- Framework of problems / Rigorous
- Selective reporting of harms / safety / adverse events / side effects
- Quality of reporting in systematic reviews of adverse events: systematic review
| Ref ID | 124 |
| First Author | L. Zorzela |
| Journal | BMJ : BRITISH MEDICAL JOURNAL |
| Year Of Publishing | 2014 |
| URL | http://www.bmj.com/content/348/bmj.f7668.abstract |
| Keywords |
• General medical • Harms • Cochrane |
| Problem(s) |
• Reliance on randomised controlled trials for harms / safety data • Selective reporting of harms / safety / adverse events / side effects |
| Number of systematic reviews included | 309 |
| Summary of Findings | Only 59 of 309 included reviews (19%) included both clinical trials and observational studies. Only observational studies were included in 109 reviews (35%), case series or case reports were included in 24 (7%). Three of 13 Cochrane reviews (23%) included observational studies compared with 165 of 296 DARE reviews (55%). Almost one third of DARE reviews (26%) did not clearly define the adverse events reviewed, nor did they specify the study designs selected for inclusion in their methods section. Almost half of reviews (n=170) did not consider patient risk factors or length of follow-up when reviewing harms of an intervention. Of 67 reviews of complications related to surgery or other procedures, only four (5%) reported professional qualifications of the individuals involved. |
| Did the article find that the problem(s) led to qualitative changes in interpretation of the results? | N/A |
| Are the methods of the article described in enough detail to replicate the study? | No |