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NICE guideline review

The National Institute for Health and Care Excellence (NICE) provide national guidance on treatments and care for people using the NHS in England and Wales. In September 2017, NICE announced a full review of its guideline for M.E., following consultation with stakeholders including Action for M.E.

NICE published the draft NICE guideline for M.E. in November 2020, reporting that:

"The draft guideline recognises that ME/CFS, which is estimated to affect over 250,000 people in England and Wales, is a complex, multi-system, chronic medical condition where there is no ‘one size fits all’ approach to managing symptoms. It stresses the need for a tailored, individualised approach to care that allows joint decision making and informed choice."

Registered stakeholders (including Action for M.E.) were given six weeks to respond. We reviewed the guideline in detail, producing summaries (see below) so that people with M.E. can more easily understand what is being proposed, and surveyed more than 1,500 children, young people and adults with M.E., along with their carers, families and professionals, to inform our response to the consultation, submitted in December 2020. Read an overview here.

The revised final guideline is scheduled to be published on Tuesday 21 April 2021.

Draft guideline summaries

A number of principles are common across the whole draft NICE guideline for M.E. These are:

• specific considerations/advice must be followed for people with severe or very severe M.E.
• specific considerations/advice must be followed for children and young people with M.E.
• any plan put in place to support the person with M.E. (eg. symptom management plan) must be tailored to the individual, by the individual, with appropriate support from a professional with experience of M.E. if needed/wanted.

The draft guideline describes four levels of severity as follows:

• People with mild ME/CFS (p 43) are mobile, can care for themselves and can do light domestic tasks with difficulty. Most are still working or in education, but to do this they have probably stopped all leisure and social pursuits. They often take days off or use the weekend to cope with the rest of the week.
• People with moderate ME/CFS (p 43) have reduced mobility and are restricted in all activities of daily living, although they may have peaks and troughs in their level of symptoms and ability to do activities. They have usually stopped work, school or college and need rest periods, often resting in the afternoon for 1 or 2 hours. Their sleep at night is generally poor quality and disturbed.
• People with severe ME/CFS (p 45) are unable to do any activity for themselves or can carry out minimal daily tasks only (such as face washing or cleaning teeth). They have severe cognitive difficulties and may depend on a wheelchair for mobility. They are often unable to leave the house or have a severe and prolonged after-effect if they do so. They may also spend most of their time in bed and are often extremely sensitive to light and noise.
• People with very severe ME/CFS (p 45) are in bed all day and dependent on care. They need help with personal hygiene and eating and are very sensitive to sensory stimuli. Some people may not be able to swallow and may need to be tube fed.

We've prepared summaries of selected sections of the draft NICE guideline:

• Summary of all advice in the draft guideline relating to people with severe or very severe M.E.
• Summary of all advice in the draft guideline relating to children and young people with M.E.
• 1.1 Principles of care for people with ME/CFS
• 1.2 Suspecting ME/CFS
• 1.3 Advice for people with suspected ME/CFS
• 1.4 Diagnosis
• 1.5 Assessment and care planning by a specialist ME/CFS team
• 1.11 Managing ME/CFS

Please note that we summarised the sections of the guideline that appeared to generate the most interest.

Why is this review important?

The current NICE guideline, published in 2007, recommends two treatment approaches, graded exercise therapy (GET) and cognitive behaviour therapy (CBT). However, patient evidence and experience repeatedly shows that GET and CBT are unhelpful and in many cases harmful.

Under-investment in research, and lack of rigour in applying appropriate research criteria to studies examining the efficacy of GET and CBT, mean that there is no reliable conclusive evidence base for treatments for M.E., including GET and CBT. This has led major international health agencies, including the Centers for Disease Control and Prevention in the US, to alter their guidance regarding CBT and GET

NICE has an ethical obligation to present a full, accurate and balanced picture of current international clinical practice when it comes to managing and treating M.E. but the guideline in its current form does not do this.

What is Action for M.E. doing about it?

Since this work began, we have worked to gather the latest patient evidence and experience from children and adults, and share this with NICE, to inform the update of its guideline.

• In 2017, NICE proposed not updating the guideline, based on their surveillance review of evidence published since 2007. Based on consultation responses from Action for M.E. and others, they changed this position, and committed to a full review.
• We took part in workshops in January and May 2018 to inform the development of the guideline. In June 2018, we responded to NICE's consultation on the draft scope for the guideline on M.E.
• Our 2019 Big Survey of more than 4,000 children and adults with M.E. has informed all our submissions to NICE, including the October 2019 call for evidence.
• We took a leading role in developing and promoting Forward M.E.'s 2019 survey of GET and CBT, with responses from more than 2,270, shared with NICE.
• We worked with Oxfords Brooks University to gather the experiences of children and young people with M.E. for guideline-development focus groups.

As well as ensuring the experiences of people with M.E. are at the heart of guideline development, we will call for the updated guideline to:

• recognise the experiences of people with M.E. and take account of how these impact on the guideline recommendations, including the significant number of patients who state that pacing has been helpful for them
• ensure it provides a full and accurate picture to patients and clinicians of the diversity of current international practice
• recommend further biomedical research into the aetiology and potential treatments of M.E./CFS, to increase knowledge and understanding of the condition.

Having been delayed due to the Coronavirus pandemic, the deadline is now expected to be published in April 2021.