Jones Stephen C, Bilous Mary, Winship Sue, Finn Paul, Goodwin James
James Cook University Hospital; University of Teesside, Middlesbrough, UK.
Blood Press Monit. 2004 Aug;9(4):219-23. doi: 10.1097/00126097-200408000-00007.
The accuracy of blood pressure measuring devices is of prime importance and should be validated before devices are used clinically. We carried out an independent evaluation of the OSCAR 2 oscillometric ambulatory blood pressure monitor (SunTech Medical model 222) according to the European Society of Hypertension International Protocol.
Adult subjects were recruited from patients and staff at The James Cook University Hospital, Middlesbrough, UK. Nine sequential same-arm blood pressure measurements were taken alternating between simultaneous readings by two independent, trained observers using mercury sphygmomanometers and the device operated by a third observer. In phase one, 15 subjects participated (five in each of the low, medium and high blood pressure ranges) with 18 subjects participating in phase two. Data from 33 subjects (11 in each of the three blood pressure ranges) were analysed for systolic (19 male, 14 female, mean age 56.0 years) and for diastolic (17 male, 16 female, mean age 51.1 years) blood pressure.
The OSCAR 2 passed the first phase of the validation process. In phase 2.1, the OSCAR 2 monitor had 71 readings within 5 mmHg, 86 within 10 mmHg and 94 within 15 mmHg for systolic blood pressure (SBP) and 72 readings within 5 mmHg, 88 within 10 mmHg and 96 within 15 mmHg for diastolic blood pressure (DBP). Mean (+/-SD) differences between observers and device were 0.9+/-2.3 mmHg for SBP and -0.5+/-2.3 mmHg for DBP. In phase 2, 24 subjects had at least two of the differences within 5 mmHg and three subjects had no differences within 5 mmHg for SBP while for DBP 25 subjects had at least two of the differences within 5 mmHg and two subjects had no differences within 5 mmHg.
The OSCAR 2 passes all requirements for validation by the International Protocol and can be recommended for clinical use in an adult population.
血压测量设备的准确性至关重要，在临床使用前应进行验证。我们根据欧洲高血压学会国际方案对OSCAR 2振荡式动态血压监测仪（SunTech Medical 222型）进行了独立评估。
从英国米德尔斯堡詹姆斯·库克大学医院的患者和工作人员中招募成年受试者。由两名经过培训的独立观察者使用汞柱式血压计同时读数，并由第三名观察者操作该设备，交替进行九次连续的同侧血压测量。在第一阶段，15名受试者参与（低、中、高血压范围各5名），第二阶段有18名受试者参与。对33名受试者（三个血压范围各11名）的收缩压（19名男性，14名女性，平均年龄56.0岁）和舒张压（17名男性，16名女性，平均年龄51.1岁）数据进行了分析。
OSCAR 2通过了验证过程的第一阶段。在2.1阶段，OSCAR 2监测仪的收缩压（SBP）有71次读数在5 mmHg以内，86次在10 mmHg以内，94次在15 mmHg以内；舒张压（DBP）有72次读数在5 mmHg以内，88次在10 mmHg以内，96次在15 mmHg以内。观察者与设备之间的平均（±标准差）差异，收缩压为0.9±2.3 mmHg，舒张压为-0.5±2.3 mmHg。在第二阶段，24名受试者的收缩压至少有两次差异在5 mmHg以内，3名受试者的收缩压在5 mmHg以内无差异；而舒张压方面，25名受试者至少有两次差异在5 mmHg以内，2名受试者的舒张压在5 mmHg以内无差异。
OSCAR 2符合国际方案验证的所有要求，可推荐用于成年人群的临床使用。
