Department of Clinical Epidemiology and Biostatistics, McMaster University, West Hamilton, Ontario L8N 3Z5, Canada.
J Clin Epidemiol. 2013 Feb;66(2):158-72. doi: 10.1016/j.jclinepi.2012.01.012. Epub 2012 May 18.
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 table 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 randomized 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 randomized 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.
结果总结 (SoF) 表呈现了以下七项(或更少)最重要结局的各项内容:研究数量和参与者数量;效应估计的置信度(证据质量);以及相对和绝对效应的最佳估计值。在准备 SoF 表时,可能会面临一些具有挑战性的选择,包括使用直接证据(可能只有很少的事件)或间接证据(替代指标)作为治疗效果的最佳证据。如果选择替代指标,则必须将其标记为替代相应的患者重要结局。另一个这样的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。如果存在疑问,一个合理的方法是同时呈现两组证据;如果这两组证据质量相似但结果不一致,则会因不一致性而进一步降低评分。对于二分类结局,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,RR 应用于基线或对照组风险以生成绝对风险。理想情况下,基线风险来自包括代表性患者的观察性研究,并确定易于测量的预后因素,以定义不同风险的组。在缺乏此类研究的情况下,相关的随机试验提供了基线风险的估计值。当相对效应的置信区间不包括差异时,人们可以在绝对风险列中简单地说明结果未能显示差异,省略点估计值并仅报告置信区间,或者添加一个注释,强调与点估计值相关的不确定性。