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系统评价指南评估:它们与安全性结局有何关系?

An appraisal of meta-analysis guidelines: how do they relate to safety outcomes?

机构信息

Global Pharmacometrics, Pfizer Limited, Sandwich, Kent, UK.

Statistics, Pfizer Inc., New York, NY, USA.

出版信息

Res Synth Methods. 2017 Mar;8(1):64-78. doi: 10.1002/jrsm.1219. Epub 2016 Sep 9.

DOI:10.1002/jrsm.1219
PMID:27612447
Abstract

Although well developed to assess efficacy questions, meta-analyses and, more generally, systematic reviews, have received less attention in application to safety-related questions. As a result, many open questions remain on how best to apply meta-analyses in the safety setting. This appraisal attempts to: (i) summarize the current guidelines for assessing individual studies, systematic reviews, and network meta-analyses; (ii) describe several publications on safety meta-analytic approaches; and (iii) present some of the questions and issues that arise with safety data. A number of gaps in the current quality guidelines are identified along with issues to consider when performing a safety meta-analysis. While some work is ongoing to provide guidance to improve the quality of safety meta-analyses, this review emphasizes the critical need for better reporting and increased transparency regarding safety data in the systematic review guidelines. Copyright © 2016 John Wiley & Sons, Ltd.

摘要

尽管在评估疗效问题方面已经得到了很好的发展,但是荟萃分析和更广泛的系统评价在应用于安全性问题方面受到的关注较少。因此,在如何最好地将荟萃分析应用于安全性设置方面仍有许多悬而未决的问题。本评价试图:(i)总结目前评估个体研究、系统评价和网络荟萃分析的指南;(ii)描述几篇关于安全性荟萃分析方法的出版物;以及(iii)介绍与安全性数据相关的一些问题和问题。确定了当前质量指南中的一些差距,并提出了在进行安全性荟萃分析时需要考虑的问题。虽然正在进行一些工作以提供指导来提高安全性荟萃分析的质量,但本评论强调了在系统评价指南中更好地报告和提高安全性数据透明度的迫切需要。版权所有©2016 约翰威利父子公司。

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