NIH ME/CFS Study is flawed from the get-go

[sometexan84]

So, I'm trying to participate in this trial study on "Post-Infectious Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (PI-ME/CFS)". (<<<< redundant title)

I'm corresponding with them to see if I "qualify". And I must say, it is very upsetting the way they're recruiting for this.

"if you cannot demonstrate in your medical records a distinct onset after an infection, you would not qualify for the study"

Aside from "Long-Covid", how are we supposed to be able to prove this? Everyone with chronic fatigue after getting COVID knows what caused it. Aside from that, it's up in the air.

When I first got CFS, I didn't know what CFS was. I didn't know what Enterovirus was. I didn't even know what EBV was. It took me MONTHS to figure all of this out, and then months after THAT to get the actual diagnoses. And by the time I got tests showing that I have active EBV and Enterovirus infections, I had already had CFS for over a year.

So no, I guess I can't demonstrate in my medical records a distinct onset after infection. Guess I am disqualified.

What really sucks is that this data is going to be flawed. They clearly don't understand ME/CFS and it is just very frustrating to me to see the very limited research funding going to CFS being used this way.

 

[Mary]

@sometexan84 - there are people with ME/CFS who can link its onset to a viral infection, though I'm not one of them either!

I looked at the tests they're going to perform, and it includes the 2-day CPET so they're actually going to check for PEM, which I think is pretty novel. Hopefully they'll be able to glean some relevant data, though I agree, their process of selecting test subjects is not the best.

 

[Hip]

Aside from "Long-Covid", how are we supposed to be able to prove this?

I don't think you would be asked to prove that your ME/CFS started with an infection; you would just be asked if it did, and they would take you on your word.

Given this study is on post-infectious ME/CFS, you would expect the recruitment criteria to require that the patients' ME/CFS began with an infection.

Studies have found that up to 90% of ME/CFS patients can remember an infectious onset, by the way.

 

[sometexan84]

I can link mine to viral infection. I just don't have the proof in medical records that show a positive acute infection at the exact time my CFS started.

I only have lab results showing active infections months after the fact.

 

[sometexan84]

I don't think you would be asked to prove that your ME/CFS started with an infection; you would just be asked if it did, and they would take you on your word.

No, she's literally asking me for proof. That quote above is what she said to me after I described everything to her.

Studies have found that up to 90% of ME/CFS patients can remember an infectious onset, by the way.

I do. I told her mine started with my enterovirus infection.

None of that matters. They want medical record proof. Do you have that?

 

[leokitten]

Unless they changed the requirements you have to also have been sick <5 years and have “severe symptoms”, which I imagine means moderate to severe or worse. See https://mecfs.ctss.nih.gov/

 

[sometexan84]

They were ok w/ my mild or moderate condition. I've only been sick for 3

 

[Hip]

No, she's literally asking me for proof. That quote above is what she said to me after I described everything to her.

Sorry, I missed that quote. That requirement of proof seems strange, as I don't think the medical records of most patients would contain details of the initial acute infection.

Sometimes the acute infection can just be a sore throat, or a gastrointestinal upset that lasts a day or two. These are not the sort of infections you would normally go to a doctor to get checked.

But I guess maybe these researchers just want to be thorough, and make 100% sure that their cohort is post-infectious.

 

[sometexan84]

That requirement of proof seems strange, as I don't think the medical records of most patients would contain details of the initial acute infection.

Exactly. I guess I'm mostly upset because I fit the criteria perfectly and really would like to have all these tests performed for free.

 

[Judee]

And by the time I got tests showing that I have active EBV and Enterovirus infections, I had already had CFS for over a year.

Don't they count your test results as "medical record" proof since they are part of your medical record. Plus, a delayed diagnosis is typical for many of us. Just because you did not get a diagnosis of EBV and Entrovirus right away shouldn't disqualify you, to my thinking. Did you explain that you have those test results?

 

[Hip]

Don't they count your test results as "medical record" proof since they are part of your medical record.

Chronically high antibody titers are unfortunately not proof that you had an acute viral infection. In fact, they are not even proof that you have a chronic ongoing infection.

The researchers who do not believe in the chronic viral infection theory of ME/CFS suggest that these high antibody titers are just the immune system going awry, pumping out antibodies when there is no infection, or very minimal infection.

Personally I am a subscriber to the chronic viral infection theory of ME/CFS; but I am just stating the views of researchers who are not.

 

[sometexan84]

Did you explain that you have those test results?

In great detail.

 

[sometexan84]

I got this response from the "Lead Investigator" in this study...

Hope that this email finds you well. Angelique has forwarded me your correspondence with her in regards to the details of your case. I understand why you may be frustrated with the entry criteria, as others have been since recruitment started in 2016. I am attaching this link to our 2019 presentation that publically reviewed the entry criteria and recruitment process for the study:

. I hope it will help explain what we are trying to do better. Take a look and let me know your thoughts.