NICE ME/CFS draft guideline - publication dates and delays 2020

See

NICE Draft Guideline Submission

 

"Registered stakeholders who have commented on the draft guideline are sent the final guideline, and comments and responses, in confidence 2 weeks before publication."

From: https://www.nice.org.uk/process/pmg...delines-and-dealing-with-stakeholder-comments

"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."

(From the chapter on finalising and publishing the guideline)

I realize that it says "in confidence" but what does this mean for the forum as a stakeholder?

Will only the committe see the final guideline but is it possible that you tell us members when you will have received it?


(Not edited for grammar/language because I can't figure out atm which words and grammar that last sentence needs to mean what I wanted to say.)

 

Good question. My personal opinion is that, ultimately, it will probably be best that we not post it to the forum until it is officially published. I doubt NICE considered the possibility of an entire forum being a stakeholder in this circumstance.

I don't see why we couldn't confirm that we have received it. If they are interested and available then I think the team who worked on compiling our submission should be able to see it before but I wouldn't want us posting it to the forum until after the embargo lifts.

 

Any news of when stakeholders will be sent draft?

 

where does this need to hide public documents come from ? .It is not like the document will contain commercially sensitive information or even politically sensitive .

 

Presumably that information is classified, at the highest level.

If it wasn't then someone would know who to call to ask them why, and that would rather be against the charter of an organisation that was created as a 'hands off' erm...thingy....so that the government could disown all responsibility for any 'unpopular' decisions.

 

I can see why they would issue the final guideline to stakeholders in confidence first.

So, if an error has been made or someone has been misrepresented they have the opportunity to put it right before publishing.

Isn't this standard practice? If I was writing a report for a client and had input from other areas of expertise I would include those experts in the final quality control review before releasing it to my client. The document couldn't be released until it was signed off by any other involved in drafting it, or at least two other people with the relevant expertise if you had done the whole thing yourself.

This protects the reputation of the company or body responsible for .producing the document and ensures the client gets an accurate, technically correct report that's fit for purpose.

 

It also gives stakeholders time to prepare a response/press release or similar.

 

This seems fine and normal and only problematic when key stakeholders are not represented, like when no one represented either the patient or even the scientifically literate side in the 2007 guidance.

One of many things too open to interpretation, what if there is consensus that patients are not stakeholders (or are too mentally unstable for it)? Which is pretty much what usually happens to keep us out of any secretive deliberations, where the maxim that if you're not at the table you are what's for lunch applies far too well.

 

Action for ME has sent a letter to NICE over the delay for the guideline:

In her letter to Dr Paul Chrisp, Director of Centre for Guidelines at NICE, Sonya says:

"I am writing to you regarding the delay to the revision of the NICE Guideline for ME/CFS and the impact we are seeing on people with ME/CFS and those that support them. I do understand that the decision to delay will not have been taken lightly and I think it would be helpful for NICE to clarify why this decision was taken so that there is a shared understanding of what underpins this decision.

"There has been concern and debate about this on social media and this speculation is creating anxiety for some which is counterproductive to the purpose of NICE Guidelines (which are there to improve healthcare) and could be avoided. I have published this letter on the Action for M.E. website and hope that you will agree to me sharing your response too.​

@InitialConditions seems to have obtained information from a FOI request.

https://twitter.com/user/status/1389664210246901765


"I have today received some information from a FOI request, because I too had concerns about the delay. I'm going to post about this issue on Friday. /1

From an initial look, I don't think there is reason to be too concerned, but the number of comments is not the only reason for the delay. /2"

 

Yes, I didn't really understand Sonya's post. Maybe she sees it as a little 'campaign'. I mean they gave justification for the delay. I had a feeling it wasn't the full story, and it turns out that's partly true. I will post on this tomorrow or Friday.

 

I decided to publish this blog post today, rather than add further details that probably aren't needed at this stage. This has been sort of rushed, so I'm open to any comments on the post and if it can be improved.

The blog is here: https://domsalisbury.github.io/mecfs/nice-mecfs-guideline-delay/

 

"Had Michael Sharpe handcuffed himself to the front entrance of the NICE offices in protest at the draft recommendations?"

 

@InitialConditions I’m not sure if I understand fully. Are you saying that the NICE guidelines have been pushed back partly because they needed to address the BPS people’s claims about GRADE not being used properly when assessing evidence? So they are re-assessing all the evidence? Or they’re going to use GRADE differently now? Or they just need time to write a good response to the concerns of the BPS people?

also what do you mean about the PEM thing? I don’t understand that bit. They want to find more studies where patients don’t have PEM?

 

There's no evidence the 'reanalysis' is a full reanalysis, or that it has been prompted by critical comments on the draft. It may well be due to comments from patient groups or charities. I really don't know who was prompted this; it's not clear from the FOI request because those details (the consultation responses) are not shared.

The PEM thing is simply a bit of evidence as to what the new analysis might be looking at. I can't speculate any further...

 

It is not 100% clear that the guideline panel has gone down the route of this further analysis to address GRADE indirectness, but I'm 90% sure from the emails that they have. As I state on the blog post, I feel this is primarily to address stakeholder comments, and not to make significant changes to the recommendations. That's just my reading. Happy for others to look through the emails and come to their own conclusions.

 

I can't respond to any comments this afternoon, as I need a break. Maybe this evening. A reminder that the FOI materials are linked in the post. Unfortunately, there are lots of emails in separate files and they are not in chronological order. The filenames of key emails are referenced in the blog.

 

So my initial thoughts and assumptions, based on what is in the blog.

BPSers, in an attempt to reverse the downgrading of their junk research, are claiming that their research papers, which sought to emphasise the chronic fatigue aspects, do actually provide evidence of their cohorts suffering PEM, so that the results are more directly applicable to pwME, and should therefore receive a higher grading. Their claim is that this evidence of PEM is hidden away in supplementary documents. My guess would be that if it is there, it will be along the lines of patients agreeing that they feel tired after exerting themselves, so hardly a definition of PEM that we would agree with.

Will it be enough to reverse the recommendations against GET that we all welcomed? Perhaps, but NICE must have felt that they were on solid enough ground to make the interim recommendations that they did, and I would like to think that this won't be enough to get their pseudo-science rated highly enough to make a difference.

This is my opinion, from an initial read. Happy to acknowledge any error that I might have made.