| Ref ID | 651 |
| First Author | P. N. Papanikolaou |
| Journal | THE AMERICAN JOURNAL OF MEDICINE |
| Year Of Publishing | 2004 |
| URL | https://www.amjmed.com/article/S0002-9343(04)00494-2/fulltext |
| Keywords |
• Cochrane • Harms • Open data |
| Problem(s) |
• Selective reporting of harms / safety / adverse events / side effects • Reliance on randomised controlled trials for harms / safety data • Weaknesses identified in some Cochrane reviews |
| Article Type | Empirical |
| Article Subtype | Cross-sectional survey/Methodological systematic review |
| First Author Country | United States |
| Aim | To look at how comprehensively Cochrane reviews documented adverse events from primary included trials |
| Level of Investigation | Descriptive |
| Summary of Findings | Systematic reviews of randomized controlled trials rarely provide large-scale evidence on specific, well-defined adverse events associated with the tested interventions. Only 25 systematic reviews in the entire Cochrane Database of Systematic Reviews contained such evidence on at least one type of harm. |
| Number of systematic reviews included | 138 |
| Number of eligible systematic reviews assessed | 1727 |
| Treatment impacted | Yes |
| Treatment impacted description | |
| Interpretation impacted | Yes |
| Interpretation impacted description | In 29% (9/31) of a sample of large trials in reviews with poor reporting of harms, specific harms were presented adequately in the trial reports but were not included in the systematic reviews. |