Prevention of Future Deaths reports · 2023
Regulation 28 report to prevent future deaths, reference 2024-0062, written 3 May 2023. A coroner writes one of these when an inquest reveals a risk that could cause further deaths unless something changes.
| Date of report | 3 May 2023 |
|---|---|
| Reference | 2024-0062 |
| Deceased | Sienna Barber |
| Coroner | Joanne Kearsley |
| Coroner area | Manchester North |
| Category | Child Death (from 2015) · Hospital Death (Clinical Procedures and medical management) related deaths |
| Organisation named | Manchester University NHS Foundation Trust |
| Source | judiciary.uk record · original PDF |
| Responses published | 3 |
Text extracted from the PDF text layer. Reproduced verbatim, including the scan's own layout.
REGULATION 28: REPORT TO PREVENT FUTURE DEATHS (1) REGULATION 28 REPORT TO PREVENT FUTURE DEATHS THIS REPORT IS BEING SENT TO: 1. The Rt Hon Steve Barclay, Secretary of State for Health and Social Care 2. 3. CORONER , President of the Royal College of Paediatrics and Child Health , Chief Executive of National Institute for Health and Care Excellence I am Joanne Kearsley, Senior Coroner for the Coroner area of Manchester North 2 CORONER'S LEGAL POWERS I make this report under paragraph 7, Schedule 5, of the Coroner's and Justice Act 2009 and Regulations 28 and 29 of the Coroners (Investigations) Regulations 2013 3 INVESTIGATION and INQUEST On the 30th January 2022, I commenced an investigation into the death of Sienna Daisy Barber, date of birth 27th May 2019 who died on the 29th January 2022 at the Royal Oldham hospital aged 2 years and 8 months old. The medical cause of her death was confirmed as 1 a) Acute necrotising bronchopneumonia due to 1 b) Group A Streptococcus. 4 CIRCUMSTANCES OF DEATH Sienna was a healthy child with no underlying medical conditions. On Sunday 23rd January she developed a high temperature. There were no specific concerns although it was noted she was eating less. The following day she was taken by her parents to her GP practice where she was examined and a suspicion of a viral infection was diagnosed. Parents were advised to continue with Calpol and to re- attend if there were any concerns. The next day Tuesday 25th January Sienna awoke and was more unwell, she had vomited and her temperature was 40.2. Parents sought advice from 111 who advised them to take her to A&E. Sienna was then taken to North Manchester General Hospital where she was triaged and examined. It was suspected Sienna had a viral respiratory tract infection, her throat was inflamed and whilst her temperature remained high, the advice was to take her home and continue with Calpol and ibuprofen. Over the next few days Sienna's temperature fluctuated. Whilst at times her temperature decreased, Sienna remained tired and lethargic and had a sore throat. __.... On Saturday 29th January 2022, Sienna began to be very agitated, flinging her arms and legs around . She was taken immediately to Rochdale Urgent Care Centre. Upon arrival she began to present with . mottling. She was immediately treated and transferred to Royal Oldham hospital where she died later that day. 5 CORONER'S CONCERNS During the course of the inquest the evidence revealed matters giving rise to concern. In my opinion there is a risk that future deaths will occur unless action is taken. In the circumstances it is my statutory duty to report to you. The MATTERS OF CONCERN are as follows:- 1. The court heard evidence that since 2014 cases of Group A Streptococcus have increased annually. After Sienna's death in December 2022 there was a significant increase of cases in young children. Whilst emergency guidance was issued to practitioners in December 2022 this related to the threshold for the administration of treatment in cases where Group A Streptococcus. This guidance has itself now been withdrawn .. The court heard that unlike other conditions such as Meningitis there is no NICE guidance for practitioners to assist them with how to diagnose / treat Group A Streptococcus. Apparently there has been previous consideration of this but a decision was taken not to provide such guidance. The court was advised this decision was taken having considered the impact of Group A Streptococcus on the whole of the population. However the court informed that there are three high risk groups, these being ; i) Children under the age of 5, ii) women who have given birth in the last month and iii) the over 75's. In my opinion consideration of guidance targeted towards these three high risk groups should be considered. 2. The court also heard that in 2019 a NICE publication considering rapid antigen testing was published. This did not recommend rapid antigen testing. However this publication excluded consideration of testing in the high risk group, the under 5's. Rapid antigen testing is carried out in other countries such as the USA and Canada. The court heard Sienna would have been entirely the sort of patient where such testing would have been appropriate on the 25th January 2022 when she was examined at North Manchester and she would have immediately been commenced on the treatment for Group A streptococcus, penicillin. In my opinion consideration should be given for rapid antigen testing in the under 5's in such cases. w ACTION SHOULD BE TAKEN In my opinion action should be taken to prevent future deaths and I believe each of you respectively have the power to take such action. 7 YOUR RESPONSE You are under a duty to respond to this report within 56 days of the date of this report, namely 26th June 2023. I, the Coroner, may extend the period. Your response must contain details of action taken or proposed to be taken, setting out the timetable for action. Otherwise you must explain why no action is proposed. 8 COPIES and PUBLICATION I have sent a copy of my report to the Chief Coroner and to the following Interested Persons namely:- The parents of Sienna Barber Manchester Foundation NHS Trust Greater Manchester Integrated Care Board I am also under a duty to send the Chief Coroner a copy of your response. The Chief Coroner may publish either or both in a complete or redacted or summary from. He may send a copy of this report to any person who he believes may find it useful or of interest. You may make representations to me the coroner at the time of your response, about the release or the publication of your response by the Chief Coroner. 9 Date 3rd May 2023 Signed(1/LQ~ ..... I •
3 responses published against this report on judiciary.uk. A response is a body's written reply to the coroner's concerns; publication is at the discretion of the Chief Coroner's office, so an absent response does not mean nobody replied.
From Maria Caulfield MP Minister for Mental Health & Women’s Health 39 Victoria Street London SW1H 0EU 13 May 2024 Joanna Kearsley, Senior Coroner The Coroner’s Office Newgate House Newgate Rochdale OL16 1AT Dear Ms Kearsley, Thank you for your Prevention of Future Deaths (PFD) report dated 3 May 2023 about the death of Sienna Barber. I am replying as the Minister with responsibility for patient safety. Firstly, I would like to say how saddened I was to read of the circumstances of Sienna’s death and I offer my sincere condolences to her family and loved ones. I am grateful to you for bringing these matters to my attention. As you may know, the National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing evidence-based guidance for the NHS on best practice. NICE’s methods and processes for developing guidelines are internationally respected and NICE keeps its guidelines under review to ensure they reflect the latest developments in evidence. In your report, you raised concerns about the lack of guidance to specifically diagnose and treat group A streptococcus infection, as well as around NICE’s publication of guidance in 2019 which did not recommend rapid tests for group A streptococcal infections in people with a sore throat. I am aware that NICE has responded to your report, citing relevant existing guidelines and the rationale for the negative recommendation on the rapid tests. I also understand from NICE that it engaged in discussions with both NHS England and the UK Health Security Agency (UKHSA). I hope that the response provided by NICE has sufficiently addressed your concerns. Given NICE’s independence, I hope you will understand that it would not be appropriate for me to comment further on NICE’s recommendations or interfere in its processes. There are two particular actions I wanted to highlight that I feel are relevant to the issues raised in your report. Firstly, due to rapidly increasing rates of Group A Streptococcus in children at the end of 2022, NHS England published interim clinical guidance on the diagnosis and treatment of children with Group A Streptococcus on 9 December 2022. We also commenced a campaign intended to inform parents and carers about the symptoms of Group A Streptococcus in babies and children, what to look out for and what action to take if they are concerned. Secondly, in February the Government and NHS England announced plans to implement Martha’s Rule in at least 100 acute or specialist NHS sites in England by March 2025. Martha’s Rule is an initiative that gives patients and their families who are concerned about deterioration in their physiological condition the right to initiate a rapid review of their case 24 hours a day from someone outside of their immediate care team. When requested, this rapid review will inform whether any new or additional action needs to be taken to help ensure patients receive the most appropriate care and treatment – which may include escalation. I hope this response is helpful. Thank you for bringing these concerns to my attention. Yours sincerely, MARIA CAULFIELD
Ms Kearsley HM Coroner Floors 2 and 3 Newgate Rochdale OL16 1AT Sent via email only Dear Ms Kearsley, 16 November 2023 Re: Sienna Barber – MFT comments on NICE’s PFD response. Thank you for your giving Manchester University NHS Foundation Trust the opportunity to provide further information following receipt of the response received by NICE to the Prevention of Future Deaths report issued following the inquest into Sienna’s death. My apologies for the delay in this response being provided. I confirm that I have considered NICE’s response and have set out my thoughts below. Background Group A streptococcus (GAS) is a Gram-positive bacterium commonly found as a commensal organism in the nose and pharynx of healthy individuals, particularly young children (up to 20% can be asymptomatic carriers). It can cause a variety of clinical conditions including tonsillitis, pneumonia, cellulitis, scarlet fever, necrotising fasciitis, and Streptococcal Toxic Shock Syndrome (STSS). The sequelae of GAS infections can be long lasting and include rheumatic fever, glomerulonephritis, and PANDAS. A Group A strep infection may become invasive (iGAS), leading to sepsis and death. Group A strep and scarlet fever are notifiable diseases, meaning the UK Government and NHS England have confirmed they are diseases that ‘may present significant risk to human health’. Management of suspected GAS infections poses a challenge, as the need to identify and treat potentially serious infection must be weighed up against the need for good antibiotic stewardship and prevention of antibiotic resistance. The UK currently has an issue with over-prescribing for sore throats despite NICE guidance on the management of sore throat. History A study published in 2020, in Archives of Disease in children stated ‘Infections are still responsible for 1 in 5 childhood deaths in England and Wales… (and) The UK has one of the highest childhood death rates (from infection) in Europe’. (1) The authors noted ‘that Group A Streptococcus has emerged as a major pathogen... reflecting a sharp increase in disease incidence since 2014 and reaching 33.2 cases/100 000 person years by 2016, the highest rate for almost 50 years’. Increased risk of GAS infection is also associated with countries who do not vaccinate children against varicella, as in the UK. (1) A comparison of mortality rates in UK children and young people compared to other EU countries showed ‘the UK had the worst- to third worst mortality rank for common infection in both sexes and all age groups’ (9) While the UK public and NHS staff have an awareness of invasive meningococcal disease, there is no such awareness around GAS, despite it being more common and with higher mortality, than meningococcus. Data from autumn 2022 covering a ten-week period showed 102 notified cases of invasive meningococcal disease, with a case fatality ratio of 6%; over the same period 520 cases of invasive Group A strep were notified, with a case fatality ratio of 13.6%. Since 2017, the incidence of scarlet fever and iGAS has increased above seasonal variation, with 2022-2023 seeing increased mortality in children under 10 (8). Current guidance There is no easily identified source of guidance on diagnosis and management of the different clinical presentations of GAS, and there is no single resource for best practice management of mild or serious infections in the UK. Due to rapidly increasing rates of GAS infections in children at the end of 2022, NHS England (NHSE) published interim clinical guidance in Dec 2022 on the diagnosis and treatment of children with sore throat. Various clinical scoring systems exist for assessing the probability of a sore throat being bacterial. NHSE temporarily reduced the clinical score required for prescription of antibiotics for sore throat, overriding the current NICE sore throat guidelines, however this was reversed in early 2023. NICE GAS guidelines are focused on the management of an outbreak and chemoprophylaxis, rather than treatment of the individual patient. In the absence of formal clinical guidelines, when GAS cases began to rise in late 2022, additional guidance and learning modules were published by RCPCH, RCEM, UKHSA and NHS England (2, 6, 7). However much of this material was directed at patients and families rather than clinicians. Certain treatments for GAS are associated with increased survival rates if implemented early but are not widely known. For example, the addition of clindamycin (12) to broad spectrum antibiotics may improve mortality, and IVIG can be administered for STSS (13). However, this information is difficult to source outside specialised clinical teams, and is not common knowledge among clinicians, leading to delays or missed treatments in a disease that requires time critical identification and treatment. The only guidance for UK clinicians for managing an infection in an individual is CKS and UKHSA guidance for scarlet fever (3, 4); the CKS guidance was outdated at the time of the surge in cases. There is no easily accessible guidance that summarises the different presentations of GAS; unlike in other developed countries, including Scotland, who have easily accessible advice for clinicians (10, 11, 14). The USA Center for Disease Control (CDC) has a dedicated website for clinicians, covering the range of possible GAS presentations, diagnosis, and management. Rapid antigen testing 5-30% of sore throats are likely to be GAS, but it is very difficult to clinically differentiate these from viral pharyngitis. Rapid antigen detection testing (RADT) is a bedside test which detects the presence of GAS from a throat swab within a few minutes. Developed countries have differed in their adoption of this test. Countries such as the UK, Netherlands, and Belgium do not currently use routine testing, although it is carried out in some centres. Other countries such as the USA, Finland, and France, advocate testing for suspected GAS disease. The decision to adopt rapid antigen testing is complicated by asymptomatic carriage in children, sensitivity and specificity of the test and the need for clear guidance on appropriate patient cohort for testing. A review by NICE in 2019 failed to show a definite benefit for use in sore throat, however this review was based on whole population assessment of patients over 5 years, which included low risk parts of the population. Patients at higher risk of invasive GAS include children under 10 years, mothers and babies in the first 28 days after birth, and patients over 75 years. Other groups who may be at higher risk include alcoholic patients, children with varicella, obese patients and immunocompromised patients. Review of benefit versus cost for the highest risk populations, in context of UK child mortality and the role GAS plays, would establish whether the cost benefit ratio was altered. Given the rate of asymptomatic carriage of GAS, there is a concern that RADT will result in an increase in antibiotic prescribing. However, it is acknowledged that there is currently significant over-prescribing of antibiotics for sore throats in both primary and secondary care. Evidence from the USA has shown that use of a RADT in conjunction with clinical scoring systems can actually reduce inappropriate antibiotic prescribing. Some NHS Trusts have already introduced GAS RADT and these include Alder Hey Children’s Hospital in Liverpool, Derby Hospital and Northwick Park, Harrow. Conclusion MFT are concerned at the need for better clinician awareness and understanding of the ways in which GAS can present, and its optimal management. We have liaised with Greater Manchester Sudden Unexpected Death of a Child team, Public Health England, and Greater Manchester Child Death Overview Panel to raise our concerns. Given the incidence of iGAS is five times that of meningococcal disease, the case fatality ratio is double, the incidence is increasing year on year (other than during lockdown), and the wide variety of ways it can present, there is a need for comprehensive, nationwide guidance for clinicians on the condition. NICE has produced comprehensive guidance on recognition and management of meningococcal disease since 2010. This guidance includes the symptoms and signs, diagnosis and management of acute and long-term presentations, as well as recommendations for further research. We recommend the development of similar guidelines for GAS. Any national guideline should include a section on RADT, with recommendations for research. This should include consideration of targeted testing of high-risk populations, and use of rapid antigen testing during an outbreak. I hope this response is helpful, please do not hesitate to contact us for any further information and/ or clarification. Yours Sincerely Paediatric ED Consultant Patient Safety Manager – Risk Team
Ms Joanne Kearsley Senior Coroner Manchester North Dear Ms Kearsley Re: RCPCH Response to the Inquest Touching the Death of Sienna Daisy Barber A Regulation 28 Report – Action to Prevent Future Deaths Thank you for sharing your Report with us regarding the tragic and untimely passing of Sienna Daisy Barber. We were saddened to read the circumstances surrounding Sienna’s death and have discussed with senior colleagues within the RCPCH and the Association of Paediatric Emergency Medicine, as well as sharing the information for learning with the British Paediatric Allergy, Immunity and Infection Group. We have read your report carefully and would like to offer a response to both of your concerns, and other areas where the Royal College of Paediatrics and Child Health will bear most impact. 1. NICE guidance for practitioners to assist them with diagnosing and treatment Group A Streptococcus. It was the case that interim guidance was withdrawn following the spike in Group A Streptococcus in December 2022, and replaced by the reinstatement of the NICE Sore Throat (Acute) NG84 guideline for all age groups1. The RCPCH endorsed this decision alongside the Royal College of Emergency Medicine, Royal College of General Practice, and NICE following a review by the NHS England Clinical Advisory Group and UKHSA Group A Strep Incident Management team, which assessed the overall clinical risk-benefit, including antimicrobial utilisation and potential for resistance and harms2. Young children are unlikely to present to emergency departments with sore throat symptoms alone. Therefore, children under five who present with fever (with or without sore throat) are assessed and managed as outlined in the NICE guideline on fever in under-fives3. This is viewed as a robust clinical guideline by paediatricians working in emergency care and supports decision making on the appropriate use of antibiotics. 1 https://www.nice.org.uk/guidance/ng84 2 https://www.england.nhs.uk/publication/group-a-streptococcus-communications-to-clinicians/ 3 https://www.nice.org.uk/guidance/ng143 2. Rapid antigen testing for under-fives Paediatricians would welcome an effective tool to help with the identification of Group A Strep, and there is a need for more research relating to their validity, including the appropriate levels of sensitivity and specificity in their performance for testing under-fives. Whilst there may be benefits of recommending rapid antigen testing in times of heightened cases, there are risks around possible over prescribing as it is possible to carry the bacteria in the throat without it being the cause of illness. Without further work to validate these tests, it is possible that false reassurances are given to patients and their families. On a population level, there are also risks around missed cases and reporting, and therefore consideration on the cost effectiveness of these tests as a public health tool is required. The other element to consider is how the health system would be able to a) provide testing capability and b) respond to these results. A rigorous consultation with health providers and professionals would be needed to inform the most appropriate way forward in this respect, and the College would be happy to contribute thinking if asked. 3. Sharing information and learning for quality improvement The College will be sharing information and suggestions for local improvement from your report with our paediatric members via its patient safety portal. The information within your report, and anticipated response from NICE, will also be shared for discussion with the RCPCH Clinical Quality in Practice group in October, where further actions may be identified. Thank you for seeking our views and reminding us of the importance of this work. Our sincere condolences are with Sienna’s family. Yours sincerely RCPCH President
See every Prevention of Future Deaths report matching Manchester University NHS Foundation Trust, and how often a new one appears.
What would an alert for this have sent me? Search the full text
Free to try — the preview shows the real matches and how many arrived in the last 12 months. Your first email alert is free.
These reports are published by the Chief Coroner's office at judiciary.uk and are © Crown copyright. The text here is reproduced from the published PDF so it can be searched. If something on this page is wrong, or you are a person named in it and want it reviewed, email drcjar@gmail.com and we will act promptly.