Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Thomas Geoffrey Wakefield who died on 23 September 2023.

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 17 April 2024 concerning the death of Thomas Geoffrey Wakefield on 23 September 2023. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Thomas’ family and loved ones. NHS England are keen to assure the family and the coroner that the concerns raised about Thomas’ care have been listened to and reflected upon. 

Your Report raises the concern that existing clinical guidance does not provide the adequate caution about the recognised risk or diagnoses for abdominal aortic aneurysm (AAA) and acute pancreatitis.

The responsibility for the relevant clinical guidelines does not fall within the remit of NHS England, who are independent of the National Institute for Health and Care Excellence (NICE) and the Royal Colleges. NHS England would therefore suggest that the coroner refer their concerns to the responsible organisations.

Notwithstanding the above, clinical leads within our organisation have reviewed the concerns raised by the coroner. As well as the NICE guidance referenced in your Report, the Royal College of Emergency Medicine (RCEM) and the British Society of Gastroenterology also produce guidance on AAA and acute pancreatitis and outline when AAA should be considered and the importance of ruling it out in individuals with presenting symptoms of both conditions. Some relevant sections are referenced below:

The NICE guideline (ng165) for Abdominal aortic aneurysm: diagnosis and management states:

“1.1.7 Think about the possibility of ruptured AAA in people with new abdominal and/or back pain, cardiovascular collapse, or loss of consciousness. Be aware that ruptured AAA is more likely if they also have any of the following risk factors:
• an existing diagnosis of AAA
• age over 60
• they smoke or used to smoke National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

12 June 2024

• history of hypertension.
1.1.8 Be aware that AAAs are more likely to rupture in women than men.
1.1.9 Offer an immediate bedside aortic ultrasound to people in whom a diagnosis of symptomatic and/or ruptured AAA is being considered. Discuss immediately with a regional vascular service if:
• the ultrasound shows an AAA or
• the ultrasound is not immediately available or it is non-diagnostic, and an AAA is still suspected.”

The RCEM best practice guidance for the Management and transfer of patients with a diagnosis of ruptured abdominal aortic aneurysm to a specialist vascular centre states:

"1. A clinical diagnosis of ruptured abdominal aortic aneurysm (rAAA) should be considered:
• In patients over the age of 50 years presenting with abdominal/back pain AND hypotension;
• In patients with a known AAA and symptoms of either abdominal/back pain OR hypotension/collapse;
• In patients where an alternative diagnosis is considered more likely on clinical grounds, rAAA still must be excluded, with radiological confirmation made prior to referral" The BSG guidelines for the Management of acute pancreatitis state:

"The value of ultrasonography lies in its ability to demonstrate gall bladder stones and dilatation of the common bile duct, as well as other pathology unrelated to the pancreas such as abdominal aortic aneurysm. CT is occasionally indicated for diagnosis, if clinical and biochemical findings are inconclusive, especially when abdominal signs raise the possibility of an alternative abdominal emergency, such as a perforation or infarction of the bowel."

I would also like to provide further assurances on national NHS England work taking place around the Reports to Prevent Future Deaths. All reports received are discussed by the Regulation 28 Working Group, comprising Regional Medical Directors, and other clinical and quality colleagues from across the regions. This ensures that key learnings and insights around preventable deaths are shared across the NHS at both a national and regional level and helps us pay close attention to any emerging trends that may require further review and action.

Thank you for bringing these important patient safety issues to my attention and please do not hesitate to contact me should you need any further information.

Dear Ms Devonish

Re: Regulation 28 Prevention of Future Deaths Report (Thomas Geoffrey Wakefield)

I write in response to your regulation 28 report dated 2 May 2024 regarding the very sad death of Thomas Geoffrey Wakefield. I would like to express my sincere condolences to Mr Wakefield’s family.

Our patient safety leads at NICE have discussed the contents of your report and the summary information given relating to the care given to Mr Wakefield, while considering the relevant published NICE guidance on this topic.

Our clinical advisers have highlighted that our guideline Abdominal aortic aneurysm: diagnosis and management (NG156) does provide details of the epidemiological factors that should be considered as pointers towards the diagnosis, and I have included a link to these factors below:

Recommendations | Abdominal aortic aneurysm: diagnosis and management | Guidance | NICE.

In addition, our guideline Pancreatitis (NG104) provides advice on the treatment of pancreatitis and gives a short outline on diagnostic features. The guidance explains that “people with acute pancreatitis usually present with sudden-onset abdominal pain. Nausea and vomiting are often present and there may be a history of gallstones or excessive alcohol intake. Typical physical signs include epigastric tenderness, fever and tachycardia. Diagnosis of acute pancreatitis is confirmed by testing blood lipase

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or amylase levels, which are usually raised. If raised levels are not found, abdominal CT may confirm pancreatic inflammation.”

Our patient safety leads have commented that. Although it is not a recommendation, the guideline also states that a raised amylase level confirms the diagnosis of pancreatitis. We feel this may be misleading as this can be caused by other conditions, including mesenteric ischaemia due to an aortic aneurysm.

We are therefore going to take the following action:

Review section 1.2 of the guideline on pancreatitis, and consider whether the wording should be changed from:

“Diagnosis of acute pancreatitis is confirmed by testing blood lipase or amylase levels, which are usually raised” to ‘A diagnosis of acute pancreatitis is supported by testing blood lipase or amylase levels, which are usually raised, although raised blood lipase or amylase levels may occur in other conditions’.

It is important to add that NICE guidelines cannot cover all clinical circumstances, and each guideline has a clearly set out and agreed scope. Our guidelines relate to specific medical conditions, and therefore cannot cover all possible differential diagnoses. Responsibility for decisions on the most appropriate treatment stays with individual clinicians, whose role it is to use their professional experience and training to make the correct decision on treatment for each of their patients. NICE guidelines are a practical tool to be used in conjunction with and not as a substitute for clinical judgement.

I hope this information and the action that we are taking is helpful, and would like to reiterate my sincere condolences to Mr Wakefield’s family.

Dear Ms Devonish

Re: Regulation 28 Prevention of Future Deaths Report (Thomas Geoffrey Wakefield)

Further to your regulation 28 report dated 2 May 2024 regarding the very sad death of Thomas Geoffrey Wakefield, I am writing to update on progress taken since our response dated 25 June 2024. In this we committed to amend our guideline for pancreatitis (NG104) from “Diagnosis of acute pancreatitis is confirmed by testing blood lipase or amylase levels, which are usually raised” to ‘A diagnosis of acute pancreatitis is supported by testing blood lipase or amylase levels, which are usually raised, although raised blood lipase or amylase levels may occur in other conditions’. Our apologies for the delay in providing an update. We can confirm that this action has now been completed via a post-publication amendment to the guideline. Our sympathies continue to be with Mr Wakefield’s family and we hope this update and action taken is of some reassurance to them.