Consent - six common pitfalls

  NEW guidance on Decision making and consent from the General Medical Council (GMC) came into effect on November 9, some 12 years after the previous 2008 version. It contains some important changes for doctors to note. In this article, I highlight six common pitfalls for clinicians to be aware of in this challenging area of practice.

1: failing to present reasonable alternatives

Doctors will often have a preferred treatment option to present to the patient. However, patients must also be offered reasonable alternatives, including the option of no treatment. In the case of Birch v UCLH NHS Foundation Trust [2008] EWHC 2237 (QB), the patient underwent a cerebral catheter angiogram. Hours later, she developed a stroke as a result of the procedure. She sued the trust for failing to offer her an MRI, an alternative to the angiogram which carried no risk of stroke. She succeeded at trial on this point.

GMC guidance, paragraph 11: "When recommending an option for treatment or care to a patient you must explain your reasons for doing so, and share information about reasonable alternatives, including the option to take no action..."

2: failing to mention risks

Nearly all interventions carry risks of harm, whether it’s a risk of infection or anaphylaxis. The hope is that the benefits outweigh the risks.

The failure to mention material risks is a common allegation in ‘lack of consent’ cases. A material risk is one that a reasonable person in the patient’s position would want to know or which your particular patient would want to know. Find out what matters to your patient and avoid a ‘one size fits all’ approach to disclosure.

Avoid the mistake of my ENT friend, who told me that he only tells patients about risks greater than one per cent. If a patient is a sommelier at a Michelin-starred restaurant, it is best to inform him of the risk of losing the sense of smell, however negligible it may be. The law does not provide a threshold of risk, below which there is no need to inform the patient. It depends on the materiality of that risk to the patient.

From a medico-legal point of view, if unsure whether to mention a risk, it is safest to err on the side of caution and disclose it.

GMC guidance, paragraph 23 referring to information you should discuss: "…recognised risks of harm you believe anyone in the patient’s position would want to know […] risks of harm and potential benefits that the patient would consider significant for any reason. These will be revealed during your discussion with the patient about what matters to them..."

3: failing to be accurate when talking of risks and benefits

Simply mentioning the risk of an adverse outcome is not enough. The description of the risk must be accurate. If a doctor says there is a five per cent chance of paralysis from an operation and the true figure is 20 per cent, the patient could legitimately say that he was misinformed and that the correct figure would have altered his risk-benefit calculation.

In Thefaut v Johnston [2017] EWHC 497 (QB), the surgeon wrongly informed the patient that the spinal operation had "at least a 90 per cent chance" of ridding her of her leg pain. This was an overestimate. The experts agreed that the true figure was about 85 per cent. The judge stressed that the 90 per cent figure was expressed as a minimum and noted: “I accept that ‘at least 90 per cent’ is over optimistic not least because that could imply 95 per cent or 97 per cent, both of which fall into Mr Johnston's risk bracket or range […] The difference between 85 per cent and (say) 95 per cent is 10 per cent which is a potentially important difference.”

This error undermined the validity of the patient’s consent. The lesson is clear: be accurate when providing information about risks.

GMC guidance, para 21: "You must give patients clear, accurate and up-to-date information, based on the best available evidence, about the potential benefits and risks of harm of each option, including the option to take no action."

4: failure to record details of the consent conversation

Many consent cases against doctors go like this: the claimant asserts: “The doctor never told me about the risk of this complication, which has now ruined my life”. The doctor responds: “Yes, I did. I always tell patients about this”. The medical records do not mention the complication, although a sentence in the clinic letter suggests that there was a discussion about risks and benefits.

It is often difficult to predict how a judge would resolve such a factual dispute but what is clear is that few lawyers would pursue a case if the contemporaneous records refer to the relevant complication.

GMC guidance, para 50: "Keeping an accurate record of the exchange of information leading to a decision in a patient’s record will inform their future care and help you to explain and justify your decisions and actions."

5: failure to take enough time

Sir William Osler said “never hurry – hurry is the devil. More people are killed by hurry than by disease.” Just as it is unwise to rush a medical procedure, so too is it to rush a consent process. You might omit important information or disclose it so hurriedly that the patient misunderstands. I have seen doctors obtain consent in the same way the person at the phone shop reads me the terms and conditions of a new contract. This robotic ‘tick box’ approach is to be avoided. The new GMC guidance talks of a "meaningful dialogue" between doctor and patient. This requires a more patient, interactive, and engaged process.

GMC guidance, para 55: "...filling in a consent form isn’t a substitute for a meaningful dialogue tailored to the individual patient’s needs."

6: failure to obtain consent in good time

In some cases, consent is obtained in hospital only hours or minutes before surgery. This is unlikely to give the patients the time and space to make an informed decision.

Mr Justice Green in Thefaut observed: "this [immediately prior to surgery] is neither the place nor the occasion for a surgeon for the first time to explain to a patient undergoing elective surgery the relevant risks and benefits. At this point, on the very cusp of the procedure itself, the surgeon is likely to be under considerable pressure of time (to see all patients on the list and get to surgery) and the patient is psychologically committed to going ahead."

This mutual momentum, the judge noted, was hard to stop.

GMC guidance, para 27(g): "...give them [patients] time and opportunity to consider it [the information] before and after making a decision."

Conclusion

Obtaining consent is a clinical skill like any other. Some doctors do it well and others not. How good is your consenting process, and can it be improved?

A good start would be to read the new GMC guidance on consent. The guidance is the yardstick that your regulator and lawyers will use to gauge the quality of your consent.

Daniel Sokol is a medical ethicist and barrister at 12 King’s Bench Walk, London. He is the author of “Tough Choices: Stories from the Front Line of Medical Ethics” Book Guild, 2018) and provides one-to-one training in medical ethics for doctors through the Centre for Remedial Ethics

Twitter: @danielsokol9