GRADE 指南：19. 评估结局或价值观和偏好的重要性的证据确定性——偏倚风险和间接性。
GRADE Guidelines: 19. Assessing the certainty of evidence in the importance of outcomes or values and preferences-Risk of bias and indirectness.
机构信息
Department of Health Research Methods, Evidence, and Impact & McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8N 4K1, Canada.
Department of Health Research Methods, Evidence, and Impact & McMaster GRADE Centre, McMaster University, 1280 Main Street West, Hamilton, Ontario L8N 4K1, Canada; Centro Cochrane Iberoamericano, Instituto de Investigacion Biomedica (IIB Sant Pau-CIBERESP), Sant Antoni Maria Claret 167, 08025 Barcelona, Spain.
出版信息
J Clin Epidemiol. 2019 Jul;111:94-104. doi: 10.1016/j.jclinepi.2018.01.013. Epub 2018 Feb 13.
OBJECTIVES
The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) working group defines patient values and preferences as the relative importance patients place on the main health outcomes. We provide GRADE guidance for assessing the risk of bias and indirectness domains for certainty of evidence about the relative importance of outcomes.
STUDY DESIGN AND SETTING
We applied the GRADE domains to rate the certainty of evidence in the importance of outcomes to several systematic reviews, iteratively reviewed draft guidance and consulted GRADE members and other stakeholders for feedback.
RESULTS
This is the first of two articles. A body of evidence addressing the importance of outcomes starts at "high certainty"; concerns with risk of bias, indirectness, inconsistency, imprecision, and publication bias lead to downgrading to moderate, low, or very low certainty. We propose subdomains of risk of bias as selection of the study population, missing data, the type of measurement instrument, and confounding; we have developed items for each subdomain. The population, intervention, comparison, and outcome elements associated with the evidence determine the degree of indirectness.
CONCLUSION
This article provides guidance and examples for rating the risk of bias and indirectness for a body of evidence summarizing the importance of outcomes.
目的
推荐评估、制定与评估分级（GRADE）工作组将患者价值观和偏好定义为患者对主要健康结局相对重视程度。我们提供 GRADE 指导意见，用于评估结局相对重要性证据的偏倚风险和不准确性领域的确定性。
研究设计和设置
我们将 GRADE 领域应用于评估几项系统评价中结局重要性证据的确定性，对指导意见草案进行迭代审查，并征求 GRADE 成员和其他利益相关者的反馈意见。
结果
这是两篇文章中的第一篇。针对结局重要性的证据体始于“高确定性”；对偏倚风险、不准确性、不一致性、不精确性和发表偏倚的担忧会导致降级为中确定性、低确定性或极低确定性。我们提出了偏倚风险的子领域，如研究人群选择、缺失数据、测量仪器类型和混杂因素；我们为每个子领域制定了项目。与证据相关的人群、干预、比较和结局要素决定了不准确性的程度。
结论
本文为评估总结结局重要性的证据体的偏倚风险和不准确性提供了指导和示例。
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