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

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It is an extremely sad circumstance that this community screams for change so much and at the same time there are not enough me/cfs patients in the US to get to the NIH. What us going on there?
 
butter. said:
It is an extremely sad circumstance that this community screams for change so much and at the same time there are not enough me/cfs patients in the US to get to the NIH. What us going on there?
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I agree it's really disappointing. But perhaps not too surprising.

They have pretty strict criteria - less than 5 years with ME, initial infectious trigger on their medical records diagnosed by a doctor, well enough to cope with the travel and days of testing, not having any other condition that might contaminate the test results. And willing to take the risk of being made much sicker by PEM resulting from participating, which is likely to put off a lot of people with caring or work responsibilities.

With so few doctors clued up enough to diagnose ME in the early stages and knowing about the study so they can suggest their patients participate, and many undiagnosed until years after ME starts, or with gradual onset, I think it's not that surprising it's hard to get enough participants.

And they can only take one or two at a time, and only they have to do controls as well. And I think it has been deferred for the duration of Covid-19.
 
I think highlighting study opportunities like this one is something more people could do to help with research progress. It doesn’t cost any money.

Ideally we would like a bigger sample size but it makes it harder to argue for with recruitment difficulties.
 
Trish said:
They have pretty strict criteria - less than 5 years with ME, initial infectious trigger on their medical records diagnosed by a doctor, well enough to cope with the travel and days of testing, not having any other condition that might contaminate the test results.
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I don't mean to sound ghoulish, and maybe this has been discussed elsewhere, but I wonder if they are considering recruiting long-covid patients for the NIH ME/CFS study. If long-covid patients meet the ME/CFS criteria, I'm not sure why knowing their infectious trigger would disqualify them. It's seems pretty clear that ME can be triggered by more than one thing. Covid-19 may just be making its cases more visible.
 
Dolphin said:
I get your point, but part of the issue seems to have been a relative lack of suitable people with ME/CFS coming forward.
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Well that is an issue for the researchers to solve, and that takes a lot of thought and effort as the DecodeME team will confirm. The NIH picked a cohort that would be difficult to find in the first place, and then have made minimal outreach attempts, their assumption that the right patients would be queue up in sufficient quantities to take part is on them.
 
Andy said:
Well that is an issue for the researchers to solve, and that takes a lot of thought and effort as the DecodeME team will confirm. The NIH picked a cohort that would be difficult to find in the first place, and then have made minimal outreach attempts, their assumption that the right patients would be queue up in sufficient quantities to take part is on them.
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I’m afraid I dislike this sort of attitude: this is not some sort of company where the ME community doesn’t benefit from the project. And DecodeME are in such a strong position with regard to recruitment partly because people with ME and ME charities promoted the recruitment. My point is that the ME community could similarly make a big effort to promote this rather than simply say “it’s in them”.
 
Dolphin said:
I’m afraid I dislike this sort of attitude: this is not some sort of company where the ME community doesn’t benefit from the project. And DecodeME are in such a strong position with regard to recruitment partly because people with ME and ME charities promoted the recruitment. My point is that the ME community could similarly make a big effort to promote this rather than simply say “it’s in them”.
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DecodeME are in a strong position because they engaged with the community before the start of the study, the NIH haven't come close to doing that, before or after, to the same level. You are as aware as I am that there is a lot of suspicion towards the NIH which will mean, rightly or wrongly, that the community won't make much effort at promotion.

And sure, the patient community could promote it more, but to help them do so it needs to be made as easy as possible and the NIH haven't done that. It's not going to help the NIH if the finger is pointed at the community and it's said "it's your fault because you didn't promote it"; they need to understand where they didn't do enough to engage the community, I don't get the sense though that they are open to that kind of feedback.
 
Andy said:
DecodeME are in a strong position because they engaged with the community before the start of the study, the NIH haven't come close to doing that, before or after, to the same level. You are as aware as I am that there is a lot of suspicion towards the NIH which will mean, rightly or wrongly, that the community won't make much effort at promotion.

And sure, the patient community could promote it more, but to help them do so it needs to be made as easy as possible and the NIH haven't done that. It's not going to help the NIH if the finger is pointed at the community and it's said "it's your fault because you didn't promote it"; they need to understand where they didn't do enough to engage the community, I don't get the sense though that they are open to that kind of feedback.
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Those may be some relevant issues. But if people are complaining that the progress with this project is slow, it suggests they or at least many of them think the project is worthwhile. If that is the case, I think they should try to promote recruitment of it. I don’t think it’s that complicated to do: last time I checked, there was a specific webpage.

There is no guarantee research progress happens for a particular condition as quickly as someone with it would like. I think people should try to do what they can to speed progress and highlighting research opportunities generally is free.

Also this isn’t specific to the NIH: quite a lot of studies in the field struggle with recruitment.
 
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Dolphin said:
I get your point, but part of the issue seems to have been a relative lack of suitable people with ME/CFS coming forward.
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I think they’ve been way too restrictive with cohort requirements thinking this is going to give them cleaner results in the end or help with discovery. I highly doubt it.

I went through the entire enrollment process years ago, right when they started enrolling, they got every single one of my ME and other medical records from 10 years prior to that time. I have post-viral ME and medical records show that and fully meet CCC and ICC criteria.

I wasn’t accepted because I wasn’t severe enough at the time and because I supposedly tried too many different drug treatments. It was really absurd to me. I also found it really annoying because in the beginning they used not have the very severe symptom specification to enroll in the study.

This phrase was added after unless I’m not remembering my reaction at that time:

https://mecfs.ctss.nih.gov/
  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
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Dolphin said:
I’m afraid I dislike this sort of attitude: this is not some sort of company where the ME community doesn’t benefit from the project. And DecodeME are in such a strong position with regard to recruitment partly because people with ME and ME charities promoted the recruitment. My point is that the ME community could similarly make a big effort to promote this rather than simply say “it’s in them”.
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How are you going to get pwME who “have severe symptoms”, so meaning at the best moderate-to-severe severity or worse, to travel to NIH??? It’s stupid.
 
leokitten said:
I think they’ve been way too restrictive with cohort requirements thinking this is going to give them cleaner results in the end or help with discovery. I highly doubt it.

I went through the entire enrollment process years ago, right when they started enrolling, they got every single one of my ME and other medical records from 10 years prior to that time. I have post-viral ME and medical records show that and fully meet CCC and ICC criteria.

I wasn’t accepted because I wasn’t severe enough at the time and because I supposedly tried too many different drug treatments. It was really absurd to me. I also found it really annoying because in the beginning they used not have the very severe symptom specification to enroll in the study.

This phrase was added after unless I’m not remembering my reaction at that time:

https://mecfs.ctss.nih.gov/
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Thanks for applying and for sharing your medical records.

To be honest, if you had tried a lot of different drug treatments, it's not the worst exclusion i.e. it wouldn't make me think less of them for doing it.
 
leokitten said:
How are you going to get pwME who “have severe symptoms”, so meaning at the best moderate-to-severe severity or worse, to travel to NIH??? It’s stupid.
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It's a difficult one all right. But then some people would say that you are going to find more abnormalities, the more severe people are. Some people complain that people with severe ME are not used enough in studies.
So again, it wouldn't make me think less of them.

Some people have come forward and I think if it was promoted more, more progress might be made towards the relatively modest target.
 
Dolphin said:
It's a difficult one all right. But then some people would say that you are going to find more abnormalities, the more severe people are.
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The problem I’ve always found with that reasoning is there is ZERO scientific basis for this assumption, it’s just completely made up.

Maybe more severe patients will make it much more difficult and clouded to analyze and interpret the results, because they could have more downstream abnormalities that are harder to connect to each other and back to the core pathophysiology of this disease, therefore also making it much harder to generate new hypotheses from the results.

They are assuming that the more severe you are that you supposedly have the same abnormalities as a mild patient but more pronounced. This is a wild assumption and it could be like I said not necessarily more pronounced but severe patients have many more abnormalities that are harder to connect and interpret.
 
leokitten said:
The problem I’ve always found with that reasoning is there is ZERO scientific basis for this assumption, it’s just completely made up.

Maybe more severe patients will make it much more difficult and clouded to analyze and interpret the results, because they could have more downstream abnormalities that are harder to connect to each other and back to the core pathophysiology of this disease, therefore also making it much harder to generate new hypotheses from the results.

They are assuming that the more severe you are that you supposedly have the same abnormalities as a mild patient but more pronounced. This is a wild assumption and it could be like I said not necessarily more pronounced but severe patients have many more abnormalities that are harder to connect and interpret.
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it’s an interesting question alright. Do you think there are many abnormalities that would show up in the mild but not the moderate and moderate severe?

If this study found no abnormalities, it would be disappointing and might have a negative effect on NIH interest. To me, it seems a safer option for an initial study to be towards the more severe end of things.
 
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