Decisions, decisions – informed consent in the 21st century

consent pic

 

Obtaining consent for medical procedures has become more nuanced, and potentially more demanding for doctors. The Supreme Court has decided that information given during the consent process should include any ‘material risk’ that a ‘reasonable person’ in that patient’s situation would want to know about. Quoting from the Nadine Montgomery judgement,

“The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”

The essential change is that the explanations about complications and benefits should no longer be based on what a ‘responsible body of medical opinion’ would agree is appropriate (AKA the Bolam test), but on what the reasonable patient should be aware of, based on their particular situation and concerns.

It is no longer about being open about complications that occur more than 1 in a 100 or 1 in a 1000 times (traditional and oft quoted thresholds during my training), but about qualitative impact. If the risk of something bad happening is 1 in 100,000, but for that patient the bad thing is likely to have a massive impact (e.g. loss of vision in the right eye when they are already blind in the left), it should be mentioned during the consent process. Doctors should not wait to be asked, but should explore their patients’ sense of what is important to them. But nor should doctors off-load every tiny risk in an indigestible and incomprehensible list, as that is not likely to increase their patients’ general understanding.

So, in the post-Montgomery consent era, doctors must tread a fine line between creating an atmosphere of transparency and a fog of defensive detail.

For most of us the Montgomery ruling hasn’t really changed the way we do consent. Good doctors have always had patient-specific, patient-centred conversations. It does serve to remind us that there is more to consent than dishing out statistics – it is a personalised process that must be tailored to the individual. However, the pressure of time does not allow a luxurious approach to taking consent, and for procedures that are high volume and low risk (for instance endoscopy, my own specialty) the process can be very routine indeed.

 

 

Medical ethics is founded on the concept of informed consent. Autonomy does not exist without it. Physical actions on a patient are ‘battery’ if permission is not given, and permission to be touched can only be given if the patient is given the opportunity to make a reasoned decision. Yet how much reasoning should patients be expected to undertake?

Imagine Mrs X has a lung tumour which is, fortunately, resectable. She meets her surgeon, and he explains that the operation is complex but usually successful. There are risks, not only of death, but of long term debility. The patient has ‘little choice’ – her words. And it is true, she has no choice if she wants to be free of cancer. There are open conversations about the risks, but when they are described her eyes glaze over. The doctor senses this and does not persist in his attempt to describe the potential complications. She has made her mind up to have the surgery – it is obvious. Her informed consent may be somewhat shallow, though the ‘material risks’ associated with the operation are as potentially impactful for her than for any other patient. Yet, for her, the consent conversation is probably appropriate.

Or imagine Mr Y. He has been struggling with back pain for six months, and now the time has come to get seen by a surgeon. Yes, surgery is inevitable, and it will be delicate surgery on the spinal nerves. Paralysis is the big worry – a material risk in anybody’s book. The surgeon is clear about the risk of nerve damage, but also throws in a few more that the patient hadn’t considered. Impotence. For him this would be earth shattering. He can barely bring himself to think about. He wishes, actually, that it hadn’t been mentioned. He has to have the operation before the disc in his back does any more damage to his spinal cord… he has no choice. Mr Y goes home and worries. He fixates on the impotence. But it’s only 1 in a 1000, perhaps even less. On the day of the operation he is asked to sign the consent form. He holds back, pen in hand. He doesn’t want to. He doesn’t want to be impotent. The surgeon looks at him quizzicaly,

“Are you having second thoughts?”

“It’s the impotence. I didn’t realise, at the beginning, that it could happen.”

“I haven’t seen a case personally, it’s very rare. Very. Don’t focus on that.”

“You’ll be careful?”

“Of course.”

He signs. He feels under duress. Not from the surgeon, but from the situation. He needs a procedure, it has risks. The choice he has is – submit to surgery and risk bad things, or do nothing, risk nothing, and be left in pain. This is the reality of informed consent. It is developed in the context of vulnerability.

Last example: Miss Z, a biochemist, well versed in statistics and probability. She has come to hospital with a severe headache and needs a lumbar puncture (LP) to exclude a subarachnoid (brain) haemorrhage. She is in pain, but fully conscious. A young doctor asks her to sign a consent form before starting the procedure. He explains how the LP will be done, and mentions side effects or complications including infection, bleeding, severe or moderate headache, nerve damage, and failure. It is a rather miserable litany of negative possibilities. Miss Z presses the doctor on the precise incidence of these complications; they range from over 5% for headache to 1 in several tens of thousands for permanent nerve injury. Miss Z mulls over the information. The doctor, standing by the bed with a tray of equipment, waits. And waits. Miss Z decides.

“I don’t want it. You’ve put me off.”

The doctor has not faced this situation before. She says,

“But you have to have it, if we want to know whether you have had a bleed.”

“I’ll take my chances. The doctor said in casualty it was pretty unlikely anyway.”

“It might be unlikely, but if it is a bleed, and we don’t identify it, you could have another, larger bleed, in a few days.”

“It sounds like you’re trying to frighten me into it.”

“I’m not, it’s just important you know why we want to do it. It’s important.”

“I’ll take the chance. I don’t want another headache, or nerve damage.”

“Let me call my consultant.”

“Why, so she can talk me into it. Don’t worry, I’ve made my mind up.”

And the doctor nods and walks away. He doesn’t understand. Patients just don’t do that. They always agree. He meets a colleague in the corridor and tells her about it. “Totally got the wrong end of the stick,” he sneers. “I wish I hadn’t told her about the risks. She needs that LP.” His colleague says, wisely, “You think that. But it’s her body. Don’t cut yourself up over it. She’s perfectly capable of making a decision. And she has.”

 

 

The temptation to take a paternalistic or controlling approach is ever-present, for we doctors are usually quite sure about what is right for our patients. But we cannot hold back information out of concern that it will influence our patients’ decisions; it is supposed to influence their decisions, even if some of those decisions do not seem quite right to us. Our job is not to ensure that their decisions are identical to ours, but to ensure that they can make a real decision.

 

Thanks to Dr Katherine McCombe, consultant anaesthetist, whose excellent Grand Round on the subject of consent inspired this post.

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