Technol Health Care. 2023;31(1):141-149. doi: 10.3233/THC-220122.
Peak expiratory flow meters (PEFMs) have emerged as primary tools used for diagnosing and monitoring a range of respiratory diseases including asthma and chronic obstructive pulmonary disease, and the performance of these meters will thus impact disease evaluation.
The aim of this study was therefore to assess the technical performance of mechanical and electronic PEFMs commonly used in clinical practice.
The accuracy, repeatability, airflow resistance, frequency response, and linearity of five electronic and seven mechanical PEFMs were measured using a standard flow/volume simulator in accordance with nine A-waveforms and three B-waveforms defined in ISO 23747:2015 issued by the International Standards Organization (ISO).
The accuracy, repeatability, linearity, airflow resistance, and frequency response pass rates for these 12 different PEFM brands were 41.67%, 75.00%, 50.00%, 75.00%, and 25.00%, respectively. Just 16.67% (2/12) of the tested PEFMs met all evaluated criteria, whereas the remaining PEFMs partially met these criteria. There were no significant differences between the two tested PEFM types in the low flow rate waveform test (P> 0.05), although there were significant differences in the medium and high flow rate waveform test (P< 0.05). In addition, the overall PEFMs test had poor accuracy and good repeatability, although most of the repeatability errors occurred in the BTPS state.
PEFMs commonly used in clinical settings exhibit variable technical performance, and relevant departments need to strengthen PEFM quality control and management in China.
呼气峰流速仪(PEFMs)已成为诊断和监测多种呼吸系统疾病(包括哮喘和慢性阻塞性肺疾病)的主要工具,因此这些仪器的性能将影响疾病评估。
本研究旨在评估临床实践中常用的机械和电子 PEFMs 的技术性能。
根据国际标准化组织(ISO)发布的 ISO 23747:2015 中定义的 9 个 A 波和 3 个 B 波,使用标准流量/体积模拟器测量了 5 个电子和 7 个机械 PEFMs 的准确性、重复性、气流阻力、频率响应和线性度。
这 12 个不同 PEFM 品牌的准确性、重复性、线性度、气流阻力和频率响应合格率分别为 41.67%、75.00%、50.00%、75.00%和 25.00%。只有 16.67%(2/12)的测试 PEFMs 符合所有评估标准,而其余的 PEFMs 部分符合这些标准。在低流量波形测试中,两种测试的 PEFM 类型之间没有显著差异(P>0.05),尽管在中高流量波形测试中存在显著差异(P<0.05)。此外,尽管大多数重复性误差发生在 BTPS 状态下,但总体 PEFMs 测试的准确性较差,重复性较好。
临床环境中常用的 PEFMs 表现出不同的技术性能,中国相关部门需要加强 PEFM 的质量控制和管理。