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试验序贯分析解读:利用韩国麻醉学期刊发表的荟萃分析的事后分析。

Explanation of trial sequential analysis: using a post-hoc analysis of meta-analyses published in Korean Journal of Anesthesiology.

机构信息

UOC Anesthesia and Intensive Care Unit, University Hospital of Padua, Padua, Italy.

UOC Anesthesia and Intensive Care Unit, Department of Medicine-DIMED, University of Padua, Padua, Italy.

出版信息

Korean J Anesthesiol. 2021 Oct;74(5):383-393. doi: 10.4097/kja.21218. Epub 2021 Jul 20.

Abstract

BACKGROUND

Trial sequential analysis (TSA) is a recent cumulative meta-analysis method used to weigh type I and II errors and to estimate when the effect is large enough to be unaffected by further studies. The aim of this study was to illustrate possible TSA scenarios and their significance using meta-analyses published in the Korean Journal of Anesthesiology as working material.

METHODS

We performed a systematic medical literature search for meta-analyses published in the Korean Journal of Anesthesiology. TSA was performed on each main outcome, estimating the required sample size on the calculated effect size for the intervention, considering a type I error of 5% and a power of 90% or 99%.

RESULTS

Six meta-analyses with a total of ten main outcomes were included in the analysis. Seven TSAs confirmed the results of the meta-analyses. However, only three of them reached the required sample size. In the two TSAs, the cumulative z-lines were not statistically significant. One TSA boundary for effect was reached with the 90% analysis, but not with the 99% analysis.

CONCLUSIONS

In TSA, a meta-analysis pooled effect may be established to assess if the cumulative sample size is large enough. TSA can be used to add strength to the conclusions of meta-analyses; however, pre-registration of the TSA protocol is of paramount importance. This study could be useful to better understand the use of TSA as an additional statistical tool to improve meta-analysis quality.

摘要

背景

试验序贯分析(TSA)是一种最近的累积荟萃分析方法,用于权衡 I 型和 II 型错误,并估计当效果足够大而不受进一步研究影响时。本研究的目的是使用《韩国麻醉学杂志》发表的荟萃分析作为工作材料来说明可能的 TSA 情况及其意义。

方法

我们对发表在《韩国麻醉学杂志》上的荟萃分析进行了系统的医学文献检索。对每个主要结局进行 TSA,根据干预措施的计算效果大小估算所需的样本量,考虑 5%的 I 型错误和 90%或 99%的功效。

结果

共纳入 6 项荟萃分析,共计 10 个主要结局。7 项 TSA 证实了荟萃分析的结果。然而,只有 3 项达到了所需的样本量。在两项 TSA 中,累积 z 线没有统计学意义。90%分析达到了效应的一个 TSA 边界,但 99%分析没有达到。

结论

在 TSA 中,可以使用荟萃分析汇总效应来评估累积样本量是否足够大。TSA 可用于增强荟萃分析结论的力度;然而,TSA 方案的预先注册至关重要。本研究有助于更好地理解 TSA 作为一种额外的统计工具来提高荟萃分析质量的使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9010/8497914/a1ea19fbe2e2/kja-21218f1.jpg

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