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  • Writer's pictureJoanne Hunt

Reflections on NICE draft for diagnosis and management of ME/CFS

On 10 November, NICE released its long-awaited draft of the guidelines on diagnosis and management of myalgic encephalomyelitis (encephalopathy) / chronic fatigue syndrome (ME/CFS). In this blog I reflect on what has changed, and what has not, together with a few points which I think are worth celebrating and other which should raise concerns. These reflections are by no means comprehensive.

Note on nomenclature

NICE notes some of the debates around the term ME/CFS when it states: “Many people with ME/CFS consider the name 'chronic fatigue syndrome' too broad, simplistic and judgemental.” I think this is an understatement. I cannot think of any other illness where one symptom out of a plethora is picked out, reduced to something that perfectly healthy people can relate to (fatigue), and is then used to sum up the entire illness experience.

Nomenclature around ME/CFS of course has a very politicised history which is beyond the scope of this blog. I hope that future research on diagnostic criteria and case definitions will help in defining sub-groups within the ME/CFS umbrella or perhaps separating the terms out (again). My personal belief is that ME and CFS should be considered as separate clinical entities. There is no judgement here about who has what illness; rather, it is clear that different people with a diagnosis of ME/CFS can in some cases have what appears to be (and what in all likelihood are) different illnesses. However, given that politics and greed have served to conflate ME and CFS to a degree where we cannot in most cases draw on research and clinical experience in such a way as to be certain as to what we are referring to, I will use ME/CFS throughout. This adds all manner of ‘ifs’ and ‘buts’, qualifications and exceptions to much of what I will discuss, but that is sadly the nature of this highly politicised and much neglected area of so-called healthcare.

Patient-led victory

Clearly, the repudiation of GET and qualification of CBT (the latter for those patients who choose it, offered as an adjunct not primary treatment) is a hard-won and incredible victory for the patient community, their advocates and evidence-based (as opposed to eminence-based) clinicians and researchers. The fact that NICE has essentially admitted that the last 13 years of pretty much systematic patient neglect (abuse) and gaslighting (abuse) within healthcare has been facilitated by ‘low’ and ‘very low’ quality evidence is deeply incriminating for those academics involved in constructing such ‘evidence’. NICE guidelines are not mandatory in clinical practice, although clinicians would need a very good reason for not following them, and non-adherence could open them up to litigation. Thus, provided these provisions remain in the final publication of the guidelines, patients should be able to insist that they are not cajoled into these treatments (or something similar with a different name) with the weight of clinical guidelines behind them.

I think it is worth saying that much of the impetus for this extraordinary change came from patients and patient-led campaign organisations; many of these patients are very ill and get little to no healthcare. Patient organisations, charities and enlightened scientists and clinicians have also made invaluable contributions. This is patient ‘activism’ at its best; I personally associate activism with self-led empowerment of marginalised groups, but I am aware that some disgruntled biopsychosocial proponents are choosing to use the term in a negative sense.

Severe and very severe of ME/CFS

The draft guidelines acknowledge the multi-system nature of ME/CFS and place greater emphasis on symptomatology and patient needs, particularly at the severe end of the spectrum. In particular, the recommendation to risk assess each interaction with severe and very severely affected patients is a welcome provision. Recommendation of home visits (notably for severe and very severe patients – this should perhaps also be offered to less severe patients) and more regular monitoring are also welcome; the fact that this has not been offered previously is again rather incriminating. On the other hand, there are suggestions in the wording of the draft that seem to contrast this acknowledgement of severe disability.

For example, the qualification of CBT for people ‘who would like to use it’ can be seen as erasing the lived experience of people with severe and very severe ME. Many people in this sub-group will not be able to undergo CBT even if they want to, both due to cognitive dysfunction, and being unable to access a clinic that delivers it. I appreciate that one set of guidelines for such a heterogeneous patient group is almost asking the impossible; however, people with severe and very severe ME/CFS have historically been largely excluded from clinical practice, research and mainstream narrative around ME/CFS.

I also note that the 2007/2018 guidelines seem to have greater emphasis on ME/CFS as a disability, for example: “The physical symptoms can be as disabling as multiple sclerosis, systemic lupus erythematosus, rheumatoid arthritis, congestive heart failure and other chronic conditions”. In fact, research suggests that ME/CFS is associated with a lower quality of life and/or functional status than these conditions and many others besides. Equally, the 2007/2018 guidelines state that ME/CFS “can cause profound, prolonged illness and disability”. I wonder why such statements have been removed in developing the new draft? I think that the profoundly disabling nature of ME/CFS, notably at the severe and very severe end of the spectrum cannot be emphasised enough. It should also be noted by NICE that some people have died of ME/CFS. I am also well aware that people with ‘mild’ and ‘moderate’ ME/CFS can still be profoundly affected and I do not intend to erase their narratives by my focus here on severe and very severe forms of ME/CFS.

The definition of severe ME is interesting: “People with severe ME/CFS are unable to do any activity for themselves or can carry out minimal daily tasks only (such as face washing or cleaning teeth)”. This does not seem to allow for possible fluctuations within the illness experience or the fact that having support can make a difference to some people. There are a number of people with severe ME/CFS who are able for example to write, produce art, advocate and research who would not qualify as severe using this definition. I consider myself severely affected (I am increasingly bedbound, only usually only able to leave the house for medical appointments and then require assistance) but I am able (very slowly, in small chunks and with great difficulty) to write and occasionally research. In my case, this is only because I have a family carer who does a huge amount for me (meals, all household tasks, sometimes personal care and all other tasks of daily living) so that I can channel my limited function into something that is meaningful to me. I know I am fortunate in this respect. I spend much of my time unable to put a coherent sentence together, but that does not mean that I cannot create something coherent over time. I prefer the definitions as per the ME Association’s Disability scale.

Health and healthcare equity

Although it is commonly recognised that ME/CFS delineates a highly heterogeneous patient group, some of the factors that make this patient group so heterogenous are oft ignored. The mess that has been created by merging ME with CFS is one of the reasons for this heterogeneity, but there are also social factors (race, ethnicity, socio-economic status, gender, sexuality and so on) which will indubitably impact. We know from broader healthcare research that many of these factors impact on health status and access to healthcare, but this is not something that NICE has recognised in its draft. To be fair, ME/CFS-specific research in this area is sorely lacking and so there is little for NICE to draw upon; however, ignoring these factors still means that some of the provisions in the draft are rather wishful thinking.

For example, throughout the draft, NICE refers to involving carers and family members of people with ME/CFS in their care. This is an important provision, but what about those cases where people with ME/CFS do not have family members or carers? There exists a subset of the ME/CFS population who are so marginalised that they will not have access to carers and will not be able to access healthcare. Unfortunately, this state of affairs has been exacerbated through the stigma created in part by NICE’s 2007 guidelines and the provisions therein (although it would be unfair to lay all the responsibility for stigma at NICE’s door). We know from patient survey data that severely and very severely affected patients often cannot access healthcare and we also know that sometimes family members do not believe the seriousness of ME/CFS. This is an issue that I doubt will change overnight on account of the new NICE guidelines. Interestingly, NICE does recognise healthcare inequity to access of care based on region. We need to broaden our lens of scrutiny to look at other drivers of health and healthcare inequity.

Nebulous language

One of my concerns with the draft guidelines is use of rather vague language and statements that might be interpreted in a number of ways.

For example, ME/CFS is described in the draft as “a complex, chronic medical condition affecting multiple body systems and its pathophysiology is unclear”. This ignores findings of pathology / abnormality within multiple body systems. In fact, this description might be used for a functional disorder where symptoms suggest involvement of multiple system, but pathology is unclear. I think it needs to be made crystal clear in these guidelines that ME/CFS is not psychosomatic or psychogenic. The World Health Organisation recognised ME as a neurological disease in 1969, ME/CFS is listed in SNOMED CT as neurological (though the term 'neurological disorder' is open to interpretation); I would like to see the term ‘neurological disease’ used in the NICE guidelines, but at the very least it needs to be made clear that ME/CFS is a primarily biological entity, not a psychosocial one.

Another example of ambiguous or rather leading language can be found under the ‘energy management’ section of the guidelines. NICE recommends a “flexible, tailored approach so that activity is never automatically increased but is progressed during periods when symptoms are improved”. Equally, NICE states that people with ME/CFS might be referred into physio or occupational therapy if they “are ready to progress their physical activity beyond their current activities of daily living.” Whilst the proscription of automatic increases in activity (as per GET) is extremely welcome, there is a clear suggestion here that progression is possible. Given that other parts of the guideline acknowledge post-exertional symptom exacerbation as a defining symptom (symptom for suspecting ME/CFS), this is rather confusing. It also raises the question of who will be making the decision of which patients are ready to progress and on what clinical basis. This uncertain stance around exercise is further confused by NICE not having recognised some of the physiological responses to activity (e.g. decreased cardiac output, suboptimal BP rise, reduced oxygen uptake, lowered anaerobic threshold and increased acidosis) that have been found in ME/CFS research. Is this a way of leaving the door open to other graduated activity approaches under different names? NICE acknowledges that any interventions based upon the deconditioning model as a cause of ME/CFS should not be used with this patient group. However, that does not rule out approaches that assume deconditioning as a maintaining or perpetuating factor. Again, the definition of what ME/CFS is and is not should be clarified.

‘Baseline investigations’

Guidance around diagnosis and differential diagnosis warrants far greater clarification: ‘baseline investigations’ are not necessarily adequate to rule out other conditions. Research has also shown concerning misdiagnosis rates in samples of people with ME/CFS referred to ‘specialist clinics’ (clinics which have now been demonstrated not to be specialist at all). This is supported by research suggesting that many GPs lack confidence and knowledge base in diagnosing ME/CFS (indeed, this is acknowledged in the NICE draft). I personally have encountered people with ME/CFS who have been refused any biomedical investigations past routine bloods (on grounds that their illness is at least in part psychosomatic and that the ‘specialist clinics’ can deal with them), who then transpire (years and decades later) to have another condition or disease (sometimes co-morbid with ME/CFS, sometimes misdiagnosed as ME/CFS). I highly suspect I am one of these people. I think in this respect there is particular need for improved medical education in certain under-diagnosed or poorly recognised conditions which might be co-morbid with ME/CFS or represent an alternative diagnosis which may be treatable. Here, I am thinking especially of heritable connective tissue disorders and cranio-cervical issues which are typically very poorly recognised and poorly understood at both primary and secondary care level.

NICE draws upon the Institute of Medicine (now National Academy of Medicine) criteria, albeit in an adapted form, in their section on diagnosis and recommends future research around diagnostic criteria for ME/CFS. This is a very welcome recommendation and I suspect such research may result in defining sub-groups under the ME/CFS umbrella as distinct clinical entities, separating out the terms ME and CFS, or finding distinct clinical entities; there has already been some interesting papers on this (see here and here). However, given the history of many and varied clinical criteria and case definitions for ME/CFS, alongside NICE’s vague reference to ‘baseline investigations’, I think there continues to be a real risk of missed diagnoses and misdiagnoses. NICE recognises the need for “performing tests for differential diagnoses as appropriate” but without clear guidance, this will be left to healthcare professionals who have expressed lack of confidence about diagnosis and who are not sufficiently trained in ‘rare’ or under-diagnosed conditions which may be mimicking or exacerbating ME/CFS symptoms. In this regard, the International Association for CFS/ME (IACFS/ME) have some excellent information on overlapping conditions and differential diagnosis in both their 2014 Clinician Primer and their 2020 Clinician Guide. Something of this nature really needs to be built into the NICE guidelines.

Healthcare professional training

The guidelines state that healthcare professionals need training “that reflects current knowledge in ME/CFS” and which is evidence-based. This is certainly long overdue. In 2019 Dr Nina Muirhead reported that, in response to a questionnaire that she had sent out to UK medical schools, less than half included ME/CFS in their curricula (reported in December 2019 InterAction magazine). Given what appears to be a structural level knowledge and training gap in the health system, who will provide this training for healthcare professionals, and what exactly will it entail?

The CFS/ME Research Collaborative (CMRC) Med Ed group, led by Dr Nina Muirhead, has developed an excellent accredited training package (in partnership with Study PRN) for healthcare professionals and it is to be hoped that training of this ilk will replace the biopsychosocial offering ‘METRIC’ provided by the Royal College of General Practitioners (METRIC has been taken offline at time of writing). Physios for ME , which was established in part to educate and support physiotherapists in working with people with ME/CFS, also have some really useful information. Patients need clarity as to who exactly is providing training on their illness and what it entails. Medical education needs to be addressed as a matter of urgency.

I also wonder whether training needs greater emphasis on the basics, such as clinical ethics. One of the draft statements particularly caught my attention in this regard: “Do not discharge someone who misses appointments because their symptoms have worsened. Contact them to explore why they could not attend and how to support them.” As a former therapist, I cannot believe that this has to be said – although I am well aware that many people with ME/CFS have been discharged from clinics because they are too ill to attend. In my opinion, there is something akin to an inverse care law within healthcare (within and across patient groups) and I think this piece of clinical advice highlights my point. Either any training for healthcare professionals needs a good dose of basic clinical ethics, or (more likely I suspect) we need to look at some of the policies and underlying structural factors within the healthcare system that allow glaring breaches of duty of care to occur.

‘Specialist’ clinics?

There is mention of ‘specialists’, ‘specialist teams’ and ‘specialist services’ throughout the guidelines. Given that the ‘specialist’ treatments and underlying treatment philosophy offered by these clinics have now been shown to lack evidence base and potentially cause harm, who are NICE referring to?

I think we need to be clear that ‘specialist’ clinics do not exist. Specialist clinics for ME/CFS have never existed as a provision that is available to all. In the NHS, the so-called specialist clinics are largely associated with professionals who are members are BACME (British Association for CFS/ME), an organisation for healthcare professionals who have historically been proponents of GET and CBT for ME/CFS, on the grounds that these treatments are ‘clinically effective’. It has to be wondered what will happen to BACME now, given that they don’t have any clinically effective treatments to offer people with ME/CFS (CBT is not proscribed by NICE, but is acknowledged as not being a clinically effective treatment). The entire raison d’être of the organisation would seem to be in question.

Perhaps this is why BACME released a ‘position statement’ on ME/CFS in October 2020, just before NICE released its draft on 10 November. It seems quite likely to me that BACME had wind of some of the main thrusts of the NICE guidelines (or perhaps had correctly interpreted the turning tide against GET with the emergence of Long Covid) and felt it necessary to do a little pre-emptive damage control. In that document, they refer to “grading activity strategies” as opposed to graded exercise. They also suggest that deconditioning, whilst not “a primary cause” of ME/CFS, may be an “additional complicating factor” for “some” people with ME/CFS. To me, this seemed to leave the door open to graded activity whilst attempting to publicly change position (naturally without taking any accountability for harms done from their previous position), in order to both save face and keep their seat at the ME/CFS diagnosis and management table.

I personally would not be at all comfortable with members of BACME continuing to deliver these clinics, in fact I question whether such clinics should be disbanded, unless it is made quite clear that the clinics are in no way specialist and are not offering clinically proven treatments. Indeed, I feel that there is an ethical issue with continuing to offer any kind of clinics where clinicians are trained in approaches lacking evidence base and which have been shown to harm some patients. BACME clinicians will need to revise not only their training modalities, but the underlying philosophy of their training.

GPs are the gatekeepers to secondary care and specialist clinics; however, research shows that many GPs lack confidence in ME/CFS diagnosis and management (something that NICE acknowledges) meaning that even if specialist care for ME/CFS existed, the chances of patients accessing it are reduced. It appears that ‘specialist’ clinics are being named as such to avoid acknowledging the elephant in the room, which is that there is no clinically proven, effective care for people with ME/CFS and few healthcare professionals who are adequately trained in ME/CFS.

What about IAPT?

IAPT (Improving Access to Psychological Therapies) is a NHS mental health service initiative whose original remit was mild to moderate depression and anxiety disorders (I dislike the word disorder but such is mainstream psychological terminology). In more recent years, the remit of IAPT has been broadened to include anything that can be shoehorned into the MUS (medically unexplained symptoms) umbrella; the NHS, or at least influential NHS advisors, consider ME/CFS to fall under this umbrella. IAPT literature has previously rejected the term MUS but promotes use of the terms ‘functional (somatic) syndromes’ or ‘persistent physical symptoms’, which are still generally regarded as being heavily psychosocial in nature. Although IAPT offers a range of psychological therapies, it is heavily predicated on a cognitive-behavioural model. Given the lack of evidence base of CBT for people with ME/CFS, what does the future hold for IAPT’s role in providing therapies for people with ME/CFS?

NICE makes mention of “CBT for ME/CFS” (presumably whether in a specialist clinic or via IAPT), for example: “CBT should be only delivered by a healthcare professional with appropriate training and experience in CBT for ME/CFS, and under the clinical supervision of someone with expertise in CBT for ME/CFS”. There are many problems with this. CBT for ME/CFS has historically been predicated upon a (bio)psychosocial model of ME/CFS (and other so called MUS) whereby the therapy seeks to correct patients’ ‘aberrant illness beliefs’ (e.g. that exercise or increased activity may cause harm, that increased symptoms might herald a need to stop activity) along with ‘maladaptive behaviours’ (such as curtailing activity in response to symptom exacerbation). To suggest that these thoughts and behaviours are maladaptive is clearly totally unacceptable.

NICE appears to state that CBT for ME/CFS does not take the above approach (but see below), yet IAPT and specialist clinic literature suggests otherwise. Further, IAPT training for clinicians and supervisors in the realm of ME/CFS and medically unexplained symptoms has also historically taken a (bio)psychosocial approach. It needs to be made very clear what assumptions are made about ME/CFS in ‘CBT for ME/CFS’ and how therapists will work with patients in this regard. I think it will take a profound cultural shift within the healthcare system to ensure that any CBT offered for ME/CFS is fit for purpose (and always with the caveat that CBT is a non-curative, supportive therapy for patients who feel it might help them with the impact of living with a disabling illness and are able to undergo therapy). It would be helpful for NICE to make it clear that ME/CFS is not to be shoehorned into this MUS umbrella term.

NICE states that ‘CBT for ME/CFS’ “does not assume people have ‘abnormal’ illness beliefs and behaviours as an underlying cause of their ME/CFS, but recognises that thoughts, feelings, behaviours and physiology interact with each other”. This does not rule out the assumption that maladaptive beliefs and behaviours are a maintaining factor in ME/CFS, or an obstacle to recovery. In fact, much literature around CBT for ME/CFS or MUS seems to allow for the fact that a virus or other external event triggered ME/CFS, but that maladaptive thoughts and behaviours then play a role in maintaining the condition. This means that NICE’s statement keeps the door open for a CBT approach that is not hugely different than the one which most clinics and IAPT use currently. This seriously concerns me.

Plus ça change?

As I read through the document I noted the recognition of ME/CFS as being fluctuating in nature, which affects everybody differently (important points - although it has to be said that some people find that their ME/CFS does not fluctuate). I also noted the emphasis on patient-centred, individualised care, management plans to be mutually agreed, right to refuse treatment without it affecting care and a ‘whole-person' flavour to healthcare which includes the streamlining of health and social care services and offering work, education and benefits related support (also all very important). Then I realised that all these things were written into the 2007/2018 NICE guidelines on the diagnosis and management of ME/CFS. Yet, personally, professionally and anecdotally I know that these particular provisions of the 2007/2018 guidelines have not always translated into clinical practice. For certain sub-groups of the ME/CFS population, I would say these provisions have very rarely translated into practice. Why the failure to translate the positive aspects of pre-existing guidelines into practice? Did the previous emphasis on and enthusiasm for GET and CBT as ‘evidence-based’, rehabilitative and near curative treatments cause clinicians to lose sight of what should be basic principles of care? Maybe, but I also believe there are structural factors within healthcare that have led to what must now be recognised as systematic neglect, misrepresentation of people with ME/CFS. These factors need to be examined in greater detail.

As previously mentioned, whilst BACME clinicians are still involved in ‘specialist’ clinics, there is likely to be little change to the status quo, at least in terms of underlying treatment and training philosophy. Whilst this raises questions of how secondary care will be able to evolve to meet the new NICE guidelines, there are also questions at primary care level. The current Quality Outcomes Framework offers no financial incentives for GPs to care for people with ‘contested’ illnesses such as ME/CFS (unlike medically legitimised illness which are QOF supported). Some qualitative research has suggested that GPs are less likely to focus their limited time on educating themselves on non-incentivised illnesses. Thus, there may be policy issues which are creating obstacles to GP led care for people with ME/CFS.

Biopsychosocial politics persist

Earlier, in the context of GET and CBT, I mentioned ‘or something similar with a different name’. I say this because considerable resistance exists to the proscription of GET and qualification of GET, in particular and predictably amongst key biopsychosocial proponents. I have no doubt that these individuals will be looking for a way to continue their biopsychosocial hegemony through whatever means possible, and one of these means may be to change the name of existing treatment, ‘tweak’ them a bit and then present them as totally different treatments. I have also heard from other people with ME/CFS (pre-draft publication) that what appeared to be GET was re-branded as ‘activity management’ or ‘upwards pacing’ and so on. I even encountered a patient (post-draft publication) who suggested that the clinic they had attended was talking about changing the name of GET and carrying on regardless, which is deeply concerning, not least because it represents a breach of patient informed consent.

Some key biopsychosocial proponents have responded to the draft by suggesting that patient ‘activism’ has taken over science and that any harms sustained by patients as a result of GET and CBT are due to poorly delivered interventions rather than the interventions themselves. These people appear to remain convinced of the evidence-base of their treatments (or at least are too professionally and financially invested to admit there is no evidence base), and I very much doubt they will let this go without a long and dirty fight. It is notable that NICE do not mention the biopsychosocial model of ME/CFS; again, this makes me suspect that other biopsychosocial approaches will be developed to replace GET and perhaps augment CBT into something that is claimed to be clinically effective.

In this respect, I was interested in the use of the term ‘holistic’ in the NICE draft (as in ‘carrying out a holistic assessment’ post-diagnosis) – a term which did not appear in the 2007/2018 guidelines. ‘Holistic’ care is something that has also been touted within the context of Long Covid care and is a term open to interpretation. I am very much in favour of holistic care where this means considering all aspects of a person and their environment (which also mean recognising where phenomena such as medical gaslighting and medical neglect impact). However, in my experience, holistic has also been used to mean biopsychosocial where the ‘bio’ is dropped and the psychosocial is informed by an individualist perspective. In other words, more of the same, with a new 'on-trend' term.

Too little too late for some people with ME/CFS

Something that repeatedly strikes me when reading through the guidelines is just how egregiously poor the level and quality of ME/CFS ‘healthcare’ has historically been. There is no evidence base for any pharmacological or non-pharmacological treatment for ME/CFS. Given that ME/CFS is an illness with a 65+ year history and a devastating impact on people’s lives (not least from medical gaslighting), this state of affairs has to be one of the most shocking examples of what can happen when politics takes precedence over patients. I have to agree with Valerie Eliot Smith, British barrister and person with ME, when she says “The history of ME remains one of the worst examples of unacknowledged institutional abuse in modern times”.

Patient survey data and qualitative research demonstrate that some people with ME/CFS have sustained major and irrevocable losses, had their life chances drastically reduced - and we have to acknowledge that the worst affected will largely be excluded from surveys and research. Some people have died from ME/CFS and from medical neglect. Whilst the gains made in this draft largely through the incredible efforts of patient and patient advocates should be celebrated, it is tragically clear that any changes will come too late for some. NICE have recognised that some people with ME/CFS have lost trust in health and social care. In my professional experience, transparency and integrity on the part of health professionals help to build patient trust. If NICE wants to facilitate the (re)building of patient trust, it should be ready to take accountability for harms done, and encourage others involved in the historical neglect of ME/CFS patients to do the same.

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