European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults
European Society of Hypertension International Protocol revision 2010 for the validation of blood pressure measuring devices in adults
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DOI：
10.1097/mbp.0b013e3283360e98
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发表时间：
2010-02-01
影响因子：
1.3
通讯作者：
Shennan, Andrew
中科院分区：
文献类型：
--
作者：
O'Brien, Eoin;Atkins, Neil;Shennan, Andrew
血压测量是临床实践中最常见的测量方法，对测量结果的解释对使用该技术的个体具有深远的影响。例如，如果测量值错误地低，则患者可能被拒绝最有价值的药物治疗以防止未来的中风和心脏病发作，而另一方面，如果测量值错误地高，则个体可能不必要地开始终身服用降低血压的药物。因此，用于测量血压的器械必须准确，并且由于血压是一个复杂的血液动力学变量，因此所有血压测量器械必须在临床环境中进行独立验证，这是公认的。血压测量器械的验证始于20世纪80年代，有一系列关于器械的特定验证方案[1]。从20世纪90年代起，随着医疗器械促进协会（AAMI）和英国高血压学会（BHS）发布标准和方案，器械确认变得更加结构化[2-7]。2002年，欧洲高血压学会（ESH）血压监测工作组（由血压测量专家组成，其中许多人在验证血压测量设备方面具有丰富的经验）发布了国际协议，该协议简化了以前的协议，并基于大量验证研究的证据[8]。该国际议定书的起草方式适用于市场上的大多数血压测量器械。因此，验证程序仅限于30岁以上的成年人（构成高血压受试者的大多数），未对特殊人群（如儿童、孕妇和老年人）或特殊情况（如运动期间）或异常病理生理情况（如房颤或老年人可能发生的动脉僵硬）提出建议。该方案不排除研究者和制造商在这些情况下应用国际方案进行评估和验证。有关此修订版的完整背景信息，建议研究人员熟悉原始方案，可直接从www. dableeducational. org.
Measurement of blood pressure is the commonest measurement made in clinical practice, and the interpretation of the figure resulting from that measurement has far-reaching implications for the individual in whom the technique is performed. If the measurement is erroneously low, for example, the patient may be denied the most valuable drug treatment to prevent future stroke and heart attack, whereas if, on the other hand, the measurement is erroneously high, the individual may be commenced on lifelong blood pressure lowering drugs unnecessarily. It is imperative, therefore, that the device being used to measure blood pressure is accurate and, because blood pressure is a complex haemodynamic variable, it is accepted that all blood pressure measuring devices must be validated independently in the clinical setting.Validation of blood pressure measuring devices began in the 1980s with a series of ad hoc validation protocols on devices [1]. From the 1990s onwards, device validation became more structured with the publication of standards and protocols from the Association for the Advancement of Medical Instrumentation (AAMI) and the British Hypertension Society (BHS)[2–7]. In 2002, the Working Group on Blood Pressure Monitoring of the European Society of Hypertension (ESH), which is composed of experts in blood pressure measurement, many of whom have considerable experience in validating blood pressure measuring devices, published the International Protocol, which simplified previous protocols and was based on evidence from a large number of validation studies [8]. The International Protocol was drafted in such a way as to be applicable to the majority of blood pressure measuring devices on the market. The validation procedure was therefore confined to adults over the age of 30 years (who constitute the majority of subjects with hypertension), and it did not make recommendations for special groups, such as children, pregnant women and the elderly, or for special circumstances, such as during exercise, or for abnormal pathophysiological circumstances, such as atrial fibrillation, or arterial stiffness as may occur in the elderly. The protocol did not preclude investigators and manufacturers from applying the International Protocol to assessment and validation in these circumstances. For full background information on this revision, it is recommended that investigators familiarise themselves with the original protocol, which can be downloaded directly from www. dableducational. org.