a Bayer AG , Berlin , Germany.
b Bayer plc , Reading , UK.
Curr Med Res Opin. 2018 Dec;34(12):2125-2130. doi: 10.1080/03007995.2018.1524751. Epub 2018 Sep 25.
To identify existing guidelines, key recommendations, and existing limitations regarding the evaluation and use of real-world evidence (RWE) in meta-analyses (MAs) to generate clinical and epidemiological evidence: a systematic review of existing recommendations.
A literature search was performed in April 2017 in MEDLINE and Embase using the Ovid platform, the Cochrane Library, and other sources. No specific inclusion and exclusion criteria were applied, and no restrictions in timeframe, language, or geographical scope were imposed.
The search strategy identified 1681 citations; 12 references were included in this review. Recommendations within the literature regarding the use of RWE in MAs are: (1) it may be useful to extract and analyze adjusted results because confounding is expected; (2) testing heterogeneity in the MA of RWE is important as it may minimize the potential for bias and generate hypotheses for future research; (3) limiting a search ≤2 bibliographic databases when conducting MAs of RWE will not provide a thorough summary of existing literature; and (4) the Meta-analysis Of Observational Studies in Epidemiology (MOOSE) checklist is a 35-item checklist developed to allow for more standardized reporting of MAs of RWE and address their limitations.
(1) No formal guidelines were found regarding the use of RWE in MAs; (2) no consensus was found on a preferred instrument for the assessment of RWE; and (3) critical appraisal of RWE is often omitted from Health Technology Assessment submissions.
The inclusion of RWE in MAs may facilitate the confirmation of conclusions drawn from randomized controlled trials and, thus, reassure decision-makers that findings can be extrapolated to real-world populations. However, qualitative and quantitative bias may co-exist in MAs of RWE. Reviewers should select the most appropriate tools that match the study designs identified in a particular systematic review.
确定现有的指南、关键建议和现有的局限性，以评估和使用真实世界证据（RWE）进行荟萃分析（MA），以产生临床和流行病学证据：对现有建议的系统评价。
2017 年 4 月，使用 Ovid 平台、Cochrane 图书馆和其他来源，在 MEDLINE 和 Embase 中进行了文献检索。未应用具体的纳入和排除标准，也未对时间范围、语言或地理范围施加限制。
搜索策略确定了 1681 条引文；本综述纳入了 12 条参考文献。文献中关于在 MA 中使用 RWE 的建议有：（1）提取和分析调整后的结果可能有用，因为预计会存在混杂；（2）在 RWE 的 MA 中测试异质性很重要，因为它可以最大限度地减少潜在的偏倚，并为未来的研究生成假设；（3）当对 RWE 进行 MA 时，将搜索限制在≤2 个书目数据库中，将不会对现有文献进行全面总结；（4）观察性研究的荟萃分析（MOOSE）清单是一个 35 项清单，旨在允许更标准化地报告 RWE 的 MA，并解决其局限性。
（1）未找到关于在 MA 中使用 RWE 的正式指南；（2）对于评估 RWE 的首选工具未达成共识；（3）健康技术评估提交中经常省略对 RWE 的批判性评价。
在 MA 中纳入 RWE 可能有助于确认从随机对照试验中得出的结论，从而使决策者相信这些发现可以外推到真实世界的人群。然而，在 RWE 的 MA 中可能同时存在定性和定量偏倚。审查员应选择最适合特定系统评价中确定的研究设计的工具。
