSO evaluation.
Extra Trees achieved the highest event-level sensitivity, detecting 35 of 37 seizure events (95%), while Random Forest provided the best balance between discrimination (AUC = 0.86) and specificity (90%). The gradient-boosted models (XGBoost, LightGBM) maintained high specificity (>97%) with more conservative detection thresholds. These results demonstrate that the ensemble framework generalizes effectively to an independent dataset with different patient demographics (adult vs. pediatric), recording equipment, and clinical protocols. Table 16 compares performance between within-dataset (CHB–MIT) and external (Siena) evaluation.
Seizure morphology, propagation patterns, and background EEG characteristics differ systematically between pediatric and adult populations. 3. Recording equipment: Different amplifier systems (CHB–MIT: unknown clinical system; Siena: BI 9800 and Galileo NT) introduce site-specific signal characteristics, including noise profiles, filtering responses, and amplitude calibration differences. 4. Power-line interference: CHB–MIT recordings required 60 Hz notch filtering (North American power grid), whereas Siena recordings required 50 Hz filtering (European power grid).
100%) reflects a domain shift between pediatric and adult populations, different recording equipment, and varying seizure morphologies. Site-specific threshold calibration would likely improve specificity for clinical deployment. Future work will evaluate the framework on additional multi-center datasets spanning diverse epilepsy subtypes to establish broader generalizability, as suggested by prior studies [ 4 ]. Temporal dynamics. The analysis operated at the segment level (5 s windows) with limited temporal context. While temporal smoothing improved event-level detection, it did not explicitly model seizure evolution.
Using standardized preprocessing and feature engineering on the CHB–MIT pediatric corpus, the system achieved near-perfect discrimination (AUC ≥ 0.99) with zero false alarms under strict clinical safety constraints. XGBoost provided the best balance of performance and reliability, combining a sensitivity above 90% with perfect specificity, supported by excellent probability calibration. These results demonstrate that multi-domain, physiologically grounded EEG features combined with calibrated gradient-boosted ensembles attain reliable, low-false-alarm performance under patient-independent evaluation.
External validation on the Siena Scalp EEG Database confirmed cross-dataset generalization, with 95% event-level sensitivity and consistent temporal lobe biomarker identification across pediatric and adult populations. Future work incorporating adaptive calibration, temporal modeling, and multi-center validation will be essential for translation into continuous bedside and ambulatory seizure surveillance. Figure 1 Representative scalp EEG segments from the CHB–MIT pediatric database. ( a ) Ten-second interictal segment from patient chb01, channel FP1-F7, showing normal background activity with preserved alpha rhythm.
Everything we examined (3)
This check searched the claim as stated. It did not run a separate search for evidence against it.