Zeng Wei-Fang, Huang Qi-Fang, Sheng Chang-Sheng, Li Yan, Wang Ji-Guang
Centre for Epidemiological Studies and Clinical Trials, The Shanghai Institute of Hypertension, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Blood Press Monit. 2012 Oct;17(5):204-6. doi: 10.1097/MBP.0b013e328359c426.
The present study aimed to evaluate the accuracy of the automated oscillometric wrist blood pressure monitor Rossmax S150 for home blood pressure monitoring according to the International Protocol of the European Society of Hypertension revision 2010.
Systolic and diastolic blood pressures were sequentially measured in 33 adult Chinese (16 women, mean age of 54 years) using a mercury sphygmomanometer (two observers) and the Rossmax S150 device (one supervisor). Ninety-nine pairs of comparisons were obtained from 33 participants for judgments in two parts with three grading phases. Data analysis was carried out using the ESHIP analyzer.
The Rossmax S150 device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10, and 15 mmHg was 70/99, 90/99, and 97/99, respectively, for systolic blood pressure, and 84/99, 98/99, and 99/99, respectively, for diastolic blood pressure. The device also achieved the criteria in part 2 of the validation study. Twenty-six and 29 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observers differences within 5 mmHg (required ≥ 24). Three and two participants for systolic and diastolic blood pressure, respectively, had all three device-observers comparisons greater than 5 mmHg.
The Rossmax wrist blood pressure monitor S150 has passed the requirements of the International Protocol revision 2010, and hence can be recommended for home use in adults.
本研究旨在根据欧洲高血压学会2010年修订版国际协议,评估自动示波腕式血压监测仪Rossmax S150用于家庭血压监测的准确性。
使用汞柱式血压计(两名观察者)和Rossmax S150设备(一名监督者),对33名成年中国人(16名女性,平均年龄54岁)依次测量收缩压和舒张压。从33名参与者中获得99对比较数据,分两部分进行判断,有三个分级阶段。使用ESHIP分析仪进行数据分析。
Rossmax S150设备在验证研究的第1部分达到了目标。收缩压方面,设备与观察者之间相差5、10和15 mmHg以内的绝对差值数量分别为70/99、90/99和97/99;舒张压方面,分别为84/99、98/99和99/99。该设备在验证研究的第2部分也达到了标准。收缩压和舒张压分别有26名和29名参与者,其设备与观察者之间的差值在5 mmHg以内至少有两个(要求≥24)。收缩压和舒张压分别有3名和2名参与者,其设备与观察者的所有三次比较均大于5 mmHg。
Rossmax腕式血压监测仪S150已通过2010年修订版国际协议的要求,因此可推荐用于成年人家庭使用。