按照修改后的英国高血压学会方案对Microlife BP 3BTO-A示波法血压监测设备进行验证。

Validation of the Microlife BP 3BTO-A oscillometric blood pressure monitoring device according to a modified British Hypertension Society protocol.

作者信息

Cuckson Alexandra C, Reinders Annemarie, Shabeeh Husain, Shennan Andrew H

机构信息

Maternal and Fetal Research Unit, GKT School of Medicine, St Thomas' Hospital, London, UK.

出版信息

Blood Press Monit. 2002 Dec;7(6):319-24. doi: 10.1097/00126097-200212000-00005.

DOI:10.1097/00126097-200212000-00005

PMID:12488652

Abstract

BACKGROUND

The market for devices for the self-measurement of blood pressure is growing, and as accuracy is of prime importance, there is increasing pressure for manufacturers to provide evidence of independent testing. Recent reviews have shown that only five automated upper arm devices for self-measurement of blood pressure have been recommended for use. We tested the Microlife BP 3BTO-A, a lightweight, upper arm, automated oscillometric device, according to a modified version of the British Hypertension Society protocol and also analysed the computer-generated oscillograms for possible causes of inaccuracy.

METHODS

One hundred and twenty-six subjects were recruited from general medical and specialist clinics and from amongst the staff at Guy's and St Thomas' Hospital, London, UK. Only 85 of these were included in the final analysis. Nine sequential readings were taken by two trained observers alternating between the mercury sphygmomanometer and the device. The last seven readings were analysed according to the British Hypertension Society protocol. Modifications to the protocol were: (1) the exclusion of patients whose blood pressure varied by more than 15 mmHg between sequential observer readings and (2) limited testing in the low systolic pressure range.

RESULTS

The Microlife achieved a grade A for both systolic and diastolic pressure according to the British Hypertension Society protocol. The mean differences (standard deviation) between the observers and the device were -1.6 (7.7) mmHg and -2.1 (6.3) mmHg for systolic and diastolic blood pressure, respectively, therefore also fulfilling the criteria set by the Association for the Advancement of Medical Instrumentation. Sub-analysis for different pressure ranges showed that the device was less accurate in the high-pressure range (>160/100 mmHg).

CONCLUSION

The Microlife can be recommended for clinical use in an adult population.

摘要

背景

用于自我测量血压的设备市场正在增长，由于准确性至关重要，制造商提供独立测试证据的压力越来越大。最近的综述表明，仅推荐了五种用于自我测量血压的自动上臂设备。我们根据英国高血压学会方案的修改版对Microlife BP 3BTO - A（一种轻便的上臂自动示波测量设备）进行了测试，并分析了计算机生成的示波图以寻找可能的不准确原因。

方法

从普通内科和专科诊所以及英国伦敦盖伊和圣托马斯医院的工作人员中招募了126名受试者。最终分析仅纳入了其中85名。由两名经过培训的观察者在汞柱式血压计和该设备之间交替进行九次连续读数。根据英国高血压学会方案对最后七次读数进行分析。对方案的修改包括：（1）排除连续观察者读数之间血压变化超过15 mmHg的患者；（2）在低收缩压范围内进行有限测试。

结果

根据英国高血压学会方案，Microlife的收缩压和舒张压均达到A级。观察者与该设备之间收缩压和舒张压的平均差异（标准差）分别为-1.6（7.7）mmHg和-2.1（6.3）mmHg，因此也符合美国医疗仪器促进协会设定的标准。不同压力范围的亚分析表明，该设备在高压范围（>160/100 mmHg）内准确性较低。