Myalgic Encephalomyelitis/Chronic Fatigue Syndrome NICE guideline: stakeholder review

2. Background

Context

2.1 ME or CFS is a complex chronic medical condition affecting an estimated 250,000 people in the UK. Around 20,000 people in Scotland are living with the condition.

The NICE guideline lists four key symptoms:

• Debilitating fatigue that is worsened by activity;
• Post-exertional malaise (PEM)/symptom exacerbation;
• Unrefreshing sleep and/or sleep disturbance; and
• Cognitive dysfunction.

2.2 Other symptoms that may be present include orthostatic intolerance and autonomic dysfunction, temperature hypersensitivity, neuromuscular symptoms, flu-like symptoms, intolerance to certain foods and drinks, heightened sensory sensitivities and pain.

2.3 Individual symptoms, and the severity of symptoms, vary widely for people with ME/CFS and can fluctuate unpredictably in nature and severity over a day, week or longer. Someone with mild ME/CFS may be able to work full time, with adaptations, whilst someone with severe or very severe ME/CFS can be bed-bound, may not be able to swallow and may need to be tube fed.

2.4 ME/CFS can be a mis-understood condition. Disbelief and mis-diagnosis could delay diagnosis and management of the condition and have serious consequences for an individual's health outcomes. The 2021 NICE guideline recognises this, noting that, "People with ME/CFS may have experienced prejudice and disbelief and could feel stigmatised by people (including family, friends, health and social care professionals, and teachers) who do not understand their illness."

ME/CFS in Scotland and development of the NICE guideline

2.5 Despite a growing recognition of the need for specialist ME/CFS services, actual implementation has been minimal. A report by Scotland's Chief Medical Officer in 2002 recognised the need for ME/CFS-specific services and set out recommendations to deliver on this aim. However, a 2010 assessment against these recommendations by the Scottish Public Health Network commented that, "recommendations of CMO's short life working group have not been implemented widely". The report went on to make 26 recommendations around diagnosis, management, education, training, and research.

2.6 More recently, in 2020, the ME-CFS Healthcare needs assessment briefing published by the Scottish Public Health Network reviewed progress against the recommendations made and concluded that they all 'remained relevant', with the caveat that many should now be considered in the context of the delivery of the Neurological Care and Support Framework, the Re-mobilise, Recover, Re-design Framework, and the General Standards for Neurological Care. Third sector ME/CFS organisations have expressed concern that the recommendations have not yet been implemented.

2.7 A Gathering Views report from Health Improvement Scotland (HIS) the following year outlined conclusions and recommendations echoing those of previous reports and identified persistent challenges for people living with ME/CFS: lack of understanding and recognition of the condition; slow diagnosis; lack of specialist support for management; and lack of support for self-management.

2.8 In October 2021 the updated NICE guideline on ME/CFS was published after some delay. NICE paused the publication due to issues raised predominantly by professional clinical bodies and released a statement that in order to have the desired impact, the recommendations must be supported by those who will implement them. This was followed by a roundtable stakeholder meeting to hear views and address four key issues around diagnosis, graded exercise therapy (GET), children and young people, and cognitive behavioural therapy (CBT), after which the guideline was published. Despite attempts at facilitating consensus, the final publication received a negative reception by some clinical members and professional bodies but is largely welcomed by patient representatives.

2.9 GET remains an issue of contention, even with the recommendation in the current NICE guideline that it should not be offered to people with ME/CFS. A core group of clinicians are supportive of trying this approach in certain circumstances whilst ME/CFS representatives are clear that its use is unhelpful, detrimental, and harmful.

2.10 In a joint statement in response to the NICE guideline, Royal Colleges commented that, whilst the guidance contained some positive changes, they, "understate the importance of activity and exercise in the management of ME/CFS and the connection between people's mental and physical health." They also questioned the evidence that informed the guideline, commenting "there is considerable disquiet in the medical profession and some patient groups about the way the data and evidence have been assessed." Link to Royal Colleges joint statement: Joint statement in response to NICE guidance on ME/CFS | Royal College of Physicians London

Guidance in Scotland

2.11 Following the publication of the NICE guideline in 2007, a Scottish Good Practice Statement (SGPS) on ME/CFS was developed and published in November 2010 by a Guidance Working Group, chaired by Sir Lewis Ritchie. Its purpose was to provide general practitioners (GPs) with guidance on the diagnosis and clinical management of patients with ME/CFS in Scotland.

2.12 Parts of the SGPS are now out of date, given the publication of the NICE guideline. Consideration also needs to be given to whether this is the most effective way of communicating changes, and of delivering information to clinicians and patients in Scotland.

2.13 An Implementation Support Note for Long COVID has been published recently to support the implementation of the clinical guideline. The Scottish Government has produced additional targeted information for primary care teams, developed with input from key stakeholders, and positive feedback has been received to date. This could be a more suitable type of vehicle and SIGN has suggested this could be a more practical approach.

2.14 In 2020 Scottish Government officials wrote to GPs, all NHS Board Chief Executives, and the Board of Academic Medicine to raise awareness of the change in guidance concerning GET and CBT recommended by the draft NICE guideline, and a cautionary note to accompany the existing SGPS was released online.

Implementing the new NICE guideline in Scotland

2.15 The appropriateness or otherwise of the SGPS or an Implementation Note as an information source for the implementation of NICE guidelines in Scotland forms one element of this research. However, in considering the implementation of the NICE guideline in Scotland, much broader issues around ME/CFS come into play. This research sets out to:

• question stakeholders about the new NICE guideline and what it means for Scotland – this will help inform the update of the SGPS or production of an Implementation Note; and
• explore operational possibilities and short-term actions: with considerations for the priorities of those living with ME/CFS.

Methodology

2.16 Our approach to undertaking this stakeholder engagement is outlined in the diagram below.

2.17 Once the team had prepared for the engagement process and designed the question schedule, information sheets, and privacy notices, contact was made with the list of stakeholders provided by the Scottish Government. This list included national ME/CFS charities, local support groups, clinicians, representatives from Royal Colleges and people living with ME/CFS. Following a Scottish Government introductory email the research team contacted the stakeholders to explain the work and to request their participation.

2.18 This list was the starting point for contacting potential participants and they were asked to cascade the information to other stakeholders who could be interested in sharing their views. Engagement took place in the following ways:

• one-to-one or paired interviews, by telephone or web-based call;
• online group discussions; and
• written responses using an online survey.

2.19 In total 37 stakeholders contributed to the review – 22 through one-to-one or paired interviews and 15 during three group discussions. Some stakeholders declined to participate or did not respond to email requests to contribute.

2.20 Overall the breakdown of stakeholders who contributed to this process were:

• 14 clinicians (from across primary and secondary care including GPs, occupational therapists, physiotherapists, neurologists);
• 10 third sector ME/CFS organisations/academics; and
• 13 people with ME/CFS or parents of children/young people with ME/CFS.

2.21 In addition to the interviews and group discussions, a short online survey with three questions was distributed to enable a wider group of participants to contribute their views. This was disseminated through third sector organisations and the original stakeholder list provided by the Scottish Government. The survey was live for three weeks and 93 responses were received in that time. The majority of respondents were people with ME/CFS and their contributions are summarised in Appendix 1.

2.22 The non-engagement of some clinical stakeholders means that this review does not fully capture the views of those stakeholders. To obtain a wider view of the thoughts from the clinical community, beyond what is captured in this exercise, other evidence

can be considered such as the joint statement in response to the NICE guideline, which is available here: Joint statement in response to NICE guidance on ME/CFS | Royal College of Physicians London

2.23 The views of the stakeholders that did contribute to this review have informed the content of this report and these are discussed in the next three chapters.