Background: Patient understanding of the consent process is often suboptimal and the reasons for this are poorly understood. In particular the role of cognitive function in assessing the level of understanding of consent has not been evaluated.
Aims: This study aims to assess the level of patient understanding of the informed consent process and the role of cognitive function in those with low levels of understanding.
Methods: The study was prospective, interviewing patients immediately after they had given consent but before undergoing their procedure. Understanding of the reason for the procedure, the risks attendant upon it, details of the procedure itself and post procedure care was scored with the total representing overall level of understanding. A mini mental state examination (MMSE) was then performed with the score recorded.
Results: 100 patients were interviewed. A low level of understanding was shown in 36%. Ninety two patients had a MMSE score greater than 24. All patients with a high level of understanding had MMSE scores greater then 24 compared with 78% of those with a low level of understanding. All patients (n = 8) who displayed a MMSE score less than 24 had a low level of understanding. Men displayed poorer levels of understanding than women. A subnormal MMSE only identified 22% of those with low levels of understanding.
Conclusions: Understanding of the consent process is suboptimal. Adequate cognitive function does not predict a high level of understanding of the informed consent process while cognitive impairment precludes it. It is evident, however that factors other than cognitive dysfunction are at play when attempting to explain low levels of understanding.
- informed consent
- mini mental state examination
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Competing interests: none declared.