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AAMI SP 10标准与英国高血压学会协议之间血压测量设备的准确性关系。

Accuracy relationship of blood pressure devices between the AAMI SP 10 standard and the British Hypertension Society protocols.

作者信息

Sun M, Jones R

机构信息

Neopath, Inc., Redmond, Washington, USA.

出版信息

Biomed Instrum Technol. 1999 Jan-Feb;33(1):62-70.

Abstract

This article analyzes and compares the accuracy requirements for the AAMI SP10 standard and the British Hypertension Society (BHS) protocol for evaluation of blood pressure devices. It generates a theoretical mapping relationship between the AAMI accuracy criteria and the BHS grading system, using these requirements. It locates within that relationship the analyses of blood pressure devices in the literature that have used both of these standards from 1990, when the original BHS protocol was published and the original AAMI SP10 standard was available, through the end of 1997. Comparison of 67 paired entries thus provides a framework for consideration of the concept of accuracy implicit in both systems against empirical testing of devices. Results of accuracy testing with each of the two systems should be consistent and convertible to the other system. The discrepancies between the theoretic combination of accuracy standards and empirical testing for each standard separately suggest a variety of difficulties in determining accuracy, such as statistical variability and test procedure variations. Using a chi-square test for matched samples, the discrepancies are found statistically significantly different (chi-square = 28.96, p < 0.001). Although there are fewer literature reports using the revised BHS protocol, the differences in the two systems suggest a potential need for an international agreement on accuracy determinations of blood pressure devices.

摘要

本文分析并比较了美国医疗器械促进协会(AAMI)SP10标准和英国高血压协会(BHS)血压测量设备评估方案的准确性要求。利用这些要求,得出了AAMI准确性标准与BHS分级系统之间的理论映射关系。在该关系范围内,定位了1990年(即最初的BHS方案发布且最初的AAMI SP10标准可用之时)至1997年底期间文献中同时使用这两种标准的血压测量设备的分析。对67对数据的比较,为对照设备的实证测试来考量这两种系统中隐含的准确性概念提供了一个框架。两种系统各自的准确性测试结果应保持一致且能相互转换。每种标准的准确性标准理论组合与各自的实证测试之间的差异,表明在确定准确性方面存在各种困难,如统计变异性和测试程序差异。使用配对样本卡方检验发现,这些差异在统计学上具有显著差异(卡方 = 28.96,p < 0.001)。尽管使用修订后的BHS方案的文献报告较少,但两种系统之间的差异表明,可能需要就血压测量设备准确性的判定达成国际协议。

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