根据美国医学仪器促进协会协议对欧姆龙HBP - 1100 - E专业血压测量设备进行验证：波斯湾吉兰队列研究（PGCS）。
Validation of Omron HBP-1100-E Professional Blood Pressure Measuring Device According to the American Association for the Advancement of Medical Instrumentation Protocol: The PERSIAN Guilan Cohort Study (PGCS).
作者信息
Joukar Farahnaz, Yeganeh Sara, Naghipour Mohammadreza, Hassanipour Soheil, Nikbakht Hossein-Ali, Mansour-Ghanaei Fariborz
机构信息
Gastrointestinal and Liver Diseases Research Center, Guilan University of Medical Sciences, Rasht, Iran.
Caspian Digestive Disease Research Center, Guilan University of Medical Sciences, Rasht, Iran.
出版信息
Med Devices (Auckl). 2020 Sep 3;13:231-236. doi: 10.2147/MDER.S253638. eCollection 2020.
BACKGROUND
Blood pressure (BP) measurement accuracy is critical to the diagnosis and management of hypertension. The aim of the present study was to validate the Omron HBP-1100-E professional blood pressure measuring device in accordance with the American Association for the Advancement of Medical Instrumentation in Iranian adults.
MATERIALS AND METHODS
Simultaneous blood pressure auscultator measurements were obtained by two observers using mercury sphygmomanometers as a reference, sequentially with a measurement by using the Omron HBP-1100-E device. Absolute device-reference blood pressure differences were categorized into three error categories (within 5, 10, and 15 mmHg), and mean device-reference blood pressure difference (standard deviation) was calculated and evaluated using the American Association for the Advancement of Medical Instrumentation criteria.
RESULTS
A total of 85 participants (250 paired readings) were enrolled to the study. 26.8%, 55.6%, and 79.6% of the device-reference blood pressure differences agreed to within 5, 10 and 15 mmHg, respectively, for systolic blood pressure, and 39.6%, 69.2%, and 81.6% of measurements for diastolic blood pressure, respectively, and failed to pass the protocol criteria. The mean device-reference blood pressure difference was 8.0 ± 13.1 mmHg for systolic BP and 2.2 ± 11.3 mmHg for diastolic BP, and was >5.0 ± 8.0 mmHg (required criteria).
CONCLUSION
Omron HBP-1100-E professional blood pressure monitor is not desirable for measuring the BP for Iranian adults as it overestimates blood pressure in this population.
背景
血压测量的准确性对于高血压的诊断和管理至关重要。本研究的目的是根据美国医学仪器促进协会的标准，在伊朗成年人中验证欧姆龙HBP - 1100 - E专业血压测量设备。
材料与方法
两名观察者使用汞柱式血压计作为参考，同时进行血压听诊测量，随后依次使用欧姆龙HBP - 1100 - E设备进行测量。将设备与参考血压的绝对差值分为三个误差类别（5 mmHg、10 mmHg和15 mmHg以内），并根据美国医学仪器促进协会的标准计算并评估设备与参考血压的平均差值（标准差）。
结果
共有85名参与者（250对配对读数）纳入研究。收缩压的设备与参考血压差值分别有26.8%、55.6%和79.6%在5 mmHg、10 mmHg和15 mmHg以内，舒张压测量值分别有39.6%、69.2%和81.6%在相应范围内，均未通过方案标准。收缩压的设备与参考血压平均差值为8.0±13.1 mmHg，舒张压为2.2±11.3 mmHg，且大于5.0±8.0 mmHg（要求标准）。
结论
欧姆龙HBP - 1100 - E专业血压监测仪不适合用于测量伊朗成年人的血压，因为它会高估该人群的血压。
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