Myalgic Encephalomyelitis/Chronic Fatigue Syndrome NICE guideline: stakeholder review

Executive Summary

Myalgic encephalomyelitis (ME) or chronic fatigue syndrome (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 four key symptoms characteristic of the condition are: debilitating fatigue that is worsened by activity; post-exertional malaise (PEM)/symptom exacerbation; unrefreshing sleep and/or sleep disturbance; and cognitive dysfunction. It affects multiple systems and can fluctuate from mild to very severe in individuals and across the population affected.

In October 2021 the updated NICE guideline on ME/CFS was published after some delay due to issues raised predominantly by professional clinical bodies. 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.

In December 2021, the Scottish Government commissioned Blake Stevenson Ltd to engage with stakeholders, including national charities, local support groups, clinicians, representatives from Royal Colleges and people with lived experience of ME/CFS, to gather their views on the NICE guideline and establish what actions they think are required to implement the NICE guideline in Scotland.

In total 37 stakeholders contributed to the review – 22 through one-to-one or paired interviews and 15 stakeholders during three group discussions. Some stakeholders declined to participate or did not respond to email requests to contribute. Overall the breakdown of stakeholders who contributed to this process were:

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

A short online survey was also distributed to a wider group of stakeholders and 93 people responded.

Stakeholders were asked about the changes made in the NICE guideline. The response from the majority of stakeholders of all types was overwhelmingly positive, with the following areas identified as particularly significant:

• Recognition that people with ME/CFS have experienced stigma and disbelief from the medical profession and validation that ME/CFS is a complex multi-systems condition.
• Non-use of Graded Exercise Therapy (GET) - highlighted as a 'massive step forward' by the ME/CFS community.
• Re-purposing of CBT - now changed to a supportive approach for living with a chronic condition, rather than positioned as a curative.
• Specific reference to severe and very severe ME/CFS and to children and young people in the guidance was welcomed.
• The emphasis on co-production of management and that people are the experts in their own care was acknowledged.
• Stakeholders welcomed the guidance's improved diagnostic criteria and aspirations for specialist care.

In considering the changes in the NICE guideline, stakeholders were asked which aspects should be prioritised. The majority of stakeholders focused on three key elements: ensuring that the practice of GET ends; undertaking education and training with clinicians; and developing specialist services and referral pathways. There was consensus that these needed to be achieved or committed to before the NICE guideline could be implemented.

Discussion identified two aids to implementation: an existing ME/CFS specialist-nurse led service in Fife and the knowledge and experience of ME/CFS third sector organisations. However, there were considerably more barriers:

• Scepticism: the embedded disbelief of some sectors of the clinical community around the veracity of ME/CFS and whether it is psychological rather than biomedical.
• Lack of knowledge: the paucity of training and education about ME/CFS means clinicians lack confidence over diagnosis and management of the condition.
• Lack of specialists: anyone with specialist knowledge tends to have lived experience of ME/CFS rather than develop expertise as a result of clinical pathways.
• Lack of investment: this has signalled to some that ME/CFS is not a priority, and means that education is not in place, nor pathways for management of the condition.
• Lack of ownership: although ME/CFS is defined by WHO as a neurological condition, it does not sit neatly under any one banner, and there is a reluctance to take it on for this reason.

Despite these barriers, feedback suggested that moving forward should concentrate on the development of specialist services, partnership working, the education of current and future clinicians and leadership from the Scottish Government.

Specialist services would combine local, community-based clinics supported by specialist consultant expertise at regional or national level. These could be housed in mainstream services or based around existing successful models such as the Chronic Pain Speciality Network. Learning from the pandemic might enable the use of blended delivery, with the option of virtual clinics. Partnership working, both with ME/CFS patients to draw insight from their lived experience and with third sector organisations who provide peer-to-peer support, would enable development of patient-centred specialist services.

The broad recommendations resulting from this consultation are summarised below:

• The Scottish Good Practice Statement is updated to reflect the changes within the guideline.
• There is a visible commitment to supporting the key changes within the guideline, to help end the scepticism and disbelief.
• The publication of the revised SGPS is accompanied with promotional activities and awareness raising.
• Consideration is given to the most effective approaches to improve GP knowledge, confidence and understanding of ME/CFS through an appropriate education programme.
• Pilot services are funded in a selection of NHS boards to test the development of specialist services with patient involvement and third sector collaboration embedded in the design.
• The option of including ME/CFS as a specialist network within the Modernising Patient Pathway Programme is explored.
• More research into ME/CFS is actively encouraged within the academic sector.