Mr Alwitry is an experienced and award-winning Ophthalmologist and Eye Surgeon based in the East Midlands. He has written two text books and edited a third. He has published more than 35 research articles and has a Masters in Medical Law. He is a Speciality Advisor in Ophthalmology to the Care Quality Commission.
The annual clinical negligence bill against the National Health Service (NHS) in England has increased considerably from £0.3 billion in 2004 and 2005 to £2.3 billion in 2019 and 20201. Clinical negligence pay-outs account for more than 1.5% of the annual NHS budget in England (£148.8 billion)2. The rising costs have been attributed to increases in both claim volumes and legal costs2.
Ophthalmology attracts significant litigation, which is unsurprising in that cataract surgery is the most frequently performed operation in the NHS, and Ophthalmology accounts for 8% of the 94 million hospital outpatient attendances and is the busiest outpatient attendance specialty3.
Cataract surgery is also very successful at restoring vision, with an excellent safety profile, making it more likely a patient will seek to attribute blame if things do not go to plan and vision is lost. Ophthalmology is not a big hitter when it comes to quantum though, and therefore is not in itself a big burden on the NHS’s litigation bill.
As with every speciality and, I am sure, in common with many of my expert colleagues I see the same errors happening again and again. The recurrent harm from avoidable clinical errors is heart breaking on many levels. The cause of the harm is often not high level but occurs due to well established forms of cognitive errors and bias. Historically healthcare has struggled to learn from these errors and implement effective change however there is hope on the horizon in the form of the new Patient Safety Incident Response Framework (PSIRF) which is being developed and rolled out across healthcare in the UK4.
PSIRF sets out the NHS’s approach to developing and maintaining effective systems and processes for responding to patient safety incidents for the purpose of learning and improving patient safety. The framework represents a significant shift in the way the NHS responds to patient safety incidents and is a major step towards establishing a safety management system across the NHS. It is a key part of the NHS patient safety strategy.
The PSIRF supports the development and maintenance of an effective patient safety incident response system that integrates four key aims:
1. Compassionate engagement and involvement of those affected by patient safety incidents,
2. Application of a range of system-based approached to learning from patient safety incidents,
3. Considered and proportionate responses to patient safety incidents, and
4. Supportive oversight focused on strengthening response system functioning and improvement.
Below I discuss a few conditions which are not solely ophthalmology related in view of the varied readership.
Could it be GCA?
One of the most disheartening errors that can be potentially blinding for patients is missing a diagnosis of Giant Cell Arteritis (GCA). I personally see one or two cases of missed GCA a year with catastrophic visual outcomes. It must be remembered that GCA can cause intermittent ocular symptoms, which may not manifest as any clinical signs when the patient is examined. A history of new head pain, which may be headache, temporal pain, jaw pain or even earache, in a patient over 50 years of age with ocular symptoms should raise the concern that it could be GCA. These symptoms may be only intermittent blurring of vision, frank amaurosis fugax (in 30%), or diplopia (in 5%)5. Visual acuity may be normal, as may ocular motility. A GP diagnosis of sinusitis or migraine may be misleading and falsely reassure the Emergency Medicine doctor or the Ophthalmologist. Taking a C-Reactive Protein (CRP) blood test is a prudent measure and if it comes back high, referral to the rheumatology service to exclude a diagnosis of GCA could be potentially sight preserving. Untreated, I have seen numerous cases of patients being left blind in both eyes.
Could it be hydroxychloroquine retinal toxicity?
Recent data have highlighted that hydroxychloroquine retinopathy is more common than previously reported. The prevalence following long-term use appears to be around 7.5% and depending on dose and duration of therapy can increase to 20-50% after 20 years of therapy. Risk increases for patients taking more than 5mg/kg/day for more than 5 years6 The retinopathy is manifest as damage to the central photoreceptors and thus central visual loss. This is important, as the only intervention to prevent further damage is stopping the drug. The risk is increased for patients taking more than 5mg/kg/day, those also taking Tamoxifen, and those with renal impairment7.
Harm, and consequent litigation, occurs when a clinician is faced with a patient complaining of visual symptoms who has been on hydroxychloroquine for some time. Often, they are a frail elderly lady who is being overdosed according to the guidance regarding dosage per kg of body weight leaving open the allegation that the overdosage caused the toxicity. They may have started off at one weight on commencement of the drug and then lost significant weight afterwards. Failure to stop the drug and failure to refer for an Ophthalmological assessment can result in irreversible visual loss and harm.
Could it be orbital cellulitis?
Orbital cellulitis is defined as a serious infection that involves the muscle and fat located within the orbit. It is also sometimes referred to as post-septal cellulitis. Orbital cellulitis does not involve the globe itself and the visual loss and damage to vision is usually due to an orbital compartment syndrome. Although orbital cellulitis can occur at any age, it is more common in the paediatric population. The causative organisms of orbital cellulitis are commonly bacterial originating from the sinuses.
Orbital cellulitis is potentially blinding and requires urgent treatment with antibiotics and close observation/monitoring of vision. The damage to the eye and vision is usually caused by the bacterial infiltration and inflammatory swelling in the orbit. This increases the orbital pressure. The orbit cannot decompress as it has three bony walls. The globe can move forward slightly but then it is restricted by the orbital septum. Pressure increases and the optic nerve and its blood supply become compromised. After 90 minutes of being deprived of blood supply, and thus oxygen, the retina/eye starts to die and irreversible damage ensues.
There are several common scenarios which present in litigation cases:
1. Missed diagnosis. The eyelid is red and swollen and a diagnosis of pre-septal cellulitis is made. The general practitioner or emergency doctor give antibiotics but fail to look at the eye hidden under the swollen lid. Underneath the lid the eye itself is red and inflamed. There is clear orbital cellulitis which is missed and vision is lost.
2. Missed orbital compartment syndrome. Orbital cellulitis is treated aggressively with antibiotics but the eye is not checked regularly. Vision is not assessed and when it is finally measured it is markedly reduced. The orbital pressure went dangerously high and this was missed resulting in potential blindness.
3. Failure to intervene quickly. Orbital cellulitis is diagnosed and vision reduced. There is a failure to intervene acutely/immediately with a lateral cantholysis/canthotomy (a procedure where a cut is made in the suspensory ligaments of the orbital septum allowing the globe to move forward and relatively decompress the orbit) or a failure to take urgent surgical action to drain an orbital abscess.
It is vital to differentiate pre-septal from orbital cellulitis. With pre-septal cellulitis the lid is swollen and red but the eye itself is white, vision is normal, and there is no restriction of eye movement. In orbital cellulitis the eye is red, the vision may be reduced, the eye may be proptosed (protruding) and there is pain on ocular movement. If the lid is so swollen that the eye cannot be examined orbital cellulitis needs to be excluded with imaging.
Could there be a meningioma?
Ophthalmology clinics are unsurprisingly full of patients complaining of loss of vision and there are numerous reasons why vision could be lost. One of the diagnoses which is missed is the presence of a meningioma compressing the optic nerve. The typical growth pattern of these tumours is slow, producing insidious and chronic visual disturbances.
Often the vision goes down and there is a visual field defect detected. The patient is referred into a glaucoma clinic or a cataract clinic. Both of these conditions can co-exist and they can together cause reduced vision and a reduced field of vision. The optic nerve is usually pale which is missed. There is a delay to neuroimaging and by the time it is done vision is lost. Surgical intervention often takes place to try and remove the tumour which results in more damage to the optic nerve and the visual field resulting in permanent harm.
Usually there is an allegation that there was a delay to diagnosis which meant that a curative resection was no longer possible and that there was irreversible visual loss.
Could it be a corneal ulcer?
The cornea is the clear window at the front of the eye responsible for the majority of the focusing power of the eye. Contact lens wearers are at risk of corneal ulcers/infections which can be potentially severe and potentially blinding. They are also at risk of acanathamoeba keratitis. Acanthamoeba keratitis is a rare but serious infection of the eye that can result in permanent visual impairment or blindness. This infection is caused by a microscopic, free-living amoeba (single-celled living organism) which is very common in nature and can be found in bodies of water (for example, lakes and oceans), soil, and air.
Red eyes are a common condition faced by numerous clinicians and the go-to diagnosis is conjunctivitis. In the vast majority of cases this is the correct diagnosis and topical antibiotics in the form of eye drops can be effectively prescribed. In contact lens wearers it is different, and the clinician needs to exclude a corneal ulcer. A corneal ulcer is usually visible as a white opaque area on the cornea. If this is seen urgent referral to the ophthalmology service is required. A breach of duty is often asserted due to failure to consider a corneal infection in a contact lens wearer. Appropriate safety netting is vital in such cases as, if no ulcer is seen, then it is important the patient is advised to return if symptoms fail to resolve or worsen.
Ophthalmologists are often in the firing line for failing to pick up/consider acanthamoeba infection until significant damage, usually manifesting as corneal scaring, is done.
A red eye in a contact lens wearer is a red flag and should prompt concern of a corneal infection.
Ophthalmology is a fascinating speciality and I spend my working day trying to improve and preserve vision. Visual loss is devastating and has a massive impact on patients.
A 2019 study8 reported that respondents would rather have 4.6 years of life in perfect health instead of 10 years of life with total vision loss. Losing sight concerns people more than the loss of memory, speech, hearing, or chronic health conditions, such as HIV/AIDS and heart disease. It may not be a high priority in terms of the volume of payments made but avoidable visual loss is something we need to continue to tackle as well as developing pathways to effectively learn from litigation.
References:
[1] NHS Resolution. Annual report and outcomes 2019/20 https://resolution.nhs.uk/2020/07/16/nhs-resolutions-annual-report-and-accounts-2019-20/ [accessed 7th May 2023]
[2] Yau CWH, Leigh B, Liberati E, et al. Clinical negligence costs: taking action to safeguard NHS sustainability. BMJ. 2020;368: m552.
[3] http://www.ewin.nhs.uk/sites/default/files/Ophthalmology_ Evidence%20Brief.pdf [accessed 7th May 2023]
[4] https://www.england.nhs.uk/patient-safety/incident-response-framework/ [accessed 7th May 2023]
[5] Hayreh SS, Podhajsky PA, Zimmerman B. Ocular manifestations of giant cell arteritis. Am J Ophthalmol. 1998;125(4):509-20.
[6] Melles RB, Marmor MF. The risk of toxic retinopathy in patients on long-term hydroxychloroquine therapy. JAMA ophthalmology. 2014;132(12):1453-60.
[7] Yusuf IH, Foot B, Galloway J, Ardern-Jones MR, Watson SL, Yelf C, et al. The Royal College of Ophthalmologists recommendations on screening for hydroxychloroquine and chloroquine users in the United Kingdom: executive summary. Eye (London, England). 2018;32(7):1168-73.
[8] Enoch J, McDonald L, Jones L, Jones PR, Crabb DP, Evaluating Whether Sight Is the Most Valued Sense. JAMA Ophthalmol. 2019; 137(11): 1317–1320.
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