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[GRADE指南:12. 编制结果总结表 - 二分法结局]

[GRADE guidelines: 12. Developing Summary of Findings tables - dichotomous outcomes].

作者信息

Langer Gero, Meerpohl Joerg J, Perleth Matthias, Gartlehner Gerald, Schünemann Holger

机构信息

Institut für Gesundheits- und Pflegewissenschaft, Medizinische Fakultät der Martin-Luther-Universität Halle-Wittenberg, Halle (Saale).

出版信息

Z Evid Fortbild Qual Gesundhwes. 2013;107(9-10):646-64. doi: 10.1016/j.zefq.2013.10.034. Epub 2013 Nov 9.

Abstract

Summary of Findings (SoF) tables present, for each of the seven (or fewer) most important outcomes, the following: the number of studies and number of participants; the confidence in effect estimates (quality of evidence); and the best estimates of relative and absolute effects. Potentially challenging choices in preparing SoF tables include using direct evidence (which may have very few events) or indirect evidence (from a surrogate) as the best evidence for a treatment effect. If a surrogate is chosen, it must be labeled as substituting for the corresponding patient-important outcome. Another such choice is presenting evidence from low-quality randomised trials or high-quality observational studies. When in doubt, a reasonable approach is to present both sets of evidence; if the two bodies of evidence have similar quality but discrepant results, one would rate down further for inconsistency. For binary outcomes, relative risks (RRs) are the preferred measure of relative effect and, in most instances, are applied to the baseline or control group risks to generate absolute risks. Ideally, the baseline risks come from observational studies including representative patients and identifying easily measured prognostic factors that define groups at differing risk. In the absence of such studies, relevant randomised trials provide estimates of baseline risk. When confidence intervals (CIs) around the relative effect include no difference, one may simply state in the absolute risk column that results fail to show a difference, omit the point estimate and report only the CIs, or add a comment emphasizing the uncertainty associated with the point estimate. KEY STATEMENTS: Summary of Findings (SoF) tables provide succinct; easily digestible presentations of confidence in effect estimates (quality of evidence) and magnitude of effects. SoF tables should present the seven (or fewer) most important outcomes. These outcomes must always be patient-important outcomes and never be surrogates, although surrogates can be used to estimate effects on patient-important outcomes. SoF tables should present the highest quality evidence. When the quality of two bodies of evidence (e.g., randomised trials and observational studies) is similar, SoF tables may include summaries from both. SoF tables should include both relative and absolute effect measures, and separate estimates of absolute effect for identifiable patient groups with substantially different baseline or control group risks.

摘要

研究结果总结(SoF)表针对七个(或更少)最重要的结局,分别呈现以下内容:研究数量和参与者数量;效应估计的可信度(证据质量);以及相对效应和绝对效应的最佳估计值。编制SoF表时可能具有挑战性的选择包括:使用直接证据(可能事件数量很少)或间接证据(来自替代指标)作为治疗效果的最佳证据。如果选择了替代指标,必须标明其替代的相应患者重要结局。另一个此类选择是呈现来自低质量随机试验或高质量观察性研究的证据。如有疑问,合理的方法是同时呈现两组证据;如果两组证据质量相似但结果不一致,则应因不一致性而进一步降低评级。对于二元结局,相对风险(RR)是相对效应的首选衡量指标,并且在大多数情况下,应用于基线或对照组风险以生成绝对风险。理想情况下,基线风险来自观察性研究,这些研究纳入具有代表性的患者,并确定易于测量的预后因素以定义不同风险组。在没有此类研究的情况下,相关随机试验可提供基线风险估计值。当相对效应的置信区间(CI)不包含差异时,可以在绝对风险列中简单说明结果未显示差异,省略点估计值并仅报告CI,或者添加注释强调与点估计值相关的不确定性。关键陈述:研究结果总结(SoF)表提供了对效应估计的可信度(证据质量)和效应大小的简洁、易于理解的呈现。SoF表应呈现七个(或更少)最重要的结局。这些结局必须始终是患者重要结局,绝不能是替代指标,尽管替代指标可用于估计对患者重要结局的影响。SoF表应呈现最高质量的证据。当两组证据(例如,随机试验和观察性研究)的质量相似时,SoF表可包括两者的总结。SoF表应同时包括相对效应和绝对效应测量值,以及针对具有显著不同基线或对照组风险的可识别患者组的绝对效应单独估计值。

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