NICE guideline review: A list of appointees to the ME/CFS Guideline Committee has now been published

[ukxmrv]

Did you also get the impression that a technical team wrote the first draft of the text? From reading the minutes it seemed like the committee members were just commenting and proposing adjustments to a text that was allready there...

Yes, I did get that impression.

Also I had conversations with the RCP NICE team who were at the 2 stakeholder meetings. They did give the impression that the evidence searches and the drafting would be done by their team members with input from the GDG members.

My strong impression was that the RCP's National Guidelines Centre staff think that they very much control the process with the GDG merely rubber stamping what they do. NICE may have given one impression through Prof Mark Baker but I don't think that is how the NGC staff think it works at all.

As an example, I had a conversation with a senior member of the RCP's and they said a team member would do the evidence search and they were surprised when I explained the problems. They didn't seem to be willing to get their head around it.

In part this is a bureaucracy that thinks that quality is whatever Cochrane tells them it is.

I see huge battles with the RCP's guidelines group ahead.

 

[JemPD]

Also I had conversations with the RCP NICE team who were at the 2 stakeholder meetings. They did give the impression that the evidence searches and the drafting would be done by their team members with input from the GDG members.

sorry if i've missed something but Is this RCP the royal college of physicians, royal college of psychs, or something else? if the former why are they writing a guideline NICE are supposed to be writing?

 

[ukxmrv]

sorry if i've missed something but Is this RCP the royal college of physicians, royal college of psychs, or something else? if the former why are they writing a guideline NICE are supposed to be writing?

NICE outsource to this group

https://www.rcplondon.ac.uk/national-guideline-centre-ngc

 

[JemPD]

NICE outsource to this group

https://www.rcplondon.ac.uk/national-guideline-centre-ngc

Oh great, so NICE simply hire the royal college of physicians to write the GL ... the rcp... their former president being prof sir simon.... We are royally screwed.

I dont know how i missed this... but surely these are the people who're actually in control, pulling the strings, not NICE at all!... no wonder the committee is full of nightmare BPSers. No wonder they put CS in an impossible position, they'll have known full well that ther'd be an outcry if they didnt choose him, so they hamstring him instead.

It seems like it'll be a miracle, an absolute miracle, if we dont end up with an even worse guideline than before.

ETA :just in case anyone doesnt read further in this thread - i was wrong about Sir Simon - he was not former president.

 

[Trish]

Oh great, so NICE simply hire the royal college of physicians to write the GL ... the rcp... their former president being prof sir simon.... We are royally screwed.

SW was president of the Psychiatrists, not the Physicians. He's currently, I think, president of the Royal College of Medicine, which I gather is something different from either of these.

Edit - correction, I've just checked, the one SW is currently president of is called the Royal Society of Medicine. But at least I was right on the relevant bit that it's not the physicians.

 

[JemPD]

SW was president of the Psychiatrists, not the Physicians. He's currently, I think, president of the Royal College of Medicine, which I gather is something different from either of these.

Ahhh thanks for that correction @Trish, it was the 'medicine' one i was thinking of. I knew he went from psychs to something more general - i'd thought it was physicians. My apologies to all for my error.

But even so, the rcp clearly work closely with the other royal colleges so i still think it's logical to assume the string pulling is still going on, even if it's indirect. I'd thought that NICE did these guidelines themselves, & even then i was worried, but i hadnt realised they commissioned the rcp to do it, & imho i do not think it bodes well at all.

ETA Just googled... lol it's Royal Society of Medicine.... We will get our facts straight

 

[Jonathan Edwards]

Ahhh thanks for that correction @Trish, it was the 'medicine' one i was thinking of. I knew he went from psychs to something more general - i'd thought it was physicians. My apologies to all for my error.

Note that the Royal Society of Medicine is not a formal professional body like the colleges. It is just a club with a big old library that has rooms for out of town doctors to stay overnight in when in town and a restaurant and runs lectures partly to educate but mostly to keep retired doctors from getting bored. The president is usually an older physician who has nothing much better to do and likes gossiping. I have no idea why a psychiatrist would want to be bothered with it.

The guideline development group under the RCP is probably a fairly autonomous unit so its viewpoint will depend on the specific people involved. The same applies to NICE I guess so I am not sure it really matters what the name is. The technical side is likely to be done by salaried people with a fairly conventional mindset.

 

[Sly Saint]

NICE outsource to this group

https://www.rcplondon.ac.uk/national-guideline-centre-ngc

I see the NGC are also currently doing the guidelines for Suspected neurological conditions:

https://www.nice.org.uk/guidance/indevelopment/gid-cgwave0800/documents

 

[Suffolkres]

Note that the Royal Society of Medicine is not a formal professional body like the colleges. It is just a club with a big old library that has rooms for out of town doctors to stay overnight in when in town and a restaurant and runs lectures partly to educate but mostly to keep retired doctors from getting bored. The president is usually an older physician who has nothing much better to do and likes gossiping. I have no idea why a psychiatrist would want to be bothered with it.

The guideline development group under the RCP is probably a fairly autonomous unit so its viewpoint will depend on the specific people involved. The same applies to NICE I guess so I am not sure it really matters what the name is. The technical side is likely to be done by salaried people with a fairly conventional mindset.

Yes, I can say the restaurant is rather good. I went to a lecture there this time last year triggered by the Soil association who has one of the RSM notaries as a Trustee....

President of the Epidemiology and Public Health Section of the RSM



The lecture, pesticides and food, had some very good speakers and some who were crap, ie industry bods, DEFRA etc.....

This was followed up by,

Please see a letter from the President of the Epidemiology Section following the meeting on Monday:

“I was very pleased you were able to attend the meeting at the RSM on Monday on the subject of pesticides and food. I hope you found it as interesting as I did. I thought I would drop you a note about our next meeting.
The title of the meeting is, "Antimicrobial resistance and agriculture: is there a threat to public health and how is British farming responding?"

Best wishes
Gabriel Scally

President of the Epidemiology and Public Health Section of the RSM”


Royal Society of Medicine
1 Wimpole Street,

Gabriel studied medicine at The Queen’s University of Belfast. He specialised in general practice and subsequently public health. From 1989-93 he was Chief Administrative Medical Officer and Director of Public Health for the Eastern Health and Social Services Board in Northern Ireland.

 

[Barry]

A question for @JaimeS, @Jonathan Edwards, @Simon M, and anyone else who feels qualified to answer.

The outcome of the NICE guideline review will have significant impact on ME health care and ME research around the world I imagine, no matter which way it goes, so it is in everyone's interests, no matter where in the world they are, to try and ensure it turns out right. As has been said before, developing NICE guidelines are far and away based on evidence (even though we know how poor quality that evidence can sometimes be).

Clearly it is going to be some years, even at the most optimistic, before enough is known about ME to provide good quality peer reviewed evidence of what the essential biological mechanism of ME is, let alone how to hopefully go about treating/curing/preventing it. All this would come far too late for this NICE guideline review. But for this guideline review, something of much smaller scope is needed, to blow the whole thing wide open, and I'm wondering if that at least might have some chance of materialising as peer reviewed evidence within the next year, 18 months or so, in time to stop any BPS brigade in their tracks.

The single major issue that needs dropping from the NICE guidelines, lock, stock and barrel, is GET. That is the most damaging, and if it went then so would CBT in its existing "GET-light" form for ME. So the one and only piece of peer-reviewed evidence that is needed to present to NICE, is that exercise for PwME has a statistically significant probability of worsening a biological abnormality that contributes to PwME's symptoms.

What are the chances for this level of evidence, for this very confined scope, being available within this timescale? If it seems unlikely, is there any way that existing research could be targeted more closely at this objective? Because it could greatly affect potential funding for further research I imagine, no matter where, depending on the outcome of the NICE guideline review.

 

[obeat]

A question for @JaimeS, @Jonathan Edwards, @Simon M, and anyone else who feels qualified to answer.

The outcome of the NICE guideline review will have significant impact on ME health care and ME research around the world I imagine, no matter which way it goes, so it is in everyone's interests, no matter where in the world they are, to try and ensure it turns out right. As has been said before, developing NICE guidelines are far and away based on evidence (even though we know how poor quality that evidence can sometimes be).

Clearly it is going to be some years, even at the most optimistic, before enough is known about ME to provide good quality peer reviewed evidence of what the essential biological mechanism of ME is, let alone how to hopefully go about treating/curing/preventing it. All this would come far too late for this NICE guideline review. But for this guideline review, something of much smaller scope is needed, to blow the whole thing wide open, and I'm wondering if that at least might have some chance of materialising as peer reviewed evidence within the next year, 18 months or so, in time to stop any BPS brigade in their tracks.

The single major issue that needs dropping from the NICE guidelines, lock, stock and barrel, is GET. That is the most damaging, and if it went then so would CBT in its existing "GET-light" form for ME. So the one and only piece of peer-reviewed evidence that is needed to present to NICE, is that exercise for PwME has a statistically significant probability of worsening a biological abnormality that contributes to PwME's symptoms.

What are the chances for this level of evidence, for this very confined scope, being available within this timescale? If it seems unlikely, is there any way that existing research could be targeted more closely at this objective? Because it could greatly affect potential funding for further research I imagine, no matter where, depending on the outcome of the NICE guideline review.

Isn't Karl Mortens research funded by MEA trying to answer whether GET can cause deterioration? Not sure how strong the methodology is.

 

[Russell Fleming]

I agree.

Also:

1) I understand that committee members should not be allowed to discuss the details of the NICE guildline meetings publicly before the process is complete, but it seems odd that someone whose views on CBT/GET are well known cannot continue to express those views while serving on the committee. If those views do not amount to a COI, and the person’s views do not disqualify them from being appointed in the first place, what possible negative effect could it have for that person to continue to express the views which they are known to hold?

Has anyone found any official NICE rules about this issues, or is it just something that has been made up for this particular guideline review?

2) If Charles had become a full member of the committee, the MEA would still have been able to post on social media etc. And, even if he had accepted the constraints imposed on him, I can’t see why Charles wouldn’t have been able to continue to advise the MEA about what to say, as long as the statements were not put out in his name.

@Russell Fleming Do you know the answers to questions in point 1 and was point 2 considered?

Hi

I don't have the answers I am afraid and am as confused by the workings of the committee as I suspect others are.

Dr Shepherd had he accepted the offer to become a full member would have been gagged from speaking about any of the issues included in the NICE guideline, and this would have affected his speaking engagements as much as it would the statements, medical information and blogs he writes for the ME Association. He felt to be so restricted for two years was asking too much, hence his decision to suggest a co-opted position which didn't have the same restrictions. Unfortunately, this means he doesn't have a vote. But he can still attend all the meeting and give evidence which he intends on doing.

We do not know the weight NICE will place on the evidence provided by expert witnesses, co-opted members, or voting members. We do not know if NICE will individually review and rate research evidence - though I suspect they will but whose interpretation will be listened to most avidly?

We do not know what will prompt a vote or if full members with COIs will be unable to vote. We don't know if votes will be taken on all issues or only on issues where there is a split opinion. And we don't know if the Chair has the deciding vote in the event of a tie.

I really wish I knew more.

Russell

Edits: Grammar. I am knackered!

 

[Hoopoe]

@Barry Mark Vink spotted that in a study by Moss-Morris, VO2peak declined after GET.

In order to assess physical fitness, each participant underwent incremental exercise testing to determine maximum aerobic capacity (VO2peak) on a motorized treadmill. Testing was conducted by a research assistant blind to treatment condition.

The graded exercise protocol used in our study was based on Fulcher and White’s (1997) protocol.

Although the difference is supposedly not statistically significant. They explain the reason for this:

the physiological data need to be treated with caution, as complete data were only available for just over half of the sample. This was due to the fact that ten patients refused to have a second test as they believed the initial test was harmful to them, five failed to continue until they perceived them-selves to have reached maximal effort, making their data invalid and the data from two patients could not be used due to equipment failure.

These were patients meeting Fukuda criteria that self-selected for a GET trial. They believed it could work.

 

[Hoopoe]

@Jonathan Edwards do you believe the above is sufficient evidence that GET is problematic even in studies?

 

[Joel]

A question for @JaimeS, @Jonathan Edwards, @Simon M, and anyone else who feels qualified to answer.

The outcome of the NICE guideline review will have significant impact on ME health care and ME research around the world I imagine, no matter which way it goes, so it is in everyone's interests, no matter where in the world they are, to try and ensure it turns out right. As has been said before, developing NICE guidelines are far and away based on evidence (even though we know how poor quality that evidence can sometimes be).

Clearly it is going to be some years, even at the most optimistic, before enough is known about ME to provide good quality peer reviewed evidence of what the essential biological mechanism of ME is, let alone how to hopefully go about treating/curing/preventing it. All this would come far too late for this NICE guideline review. But for this guideline review, something of much smaller scope is needed, to blow the whole thing wide open, and I'm wondering if that at least might have some chance of materialising as peer reviewed evidence within the next year, 18 months or so, in time to stop any BPS brigade in their tracks.

The single major issue that needs dropping from the NICE guidelines, lock, stock and barrel, is GET. That is the most damaging, and if it went then so would CBT in its existing "GET-light" form for ME. So the one and only piece of peer-reviewed evidence that is needed to present to NICE, is that exercise for PwME has a statistically significant probability of worsening a biological abnormality that contributes to PwME's symptoms.

What are the chances for this level of evidence, for this very confined scope, being available within this timescale? If it seems unlikely, is there any way that existing research could be targeted more closely at this objective? Because it could greatly affect potential funding for further research I imagine, no matter where, depending on the outcome of the NICE guideline review.

There will probably be a few smaller findings that will impact the outcome to some degree, and it's plausible that GET could be removed from the guideline on today's evidence if it is properly put forward and fairly considered, but I don't think it likely there will be any single piece of new evidence like you're hoping for in the next couple of years. Here's hoping though.

 

[Jonathan Edwards]

@Jonathan Edwards do you believe the above is sufficient evidence that GET is problematic even in studies?

It looks to me as if the VO2 max dropped for both exercise and control groups. Not sure what that means.

 

[Hoopoe]

It looks to me as if the VO2 max dropped for both exercise and control groups. Not sure what that means.

Right. I missed that.

There was also this

With regards to the physiological data, the lack of an increase in aerobic fitness following exercise therapy was unexpected. A similar training programme in CFS patients did manage to show an improvement in fitness (Fulcher & White, 1997). However, three things may help to explain this discrepancy. First, many patients terminated their VO2 max test for reasons other than maximal effort. As a result less than 25 percent of VO2max tests achieved a true maximum, as defined by physiological responses (Baldi et al., 2003). Consequently, we used VO2peak as our measure of fitness.

 

[Hoopoe]

So this study is somewhere between uninterpretable and consistent with CBT/GET not increasing fitness. Edit: as far as the physiological data is concerned.

 

[Jonathan Edwards]

What are the chances for this level of evidence, for this very confined scope, being available within this timescale? If it seems unlikely, is there any way that existing research could be targeted more closely at this objective? Because it could greatly affect potential funding for further research I imagine, no matter where, depending on the outcome of the NICE guideline review.

I don't see any reliable way of showing that GET does long term harm at least in the foreseeable future. Short time drops in things like VO2 max do not tell us anything about long term benefit or harm. (Personally I think we need some long term altimetry studies and I think there is some enthusiasm for setting these up now.) I think it is more important to gather together the arguments relating to the evidence we have. I think the arguments are quite strong for GET being problematic.

We do not know if NICE will individually review and rate research evidence - though I suspect they will but whose interpretation will be listened to most avidly?

Many of the committee members are already familiar with most of the relevant evidence and have an opinion on its value. I don't think there is any great risk of things being 'missed out'. The question is what the consensus on the committee will be once evidence has been considered. If a substantial proportion of the committee are very sceptical about evidence then it seems to me that has to be reflected in whatever recommendation is produced.

 

[Hoopoe]

I don't see any reliable way of showing that GET does long term harm at least in the foreseeable future. Short time drops in things like VO2 max do not tell us anything about long term benefit or harm. (Personally I think we need some long term altimetry studies and I think there is some enthusiasm for setting these up now.)

How do you envision such a study? Who would do it? Is it ethical to conduct it for the purpose of confirming safety or harms?