Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults
Working Group on Blood Pressure Monitoring of the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults
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DOI：
10.1097/00126097-200202000-00002
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发表时间：
2002-02-01
影响因子：
1.3
通讯作者：
Gerin, W
中科院分区：
文献类型：
--
作者：
O'Brien, E;Pickering, T;Gerin, W
随着自动化和半自动血压测量设备的市场推广，潜在的购买者需要能够让自己相信，这些设备已经根据商定的标准进行了评估[1]。考虑到这一点，医疗器械促进会(AAMI)于1987年发布了电子或无液血压计标准[2]，其中包括用于评估设备准确性的协议，英国高血压协会(BHS)于1990年遵循了该协议[3]。这两项规定都在1993年进行了修订[4，5]。这些在细节上不同的方案有一个共同的目标，那就是验证程序的标准化，以建立准确度和性能的最低标准，并促进一种设备与另一种设备的比较[6]。自从它们引入以来，大量的血压测量设备已经根据一种或两种协议进行了评估。然而，经验表明，议定书所要求的条件极难满足。这尤其是因为需要招募的受试者数量很多，需要测量的血压范围也很大。完成验证研究所需的时间如此之长，以至于很难在调查期间招聘训练有素的工作人员。这些因素使得验证性研究难以进行，而且非常昂贵，结果是准备进行验证研究的中心越来越少。这尤其令人遗憾，因为需要独立验证的设备比以往任何时候都多。
With the increasing marketing of automated and semi–automated devices for the measurement of blood pressure, potential purchasers need to be able to satisfy themselves that such devices have been evaluated according to agreed criteria [1]. With this in mind, the Association for the Advancement of Medical Instrumentation (AAMI) published a standard for electronic or aneroid sphygmomanometers in 1987 [2] that included a protocol for evaluating the accuracy of devices, this being followed in 1990 by the protocol of the British Hypertension Society (BHS)[3]. Both of these were revised in 1993 [4, 5]. These protocols, which differed in detail, had a common objective, namely the standardization of validation procedures to establish minimum standards of accuracy and performance, and to facilitate the comparison of one device with another [6].Since their introduction, a large number of blood pressure measuring devices have been evaluated according to one or both protocols. Experience has, however, demonstrated that the conditions demanded by the protocols are extremely difficult to fulfil. This is especially so because of the large number of subjects who have to be recruited and the ranges of blood pressure required. The time required to complete a validation study is such that it is difficult to recruit trained staff for the duration of an investigation. These factors have made validation studies difficult to perform and very costly, with the result that fewer centers are prepared to undertake them. This is particularly unfortunate as more devices than ever before are in need of independent validation.