Mr Alwitry is a Consultant Ophthalmologist working in the East Midlands and is a speaker at the 2024 Medico-Legal Conference. He has a Masters in Medical Law and is a Speciality Advisor to the CQC. He has an active interest in teaching and training in Medico-legal issues, delivering lectures around the country on patient safety, learning and consent. He is also author of "Complaints, Litigation and Clinical Errors" published by Taylor and Francis, a book for all medical and allied professionals.
The Consent process is a vital part of the patient pathway and is far more than just getting the patient to sign on the dotted line. In my work in litigation, I often see issues around informed consent resulting in complaints and potential clinical negligence claims. Anecdotally I can see an increasing number of these cases.
We have a duty of care to the patient to engage with them and we need to undertake our work in partnership with them. We undertake a lot of operations every year and the vast majority are carried out without complications. A lot of our work is standard and straight forward and therefore when things go wrong patients inevitably ask the question as to why it happened.
From my speciality cataract surgery, one of the most common operations, is arguably one of the safest procedures carried out within the NHS. Everyone gets cataracts to some degree and when you reach a certain age you will inevitably have some degree of lens opacity. The operation is only about 20 minutes long and the visual recovery is almost immediate. Often patients are in hospital only for a few hours and go home the same day. They know people who have had cataract surgery, and everything was fine. They may have had their first eye done and everything was fine. So, when things go wrong, and they lose vision they seek to apportion blame.
It is often hard to opine on surgery and surgical complications. If things go wrong such as a clip falling off a bile duct during cholecystectomy is that a breach of duty? Naturally these complications will be consented for, but patients cannot consent for negligent treatment.
When things go well patients do not complain and in the vast majority of cases this is the case, but we all are painfully aware that sometimes things can and do go wrong.
I liken the surgery to a bridge we guide the patient over. There is a chasm beneath with some stormy waters they could fall into. We take them from the proximal side of health issue and aim to take them over to the other side where there is resolution of their issue. The vast majority get over it without a problem, but it does not take away from the necessity to fully inform the patient of the dangers involved. If everything goes well does it matter? Well yes it does. Turning up for the surgery does not mean that they are willing to take any risk.
If I were on an adventure outing and crossed the bridge mentioned above only to be told afterwards that 1 in 100 people who did so fell and lost their lives I would not be happy. Even having already crossed it safely I would be aggrieved at the loss of choice. I turned up for the trip but did not want to take such a risk without my prior consent. I would have rather stayed on this side of the chasm. Patients need to enter the process with open eyes (pun intended from an ophthalmologist perspective).
Whatever our attitudes to consent were, the pivotal Montgomery case in 20151 was a landmark for informed consent in the UK and significantly changed the playing field for us as clinicians.
Montgomery vs Lanarkshire had nothing to do with eyes but the implications of it are important for all specialities. It involved the case of Nadine Montgomery, a woman with diabetes and of small stature. She was pregnant and delivered her son vaginally. He sadly experienced complications owing to shoulder dystocia resulting in hypoxic brain damage with consequent cerebral palsy. Mrs Montgomery brought a claim against Lanarkshire Health Board, alleging that she should have been advised of the 9-10% risk of shoulder dystocia associated with vaginal delivery notwithstanding the risk of a grave outcome was small (less than 0.1% risk of cerebral palsy).
The case and judgment centres around the fact that her obstetrician had not disclosed the increased risk of this complication in vaginal delivery, despite the mother specifically asking if the baby’s size was a potential problem. Montgomery sued for negligence, arguing that, if she had known of the increased risk, she would have requested a caesarean section. She was effectively deprived of choice.
The Supreme Court found in her favour in March 2015. It established that, rather than being a matter for clinical judgment to be assessed by professional medical opinion, a patient should be told whatever they want to know, not what the doctor thinks they should be told.
The final judgment should be read and absorbed by us all:
'An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken.
'The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.
'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.'
It was a clear boost for patient autonomy over medical paternalism and frankly I was amazed that it made it into Court. It seems like a “no-brainer” and what we should have been doing anyway.
Clearly, we have now moved from the ‘reasonable doctor’ to the ‘reasonable patient’ test as the marker for consent and rightly so.
From a legal perspective, prior to Montgomery, the Bolam test2 in England was used to determine what should be disclosed. This tested whether a doctor’s conduct would be supported by a responsible body of clinicians. So, previously if a responsible body of clinicians felt that the amount of information provided was reasonable and what they would have done, it was acceptable in law.
In Ophthalmology we are fortunate in that we are rarely in an emergency situation which requires rapid consent. Most of the time we operate electively and patients have time to consider their options and the risk involved.
We are however challenged by the delicate and specific nature of the eye and eye anatomy. Patients understand the concepts of broken bones, gall stones and complications such as deep vein thrombosis, infection and scars. They understand that they can bleed from an abdominal procedure and that in cancer procedures sometimes it is impossible to clear away the disease but what do they understand by the term posterior capsule rupture? Do they truly understand what it is all about and how do we educate them to give them true informed consent without teaching them and testing them on the anatomy of the eye?
We also have an elderly population who may not understand everything we tell them. And there lies the rub of generalisation and paternalism in our profession. We should move away from the classification of elderly and really assess the individual patient and their level of understanding and need to understand.
Despite my best efforts to consent patients and my explanation about “the clear cellophane type bag around the lens that can sometimes rupture and allow the jelly at the back to come forward or even worse allow the lens to fall to the back” and what I consider a great explanation about how I “break the lens up with ultrasound and suck it out with a vacuum” I still get patients on the table asking “what are you actually doing” and “Oh, I thought it was just a membrane you peeled away”.
We have a duty to educate patients and inform them about what we are going to do and what the possible complications are. Furthermore, it is vital that we engage with the patient on their level. Many of the patients I see are less young and we do need to make a judgment on how much they will comprehend but that should be an active judgment based on the individual patient, their needs, their understanding and their particular circumstances. It is an active process and not a passive one.
The concept of empowering autonomy has a contradiction when patients do not want to know the risks of surgery. In my speciality eyes and vision are emotive and a cause for anxiety.
One prospective survey study by Tan and colleagues3 investigated 100 patients’ preferences for information and discussion prior to routine cataract surgery. Of the entire group of 100, 32 did not wish to know "anything at all" about risks and would prefer to leave decision making to their ophthalmologist; 22 were interested only in knowing their overall chance of visual improvement; and 46 welcomed a general discussion of possible complications, of whom 25 went on to enquire about specific complications.
In the era of informed consent and respecting patient autonomy should we be forcing the third of patients who do not wish to know “anything at all” about the risks to listen to us as we relay what could go wrong but probably wouldn’t? The answer is yes naturally but who are we protecting, the patient or ourselves? Are we writing things on the consent form purely to point to it later if things do go wrong or are we truly engaging in the process and ethos of consent? Sadly, I see a bit of both occurring regularly.
I often get told by the patient that they do not want to know the risks and trust me, a position and responsibility which continues to humble me. I do operating lists of ten cataract patients, and I am still awed that they trust me with their sight and ten people wake up next day to new vision.
If they do not want to know the risks is that such a bad thing? When I get on an aeroplane, I am putting my life and safety in the hands of the pilot and the airline. Do I question how many times they have flown or what their safety track record is? Do I ask to assess the maintenance logs for the plane or do I trust that all the safety checks have been done and they will keep me as safe as they can?
Clearly healthcare is different to flying on a plane and we need to do everything we possibly can to engage with patients and ensure they are making informed decisions about their care. We do not have time, and there are barriers in place, but we need to make time. More and more we will face patients asserting they were not told of risks and so we, as a medical profession, need to safeguard ourselves by documenting what patients are told (handing an information sheet to a patient or getting them to sign a form is not good enough) and more importantly ensure that they understand what we are telling them.
Consent will continue to evolve and we need to evolve with it. The patient has to come first.
References:
[1] Montgomery v Lanarkshire Health Board [2015] UKSC 11.
[2] Bolam v Friern Hospital Management Committee (1957) 1 WLR 582.
[3] Tan LT, Jenkins H, Roberts-Harry J, Austin M. Should patients set the agenda for informed consent? A prospective survey of desire for information and discussion prior to routine cataract surgery. Ther Clin Risk Manag. 2008 Oct;4(5):1119-25.
Published by: