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本文引用的文献

1
Recommendations and Practical Guidance for performing and reporting validation studies according to the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO).根据医疗器械促进协会/欧洲高血压学会/国际标准化组织(AAMI/ESH/ISO)发布的《血压测量设备验证的通用标准》,为开展和报告验证研究提供的建议和实用指南。
J Hypertens. 2019 Mar;37(3):459-466. doi: 10.1097/HJH.0000000000002039.
2
Efficacy of self-monitored blood pressure, with or without telemonitoring, for titration of antihypertensive medication (TASMINH4): an unmasked randomised controlled trial.自我监测血压(无论是否结合远程监测)在调整降压药物剂量方面的疗效(TASMINH4):一项非盲随机对照试验。
Lancet. 2018 Mar 10;391(10124):949-959. doi: 10.1016/S0140-6736(18)30309-X. Epub 2018 Feb 27.
3
An Assessment of the Accuracy of Home Blood Pressure Monitors When Used in Device Owners.家用血压监测仪在设备使用者中使用时的准确性评估。
Am J Hypertens. 2017 Jul 1;30(7):683-689. doi: 10.1093/ajh/hpx041.
4
Self-monitoring blood pressure in patients with hypertension: an internet-based survey of UK GPs.高血压患者的自我血压监测:一项针对英国全科医生的基于互联网的调查。
Br J Gen Pract. 2016 Nov;66(652):e831-e837. doi: 10.3399/bjgp16X687037. Epub 2016 Aug 30.
5
Patients' and clinicians' views on the optimum schedules for self-monitoring of blood pressure: a qualitative focus group and interview study.患者和临床医生对血压自我监测最佳方案的看法:一项定性焦点小组和访谈研究
Br J Gen Pract. 2016 Nov;66(652):e819-e830. doi: 10.3399/bjgp16X686149. Epub 2016 Jul 5.
6
How Accurate Are Home Blood Pressure Devices in Use? A Cross-Sectional Study.家用血压测量设备的准确性如何?一项横断面研究。
PLoS One. 2016 Jun 1;11(6):e0155677. doi: 10.1371/journal.pone.0155677. eCollection 2016.
7
Accuracy of monitors used for blood pressure checks in English retail pharmacies: a cross-sectional observational study.英国零售药店用于血压检测的监测仪准确性:一项横断面观察性研究。
Br J Gen Pract. 2016 May;66(646):e309-14. doi: 10.3399/bjgp16X684769. Epub 2016 Mar 29.
8
Reliability of home blood pressure monitoring: in the context of validation and accuracy.家庭血压监测的可靠性:在验证与准确性的背景下
Blood Press Monit. 2015 Aug;20(4):215-20. doi: 10.1097/MBP.0000000000000121.
9
Type and accuracy of sphygmomanometers in primary care: a cross-sectional observational study.基层医疗中血压计的类型和准确性:一项横断面观察性研究。
Br J Gen Pract. 2011 Sep;61(590):e598-603. doi: 10.3399/bjgp11X593884.
10
Self-Monitoring of Blood Pressure in Hypertension: A UK Primary Care Survey.高血压患者的血压自我监测:一项英国初级保健调查。
Int J Hypertens. 2012;2012:582068. doi: 10.1155/2012/582068. Epub 2011 Oct 16.

高血压患者所拥有的血压监测仪的准确性(ACCU-RATE 研究):英格兰中部的一项横断面、观察性研究。

Accuracy of blood-pressure monitors owned by patients with hypertension (ACCU-RATE study): a cross-sectional, observational study in central England.

机构信息

Institute of Applied Health Research, University of Birmingham, Edgbaston.

Nuffield professor of primary care health sciences.

出版信息

Br J Gen Pract. 2020 Jul 30;70(697):e548-e554. doi: 10.3399/bjgp20X710381. Print 2020 Aug.

DOI:10.3399/bjgp20X710381
PMID:32482629
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7274541/
Abstract

BACKGROUND

Home blood-pressure (BP) monitoring is recommended in guidelines and is increasingly popular with patients and health professionals, but the accuracy of patients' own monitors in real-world use is not known.

AIM

To assess the accuracy of home BP monitors used by people with hypertension, and to investigate factors affecting accuracy.

DESIGN AND SETTING

Cross-sectional, observational study in urban and suburban settings in central England.

METHOD

Patients ( = 6891) on the hypertension register at seven practices in the West Midlands, England, were surveyed to ascertain whether they owned a BP monitor and wanted it tested. Monitor accuracy was compared with a calibrated reference device at 50 mmHg intervals between 0-280/300 mmHg (static pressure test); a difference from the reference monitor of +/-3 mmHg at any interval was considered a failure. Cuff performance was also assessed. Results were analysed by frequency of use, length of time in service, make and model, monitor validation status, purchase price, and any previous testing.

RESULTS

In total, 251 (76%, 95% confidence interval [95% CI] = 71 to 80%) of 331 tested devices passed all tests (monitors and cuffs), and 86% (CI] = 82 to 90%) passed the static pressure test; deficiencies were, primarily, because of monitors overestimating BP. A total of 40% of testable monitors were not validated. The pass rate on the static pressure test was greater in validated monitors (96%, 95% CI = 94 to 98%) versus unvalidated monitors (64%, 95% CI = 58 to 69%), those retailing for >£10 (90%, 95% CI = 86 to 94%), those retailing for ≤£10 (66%, 95% CI = 51 to 80%), those in use for ≤4 years (95%, 95% CI = 91 to 98%), and those in use for >4 years (74%, 95% CI = 67 to 82%). All in all, 12% of cuffs failed.

CONCLUSION

Patients' own BP monitor failure rate was similar to that demonstrated in studies performed in professional settings, although cuff failure was more frequent. Clinicians can be confident of the accuracy of patients' own BP monitors if the devices are validated and ≤4 years old.

摘要

背景

家庭血压(BP)监测在指南中被推荐,并且越来越受到患者和卫生专业人员的欢迎,但是患者自己的监测器在实际使用中的准确性尚不清楚。

目的

评估高血压患者使用的家庭 BP 监测器的准确性,并调查影响准确性的因素。

设计和设置

在英格兰中部的城市和郊区环境中进行的横断面、观察性研究。

方法

在英格兰西米德兰兹郡的七个实践中,对高血压登记册中的患者(n=6891)进行了调查,以确定他们是否拥有血压监测器并希望对其进行测试。将监测器的准确性与校准的参考设备进行比较,在 0-280/300mmHg 之间以 50mmHg 的间隔进行静态压力测试(静态压力测试);在任何间隔处与参考监测器的差异为+/-3mmHg 被认为是失败。还评估了袖口的性能。通过使用频率,使用时间,制造和型号,监测器验证状态,购买价格以及以前的任何测试来分析结果。

结果

在总共 331 个接受测试的设备中,有 251 个(76%,95%置信区间[95%CI]=71-80%)通过了所有测试(监测器和袖口),有 86%(95%CI=82-90%)通过了静态压力测试;主要的缺陷是因为监测器高估了血压。可测试监测器中,有 40%未经过验证。在经过验证的监测器上,静态压力测试的通过率更高(96%,95%CI=94-98%),而未经过验证的监测器的通过率更低(64%,95%CI=58-69%),零售价格超过£10(90%,95%CI=86-94%),零售价格低于£10(66%,95%CI=51-80%),使用年限不超过 4 年(95%,95%CI=91-98%),使用年限超过 4 年(74%,95%CI=67-82%)。总共,有 12%的袖口失败。

结论

患者自己的 BP 监测器的失败率与在专业环境中进行的研究中所显示的失败率相似,尽管袖口的失败率更高。如果设备经过验证且使用年限不超过 4 年,则可以确信患者自己的 BP 监测器的准确性。