INFORMED CONSENT: ARE WE DELUDING OURSELVES? A RANDOMIZED CONTROLLED STUDY

Authors


Sir,

Poor communication and poor documentation are two of the commonest ways in which surgeons expose themselves to the threat of litigation [1]. Masood et al.[2] are therefore to be commended for highlighting potential communication difficulties encountered during the consent process.

However, I do not think that their study provides sufficient evidence to discard standardised written consent forms, nor for a complete reappraisal of the current consent process. Their conclusion that written information is inadequate for enhancing understanding, or at least information retention, is not a universal one. Several studies conclude the opposite [3–6].

The inability of patients to recall information given to them during the consent process is a well-recorded phenomenon. Not surprisingly, patients’ recall of information is best immediately after signing a consent form and deteriorates from then on [7]. The findings of Masood et al., that patients remember so little of the detail of the process of consent, particularly when questioned some days afterwards, is not new. Poor recall some time after the process of consent has taken place does not in anyway mean that informed consent had not been obtained; it might simply be due to the capricious nature of human memory. We must be very clear about this, for misinterpretation of this study could lay us all open to the threat of suit. Many patients will simply have forgotten what they have been told, even though they acknowledge understanding during the consent consultation, arguing later that they were not informed.

It is for this reason that written documentation (a written checklist) is so vital, for it ensures that the fallible surgeon (all of us, occasionally) does not sometimes forget to mention a particular risk or outcome, and it provides documentary evidence that the surgeon said what they claimed to have said, that he or she made an effort to inform the patient. It might be our only defence, but it is still a robust one. This is one reason why in Oxford we have adopted a standardised, written, procedure-specific consent checklist (modified and expanded from those published by BAUS). We use these partly as a prompt to mention complications we otherwise sometimes forget to mention. A copy is filed in the patient’s notes and a copy given to the patient, well in advance of surgery.

Finally, that Masood et al. found that 91% of patients felt that the description of complications was adequate, and that no patient had any criticism of the consent procedure, is reassuring. This is certainly an improvement on a previous study, where half of the patients were unhappy with the amount of information they had received [7]. I would therefore caution against dispensing with written consent information checklists. It is difficult to envisage a workable system that could replace them, while still giving the surgeon time to actually do the operation!

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