Evaluation of Measurement Reliability and Agreement of a Wearable ECG Device (HEH) Compared with a Standard ECG Device
Abstract
Objectives: This study aimed to evaluate the measurement reliability and agreement of a wearable electrocardiogram (ECG) device (HEH) compared with a standard 12-lead ECG device (FX) to validate its clinical utility in Korean medicine practice.Methods: In a randomized sequential method-comparison study of 94 adults, ECG parameters were sequentially measured using both the HEH and FX devices during a single visit. Primary efficacy variables were heart rate, RR interval, and QRS interval. Secondary efficacy variables were the PR interval, QT interval, QTc interval, and axis. Inter-device reliability and agreement were assessed using the Intraclass Correlation Coefficient (ICC; two-way mixed model, absolute agreement) and Bland-Altman plots. Results: HEH demonstrated excellent reliability for the primary efficacy variables (ICC>0.90) and good reliability for the secondary efficacy variables (ICC>0.87). Bland-Altman analysis revealed that the mean difference was near zero for all variables. The mean difference for heart rate fell within the allowable limits defined by ANSI/AAMI/IEC 60601-2-27:2011. The mean differences for the QRS, PR, and QT intervals fell within the allowable limits defined by the KS C IEC 60601-2-25 CSE study criteria. Axis showed good ICC (0.876) but a relatively higher mean absolute difference (MAD=13.1°).Conclusions: The HEH device demonstrates high reliability and agreement comparable to those of the standard ECG device (FX). These findings suggest that…
How strong is the evidence?
Evidence Hub reads this as a randomized trial. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 94 participants or records.
Read the paper
Related studies
- Antioxidant efficacy and the upregulation of Nrf2-mediated HO-1 expression by (+)-lariciresinol, a lignan isolated from Rubia philippinensis, through the activation of p38
- Anti-influenza virus activity of green tea by-products in vitro and efficacy against influenza virus infection in chickens
- Therapeutic Potential of Mesenchymal Stem Cells (MSCs) and MSC-Derived Extracellular Vesicles for the Treatment of Spinal Cord Injury
- The intratumoral administration of ferucarbotran conjugated with doxorubicin improved therapeutic effect by magnetic hyperthermia combined with pharmacotherapy in a hepatocellular carcinoma model
- Enhanced anticancer efficacy of TRAIL-conjugated and odanacatib-loaded PLGA nanoparticles in TRAIL resistant cancer
- In vivo tracking of bioorthogonally labeled T-cells for predicting therapeutic efficacy of adoptive T-cell therapy
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.