Bortolotto L A, Henry O, Hanon O, Sikias P, Mourad J J, Girerd X
Department of Internal Medicine, Hôpital Broussais, Paris, France.
Blood Press Monit. 1999 Feb;4(1):21-5. doi: 10.1097/00126097-199904010-00004.
The validation of self-measurement devices for clinical use by elderly patients has been recommended. The Omron HEM-722C device has recently been validated according to the British Hypertension Society (BHS) protocol for use for general populations and the Omron HEM-735C is a new fully automatic device with a high capacity for storage of measurements that is integrated with a personal computer.
To perform a clinical validation for use by elderly people of the Omron HEM-722C and HEM-735C devices according to the revised protocol of the BHS and the criteria of the Association for the Advancement of Medical Instrumentation (AAMI).
We carried out a main validation test according to the revised BHS protocol for validation procedures for special groups on two groups of 30 subjects aged more than 65 years (29 men and 31 women), 11 of 30 with systolic blood pressures (SBP) <110mmHg, 10 of 30 with SBP >200 mmHg, 15 of 30 with diastolic blood pressures (DBP( <70 mmHg and 10 of 30 with DBP >110 mmHg. The results were graded according to the BHS system from A to D.
The Omron HEM 722C achieved an overall A/A grading and satisfied the AAMI criteria for accuracy whereas the Omron HEM-735C achieved an overall B/A grading and satisfied the AAMI criteria for accuracy. The sphygmomanometer measurements were 147 +/- 31/79 +/- 15 and 144 +/- 30/78 +/- 15 mmHg (means+/-SD) respectively, for the models 722C and 735C. The average differences between mercury sphygmomanometer and HEM-722C readings for SBP and DBP were, respectively, 0.76+/-5 and 0.41+/-8 mmHg; those for HEM-735C were, respectively, 0.24+/-8 and 0.9+/-8 mmHg. Readings of the HEM-722C device differed by less than 5 mmHg for 76% of systolic readings and 96% of the readings differed by less than 10 mmHg. Diastolic measurements differed by less than 5 mmHg for 71% and less than 10 mmHg for 71 and 87% of all readings. Readings of the HEM-735C device differed by less than 5 mmHg for 68% of systolic readings and 74% of the readings differed by less than 10 mmHg. Diastolic measurements differed by less than 5 mmHg in 74% and less than 10 mmHg in 88 and 87% of all readings.
On the basis of these results, for elderly subjects both self-measurement devices (Omron HEM-722C and HEM-735C) satisfied the validation criteria of the BHS and therefore can be recommended for the clinical measurement of blood pressure in elderly patients.
已建议对老年患者临床使用的自测设备进行验证。欧姆龙HEM - 722C设备最近已根据英国高血压协会（BHS）针对普通人群的方案进行了验证，而欧姆龙HEM - 735C是一款新型全自动设备，具有高测量存储容量，并与个人计算机集成。
根据BHS的修订方案和美国医疗仪器促进协会（AAMI）的标准，对欧姆龙HEM - 722C和HEM - 735C设备供老年人使用进行临床验证。
我们根据BHS针对特殊群体验证程序的修订方案，对两组各30名65岁以上受试者（29名男性和31名女性）进行了主要验证测试，30名受试者中11名收缩压（SBP）<110mmHg，10名SBP>200mmHg，15名舒张压（DBP）<70mmHg，10名DBP>110mmHg。结果根据BHS系统从A到D进行分级。
欧姆龙HEM 722C总体获得A/A分级，满足AAMI准确性标准，而欧姆龙HEM - 735C总体获得B/A分级，满足AAMI准确性标准。722C和735C型号的血压计测量值分别为147±31/79±15和144±30/78±15mmHg（均值±标准差）。汞柱式血压计与HEM - 722C的SBP和DBP读数平均差异分别为0.76±5和0.41±8mmHg；与HEM - 735C的平均差异分别为0.24±8和0.9±8mmHg。HEM - 722C设备76%的收缩压读数差异小于5mmHg，96%的读数差异小于10mmHg。舒张压测量值71%差异小于5mmHg，71%和87%的所有读数差异小于10mmHg。HEM - 735C设备68%的收缩压读数差异小于5mmHg，74%的读数差异小于10mmHg。舒张压测量值74%差异小于5mmHg，88%和87%的所有读数差异小于10mmHg。
基于这些结果，对于老年受试者，两种自测设备（欧姆龙HEM - 722C和HEM - 735C）均满足BHS的验证标准，因此可推荐用于老年患者的血压临床测量。
