Sunday, March 27, 2011

Is informed consent bad for your health?

A letter in this weeks Lancet is worth considering. Having been involved in a number of clinical studies in paediatric intensive care units, this resonated with me. The purpose of seeking informed consent from an individual enrolled in a clinical study is to ensure that they are protected in so far as possible and are fully aware of any possible risks entering this study may entail. The benefits of enrolling in a study, apart from the societal good of increasing knowledge is that there is some evidence that patients in a clinical study, regardless of whether they receive the experimental treatment or conventional treatment receive  better quality of care. There is also the possibility that they may benefit from the experimental intervention.
Using data from the CRASH trial, researchers estimated that in hospitals which sought consent from relatives, there was a 1.2 hour delay in initiating treatment compared to those hospitals in which no consent was sought. Applying these data to an analysis of the CRASH-2 trial, the researchers estimated that a one hour delay in commencing treatment resulted in a reduction in the percentage of patients responding to treatment from 63% to 49% with a likely increase in death and disability being the result.
There are two consequences; first the delay results in an increased risk of poor outcomes, second, the delay may obscure benefits that accrue from administering a time sensitive treatment.
 This has important ethical and scientific implications.

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