Future directions of research into harms in randomised controlled trials

The Consort group includes many initiatives to improve reporting of results from randomised controlled trials (RCTs). The original Consort statement in 1996 was developed to provide a standardised way for authors to report their trial findings.1 Since then there have been two updates to the statement as well as many extensions including the 2004 Consort harms.2 The harms extension resulted, however, in limited improvements in? practice.3The latest update aims to tackle this lack of impact by integrating the harm reporting guidelines into the main Consort checklist.4 This reflects the need for balance in reporting both harm and benefit. While this guidance can support improved reporting, as trialists, one of the major challenges we face is how to analyse and summarise complex harm data. We must now turn our energies to this unmet need which goes beyond Consort’s remit. We must improve the analysis of adverse events better to identify true…
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