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Any new intervention will have benefits and burdens, some of which will be predictable and others unpredictable. Therefore, it is imperative that all new interventions are evaluated within a stringent framework to understand both the benefits and harms. The predictable effects must be measured prospectively, and the population who experience any adverse outcomes characterised in order to refine the use of the intervention. Once harms are identified, if they are unable to be mitigated then they can have risk management plans put in place or focus the intervention only on specific sub-populations who do not experience identified harms. Unpredictable harms need to be sought vigilantly and characterised in frequency and magnitude.
This approach is commonly applied to new medicines and increasingly to non-pharmacological treatments including new and modified systems of care. Unfortunately, robust evaluations of such complex interventions such as systems of care, care …
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