- Framework of problems / Objective
- Interpreted without considering certainty or overall quality of the evidence base
- A systematic survey showed important limitations in the methods for assessing drug safety among systematic reviews
| 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 |
Harms Protocols Multiplicity Heterogeneity Certainty |
| 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 |