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动态血压监测仪的准确性:验证研究的系统评价。

Accuracy of ambulatory blood pressure monitors: a systematic review of validation studies.

机构信息

Primary Care Clinical Sciences, University of Birmingham, Edgbaston, Birmingham, UK.

出版信息

J Hypertens. 2013 Feb;31(2):239-50. doi: 10.1097/HJH.0b013e32835b8d8b.

DOI:10.1097/HJH.0b013e32835b8d8b
PMID:23303347
Abstract

BACKGROUND

Recent research and guidelines recommend the routine use of ambulatory blood pressure monitoring for the diagnosis of hypertension, so accuracy of such monitors is more important than ever.

AIM

: To systematically review the literature regarding the accuracy of ambulatory monitors currently in use.

METHODS

Medline, Embase, Cinahl, the Cochrane database, Medion and the dabl Educational Trust website were searched until February 2011. No language or publication date limits were applied. Data were extracted separately by two independent reviewers. Methodological quality was assessed by whether a validation protocol had been used and followed correctly.

RESULTS

From 5420 journal articles identified, 108 met the inclusion criteria. Excluding studies assessing monitors no longer in use, 40 relevant studies were found using 21 different monitors. Thirty-eight (95%) studies used a validation protocol of which 28 studies assessed a monitor in the general population. Of these, protocols were passed in 24 of 28 studies, but 12 of 24 (50%) found a difference of at least 5 mmHg systolic between the test device and the reference standard for 30% or more of the readings. Of the 10 studies conducted in special population groups (e.g. pregnancy, elderly people), only four devices passed the protocols. Only six (16%) studies correctly adhered to the protocols.

CONCLUSION

Published validation studies assessed most ambulatory monitors as accurate, but many failed to adhere to the underlying protocols, undermining this conclusion and peer review standards. Furthermore, most monitors which 'passed' validation showed significant variation in blood pressure from the reference standard, highlighting inadequacies in older validation protocols. Future validation studies should use protocols with simpler methodologies but more rigorous accuracy criteria.

摘要

背景

最近的研究和指南建议常规使用动态血压监测来诊断高血压,因此此类监测仪的准确性比以往任何时候都更加重要。

目的

系统回顾目前使用的动态监测仪准确性的相关文献。

方法

检索了 Medline、Embase、Cinahl、Cochrane 数据库、Medion 和 dabl 教育信托网站,检索时间截至 2011 年 2 月。未对语言或出版日期进行限制。由两名独立评审员分别提取数据。通过是否使用和正确遵循验证方案来评估方法学质量。

结果

从 5420 篇期刊文章中,有 108 篇符合纳入标准。排除评估不再使用的监测仪的研究,发现了 40 项使用 21 种不同监测仪的相关研究。其中 38 项(95%)研究使用了验证方案,其中 28 项研究评估了普通人群中的监测仪。在这些研究中,有 24 项研究的方案得到通过,但其中 12 项(50%)发现测试设备与参考标准相比,有 30%或更多读数的收缩压差异至少为 5mmHg。在 10 项特殊人群(如妊娠、老年人)研究中,只有 4 种设备通过了方案。只有 6 项(16%)研究正确遵循了方案。

结论

发表的验证研究评估了大多数动态监测仪的准确性,但许多研究未能遵守基础方案,从而削弱了这一结论和同行评审标准。此外,大多数通过验证的监测仪与参考标准相比,血压显示出显著差异,突出了旧验证方案的不足。未来的验证研究应使用具有更简单方法学但更严格准确性标准的方案。

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