'Legacy publication of a 2009 validation of the Riester Big Ben Square Desk aneroid device for blood pressure measurement according to the European Society of Hypertension International Protocol for validation of blood pressure measuring devices in adults (2002)'.

IF 1.2 4区 医学 Q4 PERIPHERAL VASCULAR DISEASE Blood Pressure Monitoring Pub Date : 2024-08-01 Epub Date: 2024-03-11 DOI:10.1097/MBP.0000000000000702
Ryan J McNally, Janette Dunkerley, Maureen Holland, Ruth Eatough, Peter Lacy, Richard J McManus, Neil Chapman, Philip J Chowienczyk, Philip Lewis, Christopher E Clark, Elizabeth Denver, Annette Neary, Sinead T J McDonagh, James P Sheppard
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Abstract

Objective: To report a validation of the Riester Big Ben Square Desk Aneroid Sphygmomanometer according to the international protocol developed by the Working Group on Blood Pressure Monitoring of the European Society of Hypertension 2002 (ESH-IP 2002) in the interest of transparency. This legacy publication is intended to assure users that the device satisfied the requirements in place at that time.

Methods: Performance of the device was assessed by participants' age, sex, arm circumference and entry SBP/DBP. Validation was performed in 33 participants. The sphygmomanometer was assessed according to the ESH-IP, which defines zones of accuracy compared to the mercury standard as ≤5, ≤10, ≤15 mmHg or more.

Results: The mean (± SD) age was 50.5 ± 13.0 years, range 29-71 years, entry SBP 142.6 ± 23.7 mmHg, entry DBP 89.0 ± 17.8 mmHg. The device passed all the requirements listed and the validation protocol. The Riester Big Ben Square Desk aneroid sphygmomanometer slightly underestimated the observer-measured SBP, yet slightly overestimated DBP. The observer-device disagreement was -0.8 ± 6.4 mmHg SBP and +0.6 ± 4.0 mmHg DBP.

Conclusion: These data show that the Riester Big Ben Square Desk aneroid sphygmomanometer fulfilled the ESH-IP 2002 requirements for the validation of BP monitors. It was on this basis that the British and Irish Hypertension Society recommended it for clinical use in the adult population.

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根据欧洲高血压学会成人血压测量设备验证国际协议(2002 年),2009 年发布了 Riester Big Ben Square Desk 无液血压测量仪的验证结果。
目的根据欧洲高血压学会 2002 年血压监测工作组 (ESH-IP 2002) 制定的国际协议,报告 Riester Big Ben Square Desk 无创血压计的验证情况,以提高透明度。该传统出版物旨在向用户保证该设备符合当时的要求:方法:根据参与者的年龄、性别、臂围和初始 SBP/DBP 评估设备的性能。对 33 名参与者进行了验证。根据 ESH-IP 标准对血压计进行了评估,该标准将与水银标准相比的精确度区域定义为≤5、≤10、≤15 mmHg 或更高:平均(± SD)年龄为 50.5 ± 13.0 岁,范围为 29-71 岁,入选 SBP 为 142.6 ± 23.7 mmHg,入选 DBP 为 89.0 ± 17.8 mmHg。该设备通过了所列的所有要求和验证协议。Riester Big Ben Square Desk 无创血压计略微低估了观察者测量的 SBP,但略微高估了 DBP。观察者与设备之间的差异为 -0.8 ± 6.4 mmHg SBP 和 +0.6 ± 4.0 mmHg DBP:这些数据表明,Riester Big Ben Square Desk 无创血压计符合 ESH-IP 2002 对血压计验证的要求。在此基础上,英国和爱尔兰高血压学会建议将其用于成人临床。
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
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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