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 Cochrane
Harms
General medical
Problem(s) Selective reporting of harms / safety / adverse events / side effects
Reliance on randomised controlled trials for harms / safety data
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? Not Applicable
Are the methods of the article described in enough detail to replicate the study? No