Abstract：
To identify and summarize the global research literature on validation of automated noninvasive blood pressure measurement devices (BPMDs) with upper arm cuff, develop a repository of validated BPMDs in compliance with the 2020 World Health Organization technical specifications, and identify challenges and gaps in evidence base on validated BPMDs.
A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website.
We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings.
Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation.
A scoping review was conducted. Primary research validating BPMDs complying with the 2020 World Health Organization technical specifications (ie, semiautomated/automated noninvasive devices with upper arm cuff), published in English between January 2000 and December 2021, was included. We searched MEDLINE, Web of Science, Scopus, EMBASE, CINAHL, CENTRAL, ProQuest and the dabl website.
We included 269 studies validating 251 BPMDs across 89 manufacturers. Omron (29%), Microlife (10%), and A&D Company (8%) were the top 3 manufacturers. The 3 most frequently used validation protocols were the European Society of Hypertension-international protocol 2002 (27%), European Society of Hypertension-international protocol 2010 (25%), and modified British Hypertension Society protocol 1993 (16%), respectively. Nearly 45% of the validated BPMDs were intended for use in clinical settings, 38% were for home or self-measurement use, and 48% were for general adults. Most studies reported that BPMDs passed the validation criteria. There was inadequate reporting across studies, especially pertaining to validation settings.
Most BPMDs fulfilled the validation criteria. However, there are considerable gaps in BPMD research in terms of geographical representation, including specific target populations and diseases/conditions, and a range of arm circumferences. Additionally, a potential strategy is required to accelerate the adoption of the Association for the Advancement of Medical Instrumentation (AAMI)/European Society of Hypertension/International Organization for Standardization Universal Standard (International Organization for Standardization 81060-2:2018) for BPMD validation.
摘要：
背景：为了确定和总结有关验证带上臂袖带的自动无创血压测量设备（BPMD）的全球研究文献，开发符合2020年世界卫生组织技术规范的经过验证的BPMD存储库，并基于经过验证的BPMD确定证据中的挑战和差距。
方法：进行了范围审查。验证符合2020年世界卫生组织技术规范的BPMD的初步研究(即，带上臂袖带的半自动/自动非侵入性设备)，在2000年1月至2021年12月期间以英文出版，包括在内。我们搜索了MEDLINE,WebofScience,Scopus,EMBASE,CINAHL,中部,ProQuest和dabl网站。
结果：我们纳入了269项研究，验证了89个制造商的251个BPMD。欧姆龙（29%），微生命（10%），A&D公司（8%）是排名前三的制造商。3个最常用的验证方案是欧洲高血压协会-国际方案2002（27％），欧洲高血压学会-2010年国际协议（25％），并修改了1993年英国高血压协会协议(16%)，分别。近45%的经过验证的BPMD旨在用于临床环境，38%用于家庭或自我测量，48%为一般成年人。大多数研究报告BPMD通过了验证标准。研究报告不足，特别是有关验证设置。
结论：大多数BPMD符合验证标准。然而,在地理代表性方面，BPMD研究存在相当大的差距，包括特定的目标人群和疾病/状况，和一系列的手臂圆周。此外,需要一个潜在的战略来加速采用医疗器械促进协会(AAMI)/欧洲高血压学会/国际标准化组织通用标准(国际标准化组织81060-2:2018)进行BPMD验证.
方法：进行了范围审查。验证符合2020年世界卫生组织技术规范的BPMD的初步研究(即，带上臂袖带的半自动/自动非侵入性设备)，在2000年1月至2021年12月期间以英文出版，包括在内。我们搜索了MEDLINE,WebofScience,Scopus,EMBASE,CINAHL,中部,ProQuest和dabl网站。
结果：我们纳入了269项研究，验证了89个制造商的251个BPMD。欧姆龙（29%），微生命（10%），A&D公司（8%）是排名前三的制造商。3个最常用的验证方案是欧洲高血压协会-国际方案2002（27％），欧洲高血压学会-2010年国际协议（25％），并修改了1993年英国高血压协会协议(16%)，分别。近45%的经过验证的BPMD旨在用于临床环境，38%用于家庭或自我测量，48%为一般成年人。大多数研究报告BPMD通过了验证标准。研究报告不足，特别是有关验证设置。
结论：大多数BPMD符合验证标准。然而,在地理代表性方面，BPMD研究存在相当大的差距，包括特定的目标人群和疾病/状况，和一系列的手臂圆周。此外,需要一个潜在的战略来加速采用医疗器械促进协会(AAMI)/欧洲高血压学会/国际标准化组织通用标准(国际标准化组织81060-2:2018)进行BPMD验证.
