USA: National Institutes of Health (NIH) intramural ME/CFS study

[Kalliope]

Not able to go through a lot of text now, so could someone please direct me towards the requirements for ME patients they're requiting?

It is interesting that they'll accept patients from abroad. But only those who have been ill for less than five years? Are there other requirements?

 

[Andy]

Not able to go through a lot of text now, so could someone please direct me towards the requirements for ME patients they're requiting?

It is interesting that they'll accept patients from abroad. But only those who have been ill for less than five years? Are there other requirements?

All participants must be 18-60 years old and have at least a 7th grade education. Volunteers must fit into one of the groups below. There will be 3 inpatient groups, one outpatient focus group, and a technical development sub-study:

1. Inpatient ME/CFS group: Those with ME/CFS that started after an episode of infection who have severe symptoms based lasting between 6 months to 5 years, based on the study evaluation
2. Inpatient Lyme Group: Those who had Lyme disease that was treated and had complete resolution;
3. Inpatient Healthy Volunteer Group: Those in good general health
4. Outpatient ME/CFS Focus Group: Those with ME/CFS who will participate in telephone focus groups only. They will not have inpatient visits.
5. Technical Development Sub-study: Healthy volunteers and people with ME/CFS having only functional magnetic resonance imaging (fMRI) and transcranial magnetic stimulation (TMS) and clinical MRI.

https://mecfs.ctss.nih.gov/

Also

10. Are diagnostic criteria going to be used in the adjudication process?
The adjudication committee will consider the 1994 Fukuda, 2003 Canadian Consensus criteria, and additional information collected during the initial study visit in the adjudication process.

 

[Little Bluestem]

When I saw that expenses were paid, I was considering applying until I saw the less that 5 years bit.

 

[Jim001]

I feel like ME/CFS clinicians would be the best people to help recruit for the NIH study since they are the ones who have direct contact with the most patients, and probably a lot of patients who are being newly diagnosed. I wonder if that's being done.

 

[wigglethemouse]

http://simmaronresearch.com/2019/03/nath-intramural-chronic-fatigue-study/

These two sections caught my eye. The numbers are small but very intriguing

High Percentage of Rare Diseases
It’s a small sample set but it’s remarkable how many people participating in the first week were diagnosed with a rare disease. In something of a testament to the thoroughness of the study, almost third of week one participants (6/19) were found to have a rare disorder which the researchers believed was probably causing their symptoms and dismissed from the study. One appeared to have Parkinson’s Disease, another a neurological disease and I’m unsure of the others.

I've often wondered if many of us have a known rare disease. Rare diseases are so hard to diagnose and the medical profession does not have many diagnosticians checking patients for these despite what we see on TV shows such as "House". Hopefully Nath expands on this in his upcoming NIH Conference presentation

Quite a few people with autoimmune disorders have shown up during the filtering out process. Nath suggested that could be an interesting cohort to study on its own. He’s also found quite a bit of head injury and loss of consciousness – which makes MRI and brain scans difficult to assess – and people with seizures and strokes. Interestingly, bnly one person had had a diagnosis of major depression….

Not clear if these were filtered out, or part of the study. I would bet that most ME patients have not been tested for the full suite of autoimmune diseases - only the most common ones seem to be tested for...... Could this be why Ritux worked in some people in the Norwegian trials?

I strongly believe we need ME/CFS literate specialists - or even better Complex Disease specialists who work on patients that other doctors have discarded and are able to check for more autoimmune and rare diseases.

 

[rvallee]

http://simmaronresearch.com/2019/03/nath-intramural-chronic-fatigue-study/

These two sections caught my eye. The numbers are small but very intriguing

I've often wondered if many of us have a known rare disease. Rare diseases are so hard to diagnose and the medical profession does not have many diagnosticians checking patients for these despite what we see on TV shows such as "House". Hopefully Nath expands on this in his upcoming NIH Conference presentation

Not clear if these were filtered out, or part of the study. I would bet that most ME patients have not been tested for the full suite of autoimmune diseases - only the most common ones seem to be tested for...... Could this be why Ritux worked in some people in the Norwegian trials?

I strongly believe we need ME/CFS literate specialists - or even better Complex Disease specialists who work on patients that other doctors have discarded and are able to check for more autoimmune and rare diseases.

Not surprised in the least by these numbers. This is by far the most harmful consequence of the dogma of psychosocial MUS, it discourages investigation and amplifies the problem of misdiagnosis. It hurts people with ME. It hurts people with other misdiagnosed conditions who get caught in the wastebasket. It hurts people who could benefit from psychotherapy by clogging their services. It demoralizes people providing those services because they are given an impossible task. It hurts nearly everyone while providing no measurable benefits.

And that's with a carefully selected group, unlike the diagnostic wastebasket done by psychosocial clinicians. Their numbers must be even worse on that count.

 

[Hoopoe]

A wastebasket it may be but we still need studies to better understand what is being misdiagnosed and what's wrong with those where no known disease can be identified.

 

[wastwater]

This is interesting as I found I have a rare genetic disorder Axenfeld rieger syndrome but then found many with ARS seem to have FM ME
Following FOXC1 I can reach a lot of what ME is supposed to be
Eg you want heat shock 70 proteins I got that
B and t yes and lots of other angles now just following that one gene FOXC1

Maybe they got rid of all there best clues

 

[wigglethemouse]

A wastebasket it may be but we still need studies to better understand what is being misdiagnosed and what's wrong with those where no known disease can be identified.

Didn't Ron Davis talk about how he could get no funding for the Severely ill project as NIH does not fund that kind of investigation? Does anyone now if the NHS in the UK is set up to do a deep dive on a disease group to gather more information about said disease?

One thing that may help move your thought forward is the Clinician Coalition of ME/CFS practitioners that Dr. Lucinda Bateman is coordinating in the US. If they can start uncovering the autoimmune and rare disease patients that meet strict ME criteria and share that information by writing case studies it could possibly move the field forward by identifying new subsets that can then be leveraged. That would not cost that much money, mainly the doctors time.

 

[Hoopoe]

The requirements to enter the study:

Those with ME/CFS that started after an episode of infection who have severe symptoms based lasting between 6 months to 5 years, based on the study evaluation

The first step is a pre-screening process, and then a 5-10 day initial phenotyping inpatient visit. I understand that it's at this stage where the previously missed diseases were recognized.

 

[Ravn]

These two sections caught my eye.

Same here.
If Cort reported correctly then these patients who were found to have other conditions had been carefully prescreened by ME experts and met CCC including PEM (Cort said this in the comments). This raises some questions:

• Were they misdiagnosed and never had ME (despite meeting CCC & PEM)? This would mean PEM is not unique to ME after all, and CCC is not that good at identifying ME.
• Did they have both ME and another condition, as two separate issues?
• Did their other condition cause their ME? This could fit with the idea of subgroups such as, for example, an autoimmune subgroup.
• Did their ME cause them to develop another condition?

 

[Hoopoe]

If true this seems to align with the view that the diagnostic criteria are fairly bad.

 

[Trish]

Those with rare conditions may have had ME as well, I guess, but were excluded from the study so their rare condition would not confuse the data.

 

[wastwater]

I think it may of been that some with a rare condition had within it inherited a tendency towards developing ME and if so that will narrow things down and the pathways be easier to see
And there maybe many but I wonder if they come to a similar important spot

 

[Milo]

It goes on to say that diagnosing ME means that the patient enters a black hole where all the symptoms experienced by patients are blamed to ME and therfore undeserving of further investigation into other pathologies. It’s as if diagnosis of ME disabled physicians into looking for more.

 

[Forbin]

High Percentage of Rare Diseases
It’s a small sample set but it’s remarkable how many people participating in the first week were diagnosed with a rare disease. In something of a testament to the thoroughness of the study, almost [a] third of week one participants (6/19) were found to have a rare disorder which the researchers believed was probably causing their symptoms and dismissed from the study. One appeared to have Parkinson’s Disease, another a neurological disease and I’m unsure of the others.

Wait... that can't be right. We have it on the highest authority that...

However, the simple combination of history, examination and basic tests will establish those who require further investigation. In the majority this simple screen will be normal, and over investigation should be avoided. Not only is it a waste of resources, it may not be in the patients' interest, and may reinforce maladaptive behaviour in a variety of ways.
https://jnnp.bmj.com/content/jnnp/54/8/669.full.pdf

 

[Aroa]

I wouldn´t exclude the possibility that PEM is unique to ME.

I presume that current studies may also have a significant percentage of non Me patients. It is difficult to have the right answers if you are mixing patients with several conditions.

Anyway I look forward to watching Dr. Nath´s talk.

Hopefully this NIH meeting will give us finally some answers !!!

 

[Inara]

This would mean PEM is not unique to ME after all

PEM is not unique to ME.

 

[Wonko]

I wouldn´t exclude the possibility that PEM is unique to ME.

Various discussions have been had on PEM on here.

Practically everyone here knows what it is, or at least has significant commonalities with the majority in their experience of it.

The problem is a definition was never agreed on, there seemed to be too many things which might be part of it, with no one being quite sure if people were talking about the same experience of a specific aspect, i.e. if it was just a language problem or if people were talking about different things.

Enough of that occured so that no real progress was made in coming up with an operational definition.

It seems PEM is a very wooly thing.

Or that's my interpretation of my recollection of the odd times I dipped into the threads.

It's also unlikely to be ME specific, from memory of posts even over the last week it appears a few other conditions have something that would fit well within the wooly PEM pwME experience.

 

[Forbin]

Quite a few people with autoimmune disorders have shown up during the filtering out process. Nath suggested that could be an interesting cohort to study on its own. He’s also found quite a bit of head injury and loss of consciousness – which makes MRI and brain scans difficult to assess – and people with seizures and strokes. Interestingly, bnly one person had had a diagnosis of major depression….

I do wonder about the exclusion of all autoimmune disorders, though. I believe Dr. Hanson and others have found similarities in the makeup of the mircobiome between some ME/CFS patients and patients with Crohn's disease and chronic ulcerative colitis, both of which are believed to be autoimmune in nature. It could be that autoimmunity in the gut can either be a consequence or a component of the mechanism of ME.