NIH post-infectious CFS study

[Bob]

Is this the intramural study that Collins recently promised?

Yes. Pretty certain it is.

 

[duncan]

I do not care for the PI-CFS definition used in the study description.

This has a feel for me reminiscent of the NIH's efforts to study PTLDS - potentially wrong out of the starting gate, and more or less going through the motions.

One has to hope this doesn't reduce down to posturing.

 

[Nielk]

Background:


Post-infectious chronic fatigue syndrome (PI-CFS) refers to long-lasting fatigue and inability to exercise that can occur after a person has an infection. It can also cause pain, sleep problems, depression, and anxiety. Researchers want to learn more about its causes.

This is not a study of a distinct disease - ME. It is a study of a symptom - fatigue ,that presents itself after an infection.

I remember Collins explaining to an interviewer that this study will also help us explain the fatigue that many cancer patients experience.

 

[Nielk]

The purpose of the exercise test is to make participants tired

- Lol

 

[Nielk]

---- The PI Avindra Nath will be on the CDC PCOCA call on 16 Feb. EDIT - Avindra Nath will be on the CDC Grand Rounds (not the PCOCA call).

Yes - Now it makes sense why this doctor Nath that everyone is so excited about because he is such a highly respected doctor will be presenting at the CDC Grand Rounds meeting. He will be presenting this proposed study on fatigue!

What I don't understand is why is there no outrage about this from the patient community??????

Dr. Francis Collins states that he understands how serious this disease is and will put effort in studying it. Everyone is jumping from joy. Now we see what the study is - it has nothing to do with ME or even ME/CFS. It has to do with unexplained fatigue after an infection.

If we don't react to this with a rebellion, we deserve what we get - imo

 

[duncan]

@Nielk, I could not have said that better.

It is important that we not be happy simply because CFS is in the title of a study.

 

[BurnA]

- Lol

It says they will perform tests post exercise.
It doesn't say when post exercise. I would have thought during PEM would be most appropriate. But this can be 24-48 hours after exercise. If they simply take tests immediately post exercise it won't reveal anything about PEM.

 

[medfeb]

I've just realised that the information on that webpage doesn't exclude using the CCC as part of the study. It simply lists the minimum enrolment criteria. They can carry out sub-diagnosis using CCC after recruitment. But it would be better to use CCC and/or Reeves/Fukuda for recruitment.

I think I read that this was going to be 40 patients. If that is 40 total spread across 3 control groups and the PICFS group, then that's potentially as few as 10 in the PICFS group and even fewer who meet CCC.

 

[Nielk]

It says they will perform tests post exercise.
It doesn't say when post exercise. I would have thought during PEM would be most appropriate. But this can be 24-48 hours after exercise. If they simply take tests immediately post exercise it won't reveal anything about PEM.

They don't even imply that PEM exists! It is not needed for inclusion as a cohort.
They are simply interested in fatigue. A by circle exercise will aggravate fatigue.

 

[Scarecrow]

Dr. Francis Collins states that he understands how serious this disease is and will put effort in studying it. Everyone is jumping from joy. Now we see what the study is - it has nothing to do with ME or even ME/CFS. It has to do with unexplained fatigue after an infection.

I don't see an awful lot of people jumping for joy.

My approach to this study was always wait and see until we knew more. Now we do know more and I can't say I like it.

To be fair to Collins and the NIH, it was always pitched as a post infectious study. I just hoped it wouldn't turn out as it has. It looks to me as if they are going to have a very mixed group of patients: six months to five years.

If the study goes ahead as it is, it will only be redeemed if they subtype like mad. I really don't see the point of studying self-resolving post infectious fatigue. What a waste.

And I agree, we should protest about it.

 

[Bob]

It says they will perform tests post exercise.
It doesn't say when post exercise. I would have thought during PEM would be most appropriate. But this can be 24-48 hours after exercise. If they simply take tests immediately post exercise it won't reveal anything about PEM.

It's a two-day exercise test.

 

[Scarecrow]

I think I read that this was going to be 40 patients. If that is 40 total spread across 3 control groups and the PICFS group, then that's potentially as few as 10 in the PICFS group and even fewer who meet CCC.

Well, that's the sub typing approach scuppered. Yikes!

(Surely it would be 40 patients / controls per group.)

 

[roller]

good... when are they expecting results?

Lyme disease, were treated, and don t have fatigue symptoms

is it known how many that are (%) ?
per country, gender, age, specialiced/non-specialiest doctor, what meds...

 

[Bob]

If we don't react to this with a rebellion, we deserve what we get - imo

Agreed that we need to demand that they investigate patients with PEM/PENE.

Everyone is jumping from joy.

I think you've misinterpreted the thread, Nielk. I think I've been the most enthusiastic and I'm not jumping for joy.
However, if we can get the selection criteria changed then I think it could be a very interesting study.

 

[Scarecrow]

Well, that's the sub typing approach scuppered. Yikes!

(Surely it would be 40 patients / controls per group.)

A further question. Is it even worth a data mining exercise with n = 40?

 

[shannah]

Let's face the facts.

Have these people ever been proficient at designing a study about ME that produces meaningful unequivocal results?

They've never understood ME. There's no shame in admitting what we all know to be true. Why don't they just consult with outside ME experts and recruit the help and guidance they so desperately need to put together a solid study that will produce meaningful results and move the field forward.

The patient community would have a lot more respect for them and it would be a step to restore some faith and trust in them. Why dick around now?

Even the fact that they left out the details of the exercise testing. We know the way in which the tests are performed are the important part. There's more involved than just cycling. Didn't they realize we would jump all over that one wanting to know the details? If it's being done correctly, spelling that out in itself would have been a good will gesture. Have they learned nothing about us?

 

[Nielk]

I think you've misinterpreted the thread, Nielk. I think I've been the most enthusiastic and I'm not jumping for joy.
However, if we can get the selection criteria changed then I think it could be a very interesting study.

I stated that everyone was jumping from joy when Collins announced that he is concentrating on ME/CFS and will spend NIH money to start an intramural study. This study that they are proposing has nothing to do with our neuroimmune disease, yet, Collins will claim that it is and that funding is being spent on the disease. In my opinion, this is worse than doing nothing.

 

[Nielk]

In addition, there was a great elation when it was announced that Dr. Nath will be presenting at the CDC Grand Rounds this month. It was pointed out how distinguished of a doctor he is and that we are fortunate that he is getting involved with us. I had pointed out that he has no experience with ME/CFS, but, noone seemed to care.

He is the lead investigator of this study on fatigue, and this is what he will be presenting at the CDC meeting to thousands of clinicians. They will all hear how this is a study of chronic fatigue syndrome which is equivalent to unexplained fatigue.

I am outraged! Not only are they not carrying out what they promised, but they can now claimed that they provided funding and are using the best of scientists for the disease.

What will it take for our community to wake up and see what is clearly in front of our eyes. We are being had. Collins is not interested in a disease. he is interested in symptom. A symptom that is present in many diseases as well as in ME/CFS.

 

[Bob]

@Nielk, we don't actually know if they will use the CCC in the study or not. But I don't think you'll find many of us happy that they're using Reeves 2005, and if they're ignoring PEM/PENE. Despite Collins' language of 'fatigue', I had assumed they would be using the CCC at least as a subgroup, as that's the direction of travel these days. I hope that we can put enough pressure on them so that they include a CCC cohort. It's not difficult for them to subclass their participants: they just need to use the De Paul questionnaire, which they might be doing anyway.

 

[Bob]

If they want to use a broad criteria for recruitment, they should be using SEID rather than Reeves. Otherwise they wasted a million dollars on the IOM report.