GRADE方法中,随机试验起评即为高质量证据,观察性研究起评即为低质量证据;但若证据本身存在高发表偏倚风险,则两者证据质量级别都应降低。即使最佳证据汇总表纳入的各项研究仅有低发表偏倚风险,发表偏倚仍会极大高估效应值。当可得证据来自小样本研究、且多数由厂商资助时,作者应怀疑存在发表偏倚。若干基于检验数据类型的方法可用于评价发表偏倚,其中最常用的为漏斗图,但这些方法都有较大局限。发表偏倚可能较常见,必须特别关注早期结果、对样本量与事件数都很小的早期试验结果尤需小心。
Types of publication bias and its background are introduced in this paper, and publication bias can be investigated and deal with three methods: funnel plot, trim and filling method, and formula method. Those methods can be used to detect publication bias in conducting systematic reviews.
ObjectiveTo explore the application of enhanced funnel plots (EFP) and trial sequential analysis (TSA) in robustness assessment of meta-analysis results.MethodsData were extracted from published meta-analysis. The EFP was used to evaluate the robustness of the significance and heterogeneity of the current meta-analysis. The TSA was used to judge the sufficiency of the cumulative sample size of the current meta-analysis and to assess the robustness of conclusions based on current evidence.ResultsThe EFP showed that the meta-analysis results of low-density lipoprotein (LDL) was robust, and the meta-analysis results of triglyceride (TG), total cholesterol (TC) and high-density lipoprotein (HDL) were not stable. The TSA showed that the cumulative sample size of LDL had reached the required information size (RIS), and the current conclusion was stable. The cumulative Z value of TG, TC and HDL neither reached the RIS nor passed through the TSA monitoring boundary or futility boundary, indicating that current conclusions were not robust.ConclusionsThe combination of EFP and TSA can make a comprehensive judgment on the robustness of current meta-analysis results, and provide methodological support in the robustness assessment of results for future systematic reviews and meta-analyses.