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HEALTH CARE REFORM
Adverse Events in Randomized TrialsNeglected, Restricted, Distorted, and Silenced
John P. A. Ioannidis, MD
Arch Intern Med. 2009;169(19):1737-1739.
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Accurate information on harms of medical interventions is essential for evidence-based practice. Most newly introduced treatments usually have small, incremental benefits, if any, against already available interventions, and differences in the profile of harms should play a key role on treatment choice. Randomized trials offer an excellent opportunity to evaluate harms of interventions using the most robust experimental design available in clinical research. However, several empirical evaluations (Table) have shown that many trials do not report harms or report them in a fragmented or suboptimal way. In this issue, an excellent study by Pitrou et al1 adds more evidence on this issue.
Table appears in full text version.
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Table. Empirical Studies Evaluating the Reporting of Harms in Randomized Trialsa
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Pitrou et al1 evaluated 133 trials published recently in 6 high–impact factor journals. Most previous empirical studies had examined older trials and typically selected articles based on topic; only 2 . . . [Full Text of this Article] AUTHOR INFORMATION
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