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Reporting of Safety Results in Published Reports of Randomized Controlled Trials

2009 Archives of Internal Medicine  
Reports of clinical trials usually emphasize efficacy results, especially when results are statistically significant. Poor safety reporting can lead to misinterpretation andinadequateconclusionsabouttheinterventionsassessed. Our aim was to describe the reporting of harm-related results from randomized controlled trials (RCTs). Methods: We searched the MEDLINE database for reports of RCTs published from in 6 general medical journals with a high impact factor. Data were extracted by use of a
more » ... ed by use of a standardized form to appraise the presentation of safety results in text and tables. Results: Adverse events were mentioned in 88.7% of the 133 reports. No information on severe adverse events and For editorial comment see page 1737
doi:10.1001/archinternmed.2009.306 pmid:19858432 fatcat:xv2e4poulvfxpf4vfxnvyee6yu