In the recent clinical negligence case of Powell v University Hospitals Sussex NHS Foundation Trust, the court considered several issues in relation to the advice a patient was given. One concerned an inadequate patient consent form.
The claimant had undergone a revision knee replacement. A couple of months later she was in pain and had a second operation, this time to investigate and treat possible infection. There was a dispute as to what advice her surgeon had given and the only written evidence was a consent form. However, the form was inadequate.
The case raises a number of issues but there are three lessons of interest to learn about consent forms from the case.
1. They need to be legible.
That may sound obvious but in this case the judge described the consent form as, ‘in its material respects illegible’.
If your advice is being scrutinised, an illegible form is not a good starting point.
2. They need to be comprehensible.
Again, this one was not. The surgeon accepted that ‘if what was written on the form at the sections on proposed procedure and risks was read out to Mrs Powell, she would not have understood what was meant without explanation’.
In reformulating the law governing advice to patients in Montgomery v Lanarkshire Health Board, Lord Reed had emphasised the need to explain the medical position without technicality and in a way the patient can understand. The doctor’s role involves dialogue with the patient. The patient needs to understand the benefits and risks of the proposed treatment and of reasonable alternatives in order to make an informed decision. As Lord Reed said, ‘This role will only be performed effectively if the information provided is comprehensible’.
He went on to say, ‘The doctor’s duty is not therefore fulfilled by bombarding the patient with technical information which she cannot reasonably be expected to grasp…’.
So, use language a patient can understand.
3. A signed consent form does not necessarily mean a patient has consented.
Again, in Montgomery, having said that a doctor’s duty is not fulfilled by bombarding a patient with information, Lord Reed went on to add ‘let alone by routinely demanding her signature on a consent form’.
In Powell, the judge in fact found that the patient had given consent. However, there have been other cases where a patient was found not to have given consent despite having signed a consent form.
Advising patients and enabling them to consider their options is best thought of as a process. A signed consent form is one moment in that process. It is also only one piece of evidence that a patient has been correctly advised and consented to a procedure. Consent forms do not tell the whole story or give the full picture. For instance, they do not normally explain the risks of alternative procedures or explain why the patient has chosen one rather than another. Consent forms do not normally explain the significance of risks. I often see consent forms which record, ‘bleeding, infection, nerve damage…’ but what does this mean to a patient? Most patients would probably think infection is treated with a short course of antibiotics but, for Mrs Powell, it led to an above knee amputation.
So, consent forms often tell us little. In my experience, doctors often think they are more significant than is actually the case. Mrs Powell’s case is a useful reminder of their limits.