Evidence map›Paper›PMID 40033253›Full record

ArticleBMC medical informatics and decision making2025

Reliability and validity of a novel single-lead portable electrocardiogram device for pregnant women: a comparative study.

Haixue Wang, Jianwei Wang, Wei Jing, Shanshan Dai, Deyun Zhang, Shijia Geng, Haijun Wang, Shenda Hong

Abstract readComparative StudyValidation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC medical informatics and decision making, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

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3citing papers in PubMed
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1 · What the graph read from it

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3 · Its place in the literature

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3 citing papers in PubMed.

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4 · The record

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5 · Who and what money

Authors and funding

8 authors.

Haixue Wang *National Institute of Health Data Science, Peking University, Peking University Health Science Center- Weifang Joint Research Center for Maternal and Child Health, Beijing, China.
Jianwei Wang *Weifang Maternal and Child Health Hospital, Peking University Health Science Center-Weifang Joint Research Center for Maternal and Child Health, Weifang, Shandong Province, China.
Wei JingWeifang Maternal and Child Health Hospital, Peking University Health Science Center-Weifang Joint Research Center for Maternal and Child Health, Weifang, Shandong Province, China.
Shanshan DaiWeifang Maternal and Child Health Hospital, Peking University Health Science Center-Weifang Joint Research Center for Maternal and Child Health, Weifang, Shandong Province, China.
Deyun ZhangHeartVoice Medical Technology, Hefei, China.
Shijia GengHeartVoice Medical Technology, Hefei, China.
Haijun WangDepartment of Maternal and Child Health, School of Public Health, Peking University, Peking University Health Science Center-Weifang Joint Research Center for Maternal and Child Health, Beijing, China. whjun1@bjmu.edu.cn.
Shenda HongNational Institute of Health Data Science, Peking University, Beijing, China. hongshenda@pku.edu.cn.

Funding

Beijing Natural Science Foundations QY23040National Natural Science Foundation of China No.62102008
6 · The paper itself

Abstract

backgroundWenXinWuYang, a novel portable Artificial Intelligence Electrocardiogram (AI-ECG) device, can detect many kinds of abnormal heart disease and perform a single-lead ECG, but its reliability and validity among pregnant women is unclear. The aim of this study was to assess the reliability and validity of heart rate, ECG measurements and diagnostic results by compared the portable device with a clinical 12-lead ECG among pregnant women.

methodsWe conducted a clinical study at a municipal-level maternal and child health care hospital. The pregnant women who visited the ECG room for ECG examination were invited to participate in this study. Each participant underwent three ECG recordings: one with conventional 12-lead ECG and two with WenXinWuYang ECG. The first WenXinWuYang ECG was recorded simultaneously with the 12-lead ECG. We collected heart rate, ECG measurements, and diagnostic results related to arrhythmias from both ECG devices. The data were then analyzed using Spearman rank correlation coefficients, consistency analyses, and Bland-Altman plots.

resultsThe study included 287 ECG recordings from 99 pregnant women, with a balanced distribution across different stages of pregnancy. We observed strong to moderate correlations between the two WenXinWuYang measurements for heart rate (r = 0.847), PR interval (r = 0.728), QRS duration (r = 0.636), QT interval (r = 0.836), and QTc interval (r = 0.648), with a diagnostic consistency rate exceeding 90.0%. When compared with the 12-lead ECG, the mean differences for heart rate, PR interval, QRS duration, QT interval, and QTc interval were - 0.4 ± 3.1 bpm (r = 0.957), 14.6 ± 12.4 ms (r = 0.537), 7.0 ± 8.9 ms (r = 0.136), 2.1 ± 12.0 (r = 0.774), and 6.6 ± 16.5 (r = 0.663), respectively. Although the correlation coefficient was low in QRS duration, Bland-Altman results showed moderate to strong agreement between these intervals. Sinus rhythm recognition was fully consistent with the 12-lead ECG, with higher validity in detecting arrhythmias (sensitivity 84.2%, specificity 97.5%). Similar trends existed among different stages of pregnancy.

conclusionWenXinWuYang demonstrated acceptable reliability and validity in measuring heart rate, ECG measurements, and detecting arrhythmias among pregnant women.

Indexed as

Arrhythmias, CardiacArtificial IntelligenceElectrocardiographyAdultFemaleHeart RateHumansPregnancyReproducibility of ResultsYoung Adult12-lead ECGECGPortable deviceReliabilityValidity

Identifiers

PMID40033253
PMCPMC11877860

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