Accuracy, Clinical Utility, and Usability of a Wireless Self-Guided Fetal Heart Rate Monitor.
Accuracy, Clinical Utility, and Usability of a Wireless Self-Guided Fetal Heart Rate Monitor.
复制标题
无线自引导胎儿心率监测器的准确性，临床实用性和可用性。
DOI：
10.1097/aog.0000000000004322
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发表时间：
2021-04-01
影响因子：
7.2
通讯作者：
Neppe C
中科院分区：
文献类型：
--
作者：
Porter P;Muirhead F;Brisbane J;Schneider B;Choveaux J;Bear N;Carson J;Jones K;Silva D;Neppe C
无线胎儿心率监测仪的评估表明，与胎心宫缩描记法评估的心率高度一致，并且可以在家中使用。评估无线胎儿和母亲心率监测仪监测胎儿心率 (FHR) 的准确性、临床实用性和可用性。我们对 18 岁或以上单胎妊娠至少 12 周的女性进行了一项前瞻性、单中心研究。使用心跳监测器和心宫监护仪进行胎心率记录以评估准确性。临床医生在诊所使用心跳监测器。女性在诊所或家中无需协助即可使用该设备。产科医生评估了胎心率曲线的临床效用。女性使用系统可用性量表对心跳监测器进行评分。共有 81 名参与者提供了 126 段录音。与胎心监护仪相比，心率监测仪的准确性非常出色，平均 FHR 的一致性限度 (95%) 在每分钟心跳数 (bpm) -1.6 (CI -2.0 至 1.3) 和 +1.0 (CI 0.7–1.4) 之间，平均差值 -0.3 bpm，组内系数 0.99。在所有情况下均检测到胎心率。临床医生检测胎心率的中位数（四分位距）为 0.5 (0.2–1.2) 分钟，在 95% (39/41) 的情况下获得了超过 1 分钟的连续轨迹。家庭用户检测胎心率的中位时间为 0.5 (0.2–2.0) 分钟，在 92% (24/26) 的情况下获得超过 1 分钟的连续追踪，总追踪时间中位为 4.6 (4.4–4.8) 分钟。 100% (55/55) 的临床医生和 97% (31/32) 的家庭录音认为这些痕迹在临床上有用。心跳监视器的可用性和易学性排名在 96-100%。心跳监测器准确且易于临床医生和参与者使用。在家记录的数据相当于使用当前低风险妊娠评估协议获得的数据，可能允许该设备用于远程医疗咨询。澳大利亚新西兰临床试验注册中心，ACTRN12620000739910。本研究中使用的 HeraBEAT 设备由 HeraMED Pty Ltd（HeraMED，内坦亚，以色列）借用。该研究得到了 PHI 研究小组（非营利性）的支持，该小组负责统计师费用和研究助理的工资。 Joondalup Health Campus 向 PHI 研究小组提供基础设施支持和 IT 实物服务。
Evaluation of a wireless fetal heart rate monitor demonstrates high agreement with heart rate, as assessed by cardiotocography, and is feasible for use at home. To evaluate the accuracy, clinical utility, and usability of a wireless fetal and maternal heartbeat monitor to monitor fetal heart rate (FHR). We conducted a prospective, single-center study of a convenience sample of women aged 18 years or older with a singleton pregnancy of at least 12 weeks of gestation. Fetal heart rate recordings were performed using both the heartbeat monitor and cardiotocography to evaluate accuracy. Clinicians used the heartbeat monitor in the clinic. Women used the device, unassisted, during a clinic visit or at home. Obstetricians assessed the clinical utility of FHR traces. Women rated the heartbeat monitor using the System Usability Scale. A total of 81 participants provided 126 recordings. The accuracy of the heartbeat monitor was excellent compared with cardiotocography, with limits of agreement (95%) for mean FHR between −1.6 (CI −2.0 to 1.3) and +1.0 (CI 0.7–1.4) beats per minute (bpm), mean difference −0.3 bpm, intraclass coefficient 0.99. The FHR was detected on all occasions. Clinicians took a median (interquartile range) of 0.5 (0.2–1.2) minutes to detect the FHR, obtaining a continuous trace of longer than 1 minute in 95% (39/41) of occasions. Home users took a median of 0.5 (0.2–2.0) minutes to detect the FHR, obtaining a continuous trace of longer than 1 minute in 92% (24/26) of occasions, with a median total trace time of 4.6 (4.4–4.8) minutes. The traces were deemed clinically useful in 100% (55/55) of clinician and 97% (31/32) of home recordings. The heartbeat monitor ranked in the 96–100th percentile for usability and learnability. The heartbeat monitor was accurate and easy for clinicians and participants to use. Data recorded at home were equivalent to those obtained using current assessment protocols for low-risk pregnancies, potentially allowing the device to be used in telehealth consultations. Australian New Zealand Clinical Trial Registry, ACTRN12620000739910. The HeraBEAT devices used in this study were loaned by HeraMED Pty Ltd (HeraMED, Netanya, ISRAEL). The study was supported by PHI Research Group (not-for-profit), which was responsible for Statistician fees and Research Assistants' salaries. Joondalup Health Campus provided infrastructure support, and IT services in-kind to the PHI research group.