Harms

Evidence-based healthcare resources often have great difficulty in providing good quality evidence on harms. Most RCTs are not designed to assess harms adequately: the sample size is too small, the trial too short, and often information on harms is not systematically collected. Often a lot of the harms data are in the form of uncontrolled case reports. Comparing data from these series is fraught with difficulties because of different numbers receiving the intervention, different baseline risks and differential reporting. We aim to search systematically for evidence on what are considered the most important harms of an intervention. The best evidence is from a systematic review of harms data that attempts to integrate data from different sources. However, because of these difficulties and following the maxim "first one must not do harm" we accept weaker evidence in the Harms than in the Benefits section. This can include information on whether the intervention has been either banned or withdrawn because of the risk of harms.

Harms Resources
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