BMJ editorial: Updated NICE Guideline on chronic fatigue syndrome, 2020, Stokes and Wade

dave30th · Dec 16, 2020

What a piece of nonsense. for years they have pushed everyone with "CFS" into one of two pathways, based on RCTs that they claimed proved their case. Now that evidence is no good. And it is really shocking that she is claiming long-Covid proves people get better with rehab support. When did long-Covid end? What rehab support is she talking about? She is claiming an indivualized approach is he way to go when they have argued the opposite for three decades. Not much variety in their CBT/GET template. These people really seem desperate.

Jonathan Edwards · Dec 16, 2020

I am quite shocked that this is an editorial. Normally a politically fired piece like this would be Point of View or a letter. Editorials can deal with quirky ideas but if they put forward a political view on policy they have to be assumed to represent the view of the editor. Does the editor really want to be associated with such a muddle of self-contradictory ill-informed ideas? Maybe.

Hoopoe · Dec 16, 2020

dave30th said: ↑

And it is really shocking that she is claiming long-Covid proves people get better with rehab support.
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It appears that most people will get better regardless of what they do or don't do. A controlled study is needed to distinguish the effect of treatment from the effect of time passing.

dave30th · Dec 16, 2020

strategist said: ↑

It appears that most people will get better regardless of what they do or don't do. A controlled study is needed to distinguish the effect of treatment from the effect of time passing.
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most will likely get better over time, if past experience can be trusted. presumably some will have long-term complications that do not seem to resolve for years. how she thinks this "proves" anything is bizarre

Trish · Dec 16, 2020

Quote: "...an important minority do improve..." So that's where we sick folk went wrong - we're not important enough to improve.

Kalliope · Dec 16, 2020

https://twitter.com/user/status/1339306954812899328

Kalliope · Dec 16, 2020

https://twitter.com/user/status/1339308651073445892

https://twitter.com/user/status/1339310948021129217

Jonathan Edwards · Dec 16, 2020

It is bizarre - NICE was misled by qualitative accounts from patients. So what we need is fewer controlled trials and lots more qualitative accounts of patients getting better because you need individualised qualitative accounts for complicated illnesses
(but maybe not by patients).

Hoopoe · Dec 16, 2020

Thanks to Anil sharing a copy, I have been able to read more than the initial part that's visible on the BMJ website.

I couldn't quite muster the energy to write out a detailed critique but will just say: it is nothing more than a protest against the loss of undeserved privilege. She doesn't give any good reasons why clinical trials for therapist delivered treatments should be held to a different standard. All she says is that they can't meet high standards.

(she also talks about how holistic individualized rehab is better in reality than in clinical trials but I wonder how she knows this - presumably she thinks herself free of bias, perfectly objective and more reliable than a clinical trial, which makes me suspicious that these people think of clinical trials as bureaucratic formality, not as method of acquiring knowledge)

Dolphin · Dec 16, 2020

Jonathan Edwards said: ↑

Editorials
Updated NICE guidance on chronic fatigue syndrome
BMJ 2020; 371

Lynne Turner-Stokes, Northwick Park professor of rehabilitation1,

Derick T Wade, professor of neurological rehabilitation

Correspondence to: L Turner-Stokes lynne.turner-stokes@nhs.net

Why standard approaches to evidence evaluation must change

An update of the National Institute for Health and Care Excellence (NICE) guidelines for diagnosis and management of chronic fatigue syndrome (also known as myalgic encephalomyelitis (CFS/ME)) is open for consultation, closing on 22 December.1 In contrast to the 2007 guidelines,2 which recommended interventions such as cognitive behavioural therapy and graded exercise therapy for people with mild or moderate CFS/ME, the update cites a “lack of evidence for the effectiveness of these interventions” despite the overall positive results of randomised evidence published since 2007.3 4 5

Instead, the new draft emphasises the potential harms of exercise, based on qualitative evidence provided by a small number of service users, and the balance has shifted towards helping patients to adjust to the long term debilitating effects of CFS/ME. It also shortens the timescale for diagnosis of CFS/ME, to include patients with symptoms persisting for just 12 weeks, even though the criteria developers recommend six months.6 This change in attitude away from rehabilitative interventions is worrying, as many patients do recover from chronic fatigue symptoms. Importantly, as the covid-19 pandemic shows, although fatigue, post-exertional malaise, and other symptoms may persist for weeks or months after viral illness, symptoms can improve over time with appropriate support and rehabilitation. The proposed update has therefore provoked a highly polarised response.

One fundamental problem is the NICE approach to evaluating evidence. NICE uses the GRADE system, which sets out a series of isolated questions using the PICO (patient, intervention, comparison, and outcome) framework and then rates the quality of research evidence for each recommendation. Within the hierarchy, evidence from randomised trials starts high but is downgraded if trials fail to meet strict quality criteria.

Many of these criteria were formulated for evaluating drug trials and focus on design features that are poorly applicable to complex interventions such as rehabilitation for people with CFS/ME or other complex conditions (box 1). Designs other than randomised trials are considered low quality, however well executed. Taken together, these challenges result in “low” or “very low” quality ratings for evidence from even the best studies of complex interventions.

Box 1
Quality criteria that are poorly applicable to complex conditions

Risk of bias—Double blinding is impossible as patients can never be truly blinded to interventions that require their active participation

Precision—Patient populations are relatively small and heterogeneous in complex conditions. Confidence intervals are consequently wide, so studies are downgraded for “imprecision”

Directness—This requires the intervention to be evaluated in the population of interest. Even the most definitive studies of complex conditions may be downgraded as “indirect” if the diagnostic criteria that were current at the time of the trial have been superseded (even if only marginally different)

Consistency—Interventions must be fully described and replicated in all participants. While simple for a drug, this is neither possible nor appropriate for rehabilitation interventions, which should always be individually tailored in full collaboration with each patient

Objective outcome measures—This favours physiological or standardised performance measures. Patient-reported outcomes such as pain, distress, and function in their daily lives are downgraded as “subjective” despite their widely accepted clinical importance.

Patients with CFS/ME are not a homogeneous group.7 As is the case with other complex conditions, each person’s experience is unique, and the intervention(s) needed will depend on their particular symptoms, circumstances, and preferences. Some people recover completely, but for others CFS/ME is a relapsing or long term condition requiring ongoing professional support. Here, goals for intervention may be to manage and prevent deterioration as well as supporting adjustment. One-off, short term interventions are rarely the answer.

Holistic rehabilitation
Integrated rehabilitation takes a holistic approach, providing an individually tailored programme focused on personal goals agreed between the patient and the rehabilitation team.8 For patients with CFS/ME, such programmes combine a range of physical, cognitive, and psychological approaches depending on patients’ preferences and priorities. These may include elements of cognitive behavioural therapy, exercise, pacing, or endurance building. Active engagement by patients and their families is essential, and is more likely if patients have been fully involved in the choice of interventions, which are then incorporated into everyday activities.

Although this is basic common sense, current NICE methods would discount any randomised controlled trials using this approach, citing risk of bias, inconsistency, imprecision, and subjective outcomes. Faced with this rigid structure, trialists have been forced to break down rehabilitation into separate component parts that often bear scant resemblance to clinical practice. Trials in people with CFS/ME typically allocate participants to one or more isolated interventions—such as cognitive behavioural therapy, graded exercise therapy, or adaptive pacing—regardless of their actual needs or preferences.

Holistic integrated rehabilitation supplies the equivalent of a well tailored suit, fitted to the individual patient, with room for adjustment as needs change. It is more expensive in the first instance, but there is strong evidence for the effectiveness and cost efficiency of such bespoke programmes in other complex conditions.9 10 By failing to understand the fundamental principles of good medical practice in these complex, multifactorial conditions, NICE methods continue to foster a fragmented approach in which some patients are effectively provided with trousers only, and others with just the jacket—typically on a short term (“hire”) basis. Small wonder that the trials have overall success rates of under 50%, although an important minority of patients do improve.

It is easy to see why people with CFS/ME might be upset about the research evidence underpinning their management options. Often disbelieved by clinicians, many find themselves fobbed off with a prescription for gym membership or a course of exercise classes under the pretext of evidence based practice. Offered in this form, it is unsurprising that the general concept of exercise is seen as harmful.

However, instead of recommending fully integrated rehabilitation with patients and clinicians working in partnership, NICE has chosen simply to downplay the evidence supporting graded exercise therapy and cognitive behaviour therapy, with the worrying consequence that these interventions will not be available in the future, even to those who would benefit. The updated guideline could have unintended adverse consequences for large numbers of patients, especially if used in the management of long covid.

Complex interventions for complex conditions are becoming the dominant healthcare reality, and if NICE is to serve any useful purpose in this arena, it needs to develop a more appropriate way to evaluate evidence. Existing evidence shows that some patients with CFS/ME do benefit from various components of rehabilitation, and our first priorities should be to identify who is likely to respond to which intervention(s), and to ensure that each patient’s needs are met.

This can only be achieved through systematic collection and longitudinal analysis of real life clinical data on a large scale. Rehabilitation prescriptions are one way forward. These are individualised records of patients’ rehabilitation needs and the plans to provide for them, alongside centralised data collection to track how well those needs are met over time.11 Proof of principle already exists within the major trauma pathways,12 and is now being extended into other areas, including long term care. Such long term observational research is no less important than randomised trials, and NICE should consider using alternative appraisal systems that are independent of trial design, providing a better fit for this kind of evidence.13

Above all, it is time to recognise that person centred rehabilitation, delivered over an appropriate period, is much more likely to provide tangible benefits than the piecemeal, disjointed efforts that continue to be fostered by the current NICE guideline methods.

Footnotes

Competing interests: The BMJ has judged that there are no disqualifying financial ties to commercial companies. The authors declare no other interests. The BMJ policy on financial interests is here: https://www.bmj.com/sites/default/files/attachments/resources/2016/03/16-current-bmj-education-coi-form.pdf.

Provenance and peer review: Commissioned; not externally peer reviewed.

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The BMJ over the years has been quite biased in the papers and editorials it has published.
But it has let through lots and lots of critical e-letters.

They don't need to be tight like letters for publication.

Best to avoid any ad hominems.

Best to include at least one or two references at the end. One obvious one is the piece you are replying to. Even webpages can count as references for this purpose as long as they're put along the bottom.

MSEsperanza · Dec 16, 2020

strategist said: ↑

(she also talks about how holistic individualized rehab is better in reality than in clinical trials but I wonder how she knows this - presumably she thinks herself free of bias, perfectly objective and more reliable than a clinical trial, which makes me suspicious that these people think of clinical trials as bureaucratic formality, not as method of acquiring knowledge)
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From the BMJ editorial:

Holistic integrated rehabilitation supplies the equivalent of a well tailored suit, fitted to the individual patient, with room for adjustment as needs change. It is more expensive in the first instance, but there is strong evidence for the effectiveness and cost efficiency of such bespoke programmes in other complex conditions. [9, 10].
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References for those "other complex conditions" are:

[9] Turner-Stokes L, Pick A,Nair A, Disler PB, Wade DT, Multi-disciplinary rehabilitation for acquired brain injury in adults of working age. Cochrane Database Syst Rev2015;12:CD004170. doi:10.1002/14651858.CD004170.pub3 pmid:26694853

[10] Turner-Stokes L, Williams H, Bill A, Bassett P, Sephton K., Cost-efficiency of specialist inpatient rehabilitation for working-aged adults with complex neurological disabilities: a multicentre cohort analysis of a national clinical data set. BMJ Open2016;6:e010238. doi:10.1136/bmjopen-2015-010238 pmid:26911586

Tom Kindlon · Dec 16, 2020

https://twitter.com/user/status/1339336829640855554

dave30th · Dec 16, 2020

Tom Kindlon said: ↑

https://twitter.com/user/status/1339336829640855554

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And check out the second sentence of his statement. He loved RCTs for CFS nine years ago, and we could have confidence in the PACE results. Now that NICE says PACE results are meaningless, it turns out Wade thinks RCTs can't provide good evidence.

“CFS is common, and it is vital to know whether treatments proposed and/or used are safe and are effective. Randomised controlled trials provide the best and only reliable evidence on safety and effectiveness of any intervention in any condition. The trial design in this study was very good, and means that the conclusions drawn can be drawn with confidence."

Sean · Dec 17, 2020

This change in attitude away from rehabilitative interventions is worrying,

Not if they don't work.

Jonathan Edwards said: ↑

But where is there a scrap of evidence for this? Randomised trials show that the effect is close to zero, especially when the y axis is displayed properly.
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I do like a good science burn with my porridge in the morning.

strategist said: ↑

She doesn't give any good reasons why clinical trials for therapist delivered treatments should be held to a different standard. All she says is that they can't meet high standards.
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Goalpost shifting is not science.

At least they are admitting, and in some detail, that they can't meet the minimum standards required for actual science.

MSEsperanza · Dec 17, 2020

MSEsperanza said: ↑

References for the "overall positive results of randomised evidence published since 2007". [3, 4, 5]

[3] = Cochrane review

[4] = A systematic review from 2015 I havn't heard of before, published by Clinical Psychology Review

[5] = PACE trial
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MSEsperanza said: ↑

References for those "other complex conditions" are:

[9] Turner-Stokes L, Pick A,Nair A, Disler PB, Wade DT, Multi-disciplinary rehabilitation for acquired brain injury in adults of working age. Cochrane Database Syst Rev2015;12:CD004170. doi:10.1002/14651858.CD004170.pub3 pmid:26694853

[10] Turner-Stokes L, Williams H, Bill A, Bassett P, Sephton K., Cost-efficiency of specialist inpatient rehabilitation for working-aged adults with complex neurological disabilities: a multicentre cohort analysis of a national clinical data set. BMJ Open2016;6:e010238. doi:10.1136/bmjopen-2015-010238 pmid:26911586
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In addition, reference [8] for "integrated rehabilitation takes a holistic approach" is authored by the editorial's co-author Wade and and all of the following references, including the references to rehabilitation after Covid-19, are lead-authored or co-authored by Turner-Stokes and partially by Wade.

[11] British Society of Rehabilitation Medicine. Rehabilitation in the wake of COVID-19: a phoenix from the ashes. 2020. https://www.bsrm.org.uk/downloads/covid-19bsrmissue2-11-5-2020-forweb11-5-20.pdf

[12] National Clinical Audit for Specialist Rehabilitation Following Major Trauma. Final report. Health Quality Improvement Partnership, 2019. https://www.kcl.ac.uk/cicelysaunders/about/rehabilitation/nhs-audit-report-v9-rgb.pdf

Jonathan Edwards · Dec 17, 2020

Isn't it extraordinarily insulting to refer to those who put together the harms observations as a few 'service users' - like the pesky people who leave garbage on public transport. Matronising at its most egregious.

Shinygleamy · Dec 17, 2020

rvallee said: ↑

What an impertinent, insulting thing to publish by BMJ. By someone who is not even party to any of this, with a ridiculous conflict of interest being a rehabilitation specialist whining that an invalid rehabilitation paradigm has been discredited.

More than anything this editorial is a whiny rant about the fact that their work cannot meet the standards of science and that this is unfair. It isn't. You are required to prove your claims in science. You cannot and never did. End of story. Being able to push it into practice without evidence means nothing. With time, reality always asserts itself and it finally did.

Everything is about them, their little person, how it affects them. They cannot possibly think of the larger consequences of their navel-gazing. They take no consideration for the enormous harm they leave behind.

Ignorant, impertinent and insulting. All normal things to publish in a medical journal. All very normal things by professionals.
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It reminds me very strongly of the dissolution of the slave trade. Those that that tried to stop it being abolished came up with all sorts of ridiculous arguments; black people are not human, etc, (a lot of todays racist beliefs came from that time) And who created these contentions? Slave traders.

Sasha · Dec 17, 2020

Always astonishes me that when considering secondary gains for patients, these people don't consider the primary losses.

chrisb · Dec 17, 2020

the update cites a “lack of evidence for the effectiveness of these interventions” despite the overall positive results of randomised evidence published since 2007.345

Since when has randomisation of evidence played a part in evaluation in scientific discourse? Perhaps the authors of the updates prefer evidence unrandomised.

This change in attitude away from rehabilitative interventions is worrying, as many patients do recover from chronic fatigue symptoms.

What does recovery from chronic fatigue symptoms have to do with it?

EDIT typo

Gecko · Dec 17, 2020

Not sure if anyone has yet pointed out on this thread that Turner Stokes is on the NICE Long Covid committee...

Edit to add evidence:

Greenhalgh noted that both she and Turner-Stokes were on the NICE committee for LongCovid and expected to see the COVID and CFS guidelines aligned on messaging
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https://www.s4me.info/threads/longcovid-and-cfs-nice-guidelines.17338/

Guessing Turner-Stokes at least won't want them to be aligned anymore!

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