Turner Martin J, van Schalkwyk Johan M, Irwig Les
Department of Anaesthetics, School of Public Health, University of Sydney, Sydney, Australia.
Blood Press Monit. 2008 Apr;13(2):91-9. doi: 10.1097/MBP.0b013e3282f7691c.
To quantify overdetection and underdetection of hypertension caused by systematic sphygmomanometer errors permitted by the current European standard (EN 1060 'noninvasive sphygmomanometers').
We carried out Monte Carlo simulation of measurement of blood pressure (BP) of the adult Australian population using sphygmomanometers showing systematic errors compliant with the EN 1060 standard. We repeated the simulations limiting systematic sphygmomanometer errors to +/-1 mmHg. Simulated BP measurements included systematic sphygmomanometer error, random intraindividual BP variability and random measurement error.
After three visits, underdetection of hypertension is common owing to variability of BP measurements and systematic errors of sphygmomanometers. After three visits, the wide tolerances of EN 1060 are responsible for approximately 4.9 and 11% of underdetection of systolic and diastolic hypertension, respectively. Underdetection is worse in some groups, for example, permitted sphygmomanometer error causes 20% of all undetected systolic hypertension in 18-24 year-old women. The current standard also results in overdetection of hypertension. Permitted sphygmomanometer error causes 5.8 and 14% of the overdetection of systolic and diastolic hypertension, respectively, after three visits. Overdetection is worse in some groups, for example, after three visits, permitted sphygmomanometer error causes 19% of falsely detected diastolic hypertension in 18-24 year-old men. For all adults, reduction of permitted sphygmomanometer error to +/-1 mmHg achieves approximately the same improvement in hypertension detection as at least one additional visit to the clinician.
Systematic sphygmomanometer errors permitted by the current standard are a preventable cause of clinically significant overdetection and underdetection of hypertension. The standard should be revised to make the effects of equipment related systematic errors negligible compared with the effects of physiological variability.
量化由当前欧洲标准（EN 1060“无创血压计”）允许的血压计系统误差所导致的高血压过度检测和检测不足情况。
我们使用显示符合EN 1060标准的系统误差的血压计，对成年澳大利亚人群的血压测量进行了蒙特卡洛模拟。我们将血压计系统误差限制在±1 mmHg重复进行模拟。模拟的血压测量包括血压计系统误差、个体内血压随机变异性和随机测量误差。
经过三次就诊后，由于血压测量的变异性和血压计的系统误差，高血压检测不足很常见。经过三次就诊后，EN 1060的宽泛公差分别导致收缩期和舒张期高血压检测不足的约4.9%和11%。在某些群体中检测不足情况更严重，例如，允许的血压计误差导致18 - 24岁女性中所有未检测到的收缩期高血压的20%。当前标准还导致高血压过度检测。经过三次就诊后，允许的血压计误差分别导致收缩期和舒张期高血压过度检测的5.8%和14%。在某些群体中过度检测情况更严重，例如，经过三次就诊后，允许的血压计误差导致18 - 24岁男性中19%的舒张期高血压被错误检测。对于所有成年人，将允许的血压计误差降至±1 mmHg在高血压检测方面实现的改善与至少再去看一次临床医生大致相同。
当前标准允许的血压计系统误差是临床上高血压显著过度检测和检测不足的可预防原因。应修订该标准，以使与生理变异性影响相比，设备相关系统误差的影响可忽略不计。
