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血压自助测量设备验证研究的有效性:一项系统评价。

The validity of blood pressure kiosk validation studies: a systematic review.

作者信息

Al Hamarneh Yazid N, Houle Sherilyn K D, Chatterley Patricia, Tsuyuki Ross T

机构信息

Department of Medicine, EPICORE Centre/COMPRIS, University of Alberta, Edmonton, Alberta, Canada.

出版信息

Blood Press Monit. 2013 Jun;18(3):167-72. doi: 10.1097/MBP.0b013e328360fb85.

DOI:10.1097/MBP.0b013e328360fb85
PMID:23635486
Abstract

OBJECTIVE

Public-use blood pressure (BP) kiosks are commonly used, and yet their accuracy has been questioned on the basis of the results of the published validation studies. However, the adherence of these studies to established validation standards has not been studied. We carried out a systematic review of the published peer-reviewed literature on the validity of public-use BP kiosks to assess their adherence to validation standards.

METHODS

With medical librarian assistance, the literature was searched systematically for studies claiming to validate kiosks up to June 2012. Studies were limited to English articles that studied adult patients and were excluded if they were carried out solely on pregnant women. Two authors independently compared the study methods with those recommended in the Association for the Advancement of Medical Instrumentation, British Hypertension Society and the European Society of Hypertension International Protocol validation standards.

RESULTS

Nine studies were identified, of which only one came close to adhering to selected validation standard criteria, and found the device to be accurate. One study found device accuracy with poor adherence to standards, whereas the remaining seven found device inaccuracy with poor adherence to standards, therefore potentially reporting false conclusions.

CONCLUSION

The majority of the reviewed studies validating public-use BP kiosks did not adhere to existing validation standards and therefore may have reported false conclusions. The one study that came close to following the validation standards found the device tested to be accurate. Readers must critically appraise the quality of validation studies published on these devices before interpreting their accuracy, and future studies should better adhere to existing validation standards to reduce the risk of reporting potentially false conclusions.

摘要

目的

公共血压测量亭被广泛使用,然而,根据已发表的验证研究结果,其准确性受到了质疑。但是,这些研究对既定验证标准的遵循情况尚未得到研究。我们对已发表的关于公共血压测量亭有效性的同行评审文献进行了系统综述,以评估它们对验证标准的遵循情况。

方法

在医学图书馆员的协助下,系统检索了截至2012年6月声称对血压测量亭进行验证的研究文献。研究仅限于针对成年患者的英文文章,若仅针对孕妇进行研究则被排除。两位作者独立将研究方法与美国医疗仪器促进协会、英国高血压学会和欧洲高血压学会国际协议验证标准中推荐的方法进行比较。

结果

共识别出9项研究,其中只有1项接近遵循选定的验证标准,且该研究发现该设备准确。1项研究发现设备准确但对标准的遵循情况较差,而其余7项研究发现设备不准确且对标准的遵循情况较差,因此可能得出了错误结论。

结论

大多数审查的验证公共血压测量亭的研究未遵循现有验证标准,因此可能得出了错误结论。接近遵循验证标准的那项研究发现所测试的设备准确。读者在解读这些设备的准确性之前,必须严格评估关于它们的验证研究的质量,未来的研究应更好地遵循现有验证标准,以降低得出潜在错误结论的风险。

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