Surgical consent: permission or a decision?

So much emphasis is placed on the consent form; we are lectured about it’s importance from our first days as an intern. Like no other form, it is constantly being modified in order to make the form better reflect the role it is meant to play. But what is that role? Is the consent form simply a permission slip, designed to minimise the risk of surgeons being sued if complications occur? Or is it a statement by the patient that they have considered all the options and have come to a decision to have this treatment over all other options, despite the risks? Looking at the form, it is a bit of both, and it probably performs the latter function very poorly.

If the purpose of a consent form is merely to cover all the complications and to permit the surgeon to proceed, therefore avoiding charges of assault, then what should it contain? The minimum would be a list (in any form: comprehensive or a summary) of complications for them to consider. Health departments take this line in official documents regarding the consent process, that it should cover all potential risks ‘material’ to the patient. The idea is that once informed of all the risks, the patient would sign the form if they considered those risks worth taking in order to have the procedure.

But how can a patient know if the risks are worth taking if they don’t know the other side of the equation: the magnitude and probability of any potential benefits? Taking this further, even if they had accurate information about the relevant risks and benefits of the proposed treatment, in order to be properly informed they should also receive accurate information about the relative risks and benefits of any alternative treatment, including not having any treatment.

What information should make up ‘informed’ consent?
According to the NHMRC (here), for patients to receive truly informed consent, they should be given objective, relevant information about the expected benefits and material risks of the proposed treatment and the of any alternatives, including the risks and benefits of having no treatment.

Paternalism: doctor knows best
It may seem too hard to convey this information, and often the patient is happy for the doctor to make the decision for them based on the doctor’s expert knowledge and the knowledge of the patient’s condition. Some doctors also prefer this approach. Sometimes a discussion of the risks and benefits may distress a patient or lead them to making a decision that is not in their best interests. If so, the doctor may use their ‘therapeutic privilege’ and decide for the patient, after all, they are the expert.

There are two problems with having the doctor decide.
Firstly, it has been shown that doctors are more likely to recommend treatments to patients than they are to recommend those same treatments to themselves or their family (here and here). This indicates that they are knowingly overestimating the benefits and/or underestimating the harms of the proposed treatment. Secondly, it has also been shown that doctors also unknowingly overestimate the effectiveness and underestimate the harms of the treatments they provide (here and here). In other words, the doctor may not provide objective, accurate information.

Does more information help?
There is evidence that properly informing patients of the implications of their decisions (using tools such as decision aids, which contain extensive information on the treatment options laid out in a way that is easy to understand) decreases decisional conflict, increases knowledge about the condition and the risks and increases patient satisfaction with the decision they make (here and here). Interestingly, it also makes people less likely to participate in questionable screening practices (like PSA testing) and more likely to choose treatment for diabetes (a good thing). More interestingly, in some cases increasing the information provided to patients makes them less likely to undergo surgery, including orthopaedic surgery (here).

Compiling and editing the required information into a format that maximises patient understanding and retention is not easy. Professional societies, governments, academic institutions and patient groups have a role to play in developing this information but this will only occur at the hand of clinicians. I see a role for the AOA and its specialist societies in developing high quality decision aids.

The bottom line
Consent is there because of patient autonomy – the notion that people should decide for themselves what happens to them. If they have the capacity to do so, they should make a voluntary informed decision about their treatment. The consent forms we currently have do not ensure this.

The process of consent for surgery has improved considerable over recent decades but the continued focus of the consent form as a legal waiver instead of a reflection of an informed decision undermines our efforts to properly inform our patients.

The solution
The consent process needs to be changed to ensure that patients are properly informed of the magnitude and probability of the risks and benefits of the proposed treatments and the alternatives, and this information should be delivered in a way that is easy for patients to understand. The improvement in communication will lead to happier patients who are more satisfied with the decision they make, and they may even be less likely to sue.