Challenges in systematic reviews that assess treatment harms

Ref ID 156
First Author R. Chou
Year Of Publishing 2005
Keywords Harms
Problem(s) Reliance on randomised controlled trials for harms / safety data
Inclusion of observational / non-randomised studies
Selective reporting of harms / safety / adverse events / side effects
Number of systematic reviews included 96
Summary of Findings Of 96 Evidence-based Practice Center evidence reports published between December 1998 and April 2004, 71 addressed health care interventions associated with potential harms. Of these, 11 did not assess harms. Two of the 11 evaluated surgical interventions, and the other 9 evaluated pharmacologic interventions or approaches to diagnostic testing and disease management. Of the 60 remaining EPC reports, 34 included observational studies of adverse events. Quality of observational studies is difficult to uniformly assess due to differences in study design for harms data and data from these studies is often inappropriately combined.
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