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

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Greater community participation will help expand the impact of this important study regarding the biological basis of ME/CFS

Greater community participation will help expand the impact of this important study regarding the biological basis of ME/CFS

SMCI has received an exclusive update regarding progress in recruiting and processing patients and controls for the NIH Intramural Clinical Study (see study description below from the NIH website). The chart below shows, at the top of the “funnel,” the number of potential study participants and, at the bottom, the number who have completed the process.
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https://solvecfs.org/me-cfs-study-participants-needed-at-nih/
 
I would have done it if I didn't have to travel across the Atlantic for it, with extensive testing for free and all in one place and the potential for ruling out other conditions I think it would benefit me (in addition to helping the study).

Having to drive hours to get there would be the biggest barrier for me as more than an hour or two (tops) in a car would destroy me and I think most PwME. The inclusion criteria are also very strict, you don't qualify if your onset was gradual among other things.
 
andypants said:
I would have done it if I didn't have to travel across the Atlantic for it, with extensive testing for free and all in one place and the potential for ruling out other conditions I think it would benefit me (in addition to helping the study).

Having to drive hours to get there would be the biggest barrier for me as more than an hour or two (tops) in a car would destroy me and I think most PwME. The inclusion criteria are also very strict, you don't qualify if your onset was gradual among other things.
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Ditto, I am eligible and if somehow a UK centre was available I would be more than willing to risk the crash to take part but there's no way I'd make it to the US.
 
Dolphin said:
Yes, though just in case anyone missed it, you actually get most/all of your expenses paid plus decent amounts of money. I really hope they get the numbers.
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As do I but with the expected time commitment it would obviously mean that anybody still working is highly unlikely to be able to take part. I also think that the requirement that the participants be less than 5 years into their illness will play a huge part in restricting numbers - it may well be for valid medical reasons but how long will it take for the average person to get a diagnosis? Then, if it's less than 5 years, how likely are they to learn of the research and the fact they could take part?

Given that the online patient community, I would argue, tends to be the longer term affected, do we know what extra efforts the NIH are making to capture newly, or more recently, diagnosed patients?
 
Andy said:
Given that the online patient community, I would argue, tends to be the longer term affected, do we know what extra efforts the NIH are making to capture newly, or more recently, diagnosed patients?
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I don’t know. But lots of ME/CFS studies can struggle to get the numbers. I try to help when I can e.g. have used boosted ads on Facebook (a contact of mine works for Facebook and lets me use some of her ad money for ME/CFS items). Unfortunately last time I checked, there was no obvious way to do targeted ads for people interested in ME/CFS (there was previously). Anyway I think the ME/CFS community should do what it can to highlight opportunities.
 
I didn't really mean that question to be aimed at you, though I appreciate it reads that way. I agree that the community should do what I can but I can see why the NIH may well be struggling to recruit. I'll try to remember to put something up on the forum Facebook page soon.
 
I do wonder if their inclusion criteria are so strict that they are going to end up with a sample that is actually not representative.....
Most of us have other comorbidities and what if that is actually an important piece of the jigsaw? By studying only people who don’t, might they not end up with the wrong jigsaw?
 
I applied to it (I meet being under the 5 year criteria) but unfortunately after being reviewed for quite some time, was denied. Although it certainly entails a decent amount of commitment, to help research I would have signed up for anything.

In any event, hope they can get their numbers they are seeking.
 
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?
 
Kalliope said:
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?
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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.
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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.
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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.
 
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.
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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….
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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.
 
wigglethemouse said:
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.
Click to expand...
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.
 
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