Benetti Elisabetta, Fania Claudio, Márquez Hernández Verónica, Palatini Paolo
Department of Medicine, University of Padova, Padua, Italy.
Blood Press Monit. 2014 Jun;19(3):176-9. doi: 10.1097/MBP.0000000000000030.
The objective of this study was to determine the accuracy of the Thermor BIOS BD215 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension (ESH). Device evaluation was carried out in 33 patients. The mean age of the patients was 57.0 ± 15.0 years, the mean systolic BP was 142.0 ± 20.3 mmHg (range 100-177 mmHg), the mean diastolic BP was 88.0 ± 14.6 mmHg (range 48-123 mmHg), and the mean arm circumference was 28.0 ± 3.0 cm (range 24-33 cm). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 0.6 ± 4.2 mmHg and underestimated diastolic BP by -0.5 ± 3.2 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the Thermor BIOS BD215 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.
本研究的目的是根据欧洲高血压学会(ESH)的国际协议,确定Thermor BIOS BD215设备用于家庭血压测量的准确性。对33例患者进行了设备评估。患者的平均年龄为57.0±15.0岁,平均收缩压为142.0±20.3 mmHg(范围100 - 177 mmHg),平均舒张压为88.0±14.6 mmHg(范围48 - 123 mmHg),平均臂围为28.0±3.0 cm(范围24 - 33 cm)。严格遵循了协议要求。该设备通过了所有要求,符合协议标准。平均而言,该设备收缩压高估了0.6±4.2 mmHg,舒张压低估了-0.5±3.2 mmHg。设备与观察者之间的差异与患者的临床特征无关。这些数据表明,Thermor BIOS BD215设备符合国际协议的验证要求,可推荐用于成年人群的临床使用。