2018: Discussion on the NICE procedure: what to expect next?

Been reading through some documents from the previous NICE guideline procedure (Dolphin posted most of them in this thread). They give some insight into the normal course of events and what we could expect to happen next at NICE.

I think at the first stage the Guideline Development Group (GDG, what we previous called the guideline committee) is to set out a series of key questions that will form the basis for a subsequent evidence review. The previous time these questions were:

1) What are the existing case definitions for chronic fatigue syndrome in adults and children and what evidence exists to substantiate or validate these case definitions?​

2) Are there any substantiated or validated evaluations to support the diagnosis of chronic fatigue syndrome in adults and children? (Subquestion: In people presenting with early suspected CFS/ME (before 6 months) what are the risk factors/ prognostic flags that might be linked with progression to CFS/ME?) ƒ​

3) Does the evidence show that any particular intervention or combination of interventions is effective in treatment, management or rehabilitation of adults and children with a diagnosis of CFS/ME? (Subquestion: In people presenting with early suspected CFS/ME what interventions might be effective in preventing progression to CFS/ME?) ƒ​

4) What are the information needs of healthcare professionals, patients and carers?​

5) What are the support needs of healthcare professionals, patients and carers?​

It will probably be important to have the controversy surrounding the research on GET/CBT form a separate question, making sure it's not simply included in the more general search for effective treatment trials. A separate question for this issue will be required to go into depth on the methodological flaws of the studies and the patient surveys that indicate harm by GET/CBT.

Then it’s up to the technical staff to do an evidence review of these issues. Last time they were supported by a large report from the University of York. The problem was that this report only summarized RCT’s and mostly ignored patient surveys and scientific studies on PEM (these had to be assessed separately by the technical staff), making the evidence for GET/CBT look more solid than it was.

Last time the technical staff came from The National Collaborating Centre for Primary Care (NCC-PC), which was based at the Royal College of General Practitioners (RCGP). I don’t know how these relate to each other (if they are similar with simply a different name) but this time the technical staff comes from the National Guideline Centre (NGC). As Andrew Dillon explained in response to the letter by Graham et al.:

"We have commissioned the National Guideline Centre (NGC) to develop this guideline and they are responsible for managing the recruitment of the committee. Shortlisting and interviews are carried out by the chair or vice chair of the committee and the director of NICE’s Centre for Guidelines or an appointed deputy and/or a senior member of staff from the guideline developer. The NGC is a multi-disciplinary health services research team funded by NICE to produce evidence-based clinical practice guidelines on our behalf. It is hosted by the Royal College of Physicians (RCP) and it has governance partnerships with the Royal Colleges of General Practitioners, Nursing, Physicians and Surgeons and the RCP.” ​

The more NICE documents I read, the more I believe that these unknown NGC persons will have a stronger influence on the NICE guideline than the actual Guideline Development Group. The document provided in this post (see below, somebody shared it on a Facebook group) in which the NGC presented itself to ME/CFS stakeholders, indicates that they will “search for evidence, abstract, distil and synthesize.”

But their influence goes much further. Anyone who has taken a look at the minutes of the previous NICE meetings will have noticed that committee members mostly respond to a text that’s already there. I’m now pretty confident that the technical staff (the NGC) writes that text: they draft the guideline. The Guideline Development Group simply comments, gives directions and votes if a particular decision is to be made.

That corresponds with what Charles Shepherd explained in a talk to the Sheffield ME & Fibromyalgia Group (the Section on NICE starts around minute 42:30). Shepherd said:

“So the guideline group is now being brought together and the next stage is for the guideline group to then meet and then the evidence gathering process will start, so they will review all the published clinical trials […] So next year the group will be meeting - I think these sort of group meet every month or so, and they look at what’s coming in. The evidence is all analyzed by academics to give pointers to what is good quality evidence, poor quality evidence etc. etc. And then the process of writing the guideline starts. That’s what’s done by a professional team at NICE, it’s not actually done by members of the group themselves. And then the drafts are looked at, and then they go back to the stakeholders. […] And then finally […] the aim is to publish the guideline in October 2020.”​

The previous time, the GDG met on 15 occasions, at approximately monthly intervals.

Interestingly the GDG was aided in making difficult decisions (for example should ferritin or B12 be tested in making the diagnosis of CFS/ME?) by a questionnaire. All stakeholder organisations registered with NICE in May 2005 were contacted and asked to nominate 5 to 50 people with knowledge or experience of CFS/ME to take part in the questionnaire. Questionnaires were sent to 399 participants. Of these, 219 completed the questionnaire (119 patients, 29 cares, 63 health care professionals and 8 unknowns). The answers to this questionnaire were used to help the GDG in making difficult decision but overall there was "good agreement between the GDG and the wider group in most areas".

 

I’ve also been skimming through the comments on the guideline draft from 2006. These comments were very extensive, hundreds of pages long in total (not fun to read)... What struck me at first glance was how strong the opposition was to this guideline.

As far as I can tell all patient organizations (25% ME Group, Action for ME, Local ME, ME Research UK, ME Association, Blue Ribbon for the Awareness of ME, Invest in ME, Welsh Association of ME & CFS Support etc.) submitted a detailed critique, arguing that it’s inappropriate to promote GET and CBT. But what surprised me the most was how professional organizations were also criticizing the guideline, often making accurate points.

I will try to give a short overview below with some quotes, although as an outsider I can’t really judge if these came prestigious or rather marginal institutions. It would be great to hear thoughts and comments from patients or advocates who followed these events at the time, back in 2005-2007.


Association for Psychoanalytic Psychotherapy in the NHS (APP)
“we are concerned that NICE is misleading patients and health professionals on the question of CBT as the treatment of choice patients who suffer from CFS, and health professionals who try to care for them, are faced with a great deal of uncertainty in the evidence and unknowns in the causes and understanding of how to help this condition it is clearly unhelpful for people to be given misleading advice, or to have their expectations raised on a false basis: there is no evidence which supports CBT as having better outcomes relative to other psychological therapies; there is some evidence to support counselling having better outcomes, and being more cost-effective than CBT; there is also evidence that many CFS sufferers do not find CBT suitable as a treatment.”

Association of British Neurologists
“The draft guideline is fundamentally flawed because it presupposes certain interventions (CBT and GET) to be highly effective in CFS/ME for routine clinical use despite lack of adequate evidence. […] The guideline is also selective in its review of existing literature and is heavy influenced by psychiatric view of the condition. Indeed, it almost seems to the reader that a select group of psychiatrists with a polarised view of this complex condition is directing the development of the guideline from “behind the scene”. […]The guideline needs to be thoroughly revised to reflect our current understanding of this condition rather than the supposition of the psychiatrists.”

Cambridgeshire Neurological Alliance
"NICE purport these Guidelines to be in relation to CFS/ME which, in its very definition, is a Neurological Condition. Yet, these Guidelines contain no reference to the World Health Organisation (WHO) classification of “CFS” and “ME”, listed under WHO-IDC-10 G93.3, as a “disorder of the nervous system”. […]the very nature of the illness, be entitled to. It cannot be professed, imagined or even seen, that a “treatment”, “cure” or “prevention” of neurological conditions can be through “Graded Exercise Therapy” (GET), “Cognitive Behavioural Therapy” (CBT) and “Exercise Therapy” (ET) […] Furthermore, the evidence that is quoted as a basis for the NICE Guidelines, appears to strongly promote GET/CBT/ET treatments and therefore, appears not only biased, but also flawed, skewed and somewhat “thrown-together,” with a lack of the numerous medical and scientific research references that span more than fifty years regarding some of the world-renown Microbiologists, Virologists, Neurologist, Haematologists and immunologists in respect of ME and CFS/ME. It is noted, that many of the apparent “concocted” notions on CFS/ME being “managed, treated and cured” are the same named persons as those who appear as a very small group (trio, almost) of Psychiatrists, well known to have strong links with Medical Insurance companies, Department of Work & Pensions (DWP) Pharmaceutical companies, with their “wonder-cure” of “GET/CBT/ET”"

The British Psychological Society
"there appears to be an assumption in the drafts that any differences between subgroups are of no clinical significance. In other illnesses, differences are taken into account when determining management. This is true for diseases like breast cancer, and psychiatric disorders like depression. Why should CFS be different? […]Definitions of ME such as that of Dowsett and Ramsay could be evaluated and offered to GPs. […] Findings such as those by Innes 1970, McGarry et al 1994, Lane et al 1998, Natelson et al 2005 and Paul et al 1994 are difficult to explain in terms of the CBT model and underline the need for a more flexible approach to the illness. The evidence of ongoing infection and immune activation in this subgroup, plus studies of structural changes in muscle tissue and the effects of exercise on muscle strength (not documented as yet in CFS) means that GET (and challenging somatic attributions) may not be appropriate in this subgroup and that the draft needs to assess alternatives to exercise programmes, such as pacing. […]There are no trials of CBT or GET which show that these interventions are effective in patients with ME or strictly-defined (CDC 1988) CFS. All the trials showing benefits selected their patients using broader criteria (Oxford, CDC 1994). None reported an improvement in somatic symptoms. This aspect of the literature on CBT should be included in the draft. Science also provides us with a number of plausible reasons why any type of graded activity might not help subgroups like ME. ME is associated with an abnormal response to exertion which can last for more than 24 hours. Based on the findings of Paul et al (1999), any exercise during the ‘recovery’ period may well make these patients worse. This is supported by the work of Black and McCully (2005) […] Logically, one might argue that the post-viral group studied by Hickie et al (2006) is likely to require a different approach to patients whose fatigue reflects long term stress. Do we really want to offer a comparatively expensive intervention such as CBT to patients whose attributions are consistent with the history of their illness, who have a positive attitude and who are as active as their illness allow them to be (see cases 1 and 2)? Is this not overtreatment? […]The recommendations for CFS are therefore a little like offering everyone with headaches an aspirin plus advice to reduce stress. It’s fine for a lot of patients, but not good enough for those with migraine, cluster headaches and brain tumours."

Mid Staffordshire General Hospitals NHS Trust
"We do not believe, or accept, that “GET is appropriate and it is simply ludicrous to even suggest for the severely affected. […]The psychosocial bias which is evident throughout the NICE draft is exposed yet again.

"It is stated that “CBT or psychological approaches to CFS/ME do not imply that symptoms are psychological, ‘made up’ or in the patient’s head. It is used in many health settings including cardiac, cancer, diabetes and chronic pain as well as with mood disorders such as anxiety and depression.” This comparison is highly misleading as CBT is normally used as a back up for cardiac, cancer, diabetes and Multiple Sclerosis treatments and only used when the patient has problems coping with their illness or changes to lifestyle. To promote the automatic referral of PWME for CBT is tantamount to treating them as suffering with a behavioural disorder."

West Midlands Consortium
"It appears that NICE have started with the hypothesis that CBT works, and then attempted to support that hypothesis. […] There is far too much emphasis on GET, and we are concerned how the word ‘exercise’ is portrayed. It is being presented as something that 'leads to recovery.' We have seen no evidence of this.

"To talk about ‘symptom over-vigilance’ is offensive and should be removed. Does this appear in the M.S. NICE guidelines? ‘decreasing somatic attributions’ and address symptom over vigilance …’ This is offensive and based upon misguided opinion rather than evidence."

Royal College of Physicians of London
"We do not believe that an acceptable definition of CFS/ME has been adhered to. For instance, the commonly accepted definition for research and diagnosis is that of Fukuda et al 1994. The consensus group here have presented their own definition, which really describes fatigue for four months in the adult, with one, of a limited number, of other symptoms. This opens up the diagnosis from CFS/ME into a wider remit of fatigue disorders and not what is Generally accepted in medical practice as the heterogeneous group of fatigue conditions known as CFS. […]It also states the therapies of first choice should be CBT or GET. We feel that these are not either/or therapies, but quite different in their total effects and would be additive. The major studies on GET have only been used in ambulant patients who are able to travel, and never in isolation but always with a General management package, including recommendations for lifestyle changes etc. Clinical evidence and patient experience suggests strongly that some patients may be worsened with GET and more emphasis should be stated that it should be used in individuals who are able to sustain regular day to day activities and that appropriate supervision would be required.

"[…] This is managing setbacks: We think this is a potentially dangerous statement, that with increase in CFS/ME symptoms, exercise or physical activity should be maintained if possible to avoid the negative effects of deconditioning. not aware of any clinician who would make this recommendation, except in a very mildly affected patient. There are many reasons for setbacks in CFS, including excess physical activity or stress. If this is the case, and activity levels remain unchanged, the patient is at risk of having a more major or serious relapse."

Sheffield South West Primary Care Trust
"The narrow focus of the NICE Guidelines may lead to helpful approaches or creativity being undermined and patient preference/clinical judgement being undervalued."

British Association for Counselling and Psychotherapy (BACP)
"It would be a shame to antagonise patient groups, which are often not convinced by the benefits of CBT as demonstrated in clinical studies. (We refer again to the Action for ME survey findings above). By putting the shared care recommendation first, the guideline underlines its commitment to good communication and the patient staying in control of their treatment, etc."

The Chartered Society of Physiotherapy
"Do not agree that evidence base is strong enough for GET. […] GET is dangerous without activity management first and without pacing included to take symptom management into account with any increased physical or mental activity."

 

Exactly, which is the point I have been making, in that the RCP are the powerhouse and instigator of most of the problems it would appear with constitution of the GDG....."The NGC is a multi-disciplinary health services research team funded by NICE to produce evidence-based clinical practice guidelines on our behalf. It is hosted by the Royal College of Physicians (RCP)......." They are also 'contractors' and 'untouchables'.....

 

Wow. In context of current situation it may be worthwhile making these extracts public.

 

Wonder if a certain neurologist (AC) who attended the January NICE meeting had a hand in this. If so, thank you!
He managed a very good question right at the outset about "evidence" and grading of the available evidence. The question was not adequately answered by Sir Mark Baker......

 

Yes.........but then along came the PACE trial..........

 

Good grief - I wasn't completely with-it when reading this, and assumed that it was comment on the new recommendations. It looks as though it was completely ignored.

 

Back in 2007, one of three lay members, Tanya Harrison, resigned from the committee. “I fear that when this guideline comes out, I, and hundreds of thousands of other patients, will be worse off", she wrote.

Harrison felt that many problems stemmed from the scope of the guideline and the York Review: “the question posed by the York team looked for papers on ‘GET and ME/CFS’, it did not however search for papers on ‘Exercise and ME/CFS’, and this meant that the many papers showing the potential harm of exercise on the bodies of people with ME/CFS, and that people with ME/CFS react adversely to exercise were not picked up, and no matter how many times I brought them up in the meetings, I was told that the scope of the guideline meant that they could not be discussed.”

Two patients with ME, Douglas Fraser and Kevin Short, brought matters to court and managed to achieve a Judicial Review into the 2007 NICE Guideline. They challenged not only the emphasis on GET and CBT but also that NICE had broadened the diagnostic criteria as to what can be diagnosed as ME/CFS. Unfortunately they lost on all grounds.

Then finally there are the recent petitions for reviewing the 2007 guideline and for withdrawing the GET/CBT recommendation in the meantime. Both have more than 10.000 signatures.

So it’s seems like the 2007 NICE guideline CG53, could very much be the most contested and protested in NICE's history.

Does anyone has examples of NICE guidelines that were equally controversial?

 

Thank you @Michiel Tack for reviewing the process followed in 2007, and reminding us/ revealing what a distorted process that was.

 

2006 response to draft guideline from Association of British Neurologists:

...which not only failed to provide any reliable evidence to support the claim that CBT and GET are effective treatments for ME/CFS, but, as @Jonathan Edwards points out in his letter to the Scottish Parliament, actually tells us that the theory behind the CBT/GET treatment is wrong:

And yet, in the 2017 10-year surveillance report on the NICE guideline the Association of British Neurologists wrote:

 

Surprisingly good comments.

This opposition and the fact that the review is happening at all because past objections turned to be entirely correct need to be a big part of the discussions. The fact that the last normal process lead to such a catastrophic outcome should make it clear that the standard approach cannot work here, as it has already failed. To repeat the exact same mistake is simply unacceptable.

This is the context in which the review is happening: the normal process failed massively. This has to be explained. It has to be put in context as to why it failed the last 2 times (including the 2017 continuation). This is absolutely not normal. I doubt there is much precedent for clinical guidelines that are this strongly objected and nearly universally objected to by patients.

And the current guidelines have had over a decade to prove themselves so the decade+-old subjective research that supported the current guidelines have to cede most of its ground to real-world data from the implementation of the guidelines. Where is this data? By what measure were the guidelines continued in 2017? On what basis of success?

 

Yes that all seem very clear.

Wow. these comments are reallllly disturbing. Esp the ones from Neuros & RCP.... if that was what they said then (pre PACE & all the other bullshit of Crawley et al taking them in).... & the guideline still turned out as it did..... what hope is there for us now - when it is evident every official org - neuros, physios, NHS etc has drunk the coolaid & would no longer make the same comments today - sold on the BPS paradigm as they now are, in their ignorance.
They were all clearly skeptical before - they're fully on board the BPS bandwagon now!

God help us.

 

It looks like the NCP will draw up something truly catastrophic & it will be lovingly welcomed by all except a few patient orgs who will be written off as 'anti science activists'. I really do feel properly afraid for the future now.

But at least when the truth comes out the change in attitude fo all these groups will be yet more very clear, traceable evidence of the influence of the BPS BS - so it may be easier to hold people accountable

 

Nice mention by the Cambridgeshire Neurological Alliance of the Unholy Trinity.

 

Ah, so that's not a professional group?

 

I'm not sure I understand your question so I'll clarify my statement which was a little vague.
The CNA mentioned in their statement that there seemed to be three people in psychiatry (they did not name them) who were responsible for most of the push to use CBT/GET in ME (their names popping up routinely everywhere in this regard).

I take that to mean Wessely, Sharpe and White. And it was me who christened them the unholy trinity (which was why I was kinda vague, as I was being naughty).

 

Now we're a decade after NICE promoted CBT/GET, the professionals and 'experts' are going to be those who have worked within these guidelines. This entrenched power is going to make it extremely difficult to make any progress, especially as it seems that the systems around NICE ended up appointing people like Burton to the guidelines committee.

 

As has been remarked before, history records few examples of rats boarding sinking ships. They will do so at their peril. People are starting to notice.

 

The PACE Trial for chronic fatigue syndrome: choppy seas but a prosperous voyage
A large clinical trial might be said to resemble an ocean liner, which is leaving Southampton to sail to New York. It is a complicated system. There will be a captain on the bridge and a large crew. They will have filed a course some time before they set sail, but not everything can be foreseen in advance; the weather for example. Sometimes small corrections to the route will need to be made en voyage. These will be meticulously recorded, authorised by the ship’s owners, otherwise known as the Trial Steering Committee, which can overrule the captain if needed. Occasionally something happens; the vessel is seaworthy, the cabins are ready, and the band has started playing, but the ship never sets out, most often because they can’t get enough passengers on board to make the voyage worthwhile. Very occasionally there is a shipwreck, but this is very rare. Few trials suffer the fate of the Titanic, but sometimes the ship gets to the USA, but not to New York, but some other place; destination changed en route, which is considered bad form. In that case, people may debate for years afterwards what actually pushed them off course, and what that means. But most often the ship does eventually dock in New York, with satisfied passengers, and a tired but relieved crew.

Such a ship was the clinical trial known as PACE, standing for Pacing, graded Activity, and Cognitive behaviour therapy: a randomised Evaluation. It was a very large ship, one of the largest of its kind, and its voyage was undoubtedly one of the choppiest crossings ever.