UK NICE 2021 ME/CFS Guideline, published 29th October - post-publication discussion

Selection of cohorts is always a matter for the individual experiment or study. Journal referees may ask for certain criteria to be used but there is no particular reason why they would ask for what is in NICE guidelines. In research criteria are justified by:
1. Being suited to the scientific question being asked - and so all sorts of different criteria for cohorts can be appropriate for different purposes
2. Being comparable to other studies. Academic groups tend to try to agree on comparable criteria for studies where it is relevant. That is usually done by agreement across relevant international societies. For ME referees are likely to look around in the same way that NICE did for guidance and rely on published proposals such as CCC or IOM.

But nobody is required in science to choose cohorts a fixed way, nor should they be.

 

From the stakeholder questionnaire - zoom meeting next week for discussion with Blake Stevenson who have the Scottish Government commission for engagement
Qiote esasy to respond as other than 1 speciliast nurse we have no " experts". Scottish Good Practice Guide is pretty much out nof date though some of the principles are not too bad.

If anyone wishes to comment/ raise issues I can feed back into a consulting group prior to next week's meeting
Discussion questions - stakeholder review of ME/CFS NICE Guidelines

NICE guidelines

In October 2021, NICE produced new guidelines about diagnosing and managing ME/CFS in children, young people and adults. It includes recommendations on diagnosis, assessment, and care planning, safeguarding, access to care and managing ME/CFS and its symptoms.

1. Which, if any, of the changes made by the NICE guideline did you welcome?

2. When you consider the recommendations in the NICE guidelines, in the short term, what should be the key areas of focus and priority in Scotland?

3. What existing infrastructure or services in Scotland could help the implementation of these guidelines?

4. What existing infrastructure or services in Scotland could hinder the implementation of these guidelines?

Implementation note

The Scottish Government is considering the production of an implementation note, to support the practical implementation of the NICE guidelines, a similar approach was taken recently regarding guidance for long COVID.

5. What do you think would be the advantages of an implementation note for the NICE guidelines? What would be the disadvantages?

6. What elements of the Scottish Good Practice Statement (SGPS) can inform or be preserved in the development of an implementation note?

7. What other guidance or principles could shape, or be referenced in, this implementation note? (e.g. Scotland’s self-management strategy for long term conditions Gaun Yersel!, the SGPS companion documents Quick Reference Clinical Guide and Patient Guide)

8. What practical tools could assist clinicians in implementing these guidelines?

Services for people with ME/CFS

The NICE guidelines mention multidisciplinary teams, and specialist services.

9. What does management of ME/CFS currently look like? (view from clinicians and people with ME/CFS)

10. What pockets of established good practice or developing practice are you aware of? Do the NICE guidelines support or enable this way of working?

11. What could a specialist service look like for people with ME/CFS? How would we look to begin developing such an approach? Who would be the key members of a multi-disciplinary team? Where should this service sit?

The NICE guidelines also recommends that services need to adapt and be delivered as appropriate to the needs of the individual (e.g. adapting time & length of appointments, offering remote appts)

12. What has been learnt from providing services during the pandemic and supporting people with long COVID, that could benefit people with ME/CFS?

Moving forward

13. How should we work together across sectors to implement the NICE guidelines?

14. What would help in mediating and improving relationships between patient and clinical groups to move forward care for people with ME/CFS?

15. How can awareness and understanding of ME/CFS be promoted in primary care / clinical settings? What should clinicians know to make a difference to the experience of people with ME/CFS?

16. How could we establish clinical champions for ME/CFS in Scotland?

 

Hopefully they will be required to include appropriate objective outcome measures.

However, the main current researchers will do all they can to get round this.

Sadly, the changes in the NICE Guidelines, although a huge step in the right direction, is only one step in a long process

 

Slightly tangenital (as always) but I wouldn't hold out much hope of UK Government research awards learning from the NICE guidelines. E.g. the review of the evidence base found that pretty much all of the studies were low quality - unblinded with subjective outcome criteria (they could e.g. have used actimetry - FitBit type devices as objective outcome criteria).
These studies are funded by NIHR - which is funded by [EDIT - Department of Health & Social Care - DHSC] - the same Department funds NICE --- so the Department can't even manage a coherent strategy i.e. assessing research to see if it can actually help inform the NICE guidelines.

I've tried to raise this incoherence via emails to the APPGs [ME/CFS & Corona virus - long covid is already being targeted by the researchers who do the crap ME/CFS research] but [EDIT - DHSC] replies state that NIHR is responsible for research funding --- funds "high quality" research ----
The audit office just might be a route to challenge this waste of public money [EDIT - and/] or the public accounts committee.

Welcome to the Kafkaesque world of Government policy re ME/CFS research +++ to be fair the same fate awaits the long covid community.

 

@FMMM1 - getting late in the day ? Department of Health & Social Care rather than DWP. Spot on though re: lack of joined up thinking - or is it just lack of thinking ?

 

Historically, and for generally sound reasons UK research funding has been arms length from Government and subject to only limited prescription by the funding bodies, so setting out some kind of rule on cohort selection would be anathema to the system. A funding body could set a specific challenge to research only on NICE 2021, but that would be the limit. As attractive as using only NICE 2021 might seem, we need to think how we would have viewed that applying to NICE 2007 !

More generally I think we have to ask whether research cohorts selected exclusively on the basis of a single diagnostic and/or treatment criteria set, in a disease which displays significant heterogeneity and which is defined only by symptomology, is actually sound science ? In doing so there would be a danger of circularity - where the disease is defined at outset by what may be a poor representation of the actual patient population. We have no way to know whether more tightly or differently constrained definitions reduce or indeed increase heterogeneity.

What is probably most useful at this point is to (as various studies have already done) use multiple criteria sets but to ensure these are separable in any analysis, enabling comparison of sets in their respective capture of participants by study outcome.

 

Do you mean the type of circularity that's been happening in ME research for the last forever?

and still seems to be happening, despite the new GL?

 

I fully agree with your post, particularly that the criteria should be broad - ME/CFS is not like e.g. diabetes - diseases which have a biomarker to guide cohort selection. However, I , and I'm confident you, draw the line at utterly pointless studies i.e. which provide results which we can have no confidence in.

 

I agree with your point #1. I was thinking of point 2 - selecting a comparable cohort of people across studies.

The US has established the IOM to identify ME/CFS clinically. But NIH's position has been that we don't know enough to say that even PEM should be required in research and that therefore, any definition, including Fukuda, can be used to select ME research cohorts. Do you expect UK researchers will do the same?

I'm asking because IMO that lack of consensus on at least some basic rules for patient selection - e.g key features such as PEM that have to be present to be identified as an ME patient - will impede comparability across research studies.

 

To be honest I have never seen comparability across research studies as being of great importance. Good studies produce answers. Poor studies don't. When I was researching RA I never found disease criteria relevant. Each time I was asking a different question.

Criteria are important for epidemiology but the good studies report rates for several criteria anyway.

Science should not follow rules. It should follow clear thinking.

 

So does this suggest its reasonable for ME researchers to identify ME cases in their studies using whichever of Oxford, NICE 2007, Fukuda, IOM, CCC, ME-ICC, and NICE 2021 they prefer? And does that apply to Long COVID researchers who wish to identify ME cases in their cohorts? I'd think continuing to use Oxford, NICE 2007, and Fukuda will only confound the evidence base.

 

I agree that if you interested in an illness characterised by PEM then you should put that in your criteria. But every piece of medical research asks a different question. Would LongCovid research be ME research? - depends.

In general much more confusion is caused by trying to pigeonhole research than by allowing researchers to think clearly and ask well tailored questions.

To me the problem of criteria is trivial in comparison to the problem of useless methodology. If PACE had been carried out well then it would have given a useful result on its own terms. The result would almost certainly still have been negative so that would be fine. A negative conclusion could be applied right across the fatigue spectrum.

 

The greatest danger of the NICE committee failing to reach a sensible conclusion came from downgrading evidence quality on the pretext of disease criteria within the bogus GRADE system rather than applying clear thinking and downgrading on bad methodology.

Arguing on the basis of disease criteria seems to me to be the best way for PWME to bury their chances of credibility.

 

Yes, and that is the right conclusion. It does not alter the different conclusion that those who are breathless, and have evidence of infection, benefitting.

There will always be examples of too wide or too narrow a choice of study group but interpolating from a wide group to a subgroup is always more justified than extrapolating from a narrow group to a wide one.

Oxford studies get criticised on the grounds that they are showing benefits in too wide a group. But in a way they are even more useful for having used Oxford because they show treatments do not even work for the wide group. On your argument that might mean that this might miss the fact that they did work for people with PEM. That seems nuts to us but on their original theory it would actually be the prediction - that only the people with PEM would have their fear of exercise reversed.

 

Yes, all I can say is take note and think clearly in the future when you are able.
It is a tragedy that things like GRADE are being taught as good methodology. I don't think that sort of dumbing down happened in my day. But all sorts of other crimes were committed I guess.

 

Yea there's a need to challenge the Department for Health and Social Care [DHSC] for this incoherence or as per CRG - lack of thinking - I actually think it's uncaring officials in DHSC.
The other target should be NIHR - funding body cc DHSC, APPGs (ME/CFS & covid) & ME/CFS & long covid charities.

 

[EDIT - added quote]
"The greatest danger of the NICE committee failing to reach a sensible conclusion came from downgrading evidence quality on the pretext of disease criteria within the bogus GRADE system rather than applying clear thinking and downgrading on bad methodology."

Nailed it.