GRADE 指南：21 部分 1. 研究设计、偏倚风险和间接性，用于对一组证据进行测试准确性的确定性评估。
GRADE guidelines: 21 part 1. Study design, risk of bias, and indirectness in rating the certainty across a body of evidence for test accuracy.
机构信息
Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8S4K1, Canada; Department of Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
出版信息
J Clin Epidemiol. 2020 Jun;122:129-141. doi: 10.1016/j.jclinepi.2019.12.020. Epub 2020 Feb 12.
OBJECTIVES
This article provides updated GRADE guidance about how authors of systematic reviews and health technology assessments and guideline developers can assess the results and the certainty of evidence (also known as quality of the evidence or confidence in the estimates) of a body of evidence addressing test accuracy (TA).
STUDY DESIGN AND SETTING
We present an overview of the GRADE approach and guidance for rating certainty in TA in clinical and public health and review the presentation of results of a body of evidence regarding tests. Part 1 of the two parts in this 21st guidance article about how to apply GRADE focuses on understanding study design issues in test accuracy, provide an overview of the domains, and describe risk of bias and indirectness specifically.
RESULTS
Supplemented by practical examples, we describe how raters of the evidence using GRADE can evaluate study designs focusing on tests and how they apply the GRADE domains risk of bias and indirectness to a body of evidence of TA studies.
CONCLUSION
Rating the certainty of a body of evidence using GRADE in Cochrane and other reviews and World Health Organization and other guidelines dealing with in TA studies helped refining our approach. The resulting guidance will help applying GRADE successfully for questions and recommendations focusing on tests.
目的
本文提供了更新的 GRADE 指导，介绍了系统评价和卫生技术评估的作者以及指南制定者如何评估针对检测准确性（TA）的证据体的结果和证据确定性（也称为证据质量或估计可信度）。
研究设计和设置
我们概述了 GRADE 方法，并介绍了临床和公共卫生领域中 TA 评估的等级确定指导，回顾了关于检测的证据体结果的呈现。这篇关于如何应用 GRADE 的 21 条指导文章的两部分中的第 1 部分重点关注理解检测准确性研究设计中的问题，概述了各个领域，并专门描述了偏倚风险和间接性。
结果
我们通过实际示例描述了使用 GRADE 评估证据的评估者如何评估专注于检测的研究设计，以及他们如何将 GRADE 领域的偏倚风险和间接性应用于 TA 研究的证据体。
结论
在涉及 TA 研究的 Cochrane 和其他综述以及世界卫生组织和其他指南中，使用 GRADE 对证据体的确定性进行评级有助于完善我们的方法。由此产生的指导将有助于成功地针对专注于检测的问题和建议应用 GRADE。
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