Statistical considerations for testing automated sphygmomanometers in special patient populations.

IF 1.2 4区医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2023-06-01 DOI:10.1097/MBP.0000000000000644

Bruce S Alpert, Paul Matsumura, Colin O Wu, Bruce Friedman, Doris Flotzinger, David Osborn

引用次数: 0

Abstract

The International Standards Organization 81060-2:2018 is the current global Standard for the validation of automated sphygmomanometers. It specifies the requirements for clinical studies on the general population, as well as additional requirements for special populations, which might have physiologic characteristics that affect the accuracy of blood pressure measurements. This paper summarizes the statistical methodology behind the sample size required to test automated sphygmomanometers in these special populations and specifically addresses the pregnant patient population.

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在特殊患者群体中测试自动血压计的统计考虑。

国际标准组织81060-2:2018是目前自动血压计验证的全球标准。它规定了对一般人群进行临床研究的要求，以及对特殊人群的额外要求，这些人群可能具有影响血压测量准确性的生理特征。本文总结了在这些特殊人群中测试自动血压计所需样本量的统计方法，并特别针对怀孕患者群体。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Blood Pressure Monitoring 医学-外周血管病

CiteScore

2.00

自引率

7.70%

发文量

110

审稿时长

>12 weeks

期刊介绍： Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research. This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine. Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.

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