Rogoza A N, Pavlova T S, Sergeeva M V
Department of New Diagnostic Methods, Cardiology Research Complex, Moscow, Russia.
Blood Press Monit. 2000 Aug;5(4):227-31. doi: 10.1097/00126097-200008000-00006.
The validation of self-measurement devices has been recommended. Automatic monitor A&D UA-767 (A&D Company, Ltd, Tokyo, Japan) is well known and widely used, but not tested according to the Association for Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS) recommendations.
To perform a clinical validation for use by adults of the A&D UA-767 device according to the criteria of the AAMI and a modified BHS protocol.
The test concerned 101 subjects (57 men and 44 women) aged 15-85 years with arm circumferences of 22-39 cm, a systolic blood pressure (SBP) range of 89-206 mmHg, and a diastolic blood pressure (DBP) range of 53-122 mmHg. For each subject, three readings of the UA-767 were compared with simultaneous auscultatory measurements by two trained independent observers who used a mercury manometer and dual stethoscope. The results were graded according to the BHS (1990 and 1993) and AAMI recommendations.
Observers showed close agreement, with mean differences of 1.1+/-2.4 mmHg for SBP and -0.7+/-2.0 mmHg for DBP. The proportion of values agreeing to within 5, 10 and 15 mmHg were 93, 100, and 100% for SBP and 97, 100, and 100% for DBP for the two observers. The sphygmomanometer measurements were 132+/-24/79+/-14 mmHg (mean+/-SD). The average difference between the mercury sphygmomanometer and A&D UA-767 readings for SBP and DBP were, respectively, -0.4+/-5.4 and -0.4+/-4. 8 mmHg. The proportion of values agreeing to within 5,10, and 15 mmHg were 82, 94, and 98% for SBP and 80, 95, and 98% for DBP for the observers and device (A/A grade for BHS).
For an adult population, the A&D UA-767 device for the self-measurement of blood pressure satisfied the AAMI criteria, achieved a BHS grade of A/A and can therefore be recommended for monitoring blood pressure in home and clinical conditions by patients with mild-to-moderate arterial hypertension.
自我测量设备的验证已获推荐。自动监测仪A&D UA - 767（日本东京A&D公司）广为人知且被广泛使用，但未按照美国医疗仪器促进协会（AAMI）和英国高血压学会（BHS）的建议进行测试。
根据AAMI标准和改良的BHS方案，对A&D UA - 767设备供成年人使用进行临床验证。
测试涉及101名年龄在15 - 85岁之间的受试者（57名男性和44名女性），臂围为22 - 39厘米，收缩压（SBP）范围为89 - 206 mmHg，舒张压（DBP）范围为53 - 122 mmHg。对于每位受试者，将UA - 767的三次读数与两名经过培训的独立观察者同时使用汞柱血压计和双听诊器进行的听诊测量结果进行比较。结果根据BHS（1990年和1993年）以及AAMI建议进行分级。
观察者之间的一致性良好，SBP的平均差值为1.1±2.4 mmHg，DBP的平均差值为 - 0.7±2.0 mmHg。两名观察者的SBP在相差5、10和15 mmHg范围内的数值比例分别为93%、100%和100%，DBP的相应比例分别为97%、100%和100%。血压计测量值为132±24/79±14 mmHg（平均值±标准差）。汞柱血压计与A&D UA - 767在SBP和DBP读数上的平均差值分别为 - 0.4±5.4 mmHg和 - 0.4±4.8 mmHg。观察者与设备在相差5、10和15 mmHg范围内的数值比例，SBP分别为82%、94%和98%，DBP分别为80%、95%和98%（BHS的A/A级）。
对于成年人群，用于自我测量血压的A&D UA - 767设备符合AAMI标准，达到BHS的A/A级，因此可推荐用于轻度至中度动脉高血压患者在家庭和临床环境中监测血压。
