| 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 |
| Article Type | Empirical |
| Article Subtype | Cross-sectional survey/Methodological systematic review |
| First Author Country | Canada |
| Aim | To assess the quality of reporting of harms in systematic reviews published in the Cochrane Database or the Database of Abstracts of Systematic Reviews from January 2008 to April 2011, and to determine the need for a reporting guideline specific for reviews of harms. |
| Level of Investigation | Descriptive |
| 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. |
| Number of systematic reviews included | 309 |
| Number of eligible systematic reviews assessed | 4644 |
| Treatment impacted | No |
| Treatment impacted description | |
| Interpretation impacted | Not Applicable |
| Interpretation impacted description |