Science for ME submission to the NICE draft ME/CFS guideline consultation, December 2020, and submission on substantive errors, August 2021

Here is the Science for ME submission to NICE (The UK National Institute for Health and Care Excellence) consultation on its draft guideline: ME/CFS: diagnosis and management

The following posts were copied to the NICE template and submitted on 20th December 2020. A PDF version of the submission can be accessed here, https://www.s4me.info/docs/S4ME-NICE-Guideline-Submission.pdf.

There were a few minor edits such as spelling out abbreviations, and clarifications of the use of the term 'relapse' in a few places, after transfer to the template and as can be seen in the PDF version, but otherwise the submission is as shown on this thread.

Our submission was based on extensive feedback from members, followed by drafting and editing by a small team. Many thanks to all who contributed.

ETA: A few minor changes to text, and added link to the PDF version of the submission.


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Science for ME's submission to NICE about substantive errors in the August version of the Guideline starts here

 

General

Introduction to our submission

Our submission is based on extensive discussions of the guideline by members of a science-focused ME/CFS online forum (Science for ME), which has a diverse membership that includes people with ME/CFS of all severity levels, carers, scientists and clinicians.

We thank the ME/CFS guideline committee and NICE staff for their good work on this guideline to date. The outcome, as evidenced by the draft, is a significant step towards improving services for people with ME/CFS and correcting stigmatising views and approaches. We commend the committee for the thoroughness and scientifically sound approach of their examination of the research into therapies intended to treat or cure ME/CFS.

We ask the committee to be equally rigorous in their use of evidence for other aspects of their recommendations. Having given careful consideration to the guideline recommendations and supplementary documentation, we provide detailed recommended changes which would better reflect the outcomes of the evidence reviews, while removing some of the assumptions and decisions based solely on the committee members' experience.

We highlight here three main areas of concern:

1. Diagnosis:
We agree that the IOM criteria form a suitable basis for clinical diagnosis. However, the committee has made significant changes to the IOM criteria which will exclude a number of people from being diagnosed with ME/CFS, despite meeting the requirements of the IOM criteria. We do not think the experience of a small committee is an adequate basis for creating new untested criteria with the result that people who do not exhibit cognitive difficulties may be denied appropriate diagnosis and condition management, potentially leading to harm.

2 Management:
People with ME/CFS need input from medical and care services to help them learn how they can manage their limited energy in order to reduce the occurrence of post-exertional malaise (PEM) and long term deterioration. We have recommended a more straightforward self management approach using symptom-contingent pacing, with guidance as needed from specialist nurses who can also help with managing symptoms, including reviewing medications, with making necessary life changes, and by providing informal wellbeing support for those who want to talk about feelings that arise naturally as a result of living with a chronic debilitating illness. Physical activity programmes for those whose symptoms have improved, and CBT for psychological support, are neither evidence based, nor necessary. We recommend they be removed from the guideline, where their inclusion presents a real risk of harm, with GET and directive CBT continuing to be provided under different names.

3 Terms used in the guideline:
We are concerned that some of the terms introduced or defined are an unnecessary departure from current usage by clinicians, researchers, people with ME/CFS and in publications. This will add a further layer of misunderstanding and hamper communication between people with ME/CFS and their clinicians. Of particular concern are the introduction of the colloquial and easily misinterpreted 'energy envelope' and 'flare'; the complete lack of mention of 'pacing'; and the renaming of the almost universally recognised term 'post-exertional malaise', which has been replaced with the vague and misleading 'post-exertional symptom exacerbation'.

The recommendations that address the requirements of people with severe and very severe ME/CFS will make a real difference to wellbeing for many with ME/CFS. We have noted that people with less severe illness may also require similar accommodations, especially during periods of deterioration.

Finally, we note that the improvements to the guideline are a necessary, important step, but it will take commitment and cooperation from many to achieve the complete re-orientation of ME/CFS services that is required. We urge the committee to build into the guideline safeguards and requirements for accountability to ensure that the promise of evidence-based patient care is realised.

 

General

Medical care models and the use of evidence.

NICE guidance for the management of conditions for which there is no effective treatment must be based on the best available evidence, just as it is for conditions for which there are effective treatments. Where the guideline cannot make evidence-based recommendations that may lead to improvements, it must fulfil its brief to ensure recommendations do not lead to deterioration or harms.

We ask the committee, in reviewing stakeholder feedback and amending the guideline, to examine the approach they have used in developing their recommended model of care, the assumptions underlying the recommendations, and whether the included recommendations are well supported by their own evidence reviews.

The committee has made recommendations that can be implemented by minor adaptations to current service provision utilising the therapist specialisms that are currently providing CBT and GET as treatments for ME/CFS. This may have the short-term advantage of causing minimal upheaval to services, upset to healthcare professionals with entrenched beliefs about cause of or appropriate treatment for ME/CFS, and prima facie appear to be cost-efficient. It may also seem that switching from providing programmes on GET or CBT to courses on 'energy management' is a good fit, with CBT therapists providing psychological support as they do so.

However, the clinical effectiveness evidence for CBT for ME/CFS was all of low or very low quality (Evidence Review G, pp.72-119, p. 318 line 23). There can therefore be no justification for provision of ME/CFS services by CBT therapists, as to provide support for other aspects of care, such as energy management or medical symptoms, would exceed the bounds of their expertise and risk harm to people with ME/CFS. Services staffed by HCPs who have provided GET and CBT as treatment for ME/CFS for years are likely to continue to foster a shared mindset amongst staff that ME/CFS can be treated by increasing physical activity or changing thoughts and behaviours. Retraining of such staff is unlikely to be adequate to prevent old methods from creeping into updated approaches, and harms to people with ME/CFS from resulting. It should also be self-evident that provision of CBT for ME/CFS is not cost-effective because there is no good quality effectiveness evidence to support it.

In the review of qualitative evidence, themes of validation, relationship with therapist and support were found not to be specific to CBT (Evidence Review G, p.324 lines 41-43). Support, validating patient experience, listening and building rapport are elements of care that may be provided in interactions with any healthcare professional (HCP). Our members report that the natural reactions to living with a chronic debilitating disease, such as frustration and sadness, are often helped more by assistance with the practicalities of the major upheaval to their lives, and from ready access to a HCP who understands all aspects of their condition, than from undergoing a psychological therapy, which itself depletes already scarce energy and may lead to worsening.
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There is likewise no reliable evidence to support the recommendations for physical activity programmes for some people with ME/CFS, or to suggest that increasing by flexible increments while remaining within a person's 'energy envelope' is feasible as a concept, has benefits (as suggested at 1.11.19) or is safe. The recommendations in the subsection on 'Physical activity' present a form of graded exercise therapy, for which the evidence review established, there is no reliable evidence. The portrayal in the guideline of activity programmes involving fixed increments as being poorly evidence and potentially harmful, and programmes involving flexible increments as acceptable and potentially beneficial is a false distinction, since it is clear that clinical studies of GET included in the effectiveness review did include non-fixed increments.

There is no reliable evidence that people with ME/CFS who find their energy levels have improved would benefit from input from HCPs, with the possible exception of those transitioning from being bedbound to greater levels of mobility, for whom the recommendations under physical maintenance may be helpful alongside general advice and supervision from a physiotherapist with up-to-date ME/CFS training consistent with this guideline. Our members generally report being able to increase activity levels naturally without need of HCP input when they have experienced improvements in health. Such a 'hands-off' approach has the benefit of entailing no cost to the health system.


The third area of management covered by the draft guideline is symptom management. In contrast to the level of detail and specification of models for energy management and the new versions of CBT recommended, there is very little in the way of detail on symptom management. Yet, for many people with ME/CFS, the main reasons for seeking assistance from health and care services relate to new or worsening medical symptoms of ME/CFS, which may be severe or very severe, including orthostatic intolerance, pain and gastrointestinal symptoms, and seeking help with the practicalities of making major life changes and arranging care needs. To adequately assist with such issues without exceeding competence or bounds of expertise, the HCP must hold appropriate qualifications in a suitable discipline and have relevant experience, and up-to-date training consistent with this guideline. Currently, there is no guidance as to what types of HCP will fulfil such roles.

We therefore conclude that the model of care set out in the guideline, which will inevitably entail updating existing providers and continuing with provision of therapist-based services is neither evidence based, nor fit for purpose, and carries significant risk of continuing to cause harms of the type the guideline purports to set out to avoid.
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Instead we recommend a consultant-led model of care, with comprehensive support and care provided by specialist nurses. This would more closely mirror the fields and levels of expertise set out in the multiple sclerosis NICE Guideline (CG186), in which a consultant neurologist and specialist MS nurses are specified as relevant professionals to involve in the person with MS's care. Such a model would involve a specialist team led by a consultant from a relevant biomedical discipline with specialist knowledge of ME/CFS who would see new patients for thorough investigation and confirmation of diagnosis, with a team of specialist nurses providing the role of the HCP who will be the main contact for people with ME/CFS, and able to assist them with energy management, symptom management and informal psychological support. Provision of therapies such as physiotherapy, occupational therapy, and psychological support such as counselling, would be supplementary for those who want and need them.

The advantages of this model:

a) The nurse's skills and training enable them to help with advising and monitoring many aspects of the person's health needs, to deal with more than one issue during an interaction with the person with ME/CFS, and to liaise as needed with the consultant. This more comprehensive service is cost-effective, and is energy-efficient for the patient;

b) Avoids harm, including by not facilitating the continuation of the unevidenced treatments of physical activity programmes and CBT, or the stigmatising ideas that underpin them;

c) General practitioners are supported with access to specialist medical advice, while time-consuming patient education and support functions are carried out by nurses with specialist expertise;

d) People with severe or very severe ME/CFS and their families and carers would receive specialist support. This provision of a medical care model, where the nurse helps patients of all severity levels, is vital for people with ME/CFS, as any individual's severity level can worsen rapidly, with the need for provision to be already in place for accessible specialist ME/CFS care.


Finally, we set out the aims for medical care and support provision that we consider should guide the inclusion of any recommendation in this guideline:

1. Evidence based: That all treatment offered, whether intended to be curative, to improve symptoms or to prevent worsening, be based on high quality scientific evidence.

2. First do no harm: That all medical and therapeutic care provided does no harm, whether by allowing harmful treatments to continue under new names, or by lack of provision of appropriate services that meet the needs of people with ME/CFS.

3. Accessible: That for people with ME/CFS of all severity levels, the provision of care can be accessed when needed in a form the patient can cope with without detriment to their health, and that takes account of their specific needs and limitations

4. Expert: That the person providing the advice, treatment or care has appropriate qualifications and experience, as well as up-to-date knowledge of ME/CFS in accordance with this guideline.

5. Efficient - in terms of cost, time and energy of the patient: With the same person understanding and able to advise on all their health needs, not having to see different people for energy and symptom advice and support with coping with life changes etc.

6. Consistent: medical support and care is provided by a single HCP who knows the person with ME/CFS and their needs, and can either help or refer on if needed.

 

General

We have made comprehensive and detailed suggestions for changes to the draft guideline and we are only one of many stakeholders making a submission. The total amount of feedback for the Guideline Committee to consider will be large, with some points likely to provoke strongly opposing views. We therefore encourage the Committee to ensure that they have sufficient time to consider the stakeholder feedback and if necessary take longer than planned in doing so.
We are sure that people with ME/CFS will understand some delay in order to produce the best possible guideline.



General

Medically Unexplained Symptoms (MUS)

When ME/CFS is mischaracterised as ‘medically unexplained symptoms’ (MUS), 'ME/CFS' may be viewed as a term for a cluster of non-specific symptoms overlapping with other poorly understood conditions (e.g. IBS) and undiagnosed symptoms, rather than as a term for the distinct medical condition, ME/CFS, as NICE acknowledges it to be.

Approaches used for MUS (also referred to as ‘persistent physical symptoms’ (PPS)) are likely to be completely inappropriate for people with ME/CFS and may include physical activity programmes and CBT as treatment for MUS. This guideline recognises that these approaches should not be offered as treatments for ME/CFS and are potentially harmful. Services and clinicians taking this approach are unlikely to take the limitations imposed by post-exertional malaise and the absence of reliable effectiveness evidence for the application of MUS treatment approaches to ME/CFS adequately into consideration.

Any characterising of ME/CFS as MUS therefore creates significant risk of harm to people with ME/CFS, both to their health and by causing a loss of trust in the health system, with no mitigating benefit.

Therefore, in order to protect people with ME/CFS from harm, we ask that the guideline makes it clear that people with ME/CFS should not be referred to MUS services, and ME/CFS should not be framed as MUS (or PPS or similar terms) for diagnosis, assessment, management, treatment or any other purpose.

 

Section 1.1 Principles of care for people with ME/CFS

1.1 - 1.5

1.1.1

p.4 line 5: The word ‘complex’ should be deleted. The underlying pathology is unknown so cannot validly be described as 'complex'. 'Complex' can be misunderstood to imply inaccurately that there are complex 'biopsychosocial' factors. It can also subtly imply that patients are 'difficult'.

p.4 lines 5-6: The first bullet point of 1.1.1 should include that onset of ME/CFS is typically triggered by an infectious illness.

p.4 line 7: The words 'can have' should be replaced with 'has'. i.e., ‘[ME/CFS] has a significant impact on people’s (and their families and carers’) quality of life’. ME/CFS has a significant impact on the lives of all people with ME/CFS, regardless of severity level.

p.4 line 10 The words ‘affects each person differently’ should be deleted. This is true for all medical conditions. Highlighting it here suggests more variability than is the case and may lead to misdiagnoses. Diagnosis requires meeting specific criteria (section 1.2).

p.4 lines 10-11 The term ‘substantial incapacity' is vague and the clause does not adequately convey the impact of severe and very severe ME/CFS or acknowledge the impact of ME/CFS for mild cases.
Suggested wording: ‘varies widely in severity - from mild ME/CFS where there is significant debility and greatly reduced capacity for activity to severe and very severe ME/CFS, where the person is bed-bound and requires comprehensive personal care.’

p.4 line 13: The words ‘change unpredictably’ should be qualified with 'sometimes', i.e. 'symptoms can sometimes change unpredictably'. There is often considerable predictability of nature and severity of the symptoms of ME/CFS. This predictability is the foundation of symptom-contingent pacing with the aim of avoiding post-exertional malaise (PEM).

p.4 lines 14-15: The words, 'ranging from being able to carry out most daily activities to severe debilitation' should be deleted. It incorrectly gives the impression a given person with ME/CFS may range between being able to carry out most daily activities to severe debilitation over ‘days, weeks or longer’, implying severe and very severe ME/CFS may remit significantly over short time frames.

p.4 line 15: We suggest addition of a fifth bullet point to 1.1.1, stating that there is no evidence that ME/CFS is a psychosomatic condition or caused or perpetuated by emotional distress or personality traits.

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1.1.2

p.4 lines 16-18: This clause should also recognise that ill-informed attitudes to ME/CFS have led to real harm for many people with ME/CFS. Suggested wording: 'Recognise that people with ME/CFS may have experienced prejudice, disbelief, felt stigmatised and been harmed by people who do not understand their illness.’

Thank you for acknowledging the prejudice that people with ME/CFS experience and pointing out its impact on perceptions of and willingness to engage with health services.

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1.1.3

p.5 lines 3-4: What is meant by, ‘acknowledge to the person the reality of living with ME/CFS and how symptoms could affect them’?
The meaning of this clause is not clear. We suggest that for clarity, this bullet point be broken down into two bullet points:
Suggested edit:
1. ‘Provide the person with ME/CFS with information about the condition, including information on how it is likely to affect their daily life. See section 1.6 Information and support.’
2. ‘Listen to and acknowledge the person with ME/CFS’ account of their experience of living with ME/CFS and its symptoms and how these affect them. Do not seek to minimise the impact of the illness.’

p.5 line 5: We are pleased to see inclusion of recommendations on building supportive, trusting and empathetic relationships.

p.5 line 8: We suggest inclusion of a fifth bullet point in 1.1.3, as follows: ‘ensure that the person with ME/CFS is fully informed about and involved in all aspects of the planning and delivery of their care.’

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1.1.4

p.5 lines 9-14: We are pleased to see recognition that people with ME/CFS need early and accurate diagnosis, and regular monitoring and review.

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1.1.5

p.5 lines 15-18: Include that refusal of assessment for and development of the ‘management plan’ or refusal to restart any part of it should be acceptable without this affecting other aspects of care.
Suggested wording: ‘Explain to people with ME/CFS and their family or carers (if appropriate) that they have the right to decline assessment for and development of the management plan (medical care plan), or to decline, withdraw from or refuse to restart any part of their management plan and it will not affect other aspects of their care.’

p.5 line 16: We consider the term ‘medical care plan’ to be more appropriate than ‘management plan’. The former makes it clear that it is a plan to deliver care. The term ‘management plan’ implies that the person with ME/CFS and their condition are to be managed. All uses of ‘management plan’ throughout the draft guideline should be changed to ‘medical care plan’.

p.5 line 18: There are no treatments for ME/CFS, so what treatments or otherwise are being referred to in using the term ‘intervention’?
The term ‘intervention’ should not be used. It has connotations of people being told 'hard truths' about their behaviour in order to bring about improvement. As there is no treatment for ME/CFS, the types of medical assistance that can be provided may be better termed 'support' than 'intervention'.

 

1.1.6 - 1.1.11

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1.1.6

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1.1.7

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Awareness of severe and very severe ME/CFS and its impact

1.1.8

p.6 lines 7-27: We think this section represents a significant advance in clearly stating the needs of people with severe and very severe ME/CFS and how these can be met. We include a reaction of an S4ME forum member with ME/CFS to illustrate this:
'it made me cry with happiness when I read it - and the sense of sheer relief in this house when we read it. I just ask that it does not get diluted down, please, because this section will help me not only with hospital care, but social services, with my MP, with housing, even just other people personally...with every aspect of my life.'

p.6 lines 7-29: We suggest renaming the subheading 'Awareness of severe or very severe ME/CFS and its impact' to 'Symptoms of ME/CFS and their impact'.

Replace 'Be aware that people with severe or very severe ME/CFS' (line 8) with 'Be aware that people with ME/CFS'. While people with severe and very severe ME/CFS may experience these symptoms all of the time, people with less severe illness may also experience these symptoms, particularly during PEM.

Remove ‘and constant’ from the clause ‘severe and constant pain’ (line 12)

Remove the words 'severe or very severe' from line 28 (1.1.9).

Add a subheading, 'People with severe or very severe ME/CFS' at page 7 line 17 before 1.1.10.

1.1.8 and 1.1.9 would then address all people with ME/CFS of all severity levels, and take into account that while people with severe or very severe ME/CFS may experience symptoms in 1.1.8 and require recognition of the impact of symptoms as detailed in 1.1.9 all the time, symptoms and debility for people with mild or moderate ME/CFS may match those of severe or very severe ME/CFS during PEM or prolonged deterioration. The guideline should not give the impression (as it does currently) that mild and moderate ME/CFS does not involve these symptoms impacting wellbeing, communication, mobility and ability to interact with others and care for themselves. Accommodations need to be made to help people with ME/CFS of all severity levels avoid over-exerting and triggering PEM or relapse.

p.6 line 14 +
p.7 line 15: The term ‘noise’ should be replaced with the term ‘sound’ here and for every use of ‘noise’ in the guideline. ‘Noise’ suggests that sound must be loud to a person of normal hearing to be problematic to a person with ME/CFS. This is not the case; quiet sound can be extremely difficult to tolerate for people with ME/CFS with severe sensitivity to sound.

p.6 lines 14-15: It should be made clear that exposure to light, sound, touch, movement and extremes of temperature if poorly tolerated can lead to PEM. For those with severe sound sensitivity, exposure to sound can cause rapid and potentially long-term deterioration.

p.6 lines 20-21: ‘insomnia’ should be added to the bullet point on sleep disturbance.

p.6 lines 22-23: ‘gastroparesis’ should be added to the bullet point on gastrointestinal difficulties.

p.6 lines 26-27: This should be amended to reflect that there are other subtypes of orthostatic intolerance not listed here.
Suggested phrasing:
'orthostatic intolerance. People with severe ME/CFS may only be able to be upright for a very short time, if at all, before experiencing symptoms including dizziness, pallor, nausea and vision problems.'

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1.1.9

p.7 line 8 This should be amended to include recognition that people with ME/CFS who need wheelchairs will need ones that fully recline, support the whole head and body, and be easily adjustable to change posture to minimise pain.

p.7 lines 9-10 +
p.7 lines 24-26: The guideline should provide further information on arranging and seeking funding for suitably trained advocates (ideally with experience in ME/CFS) for people with ME/CFS, and acknowledge it takes time for them to get acquainted with the specifics of an individual’s case to advocate effectively for them.

p.7 line 16: After line 16, a further bullet point should be added for recognition of the sensitivities to sound and smells experienced by people with severe or very severe ME/CFS in all circumstances, including whenever communicating with or assisting the person with ME/CFS with activities of daily living.

p.7 line 16: After line 16, a further bullet point should be added to include recognition that people with severe or very severe ME/CFS may need to remain in a horizontal or reclined position most or all of the time, and may require special equipment to enable this.

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1.1.10

p.7 lines 17-21: The guideline should acknowledge that personal care for someone with very severe ME may take more time than standard rates allow for in social care planning and that planned care may not be able to be done on days when the patient is too unwell.

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1.1.11

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1.2 Suspecting ME/CFS

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1.2.1

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1.2.2:

p. 8 lines 5-9: We suggest addition of a bullet point in 1.2.2 stating the person with ME/CFS should keep an activity and symptom diary for review as part of this assessment. This should be compared with premorbid activity levels and may assist with the identification of PEM and so with a diagnosis.

p.8 line 8: Replace with: 'a psychological wellbeing assessment, if indicated or requested by the person with ME/CFS. Do not assume natural reactions to ME/CFS symptoms such as worry or changes in behaviour such as withdrawal from activities are indicators of mental health disorders.'

The term 'psychological wellbeing assessment' should be defined.

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1.2.3

p.8 line 10: We suggest the criteria for suspecting ME/CFS could be clarified by providing information on common medical conditions that may result in a similar symptomatology, as this may aid physicians in ruling out such diagnoses and prevent mis-diagnosis with ME/CFS.

p.8 line 11 +
p.10 line 23: The word ‘persistent’ should be deleted due to similarity of 'persistent symptoms' to the term ‘persistent physical symptoms’ (PPS). The term PPS is often used interchangeably with ‘medically unexplained symptoms’ to describe physical symptoms for which an explanation has not yet been found, inappropriately implying there is no medical explanation to be uncovered and mental health issues are an underlying factor irrespective of whether they are actually present. Application of these terms may deter physicians from making appropriate referrals and investigations.

Further, the wording 'diagnosis can only be confirmed after 3 months of persistent symptoms' implies that all required symptoms must be present all the time for diagnosis to be made. PEM, by definition is an intermittent symptom related to activity level. Assuming it has to be 'persistent' may lead to missed diagnoses.

p.8 line 16: Should include that specific onset typically follows an infectious illness. Should also acknowledge that some cases have gradual onset; not to specify this may exclude this subset from a diagnosis of ME/CFS, potentially leading to inappropriate management advice and harm to people with gradual onset ME/CFS. The IOM requirement for specific onset is qualified by ‘not lifelong’.

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Box 1 Symptoms for suspecting ME/CFS

p. 8 line 17: Rather than giving an incomplete and misleadingly brief description of the core ME/CFS symptoms in Box 1, with hyperlinks to the definitions which may be ignored, it would be more helpful to provide the full definitions of each term at this crucial stage of the guideline where the terms are first introduced and need to be understood correctly for accurate diagnosis.

p 8 line 17: Box 1:
Fatigability and fatigue:

The list of core symptoms, though based on the IOM criteria, has changed the first criterion from a description that clearly includes both fatigability (described as impairment to engage in former levels of activity) and fatigue, as two different features of the first criterion. We recommend adding back fatigue, described as IOM does, as "often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest".

p.8 line 17: Box 1:
PESE/PEM:

The term PESE should not be used. We support the continued use of the well recognised term 'post-exertional malaise' (PEM). There is a strong argument for including the word 'malaise' which has the specific medical meaning of feeling generally very unwell, and describes the experience of PEM well. Guidelines should work with widely accepted terms, rather than inventing new ones. PEM is the term used in international ME/CFS research and it is the term used in a wide range of training and information resources.

p.8 line 17: Box 1:
Unrefreshing sleep:

The bullet point on unrefreshing sleep should be revised. It is not clear what is meant by ‘unrefreshing sleep’. The first subcategory of unrefreshing sleep lists symptoms experienced on waking; the second lists types of disordered sleep. It is not clear if symptoms on waking must be worse than normal to qualify as unrefreshing sleep, or if sleep not helping to resolve symptoms of ME/CFS is being mistaken for ‘unrefreshing sleep’. Disordered sleep patterns may lead to increased symptoms on waking, but proper sleep does not lead to people with ME/CFS feeling better.

‘Insomnia’ should be included in ‘broken or shallow sleep, altered sleep pattern or hypersomnia’, as this is a significant symptoms for some people with ME/CFS.

p.8 line 17: Box 1:
Cognitive difficulties:

We are deeply concerned that cognitive difficulties are a requirement for suspecting ME/CFS in Box 1.

This guideline recommendation is said to be based on the experience of the guideline committee (Evidence Review D, p.51 lines 26-28). The experience of a small committee is not an adequate basis for creating untested criteria. Promotion of cognitive difficulties to a requirement is a significant modification to IOM criteria, not a slight one (as claimed in Evidence Review D p.49 lines 44-45). It will significantly skew the balance of inclusion/exclusion towards exclusion, preventing a substantial subset of people who do not experience cognitive difficulties from obtaining a rightful diagnosis of ME/CFS, leading to inappropriate management advice and harms.

We recommend that the IOM criteria should be followed in full, with the fourth listed required symptom being one of either cognitive difficulties or orthostatic intolerance.

We would also agree to making the criteria for diagnosis less stringent by moving both cognitive difficulties and orthostatic intolerance to the list of other common symptoms.

What we see no justification for, and harm resulting from, is the Committee's decision to make it mandatory for diagnosis that the person reports cognitive difficulties. We do not think it is right to exclude many people who meet internationally recognised ME/CFS criteria from being diagnosed with ME/CFS and getting the support and help they need.

We are pleased to see a thorough description of cognitive difficulties with inclusion of subtypes and these should be retained in any amendment to cognitive difficulties in the criteria.

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1.2.4:

p.9 lines 2-16: Should include a bullet point for gastrointestinal symptoms. Nausea is currently only addressed as a symptom of orthostatic intolerance.

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1.2.5:

p.9 lines 17-20: Members support an early provisional diagnosis but there was concern that patients be given information about the likelihood of recovery that is appropriate for the length of illness.
Add: 'Ensure that any advice about the likelihood of recovery takes into account the time since onset: recovery rates are initially high but decrease to a lower level over the first two years of illness.'

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1.2.6


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1.2.7

p.10 lines 1-3: Include recommendation for specialist input for all cases of suspected ME/CFS, since there is evidence of significant misdiagnosis in primary care.

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Referring children and young people with suspected ME/CFS
1.2.8

 

1.3 Advice for people with suspected ME/CFS

1.3.1

p.10 lines 15-21: The advice to people with suspected ME/CFS to rest and not to use more energy than they perceive they have is good and should be retained. We suggest the term 'symptom-contingent pacing' be used throughout the guideline, to convey that activity levels should be judged on current symptoms with the object of avoiding post-exertional malaise.

p.10 lines 17-19
Suggested alternative wording:
'Not to use more energy than a level that the person can sustain easily without leading to worsening symptoms, and not to continue increasing activity if symptoms begin to worsen.'
Reasoning: This avoids introducing new patients to a confusing metaphor (energy envelope).

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1.3.2:

p.10 line 22:
People with suspected ME/CFS need to be given information about the likelihood of recovery that is appropriate for the length of their illness.
Add to 1.3.2: 'Advise them that the likelihood of recovery decreases as time since onset increases; rates of full recovery are initially high but decrease to a lower level over the first two years of illness.'

 

1.4 Diagnosis

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1.4.1

p.11 line 3: We suggest a list of common conditions that should be excluded as part of the diagnostic process and a list of tests that should be carried out be specified, so that GPs have guidance on this for cases where specialist referral is not possible.

p.11 lines 5-6: Include that diagnosis should ideally be made by a specialist physician who has up-to-date knowledge of ME/CFS in keeping with this guideline, but acknowledge that the person may not be able to travel to a specialist service for diagnosis, and diagnosis by GP with input from a specialist physician may be appropriate in such cases.

p.11 lines 5-6: We agree with early provisional diagnosis. We suggest this recommendation include that investigations should be continued after diagnosis to rule out other possible conditions. A single referral may have a wait time of more than three months, but management in accordance with this guideline should not be delayed if ME/CFS is suspected.
Add: 'Management in accordance with this guideline should not be delayed if ME/CFS is suspected, even if investigations to rule out other conditions continue.'

p.11 line 6: Wording 'persisted for' implies that symptoms must have been present all the time for diagnosis to be made. Inclusion of this wording may lead to failure to diagnose ME/CFS for many.

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1.4.2

p.11 lines 7-8:
Replace with: 'After a primary care provisional diagnosis, refer the person to a consultant working in a relevant biomedical discipline who has specialist knowledge of ME/CFS in accordance with this guideline to carry out any further tests needed to confirm the diagnosis. If the patient agrees, the consultant led team should develop a management plan (medical care plan) with the patient. In severe cases this may require a home visit or other special arrangements.'

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1.4.3

p.11 lines 9-12: Not every young person will want a management plan (medical care plan), be able to travel to see a specialist team, or even be able to participate in an evaluation in their own home.
Replace with: 'After provisional diagnosis, with the agreement of the child with ME/CFS and their family, or the young person with ME/CFS, refer them to a paediatrician working in a relevant biomedical discipline who has specialist knowledge of ME/CFS in accordance with this guideline to confirm diagnosis and develop a medical care plan (management plan).'


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1.5 Assessment and care planning by a specialist ME/CFS team

p.11 line 13: There should be a clear statement in section 1.5 that people with ME/CFS should not be referred to MUS or fatigue clinics for assessment and care planning or at any other stage in the diagnosis, assessment and care of ME/CFS, as these clinics do not specialise in ME/CFS and may take an inappropriate approach which does not adequately take considerations specific to ME/CFS into account. People with ME/CFS should only be referred to pain clinics that have an up-to-date understanding of ME/CFS in keeping with this guideline.

—————————————-
1.5.1:

p.11 lines 15-16: Why is there an additional requirement for a ‘holistic assessment’ after diagnosis is made?
A proper diagnostic process should include taking a full history and conducting physical exams. Performing a ‘holistic assessment’ in addition means duplication of history-taking, physical exams and assessments, which may be difficult for people with ME/CFS to achieve and may cause worsening.

p.11 line 15: The guideline should suggest that input for original development of a management plan (medical care plan) should be taken from recent medical notes where possible. Information should be gathered by modes of communication accessible for the person with ME/CFS, e.g., by email, or correspondence by post, enabling them to respond at their own pace. If face-to-face visits are required to enable this home visits should be offered for the moderate, severe and very severe. We also suggest linking to 1.8 'Access to care' in 1.5.1.

p.11 line 15: It should be specified that this assessment should only be carried out by a physician with up-to-date knowledge of ME/CFS in keeping with this guideline.

p.11 line 15: The word ‘holistic’ should be deleted. It is commonly associated with alternative medicine.

p.12 lines 1-2: the words, 'and other causes of physical or emotional stress' should be deleted. This is already covered by 'anything known to exacerbate symptoms', so duplicates content. Deletion may also reduce risk of misinterpretation that ‘stress’ may be a cause or perpetuating factor of ME/CFS.

p.12 line 4: The word ‘psychosocial’ should be deleted. The wording, ‘The impact of symptoms on wellbeing’ is adequate. ‘Psychosocial’ is a loaded term in the context of ME/CFS. We do not think that formal psychological assessment is relevant unless it is requested or indicated.

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1.5.2:

p.12 line 10: It should be specified in 1.5.2 that the ‘management plan’ should be developed by a GP, consultant physician, or specialist nurse who is part of the consultant's team, and they should have up-to-date ME/CFS training in accordance with this guideline. There should be recommendation for ongoing specialist oversight where available but with acknowledgment some people with ME/CFS may prefer or only be able to access assessment and care planning by their GP. People with ME/CFS under a consultant should not be discharged back to their GPs unless requested, to enable continuity of care and prevent repeat re-referral. Include that the person with ME/CFS should have a named contact (per recommendation 1.10.3) who will ideally be a specialist nurse with up-to-date training in ME/CFS consistent with this guideline.

p.12 line 10: We consider the term ‘medical care plan’ to be more appropriate than ‘management plan’. The former makes it clear that it is a plan to deliver care. The term ‘management plan’ implies that the person with ME/CFS and their condition are to be managed. All uses of ‘management plan’ throughout the draft guideline should be changed to ‘medical care plan'.

p.12 lines 25-26: The recommendations referred to as covering symptom management should read ‘1.11.24-1.11.42’ (and not 1.11.27-1.11.50 as they do presently). This would correctly cover the section on ‘Managing orthostatic intolerance’, which is currently excluded from the range given, and would also correctly remove reference to the section on ‘Psychological support’, as psychological support should not be offered to manage symptoms of ME/CFS.
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1.5.3

p.13 line 2: The words ‘The plan should be mutually agreed’ should be deleted. It may contradict the earlier clause ‘the person with ME/CFS is in charge of the aims of their management plan’. Healthcare workers may have unrealistic ideas about what activity levels and types the person with ME/CFS can cope with, meaning development of unsustainable management plans which may result in harm to people with ME/CFS.

p.13 lines 9-10: We suggest inclusion of the words 'the person with ME/CFS should be kept informed at all stages of assessment for and development of the management plan (medical care plan) and be provided with copies of written records of these'.

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1.5.4

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1.5.5:

p.13 line 13: The word ‘holistic’ should be deleted. It is commonly associated with alternative medicine.

p.13 lines 12-13: 1.5.5 should include that home visits to collect large amounts of information from people with severe or very severe ME/CFS are unlikely to be successful or safe. Almost all people with ME/CFS would benefit from being given the questions online or in hard copy so they can be completed at their own pace. We also suggest inclusion of a link at 1.5.5 to 1.8 ‘Access to care’.

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1.6 Information and support

p. 13 line 14: We appreciate that section 1.6 sets out the major impact of the illness on the lives of people with ME/CFS and makes it clear how important accurate and up-to-date information on financial and social support for people with ME/CFS and their families and carers are.

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1.6.1:

p.13 lines:16-18: ‘individual or group peer support’ may be added to the list of example formats. Our members find interacting with other people with ME/CFS (whether in person or online) a useful means of learning how to cope with the condition.

—————————————
1.6.2:

——————————————
1.6.3:

p.14 lines 9-14: We strongly agree information provided to people with ME/CFS and their families/carers should be up-to-date. However, it should also be stated that it must be in accordance with this guideline. It should not be about ‘chronic fatigue’, or medically unexplained symptoms (MUS), or based on excessively broad diagnostic criteria that excludes post-exertional malaise as a requirement for diagnosis. It should not suggest recovery can be achieved by exercise, increasing activity, changing behaviours or beliefs about the illness, or better stress management. It should not present speculation on cause of ME/CFS as fact.

p.14 lines 9-14: Add: 'ME/CFS information prepared prior to this guideline must be reviewed and, if necessary, re-written to ensure compliance with this guideline before it is distributed'.

—————————————
1.6.4:

p.14 line 16: Delete: ‘that affects everyone differently’. This is true for all medical conditions. Highlighting it here suggests more variability than is the case and may lead to misdiagnoses. Diagnosis requires meeting specific criteria (section 1.2).

p.14 lines 16-18: Clarify that while symptoms may fluctuate, overall severity status may deteriorate significantly and rapidly, but overall improvement (when this does take place) usually happens gradually over much longer time periods.

p.14 line 19-21: Delete, as repeats content at lines 16-18 and 22-24. Alternatively, replace ‘often’ with ‘may’ and remission should be qualified with ‘partial’ to clarify that remission may not mean complete remission. I.e., ‘may involve periods of partial remission and relapse’. Although the condition can fluctuate, our members report that periods of complete remission are rare, so the current phrasing could be misleading.

p.14 lines 22-24: This statement is not correct given that diagnoses are being given before 6 months. Discussion of prognosis for adults and children would be best covered in the same recommendation.
Replace with: 'varies in long-term outlook from person to person. Recovery rates decrease with increasing lengths of illness. Recovery rates are initially high but full recovery is rare after two years. The outlook for children and young people tends to be better than in adults.'

p.14 line 25: Should replace ‘can have’ with ‘has’, i.e., ‘has a major impact on people’s lives’, as ME/CFS always has a major impact on people’s lives.

p.14 lines 26-27: Should replace ‘may’ with 'will', i.e., 'will need to adjust how they live’. The use of 'may' underplays the effect of even mild ME, which by diagnostic definition significantly reduces the ability to carry out daily activities.
We suggest adding: 'Many people with ME/CFS will need to make significant adjustments to or discontinue their current work or educational commitments.'

p.14 lines 28-29: Lines 28-29 should be deleted. ME/CFS is worsened by cumulative energy expenditure in excess of what can be tolerated. It is therefore incorrect to refer to specific triggers. We are not aware of reliable evidence that childbirth causes a worsening of ME/CFS greater than any similar exertion might, and some women report an improvement during pregnancy or after giving birth.

p.14 lines 30-31: The words 'may be self-managed with support and advice' underplays the seriousness of the illness. People with very severe ME/CFS may be completely reliant on others.
Replace with: 'has no cure or effective treatments. Energy management (including symptom-contingent pacing) may help to reduce the impact of symptoms.'

p.14 line 31: Add a bullet point in 1.6.4 to explain that ME/CFS can be worsened by over-exertion and that it is important for the person with ME/CFS to avoid over-exertion for this reason.

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1.6.5:

p.15 lines 1-3:
Discussion of prognosis for adults and children would be best covered in the same recommendation.
Replace with: 'varies in long-term outlook from person to person. Recovery rates decrease with increasing lengths of illness. Recovery rates are initially high but full recovery is rare after two years. The outlook for children and young people tends to be better than for adults.'

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1.6.6:

p.15 line 8: After 1.6.6, add a new recommendation: 'provide appropriate letters and reports to benefits and insurance agencies in support of unemployment and disability benefits and claims. Ensure patients have been recently reviewed so such reports are up to date.'

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1.6.7

————————————
1.6.8
————————————
1.6.9:

p.15 lines 16-18: After 1.6.9, add a new recommendation: 'With the consent of the person with ME/CFS, provide information to care agencies about the severity of their symptoms and their specific needs.’

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1.6.10
————————————
1.6.11
————————————
1.6.11
————————————
1.6.12
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1.7 Safeguarding

p.16 line 5 (General): Move the content of 1.7 Safeguarding ME/CFS to the Section 1.2 Suspecting ME/CFS. The reason safeguarding requires comment in this guideline is because there have been failures on the part of doctors to recognise ME/CFS, and to convey that diagnosis and the implications of it clearly to social services. Therefore, it is an issue of needing to take great care when considering differential diagnoses of mental illness or parental abuse or neglect. The currently separate section on safeguarding may actually contribute to the incorrect suggestion that safeguarding is more likely to be required in ME/CFS than in other chronic illnesses.

p.16 line 5: We appreciate the clear statements in 1.7 that professionals involved in safeguarding should have experience in ME/CFS, that symptoms of severe or very severe ME/CFS may be confused with signs of abuse or neglect, and that response to possible child abuse and neglect should be considered in the same way for children and young people with confirmed or suspected ME/CFS as with any child with a chronic illness or disability.

p. 16 line 5: There will need to be substantial retraining of health and social care professionals involved in safeguarding processes for people with ME/CFS. Such training should be in accordance with the recommendations in this guideline.

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1.7.1:

p.16 lines 6-8: Add at the beginning of the recommendation: 'Considerable harm has been caused by mistaking ME/CFS as mental illness, abuse or neglect'. Specify that training and experience should be in accordance with the recommendations in this guideline. Older training and previous experience may be out of date and lead to inaccurate assessments and significant harm to people with ME/CFS.
lines 6 - 8: The sentence 'Safeguarding assessments in people with confirmed or suspected ME/CFS should be carried out or overseen by health and social care professionals who have training and experience in ME/CFS' can be misread as suggesting everyone with ME/CFS needs a safeguarding assessment. We recommend adding to the beginning of the sentence: 'If abuse or neglect is suspected, ... '
--------------
1.7.2

p.16 9-11
Replace with this: 'Recognise that people with ME/CFS, particularly those with severe or very severe ME/CFS, are at risk of their symptoms being confused with signs of mental illness (including eating disorders) or of abuse or neglect.'
We recommend moving section 1.7.2 to before section 1.7.1 to emphasise that this section is about the problems of symptoms of ME/CFS being misinterpreted as safeguarding issues.

———————
1.7.3:

p.16 lines 12-15: It should be recommended that in the best interests of the person with ME/CFS, where possible, a health or social care professional chosen by the person with ME/CFS be involved in any such assessment.

p.16 lines 12-15: Include ensuring that where possible, the person with ME/CFS should have a family member or advocate present for any such assessment.

p.16 lines 12-15: Add that health and social care professionals should only have involvement if they understand that ME/CFS is not a psychiatric disorder and that it is not appropriate to reframe the symptoms of ME/CFS as another condition.

p.16 lines 12-15: Specify that ‘training and experience in ME/CFS’ must be up-to-date and consistent with this guideline, as inadequately informed health and social care workers may do enormous harm.

—————————————
1.7.4

————————————-
1.7.5

—————————————
1.7.6

page 17 lines 8-19
We recommend moving section 1.7.6 to the beginning of the 'children and young people' section, before section 1.7.4. This would help to emphasise that the issue being addressed is misunderstanding of symptoms leading to inappropriate diagnosis of FII and other safeguarding issues.

p.17 lines 14-16: Should also cover refusal of assessment for and development of the management plan or declining to restart any part of it.
Suggested wording: ‘declining assessment for and development of a management plan (medical care plan), or disagreeing with, declining, withdrawing from or refusing to restart any part of their management plan (medical care plan), either by the child or young person, or by their parents or carers on their behalf’

p.17 line 19: Should include not participating in home schooling.

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Section 1.8 Access to Care

page 17 line 20
Access to Care: Overall section 1.8 is helpful. We are concerned that there will be a wide gap between what is recommended and what happens in practice. We recommend that the importance of this section be emphasised in the guideline. Many people with ME/CFS currently have no access to current medical services, not just for their ME/CFS symptoms, but for other serious comorbidities and even for emergencies, because of insurmountable barriers to access.

page 17 line 20
Add:
We recommend that an NHS endorsed ME/CFS passport be developed that sets out the requirements of the individual patient during health care interactions. Information about the patient's requirements should be included in their medical notes and made clear to all clinical and hospital staff who deal with them.

1.8.1

page 17 line 21
'people with ME/CFS...' Add: 'and those awaiting possible ME/CFS diagnosis'.

page 18 line 1
Add: 'discussing any proposed referral with the person with ME/CFS before making it and considering related access needs'

page 18 line 6
replace 'noise' with 'sound (speak quietly)' It is not just loud sound that affects people with ME/CFS.

page 18 lines 8-9
care flexibility: Add email, and letter as options. Add providing a quiet, dimmable separate place to lie down, and option to wait in car, while awaiting appointment.
Make it clear that this applies for all severity levels of ME/CFS.
Add: People with ME/CFS who live alone and have no car may need assistance with arranging safe and manageable transport to and from appointments, or home visits.

page 18 line 9
Add 'be aware of the patient's cognitive problems and physical fatigability during consultations. Make accommodations for this, for example by making use of written and electronic communication before and after a consultation. Allow patients to bring notes prepared in advance to be entered in their medical records. For patients with severe ME/CFS and others who request it, provide a written summary of all consultations.'

1.8.2

1.8.3

page 18 line 15
change 'fear of relapse' to 'likelihood of triggering PEM or deterioration', as 'fears' are likely to be rational and founded in experience (see Evidence Review G, p.326, lines 45-47).

page 18 line 18
Add an extra bullet point: 'The person is likely to have prepared with pre-emptive rest in order to be able to attend an appointment.'

1.8.4

page 18 line 19
People with severe or very severe ME/CFS
This section should also be applied to people with moderate ME/CFS who are largely housebound and have similar problems with access to and use of services.

page 18 line 23
add: communication with a carer on the person with ME/CFS's behalf (with their agreement).
add: communications that are not real-time (such as texts and emails) may be particularly useful for this group.

Hospital care

1.8.5

page 19 line 7
replace 'noise' with 'sound', as even quiet sounds may be a problem for some people with ME/CFS.

People with severe or very severe ME/CFS

1.8.6

page 19 lines 13-16
add: where needed arrange ambulance travel to and from hospital or hospital stretcher between car and ward.

page 19 line 19
Add bullet points to Section 1.8.6:
- 'minimise disruption to the patient's sleep, where possible accommodate the patient's sleep schedule.
- Ensure nursing and other appropriate staff are apprised of needs re assistance with washing, toileting, and feeding when required. Some people with ME/CFS without having the outward appearance of needing support, may need assistance.

page 19 line 20
'aim to provide a single room where possible' is not sufficient.
People with severe or very severe ME/CFS are likely to deteriorate in a hospital ward. For these people, a single room is not a 'nice to have' but a need; they are likely to choose not to be in hospital if their need for a quiet low-stimulus room cannot be met.
Add: people with very severe ME may be unable to communicate their needs, with hospital staff. Provision should be made for their carer to stay with them in hospital to assist staff in ensuring care is provided to minimise symptom exacerbation.

page 19 lines 21-29
This section needs to make it clear that ordinary minor stimuli may be very painful and may lead to prolonged symptom worsening.
line 25: add: 'and being aware that physical examinations, tests and scans can cause severe pain or deterioration. Ensure the patient is listened to and provide any needed accommodations, sedation or pain relief.
line 26: 'lights dimmed' add 'and off whenever possible'.
line 27: Change 'noise' to 'sound'
line 29: Change 'strong smells' to 'smells'.

Maintaining independence

1.8.7

page 20 lines 6-7
'access to outside space'
Some people with ME/CFS may have great difficulty accessing public spaces due to the impact of sounds and social contact, and so a private outside space such as a garden may be important for well-being and health maintenance e.g. exposure to sunlight.

page 20 line 9
'glare from lights' change to 'reduce light levels'.

page 20 line 10
'loud noise' change to 'sound at levels that cause them problems'
Add 'Exposure to sensory stimuli, at levels healthy people can easily tolerate, is not only difficult to cope with at the time, but can lead to rapid physical and/or cognitive deterioration.'

page 20 line 11
Add: Accommodation not at ground level will usually present difficulties for people with ME/CFS, particularly for people using wheelchairs, and especially reclining wheelchairs. Even if lifts are large enough, sounds and vibrations can be troublesome for people with severe sensitivities and may not be available during an emergency evacuation.

1.8.8

page 20 lines 17 - 18
'families and carers ...'
Add: 'and care agencies and their staff'
It should not be assumed that people with ME/CFS have families or consistent carers.
Add: The medical team should liaise with social services and care agencies to ensure they have up to date written information on the individual's care needs, including extra time needed for some care tasks.
Add: Ensure the person with severe or very severe ME has access to appropriately trained advocacy services to help them access the medical, care, practical support and financial support they need.
Add: Consider, where appropriate, referral for respite care or palliative care services. In very severe cases it may be appropriate to consult a palliative care specialist.

Aids and adaptations

1.8.9

page 20 lines 20-22
Add: For patients who don't yet have a management plan (medical care plan), do not delay access to aids and appliances until the plan is completed.

1.8.10

1.8.11

page 20 lines 29 - 30
delete 'taking into account risks and benefits'. An evaluation of risks and benefits should be done for any recommendation for aids and adaptations, but its explicit mention here seems to reinforce the mistaken view that the use of aids can lead to a reduced incentive to be active.

page 20 line 30
Add: Orthostatic intolerance may mean that some people with ME/CFS require fully tilting and reclining wheelchairs and chairs.

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Section 1.9
Supporting people with ME/CFS in work, education and training

1.9.1

page 21 lines 4 - 5
Many people with ME/CFS will not be able to return to work or education at all, or may gradually deteriorate due to doing more than can be sustained. Therefore the advice needs to be realistic. People with ME/CFS need to be made aware that recovery is most likely in the first two years. After that time, there is only a very small probability of a full recovery and plans to return to work may be unrealistic. Clarity about this will help the patient and their family plan appropriately.

Add bullet point to 1.9.1:
- 'Ensure the person has information on how to access advice on the financial implications of, and their rights in relation to, changes to employment arrangements including stopping and starting work, and reducing hours.'


1.9.2

p.21 lines 11-14
Not all patients have, are able to get, or want, management plans. Not all information in a management plan should be shared with an employer, school or support service. Information provided to third parties needs to be limited to that which is directly relevant. Replace with 'Offer to liaise on the person's behalf (with their informed consent) with employers, education providers and support services. Give them information about ME/CFS, and relevant aspects of the person's illness, including any adjustments required.'

Add bullet points to 1.9.2:
- 'Ensure the person with ME/CFS is included in all decision making with employers, apprised of the content of all discussion, and provided with copies of all correspondence relating to them.'

- 'communications between a person's employer or education provider, health and social care professionals, and training and education services must respect patient confidentiality and comply with relevant data protection law at all times'

1.9.3

1.9.4

page 22 lines 1-2
We are concerned about the statement 'discuss the child or young person’s management plan'. This may include information not appropriately shared with people other than their medical team. Only relevant parts should be discussed, and only with informed consent.

page 22 lines 3-5
Add 3 bullets points to 1.9.4:
- 'The child or young person's health needs to take priority over education, and there may be times when it is best to step away from education to allow the child to rest without pressure of trying to keep up with work. Flexibility needs to include complete breaks during times of severe illness.'

- 'When relevant, health and social care professionals should explain to training and education services that some children and young people with ME/CFS are not only unable to attend school but may have significantly reduced ability to engage in online or home schooling, or may need to discontinue schooling of any form altogether on either a short or long-term basis.'

- 'Ensure the young person with ME/CFS is included in all decision making with education providers, apprised of the content of all discussion, and provided with copies of all correspondence relating to them.'

1.9.5

1.9.6

page 22 lines 10-12
This is both too prescriptive and unrealistic.
Suggested replacement version:

'Advise children and young people with ME/CFS (and their parents and carers) that:

- The first priority should be to avoid any deterioration of health while achieving some quality of life

- they should be free to choose which aspects of education, home and family life and social activities they prefer to spend their very limited energy on, without pressure to conform to social norms expected of heathy children. For some this may mean withdrawing from education. There should be no pressure to return to education until their health allows

- recognise cognitive problems that are part of ME/CFS may make some subjects too difficult for the child to study. Flexibility on subject choices is important.'

 

Section 1.10 Multidisciplinary care

p.22 line 13: We suggest changing the heading of section 1.10 from 'Multidisciplinary care' to 'Coordination of care', as referred to in Evidence Review I (p.23 line 46) and to reflect use in the NICE clinical guideline, 'Multiple sclerosis in adults: management' (CG186). The current section 1.10 heading is misleading as it implies all people with ME/CFS need multidisciplinary care. Many people with ME/CFS will neither need nor want multidisciplinary care, having no need for physiotherapy, occupational therapy, psychological therapy or dietary advice. Many will be well served by consultant diagnosis, and ongoing help and review as needed by a specialist nurse and GP.

We are pleased the committee has recognised the importance of a single point of contact to coordinate care for people with ME/CFS in order to mitigate the risk of contact and appointments with several different people impacting 'negatively on the person’s health potentially worsening symptoms' (ER I p.21 lines 26-29; pp.24-25).

However, we disagree with the committee's decision not to specify professions that ought to make up the specialist team (Evidence Review I p.23 lines 26-30), as we consider this will lead to people with ME/CFS undergoing multiple appointments with different healthcare professionals (HCPs), regardless of coordination of care by a named contact. It also risks issues being dealt with by therapists of the wrong specialism, risking mismanagement and harms to people with ME/CFS. There is the further concern that someone allocated, for example, a psychologist, as their point of contact, will avoid further use of the service even when they need help, because they do not see the relevance of psychology to their need.

To remedy this risk of worsening for people with ME/CFS, we recommend the guideline specify a streamlined specialist team, led by a consultant of a suitable biomedical discipline with specialist knowledge of ME/CFS, who would confirm diagnosis, order appropriate tests and referrals if needed and oversee care. Specialist nurses with up-to-date training consistent with this guideline would then fulfil the role of main point of contact for the person with ME/CFS and provide comprehensive support and care for most issues for which the person with ME/CFS may seek input. This would more closely mirror the NICE guideline for multiple sclerosis (CG186), in which a consultant of appropriate discipline (neurologist) and MS specialist nurses are specified to form part of the team.


Rationale:

The evidence for a multidisciplinary approach to care in ME/CFS is unacceptably low, with only two studies included on the basis they were the only evidence despite not comparing different MDTs (Evidence Review I, p.9). Both were of low to very low quality evidence (Evidence Review I, p.22 line 1). The quantitative evidence was stated to be limited and thus the cost-effectiveness of ME/CFS specialist MDTs uncertain (Evidence Review I, p.25, lines 26-27). One cost-utility analysis found multidisciplinary rehabilitation (physical therapist, occupational therapist, psychologist and social worker) not to be cost effective compared to CBT (ICER £106,000 per QALY gained. Evidence Review I, p.20). It is acknowledged that cost-effectiveness is 'likely to depend on the staff-mix in the team and the therapies offered.' (Evidence Review I, p.25 lines 27-28.)

In light of the dearth of effectiveness and cost-effectiveness data, it is therefore hard to understand the leap of logic made in the following statement: 'The exact cost effectiveness of a specialist team is uncertain, but the committee were convinced that their provision would be a good use of NHS resources, leading to faster access to appropriate care and substantially better patient outcomes for people with ME/CFS.' (Evidence Review I, p.25 line 48 - p.26 lines 1-3.)

We believe the model of care we propose would by comparison be streamlined and cost-effective. A specialist ME/CFS nurse would be able to provide competent care spanning a significant number of the areas of expertise specified at 1.10.1 (also Evidence Review I, p.26, lines 11-20), and would therefore be able to provide post-diagnosis support and education on a wide range of issues, including energy management, flares and relapses, symptom management (including medication review), dietary and mobility issues, and be able to provide informal support for emotional wellbeing (See Evidence Review G, p.325, lines 5-9 re importance of someone being available to talk to if help is needed as a form of safeguard). They can support the person with ME/CFS to learn the skills and strategies to self-manage effectively, and provide support if the person with ME/CFS overexerts themselves and experiences worsening (Re importance of these, see Evidence Review G, p.322, lines 33-35, 42-43). Nurses would be able to provide such support by phone, email or home visit and deal with multiple issues in one interaction.

In contrast, therapists from various disciplines such as CBT, physiotherapy and occupational therapy, would be hampered by the narrowness of their field, and would be unable to fulfil such a role without exceeding the bounds of their expertise. The provision of care and support by a specialist nurse as main point of contact would therefore reduce risk of worsening to people with ME/CFS by virtue of multiple appointments with multiple HCPs and inappropriate management advice, and would be comparatively cost-effective.

We agree with the statement in Evidence Review I that most people with ME/CFS will only require a few elements of the areas of expertise specified and only at specific points in time (p.26 line 21). We think early, accurate diagnosis by a consultant with up-to-date knowledge of ME/CFS combined with specialist nurse post-diagnosis support will field most of these elements and reduce the extent and range of healthcare provision required downstream.


Provision of care:

Such provision would allow for continuity of care and for the specialist nurse to familiarise themselves with the individual circumstances of the person with ME/CFS, as recommended in NICE clinical guideline 'Patient experience in adult NHS services' (CG138).

People with mild or moderate ME/CFS may prefer their GP to provide ongoing care or may choose to continue to consult the specialist nurse. People with severe to very severe ME/CFS, are likely to need to continue to be cared for by the specialist team, in conjunction with their GP.

Where the person with ME/CFS is referred to a different specialism for investigation of symptoms, the consultant would explain the limitations and particular needs of the person with ME/CFS so that these can be accommodated.

Access to specialist services will be difficult for many patients either geographically or because they are too sick to travel. Provision should be made for phone and online access, and home visits by the specialist nurse.

In keeping with the MS guideline (CG186) and absence of reliable evidence for CBT to cure, treat or support to manage the symptoms of ME/CFS (Evidence Review G, pp.72-119, p. 318 line 23), we do not think the specialist team should be specified to include CBT therapists. Any qualitative evidence that some people find CBT helpful appears to be largely based on the non-specific skills of a good listener who has rapport with and believes the patient, and whom the patient feels they can contact for support if needed, not on the particular modality of psychological support. (Non-specific benefits of CBT noted in Evidence Review G, p.324 lines 41-43). Such elements of care can be provided by an empathic specialist nurse. For those needing further emotional support, access can be provided to a psychological therapist.

We strongly recommend it be specified that specialist teams should not be led by a mental health specialist, psychiatrist, psychologist, or psychological therapist. We regard stating this in the guideline to be necessary as the draft guideline recommendations represent a significant departure from the 2007 NICE guideline (CG53), on which most current services are based. Their service model is no longer appropriate now that GET and directive CBT that is intended to treat ME/CFS are specifically excluded from the guideline.


-------------------------

1.10.1

page 22 line 21
Delete this line. There is no evidence that patients with ME/CFS have emotional needs as part of their core condition any more than those with other chronic disabling diseases have. Specifying this in the guideline seems to perpetuate the myth that people with ME/CFS are particularly emotionally susceptible, or need help with sexual relationships in a way that is not specified in, for example, the MS guideline.

1.10.2

p.23 lines 5 - 6
Providing they would not prefer a GP to oversee their care, we recommend that people with ME/CFS of all severity levels should remain under the overall management of a consultant, with the GP and/or specialist nurse providing services as required. Very few GPs have the time or knowledge to provide helpful input either in daily management, or in dealing with severe cases. The specialist nurse is likely to have much more knowledge of ME/CFS than the GP, and would be accessible by phone, email or home visit and provide vital liaison with the consultant.

1.10.3

p. 23 lines 7-10
We support the need for a named contact and think this should be specified as someone with a medical, not a therapy, specialism, likely best served by a specialist nurse, as is provided for other chronic disabling diseases.
___________________

Question 1

Which areas will have the biggest impact on practice and be challenging to implement? Please say for whom and why.

Re-orientation of clinical care teams
With the recognition that the CBT and physical rehabilitation approaches are ineffective, the work of existing ME/CFS clinics must change. It is no longer appropriate for ME/CFS clinics to be managed or run by teams trained in CBT, psychotherapy, health psychology, psychiatry or occupational therapy. There is no need for therapists to provide individual and group courses of multiple sessions based on a psychological and behavioural model. These will need to be closed down as no longer fit for purpose, and their staff redeployed.

New physician led medically focused teams will need to be set up, modelled on, and possibly in some instances sharing some staff and facilities with, those provided for other chronic disabling physical diseases such as multiple sclerosis and Parkinson's disease, with specialist nurses whose skill set better qualifies them to assist ME/CFS patients with managing their condition including both energy management, symptom monitoring and treatment, as well as helping with arranging appropriate assistance for work, education, financial, social and personal care needs. Specialist services such as physiotherapy for those who need them will also need to be available.

Increasing expertise in ME/CFS
Training of these new teams will need to be led by people with experience of working with people with ME/CFS in a manner which is fully in accordance with the new guideline. There is likely to be very limited availability of such trainers. It would be completely inappropriate for the training to be led by current providers of services based on the old guideline.

A transition phase
The transition to the new approach to ME/CFS is likely to be a challenging time for GPs too. They may have long-term patients who understand the implication of the new guidelines in much more detail than they do, and have high expectations that everything will change immediately. They will also encounter patients whom they need to diagnose with ME/CFS, but then not quite know what to do with them – 10-minute appointments aren't suitable for helping new patients learn even the basics of energy management, let alone how to cope with all the other aspects of the condition.

CCGs will need to plan the transition phase, including support for GPs needing to manage new patients without a ready-made network of clinics or an experienced consultant to manage patients with more severe symptoms. Getting a specialist nurse service up and running quickly, with nurses fully trained in accordance with the new guideline, under the supervision of physicians with up to date knowledge of ME/CFS and the guideline, should be prioritised, as should the provision of up to date materials for patients about ME/CFS.

Care of people with ME/CFS who have given up on the health system
Past users of clinics based on the old CBT/GET treatments should be informed of the new approach to ME/CFS. This could allow those patients who have avoided interacting with NHS services to benefit from the improvements recommended by the new guidelines. Just as with any medication that is withdrawn, the NHS has a responsibility to recall patients for a review and transfer to the new medical care approach.

Improved care of people with severe and very severe ME/CFS
There needs to be a suite of services including specialist nurses delivering care by email, text or phone and able to advocate for their patients; as well as mobile medical services delivering care to the person's home. There is a need for specialist high dependency housing for the more severely affected patients. Nursing homes are rarely suitable, as the most severely affected patients have severe sensory sensitivities and cannot be adequately shielded in a nursing home. Similarly, hospitals should have provision for appropriate sensory shielded single rooms for severely affected ME/CFS patients who need inpatient treatment and care.

Coordinated management and monitoring
Provision of new services compliant with the new guideline will need to be monitored closely by a national body set up for the purpose, using a robust system of compliance checks and quality control and with power to close down and replace inadequate services. There will also need to be a requirement for harms monitoring by these new services going forward and parity of harms monitoring for non-pharmacological approaches to condition management. If trust is to be restored, wholesale change is needed, including new medically oriented teams and rigorous monitoring of the new services.

_________________________

Question 2

Would implementation of any of the draft recommendations have significant cost implications?

Using health and social care professionals who have good knowledge of the reality of ME/CFS (especially for those with moderate to very severe ME/CFS), should halt the problem of disabling symptoms being mistaken for signs of abuse, neglect or mental incapacity. This will result in significant cost and resource savings relating to inappropriate child care proceedings or sectioning of adults who are unable to eat or function due to their severe symptoms.

There will need to be initial significant redeployment and retraining as the professions employed in ME/CFS teams are reoriented away from a psychotherapeutic and behavioural model to a medical and energy management model. This will involve some initial costs in redeploying existing staff and recruiting and training new staff.

Investment in useful care of people with ME/CFS is fully justified on the basis of the severity and long term nature of ME/CFS. It should, in the long run, save NHS money that has, until now, been wasted on poorly co-ordinated diagnostic processes and often lengthy and ineffective therapies.
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1.11 pt I Managing ME/CFS
Energy management, Physical maintenance, physical activity

1.11.1 - 1.11.3 (1 of 4)

1.11.1

p.24 lines 4-5: We agree with this statement and its inclusion in the guideline.

—————————————————
Energy management
1.11.2

p. 24 line 7: We suggest substantial revision of subsection 1.11.2 to incorporate the following:

'[Energy management]:
1. Is not curative and should not be expected to result in an increase in capacity for activity over time;
2. Is a self-management strategy for people with ME/CFS that involves:

a. limiting activity to minimise symptoms, primarily PEM
b. reserving capacity for activities that matter most to the person with ME/CFS;​

3. Takes into consideration the cumulative effects of all activity (both physical and cognitive) and the mitigating effects of rest;
4. Recognises that each person has a different and fluctuating energy limit, and they are the best judge of their own limits (lines 16-17);
5. does not involve undertaking the same amount of activity every day, as to avoid PEM activity levels should be adjusted according to symptoms and the need for pre-emptive rest;
6. requires the person learn from experience to identify a level of activity that is normally safe, relationships between levels of activity and symptoms, and warning signs they should rest;
7. can include help from a healthcare professional to recognise relationships between levels of activity and symptoms, particularly for children and young people who may find it harder to judge their limits and can overreach them;
8. Utilises symptom-contingent pacing to avoid PEM, whereby the person adjusts activity levels based on how they feel;
9. does not have increasing activity as its objective, even in flexible increments;
10. can be difficult due to symptom fluctuation and as not all energy demands are predictable;
11. requires that the person has requisite support, and has living and (if appropriate) work/education environments where the required actions such as limiting activity, pausing tasks and resting can occur.
12. is not based on any hypothesis about the cause of ME/CFS, as no cause of ME/CFS has been established.

p.24 lines 11-12: The person with ME/CFS will have the most insight as to how they are impacted by activity. There is no need to say of a self-management strategy that the person themselves leads it, and, after the person with ME/CFS has learned the principles, there may not be a need for the involvement of a health professional.
Replace with:

'is a self-management strategy for people with ME/CFS that involves:

a. limiting activity to minimise symptoms, primarily PEM;
b. reserving capacity for activities that matter most to the person with ME/CFS.'​

p.24 line 13: Replace with: 'takes into consideration the cumulative affects of all activity (both physical and cognitive) and the mitigating effects of rest.'

p.24 lines 14-15: Metaphors like ‘energy envelope’ may confuse readers and introduce untested terminology that will be unfamiliar to HCPs. It is better to convey in plain language that ‘energy management’ can help people to gauge how to avoid over-exerting themselves to reduce occurrence of PEM. We suggest use of the term ‘symptom-contingent pacing’ to convey in plain language that activity levels should be judged on current symptoms and the likely impact of activity on these with the object of avoiding PEM. This term can be clearly contrasted with potentially harmful forms of pacing, such as schedule-contingent or activity-contingent pacing. Including explanations of these terms in the guideline may go some way to address the issue raised by the Committee of the range of interpretations and lack of a standard definition for the term ‘pacing’ (Evidence Review G, p.322 lines 5-11). See https://www.physiosforme.com/pacing for information on symptom-contingent pacing.

Replace with:
‘[Energy management] does not involve undertaking the same amount of activity every day, as in order to avoid PEM, activity levels should be adjusted according to symptoms and the need for pre-emptive rest.'

p.24 lines 18-20: It is not realistic to expect a healthcare professional to be on hand to recognise when a person with ME/CFS is approaching their limit. The aim of any professional input should be to equip the person (and family if necessary) with knowledge for self-management.
Replace with :

• requires the person learn from experience to identify a level of activity that is normally safe, relationships between levels of activity and symptoms, and warning signs they should rest;
• can include help from a healthcare professional to recognise relationships between levels of activity and symptoms, particularly for children and young people who may find it harder to judge their limits and can overreach them;

p.24: lines 21-24: Should be deleted and replaced with an explanation of the concept of symptom-contingent pacing, whereby the person with ME/CFS controls their activity level to minimise PEM and the symptoms of ME/CFS. There is no evidence that increasing activity leads to improvement in people with ME/CFS.

‘Progression’ when symptoms are improved may still instigate PEM or relapse. ‘Pull back’ is vague and does not convey the extent of reduction that may be needed.
Replace with:

• 'Utilises symptom-contingent pacing to avoid PEM, whereby the person adjusts activity levels based on how they feel;
• does not have increasing activity as its objective, even in flexible increments;;
• can be difficult due to symptom fluctuation and as not all energy demands are predictable;
• requires that the person has requisite support, and has living and (if appropriate) work/education environments where the required actions such as limiting activity, pausing tasks and resting can occur.'

p.25 lines 1-2: Should be deleted. There is no evidence that energy management results in an increase in activity levels over time, or even stabilises the illness.

p.25 line 3: If such a statement is included, it should be more encompassing since there are a number of unevidenced and harmful hypotheses on cause that may be invoked in connection with energy management.
Suggested wording: '[Energy management] is not based on any hypothesis about the cause of ME/CFS, as no cause of ME/CFS has been established.’

————————————————————
1.11.3

p.25 4-14:
In its current form, 1.11.3 focuses on the HCP extracting information and delivering plans. Explicit mention of practical assistance on matters like helping the person to consider stopping or reducing work/school and helping them to implement any decisions they make is missing. These are things that will have significant impact on the person with ME/CFS’ health and quality of life and should happen before any formal energy management planning. There is no point, for example, making an energy management plan for the situation of the person working full-time if, with some discussion, the person would have decided they needed to be working part-time.

We suggest insertion of a new recommendation between 1.11.2 and 1.11.3 on information about energy management that should be discussed with the person with ME/CFS. Suggested wording and points for inclusion:

'Provide the person with ME/CFS with information from reliable sources about energy management (including 'symptom-contingent pacing'). Discuss the following with them:

1. Their current activity and rest pattern and symptoms. This may be helped by the person keeping a symptom and activity diary in advance of the consultation;
2. Planning for increased flexibility to allow increased rest and reduced activity. This may include stopping or reducing work/school or ensuring there are suitable places for scheduled rests;
3. Communicating with friends and family re how best they can provide support;
4. Finding ways to reduce daily activity whilst maintaining quality of life, e.g., delegating tasks, ceasing low priority activities, utilising adaptations to reduce exertion (mobility aids, Blue Badge, working or schooling from home);
5. reducing time in high energy demanding environments such as places that are noisy/bright (or using aids such as noise cancelling headphones or dark glasses);
6. Planning responses to PEM and longer deterioration;
7. Information on peer support;
8. Assistance for friends and family who may need to adapt to these changes.'​

p.25 lines 4-14:
Not all people with ME/CFS will want or need an energy management plan, and many people with ME/CFS would benefit more from advice from HCPs that enables them to better cope with ME/CFS, reduce activity, access aids and get in touch with patient organisations, than from focus on assessments to create energy management plans. Energy management plans place additional restrictions on already constrained lives; creating an environment where they can be followed is an activity in itself. For people with mild and moderate ME/CFS, plans are highly likely to be abandoned for more pragmatic approaches (see Evidence Review G p.323 lines 8-10), possibly leaving people feeling that they have failed. Members of our forum found the ambitious daily schedule approach of GetSetJulie for example, patronising and unworkable.

Energy management planning may be of more relevance to people with severe or very severe ME/CFS, who may require highly predictable routines to prevent worsening from unpredictable energy expenditure.

We suggest insertion of a new recommendation between 1.11.2 and 1.11.3 recognising the agency of people with ME/CFS in deciding whether they want or need an energy management plan.

Suggested wording and points for inclusion:

‘Recognise that:

• many people with ME/CFS will not want, require or even benefit from an energy management plan and ongoing professional assistance with energy management, particularly if initial discussions about energy management are done well and good resources are provided;
• some people with ME/CFS may not be able to decrease activity levels to a level that usually prevents PEM without additional practical support and care, or at all. In these cases, securing the support and care should take priority over completing an energy management plan;
• the person with ME/CFS should be able to choose whether to have an energy management plan or not, or to stop or restart an energy management planning process.'

p.25 lines 4-6:
The words ‘goals’ and ‘expectations’ though qualified with ‘realistic’ create an expectation goals will be set and worked towards. This may cause harm either by assuming the person with ME/CFS should increase activity to achieve a goal or by creating a sense of failure if they cannot. Further, some people may not want or need a management plan. There is no reliable evidence for 'benefits in setting of goals'. In Evidence Review G (p.336, lines 23-35), it is acknowledged that rigid or unrealistic goals can lead to deterioration and feelings of pressure and blame. A goal that is unrealistic or rigid to a person with ME/CFS may seem achievable to a HCP, leading to conflict and feelings of pressure and blame.

Suggested replacement wording:
'If the person with ME/CFS would like an energy management plan, discuss and record the person's:'

p.25 lines 4-14: We suggest addition of a bullet point for the sensory impact of the person with ME/CFS’ home and (if relevant) work/school environments, including light and sound exposure.
Suggested wording: 'sensory sensitivities including light and sound exposure at home and work or school if relevant'

p.25 lines 4-14: We suggest addition of a bullet point that the plan should cover responses to a deterioration of symptoms.
Suggested wording: 'ability to recognise and appropriately manage PEM and periods of longer deterioration'

p.25 line 9: Add ‘and whether the person has or needs help.’

 

1.11.4 - 1.11.10 (2 of 4)

1.11.4:

p.25 lines 15-22
Recommendation 1.11.4 is too oriented to forward planning of activities, and makes no mention of taking notice of symptoms. It is based on the assumption the patient knows their 'energy envelope', a term we have advised against using, and something many people will find difficult to estimate.
The words ‘as the first step’ should be deleted.

Replace section 1.11.4 with:
If the person wishes, help them make an energy management plan. This notes how they will manage periods of rest, activity and pre-emptive rest. Ensure that any plan is flexible so the patient can be guided by their symptoms to take sufficient rest breaks during activities, and to reduce activity and rest more if symptoms worsen.

———————————————
1.11.5:

p.25 lines 23-24: Replace with:
'During periodic care reviews, the person with ME/CFS should be asked about their energy management and the frequency of PEM.'

————————————————
1.11.6:

p.25 lines 25-26: This clause should include that reducing activity should be advised if PEM is present and there should be recognition of the effect on function and support needs of PEM or relapse.

Most people with ME/CFS have symptoms most of the time and regularly have fluctuations in daily energy levels. The words ‘reduce their activity if increasing it triggers symptoms’ implies that people with ME/CFS should be increasing activity.

Replace lines 25-26 with:
'Advise people with ME/CFS to reduce their activity if their symptoms worsen or PEM is present. Discuss what support they may need to reduce their activity.
If they are feeling better they may naturally want to do more, but all increasing should be done gradually to avoid PEM or deterioration. Increased activity may appear to be sustainable for a few days or weeks, but may lead to relapse. Any increase should be small, and not further increased unless activity at that new level can be sustained along with the improvement in symptoms maintained for weeks.'

————————————————
1.11.7:

p.25 lines 27-29: To take into account not all people with ME/CFS will want or need to track activity and symptoms, we suggest the alternative wording:
'Some people with ME/CFS may find it useful to track activity and symptoms to understand patterns, especially early in the illness. Tools such as activity trackers, heart rate monitors, apps and diaries may help with this.'
See Evidence Review G (p.336 lines 36-42), where potential harms of increased burden of tracking is acknowledged.

—————————————————
1.11.8:

p.26 lines 1-7: Recommendation 1.11.8 currently assumes that people with ME/CFS must have professional assistance in the circumstances specified. The guideline should make clear that referrals must always be contingent on informed consent based on the person with ME/CFS genuinely wanting the assistance.

Replace with:
'If a person with ME/CFS wants assistance:

• with energy management, including support developing an energy management plan; or
• to access and use energy-saving tools and mobility aids.

refer them to a physiotherapist, occupational therapist, or specialist nurse who has up-to-date training in ME/CFS management that is in accordance with this guideline.'

If a person has had ‘reduced physical activity or mobility levels for a long time’ but is managing their illness well, we do not see what is to be achieved by referral. People with ME/CFS who start to improve are likely to be able to successfully increase activity naturally on their own. Referral may be of use to people who have been largely immobile for a long period, but a clause addressing this should be much more carefully worded and consider limitations of people with severe or very severe ME/CFS, to whom it will mostly apply.

———————————————————
1.11.9:

p.26 lines 9-11: Subject to informed consent and genuinely wanting referral, any person with ME/CFS, regardless of severity level, who would like assistance with energy management or creating an energy management plan should be referred to a specialist physiotherapist, occupational therapist or specialist nurse with up-to-date training in ME/CFS consistent with this guideline. An ill-informed HCP can do much greater harm than the absence of a formal energy management plan. A person with ME/CFS may find their activity affected by other symptoms than fatigability, such as orthostatic intolerance, pain and sleep problems which need to be managed in conjunction with energy management. A specialist nurse would be best qualified to see the full picture. If retained, 1.11.9 should link to 1.8 Access to care.

———————————————————-
1.11.10:

p.26 lines 12-15: This clause should be revised. The words ‘when agreeing’ are not appropriate, as they suggest compromise where parties differ, leading to the person with ME/CFS ‘agreeing’ to do more than they are able without worsening. Changes in activity for mild and moderate cases may also need to be small and slow or may not be possible; the clause implies this is only the case for severe and very severe.

p.26 line 15: Include a recommendation after 1.11.10 that includes the following:

'Energy management planning for people with severe or very severe ME/CFS requires a high level of specialist knowledge. Balancing a need for social connection and quality of life with the fact that even a short time on an electronic device or a small amount of talking can have a significant impact on symptoms is difficult. Health professionals who have not done energy planning for people with ME/CFS who are severely or very severely affected must first get advice from others who have.

'Recognise that deterioration in functioning can result in the person needing a very high level of care. The energy management plan should set out what will be done when this happens, including how the extra support will be provided.'​

 

1.11.11 - 1.11.16 (3 of 4)

Physical maintenance

p.26 line 16: We think the subsection, 'Physical maintenance' is a helpful, practical subsection that can make a difference to the well-being of people with ME/CFS and their carers.

————————
1.11.11:

p.26 lines 17-22: Include dental health in 1.11.11. Dental consultations present problems of travel, being upright for wait time and coping with examination for people with ME/CFS.

p.26 lines 17-18: After the first sentence, we suggest adding: ‘Any proposal for physical maintenance needs to be based on a realistic assessment of the person's ability to sustain the action. The possibility of causing PEM, consequent reduction in function and lowered PEM threshold, alongside displacement of essential activities should be weighed carefully against likely benefits of any physical maintenance.'

p.26 lines 17-22: We suggest inclusion of sensible examples of appropriate physical maintenance. Eg., ‘Muscle flexibility e.g. gentle stretches in bed.’

——————————-
1.11.12
——————————-
1.11.13
—————————
1.11.14
===============

Physical activity

p.27 line 20:

Comment on the subsection 'Physical activity':

We are pleased the committee recognises the high risk of bias presented by open label trials with subjective outcome measures, the impact of this on interpreting evidence, and that there is no good quality evidence that exercise or activity programmes are effective treatments or cures for ME/CFS (Evidence Review G, pp. 137-165, 334-335; Draft guideline: Rationale and impact, p.63 lines 7-8).

However, on the same basis, there should be no recommendation to offer physical activity programmes in this guideline. Therefore, the content of the subsection on physical activity should be deleted and replaced with a clear statement outlining types of activity and exercise programmes that should not be offered to people with ME/CFS.

Rationale:

There is no reliable evidence that physical activity programmes are effective in treating or managing ME/CFS, or increasing function or tolerance to activity in people with ME/CFS (which may be viewed as treating). Evidence quality for all GET and other exercise intervention studies was judged to be low or very low, with inconsistency of findings across outcome measures (Evidence Review G pp.137-165, 334-335).

The recommendations on considering physical activity programmes for people with ME/CFS (1.11.17 - 1.11.20) therefore introduce confusion to the guideline as to which types of activity programme are acceptable and which are not. The recommendation not to offer any therapy based on physical activity or exercise as a treatment or cure for ME/CFS is thus weakened.

Existing GET programmes that are nominally compliant (e.g. by allowing increase by flexible increments) will remain in place under the new guise of 'optional physical activity programmes', and continue to do harm to people with ME/CFS. It has been suggested by GET proponents that the poor objective outcomes and high drop out rates reported for ME/CFS specialist clinics, and the lack of support for GET from people with ME/CFS is due to an implementation problem. However, even under clinical trial conditions with delivery by well trained experts, there has been no objective evidence of benefit from any exercise or activity program.

We are pleased to see the guidance not to offer any therapy based on physical activity or exercise as a treatment or cure for ME/CFS (p.28 lines 1-2) and some of the specific guidance not to offer certain types of physical activity or exercise programmes and therapies in 1.11.16. However, the section on 'Physical activity' does not go far enough to protect people with ME/CFS from harmful programmes.

There is no justification for offering any sort of activity programme to people able to mobilise without aids. 'Programmes', however slow and gentle, are by their nature timetabled and structured, and often done in a group setting, which can encourage people to push through to keep up with the group.

It is inappropriate to offer activity programmes to people if they 'would like' them as this offers a false version of patient choice, implying by the existence of such a programme that it will improve the person's health, or the NHS would not be offering it. People with ME/CFS long to be able to do more, and find it difficult to manage cutting back their activities sufficiently to avoid PEM. Any suggestion that an activity programme might be helpful if they 'would like' it, is not supported by evidence.

We propose the content of the 'Physical activity' section be deleted and replaced with the following:

1. People with ME/CFS need advice and support to rest and avoid over-exerting to minimise PEM. If a person feels they are able to increase activity, they should be advised to proceed cautiously, particularly on good days when they may think they can do more without resulting PEM. If requested, referral to a specialist physiotherapist with up-to-date training in ME/CFS consistent with this guideline should be provided to those with problems mobilising without aids who need specialist advice.
2. If able to increase, people with ME/CFS, particularly if already ambulant, will generally do this naturally without input from a HCP.
3. ‘Activity’ and ‘physical activity’ are defined in the guideline and HCPs should recognise that an increase of any type of activity, however seemingly trivial, may cause worsening for people with severe or very severe ME/CFS.
4. Do not advise people with ME/CFS to undertake general exercise, such as going to the gym or exercising more, because this may worsen their symptoms.
5. Therapy based on physical activity or exercise is not a treatment or cure for ME/CFS and should not be offered as such.
6. There is no reliable evidence that physical activity programmes are effective in managing ME/CFS or its symptoms, or increasing function or tolerance to activity. They should not be offered as such.
7. Offering activity programmes with the objective of managing ME/CFS or its symptoms, or increasing function or tolerance to activity, can be regarded as offering them to treat ME/CFS. Any therapy based on physical activity or exercise as a treatment or cure for ME/CFS should not be offered (Rationale and impact, p.63 lines 7-8).
8. Do not offer the following to people with ME/CFS:

a. generalised physical activity or exercise programmes. This includes programmes developed for healthy people or people with other illnesses;
b. any programme that has increasing activity or exercise as its objective, regardless of whether this is by fixed or flexible increments, for example graded exercise therapy;
c. any activity or exercise programme based on a hypothesis of the cause of ME/CFS, as this is not yet known. This includes activity or exercise programmes based on deconditioning, central sensitisation, or fear avoidance, and ones that aim to desensitise people with ME/CFS to exertion or triggers (eg., light, sound) through exposure.
d. therapies derived from osteopathy, life coaching and neurolinguistic programming (for example the Lightning Process).​

We are pleased that some of the above is addressed at 1.11.15 and 1.11.16. However, we do not feel the guideline adequately protects patients from harm in its current form.

——————————————

p.27 line 20: We provide comments on each recommendation in support of our suggestion to replace the current ‘Physical activity’ section as outlined above. These comments should also be considered as stand alone feedback.

————————
1.11.15:

p.27 lines 21-23: This clause needs clarifying. It is not clear if supervised unstructured or unsupervised structured exercise is acceptable and these terms are not defined. Suggested edit: ‘Do not advise people with ME/CFS to undertake general exercise, such as telling them to go to the gym or to exercise more, as this may worsen their symptoms.’

—————————
1.11.16:

p.28 lines 1-2: Suggest replace with ‘Any therapy based on physical activity or exercise as it is not a treatment or cure for ME/CFS and should not be offered as such.’ (Rationale and impact, p.63 lines 7-8).

p.28 lines 3-5: Good. Should be retained.

p.28 lines 6-7: Suggest replace with: ‘any programme that has increasing activity or exercise as its objective, regardless of whether this is by fixed or flexible increments, for example graded exercise therapy.’

By specifying that programmes based on fixed incremental increases should not be offered, any programme based on flexible increases would remain acceptable under the guideline. E.g. Programmes with scheduled increases except when PEM is present may be viewed as incorporating flexible increments and therefore guideline compliant, yet may do significant harm.

There is no standard definition of GET (Evidence Review G, p.335 lines 8-10), and therefore no requirement that increases in GET programmes must be by fixed increments. It can be seen from Evidence Review H that, in fact, studies of GET included in the evidence review did include flexible increments. It is therefore clear that the portrayal of programmes involving fixed increments as poorly evidenced and potentially harmful and programmes involving flexible increments as of potential benefit is a false distinction; studies of GET programmes have been assessed as low or very low quality evidence regardless of whether they involve fixed or flexible increments, with inconsistency of findings across outcome measures (Evidence Review G pp.137-165, 334-335).

We provide excerpts from study summaries in Evidence Review H, illustrating increasing by non-fixed increments:

Broadbent (2016), pp.34-35:
‘Exercise sessions were progressed by increasing the duration of the session only as tolerated for each participant. The workload was not increased until participants had achieved three consecutive exercise sessions of 30 min in total with no increase in symptoms, and the increase was 10% of the current workload. If participants reported any increase in fatigue or other symptoms during post-exercise, the exercise intensity was reduced until participants felt able to manage progression.’

Clark (2017), pp.92-93:
‘If symptoms increased after an incremental change in activity, participants were advised to maintain activity at the same level until symptoms had settled, before considering another incremental increase.’

Wallman (2004), pp.230-231:
‘Subjects were instructed to exercise every second day unless they had a relapse. If this occurred or if symptoms became worse, the next exercise session was shortened or cancelled and subsequent sessions were reduced to a length that subjects felt was manageable (pacing)’

Descriptions of other GET study interventions included in the evidence review also indicated that increasing was not by fixed increment (Fulcher, 1997; Wearden, 1998; White, 2011). Further, Evidence Review G acknowledges the heterogeneity of interventions described in GET studies (p.335, lines 9-10). Therefore, it is not sufficient to recommend that 'any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy' should not be offered to people with ME/CFS. To accurately reflect the evidence and adequately protect people with ME/CFS from harms, lines 6-7 should recommend that all programmes that have increasing activity or exercise as their objective, regardless of whether this is by fixed or flexible increments, should not be offered to people with ME/CFS. This includes but is not limited to GET.

p.28 lines 8-9: Delete ‘structured’. Suggested edit: ‘any activity or exercise programme based on a hypothesis of the cause of ME/CFS, as this is not yet known. This includes activity or exercise programmes based on deconditioning, central sensitisation, or fear avoidance, and ones that aim to desensitise people with ME/CFS to exertion or triggers (eg., light, sound) through exposure.’

p.28 line 10-11: Good. Should be retained.

p.28 lines 1-11: Include an additional recommendation after 1.11.16: ‘There is no reliable evidence that activity programmes are effective in managing ME/CFS or its symptoms or increasing function or tolerance to activity. Therefore they should not be offered as such.’

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1.11.17 - 1.11.22 (4 of 4)

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1.11.17:

p.28 lines 12-15: Should be deleted and replaced with: ‘People with ME/CFS will typically naturally increase physical activity if there is an increase in capacity. Advise taking any increases in activity slowly and to cut back and rest more if symptoms increase. Refer to a specialist physiotherapist with up-to-date ME/CFS training consistent with this guideline if requested.’

Rationale: The recommendation for physical activity programmes in this section gives mixed messages about the acceptability of activity programmes and will lead to inappropriate programmes continuing in place with resultant harms to people with ME/CFS. The words 'incorporate physical activity into the management of their ME/CFS' suggests such programmes may be used to manage ME/CFS. There is no reliable evidence for this.

Evidence quality for all GET and other exercise intervention studies were judged to be of low or very low evidence quality, with inconsistency of findings across outcome measures (Evidence Review G pp.137-165, 334-335). If a condition is successfully managed by a programme, then it is treated by it; the guideline states that therapy based on physical activity should not be offered as a treatment for ME/CFS (1.11.16; Rationale and impact, p.63 lines 7-8).

The words ‘ready to progress their physical activity’ imply patients are failing in condition management in some sense if not able to increase activity.

Use of the word 'or' in line 14 suggests that people who would like to do some more physical activity should be offered it, regardless of whether they are able to progress their activity beyond their current activities of daily living or not.

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1.11.18:

p.28 lines 16-18: If retained, should specify programmes offered should be consistent with this guideline. Physiotherapists and occupational therapists delivering such programmes should have up-to-date ME/CFS training consistent with this guideline.

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1.11.19:

p.28 lines 19-22: Self report is not sufficient basis for a recommendation, and is often contradicted in trials of adequate methodology (e.g. where sufficient blinding and/or objective outcome measures are employed). There is no reliable evidence of benefits of a physical activity programme, yet this recommendation claims benefit without specifying what it is. A therapy that leads to benefits must be regarded as a treatment; the guideline specifies therapy based on physical activity or exercise should not be offered as a treatment or cure for ME/CFS (1.11.16; Rationale and impact, p.63 lines 7-8). Many have reported long-term and significant worsening after an activity or exercise programme; this clause does not adequately convey risk. Statements like this should not be in an evidence-based guideline.

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1.11.20:

p.28 line 23:
Recommendation 1.11.20 describes a form of graded exercise therapy and has no place in the guideline. It illustrates why it is not possible to recommend activity programmes without inadvertently sanctioning harmful activity programmes. The guidance to start by reducing activity and to ‘use flexible increments for people who want to focus on improving their physical activities while remaining within their energy envelope’ is not sufficient to distinguish this from harmful activity programmes for which there is no reliable evidence of effectiveness, including GET.

There is no standard definition of GET (Evidence Review G, p.335 lines 8-10), and therefore no requirement that increases in GET programmes must be by fixed increments. It can be seen from Evidence Review H that, in fact, studies of GET included in the evidence review did include flexible increments (Broadbent, 2016; Clark, 2017; Fulcher, 1997; Wallman, 2004; Wearden, 1998; White, 2011). It is therefore evident that the portrayal of programmes involving fixed increments as poorly evidenced and potentially harmful and programmes involving flexible increments as potentially helpful is a false distinction; studies of GET programmes have been assessed as low or very low quality evidence regardless of whether they involve fixed or flexible increments, with inconsistency of findings across outcome measures (Evidence Review G pp.137-165, 334-335).

Therefore, it is not sufficient to recommend that 'any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy' should not be offered to people with ME/CFS. To accurately reflect the evidence and adequately protect people with ME/CFS from harms, physical activity programmes should not be recommended in this guideline, irrespective of whether they involve increasing by fixed or flexible increments.

1.11.20 is overly prescriptive and may result in unworkably regimented routines, with worsening of or no reduction in symptoms and reduced quality of life. It appears to use the concepts of a ‘baseline’ and ‘energy envelope’ interchangeably and creates the expectation that physical activity can be successfully increased in flexible increments.

p.28 lines 25-26 +
p.29 lines 12-13: We do not support the concept of a ‘baseline’ in ME/CFS, as this inaccurately implies a level of activity that does not cause PEM from which the person with ME/CFS can increase. ‘PEM threshold’ may be a more appropriate term. But such concepts translate less well to real life; many people with ME/CFS have little option but to routinely exceed their limits due to personal circumstances and obligations, and many with ME/CFS have no spare capacity to increase without inducing PEM. See Evidence Review G, p.333 lines 20-21 where (in reference to GET programmes) it is stated qualitative evidence showed 'baseline levels were not experienced as sustainable' by people with ME/CFS.

p.29 lines 1-2: Assumes that people with ME/CFS are not using all of their 'energy envelope' and so there is unused capacity that can be devoted to physical exercise. This is not true; people with ME/CFS struggle to restrict their activity to a safe level. Also assumes that 'energy envelope' capacity (capacity for activity without inducing PEM) will be increased once a physical activity programme is embarked on, otherwise it would not be possible to continue increasing whilst remaining inside the energy envelope. There is no reliable evidence that physical activity programmes lead to such an increase in capacity and no reason to think that such programmes will not lead to harms.

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1.11.21:

p.29 lines 6-7: ‘Agree with’ should be replaced with ‘Discuss with’. The current wording may lead to the person with ME/CFS having to negotiate adjustments to physical activity with a HCP and compromise if views on activity levels differ.

p.29 lines 8-13: We do not generally see the relevance of accessing specialist ME/CFS physiotherapy services during PEM or relapse, when rest and reduction of activity should be prioritised. We suggest lines 8-13 be replaced with: ‘reducing activity and increasing rest for as long as needed until symptoms improve, and being aware that after PEM or a longer deterioration, they may not be able to return to the previous level of activity. Access may be provided to a physiotherapist with up-to-date training consistent with this guideline for advice on physical maintenance if appropriate.'

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1.11.22:

p.29 lines 14-16: Add that they may need to adapt to a new lowered level of physical activity in the long-term.

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1.11 pt II Managing ME/CFS (Symptoms management)

Rest and Sleep

p.29 line 17: CBT should not be offered to support people to manage sleep issues in ME/CFS, as the evidence review found no reliable evidence of benefit of CBT for sleep quality, and quality of evidence for all outcomes across all CBT clinical studies included in the evidence review was found to be low or very low (Evidence Review G, p.323-324, 72-119).

p.29 line 19: We are pleased to see that rest is recognised as key in managing ME/CFS. Add 'important', i.e., 'on the important role of rest in ME/CFS'.

p.29 lines 21-22:
It is not appropriate for health care professionals (HCPs) to advise people with ME/CFS 'how often and for how long' rest periods should be. This should be determined on an ongoing basis by the person with ME/CFS.
delete: 'including how often and for how long, as appropriate for each person'

p.29 lines 18-22: Add a bullet point to 1.11.23: 'Where hypersomnia is present, do not restrict sleep.' There is no reliable evidence that sleep restriction leads to a reduction of ME/CFS symptoms, and some patients and their carers report that it can cause harm. Unrefreshing sleep is one of the required symptoms for suspecting ME/CFS (p.8, Box 1). It is not something that can be resolved by standard sleep hygiene recommendations.

p.29 lines 18-22: Add a bullet point to 1.11.23: 'Sleep during the day may be helpful; the person with ME/CFS should find what works best for them'.

p.29 lines 18-22: Add an additional bullet point to 1.11.23: 'that people with severe or very severe ME/CFS may need to spend extended periods or all of their time lying in a dark, completely quiet room with little or no stimulation in order to avoid worsening.'

p.30 lines 1-2: Delete. This recommendation could be used to promote 'techniques' that have no more evidence to support them as being beneficial for rest or for ME/CFS symptoms than common sense approaches to achieving rest.

p.30 line 2: Add a recommendation after 1.11.23 clarifying guidance for GPs on prescribing medication to help with sleep if a person with ME/CFS needs it.

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Managing orthostatic intolerance

p.30 line 6: add: 'or hypertension' after hypotension, as some people experience orthostatic hypertension and treatment for this is different.

p.30 line 6: After 1.11.24 insert a recommendation: 'Be aware that in those with severe and very severe ME/CFS, orthostatic intolerance may be very severe, and result in the person not being able to sit up for more than a few seconds or minutes, or at all.'

p.30 lines 7-12: After 1.11.26, add a recommendation: 'Any clinician treating a person with ME/CFS for orthostatic intolerance should have up-to-date ME/CFS training consistent with this guideline and therefore understand that exercise may worsen the symptoms of ME/CFS, including orthostatic intolerance.'


Managing Pain

p.30 lines 13-16: Include that CBT should not be offered to support people to manage pain in ME/CFS, as there is no reliable evidence this leads to improvement. The evidence review showed no finding of benefit (versus usual care) and inconsistency of findings (versus other interventions) for pain outcomes, and quality of evidence for all outcomes across all CBT clinical studies included in the evidence review was found to be low or very low (Evidence Review G, pp. 72-119, 323-324).

p.30 lines 13-16: Recommendation 1.11.27 should include more guidance on treating pain in ME/CFS, including 'pain on touch, myalgia, headaches, eye pain, abdominal pain or joint pain without acute redness, swelling or effusion'. These types of pain are described as symptoms that may be associated with ME/CFS at 1.2.4 (p.9, lines 15-16) of this draft guideline.

p.30 lines 13-16: Add:
'Some people with ME/CFS find that over the counter pain medication may reduce their pain levels. Due to restricted mobility and access to shops, over the counter pain medication should be available by repeat prescription in packs larger than those available without prescription, subject to regular review and clear advice on dosing, side effects and risks of long-term use.'

p.30 lines 13-16: Many people with ME/CFS have chronic pain and are often unable to engage in activities that could distract from the pain. This makes pain relief particularly important. Opioid pain relief is important for quality of life for some people with ME/CFS; access to this needs to be protected unless satisfactory alternatives can be provided. The NICE guideline on neuropathic pain in adults only refers to Tramadol in rare acute cases.

p.30 lines 13-16: Add: 'New or worsening pain symptoms should be appropriately investigated and not assumed to be caused by ME/CFS.'

p.30 lines 13-16: Include that if pain has been appropriately investigated, and cannot be managed in primary care, it is possible that people with ME/CFS will be referred on to a pain management clinic. It is essential that all clinicians involved have up-to-date ME/CFS training in accordance with this guideline. Some approaches to pain management, particularly those involving exercise programmes for management of pain, can be harmful to people with ME/CFS.

p.30 lines 13-16: We note the recent confirmation by Dr Paul Chrisp of NICE that the draft NICE guideline on chronic pain does not and will not apply to people with ME/CFS. https://meassociation.org.uk/2020/0...-get-covid-19-and-new-guideline-chronic-pain/. This is important as the chronic pain guideline, with its focus on exercise, psychological therapies and alternative medicine, and withdrawal of pain relief drugs, is completely inappropriate for people with ME/CFS.
Add: 'the NICE guideline on chronic pain does not apply to people with ME/CFS.'


Managing nausea

p..31 lines 1-4: Add: 'Prescribe medication for nausea if needed.'

p.31 lines 1-4: Add: 'New or worsening nausea symptoms should be investigated, rather than assumed to be part of ME/CFS.'


Medicines

p.31 line 14: add an additional bullet point regarding approaches to drug treatment of symptoms:

• 'trialling different drugs one at a time'

Dietary management and strategies

p.32 line 7:
After 1.11.34, add: 'Some people with ME/CFS, particularly with severe or very severe presentation, can develop difficulty eating due to gastrointestinal issues. They should be offered referral to a gastroenterologist and appropriate investigations and care.

'Healthcare professionals and others should not confuse a difficulty eating due to ME/CFS-related gastrointestinal complications with psychologically based eating disorders. People with ME/CFS with difficulty eating should be treated with dignity and respect in accordance with this guideline, particularly the section 1.8 Access to Care.'