診断精度研究のバイアスリスク評価ツールQUADAS-2:a Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies 2 の活用

診断精度研究のバイアスリスク評価ツールQUADAS-2:a Revised Tool for the Quality Assessment of Diagnostic Accuracy Studies 2 の活用
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发表时间:
2014
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通讯作者:
小島原典子;森實敏夫;中山健夫;福岡敏雄;河合富士美;佐藤康仁;吉田雅博;山口直人
小島原典子;森實敏夫;中山健夫;福岡敏雄;河合富士美;佐藤康仁;吉田雅博;山口直人
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其他
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作者:
小島原典子;森實敏夫;中山健夫;福岡敏雄;河合富士美;佐藤康仁;吉田雅博;山口直人

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2003年开发了QUADAS(诊断准确性研究的质量评估)工具,这是诊断研究的质量评估工具,此后Cochrane协作建议将QUADAS用于诊断准确性的系统审查。经过进一步修订,主要是由等级(建议评估、发展和评价等级)工作组进行修订,2011年发布了QUADAS-2(http://www.bris.ac.uk/quadas/)。经原作者许可,于2014年4月在Minds网站(http://minds.jcqhc.or.jp)上进行了日语本地化,并于2014年5月在QUADAS网站上发布。最初的QUADAS工具包括评估偏见风险、适用性和报告质量的14个项目。QUADAS-2工具包括4个阶段:1)总结审查问题,2)调整工具和产生专门针对审查的指导意见,3)构建初步研究的流程图,4)评估偏见和适用性。最后一个阶段适用于4个领域:患者选择、指标测试、参考标准、流程和时机。使用“是”、“否”或“不清楚”的信号问题,根据偏见风险对每个领域进行评估。前3个领域也根据适用性进行评估。这一工具将有助于提高偏差评级的透明度,并提高对诊断准确性研究的系统审查的适用性。
The QUADAS(Quality Assessment of Diagnostic Accuracy Studies)tool, a quality assessment tool of diagnostic studies was developed in 2003, and thereafter the Cochrane Collaboration recommended QUADAS for use in systematic reviews of diagnostic accuracy. Following further revision, mainly by the GRADE(Grading of Recommendations Assessment, Development and Evaluation) working group, QUADAS-2 was released in 2011 (http://www.bris.ac.uk/quadas/). With the permission of the original authors, Japanese language localization was undertaken and released on the MINDS website in April 2014(http://minds.jcqhc.or.jp), and release on the QUADAS website is scheduled for May 2014.The original QUADAS tool includes 14 items assessing bias risk, applicability, and for reporting quality. The QUADAS-2 tool consists of 4 phases:1)summarization of the review question, 2)tailoring of the tool and the production of review-specific guidance, 3)construction of a flow diagram for the primary study, 4)assessment of bias and applicability. The last phase is applicable to 4 domains:patient selection, index test, reference standards, and flow and timing. Each domain is assessed according to bias risk using signalling questions of“yes,”“no,”or“unclear.”The first 3 domains are also assessed in terms of applicability. This tool will facilitate increased transparency in the rating of bias and improve applicability in the systematic review of diagnostic accuracy studies.