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偏倚风险评估:(6) 诊断准确性研究质量评估的修订工具(QUADAS-2)

[Risk on bias assessment: (6) A Revised Tool for the Quality Assessment on Diagnostic Accuracy Studies (QUADAS-2)].

作者信息

Qu Y J, Yang Z R, Sun F, Zhan S Y

机构信息

Department of Cardiac Surgery, Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, China.

Primary Care Unit, Department of Public Health and Primary Care, School of Clinical Medicine, University of Cambridge, Cambridgeshire CB1 8RN, UK.

出版信息

Zhonghua Liu Xing Bing Xue Za Zhi. 2018 Apr 10;39(4):524-531. doi: 10.3760/cma.j.issn.0254-6450.2018.04.028.

DOI:10.3760/cma.j.issn.0254-6450.2018.04.028
PMID:29699051
Abstract

This paper introduced the Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2), including the development and comparison with the original QUADAS, and illustrated the application of QUADAS-2 in a published paper related to the study on diagnostic accuracy which was included in systematic review and Meta-analysis. QUADAS-2 presented considerable improvement over the original tool. Confused items that included in QUADAS had disappeared and the quality assessment of the original study replaced by the rating of risk on bias and applicability. This was implemented through the description on the four main domains with minimal overlapping and answering the signal questions in each domain. The risk of bias and applicability with 'high','low' or 'unclear' was in line with the risk of bias assessment of intervention studies in Cochrane, so to replace the total score of quality assessment in QUADAS. Meanwhile, QUADAS-2 was also applicable to assess the diagnostic accuracy studies in which follow-up without prognosis was involved in golden standard. It was useful to assess the overall methodological quality of the study despite more time consuming than the original QUADAS. However, QUADAS-2 needs to be modified to apply in comparative studies on diagnostic accuracy and we hope the users would follow the updates and give their feedbacks on line.

摘要

本文介绍了诊断准确性研究质量评估修订工具(QUADAS-2),包括其开发过程以及与原始QUADAS的比较,并举例说明了QUADAS-2在一篇已发表的与诊断准确性研究相关的论文中的应用,该论文被纳入系统评价和Meta分析。与原始工具相比,QUADAS-2有了显著改进。QUADAS中包含的混淆项目已消失,原始研究的质量评估被偏倚风险和适用性评级所取代。这是通过对四个主要领域进行描述来实现的,各领域之间重叠最少,并回答每个领域中的信号问题。偏倚风险和适用性分为“高”“低”或“不清楚”,这与Cochrane干预研究的偏倚风险评估一致,从而取代了QUADAS中的质量评估总分。同时,QUADAS-2也适用于评估金标准涉及无预后随访的诊断准确性研究。尽管比原始QUADAS耗时更多,但它对于评估研究的整体方法学质量很有用。然而,QUADAS-2需要进行修改以应用于诊断准确性的比较研究,我们希望用户关注更新内容并在线提供反馈。

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