Article type
Year
Abstract
Background: There is little interest in assessing harm in clinical trials.
Objective: To compare the reporting of harm in trials of pharmacological and nonpharmacological treatment.
Methods: Reports of randomized controlled trials assessing treatment of rheumatic disease published between January 1999 and January 2005 were searched in MEDLINE and the Cochrane Central Register of Controlled Trials. A standardized abstraction form was used to extract data.
Results: 193 articles were analyzed. After adjustment for medical area, sample size, funding source and multicenter trials, data on harm were more often described in pharmacological than nonpharmacological treatment reports in terms of reporting adverse events (OR=5.2; 95% CI=[2.1-12.9]), number of withdrawals due to adverse events (OR=4.6; 95% CI=[2.0-10.9]), reporting severity (OR=3.7; 95% CI=[1.5-9.1]) and space devoted to describing harm in the report (OR=1.6; 95% CI=[1.2-2.3]).
Conclusions: The lack of reporting of harm in trials assessing nonpharmacological treatment in the field of rheumatic disease is an important barrier to adequately evaluate the benefit-harm balance of this treatment.
Objective: To compare the reporting of harm in trials of pharmacological and nonpharmacological treatment.
Methods: Reports of randomized controlled trials assessing treatment of rheumatic disease published between January 1999 and January 2005 were searched in MEDLINE and the Cochrane Central Register of Controlled Trials. A standardized abstraction form was used to extract data.
Results: 193 articles were analyzed. After adjustment for medical area, sample size, funding source and multicenter trials, data on harm were more often described in pharmacological than nonpharmacological treatment reports in terms of reporting adverse events (OR=5.2; 95% CI=[2.1-12.9]), number of withdrawals due to adverse events (OR=4.6; 95% CI=[2.0-10.9]), reporting severity (OR=3.7; 95% CI=[1.5-9.1]) and space devoted to describing harm in the report (OR=1.6; 95% CI=[1.2-2.3]).
Conclusions: The lack of reporting of harm in trials assessing nonpharmacological treatment in the field of rheumatic disease is an important barrier to adequately evaluate the benefit-harm balance of this treatment.