Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement

@article{Ioannidis2004BetterRO,
  title={Better Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement},
  author={John P. A. Ioannidis and Stephen J.W. Evans and Peter C. Gtzsche and Robert T. O’Neill and Douglas G. Altman and Kenneth F. Schulz and David Moher},
  journal={Annals of Internal Medicine},
  year={2004},
  volume={141},
  pages={781-788}
}
Reporting harms may cause more trouble and discredit than the fame and glory associated with successful reporting of benefits (1). The CONSORT (Consolidated Standards of Reporting Trials) statement, a checklist (Table 1) flow diagram first published in 1996 and revised 5 years later (2, 3), is an effort to standardize, and thereby improve, published reports of randomized, controlled trials (RCTs). One of the additions to the 2001 revision was an item about reporting adverse events. This single… 

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