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28 May 2015

How one tragic case changed the laws about medical consent for all of us

Doctors have become more patient-centred throughout my decades of practice, but there is still a long way to go.

By Phil Whitaker

A couple of months ago, the law on medical consent in the UK was fundamentally changed.

Doctors have always decided what patients should know about proposed treatments – what might be gained, what might go wrong, what alternatives there might be. These discussions are sometimes done well, but all too often they are cursory, or partial, or even non-existent. If an aggrieved patient later believes he or she wasn’t given adequate or appropriate information, a court will apply the “Bolam test”. This compares what the doctor in question advised with what a “responsible body of medical practitioners” would have said in the same circumstances. If enough of one’s peers would have behaved similarly, there is no case to answer.

That was turned on its head by the Supreme Court in March, though it will take years for the implications fully to work through. When it comes to obtaining informed consent, doctors will no longer be judged by reference to their peers’ practice. The courts will now decide whether a doctor met the expectations of any “reasonable person in the patient’s position”.

The case that brought about the change was tragic. A baby, S, became stuck in the birth canal during labour – an obstetric nightmare known as shoulder dystocia – and he sustained permanent disability because his brain was starved of oxygen. S got stuck because he was a big baby, a consequence of his mother’s diabetes. The risk of shoulder dystocia is about 10 per cent in diabetic mothers, though thankfully most instances are resolved without causing permanent injury. S’s mother’s obstetrician did not routinely discuss this risk with diabetic patients, for fear most would opt for a Caesarean section. The obstetrician’s approach was not unusual and would have passed the Bolam test, but the court ruled that Bolam did not apply because any reasonable diabetic mother would have wanted to know about the risk, and to have been offered the option of a Caesarean section.

Bolam is nigh-on sixty years old, and took effect in an era when medicine was a paternalistic profession. Doctors have become more patient-centred throughout my decades of practice, and well in advance of this Supreme Court ruling the General Medical Council’s guidance on informed consent was rewritten to reflect this. So, the recent change in the law won’t create a new direction of travel for doctors, but it will certainly speed up the journey.

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To date, it is surgeons who have made most progress towards obtaining truly informed consent. Operations represent discrete activities: they have readily measurable rates of success; and potential complications are usually well defined. These days, the best letters from surgical consultants detail all this, and advice is copied to patients for them to ponder well in advance of any proposed procedure.

The implications of the recent ruling for physicians are more complex. Our treatments are usually pharmaceutical and often involve multiple medications administered over long periods; there is no readily accessible repository of information about each drug’s defining characteristics, let alone how they all interact with each other. In recent years, our “bible” – the British National Formulary – has begun stratifying side effects according to their broad frequency of occurrence (common, rare, very rare, etc), but there is still no information about such fundamentally important questions as: how often does this medication actually help?

In future, we will need to tell patients how likely it is that the drugs will work and what the harms might be, presenting all this in a way that allows for an informed decision. We also need to give comparable details about the alternatives, which might include dietary change, regular exercise, or psychological intervention. To do this we are going to need far better information about both drug and non-drug approaches. Work is only just beginning in developing these tools. There is a very long way to go.