Long-term stability of over-the-counter cuffless blood pressure monitors: a proposal.

IF 3.1 Q2 MEDICAL INFORMATICS
Toshiyo Tamura, Shigeru Shimizu, Nobuhiro Nishimura, Masachika Takeuchi
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引用次数: 0

Abstract

Blood pressure is an important cardiovascular parameter. Currently, the cuff-based sphygmomanometer is a popular, reliable, measurement method, but blood pressure monitors without cuffs have become popular and are now available without a prescription. Blood pressure monitors must be approved by regulatory authorities. Current cuffless blood pressure (CL-BP) monitors are not suitable for at-home management and prevention of hypertension. This paper proposes simple criteria for over-the-counter CL-BP monitoring. First, the history of the sphygmomanometer and current standard blood pressure protocol are reviewed. The main components of CL-BP monitoring are accuracy during the resting condition, accuracy during dynamic blood pressure changes, and long-term stability. In this proposal we recommend intermittent measurement to ensure that active measurement accuracy mirrors resting condition accuracy. A new experimental protocol is proposed to maintain long-term stability. A medically approved automated sphygmomanometer was used as the standard device in this study. The long-term accuracy of the test device is based on the definition of propagation error, i.e., for an oscillometric automated sphygmomanometer (5 ± 8 mmHg) ± the error for the test device static accuracy (-0.12 ± 5.49 mmHg for systolic blood pressure and - 1.17 ± 5.06 mmHg for diastolic blood pressure). Thus, the long-term stabilities were - 3.38 ± 7.1 mmHg and - 1.38 ± 5.4 mmHg, which satisfied propagation error. Further research and discussion are necessary to create standards for use by manufacturers; such standards should be readily evaluated and ensure high-quality evidence.

Supplementary information: The online version contains supplementary material available at 10.1007/s12553-023-00726-6.

Abstract Image

Abstract Image

非处方无袖带血压监测仪的长期稳定性:一项建议。
血压是一项重要的心血管指标。目前,基于袖带的血压计是一种流行的、可靠的测量方法,但没有袖带的血压计也变得流行起来,现在不需要处方就可以买到。血压监测器必须得到监管机构的批准。目前的无袖带血压(CL-BP)监测仪不适合家庭管理和预防高血压。本文提出了非处方CL-BP监测的简单标准。首先,回顾血压计的历史和目前的标准血压方案。CL-BP监测的主要组成部分是静息状态下的准确性、动态血压变化时的准确性和长期稳定性。在这个建议中,我们推荐间歇性测量,以确保主动测量精度反映静止状态精度。提出了一种新的实验方案以保持长期稳定性。医学上认可的自动血压计被用作本研究的标准设备。测试设备的长期精度基于传播误差的定义,即,对于振荡式自动血压计(5±8 mmHg)±测试设备静态精度的误差(收缩压-0.12±5.49 mmHg,舒张压- 1.17±5.06 mmHg)。因此,长期稳定性为- 3.38±7.1 mmHg和- 1.38±5.4 mmHg,满足传播误差。有必要进一步研究和讨论,以制定供制造商使用的标准;这些标准应易于评估,并确保高质量的证据。补充信息:在线版本包含补充资料,下载地址:10.1007/s12553-023-00726-6。
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
Health and Technology
Health and Technology MEDICAL INFORMATICS-
CiteScore
7.10
自引率
0.00%
发文量
83
期刊介绍: Health and Technology is the first truly cross-disciplinary journal on issues related to health technologies addressing all professions relating to health, care and health technology.The journal constitutes an information platform connecting medical technology and informatics with the needs of care, health care professionals and patients. Thus, medical physicists and biomedical/clinical engineers are encouraged to write articles not only for their colleagues, but directed to all other groups of readers as well, and vice versa.By its nature, the journal presents and discusses hot subjects including but not limited to patient safety, patient empowerment, disease surveillance and management, e-health and issues concerning data security, privacy, reliability and management, data mining and knowledge exchange as well as health prevention. The journal also addresses the medical, financial, social, educational and safety aspects of health technologies as well as health technology assessment and management, including issues such security, efficacy, cost in comparison to the benefit, as well as social, legal and ethical implications.This journal is a communicative source for the health work force (physicians, nurses, medical physicists, clinical engineers, biomedical engineers, hospital engineers, etc.), the ministries of health, hospital management, self-employed doctors, health care providers and regulatory agencies, the medical technology industry, patients'' associations, universities (biomedical and clinical engineering, medical physics, medical informatics, biology, medicine and public health as well as health economics programs), research institutes and professional, scientific and technical organizations.Health and Technology is jointly published by Springer and the IUPESM (International Union for Physical and Engineering Sciences in Medicine) in cooperation with the World Health Organization.
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