Bad news to the MEA from NICE: no review considered necessary

[slysaint]

but the consultation is only two weeks, starting Monday

so that's two weeks from Monday, so the 24th is the 'deadline'(?)

The NICE question time in Basingstoke is on the 19th.
Would it not be a good idea to have representatives there to ask pertinent questions; even maybe present a petition or the letter demanding retraction of PACE or whatever?
"Attendees will have an opportunity to put their questions to David Haslam, Chair at NICE."

@charles shepherd
@Jonathan Edwards (your opinion would be very welcome).

 

[Jenny TipsforME]

I have it down as 10th to 21st @slysaint so 2 work weeks, less than a fortnight.

 

[Stewart]

I don't call ten years between the last guidelines and now as "regularly considered for review", unless there have been other times since 2007 (?)

There was a review consultation at the end of 2010 - with the decision published in early 2011 - which decided (wait for it...) *not* to review the guidelines at that time, due to an absence of new evidence that would have a significant bearing on NICE's recommendations.

A decision was later made in 2013 to move the CFS/ME guideline to NICE's new 'static list', meaning that it would subsequently be reviewed less regularly than would normally be the case.

 

[slysaint]

A decision was later made in 2013 to move the CFS/ME guideline to NICE's new 'static list', meaning that it would subsequently be reviewed less regularly than would normally be the case.

Raises more questions:
Decision made by whom? Why did they come to this conclusion (altho I can guess it had something to do with the ruddy PACE trial again)? Where were the patient representatives and ME charities?

So much for NICEs charter pledge of Transparency:
"Transparency
Clear processes underpin our work."

The processes might be clear to them but I would hardly call them transparent.

 

[Stewart]

Raises more questions:
Decision made by whom? Why did they come to this conclusion (altho I can guess it had something to do with the ruddy PACE trial again)? Where were the patient representatives and ME charities?

So much for NICEs charter pledge of Transparency:
"Transparency
Clear processes underpin our work."

The processes might be clear to them but I would hardly call them transparent.

I don't think NICE's problem is a lack of transparency - when they made the decision to move the CFS/ME guideline to the static list (from memory, the justification was that they were unaware of any research due for publication in the next couple of years which was likely to have a significant bearing on their recommendations for CFS/ME) they publicised in advance that they were minded to do this and sought stakeholder feedback before making a final decision. I know that the MEA and AfME submitted objections to the change - as did other charities - but NICE went ahead with it anyway.

(You can read the documents relating to the development of the CFS/ME guidance on NICE's website -
https://www.nice.org.uk/guidance/cg53/history - including the submissions from stakeholders relating to the static list decision and NICE's responses - https://www.nice.org.uk/guidance/cg...ncephalomyelitis-static-list-review-decision2 (starts on page 55).)

I think the problem is more that NICE's 'clear processes' won't produce guidance that is "based on the best available evidence of what works" if the "independent and unbiased Committees of experts" who develop that guidance are unavoidably - given the criteria for their recruitment - and obviously totally biased before they've even looked at the evidence (quotes taken from 'Developing NICE Guidance: the Manual', section 1.4).

The expert review committee who have just recommended 'no change' (again) to the guidance will have been composed of a) representatives of the committee who drew up the initial guideline, and b) CFS/ME 'experts' who work in/with the NHS - ie people who offer CBT and GET as part of their job. What incentive do *any* of these people have to acknowledge that the evidence base for these treatments is non-existent, when they almost certainly *all* have a history of pushing these treatments in the very recent past?

Either NICE understands that this is an usual situation and that they need to be willing to overrule an 'expert' committee which is unavoidably compromised - or this whole 'we'll bring the review process forward 12 months' undertaking is a short-sighted attempt at fobbing-off patient groups which could easily create more problems for them than it solves. One minute NICE says there *is* sufficient new evidence to justify bringing the guideline review forward - then the next it says there's *not* sufficient new evidence to justify a review after all. That's not an easy position to defend or explain...

 

[Aurator]

Some of the inclusions on that list are just bizarre. Who decides who the stakeholders are?

What would concern me more, if I didn't already think the consultation with "stakeholders" was an empty gesture, is how stakeholders' responses are to be weighed. Does sheer weight of numbers for or against change win the day, or do certain stakeholders have more influential voices in the decision than others? For all we know, some stakeholders (probably the ones who have demonstrated that they actually know something about ME, or at least know what it isn't) may have no influence at all.

I'm sceptical whether the prime movers at NICE are even willing to accept that ME/CFS is not a psychiatric illness. If they were, they would want to do something to try and understand it better, which they very plainly are not doing, and show strong signs of having no intention of doing.

 

[Deepwater]

What would concern me more, if I didn't already think the consultation with "stakeholders" was an empty gesture, is how stakeholders' responses are to be weighed. Does sheer weight of numbers for or against change win the day, or do certain stakeholders have more influential voices in the decision than others? For all we know, some stakeholders (probably the ones who have demonstrated that they actually know something about ME, or at least know what it isn't) may have no influence at all.

I'm sceptical whether the prime movers at NICE are even willing to accept that ME/CFS is not a psychiatric illness. If they were, they would want to do something to try and understand it better, which they very plainly are not doing, and show strong signs of having no intention of doing.

The problem is systemic, isn't it? The NICE committees on CFS were initially set up in order to ensure the disease remained firmly in the psychiatric camp (isn't there a remark by a politician at the time, in one of the documents that used to be classified, to the effect that they should have only psychiatrists on the panel?). Since then the gov. has declared itself unable to meddle with NICE, and the rigging and stuffing with vested interest groups has become self-perpetuating. The inclusion of the odd individual from the other side is mere window dressing. There is no more likelihood of persuading this bunch of self-serving stakeholders that ME is biological and needs to be treated as such than of persuading a slice of green cheese out of the Man in the Moon. The pressure has to be external as well - we need the media on our side and we need to somehow find the strength to a level of legitimate fuss that cannot be ignored.

 

[slysaint]

including the submissions from stakeholders relating to the static list decision and NICE's responses - https://www.nice.org.uk/guidance/cg...ncephalomyelitis-static-list-review-decision2 (starts on page 55).)

I could only find one 'agree' on this from Greater Manchester Health, all the others were disagree, but not all stakeholders appeared to have commented. Does this mean there is some kind of 'default' agree?

On the current comments form it looks as if the current proposal is NOT to update the guidelines but it is to remove CFS/ME from the static list:
https://www.nice.org.uk/guidance/cg53/documents/comments-form

"
Stakeholder consultation comments form - proposal for ‘no update’"
Consultation on the proposal for ‘no update’ opens on: 9am Monday, 10 July 2017

Comments on proposal to be submitted: no later than 5pm Friday, 21 July 2017"

The 4 questions are:
Do you agree with the proposal not to update the guideline?

Do you agree with the proposal to remove the guideline from the static list?

Do you have any comments on areas excluded from the scope of the guideline?

Do you have any comments on equalities issues?"

This is the surveillance review proposal:
https://www.nice.org.uk/guidance/cg53/documents/surveillance-review-proposal

This is worth a read (although it is long ;56 pages).
"
Surveillance proposal for consultation
We propose to not update the NICE guideline on chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy)at this time.
We propose to remove the guideline from the static list because:
 Evidence has been identified of important ongoing research in this area
–
for example a UK trial of internet-based cognitive behavioural therapy in children and young adults. This guideline therefore no longer meets the static list criteria"

I can't believe out of all the research, that FITNET is cited as an example to justify removal from the static list
I wonder who put that forward

eta: I've only got up to page 9

 

[slysaint]

From the same proposal:
"
Cognitive behavioural therapy (CBT) and graded exercise therapy (GET)
Fifty one publications (7 stemming from the PACE trial) on CBT and GET
were identified by the current surveillance review, with most studies generally
showing better outcomes with CBT and GET (such as reduced fatigue, and
increased functioning)"

I think the only way we will get change is by getting PACE and all associated research thrown out
eta: The Cochrane review is definitely a major problem.

 

[RogerBlack]

Page 32 of the proposal goes into the commentary around PACE.
In amongst saying 'if PACE evidence was downgraded, other trials prove...' (failing to note the effect on meta analysis). Also they seem to say 'these criticisms have been raised' - see the FAQ by the PACE authors.
Without significantly investigating the claims.

Oh dear.
'Peer reviewed study reports were assessed by abstract'. P2.
They diddn't actually read and assess the papers to see if the crticisms were legit.
(though as a significant number of the panel seem likely to have been involved in PACE, to be fair, they probably know the weaknesses already)

 

[Stewart]

Page 32 of the proposal goes into the commentary around PACE.
In amongst saying 'if PACE evidence was downgraded, other trials prove...' (failing to note the effect on meta analysis). Also they seem to say 'these criticisms have been raised' - see the FAQ by the PACE authors.
Without significantly investigating the claims.
)

Also from Page 32:

An update of the AHRQ report suggests that after trials using Oxford criteria were removed from the systematic review, there is insufficient evidence that CBT improved physical function, fatigue, quality of life, and employment. Trials using Oxford criteria were eligible when developing NICE guideline CG53, and topic experts had no concerns about the inclusion criteria of trials in CFS. It was also noted by topic experts that there is no gold standard definition of chronic fatigue syndrome.

It's almost as if NICE's topic experts are completely unfamiliar with the very NICE guidance that they're supposed to be considering updating. It's not about 'gold standard defnitions' - trials using the Oxford criteria are inconsistent with NICE's own definition of CFS/ME, as set out in the existing guideline (at points 1.2.1.2 and 1.3.1.3).

 

[Valentijn]

'Peer reviewed study reports were assessed by abstract'. P2.

There is no excuse for such lazy incompetence. Review by abstract is simply not acceptable, intelligent, nor scientific.

 

[sarah darwins]

Oh dear.
'Peer reviewed study reports were assessed by abstract'.

It’s like reading the blurb on the back cover of a volume of Proust and then offering an opinion on Proust. I mean, don’t get me wrong, I’ve done it — but I did have the decency to feel thoroughly ashamed of myself

 

[slysaint]

trials using the Oxford criteria are inconsistent with NICE's own definition of CFS/ME, as set out in the existing guideline (at points 1.2.1.2 and 1.3.1.3)

@Jenny TipsforME
@charles shepherd
something else to be emphasised.


Also Crawleys definition 'Chronic disabling fatigue' (CDF) which is the core symptom used in a lot of her papers; although she says she uses the NICE definition of CFS.

 

[Sean]

It was also noted by topic experts that there is no gold standard definition of chronic fatigue syndrome.

That doesn't mean anything goes.

'Peer reviewed study reports were assessed by abstract'.

That is totally unacceptable.

 

[Esther12]

I've just read their pacing section. It would be worthless to psuh for a recommendation of 'pacing' imo. We should be pushing for them to make no treatment recommendations at the moment, and recognise how seriously flawed the research claiming to show CBT and GET are effective is.

 

[Mrs Sowester]

treatment for POTS/OI would make a difference to many

 

[Cinders66]

For me NICE on their early pages need to emphasise that this is chronic systemic disease made worse by exertion, ( no wish washy stuff about debilitating fatigue, accompanied by 1 or other symptoms of unknown cause) & that patients severity can range from the mild to the bedridden and that doctors first job is to put in proper support and management so that the patient doesn't deteriorate further. The harm of poor management or repeated over exertion needs to be emphasised and I'd take the opportunity to change the name from CFS and a fatigue focus to SEID. Core symptoms of various subgroups should be discussed

The quality of life research, lower than most illness needs to be highlighted so that our Drs actually grasp the seriousness and impact of what we are dealing with

Bits could just be largely copied from the other good guidelines available, what we don't want are know nothings and Crawley types deciding things. The fact Crawley and santhouse (dubious IMO psychiatrist) were involved in the last guidelines formation makes sense.

The American low regard for CBT/GET on the CDC website and in other places can't continue to be ignored and only when CBT& GET are put in their proper place will our Drs themselves start clamouring for other effective alternatives to put to this burdensome patient group.

 

[Esther12]

treatment for POTS/OI would make a difference to many

Yes, sorry, I meant for ME/CFS specifically, with needing a greater emphasis on identifying sub-types and alternative diagnoses which do have worthwhile treatments.

 

[RogerBlack]

The harm of poor management or repeated over exertion needs to be emphasised and I'd take the opportunity to change the name from CFS and a fatigue focus to SEID.

I don't disagree on this.
There is exactly zero research on this topic, other than what is either anecdotal, or self-selecting patient surveys however. Which will _NOT_ make it into the guidelines, unless the panel is of a wholly unexpected composition.

Others have mentioned CBT and GET should be removed.
The problem with this is the guidelines say that treatment should be 'patient focussed' and 'ability to refuse any treatment' or similar.
This means you have to get past not only the hump of 'maybe harmful' to 'the average doctor and patient will be mislead and cause harm'.

In reality, there are effects not captured in the guidelines.
Someone turns up at their GP feeling crap, and gets a diagnosis of CFS. They are not at this point at a place where they can debate NICE guideline criteria.

I was surprised to see the first result "chronic fatigue syndrome uk" is a reasonable charity based page.
However, it does have 'ad' next to it.
http://www.nhs.uk/conditions/Chronic-fatigue-syndrome/Pages/Introduction.aspx - popped up as expected as the first non-ad link.

Which contains such gems as 'Most people with CFS get better over time, although some people don't make a full recovery' .

(it does however link below that to the me association website.).

On the treatment page, it contains:

CBT is a talking treatment that can help you manage CFS/ME by changing the way you think and behave.

It can help you to:

• accept your diagnosis
• feel more in control of your symptoms
• challenge feelings that could prevent your symptoms improving
• gain a better understanding of how your behaviour can affect the condition

Your CBT therapist will ideally have experience of dealing with CFS/ME and treatment will be offered on a one-to-one basis.

Using CBT doesn't mean CFS/ME is considered to be a psychological condition. It's used to treat a variety of long-term conditions.

Which notably fails to explain that this is NOT vanilla CBT, but 'illness denying' CBT.