Table 2A.
Methods for approaching and reporting harms among 70 reliable systematic reviews of gabapentin
| Harms assessment | n | (%) |
|---|---|---|
| Approach to assessing harms | ||
| Exploratory only | 27 | (39%) |
| Pre-specification only | 25 | (36%) |
| Hybrid (≥ 1 pre-specified) | 18 | (26%) |
| Specific guidance followed for assessing harms | ||
| Yes | 0 | (0%) |
| Not reported | 70 | (100%) |
| Types of harms analyzed in reviewsi | ||
| Separate and specific harms | 56 | (80%) |
| Drop-out due to harms | 35 | (50%) |
| Any non-specific harms | 29 | (41%) |
| Grouped specific harms | 9 | (13%) |
| Other (e.g., serious adverse events) | 9 | (13%) |
| Reporting of harms | ||
| Review protocol addresses harms | ||
| No protocol/registration mentioned in review | 30 | (43%) |
| Protocol/registration mentioned, but not available | 12 | (17%) |
| Protocol/registration obtained: NO, harms not addressed | 4 | (6%) |
| Protocol/registration obtained: YES, harms are addressed | 24 | (34%) |
| Abstract includes statement on harms | ||
| Yes | 57 | (81%) |
| Specific statement | 31 | |
| General statement | 26 | |
| No | 13 | (19%) |
| Use of selection criteria | ||
| Reported only pre-specified harms | 26 | (37%) |
| Yes, selection criteria: Reported a subset of harms identified | 13 | (19%) |
| Unclear–no statement on use of criteria | 31 | (44%) |
| Reported limitations of harms assessment | 46 | (66%) |
i
Reviews could assess multiple types of harms