On 10th November 2020, the consultation on the draft ME/CFS Guideline was launched by the National Institute for Health and Care Excellence (NICE). Since then, a team of #MEAction UK volunteers have worked to produce a robust and comprehensive response. Some members of the team were volunteering with #MEAction UK for the very first time, specifically to contribute to the NICE guideline response. Together with a dedicated group of long-standing volunteers, #MEAction UK has compiled a solid and articulate response.
Thanks are not only due to the team who drafted the response but also to EVERYONE who contributed: whether that was by joining one of our community calls, completing our social media polls, engaging in discussion online, emailing your comments to us or directly to NICE or by sharing our posts about the consultation. Thank you!
Overall, this Guideline is a significant improvement on the 2007 CFS/ME Guideline, and we would like to thank the committee members, and especially the lay members, for their extensive and hard work over the past couple of years.
We are thrilled to see acknowledgement of the stigma people with ME have faced; the additional recommendations for people with severe or very severe ME and for children and young people; the recommendations on different ways to access care (such as phone, video conference or home visits); the recommendation to provide aids and adaptations without delay and also the acknowledgement that cognitive behavioural therapy (CBT) is neither a treatment nor a cure for ME.
In particular, we’d like to congratulate the committee on their recognition that graded exercise therapy (GET) has caused significant harm, and their decision to recommend against this therapy in the draft Guideline. This particular change is a triumph of evidence-based decision making that puts patient safety first, in the face of significant pressure from those with vested interests.
We have conveyed to NICE the deep relief people with ME felt upon hearing this news. As Ben H, person with ME, wrote on twitter: “You’ll never see so many patients so pleased and emotional about having no treatment for their illness. That’s how unscientific, ineffective and harmful GET has been. No treatment is better than a harmful one.”
All of us at #MEAction UK urge NICE to stand by this decision.
While this draft Guideline is a major improvement, there is a need for clarification on some issues, and we remain concerned that certain recommendations could allow harmful practices to continue. We therefore argue for:
- Clarity around who will be providing care, and an explicit recommendation for a physician, preferably a consultant, to be part of every specialist team.
- Strengthening and expanding the section on training, to ensure the paradigm shift this Guideline lays out works its way into practice.
- Proactive follow up from a physician for those with suspected ME.
- Moving recommendations on safeguarding into the section on principles of care, as the stand-alone safeguarding section has already been misused.
- The removal of the section on physical activity programmes, with access to specialist advice on physical activity instead being offered under the section on energy management.
- Further downgrading of CBT, with broader guidance on the principles of any psychological support for people with ME and training required for any healthcare professional providing this.
- The removal of language around goals and incremental increases in activity – stabilisation is key and the energy management approach already enables increases in activity where the person has improved.
- A clear message from NICE that ambitious biomedical research is required.
A special special shout out and thanks goes to Sian, Laurie, Denise, Janet, Helen, Jenny, Mark, Tiggy, Barbara and the many others who have helped with this. You know who you are!
We go into much greater detail in our full response, but here’s some highlights:
The recommendations on multidisciplinary care do not align with the recommendation that a specialist team should confirm diagnosis of ME. There is no explicit mention made of the fact it will be necessary to include a physician in the team in order to confirm diagnosis, despite the fact that Evidence Review I p24 line 5 states: “The committee acknowledged that GPs did not have enough time to carry out the assessments needed to confirm a diagnosis of ME/CFS or to develop a management plan in a single standard appointment. The committee recommended that once someone with suspected ME/CFS has had persistent symptoms indicating ME/CFS for 3 months the person should be referred to a specialist team for confirmation of the diagnosis.”
#MEAction UK therefore calls on the committee to add an explicit recommendation for the presence of at least one physician, preferably a consultant, within every multidisciplinary team.
Training for health and social care professionals
Any change in approach to managing ME, hinges on both the content of new training and the ability of those undertaking it to accept and alter their views accordingly. They need to recognise and agree that “ME/CFS is a serious, chronic, complex systemic disease that often can profoundly affect the lives of patients and … is not, as many clinicians believe, a psychological problem.” We would welcome staff who have received training based on the new guidance.
#MEAction UK calls on the committee to strengthen and expand the section on training, to ensure the paradigm shift this Guideline lays out works its way into practice.
We strongly agree with the recommendation that people with suspected ME can return for a review if they develop new or worsened symptoms, and to ensure they know who to contact for advice. Other guidelines by NICE give clear recommendations of timescales that should be adhered to in the provision of care and, as this committee has found, early diagnosis and information can improve outcomes.
#MEAction UK therefore calls on the committee to change the wording of their recommendation to: “Explain to people with suspected ME that their diagnosis can only be confirmed after 3 months of persistent symptoms, and arrange a follow up appointment for that time. Reassure them that they can return for a review before then if they develop new or worsened symptoms, and ensure they know who to contact for advice.”
Although we recognise the good intentions behind including a safeguarding section, this section could be misused as the safeguarding approach taken for ME patients has been in the past. One clinical guidance summary based upon this draft guideline has already recommended that every person with ME should receive a safeguarding assessment – a deeply worrying precedent. In the feedback we have received, parents of children with ME are very concerned that instead of addressing common misconceptions, by inserting a section on safeguarding, the committee are inadvertently implying that abuse of children with ME is common, contrary to any evidence to suggest this.
#MEAction UK calls on the committee to clarify recommendations within the section on safeguarding, many of which are important and highly welcomed, and move them into the section on principles of care.
Physical Activity Programmes
It is clear the committee has understood and recognised the extensive harm caused by physical activity programmes, particularly graded exercise therapy, and there is very significant relief that the lived experience of so many people has not been ignored. While the recommendation in the new draft guideline for physical activity programmes adds more qualifiers than the 2007 Guideline, it appears likely to lead to the same outcomes of harm, deterioration, resultant distrust in healthcare professionals and therefore worse overall care for people with ME.
It is right that people with ME, alongside those with other debilitating illnesses, have access to specialist support around physical activity when requested, especially as this aspect appears key in preventing relapses. However, in their recommendation of “physical activity programmes” the committee appear to have made up an entirely new management approach that is not backed by the evidence base, be that research literature or qualitative data. The committee has acknowledged that graded exercise therapy has done harm, and has explicitly recommended against this. Under ‘Other Exercise Interventions’ (Evidence review G, page 154-165), not a single outcome rates higher than ‘very low’ on the quality of evidence, nor has any qualitative evidence been identified. Why then has the committee created a newly defined ‘physical activity programme’ in the Guideline?
#MEAction UK’s strong recommendation here is to remove this non-evidence based ‘programme’ from the Guideline in its entirety, and instead provide greater access to specialist advice and support on energy management, as this should include support in managing fluctuations in a person’s energy envelope anyway. This would enable access to physical activity advice for all people with ME, and not just those who “are ready” or “would like” to “progress their physical activity”.
Psychological Support: Cognitive Behavioural Therapy
We strongly support people with ME receiving the support they want and require to adapt to this devastating illness, including the psychological support that has ironically long been denied them through “inappropriately delivered” cognitive behavioural therapy (CBT). However the evidence base for recommending CBT alone is dubious. Looking through Evidence Review H – we note that out of 161 outcomes of CBT that were assessed, 113(70.2%) had a rating of very serious risk of bias and the remaining 48(29.8%) had a serious risk of bias. The vast majority (143/88.8%) received a quality rating of very low, with the remaining outcomes (18/11.2%) receiving a quality rating of low. A more general recommendation should be made to consider and discuss with the patient whether psychological support might be helpful.
This section on psychological support could then lay out factors that would apply to any psychological support delivered to people with ME. It should recommend that all psychological support be given by a professional with training in accordance with this Guideline, and experience of ME. General pointers relating to what the therapy should and shouldn’t include would then address all the types of therapy people with ME might seek out and receive, meaning that even private therapists would have a resource to turn to.
#MEAction UK calls for the further downgrading of CBT, with broader guidance on the principles of any psychological support for people with ME and training required for any healthcare professional providing this.
We agree that people with ME should be offered an assessment to develop an energy management plan with realistic expectations. However, we remain concerned about the language of “goals”. Evidence Review G page 336, line 26 states:
“The committee noted that where goals are rigid and unrealistic this can result in false starts, flares and relapses. The committee commented on the findings in the qualitative evidence that people had felt pressured and blamed when they could not complete the programme even though it was making their symptoms worse. The committee acknowledged the controversy around the setting of fixed unrealistic goals and the importance of understanding realistic goal setting by both the person with ME/CFS and the healthcare professional supporting any programme.“
Where there is evidence of harm from goal setting, including relapses that “can lead to a long-term reduction in the person’s energy envelope” (Guideline page 44, line 29) there must be very strong evidence of benefit to recommend such a strategy even with the caveats of “realistic” attached. Such evidence is not presented in the evidence reviews.
#MEAction UK calls for the removal of language around goals and incremental increases in activity – stabilisation is key and the energy management approach already enables increases in activity where the person has improved.
Recommendations for research
We welcome the section of Recommendations for research, but are disappointed by how sparse these recommendations are.
As this committee has found, biomedical research into ME is fragmented and small-scale because of lack of funding. Although a lot of useful research has been done, there is a need for well-funded, targeted research which in many areas will involve large-scale, carefully designed and controlled trials. Making funding available for these should be a key recommendation. Investment in research would be a sound economic investment. With 250,000 estimated sufferers in the UK, 75% of whom cannot work, effective management or treatment tools would save healthcare costs and boost tax returns.
In particular, this committee must make a recommendation for research into the causes of ME. While NICE may usually focus on treatment and management of illness, in this case research into treatments has stalled in part because the “pathophysiology is unclear.” (Guideline p4 line 6)
It is only with a clearer understanding of the pathophysiology that treatments and eventually a cure will be found.
#MEAction UK strongly urges NICE to send a clear message that ambitious biomedical research is required.