Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD 30993, USA.
Clin Trials. 2013;10(3):389-97. doi: 10.1177/1740774513479467. Epub 2013 Mar 18.
Due to the sparse nature of serious drug-related adverse events (AEs), meta-analyses combining data from several randomized controlled trials (RCTs) to evaluate drug safety issues are increasingly being conducted and published, influencing clinical and regulatory decision making. Evaluation of meta-analyses involves the assessment of both the individual constituent trials and the approaches used to combine them. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting framework is designed to enhance the reporting of systematic reviews and meta-analyses. However, PRISMA may not cover all critical elements useful in the evaluation of meta-analyses with a focus on drug safety particularly in the regulatory-public health setting.
This work was conducted to (1) evaluate the adherence of a sample of published drug safety-focused meta-analyses to the PRISMA reporting framework, (2) identify gaps in this framework based on key aspects pertinent to drug safety, and (3) stimulate the development and validation of a more comprehensive reporting tool that incorporates elements unique to drug safety evaluation.
We selected a sample of meta-analyses of RCTs based on review of abstracts from high-impact journals as well as top medical specialty journals between 2009 and 2011. We developed a preliminary reporting framework based on PRISMA with specific additional reporting elements critical for the evaluation of drug safety meta-analyses of RCTs. The reporting of pertinent elements in each meta-analysis was reviewed independently by two authors; discrepancies in the independent evaluations were resolved through discussions between the two authors.
A total of 27 meta-analyses, 12 from highest impact journals, 13 from specialty medical journals, and 2 from Cochrane reviews, were identified and evaluated. The great majority (>85%) of PRISMA elements were addressed in more than half of the meta-analyses reviewed. However, the majority of meta-analyses (>60%) did not address most (>80%) of the additional reporting elements critical for the evaluation of drug safety. Some of these elements were not addressed in any of the reviewed meta-analyses.
This review included a sample of meta-analyses, with a focus on drug safety, recently published in high-impact journals; therefore, we may have underestimated the extent of the reporting problem across all meta-analyses of drug safety. Furthermore, temporal trends in reporting could not be evaluated in this review because of the short time interval selected.
While the majority of PRISMA elements were addressed by most studies reviewed, the majority of studies did not address most of the additional safety-related elements. These findings highlight the need for the development and validation of a drug safety reporting framework and the importance of the current initiative by the Council for International Organizations of Medical Sciences (CIOMS) to create a guidance document for drug safety information synthesis/meta-analysis, which may improve reporting, conduct, and evaluation of meta-analyses of drug safety and inform clinical and regulatory decision making.
由于严重药物相关不良事件（AE）的稀疏性质，越来越多地进行并发表了将来自几个随机对照试验（RCT）的数据合并为药物安全性问题的荟萃分析，从而影响了临床和监管决策。荟萃分析的评估涉及对单个组成试验和用于合并它们的方法的评估。旨在增强系统评价和荟萃分析报告的系统评价和荟萃分析的首选报告项目（PRISMA）报告框架。然而，PRISMA 可能无法涵盖药物安全性特别是在监管 - 公共卫生环境中特别关注的荟萃分析评估中有用的所有关键要素。
这项工作旨在（1）评估一组已发表的药物安全性为重点的荟萃分析对 PRISMA 报告框架的遵守情况，（2）根据与药物安全性相关的关键方面确定该框架中的差距，以及（3）促进开发和验证更全面的报告工具，该工具将纳入药物安全性评估特有的元素。
我们根据高影响力期刊和 2009 年至 2011 年期间的顶级医学专业期刊的摘要审查，选择了 RCT 荟萃分析的样本。我们基于 PRISMA 制定了一个初步的报告框架，并增加了特定的其他报告要素，这些要素对于药物安全性 RCT 荟萃分析的评估至关重要。两位作者独立审查了每个荟萃分析中相关要素的报告情况；通过两位作者之间的讨论解决了独立评估中的差异。
确定并评估了总共 27 项荟萃分析，其中 12 项来自最高影响力期刊，13 项来自专业医学期刊，2 项来自 Cochrane 评论。超过一半的荟萃分析（> 85％）解决了超过一半的 PRISMA 元素。然而，大多数荟萃分析（> 60％）没有解决药物安全性评估的大多数（> 80％）其他报告要素。其中一些要素在任何审查的荟萃分析中都没有涉及。
本综述包括最近在高影响力期刊上发表的药物安全性为重点的荟萃分析样本，因此，我们可能低估了所有药物安全性荟萃分析的报告问题的程度。此外，由于选择的时间间隔较短，因此无法在本综述中评估报告中的时间趋势。
虽然大多数研究都解决了大多数 PRISMA 要素，但大多数研究没有解决大多数其他与安全性相关的要素。这些发现突出表明需要开发和验证药物安全性报告框架，以及国际医学组织理事会（CIOMS）目前为药物安全性信息综合/荟萃分析创建指导文件的重要性，这可能会提高药物安全性荟萃分析的报告，进行和评估，并为临床和监管决策提供信息。
