Maeve Boothby O’Neill

Dear Coroner, Re: Regulation 28 Report to Prevent Future Deaths – Maeve Bernadette Boothby O’Neill who died on 3 October 2021

Thank you for your Report to Prevent Future Deaths (hereafter “Report”) dated 7 October 2024 (amended on 8 October 2024) concerning the death of Maeve Bernadette Boothby O’Neill on 3 October 2021. In advance of responding to the specific concerns raised in your Report, I would like to express my deep condolences to Maeve’s family and loved ones. NHS England are keen to assure the family and the Coroner that the concerns raised about Maeve’s care have been listened to and reflected upon.

Your Report raises concerns over the care provision in England for patients with severe Myalgic Encephalomyelitis (ME) / Chronic Fatigue Syndrome (CFS) and that there is currently no available funding for research and development of treatment for the condition.

NHS England has engaged with the Department of Health and Social Care (DHSC), who we note your Report was also addressed to, on these matters. Following a period of consultation with key stakeholders, including those with lived experience, and the publication of the interim delivery plan on ME/CFS in late 2023 under the last Government, the DHSC have confirmed to NHS England that the development of a final ME/CFS Delivery Plan to improve the experiences and outcomes for people with the condition remains a priority and that it is their intention to publish a response summary before the end of the year.

The summary will be shaped by the consultation responses, along with continued close engagement with stakeholders, and, with relevance to the concerns raised in your Report, will encompass the three broad themes of:

1. Attitudes and education
2. Research
3. Living with ME.

It is intended that the final delivery plan will be published by the end of March 2025. NHS England will support the DHSC on the implementation of the delivery plan and National Medical Director NHS England Wellington House 133-155 Waterloo Road London SE1 8UG

27 November 2024

we would refer the Coroner to the DHSC for further information on this, as well as details of existing investment and funding for research into ME/CFS.

In addition, NHS England has also established a specific working group to determine if additional support can be provided to commissioners of ME/CFS services. A stock take of existing CFS/ME services in England is being undertaken as an initial step. If it is of assistance, we can provide further updates as this work progresses.

Your Report also raises the concern that there is limited training for doctors on ME/CFS and how to treat it, particularly for cases of severe ME. There is currently a limited evidence base for the treatment of severe ME/CFS, which does create challenge to developing educational resource. However, in May this year, in development with DHSC, NHS England published the first of three new e-learning modules. An ‘Introduction to ME/CFS’ provides an overview of the potential causes, diagnostic criteria and management strategies. A further two modules, aimed at the NHS clinical workforces, are now in development, the first of which will cover management in primary care, followed by the third module which will provide guidance on the management of severe ME/CFS in secondary care settings.

It is appropriate that the National Institute for Health and Care Excellence (NICE) responds to the Coroner on your fourth concern regarding NICE guidance on ME/CFS and nutrition support for adults. NHS England has engaged with NICE on the concerns raised in your Report and will carefully consider the response from NICE in due course.

My regional colleagues in the South West have also considered your Report and have engaged with Royal Devon University Healthcare NHS Foundation Trust (RDUH) on your Report and the care delivered to Maeve. We understand that RDUH are in the process of developing formal pathways for acute admission and emergency admission for patients with ME/CFS and that the details of these will be shared with the Coroner by the Trust.

I would also like to provide further assurances on the 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 events, such as the sad death of Maeve, are shared across the NHS at both a national and regional level and helps us to 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 Archer Re: Regulation 28 Prevention of Future Deaths Report in respect of Maeve Bernadette Boothby O’Neill I write in response to your regulation 28 report regarding the tragic death of Maeve Boothby O’Neill. I would like to express my sincere condolences to Maeve’s family and loved ones. We have reflected on the circumstances surrounding Maeve’s death and senior clinical advisers within our patient safety team have reviewed the concerns raised in your report. Following discussions with colleagues in the NHS and at the Department of Health and Social Care (DHSC), we understand they will respond fully to points 1 to 3. We make the following observations.
1. During the course of the evidence it became clear that there were no specialist hospitals or hospices, beds, wards or other health care provision in England for patients with severe Myalgic encephalomyelitis (ME). This meant that the Royal Devon and Exeter Hospital had no commissioned service to treat Maeve and patients like her. Our guideline on myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS): diagnosis and management [NG206] recommends that care for people with ME/CFS should be supported by advice and direct clinical consultation from an ME/CFS specialist team. Service commissioning and delivery is the responsibility of the relevant NHS body.

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2. During the course of the inquest it became clear that there was no current available funding for the research and development of treatment and further learning for understanding the causes of ME / Chronic Fatigue Syndrome (CFS). NICE guidelines are developed by independent committees. During development, committees often identify areas for which there are uncertainties in the evidence or for which robust evidence is lacking. They can make recommendations for research that are likely to inform future decision-making (based on a systematic assessment of gaps in the current evidence). During development of the NICE guideline on ME/CFS, the committee made a number of recommendations for research, including one on dietary strategies.
3. During the course of the inquest it became clear that there was extremely limited training for Doctors on ME/ CFS and how to treat it – especially in relation to severe ME.

NICE has supported the development of e-learning materials consistent with NICE guidance on ME/CFS. They have been produced by the NHS England Technology Enhanced Learning team and we will link to them from the guideline page on our website as they are published.

4. During the course of the inquest it became clear that the 2021 NICE guidelines on ME did not provide any detailed guidance at all on how severe ME should be managed at home or in the community and in particular whether or not there is any necessary adaptation needed to the 2017 guidance on Nutrition support for adults : oral nutrition support , enteral tube feeding and parenteral nutrition . The remainder of our response focuses on point 4 as actions to address this concern are within NICE’s control. Our guideline includes recommendations on care for people with severe or very severe ME/CFS (section 1.17). They include general recommendations on dietary management and strategies. We were not able to make more specific recommendations due to a lack of good quality evidence. For this reason, the committee made the research recommendation noted above. This section does refer to the NICE guideline on nutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition [CG32].

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While this guideline (CG32) is not specific to ME/CFS, there are recommendations on indications for nutrition support in hospital and the community (section 1.3). They say that healthcare professionals should consider enteral tube feeding in people who are malnourished or at risk of malnutrition, defined as having eaten little or nothing for more than 5 days and/or being likely to eat little or nothing for the next 5 days or longer (recommendation 1.3.2). There is also guidance on what nutrition support to give (section 1.4) and how to monitor nutrition support (section 1.5). It also includes a specific section on supporting patients in the community with enteral feeding (section 1.9).

Actions proposed In response to your report, and our learning and reflections following Maeve’s death, we will:
• review the evidence on dietary management and strategies for people with severe or very severe ME/CFS published since NG206 was introduced to determine if any specific amendments to the guideline are needed in this area.
• work with colleagues from the Royal Devon University Healthcare NHS Foundation Trust to see if there are examples of good practice that we can link to from our guideline pages.
• consider appropriate amendments to the guideline on ME/CFS to emphasise the need for appropriate nutritional support. Additionally, we are already working with colleagues from our external supplier that produces NICE Clinical Knowledge Summaries (CKS) to determine if any updates to the section on fatigue are possible. CKS topics are a source of advice and information primarily for health professionals working in primary care, but they do not constitute formal NICE guidance. I hope this response is helpful in confirming what NICE recommends and the actions that we will take because of your report relating to Maeve. I would like to reiterate my condolences to her family.

Dear Ms Archer,

Thank you for the Regulation 28 report of 7 October 2024 sent to the Secretary of State / the Department of Health and Social Care (DHSC) about the death of Maeve Boothby O’Neill. I am replying as the Minister with responsibility for long-term conditions, including myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS).

Firstly, I would like to say how saddened I was to read of the circumstances of Maeve’s death. The circumstances your report describes are deeply concerning and I am grateful to you for bringing these matters to my attention. I met with Maeve’s mother Sarah last week to offer my sincere condolences to her and her family, and to discuss how we can improve care for people with ME/CFS and work together to try and ensure no other families lose a loved one in such tragic circumstances.

The report raises concerns over:
i. no specialist hospitals or hospices, beds, wards or other health care provision in England for patients with severe ME/CFS;
ii. no current available funding for the research and development of treatment and further learning for understanding the causes of ME/CFS;
iii. extremely limited training for doctors on ME/CFS and how to treat it, especially in relation to severe ME/CFS;
iv. the 2021 National Institute for Health and Care Excellence (NICE) guidelines on ME/CFS not providing any detailed guidance at all on how severe ME/CFS should be managed at home or in the community and, in particular, whether or not there is any necessary adaption needed to the 2017 guidance, Nutrition support for adults: oral nutrition support, enteral tube feeding and parenteral nutrition.

In preparing this response, DHSC officials have liaised with NHS England, NICE and the Medical Schools Council to ensure a comprehensive approach to fully addressing your

concerns. Those organisations will be replying separately to you, focusing on the concerns that fall within their competence. My response, therefore, will primarily focus on the matters of concern relating to the funding of research into the causes of ME/CFS and the development of treatments for ME/CFS, and training for doctors on ME/CFS.

Research

On the issue of funding for research and development of treatment and further learning for understanding the causes of ME/CFS, it is not accurate to say that there is no funding available. The Government is committed to funding high-quality research to understand the causes, consequences and treatment of ME/CFS, and is actively exploring next steps for research in this area. Government research funding is currently available for ME/CFS through the National Institute for Health and Care Research (NIHR) and UK Research and Innovation.

DHSC funds ME/CFS research through the NIHR and welcomes funding applications for research into any aspect of human health, including ME/CFS. We do not usually “ring- fence” funding for any specific condition as these applications are subject to peer review and judged in open competition, with awards being made on the basis of the importance of the topic to patients and health and care services, value for money and scientific quality. In all areas, the amount of NIHR funding depends on the volume and quality of scientific activity.

The Government is aware of the devastating effect ME/CFS can have on those suffering from the condition and recognises that it is an under-researched area. Unfortunately, despite our efforts to stimulate high-quality research in this area, we have received a low number of research applications on ME/CFS. We will, however, continue to work with the community, to identify new opportunities to increase research in this area.

I can also reassure you that over the last five years, the DHSC, through NIHR, has invested over £3.6 million in research programme funding for ME/CFS. This includes over £1.5 million to the DecodeME study, co-funded with the Medical Research Council, into the genetic underpinning of ME/CFS. The study will analyse samples from 25,000 people with ME/CFS to search for genetic differences that may indicate underlying causes or an increased risk of developing the condition. This study aims to increase our understanding of the disease and therefore contribute to the research base on diagnostic tests and targeted treatments for ME/CFS.

I hope that this provides reassurance that we take seriously the challenge of ME/CFS and are committed to ensuring that those living with it have the opportunity to participate in and benefit from research, with the aim of better understanding the causes of ME/CFS, identifying new treatments and improving patient outcomes.

Training and education

In relation to the issue of training for doctors on ME/CFS and how to treat it, especially in relation to severe ME/CFS, the Department is working with NHS England to develop an e- learning course on ME/CFS for healthcare professionals, with the aim of supporting staff to

be able to provide better care and improve patient outcomes. NHS England’s e-learning package comprises three sessions. In May 2024, NHS England published the first session, with universal access, providing an overview of the condition, and aiming to increase awareness and reduce stigma around ME/CFS. The second and third sessions, currently in development, are aimed specifically at clinicians and, alongside the first session, will form a comprehensive package for NHS staff to be able to provide better care for patients with ME/CFS.

The second session will focus on management in primary care, covering personalised activity plans, concomitant conditions, such as mast cell activation syndrome and postural tachycardia syndrome, the psychological impact of being diagnosed with the condition, and what is not ME/CFS. The third session will cover management in secondary care, focusing on patients with more severe ME/CFS that require hospitalisation. This includes information on treatments and their potential benefits and risks, management of a patient who requires hospital admission, provision of a minimum stimuli environment, and support for healthcare professionals.

The Medical Schools Council will promote the NHS England e-learning package on ME/CFS to all United Kingdom medical schools, and encourage medical schools to provide undergraduates with direct patient experience of ME. The General Medical Council (GMC) is the regulator of medical schools, and it is important that education is reenforced at different stages of medical training. Royal Colleges play an important role in this. The GMC has included ME/CFS in the content map for the new national exam so all medical schools will need to teach it as a subject.

NICE supports the development of e-learning materials that are consistent with NICE guidance and will promote the NHS England e-learning package on the guideline page on their website when available.

Next steps

Under the previous government, the Department published the ME/CFS interim delivery plan in August 2023, alongside a public consultation which closed in October 2023. It has been my priority since my appointment to publish a summary of responses to this consultation, which we are intending to publish in December. Following the publication, we will reconvene the ME/CFS Task and Finish Group, including senior DHSC and cross- government officials, and ME/CFS specialists and representatives from NHS England, NICE, devolved governments and ME/CFS charities and organisations. The consultation responses, alongside continued stakeholder engagement via the ME/CFS Task and Finish Group, will inform the development of the final delivery plan for ME/CFS, which we aim to publish by the end of March 2025. The plan will focus on boosting research, improving attitudes and education, and bettering the lives of people with this debilitating disease.

NHS England has agreed to support the implementation of the final delivery plan and is also establishing a specific working group to determine if additional support can be provided to commissioners of ME/CFS services. A stock take of existing ME/CFS services in England is being undertaken as an initial step. NHS England has offered to update you on progress.

NHS England colleagues in the south west of England have engaged with Royal Devon University Healthcare NHS Foundation Trust (RDUH) on your report and Maeve’s care. RDUH is in the process of developing formal pathways for acute admission and emergency admission for patients with ME/CFS. NHS England has agreed to share this with you in due course.

NICE has agreed to review the evidence on dietary management and strategies for people with severe ME/CFS published since the 2021 NICE guidelines were introduced, and amend guidance as needed. It will consider appropriate amendments to the guideline on ME/CFS to emphasise the need for appropriate nutritional support. NICE will work with colleagues from RDUH to determine examples of good practice to link into NICE guideline pages.

I hope this response is helpful in demonstrating our commitment to bolster care and support for people living with ME/CFS. Thank you for bringing these concerns to my attention.