O'Brien E, O'Malley K
Blood Pressure Unit, Beaumont Hospital, Dublin, Ireland.
J Hypertens Suppl. 1990 Dec;8(7):S133-9.
As ambulatory blood pressure measurement becomes more widely accepted in hypertension research and in the clinical management of high blood pressure, the number of devices available on the market has increased considerably, reflecting the clinical demand. These devices are expensive, both in terms of capital and running costs. As we rely increasingly on data produced by ambulatory systems, it becomes increasingly important that they be shown to be accurate. Initially protocols for the validation of ambulatory devices were designed on an ad hoc basis, so that many studies were inadequately designed and comparison of data between studies was usually impossible. The American National Standard published by the Association for the Advancement of Medical Instrumentation (AAMI) remedied this situation in part, and the recent publication of the British Hypertension Society (BHS) protocol for the validation of ambulatory systems has further advanced the demand for accuracy. The BHS protocol includes most of the AMMI standard recommendations, but in addition there are sections on observer training, in-use assessment and inter-device variability. In addition, performance characteristics, computer facilities and details on such practical matters as cost and maintenance are sought. Finally, the BHS protocol provides a grading system of validation which allows comparisons between devices and studies.
随着动态血压测量在高血压研究和高血压临床管理中越来越被广泛接受，市场上可用的设备数量大幅增加，这反映了临床需求。这些设备无论是在资金成本还是运营成本方面都很昂贵。随着我们越来越依赖动态系统产生的数据，证明这些设备的准确性变得越来越重要。最初，动态设备验证方案是临时设计的，因此许多研究设计不充分，而且通常无法对不同研究的数据进行比较。美国医学仪器促进协会（AAMI）发布的美国国家标准部分地弥补了这种情况，英国高血压学会（BHS）最近发布的动态系统验证方案进一步提高了对准确性的要求。BHS方案包括了AAMI标准的大部分建议，但此外还有关于观察者培训、使用中评估和设备间变异性的章节。此外，还要求提供性能特征、计算机设施以及成本和维护等实际问题的详细信息。最后，BHS方案提供了一个验证分级系统，允许对不同设备和研究进行比较。
