NICE ME/CFS guideline - draft published for consultation - 10th November 2020

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Trish said:
https://www.bmj.com/content/374/bmj.n1937
Top right under Article Tools. Click on Respond to this article. You have to give your name etc. Be careful with the address - you have to fill it in, and it is published, so only give as much of your address as you want public. I just fill in UK.

You don't have to have a subscription.

You can't edit once submitted, so check carefully.

And you have to wait to see if it's got through. I made the mistake of thinking it hadn't and submitted again.

You get an automated email saying it's been received, and then you wait for an editor to approve it before it appears.
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Thanks @Trish @Caroline Struthers just submitted this* and got the auto-acknowledgement email.


*"Dear Editor

NICE published its draft updated guideline on ME/CFS on 10 Nov 2020. There are comments in this article re the quality of the evidence. If anyone is concerned re NICE's evidence review e.g. the determination that "The majority of the evidence was of low and very low quality"* then they have had had ample opportunity to challenge that [*page 317 -https://www.nice.org.uk/guidance/GID-NG10091/documents/evidence-review-7] .

Nor is there anything for researchers who e.g. wish to evaluate exercise, or psychological interventions, to fear from this review. Typically the studies determined to be of "low and very low quality" were unblinded and used subjective outcome criteria (questionnaires). Fluge and Mella e.g., who evaluated Rituximab in ME/CFS, used actigraphy/actimetry, an objective outcome indicator. In fact the PACE study was intended to include actigraphy/actimetry; however, these objective outcome criteria were dropped. Had objective outcome criteria been included in PACE then the quality of the evidence would not have been considered "low /very low quality". Of course objective outcome criteria are likely to have shown that exercise [GET] and psychological interventions [CBT] weren't effective.

To summarise, there is nothing in the NICE review for those wishing to carry out research into exercise, or psychological interventions, to fear - just those wishing to carry out "low and very low quality" studies using subjective outcome criteria (questionnaires) rather than objective outcome criteria (actigraphy/actimetry). From a Doctor's perspective there is a need for objective evaluation of interventions - the NICE review is therefore a step in the right direction.
 
Jonathan Edwards said:
I think the only rational interpretation is that the final report will stick to the draft.
There may be a minority report from those who stepped down but it might be hard for them to produce something that doesn't look sour grapes and isn't torn to pieces.
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There is a potential concern in that Dr Shepherd in the MEA’s account of his being ‘stood down’ (see https://meassociation.org.uk/2021/0...V7JoEubq4F7dJBMWvL4kcE4qRIYaDRsfiPk-le63aXaiU ) finishes with:

Before leaving the committee I have recorded my views on some changes to the guideline that have taken place following the Stakeholder consultation on the November draft and I will comment on these when the guideline is published. To do so before August 18th would break NICE guideline committee confidentiality agreements.
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Though I agree, given the three resignations, it is unlikely this involves any significant change of tack re GET or CBT.
 
FMMM1 said:
Typically the studies determined to be of "low and very low quality" were unblinded and used subjective outcome criteria (questionnaires). Fluge and Mella e.g., who evaluated Rituximab in ME/CFS, used actigraphy/actimetry, an objective outcome indicator.
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Not sure whether Fluge and Mella actually used actigraphy? - but anyway, isn't the point here that the relevant Rituxmab trial was properly controlled beacuse it was a blinded trial?

(Apologies for just popping in -- not able to catch up ATM.)
 
InitialConditions said:
I believe stakeholders are to receive the guideline two weeks before release date, which is today. Unless anyone else has any other information?
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As a Stakeholder waiting with baited breath I did too. Think I might ring and ask!

So, just rang ‘Rupert Franklin” lead on ME Guideline development at NICE
It should be released in a few minutes…

Also any stakeholder ‘committee' who compiled and submitted (and who signed up to confidentiality per say) will be permitted to have sight of it he said.
I week to respond...
 
Hutan said:
As annoying as the BMJ's mis-representation of facts is, it seems to me that the BPS gang have been rather short-sighted in taking on NICE.

I can imagine that those independent people appointed to the guideline committee won't be thrilled to have it suggested that (assuming things are as we expect and GET is gone) they have bent to the will of the noisy patients who just can't bear to have a mental illness label. I can also imagine all the NICE staff who carefully reviewed the evidence and pronounced it useless will not be feeling delighted to have it put about in the BMJ that they didn't do their job and instead just mindlessly believed the noisy patients.

So, it seems to me that this BMJ article (and any other publicity the BPS people produce against the guideline) might actually back-fire, strengthening the resolve of people with power who otherwise might not have been too bothered, to point out the flaws in the BPS studies and help ensure they stop happening.

The logical thing for BPS people to do at this point would be to very quietly put up the surrender flag on GET for ME/CFS, if necessary sacrificing those who staked their reputations on PACE and who refuse to go quietly. And then, carry on exploiting the desperation of the people with MUS and Long Covid labels by applying rebranded mind and exercise therapies. Indeed for those BPS people who can bend like the reed rather than stand against the storm like an oak, there will probably still be easy ways to keep being paid to provide 'CBT and GET-like' services to people with ME/CFS for a long time to come.
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I hope you’re right, but I’m remembering the SMC pushback when the CDC dropped its recommendations for GET and CBT in 2017. The SMC put out a factsheet saying CDC had caved in to pressure from activists, which it later revised (see thread). We hoped that was the end of CDC recommending CBT/GET but now we seem to be back to square one following the CDC treatment evidence review (thread). I would like to believe that the new Guideline will settle things once and for all with NICE, and that BPS pushback will fail, but history suggests it won’t be that straightforward and the CBT/GET hydra will keep growing more heads, no matter how many times it is decapitated.
 
Yes, I was also concerned about Dr Shepherd's reference to "changes" in the draft - although I doubt it is anything major, I was concerned about weakening of the language that would constitute loopholes. There is already far too much reference to physical activity in the draft and I can see how concerning language could be inserted into those sections to give room to operate.
I found it more likely that there would be some weakening of the position on CBT, as there is some confusion about what CBT for ME/CFS consists in and it's still supposed to be okay to offer it in some form as a "supportive" therapy. I expect people will have tried to take advantage of any confusion about CBT and GET (calling it "pacing", "individualised", etc). I hope it remains clear that CBT is not a treatment for ME/CFS; this point is often lost.

I don't know if it's too much to hope that the draft will be strengthened and clarified, not weakened to give the kinds of people who are resigning in protest space to operate.
 
In advance, thank you to our subgroup that collated our response to the November draft, who are also envisaging imputing time into considering this draft during this embargo period.

Do we collectively need to indicate our support for you responding on our behalf to any initial issues of fact, even though you are not able to share any such response with us at present? I personally am very happy that we collectively delegate to this sub group the authority to respond to NICE on our behalf any thing necessary during this embargo period, even though such responses can not be consulted on with the forum as a whole.
 
MSEsperanza said:
Not sure whether Fluge and Mella actually used actigraphy? - but anyway, isn't the point here that the relevant Rituxmab trial was properly controlled beacuse it was a blinded trial?

(Apologies for just popping in -- not able to catch up ATM.)
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I agree that the Phase iii rituximab study was blinded - I thought they also used actimetry (need to see if I can find the study protocol).

EDIT - @MSEsperanza this seems to be it:
"2. Physical activity (Sensewear armband) [ Time Frame: Analyzed at baseline and at interval 17-21 months ]
The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 17-21 months follow-up. Changes from baseline to analysis during the time interval 17-21 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. The difference between rituximab and placebo groups will constitute secondary endpoints."
https://clinicaltrials.gov/ct2/show/NCT02229942

FURTHER EDIT - I think the key thing with actimetry/actigraphy is that they allow you to evaluate unblinded studies. The great winge, from those carrying out studies re psychological and exercise interventions, is that they cannot effectively blind these type of interventions - actimetry/actigraphy provides a workaround. @Jonathan Edwards has highlighted that these folks talk about not being to carry out good quality studies (crap) and @Simon M has highlighted the simple rule of thumb - unblinded = objective outcome indicators.
Really it's what Jonathan highlighted - a lovingly polished meal ticket shown to be a dud.
 
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MSEsperanza said:
Not sure whether Fluge and Mella actually used actigraphy? - but anyway, isn't the point here that the relevant Rituxmab trial was properly controlled beacuse it was a blinded trial?

(Apologies for just popping in -- not able to catch up ATM.)
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Not sure about the rituximab study, but they did use actigraphy with the cyclo study. The team at Haukeland/University of Bergen did provide fitbit's for pwME some time ago for a study on activity levels, but I haven't seen the results from that.
 
Michiel Tack said:
They did. But, as you pointed out, their trial was also blinded, which makes the use of subjective outcomes not a big problem.
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I think they also used actimetry/actigraphy i.e. objective outcome indicators -
"2. Physical activity (Sensewear armband) [ Time Frame: Analyzed at baseline and at interval 17-21 months ]
The patients' physical activity level, in a home setting for 7 consecutive days, is recorded using Sensewear armbands, with registration at baseline and repeated in the time interval 17-21 months follow-up. Changes from baseline to analysis during the time interval 17-21 months, for mean number of steps per 24h, maximum number of steps per 24h, mean duration per 24h with activity level at least 3.5 METs, max duration per 24h with activity level at least 3.5 METs, are recorded. The difference between rituximab and placebo groups will constitute secondary endpoints."
https://clinicaltrials.gov/ct2/show/NCT02229942
 
Extract from:

Developing NICE guidelines: the manual
Process and methods [PMG20]Published: 31 October 2014 Last updated: 15 October 2020

[My highlighting]


https://www.nice.org.uk/process/pmg...ine#releasing-an-advance-copy-to-stakeholders

(...)

Process and methods

11 Finalising and publishing the guideline

11.3 Releasing an advance copy to stakeholders
Registered stakeholders who have commented on the draft guideline (see the chapter on the validation process for draft guidelines, and dealing with stakeholder comments) and agreed to conditions of confidentiality, are sent the final guideline, the evidence reviews and a copy of the responses to stakeholder consultation comments 2 weeks before publication. This information is confidential until the guideline is published. This step allows registered stakeholders to highlight to NICE any substantive errors, and to prepare for publication and implementation. It is not an opportunity to comment further on the guideline. NICE should be notified of any substantive errors at least 1 week before publication of the guideline.

11.4 Publication
The guideline, including evidence reviews, methods, NICE Pathway, key messages for the public and most support tools (see the chapter on resources to support putting the guideline into practice) are published on the NICE website at the same time.

11.5 Launching and promoting the guideline etc
 
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Peter Trewhitt said:
In advance, thank you to our subgroup that collated our response to the November draft, who are also envisaging imputing time into considering this draft during this embargo period.

Do we collectively need to indicate our support for you responding on our behalf to any initial issues of fact, even though you are not able to share any such response with us at present? I personally am very happy that we collectively delegate to this sub group the authority to respond to NICE on our behalf any thing necessary during this embargo period, even though such responses can not be consulted on with the forum as a whole.
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Absolutely. (My bolding.)
 
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