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MEGA Questions and Answers: Latest Petition update

aimossy

Senior Member
Messages
1,106
From the link:

"Petition update

MEGA Questions and Answers
M.E./CFS Epidemiology and Genomics Alliance (MEGA)
United Kingdom
Oct 5, 2016 — Many of you have asked us questions about MEGA. We have not yet applied for funding and the patient advisory groups have not yet met to provide advice. So these are our preliminary thoughts at the moment. Some of this will change as we work on the first application (see below) and during consultations prior to future applications. We want to engage with as many people as possible especially in the current planning phase."

https://www.change.org/p/support-th...k&utm_source=petition_update&utm_medium=email
 
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Glycon

World's Most Dangerous Hand Puppet
Messages
299
Location
ON, Canada
Why are psychiatrists involved?

The MEGA consortium has brought together many experts from a wide range of different disciplines from across genetics, genomics, metabolomics, pain research, proteomics, psychiatry, sleep research and transcriptomics. Psychiatry needs to be there to complete the big picture yet it is just one minor aspect. MEGA will always be a Big Data ‘omics study, and will never be a psychiatric study.

Except the problem is not the involvement of psychiatrists, but the involvement of specific psychiatrists associated with discredited, probably dangerous, and possibly fraudulent research into ME/CFS.
 

Cheesus

Senior Member
Messages
1,292
Location
UK
I'm in favour of much of the information they have supplied here - particularly that the data will be open access and that they are recording which set of diagnostic criteria each patient meets. The former is hugely important for transparency and the latter for determining the veracity of existing criteria and ultimately determining subgroups.

However I think it is a little disingenuous to say they need paychiatry to be there simply to ensure there are a broad section of specialities represented. As there are resource constraints I think they need a better justification of the presence of psychiatry if they are going to allocate said resources towards psychiatry. The justification here seems to be "Well we thought it would be nice to have a full set", regardless of the fact that there are a number of specialities absent (not least neurology and immunology).
 
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This is all of it.

5 Oct 2016 — Many of you have asked us questions about MEGA. We have not yet applied for funding and the patient advisory groups have not yet met to provide advice. So these are our preliminary thoughts at the moment. Some of this will change as we work on the first application (see below) and during consultations prior to future applications. We want to engage with as many people as possible especially in the current planning phase.

Has the study been funded yet?

No. We are planning to apply for funding in 2017 for the first stage of the study, setting up the world’s largest Bioresource of data and samples from CFS/ME patients. Our aim is to create a resource that all researchers all over the world can use. We will then apply for further funding for the subsequent omics-based stages of our study – searching for the biological basis to ME/CFS – once the Bioresource is set up.

Will the data be open access?

Yes. Subject to individuals’ consent, the data and the samples will be available for researchers to use. We want to rapidly increase effective research (by us, by anyone) to understand the biology, causes and different types of CFS/ME.

What case definition will you use?
To do the genetic studies that we want to do, we think we need to recruit at least 10 thousand adults and 2 thousand children. The only way to do this is to recruit patients through NHS clinics throughout England. England is the only place in the world that can collect this large number of patients in a short time frame.

Patients with CFS/ME will be identified by clinicians in the NHS clinics. The clinicians will be asked to identify patients they judge from NICE criteria to have CFS/ME. This means patients with other causes of fatigue will not be recruited including (for example): those with thyroid disease, diabetes or depression that is sufficiently severe to explain their fatigue. Patients will have been examined, a full history taken and they will have had screening blood tests (to ensure other causes of fatigue have been excluded).

We will collect sufficient information on each patient to be able to say whether they have CFS/ME using other research diagnoses (for example, the CDC [Fukuda 1994] diagnostic criteria, the IACFS criteria, Canadian criteria and so on). This is in addition to the diagnoses of CFS/ME that patients will get following NICE guidance. We will listen to our patient advisory group in terms of how much data we can collect on different diagnostic criteria. Our patients advisory groups may recommend collecting less data as patients are so ill.

Why use broad criteria?

As the symptoms and genetics of CFS/ME are highly heterogeneous we think it makes sense to build a Biobank of samples from all people diagnosed with CFS/ME (diagnosed with NICE criteria, without other causes of fatigue, as above). This is because our experience from other diseases is that the genetics found for one set of people with CFS/ME will be relevant to the genetics found for another, and even to the genetics of the population at large. But afterwards, in the computer, we will separate out various subsets of people with CFS/ME according to different diagnostic criteria. This will tell us which diagnostic criteria are more effective for which people.

Why are psychiatrists involved?

The MEGA consortium has brought together many experts from a wide range of different disciplines from across genetics, genomics, metabolomics, pain research, proteomics, psychiatry, sleep research and transcriptomics. Psychiatry needs to be there to complete the big picture yet it is just one minor aspect. MEGA will always be a Big Data ‘omics study, and will never be a psychiatric study.

What data will you collect?

We will collect symptom data on all patients to allow us to identify which patients will be identified as having CFS/ME using different diagnoses. We will also include data on fatigue, disability, anxiety and depression. We would like to collect detailed data on pain. How much data we collect will depend on what our patient advisory group says will be acceptable to consenting patients and how much funding we get.

Will you be doing additional tests?

We would like to do additional, more time-consuming and expensive tests on a sample of patients that will help us more finely phenotype (describe CFS/ME more carefully) those recruited into the study. We don’t think we will have the money to do this for everybody or for everything. We would like to do additional studies to collect more data on pain, exercise-induced stress and sleep studies and possibly some imaging. We also want to be as sure as we can that we have carefully excluded other diagnoses such as depression and anxiety as a cause of fatigue. We haven’t worked on the details for this but will be asking our patient advisory group about what they think would be feasible and acceptable given the funding limits.

What samples will you be taking?

We will take blood and urine samples that allow us to look at the genetics, the epigenetics (how genes are modified chemically), transcriptomics (identifying which genes are turned on and which are turned off), proteomics (the proteins in the blood), and the metabolomics (what small molecules are made by our enzymes and other proteins). We will use standard procedures for collection of these samples developed previously for many other studies.

Please explain why different members are part of the MEGA team?

We will upload a list of biographies and what members have to contribute in the next few days.
 
Messages
15,786
MEGA said:
Why are psychiatrists involved?

The MEGA consortium has brought together many experts from a wide range of different disciplines from across genetics, genomics, metabolomics, pain research, proteomics, psychiatry, sleep research and transcriptomics. Psychiatry needs to be there to complete the big picture yet it is just one minor aspect. MEGA will always be a Big Data ‘omics study, and will never be a psychiatric study.
That wasn't the question. The question is why are people who believe ME is a psychosomatic or other psychiatric disorder involved in this biomedical research. Replacing real questions with easier to answer fake ones is not acceptable. They are either not listening or they are not willing to give a straight answer.
 

aimossy

Senior Member
Messages
1,106
"Patients with CFS/ME will be identified by clinicians in the NHS clinics. The clinicians will be asked to identify patients they judge from NICE criteria to have CFS/ME. This means patients with other causes of fatigue will not be recruited including (for example): those with thyroid disease, diabetes or depression that is sufficiently severe to explain their fatigue. Patients will have been examined, a full history taken and they will have had screening blood tests (to ensure other causes of fatigue have been excluded)."

Who are these clinicians - it's their judgement or using the NICE criteria to characterise?
Will they have to adhere to strict guidance of NICE criteria in referring people for the study?

What about the fact that some clinicians see a broad church that includes, to quote someone else "fifty shades of fatigue" and somatisation among other tack on psychiatric elements.

Does anyone know where to google to get a link to the NICE criteria? I can't remember if they have PEM in there or if it is described well.

To be clear I am not anti the fact that you can have ME/CFS alongside psychiatric conditions, but don't we need to have well characterised cohorts too?

Using this research to figure out criteria could be brilliant if this is done well!
 
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Messages
15,786
Will they have to adhere to strict guidance of NICE criteria in referring people for the study?
There's nothing strict in NICE. It recommends "considering" ME as a diagnosis if post-exertional something (malaise or fatigue) and other symptoms are present, but worsening symptoms in response to exertion are an additional optional symptom.

If there's no PEM, doctors should merely reconsider the diagnosis.

If there are neurological or cardiac symptoms, or swollen lymph nodes, alternative diagnoses should be considered. Which is a great way to exclude actual ME patients if so desired.

Actual NICE text:
1.2.1.2 Healthcare professionals should consider the possibility of CFS/ME if a person has:
  • fatigue with all of the following features:
    • new or had a specific onset (that is, it is not lifelong)
    • persistent and/or recurrent
    • unexplained by other conditions
    • has resulted in a substantial reduction in activity level
    • characterised by post-exertional malaise and/or fatigue (typically delayed, for example by at least 24 hours, with slow recovery over several days)
      and
  • one or more of the following symptoms:
    • difficulty with sleeping, such as insomnia, hypersomnia, unrefreshing sleep, a disturbed sleep–wake cycle
    • muscle and/or joint pain that is multi-site and without evidence of inflammation
    • headaches
    • painful lymph nodes without pathological enlargement
    • sore throat
    • cognitive dysfunction, such as difficulty thinking, inability to concentrate, impairment of short-term memory, and difficulties with word-finding, planning/organising thoughts and information processing
    • physical or mental exertion makes symptoms worse
    • general malaise or 'flu-like' symptoms
    • dizziness and/or nausea
    • palpitations in the absence of identified cardiac pathology.
1.2.1.3 Healthcare professionals should be aware that the symptoms of CFS/ME fluctuate in severity and may change in nature over time.

1.2.1.4 Signs and symptoms that can be caused by other serious conditions ('red flags') should not be attributed to CFS/ME without consideration of alternative diagnoses or comorbidities. In particular, the following features should be investigated[5]:
  • localising/focal neurological signs
  • signs and symptoms of inflammatory arthritis or connective tissue disease
  • signs and symptoms of cardiorespiratory disease
  • significant weight loss
  • sleep apnoea
  • clinically significant lymphadenopathy.
...

1.3.1.3 The diagnosis of CFS/ME should be reconsidered if none of the following key features are present:
  • post-exertional fatigue or malaise
  • cognitive difficulties
  • sleep disturbance
  • chronic pain.

These are clinical criteria, and far too vague and broad for meaningful research.
 
Messages
1,446
.
When the NICE Guidelines were published 2007, all charities and local ME groups, with the exception of three, declared the Guideline Unfit for Purpose. The charities which did not reject NICE were AFME, AYME and the Sussex CFS Society (closely allied with AFME and AYME).

At this stage why is NICE considered suitable for patient selection for such a study as MEGA.

NICE for ME is long overdue for revision.

.
 
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snowathlete

Senior Member
Messages
5,374
Location
UK
Except the problem is not the involvement of psychiatrists, but the involvement of specific psychiatrists associated with discredited, probably dangerous, and possibly fraudulent research into ME/CFS.

Exactly. This stinks of conversations behind the scenes where certain people have said, "some patients are just against psychiatry because they think it means we're saying they have a psychological illness. But obviously we aren't saying that at all...blah blah blah." They do this, we've seen it before. Portray patients as mental health biggots so people don't actually listen to the reasonable and relevant points that patients are really making.

The problem is the people involved and their beliefs and actions. If a person is from another discipline but does the same things as White and Crawley do that would be just as much of a problem.

I do question this though:
The MEGA consortium has brought together many experts from a wide range of different disciplines from across genetics, genomics, metabolomics, pain research, proteomics, psychiatry, sleep research and transcriptomics. Psychiatry needs to be there to complete the big picture yet it is just one minor aspect. MEGA will always be a Big Data ‘omics study, and will never be a psychiatric study.

Really? Why? What exactly is the justification for that statement? This is more of the kind of thing which we do not want. We want evidence based decisions, evidence based design and thinking. Not fluff that has no meaning and doesn't stand up to scrutiny. This is supposed to be an omics study for crying out loud.
 

snowathlete

Senior Member
Messages
5,374
Location
UK
I'm in favour of much of the information they have supplied here - particularly that the data will be open access and that they are recording which set of diagnostic criteria each patient meets. The former is hugely important for transparency and the latter for determining the veracity of existing criteria and ultimately determining subgroups.

However I think it is a little disingenuous to say they need paychiatry to be there simply to ensure there are a broad section of specialities represented. As there are resource constraints I think they need a better justification of the presence of psychiatry if they are going to allocate said resources towards psychiatry. The justification here seems to be "Well we thought it would be nice to have a full set", regardless of the fact that there are a number of specialities absent (not least neurology and immunology).

Funny double standard too. When White or Crawley do a study they don't include other disciplines for completeness. Rather they only involve a rather narrow set of disciplines, made up of people who share the same beliefs as them about the disease being a behavioural disorder. So why after decades of behavioural study after behavioural study like that, should they be included in an omics study?
 

Glycon

World's Most Dangerous Hand Puppet
Messages
299
Location
ON, Canada
Really? Why? What exactly is the justification for that statement? This is more of the kind of thing which we do not want. We want evidence based decisions, evidence based design and thinking. Not fluff that has no meaning and doesn't stand up to scrutiny. This is supposed to be an omics study for crying out loud.

Psychiatry is very much needed because of the nature of the symptoms. This is especially true given the criteria that are going to be used to recruit patients for this study. Sure ME/CFS isn't a psychiatric illness. But many people will be recruited into the study who do not have ME/CFS.

What is needed is GOOD psychiatry. The kind most people with ME have not had the opportunity to experience.
 

aimossy

Senior Member
Messages
1,106
I hope some more major science people weigh in.

Honestly, I'm not sure how I feel about some things but there does seem to be a lot to like in this project in my view.

I would like to know more specifics re recruitment and exclusion.
 
But many people will be recruited into the study who do not have ME/CFS.
Which isn't what they quote here
Patients with CFS/ME will be identified by clinicians in the NHS clinics. The clinicians will be asked to identify patients they judge from NICE criteria to have CFS/ME. This means patients with other causes of fatigue will not be recruited including (for example): those with thyroid disease, diabetes or depression that is sufficiently severe to explain their fatigue.