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

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

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.

Keywords: data quality; meta-analysis; network meta-analysis; safety data; systematic review.

Publication types

  • Review
  • Systematic Review

MeSH terms

  • Bayes Theorem
  • Celecoxib / therapeutic use
  • Clinical Trials as Topic
  • Cyclosporine / therapeutic use
  • Data Interpretation, Statistical
  • Drug Design
  • Evidence-Based Medicine
  • Guidelines as Topic
  • Humans
  • Meta-Analysis as Topic*
  • Network Meta-Analysis
  • Outcome Assessment, Health Care*
  • Patient Safety*
  • Pharmaceutical Preparations / economics
  • Publication Bias
  • Publishing
  • Quality Control
  • Research Design
  • United States
  • United States Food and Drug Administration

Substances

  • Pharmaceutical Preparations
  • Cyclosporine
  • Celecoxib