Following the stakeholder consultation, NICE have this morning announced they will now commence a FULL REVIEW of the guideline for ME/CFS, effectively overturning previous expert advice not to update it.

The following has been taken from the NICE website, and was shared across social media:

Sir Andrew Dillon, NICE chief executive, said: “The strong message from stakeholders was that the continuing debate about the causes of this condition and the best approach to treatment argued for a review of the current guideline.” “We will now recruit a guideline committee which will include people with the condition and their carers, the healthcare professionals who treat them and the organisations which commission that treatment. As with all the guidance we produce, we will also ensure that stakeholders have the opportunity to provide evidence and insights throughout the development of the guideline.” ‘CFS/ME is a relatively common condition affecting around 190,000 people in the UK. It comprises a range of symptoms that includes tiredness, headaches, sleep disturbances, difficulties concentrating and muscle pain.’ ‘It can cause prolonged illness and disability and although some people have relatively mild symptoms and can still manage daily activities with additional rest, others have a serious illness that severely affects their everyday lives and may be housebound. The pattern of a person’s symptoms, and their severity, can vary from day to day, or even in the same day.’ ‘Further details about the review, including a scope outlining what it will cover and information about recruitment to the guideline committee, will be published on the NICE website as they become available.’

Surveillance decision ‘We will plan a full update with a modified scope of the guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy) (NICE guideline CG53).

Reason for the decision Assessing the evidence ‘Initial assessment of the evidence against the guideline scope indicated that there was no clear signal that the identified new evidence would result in changes to the recommendations (see appendix A: pre-consultation summary of evidence from surveillance). ‘Following a stakeholder consultation on the proposal to not update the guideline, broader issues with the guideline were highlighted that called into question the guideline scope and its current relevance. ‘After further consideration of information from stakeholders including new evidence (see appendix B: summary of evidence highlighted to NICE during consultation, and appendix C: stakeholder consultation comments table) alongside the evidence identified through the surveillance review, NICE has decided to fully update the guideline with a modified scope.

Equalities ‘No equalities issues were identified during the surveillance process. Overall decision ‘After considering all the evidence and views of topic experts, we decided that a full update with modified scope is necessary for this guideline. ‘See how we made the decision for further information.

Themes from stakeholder comments

‘Several themes emerged from the comments received at consultation which are detailed below. Stakeholders highlighted concerns with the existing guideline related to diagnosis, and interventions for treatment and management. Additionally, stakeholders raised issues around service delivery in respect to variation in practice, definitions and particular sub-groups that the current guideline does not differentiate between.’

Definitions and aetiology Aetiology is outside the current scope. However many stakeholders raised the issue in respect to its impact on diagnosis and treatment.

Interventions recommended in the guideline are based on the biopsychosocial model. Stakeholders raised that since 2007, much has changed with respect to biomedical knowledge. Biological models based on measurable abnormalities may need greater consideration.

Newer terms for the disease are proposed e.g. US Institute of Medicine 2015 propose ‘systemic exertion intolerance disease’ (SEID) whilst other stakeholders advise that myalgic encephalomyelitis should be the preferred term.

Severe ME is not well covered in the guideline and can cause profound issues. Some stakeholders indicated that parents of children with severe ME sometimes find that false allegations of child abuse are made against them due to poor understanding of symptoms, care and treatment by healthcare professionals and schools.

Diagnosis Oxford criteria (used to recruit to many studies included in the guideline) and NICE criteria are too broad.

Newer diagnostic guidelines from the US Institute of Medicine (2015) and International Consensus Criteria (2011) are different from NICE criteria. Specific paediatric criteria have also recently been proposed.

Late diagnosis is an issue.

Concerns have been expressed over misdiagnosis and overlap with other conditions e.g. pernicious anemia, Ehlers-Danlos syndrome, and Postural Tachycardia Syndrome.

Consideration of new research on metabolomics and biomarkers may be warranted.

Implementation, and information and support needs There is variation in primary care management, and there is evidence of unequal access to specialist services.

Stakeholders noted that NICE’s evidence reviews are not up to date, therefore patients are not receiving the full picture on recommended treatments (such as studies that have shown inefficacy of cognitive behavioural therapy [CBT] or harms of graded exercise therapy [GET]), nor being told about alternative treatments, which may affect informed consent.

Greater support for GPs (many of whom feel ill-equipped in this respect) is needed to help with diagnosis, to provide accurate information (for example evolving evidence on risk and benefit of treatments), and to consider what an ‘individualised management plan’ might look like in practice.