Iyriboz Y, Hearon C M
Department of Kinesiology, Louisiana State University, Baton Rouge 70803-1101.
J Clin Monit. 1994 May;10(3):163-77. doi: 10.1007/BF02908856.
The purpose of this study was to provide a critical review and comprehensive outline of published guidelines for the validation of monitors for indirect blood pressure (BP) measurement in light of recent research and practical clinical experience.
Studies testing the reliability and validity of BP monitors and available guidelines for validation have been reviewed and compared.
The validation studies of instruments for indirect BP measurement have used a wide variety of sample pools, BP ranges, protocols, reference instruments, and statistical procedures, thereby making it impossible to reach a consensus. Few existing recommendations for validation have been found to be incomplete with respect to BP in various physiological states, sequence of procedures, sample, and statistical analysis.
A new sequence of procedures for validation, including assessment of instruments during exercise and in critical care, is introduced. Previously suggested sample sizes for study subjects, age, and BP groups, as well as margins of error, are statistically challenged. Insufficiency of linear relationship and aggregate agreement alone in determining the interchangeability between a reference and test instrument is demonstrated by quantification of agreement.
本研究旨在根据近期研究和实际临床经验，对已发表的间接血压测量监测仪验证指南进行批判性回顾和全面概述。
对测试血压监测仪可靠性和有效性的研究以及可用的验证指南进行了回顾和比较。
间接血压测量仪器的验证研究使用了各种各样的样本库、血压范围、方案、参考仪器和统计程序，因此无法达成共识。现有的验证建议中，很少有在各种生理状态下的血压、程序顺序、样本和统计分析方面是完整的。
引入了一种新的验证程序顺序，包括在运动期间和重症监护中对仪器进行评估。先前建议的研究对象、年龄和血压组的样本量以及误差范围在统计学上受到质疑。通过一致性量化表明，仅线性关系和总体一致性不足以确定参考仪器和测试仪器之间的互换性。
