An appraisal of meta-analysis guidelines: how do they relate to safety outcomes?
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.
Global Pharmacometrics, Pfizer Limited, Sandwich, Kent, UK.
Meg
http://orcid.org/0000-0001-5198-5274
M
Bennetts
Statistics, Pfizer Inc., New York, NY, USA.
Ed
E
Whalen
Global Pharmacometrics, Pfizer Inc., Groton, CT, USA.
Sima
S
Ahadieh
Statistics, Pfizer Inc., Groton, CT, USA.
Joseph C
JC
Cappelleri
D006801:Humans; D001499:Bayes Theorem; D000068579:Celecoxib / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D016572:Cyclosporine / Q000627:therapeutic use; D003627:Data Interpretation, Statistical; D015195:Drug Design; D019317:Evidence-Based Medicine; D017408:Guidelines as Topic; D000071076:Network Meta-Analysis as Topic; D017063:Outcome Assessment, Health Care; D061214:Patient Safety; D004364:Pharmaceutical Preparations / Q000191:economics; D017594:Publication Bias; D011643:Publishing; D011786:Quality Control; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration
D000068579:Celecoxib; D016572:Cyclosporine; D004364:Pharmaceutical Preparations
data quality; meta-analysis; network meta-analysis; safety data; systematic review