Shirasaki Osamu, Asou Yosuke, Takahashi Yukio
Omron Healthcare Co. Ltd., Yamanouchi-yamanoshita-cho, Ukyo-ku, Kyoto, Japan.
Blood Press Monit. 2007 Dec;12(6):381-3. doi: 10.1097/MBP.0b013e3282495905.
Owing to fast or stepwise cuff deflation, or measuring at places other than the upper arm, the clinical accuracy of most recent automated sphygmomanometers (auto-BPMs) cannot be validated by one-arm simultaneous comparison, which would be the only accurate validation method based on auscultation. Two main alternative methods are provided by current standards, that is, two-arm simultaneous comparison (method 1) and one-arm sequential comparison (method 2); however, the accuracy of these validation methods might not be sufficient to compensate for the suspicious accuracy in lateral blood pressure (BP) differences (LD) and/or BP variations (BPV) between the device and reference readings. Thus, the Japan ISO-WG for sphygmomanometer standards has been studying a new method that might improve validation accuracy (method 3). The purpose of this study is to determine the appropriateness of method 3 by comparing immunity to LD and BPV with those of the current validation methods (methods 1 and 2).
The validation accuracy of the above three methods was assessed in human participants [N=120, 45+/-15.3 years (mean+/-SD)]. An oscillometric automated monitor, Omron HEM-762, was used as the tested device.
When compared with the others, methods 1 and 3 showed a smaller intra-individual standard deviation of device error (SD1), suggesting their higher reproducibility of validation. The SD1 by method 2 (P=0.004) significantly correlated with the participant's BP, supporting our hypothesis that the increased SD of device error by method 2 is at least partially caused by essential BPV. Method 3 showed a significantly (P=0.0044) smaller interparticipant SD of device error (SD2), suggesting its higher interparticipant consistency of validation.
Among the methods of validation of the clinical accuracy of auto-BPMs, method 3, which showed the highest reproducibility and highest interparticipant consistency, can be proposed as being the most appropriate.
由于袖带放气速度快或呈阶梯式放气，或者在上臂以外的部位进行测量，大多数最新的自动血压计（自动BPM）的临床准确性无法通过单臂同步比较来验证，而单臂同步比较是基于听诊的唯一准确验证方法。当前标准提供了两种主要的替代方法，即双臂同步比较（方法1）和单臂顺序比较（方法2）；然而，这些验证方法的准确性可能不足以弥补设备与参考读数之间横向血压（BP）差异（LD）和/或血压变异性（BPV）方面可疑的准确性。因此，日本血压计标准ISO工作组一直在研究一种可能提高验证准确性的新方法（方法3）。本研究的目的是通过将对LD和BPV的免疫性与当前验证方法（方法1和2）进行比较，来确定方法3的适用性。
在人体受试者中评估上述三种方法的验证准确性[N = 120，45±15.3岁（平均±标准差）]。使用示波法自动监测仪欧姆龙HEM - 762作为被测设备。
与其他方法相比，方法1和方法3显示出设备误差的个体内标准差（SD1）较小，表明它们具有更高的验证可重复性。方法2的SD1（P = 0.004）与受试者的血压显著相关，支持了我们的假设，即方法2导致的设备误差标准差增加至少部分是由基本BPV引起的。方法3显示出受试者间设备误差标准差（SD2）显著更小（P = 0.0044），表明其受试者间验证一致性更高。
在自动BPM临床准确性的验证方法中，方法3具有最高的可重复性和最高的受试者间一致性，可以被认为是最合适的方法。
