Balancing the outcomes: reporting adverse events

Keech, Anthony C; Wonders, Susan M; Gebski, Val J; Cook, David I

doi:10.5694/j.1326-5377.2004.tb06241.x

Topics

Statistics, epidemiology and research design

When decisions about a new intervention are being made, the “net clinical benefit” of the intervention needs to be assessed. This requires balancing all the reported benefits and side effects of the intervention. The adverse events experienced in a trial must be known in sufficient detail for their severity and relationship to treatment allocation to be judged. Reporting of such events is the subject of item 19 of the CONSORT statement (Box 1).1

1 NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW.
2 Department of Physiology, University of Sydney, Sydney, NSW.

Correspondence:

Acknowledgements:

We thank Rhana Pike for expert assistance in preparation of the manuscript.

Competing interests:

None identified.

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