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

I was thinking more of that she seems worried GET might crawl back in again, but agree the research and it's quality must be the basis for changes. Speaking of that it was interesting to see that the CDC review report for diagnosis and treatment of ME that will be available for comments from tomorrow has evaluation of study quality and systematic review results among its themes.

 

Regarding the further work being undertaken - “the team would need to order and check hundreds of papers and then conduct any necessary reanalysis.” and “for those studies that the SH [StakeHolder] claimed proportions of the study population have PEM, these aren’t reported in the original studies, this information SH claimed are in other sources e.g. supplement papers, commentary papers, sister papers, interim reports etc…. NGC will have to retrieve all these additional sources of papers, check whether the SH’s claims are accurate, then do sensitivity analysis if the provided information is appropriate.” [FOI e-mail No. 57, communication of 24th Feb at 15.18 and reply 15.34]

Note that NICE have scope to carry out a further consultation, and that consideration was given to this: “Chris was looking to communicate with SH’s about the delay after the committee meetings in case we felt that additional time was required for a second consultation or similar”. [FOI e-mail No. 51, communication of 5th March at 13.00]. It would appear that the decision was ‘no’. Nothing further is readable on this in the material released, however there are many redactions.

The guideline committee will have a further meeting once the reanalysis has been conducted: “working on the basis of an additional 4 weeks required for the reanalysis work given the time required to source the papers, review them and hold an additional meeting.” [FOI e-mail No. 9, communication of 9th March at 17.10]. I think this meeting is scheduled for Monday coming.

This message also reveals that two different approaches to reanalysis were under consideration: “Trust that’s ok based on either approach to the reanalysis”. It’s unclear how these differed and which approach was decided - again, this is likely to be among the redacted material.

As of today the most recent committee minute posted on the NICE website is for the meeting March 22nd: https://www.nice.org.uk/guidance/indevelopment/gid-ng10091/documents The next meeting was April 19th. It was on March 29th that NICE announced the publication delay, so the April 19th meeting would be committee's first since the decision taken and presumably the meeting at which NICE informed committee of the delay decision taken and why. This is quite an inordinate delay to posting a simple minute.

Coming back to the additional work to obtain and analyse further evidence, in my view it is safe to conclude that this evidence concerns psychosocial interventions, simply because there has been such a plethora of research of this ilk. No other field of research (on management and treatment, not biomedical) would produce "hundreds of papers".

I've attached a timeline of the comms at NICE revealed by FOI (+ included committee meetings, not that the decision was taken by committee). It took quite a while for me to get to grips with the documents downloaded from Dom Salisbury's site so maybe this will save others a bit of time.

 

Thank you @HMB for your impressive work. The time line is very informative.

The delay in the new guideline could be a possible catastrophe if the Psych / GET lobby get the draft changed.

Is there any way the patient reps could be approached to make a statement?

I know that they are bound by a confidentiality agreement but NICE pulling the release just before the embargoed version was due out is an extraordinary event and really we should be getting a proper explanation for this.

 

The delay could be an excuse to give the CBT/GET lobby more time to produce evidence tailor made to change the draft guidelines.

 

It looks like the most recent Committee meeting minutes haven't been published on the guideline website. The last minutes note that the next meeting was scheduled for 19 April. I assume this went ahead; there may have even been another meeting since then. Not good enough.

 

I'd noticed that and wondered if perhaps minutes aren't posted until the following meeting has taken place, where committee members would be asked to ratify the minute of previous meeting, That said, they are very basic minutes and there's nothing in them to say the GC and being asked to agree previous minute. Anyway, I believe there was another meeting at the start of this week. It's probably worth contacting cfsme@nice.org.uk to enquire when minutes of April and June meetings will be posted on site?

 

Actually, I emailed last month and had no reply. Perhaps someone else wants to try a further email.

 

This is very possible, as technically there are no minutes for a meeting until the draft minutes have been responded to, if necessary altered and then adopted at the next meeting.

When I used to put my parish council meeting minutes on our community website, the parish council wanted something to go on line as soon as possible to encourage participation, but it was important to make clear that the draft minutes had no legal status until they had been adopted at the next meeting. So we posted ‘draft minutes’ making this clear, then replaced them with the actual minutes after the next meeting.

Any draft minutes are just the personal note taking of the person minuting the meeting, until they are formally adopted at the next meeting when they become the formal minutes of the group.

 

Yes, I hadn't thought of that. Maybe the April meeting was cancelled. But surely they've not gone nearly three months without a meeting. They were part-way through going through the recommendations.

 

Thanks for querying this with NICE. It's not good no reply, it's a very simple enquiry. Suggest chase + how about the registered Stakeholder for S4ME lodge the same enquiry?

 

Done.

 

Have you not had a response, @Andy ?

 

Nope, sorry.

I've just double checked on the guideline page and it gives the contact email address as CFS@nice.org.uk, so I'll send it again but to that address.

 

Interesting. So, at some point NICE have changed the web address from cfsme@nice.org.uk to cfs@nice.org.uk. Of course you should have received an undeliverable message to the prior address if no longer in operation, which suggests messages to that address still being read but all the same that's not certain and either way it is odd. Why change? Why not inform stakeholders of change in address?

 

I remain to be convinced that finding and handing over a large amount of money to a PR company for a media campaign is the most effective solution to our woes.

And as for judicial review, the current uk government are doing their best to rush through reforms which would limit its scope:

https://consult.justice.gov.uk/judi...udicialreviewreformconsultationdocument.pdf-1

Interested parties are up in arms:

https://www.lawgazette.co.uk/news/d...nds-judicial-review-proposals/5108338.article

And the review of judicial review may well be subject to a judicial review itself. So basically we'd better be quick if we want to launch an expensive and uncertain judicial review process before all the rules change.

On the bright side, mega class-actions are on the rise in Europe as US firms move into the European market:

https://www.lawgazette.co.uk/news/mega-class-actions-becoming-mainstream-in-europe/5108902.article

 

Trial By Error: Lowenstein’s Guardian Opinion; Eliot Smith’s Post-NICE View; Tack’s Take on Blinding Study

https://www.virology.ws/2021/06/25/...-post-nice-view-tacks-take-on-blinding-study/