THE NICE GUIDELINE ME/CFS
AUGUST 2021

It heralded a new beginning and was a guideline we could support, but NICE has paused publication at the last minute,” The ME Association.

Overview

The National Institute for Health and Care Excellence (NICE) has been working on a long-awaited and much-needed new clinical guideline for ME/CFS. The clinical guideline is important as it provides a framework of recommendations to health and social care services in England, Wales, and Northern Ireland – and is recognised in Scotland.

The review began in 2018 after many years of advocacy because the previous guideline was not fit for purpose. The guideline committee – comprising experts, clinicians and patients – has worked very hard and provided evidence-based recommendations to NICE following extensive stakeholder consultations which began last November. NICE then produced a final draft of the guideline which was sent to stakeholders in the first week of August 2021.

The final guideline was expected on 18 August, but at the last minute, and in an unprecedented move, NICE decided to halt the process. We don't yet know the full reasons behind this decision, or who in particular might have influenced this move, but it would appear to relate to the management recommendations.

However, there are a great many improvements to the new guideline that have been overlooked by those who are complaining and in the many reports from the news-media. We have been waiting 14 years for a clinical guideline that provides safe and practical recommendations, and gives due consideration to the most vulnerable in the patient community.

This further delay, after 4 years of evidence-based review is of real concern and as we have no idea when the guideline might finally emerge – or what it will look like – it could have a detrimental effect on people who are waiting for a diagnosis and practical help from health and social care services.

The ME Association is a steering group member at Forward-ME and we helped to produce a press release and statement that endorsed the new guideline. We then had to issue a rapid response when it was announced by NICE that the process had been suspended hours before publication. Journalists had already received the press release and since then the news-media has been reporting what it can discern about the reasons for this delay.

It is our hope that the roundtable meeting (announced 27 August) will enable stakeholders to reach agreement and for the guideline to be published soon. The recommendations go beyond issues relating to graded exercise and cognitive behavioural therapy. They better explain symptoms and diagnostic criteria, provide better guidance for people severely affected, for children and young people, and they would help to reduce the stigma that still surrounds the condition, while restoring relations with the NHS.

It was a good and improved guideline that promised real and much-needed support. NHS primary and secondary care would have continued to play key roles in making an accurate diagnosis, providing ongoing accessible care, and helping people manage ME/CFS safely and effectively.

NICE Timeline

  • October 2021 – Roundtable Discussion – date to be announced.
  • 18 August 2021 – Intended publication date.
  • 17 August 2021 – NICE announce delay in publication process.
  • 04 – 11 August 2021 – Final draft guideline stakeholder consultation.
  • March 2021 – NICE extend publication date to 18 August 2021.
  • November – December 2020 Draft guideline stakeholder consultation.
  • December 2019 – NICE extend publication date to December 2020.
  • January 2018 – NICE agree to review and update clinical guideline.

Contents

  1. Forward-ME response to planned roundtable meeting
  2. Forward-ME rapid response to NICE delay in guideline publication
  3. Forward-ME original press release and statement supporting new clinical guideline
  4. News-media reports

Dr Charles Shepherd, Hon. Medical Adviser, ME Association:

“We should have been welcoming the arrival of a completely new NICE guideline on ME/CFS today. A guideline that acknowledged ME/CFS as a serious and complex medical condition…

“It was a guideline that contained sensible advice on activity, energy, and symptom management – along with a revised timeline and advice for early and accurate diagnosis, and it placed special emphasis on the care and management of children and young people and those who have severe or very severe ME/CFS.

“Instead, we are discussing the huge disappointment felt by the patient community to yesterday's announcement from NICE to cancel publication today and to pause proceedings while discussions take place around objections to the new recommendations regarding CBT and GET – objections that were discussed and resolved as part of the long review process.

“On a personal basis, having spent a considerable amount of my time over the last four years working with colleagues on the preparation of this new guideline, I feel frustrated and angry…”


The NICE Guideline ME/CFS: Personal Observations – 18 August 2021

Carol Monaghan, Chair APPG on ME, Vice-Chair Forward-ME:

“The guideline release should not be postponed any further. It has taken three years to get to this stage, and it is clear that the NICE committee have been rigorous in their assessment of all relevant forms of evidence. People with ME can wait no longer for improved care and support, and I appeal to NICE to publish the new guideline without delay.”


The National, 18 August 2021

MEA NICE Guideline Leaflet

The MEA has a FREE booklet provides essential extracts from the DRAFT GUIDELINE that will help you to understand the help and support that should be available from your local health and social care services.

Neil Riley, Chairman, ME Association:

ME NEEDS RESEARCH

Sir, As an ME sufferer for 34 years I thank those who pressed for change to the guidelines (“Disputed therapies for ME abandoned”, Aug 17). Graded exercise therapy and cognitive behavioural therapy were not curative and affected some patients badly, but now let us put rancour behind us and get research done on this illness.


Letter to The Times, published, 18 August 2021

Dr Phil Hammond, Sunday Times:


“We all need to grow up, work together and embrace differences of opinion and strategy. More research and better services are clearly needed… Let’s start by publishing the NICE guidance, even if we don’t all agree on all of it. What we do agree on is that this is a real, deeply unpleasant physical illness that blights the lives of many, and long Covid makes better research and treatments an urgent priority.”

Sunday Times: ‘If we can’t agree on ME, we’ve got no chance against long Covid’

1. Forward-ME response to planned roundtable meeting

“Forward-ME have now had a number of direct communications with NICE regarding the delay, in which we have shared the concerns of the wider ME community. The guideline development process was robust and there is broad recognition that it stands up to scrutiny. It is clear that any guideline produced by this method should be published in full, and we are committed to achieving that.

“Forward-ME does recognise that the support of all stakeholders would benefit the roll-out of the new guidelines, and we understand the challenges that NICE have in achieving this. While we remain cautious about the situation, we are confident that any round-table will be conducted in good faith, and are reassured by the discussions we have had so far.

“If the Round Table does not reach the desired outcome with full publication of the new guidelines, Forward-ME and our members will take every possible step to ensure the final guidelines in their current form are published in full. Plans are in development to ensure we can act robustly if needed.

“People with ME deserve better, and we will continue to work together to achieve that.”


Forward-ME 27 August 2021

2. Forward-ME rapid response to NICE delay in guideline publication

“We are shocked and hugely disappointed to hear that the long-awaited NICE guideline has been unexpectedly delayed at the last minute.

“The document has been approved by the committee and should be published.

“We urge NICE to publish this important work without delay, so doctors can get on and support patients with this often devastating disease.”


Forward-ME 17 August 2021

3. Forward-ME original press release and statement endorsing proposed NICE clinical guideline

Forward ME had circulated a press release and statement among journalists on 17 August ahead of the original publication date for the NICE Clinical Guideline, and these can be found below. They demonstrate support for the new recommendations which included many positive developments that would help improve health and social care provision for people with ME/CFS.

Statement Introduction 

Forward-ME welcome the new NICE Clinical Guideline and hope it will lead to improved healthcare provision and better relations between healthcare professionals and people with ME. 

There is still a long way to go before we truly understand what causes and perpetuates this neurological condition, and we encourage researchers and funding bodies to prioritise investigations particularly in those areas highlighted by the guideline’s research recommendations.  

The key message the guideline carries is that ME is a medical condition that requires a biomedical approach. It is not a biopsychosocial (BPS) condition. We hope that the new guideline will signal a change in some attitudes, just as there has been for diseases such as epilepsy, MS, diabetes, and Parkinson’s in the past.  

We hope that with this new guideline health and social care professionals, clinical commissioners, charities, and people with ME will all work together to improve healthcare provision and make our incredible NHS accessible to all. 

The guideline represents a new chapter in the history of ME. There is no place for those who perpetuated the stigma and misunderstanding that has caused so many people to suffer.  

We look forward to working closely with patients, carers, health and social care professionals, commissioners and researchers to implement these recommendations and build a brighter future for people with ME. 

We were pleased when NICE agreed to review their 2007 guideline for ME/CFS in September 2018. We appreciate the care with which the Guideline Development Group have managed an extraordinarily complex assignment.  

We found the following to be particularly helpful:  

  • They respect patients in a way that is compassionate and just.  
  • They have understood the needs of the patient community and have recognised most of their needs.  
  • The special emphasis placed on the needs of children and young people is welcome.  
  • The recognition that safeguarding is important and that children and young people or those who are severely affected might be in a situation where symptoms are confused with abuse or neglect. 
  • NICE gives firm directive for informed consent and patient-centred care. It is important that people with ME  (and their family members) are completely involved and have a right to refuse care without it affecting future care in any ongoing relationship with healthcare professionals. 
  • The emphasis placed on early and accurate diagnosis and the recommendation that people with suspected ME begin diagnostic assessment within weeks of symptoms appearing. 
  • NICE no longer recommend that ME can be treated effectively using cognitive behaviour therapy (CBT) and graded exercise therapy (GET); that exercise needs to be approached with caution, and these therapies are not curative. 
  • The guideline proposes that people affected by ME take care to conserve energy and employ safe approaches to energy management 
  • Also, importantly, NICE recognise the need for continued training and education and healthcare professionals. 
  • We are pleased that specialist teams are commonly led by medically trained clinicians from a variety of specialisms. We agree that all specialist services should be led by medically trained physicians/doctors or consultants. This would help reduce regional health inequalities in medical care for this disease.  
  • We are pleased to see that the areas for research recommended by NICE, which highlight the inadequacies of current medical knowledge, are key. 

We have the following concerns: 

  • There is no acknowledgment that ME is classified by WHO and SNOMED-CT as a neurological disease; the latter mandated within NHS England and being implemented in NHS Wales, NHS Scotland and NHS Northern Ireland. These classifications are important, not only legally to healthcare providers to ensure correct implementation of the protocols, but also to people who have ME because it helps to validate the illness, encourage medical awareness  and reduce the stigma that is still experienced.  
  • The November draft contained clear statements to the effect that ‘CBT is not a treatment or cure for ME/CFS’ and ‘Do not offer CBT as a treatment or cure for ME/CFS’. These statements have been excluded from the current guideline and we feel they should not have been. 
  • The final guideline states that CBT can be used to help symptom control, though there is no evidence of effectiveness that was considered by the guideline committee. It confirms that CBT does not assume that people have “abnormal illness beliefs”, but it appears to leave the door open to accept this as an explanation for symptoms. We feel this is wrong 
  • The highly respected Oxford Handbook on Psychotherapy Ethics says therapists must clearly distinguish between CBT that helps patients cope with disease and CBT that places responsibility for the illness on the patient. They must recognise that it is legally and ethically unsustainable to provide the latter where it is possible that patients suffer from disease. 
  • We appreciate that CBT may sometimes be helpful when learning to cope with long-term debilitating illness, but we cannot understand why the guideline contains two convoluted pages of advice about CBT when the guideline for multiple sclerosis (CG186), for example, carries a single sentence. It is also too open to misinterpretation that will negate the intention of the guideline. 
  • Whilst GET is expressly excluded, the introduction of ‘exercise programmes’ with no explanation of what they could or would involve and no evidence of safety or efficacy in the evidence gathering process leaves open the possibility of further misinterpretation of the guideline or mere rebranding of current practices that will negate the Committee’s work. This risk is particularly the case where alternative diagnoses such as functional neurological disorder (FND) are assumed that incorrectly assume diagnostic equivalence. The amended guideline now risks a very probable contribution to this problem. 

For the future: 

  • It is for the funders to prioritise funding for ME research and to ensure that research is of the highest scientific and ethical quality. It is for medical, educational and social welfare practitioners to ensure that people with ME are listened to, that they are treated respectfully and lawfully.  
  • There is no place for confrontation or division that has existed between the physiological scientific consensus and those who believed that ME is a BPS condition. 

We look forward to working closely with all those concerned about ME including patients, carers, medical practitioners, or researchers to build upon the science to create a future where ME is accepted, treated appropriately and people with ME truly cared for. 

4. News-media Coverage

Forward-ME

“No minority party should be able to undermine the careful scientific consensus established by the NICE committee and the rigorous work that has been undertaken in good faith.”

Forward ME

General

Prof Chris Ponting, Professor of Medical Bioinformatics, University of Edinburgh; Investigator, DecodeME study, said:

“The new guideline should receive support from both professionals and patients alike. NICE took due care and attention developing these guidelines in a process lasting 4 years.

“It applied rigorous methodology, for which it is world-renowned, and recruited highly regarded professionals and lay people to the review panel. Consensus decisions were taken by the panel for a much improved set of guidelines.

“It would be understandable if implementation of the completed guidelines takes additional time to put new practice in place.”

https://twitter.com/CGATist/status/1427730691186429953
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