NIH post-infectious CFS study

[BurnA]

So, if you could change something would it be a) remove Walitt
B) remove FMD group
C) increase ME patient number

 

[luludji]

I still think the venom is also in the multiple use of the term "brain dysfunction" in the protocol instead of "brain pathology".
As if the only problem is wrong functioning of the brain, and the solution is let the brain function normal.
Instead of examining the brain pathology (eg chronic neuroinflammation) which leads to permanent brain damage (eg demyelination).

 

[Scarecrow]

So, if you could change something would it be a) remove Wallit
B) remove FMD group
C) increase ME patient number

D) all of the above?

 

[BurnA]

D) all of the above?

That's too easy. We all want that.

 

[duncan]

I would strongly recommend that all ME/CFS volunteers be given access to tests results - all of them - as soon as they are submitted by NIH testing teams.

I would also suggest a patient advocate be made available that can sit with the ME/CFS subjects individually to review results. A non-NIH advocate.

 

[daisybell]

I would really like NIH to provide more info about why they have picked the post-Lyme and FMD groups. At the moment I am worried about the inclusion of the FMD group. Perhaps it's a great opportunity for more research into FMD - trying to find physical causes....but given that their own draft protocol states that this is a group with psychosomatic causation, I feel concerned.

 

[Scarecrow]

So, if you could change something would it be a) remove Walitt
B) remove FMD group
C) increase ME patient number

C)

 

[Sasha]

I would really like NIH to provide more info about why they have picked the post-Lyme and FMD groups. At the moment I am worried about the inclusion of the FMD group. Perhaps it's a great opportunity for more research into FMD - trying to find physical causes....but given that their own draft protocol states that this is a group with psychosomatic causation, I feel concerned.

We need to remember that the point of this study isn't to investigate FMD. They're only there to serve as a control condition for us, and NIH appears already convinced that their condition is psychosomatic.

 

[Gemini]

They are being selected by expert clinicians, apparently.

Do we know this for sure? One would hope...

Clinicians with experience/credentials in infectious disease/immunology, i.e., Montoya, Chia, Sue Levine, Klimas would select and review the 40 patients given the nature of the study and...

Long-time experts like Byron Hyde, Dan Peterson, David Bell among others would weigh in on study definition.

 

[halcyon]

Do we know this for sure? One would hope...

If I heard correctly, the patients will be recruited from the same centers involved in the CDC multisite study. Someone correct me if I'm wrong.

 

[BurnA]

C)

Strange how Nath described the Norwegian studies as small, yet the patient no.s are not too different.

 

[searcher]

This is what I have been told too. I believe the list is Drs peterson, kogelnik, lapp, klimas, bateman, natelson, and podell, although Levine may refer a couple of patients as well.

 

[searcher]

Strange how Nath described the Norwegian studies as small, yet the patient no.s are not too different.

Although I would like the NIH study to be bigger I think that treatment studies need to be much bigger than the discovery studies. So phase iii of this study will be have many more patient than 40. And the NIH rituximab trial should be bigger too.

 

[Scarecrow]

Strange how Nath described the Norwegian studies as small, yet the patient no.s are not too different.

Yes, particularly as Fluge and Mella were trialling a treatment and have stepped up the number of participants for the Phase III, where as the NIH study is going fishing and will be making an incalculable (for me at any rate) number of comparisons. The later phases of the NIH project should deal with the false positives but with such a small number of patients, I'm pondering (without any success) how likely it will be that something important might be missed at this initial stage.

 

[Ecoclimber]

Researchers should be agnostic. As in judicial proceedings where impartiality is an issue, judges recluse themselves. I have problems with any researcher exhibiting pre-existing confirmation bias with regards to ME/CFS research. I find this troubling. Confirmation bias is a form of cognitive bias and as such is deeply rooted in ones way of thinking. Good scientific practices can diminish the effect of this bias, but they are not always followed nor infallible.

I also find the FMD control group deeply troubling since there is no underlying exact cause for FMD other than wastebasket of mental illness considering the ME/CFS physical symptoms are mild compared to those in the FMD group, especially after viewing aspects of this website http://www.functionalmovementdisorder.com/welcome/an-update-on-me/

It is rather an unorthodxox research methodolgy and perhaps might consist of control selction bias. Unless the plan is if ME/CFS is biologically null, to drop kicked the patient community into FMD group.

 

[beaker]

Researchers should be agnostic. As in judicial proceedings where impartiality is an issue, judges recluse themselves. I have problems with any researcher exhibiting pre-existing confirmation bias with regards to ME/CFS research. I find this troubling. Confirmation bias is a form of cognitive bias and as such is deeply rooted in ones way of thinking. Good scientific practices can diminish the effect of this bias, but they are not always followed nor infallible.

\

Actually, I'm quite happy to have researchers to be biased in that they have read the literature and realize this is a serious multi systemic biological illness. : )
But I know what you meant. The psychobabblers must go !

 

[Ecoclimber]

Actually, I'm quite happy to have researchers to be biased in that they have read the literature and realize this is a serious multi systemic biological illness. : )
But I know what you meant. The psychobabblers must go !

Confirmation bias is when a researcher holds a stronghly held view that through his prior research that ME/CFS is caused by psychosomatic disorder and not a biological disorder when conducting current research on ME/CFS

 

[beaker]

Confirmation bias is when a researcher holds a stronghly held view that through his prior research that ME/CFS is caused by psychosomatic disorder and not a biological disorder when conducting current research on ME/CFS

thanks for the clarification. : )

I need sleep.

 

[BurnA]

Although I would like the NIH study to be bigger I think that treatment studies need to be much bigger than the discovery studies. So phase iii of this study will be have many more patient than 40. And the NIH rituximab trial should be bigger too.

But the discovery studies are the most important. There is no point in having large treatment studies if the discovery study is flawed. If the discovery stage isn't right, the improved quality of the next stages cant make the situation better.

 

[Bob]

I also find the FMD control group deeply troubling since there is no underlying exact cause for FMD other than wastebasket of mental illness considering the ME/CFS physical symptoms are mild compared to those in the FMD group, especially after viewing aspects of this website http://www.functionalmovementdisorder.com/welcome/an-update-on-me/

Interesting to read a first-hand account of FMD. I notice that the patient experiences fatigue:
"I get extreme fatigue, I am always tired no matter what time of day."