Clinical accuracy of the Omron M3 Comfort(®) and the Omron Evolv(®) for self-blood pressure measurements in pregnancy and pre-eclampsia - validation according to the Universal Standard Protocol.
Clinical accuracy of the Omron M3 Comfort(®) and the Omron Evolv(®) for self-blood pressure measurements in pregnancy and pre-eclampsia - validation according to the Universal Standard Protocol.
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DOI：
10.2147/vhrm.s165524
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发表时间：
2018
影响因子：
2.9
通讯作者：
Asmar R
中科院分区：
文献类型：
--
作者：
Topouchian J;Hakobyan Z;Asmar J;Gurgenian S;Zelveian P;Asmar R
用于血压（BP）测量的电子设备需要根据不同当局的建议进行独立的临床验证，无论是在一般人群还是在特殊人群（如怀孕）中。根据通用标准确认方案，评估Omron Evolv®（HEM-7600 T-E）和Omron M3 Comfort®（HEM-7134-E）设备在妊娠和先兆子痫中的准确性。Evolv和M3 Comfort这两种器械均采用血压计法在肱动脉水平测量血压。该研究是根据最近发表的方案进行的，即所谓的“改良的医疗器械进步（AAMI）/英国高血压协会（BHS）/欧洲高血压协会（ESH）方案”或“通用标准方案”。每种装置的验证包括45名妊娠中期和妊娠晚期的孕妇，其中15名患有先兆子痫，15名患有妊娠高血压，15名血压正常。将观察者和器械BP值之间的BP差异分为三类（≤5、≤10和≤15 mmHg），并计算平均BP差异（试验与参考）及其SD。Evolv和M3 Comfort这两种器械在妊娠和先兆子痫中均达到了A/A级。妊娠期汞标准和器械BP值之间的平均差（SD）为：1）Evolv的收缩压（SBP）为−0.7±2.3 mmHg，舒张压（DBP）为−0.1±1.8 mmHg; 2）M3 Comfort的SBP为−1.6±2.8 mmHg，DBP为−0.1±2.3 mmHg。两种器械（Evolv和M3 Comfort）的SBP和DBP均达到A/A级，并符合妊娠和先兆子痫的确认方案标准。因此，可以推荐这两种设备用于该特定人群的家庭BP测量。
Electronic devices for blood pressure (BP) measurements need to go through independent clinical validation as recommended by different authorities, both in general and in special populations such as pregnancy. To evaluate the accuracy of the Omron Evolv® (HEM-7600T-E) and the Omron M3 Comfort® (HEM-7134-E) devices in pregnancy and pre-eclampsia according to the Universal Standard Validation Protocol. Both devices, the Evolv and the M3 Comfort, measure BP at the brachial level using the oscillometric method. The study was performed according to the recently published protocol, the so-called “modified Advancement of Medical Instrumentation (AAMI)/British Hypertension Society (BHS)/European Society of Hypertension (ESH) protocol” or the “Universal Standard Protocol.” Validation of each device included 45 pregnant women in the second and third gestational trimester of whom 15 had pre-eclampsia, 15 had gestational hypertension and 15 were normotensives. BP differences between the observer and the device BP values were classified into three categories (≤5, ≤10, and ≤15 mmHg) and the mean BP differences (test vs reference) and its SD were calculated. Both devices, the Evolv and the M3 Comfort, achieved a grade A/A in both pregnancy and pre-eclampsia. The mean difference (SD) between the mercury standard and the device BP values in pregnancy were: 1) for the Evolv of −0.7±2.3 mmHg for systolic blood pressure (SBP) and −0.1±1.8 mmHg for diastolic blood pressure (DBP); 2) for the M3 Comfort of −1.6±2.8 mmHg for SBP and −0.1±2.3 mmHg for DBP. Both devices, the Evolv and the M3 Comfort, achieved a grade A/A for both SBP and DBP and fulfill the validation protocol criteria in pregnancy and pre-eclampsia. Consequently, these two devices can be recommended for home BP measurements in this specific population.