| Ref ID | 349 |
| First Author | L. Li |
| Journal | JOURNAL OF CLINICAL EPIDEMIOLOGY |
| Year Of Publishing | 2020 |
| URL | https://www.jclinepi.com/article/S0895-4356(19)31128-X/fulltext |
| Keywords |
• Heterogeneity • Multiplicity • Protocols • Certainty • 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 |
| Article Type | Empirical |
| Article Subtype | Cross-sectional survey/Methodological systematic review |
| First Author Country | China |
| Aim | To assess the design, conduct, and analysis of systematic reviews of drug safety of Cochrane and non-Cochrane systematic reviews indexed in PubMed in 2015. |
| Level of Investigation | Descriptive |
| 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. |
| Number of systematic reviews included | 120 |
| Number of eligible systematic reviews assessed | 3879 |
| Treatment impacted | No |
| Treatment impacted description | |
| Interpretation impacted | Not Applicable |
| Interpretation impacted description |