Contribute Evidence for NICE consultation

[Jenny TipsforME]

You have probably heard that despite the huge controversy around PACE, GET etc etc NICE are still inclined towards no update to the UK clinical guidelines!
[insert expletives ]

They have however given stakeholders a two week window to change their minds.

This isn't a very accessible situation for stakeholders like us over at ME Action Network UK as patients of very few spoons.

We need persuasive, well organised evidence and we need it fast! [but we don't need loads and loads of info we can't read]

If you think you could help organise evidence send me a direct message.

 

[Jenny TipsforME]

From what I can tell of NICE, the type of info that is likely to persuade them is

• New (from 2013- as they've looked at evidence that existed then)
• /UK based, it is hard to get a grip on this, but they seem to prefer research from the UK
• /Gives info on cost effectiveness

Topics we will likely cover:

-Nature of bio problems with objective evidence (recent/UK)
-Papers showing worse after exertion (exercise stuff)
-Papers critical of PACE
-Null results from CBT/GET
- POTS and OI in ME /treatment
- treatments approved in other countries
- Patient surveys on CBT/GET

Added:
-Updates from other health agencies

If you were going to pick just one paper to reference for this what would it be?

 

[RogerBlack]

I am extremely unsure if only one paper is appropriate.
All of the recent White and crowd papers will be submitted as arguments for increasing the push on CBT, for example.

Unpublished null - FINE,

https://twitter.com/i/web/status/880674481206960128

's mentioned paper.

As additional topics:
Other health agencies recently updated recommendations. (The CDC ones, for example.)

A good overview of the exercise->normal-exercise-symptoms->fear-avoidance->rest->deconditioning->exercise alleged loop, and why it doesn't work physiologically with what we understand of muscle behaviour. (which is fine, but they don't then go on to say anything about other pathology other than fear-avoidance, which is ridiculous).

Harms to patients being poorly recorded. For example, for PACE, if you go from full-time, to part-time employed, or from able to potter about in the garden and keep up with housework, to being mostly bedbound, permanently, you will not be counted as having worsened. (unless your carer gives up).

Clear counterfactual statements from those promoting CBT.

 

[Jenny TipsforME]

Thanks, other health agency updates should definitely be included. I'll add that above.

I don't know about harms being badly recorded. Personally I agree it's an issue. Will NICE take it on board?

I am extremely unsure if only one paper is appropriate.

We'll use much more than one paper of course Just an attempt to structure the conversation here as our ability to read is limited, and if 20 people suggest 20 papers each, it will quickly become an impossible task.

 

[A.B.]

I think the hardest evidence is the whole subjective outcomes, lack of blinding, lack of improvement on outcomes less susceptible to bias.

This single handedly destroys the positive results from the entire CBT/GET evidence base. The implications are that the effectiveness of CBT/GET may be (and probably is) nothing more than an illusion. It does need to presented well though.

 

[Jenny TipsforME]

@A.B. The recent Journal of Health Psychology articles will be useful as peer reviewed papers on this topic eg

http://journals.sagepub.com/doi/full/10.1177/1359105317707531#.WR3PJLhyZtg.twitter

"The controversies surrounding the effectiveness of cognitive behavioural therapy and graded exercise therapy for chronic fatigue syndrome are explained using Cohen’s d effect sizes rather than arbitrary thresholds for ‘success’. This article shows that the treatment effects vanish when switching to objective outcomes. The preference for subjective outcomes by the PACE trial team leads to false hope. This article provides a more realistic view, which will help patients and their doctors to evaluate the pros and cons."

 

[charles shepherd]

We obviously have a long list of key concerns, along with patient and published evidence, at the MEA that supports the need for a NICE guideline view

However, before people start putting a lot of time and effort into collecting relevant evidence, I think it would be sensible to wait till stakeholders have been notified about the way in which this consultation process is actually going to take place

Having carried out what NICE will regard as a thorough review of all relevant published evidence by their expert group they will not be doing anything to encourage stakeholders (or anyone else) to submit yet more evidence

So I suspect that they may well issue stakeholders with a very structured form to complete - which will be aimed at producing comments on the decision by the expert group, and how they have made their decision, rather than an offer to go into information overload and agree to examine whatever new evidence stakeholders want to submit

There is. of course, nothing to stop individuals sending in comments and information to NICE. However, this may just be ignored - because the consultation process is almost certainly going to be restricted to stakeholders

Dr Charles Shepherd
Hon Medical Adviser, MEA

 

[Jenny TipsforME]

@charles shepherd thanks, MEActNet haven't been stakeholders before so we're learning how it works. The timeline is tight if we can submit evidence. Seems poor if we can't. It hadn't occurred to me they'd structure it so we can't point to evidence!

Perhaps best to pause until Monday and see what we get emailed...

 

[Jenny TipsforME]

Trying hard to rein in my outrage at an injustice that may in fact not happen!

 

[dangermouse]

Trying hard to rein in my outrage at an injustice that may not in fact happen!

Me too. It's about time NICE did the right thing. As they have good evidence from the MEA why are they even thinking of not reviewing? How is it ethical to maintain guidelines that include GET and CBT?

 

[charles shepherd]

Also important to note that NICE produce guidance for UK health professionals on CLINICAL ASSESSMENT, DIAGNOSIS and MANAGEMENT

So the evidence they are interested in essentially relates to these three topics - which mainly means data from clinical trials involving treatments for ME/CFS

NICE have very little interest in research findings in relation to the causation of conditions they cover

CS

 

[Large Donner]

Do we have the names of the people on the panel, who are they and have they or do they have any connections tot the BPS crowd?

 

[charles shepherd]

Do we have the names of the people on the panel, who are they and have they or do they have any connections tot the BPS crowd?

Simple answer is no

Worth having a look at the other discussion on the NICE guideline review - where I have explained that I have written to NICE to ask for details of membership of the expert group. No reply so far……..

I suspect that the answer all be NO!

CS

 

[Large Donner]

What I was also trying to ask was is there an advisory panel and also a board as such, who are separate and make the decision after gathering evidence from advisers, essentially is there a chair person?

 

[Jenny TipsforME]

@Large Donner yes I'm trying to get a handle on that type of dynamic. Will the people looking at our responses be the same people who have already said they don't think it needs updating?

 

[Large Donner]

If we take the FOI tribunal for example there were 3 judges, then also one party for and one party against who presented evidence and the decision was based on the content of both arguments.

It would just be a ludicrous situation if the decision for the NICE update is based upon who brings the most mates with them and one persons job is solely to count hands without collecting evidence, making public all transcripts and using critical judgement to make a decision with the right of appeal, as in all other processes.

I think the individuals who make the decision now need to know that we are all prepared to file a mass law suit against them as individuals if they fail to protect the patient population after being presented with the obvious evidence that CBT and GET have been a vested interest project for 3 decades.

 

[Esther12]

Not sure if this has any implications for us, but thought I'd post it, as it was in something I was reading:

6.5 Conditions associated with stigma
Some conditions, for example, se
xually transmitted diseases and drug
dependency, are associated with stigma. NICE does not consider that stigma
itself is a reason for altering its normal approach to assessing cost
effectiveness. However, NICE is aw
are that stigma may affect people’s
behaviour in a way that changes the e
ffectiveness of an intervention and that
the relief of stigma may not always be
captured by routine quality of life
assessments. Therefore, NICE expects
its advisory bodies to take these
considerations into account.

https://www.nice.org.uk/Media/Defau...ples-for-the-development-of-NICE-guidance.pdf

 

[Valentijn]

They should not be creating an evidence base from trials which don't primarily recruit with an ME/CFS criteria. It is simply absurd that Oxford fatigue studies are used to create recommendations for the treatment of patients who have a disease where PEM (even according to NICE) is a core symptom.

The past guidelines were heavily flawed as a result, and a lot of the prior evidence base needs to be thrown out.

 

[Jenny TipsforME]

@slysaint Yes we've received that info by email from NICE. Thanks for checking though.

@AndyH If you look at the stakeholders list you can see why it's important to have as many patient orgs as possible on the list, we're really outnumbered: https://www.nice.org.uk/guidance/cg53/documents/stakeholder-list-2

Several organisations saying more or less the same thing is going to be more powerful. This should be something we can pull together on.

 

[slysaint]

It will obviously take a while to wade through the document and make notes.

Haven't read it all yet but when it says there are 51 publications (7 stemming from PACE), that support the use of CBT/GET does it list which ones and who they are by?
I would think that if they are all by/include one of the same group of authors that should raise some concern(tho obviously it hasn't). I imagine they might also all use the Chalder fatigue Questionnaire created for PACE which is an entirely subjective measure and not fit for purpose when dealing with a fluctuating illness.

But I think the key issue is to hammer home that those who carried out these research trials openly admit that their research was based on their key belief that ME is psychosomatic inspite of all the evidence that proves to the contrary.

eta: I have just posted a rough tally of who wrote what, on the other thread