A systematic survey showed important limitations in the methods for assessing drug safety among systematic reviews

Ref ID 349
First Author L. Li
Year Of Publishing 2020
URL https://www.jclinepi.com/article/S0895-4356(19)31128-X/fulltext
Keywords Harms
Problem(s) Multiplicity of outcomes and lack of pre-specification for outcome reporting
Inadequate analysis of heterogeneity
Selective reporting of harms / safety / adverse events / side effects
Interpreted without considering certainty or overall quality of the evidence base
No registered or published protocol
Number of systematic reviews included 120
Summary of Findings Only 7.5% of included reviews clearly defined safety outcomes, and 5.8% defined a primary safety outcome. None stated whether the primary safety outcome was predefined. Among the 80 reviews that pooled the primary dichotomous safety data across studies, less than half (41%) conducted subgroup analysis to explore for sources of heterogeneity or reported a GRADE assessment for the overall quality of evidence. Cochrane reviews were more likely to provide a study protocol (100% vs. 23.3%; P <0.001), involve methodologists (53.3% vs. 20.0%; P <0.001), and report a GRADE assessment for the primary safety outcome.
Did the article find that the problem(s) led to qualitative changes in interpretation of the results? Not Applicable
Are the methods of the article described in enough detail to replicate the study? Yes