偏倚风险评估系列:(六)诊断试验

曲艳吉; 杨智荣; 孙凤; 詹思延

文章摘要

曲艳吉,杨智荣,孙凤,詹思延.偏倚风险评估系列:(六)诊断试验[J].中华流行病学杂志,2018,39(4):524-531

偏倚风险评估系列:(六)诊断试验

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

收稿日期:2017-08-01 出版日期:2018-04-18

DOI：10.3760/cma.j.issn.0254-6450.2018.04.028

中文关键词: 偏倚风险评估工具诊断试验系统综述

英文关键词: Risk of bias Tool for assessment Diagnostic accuracy studies Systematic review

基金项目:国家自然科学基金（71673003）

作者	单位	E-mail
曲艳吉	510080 广州, 广东省心血管病研究所, 广东省人民医院, 广东省医学科学院心外科
杨智荣	CB1 8RN 英国剑桥大学临床医学院初级医疗中心
孙凤	100191 北京大学公共卫生学院流行病与卫生统计学系, 北京大学循证医学中心	sunfeng@bjmu.edu.cn
詹思延	100191 北京大学公共卫生学院流行病与卫生统计学系, 北京大学循证医学中心

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中文摘要:

本讲座详细介绍了诊断试验准确性研究的偏倚评估工具（QUADAS-2）的主要内容，同时阐述了QUADAS-2的开发过程及与第一版QUADAS工具的区别，并举例说明QUADAS-2的使用方法和注意事项。QUADAS-2相比第一版QUADAS工具有巨大改进，例如QUADAS-2删除了QUADAS中易混淆的条目内容，仅通过对重叠度最小的4个关键领域（Domain）的描述和对每个领域内信号问题的回答完成偏倚风险和适用性两个核心方面的评价，最后得出原始研究每个领域的偏倚风险和适用性为高（High）、低（Low）或不清楚（Unclear）的结论，而不再是给出原始研究质量评价的总分，这与Cochrane干预措施系统综述中偏倚风险的评估一致。同时，QUADAS-2还可以应用于金标准中包括随访但不涉及预后问题的原始研究的偏倚风险评价。虽然开展QUADAS-2评价需要花费更多时间，但这对于诊断准确性研究的偏倚风险评价非常重要。QUADAS-2研究组后续还将在比较多种待评价诊断试验的原始研究中应用QUADAS-2进行偏倚风险评估，使用者可持续关注其进展，同时也可在线反馈使用体验或提供改进建议。

英文摘要:

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.

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