Emily Borhan, OTSIS’s Specialist Medicolegal Advisor
Mr Oliver Donaldson. OTSIS Board Member and Consultant Upper Limb Surgeon, Yeovil

Board Member, Olly Donaldson, from Yeovil, recently had a Q&A session with Emily Borhan, OTSIS’s Specialist Medicolegal Advisor, on the thorny issue of surgical consent…

Oliver: “How often consent is considered a significant issue in litigation?

Emily: “This is an interesting question, and an area that is not that widely advertised. Consent is obviously a very important part of any treatment, and therefore relevant in almost all litigation. The actual statistics on how often litigation is successful due to lack of consent are very limited. But to get an idea, there was a study carried out Queen Mary University of London that found that while the rate of increase of other claims has remained steady, cases relating to consent have risen fourfold overall since March 2015 – and where failure to inform was added as a contributory claim, the rise was nearly ten-fold. It also found that between 2005 and 2019, of 70,000 cases, just over 2,300 were linked to failure to inform, with a total value of nearly £400m. So, we can see there is certainly a significant increase.”

Oliver: “What constitutes valid consent?”

Emily: “For consent to be valid, it must be:

  • Voluntary – the decision must not be influenced by pressure from medical staff, friends or family.
  • The person must have capacity – this means the person is capable of giving consent and understands the information given to them and can use it to make an informed decision.
  • Informed – this means that the patient can make an educated and informed decision about their medical treatment. The patient must be given all of the information about what the treatment involves, including the benefits and risks; they must be aware whether there are reasonable alternative treatments, and what will happen if treatment does not go ahead.

The leading case in the area is Montgomery, and this emphasised the need for consent to be informed. It stated that informed consent is obtained once the doctor has provided you with all appropriate information so that a patient can make a fully informed choice to either accept or refuse the treatment being recommended. This test is based on the reasonable person in that situation.”

Oliver: “How many ‘patient episodes’ are required for valid consent?”

Emily: “The answer to this question will vary depending on the procedure type and the individual circumstance. It is also important to note that it is not the number of appointments, but the quality of information provided that matters. The idea that the patient has ‘consented’ to the treatment is that the patient is aware of the treatment in discussion, having full knowledge of the risks and the potential outcomes, with the patient then agreeing to proceed with treatment based on that knowledge and understanding. It would be hard to put an exact number on the amount of appointments required for this. That being said, it could be easily argued that meeting the patient once prior to treatment doesn’t provide sufficient time for the patient to take in and understand the information, and for you, as the medical professional, to feel comfortable that the patient has understood what has been discussed.”

Oliver: “Is consenting a patient on the day of surgery acceptable practice?”

  • “Sign the consent form at the end of the consent discussion, allowing the patient to take a copy for reference and reflection. On the day of the procedure, check with the patient if anything has changed since the consent discussion. If there has been a significant delay since the original signing, sign the relevant section on the form to confirm consent. The patient does not need to sign again.” – Quote from RCS – 3.5.1 Consent — Royal College of Surgeons (rcseng.ac.uk)

Emily: “Traditional practice was always to consent the patient on the day of the procedure. The main criticism of this is that the patient is not in the right frame of mind whilst they are signing the document. It can often be quite rushed, the patient may be feeling nervous or anxious, and may not actually be taking in the information provided. They also haven’t had sufficient time to think about it. It is always best practice to consent the patient prior to the day of surgery, giving them enough time to review the information, whilst not doing it too far ahead of the surgery day that they may have forgotten important details. If the patient is able to have an extra appointment to allow this to happen, and if the patient is allowed to take the consent form home to reflect on, then this would be the best situation. Obviously, it is very important to ensure that on the day of the surgery, you speak to the patient and you make sure they are still happy to proceed and that they do not have any further questions. It is also worth keeping in mind that when looking at consent from a legal perspective, the whole consent process is analysed, not just the signing of the form, which is why it is so important to make sure that you are providing the patient with all the necessary and appropriate information from the moment that you first meet, and that you document it appropriately.”

Oliver: “Should we have different processes for different procedures? i.e. total knee replacement versus knee arthroscopy.”

Emily: “To some degree, the answer to this question is ‘yes’, in the sense that each procedure you discuss will carry its own individual risks and outcomes. It is also likely that different methods of treatment will be discussed. A treatment that poses higher risk or is more complicated will often need to be discussed in greater detail. However, the actual process of consent should remain the same for all treatments you provide, in the sense that you have fully informed the patient and they are voluntarily agreeing to the treatment with full knowledge of the situation at hand.”

Oliver: “How should we document the consent discussion – is it reasonable to have a template consent letter?”

Emily: “This is a very important question, and aside from actually providing the information, is probably the most important element.  I see so many situations where the medical professional is sure they consented properly and gave all the relevant information; but without anything having been documented, they have no proof it occurred, and therefore in litigation it becomes much harder to prove. In terms of how and what to document, I would do a mix of two things: a template is always a useful start, whether that is a consent letter detailing all the information and risks, or a leaflet that has diagrams – or maybe both. The reason for this is that it can be something that is pre-made and pre-thought-out, to ensure that every issue is covered. It also enables the patient to take the information home with them to review and think about. But, in addition to this, it is also important to make notes during the consultation, that may be hand-drawn diagrams or just handwritten notes on what you are discussing during the consultation. The reason for this is that it details what you actually discussed with the patient. It also makes the consent process more personal, which means you have taken the time to talk to the patient, made sure that they understand, and that you have focused on any areas that they might be concerned about. By merely providing a template letter or leaflet, you are providing the patient with a heap of information but you are not making sure they fully understand what is being read.”

To speak with Emily, or if you need specific medicolegal advice, then please contact the OTSIS Specialist Medicolegal Hotline:

Tel: 0207 9657501 / email: otsis@m-i-c.co.uk