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

I've been told (but perhaps haven't fully understood) that traditional/established medical journals don't publish if there's been a pre-print - might have got that wrong though.

 

NEJM and JAMA ok with PP
Lancet has their own PP server

 

I can’t remember exact details but I think some quite high number — about 30% I think — of people who were admitted for this study were discovered to have other diagnoses during the initial week long stay or whatever they did. I don’t think they said what those diagnoses were.
(Edit: clarified below by a trial participant below that it was much lower — 3 out of 20)

 

Oh boy, yes @Trish.

It could just be some small downstream bits as you say. There are already sleep and pain remedies.

OI treatments might be good.
But in general, side effects from most drugs are a concern.

And, as you say replication studies are needed.

It could be a very long time before there is effective help.
At least there might be more belief, respect and kindness generated by the NIH papers.

And, interest from additional researchers.

 

Ideally, I think you'd want researchers to be agnostic going in. You probably don't want someone who comes to the research with a lot of pre-conceptions, even if those preconceptions align with your own. You'd probably even prefer someone who's skeptical of your own view, rather than aligned with it because, if they are convinced, that would indicate that the evidence is strong indeed. What you obviously don't want is someone who's so invested in their own view that if affects their objectivity.

Dr. Nath strikes me as being about as agnostic and objective about the research results as you could hope for - even if that is sometimes frustrating for us as patients.

 

Three out of the 20-some patients brought in were given other diagnoses. One had Parkinsonism, one had a rare form of cancer and passed away shortly thereafter, and another patient had myositis in addition to ME/CFS.

 

The term for this is "The Ingelfinger Rule."

 

Isn't this just evidence that the "high profile" journals are no longer concerned with progress in science, and instead are more concerned about their own perceived status and bottom line? Scientists needs to move away from these types of "high profile" journals (NEJM in particular is run by editors that are completely out-of-touch).

 

Thanks for details. Not as high as I’d remembered then.

 

I think this is likely to be variable. They are going to internally circulate the soon to be completed draft, and probably will solicit comments and suggestions, followed by at least one more rewrite. This will take time. Only then will they submit for publication. Given the pandemic it might even be the case that a paper like this is given publication priority, and extra attention might be paid to it.

 

Did they replace them with other patients? Does anyone know?

 

Nailed it --- money!

Yip these journals don't give a s--t about those desperate to see the outcome of this study. However, I think someone mentioned to me that they were coming under pressure to speed up the publication of some high profile Covid studies --- hopefully the same thing can happen here.

 

Haven't checked but the study fell short of the intended number of participants ----
Cort did an article some time ago (I think he was also a participant) and I think he dealt with the issue of those misdiagnosed/removed from the study --- where they replaced etc.

 

Again, almost all journals allow preprints. In this study only 1 out of 100 journals surveyed prohibited preprints.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7376388/#!po=12.5000

 

They had lots more patients planned but the pandemic stopped the study early. I have no idea if any of those were replacements for any misdiagnosis or comorbid patients. Even so it took them a long time to analyse the data they did have.

 

Is it the data from this study?

https://www.s4me.info/threads/chara...ronic-fatigue-syndrome-2020-nath-et-al.16927/

 

it sounds like this Colloquium is by. invitation only which means that any of the data or unpublished results will not be shared to the public unless the authors agree to share, and all the participants will agree not to share any information, most of whom will be researchers. We will have to wait.