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

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.

 

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:

Though I agree, given the three resignations, it is unlikely this involves any significant change of tack re GET or CBT.

 

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.)

 

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...

 

Have rung and been told today any minute now!

 

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.

 

Email received.

 

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.

 

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.

 

Email to stakeholders from NICE with final guideline.

 

They did. But, as you pointed out, their trial was also blinded, which makes the use of subjective outcomes not a big problem.

 

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

 

Absolutely. (My bolding.)

 

I have not received it yet despite being registered for LOcalME https://www.nice.org.uk/guidance/gid-ng10091/documents/stakeholder-list

 

Yup. We don't meet quacks in the middle.

 

I've not received anything yet, and unless they are working overtime I assume I won't see anything until tomorrow now.