New MEGA study website (30 November 2016)

[slysaint]

The way in which this will be done is clearly challenging and the subject of discussion

Someone who gave a presentation at the CMRC conference(can't remember her name) had managed to interview severe ME patients for a survey, with presumably little funds or resources.
As far as MEGA is concerned , I can't see why it wasn't top of the list of priorities for an ME research project?

 

[charles shepherd]

Someone who gave a presentation at the CMRC conference(can't remember her name) had managed to interview severe ME patients for a survey, with presumably little funds or resources.
As far as MEGA is concerned , I can't see why it wasn't top of the list of priorities for an ME research project?

This was probably Victoria Strassheim (who works with Prof Julia Newton) and her research involving people with severe ME/CFS

More info on the MEA website:

http://www.meassociation.org.uk/201...ecfs-in-the-north-of-england-3-november-2014/

 

[Cinders66]

There is quite a lot of misunderstanding about what is termed the NICE diagnostic criteria for ME/CFS

And I don't think this NICE criteria has any significant standing outside the UK

As I'm sure you are aware, the MEA has consistently been very critical of the 2007 NICE guideline and we do not regard it as being fit for purpose
And we do not believe that the NICE diagnostic criteria is a satisfactory way of diagnosing ME/CFS

HOWEVER, and this is where the misunderstanding occurs, the purpose of the NICE diagnostic criteria is to provide GUIDANCE to doctors as to when they should CONSIDER making a diagnosis of ME/CFS
And from that point of view it does have some merit

It is also worth noting that in addition to the patient having new onset and persisting fatigue that cannot be explained by another condition, and results in a substantial reduction in activity, the fatigue in the NICE criteria also has to be accompanied by:
POST EXERTIONAL MALAISE AND/OR FATIGUE (typically delayed, for example by at least 24 hours, with slow recovery over several days)

So, for the non expert doc, this is actually a fairly useful starting point when CONSIDERATION needs to be given to making a diagnosis of ME/CFS

But the NICE definition of fatigue + post exertional malaise + one other symptom from their list (eg cognitive dysfunction, pain) should not be used to make a diagnosis of ME/CFS

I also think that here in the UK, many docs are like myself when it comes to making a diagnosis of ME or CFS, and take a fairly pragmatic approach - rather than sticking dogmatically to one of the 20+ diagnostic criteria for ME, CFS, ME/CFS and SEID etc…..

What you describe Seems an inadequate, make do, simplistic way of diagnosing people under U.K. CFS umbrella. If you don't think NICE should be used to try diagnose ME/CFS, isn't it a mistake to include it in the MEGA umbrella supposedly studying ME/CFS, especially when the dominant physician in charge of patient selection ONLY ever AFAIK uses NICE criteria. Aren't we, especially in the kids cohort, in danger of recruiting 1500 with NICE not ME/CFS and 500 with more complex CFS & ME & is that the best way for pwCFS & ME?

 

[Barry53]

If this is the case then why would the researchers not consider the need to include the severely ill. They are the ones most likely to represent a group with robust findings.

Quite so. You are not going to realistically tease out the information subtleties, unless the captured data actually contains the underlying sources of such subtleties. It is no good saying "well, we are only claiming to understand sub-groups A, B and C, so we won't bother capturing data for D an E", because data from D and E may actually hold subtle but crucial information that might help make sense of A, B and C. In which case results obtained from only capturing and processing data from A, B and C, might give quite misleading answers about A, B and C.

 

[Dx Revision Watch]

My recall of the MEGA website information is that the MEGA planning group have made it clear that they want to include people with severe ME/CFS

Who comprises the MEGA "planning group"?

I may have missed something, but all I can see on the MEGA website is a list of "MEGA Team Members".

Do all the "Team Members" listed also comprise the "planning group" or is the "planning group" a sub working group and if so, who are the members of the "planning group"?

A Terms of Reference has been drafted for the PAG.

I have asked, via the MEGA website Q & A form, whether the MEGA project has a Steering Group and if so, whether a Terms of Reference has been drafted and agreed for the Steering Group.

There has been no response posted yet.

I've also asked whether and when a list of the names of those selected for the PAG is going to be published.

 

[charles shepherd]

Who comprises the MEGA "planning group"?

I may have missed something, but all I can see on the MEGA website is a list of "MEGA Team Members".

Do all the "Team Members" listed also comprise the "planning group" or is the "planning group" a sub working group and if so, who are the members of the "planning group"?

A Terms of Reference has been drafted for the PAG.

I have asked, via the MEGA website Q & A form, whether the MEGA project has a Steering Group and if so, whether a Terms of Reference has been drafted and agreed for the Steering Group.

There has been no response posted yet.

I've also asked whether and when a list of the names of those selected for the PAG is going to be published.

My understanding is that:

1 everyone who is a MEGA Team Member will be involved in the planning of the study. As we are constantly discussing the planning of the study on the internet I am using the term planning group for simplification

2 public disclosure of names of members of the PAG will the subject of discussion by the group once the group has been formed next week. My personal view is that people should be able to remain anonymous if they do not wish to have their identity placed in the public domain

3 there is not going to be a steering group - as we have at the ME Biobank (where we do not have PAG as there are patient reps on the Steering Group)

 

[Dx Revision Watch]

My understanding is that:

1 everyone who is a MEGA Team Member will be involved in the planning of the study. As we are constantly discussing the planning of the study on the internet I am using the term planning group for simplification

2 public disclosure of names of members of the PAG will the subject of discussion by the group once the group has been formed next week. My personal view is that people should be able to remain anonymous if they do not wish to have their identity placed in the public domain

3 there is not going to be a steering group - as we have at the ME Biobank (where we do not have PAG as there are patient reps on the Steering Group)

So, no Steering Group.

And no ToR for those with oversight for the project.

And potentially, no transparency about the make up of the PAG.

Thank you, Dr Shepherd.

 

[TiredSam]

HOWEVER, and this is where the misunderstanding occurs, the purpose of the NICE diagnostic criteria is to provide GUIDANCE to doctors as to when they should CONSIDER making a diagnosis of ME/CFS
And from that point of view it does have some merit

So, for the non expert doc, this is actually a fairly useful starting point when CONSIDERATION needs to be given to making a diagnosis of ME/CFS

Who are you saying that the misunderstanding occurs to? I would hazard a guess that it occurs to everyone, including the doctors the NICE diagnostic criteria are purporting to guide. Once the doctor has been helpfully guided by NICE to the point where they should consider an ME diagnosis, where do they go from there to decide whether to make a definite diagnosis? The CCC perhaps? So why not start with that instead of this wishy-washy guidance and consideration business?

The criteria should be clear, simple and umambiguous, not depend on almost legalese niceties (pun intended) or the interpretation of a couple of words most doctors will not even notice.

rather than sticking dogmatically to one of the 20+ diagnostic criteria for ME, CFS, ME/CFS and SEID etc…..

This comment conjurs up the image of GP throwing up his hands in despair as he doesn't have the time to familiarise himself with or distinguish between an unreasonable number of diagnostic criteria (this is the same GP who has just gone through the NICE guidelines with a toothcomb, carefully noting the significance of the word "consider").

However, it is the responsibility of researches to distinguish between and evaluate the different guidelines, having regard to the evidence that has accumulated on the suitability of each one. I don't think that's too much to ask of the ground-breaking scientists on the MEGA project.

 

[charles shepherd]

So, no Steering Group.

And no ToR for those with oversight for the project.

And potentially, no transparency about the make up of the PAG.

Thank you, Dr Shepherd.

The draft ToR for the PAG is on the MEGA website:

http://www.megaresearch.me.uk/get-involved/

The ToR will be finalised after consultation with the group - when it has been formed

As to the question of whether the identity of members of the PAG should be placed in the public domain, my understanding is that for fairly obvious reasons (i.e. some people with ME/CFS, as frequently occurs on PR discussions, do not want the fact that they have ME/CFS to become public knowledge) this is is a sensitive issue which the group needs to discuss and reach a decision on.

 

[charles shepherd]

Who are you saying that the misunderstanding occurs to? I would hazard a guess that it occurs to everyone, including the doctors the NICE diagnostic criteria are purporting to guide. Once the doctor has been helpfully guided by NICE to the point where they should consider an ME diagnosis, where do they go from there to decide whether to make a definite diagnosis? The CCC perhaps? So why not start with that instead of this wishy-washy guidance and consideration business?

The criteria should be clear, simple and umambiguous, not depend on almost legalese niceties (pun intended) or the interpretation of a couple of words most doctors will not even notice.



This comment conjurs up the image of GP throwing up his hands in despair as he doesn't have the time to familiarise himself with or distinguish between and unreasonable number of diagnostic criteria (this is the same GP who has just gone through the NICE guidelines with a toothcomb, carefully noting the significance of the word "consider").

However, it is the responsibility of researches to distinguish between and evaluate the different guidelines, having regard to the evidence that has accumulated on the suitability of each one. I don't think that's too much to ask of the ground-breaking scientists on the MEGA project.

Yes, there is widespread uncertainty here in the UK about how to confirm a diagnosis of ME/CFS amongst many health professionals, especially those who have no specialist interest or knowledge about the diagnosis of ME, CFS, ME/CFS or SEID.

This is because there is no agreement or rigid guidance from any part of the medical establishment here in the UK (i.e. Royal Colleges, DoH), or CPD learning modules on the subject, as to which of the numerous options should be used. Even NICE makes no firm recommendation.

Consequently, many doctors (including CS) take a very pragmatic approach involving clinical judgement combined with information from criteria (Canadian, Fukuda, IoM, ICC, Ramsay etc) and guidance (e.g. MEA purple book, CMO WG Report, NICE guideline) that they are aware of, or have to hand on the computer or bookshelf

Incidentally, the number of doctors with no specialist knowledge or interest in ME/CFS who know about the Canadian criteria, or have a copy of this criteria, is very small indeed - so it hardly hits the radar

 

[charles shepherd]

Basic information from the MEA on Early and Accurate Diagnosis of ME/CFS:

http://www.meassociation.org.uk/201...nals-that-could-improve-prognosis-9-may-2016/

More detailed information for health professionals can be found in the Clinical Assessment and Diagnosis - History, Investigations, Examination, Differential Diagnosis, Disability Assessment etc - chapter in the MEA purple book (pages 39 - 59)

 

[Cinders66]

Yes, there is widespread uncertainty here in the UK about how to confirm a diagnosis of ME/CFS amongst many health professionals, especially those who have no specialist interest or knowledge about the diagnosis of ME, CFS, ME/CFS or SEID.

This is because there is no agreement or rigid guidance from any part of the medical establishment here in the UK (i.e. Royal Colleges, DoH), or CPD learning modules on the subject, as to which of the numerous options should be used. Even NICE makes no firm recommendation.

Consequently, many doctors (including CS) take a very pragmatic approach involving clinical judgement combined with information from criteria (Canadian, Fukuda, IoM, ICC, Ramsay etc) and guidance (e.g. MEA purple book, CMO WG Report, NICE guideline) that they are aware of, or have to hand on the computer or bookshelf

Incidentally, the number of doctors with no specialist knowledge or interest in ME/CFS who know about the Canadian criteria, or have a copy of this criteria, is very small indeed - so it hardly hits the radar

I think when the GPs you describe as having no specific interest or knowledge in ME. are making the CFS/Me diagnosis "pragmatically" it isn't by making a judgement combined With info from various more respected Stricter criteria you describe, it's just dishing out the label to anyone with fatigue plus headaches or fatigue plus unrefreshing sleep issues or fatigue plus aches. I'm totally against a casual pragmatic approach with our label because it ends up diluting the illness to a rag bag, catch all less severe waste basket.
I think uk charities not endorsing stricter criteria, especially AFME who refuse to comment on such things and insist all CFS is ME is partly why things like CCC never got established here, along of course with resistance from people like White and Crawley.

 

[Dx Revision Watch]

The draft ToR for the PAG is on the MEGA website:

http://www.megaresearch.me.uk/get-involved/

The ToR will be finalised after consultation with the group - when it has been formed

As to the question of whether the identity of members of the PAG should be placed in the public domain, my understanding is that for fairly obvious reasons (i.e. some people with ME/CFS, as frequently occurs on PR discussions, do not want the fact that they have ME/CFS to become public knowledge) this is is a sensitive issue which the group needs to discuss and reach a decision on.

Dr Shepherd, I was not referring to Terms of Reference for the PAG or when the draft PAG ToR will be finalized.

What I wrote in response to your response was:

"So, no Steering Group.

And no ToR for those with oversight for the project."​

The issue was the absence of a Steering Group for the MEGA project and Steering Group ToR - an issue you appear to have sidestepped.


In relation to the PAG:

I consider there is a difference between electing to use an anonymous username on a public forum and putting oneself forward for a position on a Patient Advisory Group where one is tasked with representing the interests of others.

If a decision were reached after the group has been assembled that members of the PAG (who may be a mixture of patients, carers and others classes of stakeholder) can choose to remain anonymous, potentially, we could have a situation where none of them choose to be identified.

Which would result in no transparency for the make up of the PAG group.

Perhaps the issue of disclosure should have been discussed and agreed upon before applications were invited?


It also begs the question: if the PAG is expected to agree on and sign up to a Terms of Reference, why is there no Terms of Reference for the project overseers?

Why the absence of a Steering Group that is accountable for the project?

Is the absence of a Steering Group/Committee not a matter of concern to the org reps?

It should be.

 

[Valentijn]

As to the question of whether the identity of members of the PAG should be placed in the public domain, my understanding is that for fairly obvious reasons (i.e. some people with ME/CFS, as frequently occurs on PR discussions, do not want the fact that they have ME/CFS to become public knowledge) this is is a sensitive issue which the group needs to discuss and reach a decision on.

It would be nice to at least know which charity, fatigue clinic, or other organization they are a member of or associated with. I agree that providing the real name of patients would be a problem.

 

[user9876]

Basic information from the MEA on Early and Accurate Diagnosis of ME/CFS:

http://www.meassociation.org.uk/201...nals-that-could-improve-prognosis-9-may-2016/

More detailed information for health professionals can be found in the Clinical Assessment and Diagnosis - History, Investigations, Examination, Differential Diagnosis, Disability Assessment etc - chapter in the MEA purple book (pages 39 - 59)

We should separate out criteria for clinical and research diagnosis. One big area is around co-morbid disease. With research criteria this essentially adds noise to the signal but with clinical criteria you don't want to disclude people because they have other things wrong.

 

[BurnA]

It would be nice to at least know which charity, fatigue clinic, or other organization they are a member of or associated with. I agree that providing the real name of patients would be a problem.

I would have thought if you are representing a group of people then you have to reveal your identity.

I know many people don't want to do that for many reasons, but I think if you decide to be representative you have to be willing to forsake anonymity.

If someone was representing me I would like to know who they were.

 

[Dx Revision Watch]

Without a Steering Group/Committee accountable for the operation of the project you ain't got a project.

 

[slysaint]

Incidentally, the number of doctors with no specialist knowledge or interest in ME/CFS who know about the Canadian criteria, or have a copy of this criteria, is very small indeed

When I was diagnosed it was by my GP, who was not a specialist, but had known me/been my GP for many years. This is rarely the case now in the NHS, so a more formal symptom/testing check list for diagnosis is more crucial than ever.

 

[JoanDublin]

I would have thought if you are representing a group of people then you have to reveal your identity.

I know many people don't want to do that for many reasons, but I think if you decide to be representative you have to be willing to forsake anonymity.

If someone was representing me I would like to know who they were.

I agree with you. To do otherwise means that you are simply a patient who is a member of a group and NOT a patient representative. There is a vast difference between both concepts.

If the patient representatives are going to be used in any way to justify how the project develops and makes decisions, then names absolutely should be made public. Otherwise it's just tokenism.

 

[Dx Revision Watch]

Without a Steering Group/Committee accountable for the operation of the project you ain't got a project.

In a post in October on the MEA's website, Dr Shepherd pleaded that the project should not be strangled at birth.

IMO, the project is still in gestation stage.

The project should be halted now. No application for funding should be submitted in January.

Nothing should be taken forward until a Steering Group/Committee has been assembled.