Myalgic Encephalomyelitis/Chronic Fatigue Syndrome NICE guideline: stakeholder review

3. Findings: Views of the NICE guideline

3.1 Stakeholders were asked about the changes made in the NICE guideline and which aspects they welcomed. The responses from the majority of stakeholders, of all types, was overwhelmingly positive.

Recognition and validation

3.2 The explicit reference to the stigma and the recognition of the complexity of the condition was identified as a key achievement of the guideline and much needed to progress change.

"We welcomed the explicit reference to the stigma of ME and that people are not always believed or told things are 'all in their head'" (Third sector ME/CFS organisation)

3.3 Most clinicians, third sector contributors and people living with ME/CFS appreciated the validation of ME/CFS as a complex multi-system disease that required specialist care. A few stakeholders acknowledged that the previous guideline had not done enough to dispel the myths around ME/CFS so they appreciated the recognition of the stigma and disbelief around the condition, noting that, "we know it is not psychosomatic - and that needs to be stated loud and clear" (Clinician)

Not using Graded Exercise Therapy (GET)

3.4 All people living with ME/CFS and representatives of ME/CFS third sector organisations highlighted that not recommending the use of GET in the NICE guideline was a 'massive step forward' and 'nothing short of life changing." (Person living with ME). The ME/CFS community were very clear that GET was not only ineffective in treating ME/CFS, but extremely damaging, commenting that, "the notion that people could exercise themselves out of illness is the wrong thing for ME. Too much exercise worsens the disease. Removal of GET from the guidelines was a real breakthrough" (Third sector ME/CFS organisation).

3.5 The majority of clinicians involved in this review agreed with the non-use of GET, or at least acknowledged the importance of this change to the ME/CFS community. "[NICE have] abolished recommending CBT and GET – based around psychosocial hypothesis built on faulty beliefs and decondition –it needs [to be consigned to] the history dustbin. This is major." (Clinician)

3.6 However, a few clinicians felt that GET still had a role to play in treating people with ME/CFS "it's probably not harmful to try - increasing exercise might just mean people are wiped out for a couple of days afterwards". (Clinician)

3.7 Other clinicians questioned the evidence base that prompted this change. One noted that they were, "Disappointed in the way [GET] was removed, not entirely scientific" (Clinician) and another added that they, "question [the] evidence base around a lot of the contents. Often refers to, 'expert opinion of the committee'. It's the way I've treated throughout my career, so disappointed to see removed." (Clinician)

3.8 Comments from these clinicians around the importance of exercise in supporting general good health and the risk of deconditioning indicated that they seemed to conflate GET with supported activity programmes and pacing, expressing concern that exercise as a possible way of managing ME/CFS had been removed from the NICE guideline.

Re-purposing of CBT

3.9 From the discussions with stakeholders, the re-positioning of CBT as one of a number of possible supportive approaches, rather than as a cure for ME/CFS, was universally welcomed by the ME/CFS community, and by the majority of clinicians who took part. ME/CFS organisations recognised that this was another endorsement of the authenticity of the condition, noting that, "CBT gave the idea that ME was all in your head, [and] psych intervention like CBT could think your way out of ME. That was cobblers. Now the guidance, which I feel is appropriate, is that CBT should be offered not to cure but to help people live with difficulties of long-term conditions". (Third sector ME/CFS organisation)

"I welcome NICE's change of stance on CBT - not a curative but a supportive approach for managing the secondary impacts of ME" (Clinician)

3.10 A few clinicians were sceptical about the change in status of CBT, with one noting that, "the problem is, there's no pharmaceutical options… CBT and GET are no longer advised but that's why [individuals] came to secondary care. It makes it difficult to know what therapeutic options are available".

Severe and very severe ME/CFS

3.11 Stakeholders, especially those from the ME/CFS community, welcomed the recognition in the guideline that there is a severe and very severe end of the ME/CFS spectrum and that this needs special adaptations and extra care. One third sector organisation explained the importance, "to distinguish severe and very severe and acknowledge that they need different treatment - they are less likely to fluctuate, more likely to be very severe all the time". Another stakeholder, a clinician, commented that, "the descriptions of those with severe / very severe ME 'hit hard' as they clearly need a very different approach to those with mild / moderate ME", further noting that this distinction in severity and identification of scales of illness could help shape future services.

Children and young people

3.12 People with ME/CFS or parents of people with ME/CFS applauded the guideline for the inclusion of specific reference to the way ME/CFS impacts on children's health, education and family life. "The guideline had specific consideration for children and severely ill. They have different needs to the general population, so this recognition is helpful" (Clinician).

3.13 Although parents welcomed the recognition of the children and young people in the guideline, they were unhappy with the wording that stated, "recognise that the following are not necessarily signs of abuse or neglect in children and young people with confirmed or suspected ME/CFS." Many of the parents lived with the fear of safeguarding issues being raised and they felt that this wording should be 'very unlikely to be signs of abuse' and that the medical profession need to work closely with schools and help them understand how they can support children.

3.14 In the discussion^[1] with parents of children and young people with ME/CFS they hoped that this new recognition would result in more parental involvement in the way that future services are developed and that paediatricians would be part of any specialist team.

Reference to co-production in management of ME/CFS

3.15 A few people from the ME/CFS community noted that greater emphasis on patient experience and acknowledgement that people are experts in their own care were highlights of the guidance, along with encouragement to co-produce management strategies.

"Partnerships between patient and clinician seen as key… felt there was quite a lot of patient involvement, emphasis on pacing" (Clinician).

3.16 However, one clinician noted that the guidelines themselves could be a barrier to genuine co-production as they, "over medicalise approaches to ME - it can be obstructive in that clinicians will live by the guidelines and sometimes they might not match lived experience - means that patients and clinicians will then go backwards and forwards and wrangle over the detail concentrating on a piece of paper and not their treatment. What is needed instead is genuine co-production of treatment - established relationships with patients as genuine narrative equals". (Clinician)

Mention of specialist teams

3.17 Stakeholders from the ME/CFS community highlighted that the guideline made specific reference to specialists. They welcomed the recognition that there should be specialist services and "that the guidelines place responsibility on GPs for diagnosis and referral to specialists" (Person with ME/CFS).

3.18 However, there were a few stakeholders who wanted more clarity in the guideline about the specialists that should be involved. "What was less welcome – who should deliver it? Doesn't say this. Lots of pass the parcel going on, someone needs to be told this is your disease now get on with it." (Third sector ME/CFS organisation). Another stakeholder noted that, "Guidelines helpful in confirming what clinicians should be doing but can in themselves be a barrier - everyone is so different and needs work on a continuum so therefore so should care." (Clinician)

Better diagnostic criteria

3.19 A few stakeholders from the ME/CFS community noted that the new guideline provided improved diagnostic criteria. "ME is not a functional disorder and shouldn't be seen in this way by professionals. Diagnosis has been a complete mess, people not getting a diagnosis and a misunderstanding of what other conditions are" (Third sector ME/CFS organisation)

3.20 However, a few clinicians noted some of the challenges with the diagnostic criteria, in that:

• the coding on the GP systems needed to be updated to allow for the level of severity of ME/CFS to be added so treatment / management could be adapted accordingly;
• there needed to be a definition of 'normal' for the four key symptoms and clarity about what is outside normal parameters, e.g. many other conditions have poor sleep function as a symptom;
• more data on the prevalence levels of the condition disaggregated by severity would more accurately inform the level of need; and
• the three-month timescale for diagnosis seemed ambitious "very short, given that flu-like viruses can leave people very tired even after this length of time - people who may then go on to recover completely". (Clinician)

Short term areas of focus and priority

3.21 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.

Communicate about GET

3.22 Although the Scottish Government has already informed all GPs, NHS Boards and Scottish Academical Medical Schools of the draft NICE recommendations against using GET, people with ME/CFS and representing ME/CFS third sector organisations were clear that the immediate priority was to ensure that clinicians follow this recommendation. These stakeholders acknowledged that, "the challenge now lies in communicating this effectively - need to get a warning out there and ensure it is endorsed and stressed at the highest level." (Person living with ME/CFS).

3.23 A few stakeholders with ME/CFS or representing ME/CFS groups expressed concerns about the continued use of GET. One stakeholder said that "the guideline says doctors mustn't practise [GET], it doesn't say will stop doing it. They will continue to offer it and it causes harm, needs to be eliminated via a statutory instrument" (Third sector ME/CFS organisation). Another stakeholder noted the need to be courageous in recommending an alternative to GET, "They're [NICE] endorsing the regime of pacing [without being explicit in this]. Staying within energy envelope – now called activity management. Scotland could be brave and say that they're recommending pacing" (Clinician).

Education and training

3.24 There was consensus from all stakeholders that another key priority was education and training. Insight centred around four main elements:

• raising awareness and acceptance around ME/CFS;
• increasing the knowledge and confidence of GPs or other clinicians to diagnose ME/CFS;
• embedding knowledge about management of the condition in different care settings; and
• general awareness raising amongst other professional services and the general public.

3.25 All stakeholder types highlighted the need to focus on some key messages when educating clinicians. As one clinician explained, "[we need to] get back to basics: that is belief and acceptance from GPs that ME is a condition and making sure patients know you believe them". Although the same stakeholder acknowledged that, "this is, easy to say but not easy to do and hard to do without personal insight". Another stakeholder noted, "We need training to first dispel myths around ME and secondly to increase confidence in diagnosis, in referring to appropriate specialisms and in providing advice around management of ME". (Person with ME/CFS)

3.26 Comments often mentioned instilling confidence in GPs to make a diagnosis by providing them with education, additional resources and the backup of a specialist if they had any doubts over their conclusions. One stakeholder suggested, "educating people on how to teach PACE and energy management" (Third sector ME/CFS organisation) and another added there should be, "greater investment in research, training and encouragement towards people choosing ME as a specialty" (Person with ME/CFS).

Develop specialist services and pathways

3.27 Clinicians and people from the ME/CFS community alike noted that, "The NICE guideline cannot be implemented in Scotland as there is no infrastructure" (Clinician) explaining that the guidance issued assumed there were specialist clinics to refer people to, as in other parts of the UK.

3.28 Stakeholders commented that although the guideline was comprehensive and presented an idealised version of what ME/CFS services could and should be, "Until specialist clinics are developed, and this will take some time, GPs need to know where to refer people to" (Person with ME/CFS). A clinician added that, "often the problem is which speciality to send the patient to as the condition is so complex. Because it is a diagnosis of exclusion not a positive diagnosis it's often hard to know when to stop testing - for both clinician and patient - specialist clinics could stop the roundabout of constant tests and to-ing and fro-ing in the system".

3.29 A few stakeholders suggested that there needed to be a piece of work to show the potential financial savings across a range of health and social care services, if a specialist service was in place, with one saying that it would be "ideal to pilot a service and pathway in one area and roll it out to others if it worked… there is a cost-benefit in investing in pathways and services now." (Person with ME/CFS)

Research

3.30 Stakeholders across all types recognised the need for more research to reduce the misunderstanding about ME/CFS. Biomedical evidential research was considered important to improve understanding and potentially increase interest in the condition. "The other thing people wanted to see was research and trials – almost a hidden condition disregarded by clinicians." (Third sector ME/CFS organisation)

Next chapters

3.31 These short-term priorities are explored in more detail in the next two chapters when considering the implementation of the guideline and how to move forward.