Dr Nath's intra-mural study at NIH is currently recruiting

[duncan]

My math may be off, but in this schedule provided by @viggster they note procedures where they volunteer associated researchers names 16 times. I am surmising most of the other procedures involve technicians, e.g. MRIs.

Of those 16 times, it would appear 8 of those procedures either involve psychiatric processes, or simply involve a psychiatrist, or involve individuals who, in the past, purportedly have gone on record as opining CFS is a psych thing.

So, 50% with a potential psych component.

Now, to be fair, I'm unclear if the names given are the ones identified earlier as investigators, e.g. Gill and Snow, for instance.

But if my speculation is even close to the mark, that's a little disconcerting.

 

[Hutan]

Here's a list of the testing without breakfasts etc:

Psychological/neuropsychiatric

Psychological assessment (Sinclair)
Neuropsychological testing (Tierney)
Psychiatric inventories (Coleman)
Dr Snow interview​

(Dr Snow - presumably is the Dr Snow who is 'a clinical and research Neuropsychological Consultant to the Psychiatry Consultation Liaison Service of the National Institute of Mental Health.')

Other

Collection of specimens (eg blood, urine, buccal swab)
Physical exam (Walitt, Kreskow)
Halter monitor
Symptom profile (Walitt, Kreskow)
Muscle strength testing (Coleman)
Occupational therapy (Hodsdon) ??
Lumbar puncture
Lymphocytapheresis
Symptom assessment forms (Coleman)
Clinical assessments (Gill, Friedman, Solin)
Autonomic testing (Goldstein)
Dr Nath assessment
Sleep study
Dietician assessment
MRI​

 

[duncan]

I am also trying to wrap my brain around the logic of assigning a block of time (2.5 hours) for an occupational/rehabilitation therapist. Is she there to promote an exercise regime? Evaluate one?

I'm not sure this isn't a case of the cart before the horse, so an explanation would be welcome.

 

[Hutan]

Occupational therapy (Hodsdon) ??

Is she there to promote an exercise regime? Evaluate one?

The discredited CBT is reformed into Constructing Baskets Therapy?

so an explanation would be welcome.

In a paranoid moment I wondered if it was some kind of covert psychological assessment. But it was a fleeting moment. Really. I'm hardly ever paranoid...

Yeah, no doubt there is a good reason.

 

[duncan]

Yeah, no doubt there is a good reason.

It is likely a moot point. I have every confidence the dietician will trace back all of our problems to a deeply ingrained misunderstanding - on our part - of the food pyramid.

 

[trishrhymes]

Of those 16 times, it would appear 8 of those procedures either involve psychiatric processes, or simply involve a psychiatrist, or involve individuals who, in the past, purportedly have gone on record as opining CFS is a psych thing.

To be fair, by their nature, psychological assessments have to be done with the patient present and take time, whereas there could be a huge range of biomedical assessments also being done on the blood, stool, urine and CSF, which only take moments to collect from the patient, and are done in a lab later. So to say half the assessments are psychological is not really accurate.

Having said that, I do wonder whether any other illness would be assessed in this way. On the positive side, hopefully such an assessment will enable them to eliminate psychological factors as the major causal and perpetuating factors once and for all.

 

[duncan]

So to say half the assessments are psychological is not really accurate.

That is not what I said.

The preponderance of the psych factors is a bit troublesome relative to the stated investigators. I am concerned about weighting of opinions.

As you point out, intent likely will play a role.I hope your suggestion is correct.

 

[trishrhymes]

That is not what I said.

The preponderance of the psych factors is a bit troublesome relative to the stated investigators. I am concerned about weighting of opinions.

As you point out, intent likely will play a role.I hope your suggestion is correct.

Apologies @duncan, I think we're agreeing here, just putting it differently. I too am concerned at the role of these investigators.

 

[Knockknock]

What strikes me is psychology, neuro-psych and psychiatry assessment. One of them is completely legit, but you know, that is a lot of assessment for someone who is physically ill.

i wonder who is the Dr Gill who will perform the clinical assessment. The dr Fred Gill we know from NIH (was it state of knowledge meeting, 2011) was a psychologizer.

Best wishes @viggster

Absolutely!!!
Toooooo many phsycological and phsyquiatric assesment for an study that they are looking for immune metabolic disfuntion and deficiencies.
Thats what they need to look for, pathogen, viruses , immune, metablolism!!!
I dont believe in the NIH good intentions!!!
Remplace those phsycologist and phsyquiatric Assesment for two world class virologist infectologist to look for pathogen.
I dont see nothing like that on the study

 

[eljefe19]

Jesus the exclusion criteria is EXTENSIVE. I wanted to participate if possible but oh well.

 

[Nielk]

And as always, NIH is standing by their words. After the uproar from the ME community pointing to Wallit's beliefs about fibromyalgia and ME/CFS - that they stem from the mind, NIH placated advocates and patients by assurances that Wallit will have no hands on contact with the patients.

 

[Denise]

What strikes me is psychology, neuro-psych and psychiatry assessment. One of them is completely legit, but you know, that is a lot of assessment for someone who is physically ill.

i wonder who is the Dr Gill who will perform the clinical assessment. The dr Fred Gill we know from NIH (was it state of knowledge meeting, 2011) was a psychologizer.

Best wishes @viggster

As far as I can tell, it is the same Dr. Fred Gill.... the one who spoke at SOK in 2011 and who (earlier that same year) gave an NIH "Demystifying Medicine" talk. MassCFIDS did a write-up of that talk .

 

[mango]

No mention of Saligan? Perhaps he's busy with his own bps fatigue study (fibromyalgia, chronic fatigue syndrome, and depression).

 

[viggster]

Just to remind people: This schedule is for the first visit to NIH. The team will then look at results and an adjudication committee will determine if patients meet Canadian Consensus Criteria. If they do, they will be invited back for a second visit, which will include exercise bike + math problems to elicit PEM. Then deep testing will be done during PEM. So patients are signing up to PEM themselves, but the only way the researchers can study the phenomenon is if they can see it.

 

[duncan]

So this is still part of the screening process, @viggster? I would have thought satisfying the CCC would have been a first hurdle, well before incurring the costs to travel to and stay in Bethesda. This could (and should?) have been done in a phone or even on-line survey, and/or confirmed by one of the six (?) clinicians recommending patients.

Regardless, it is interesting to see what processes that entails, and which investigators comprise this stage. It is concerning, too.

If the wrong individuals are admitted to the study, the results could set us back years, or worse.

 

[viggster]

So this is still part of the screening process, @viggster? I would have thought satisfying the CCC would have been a first hurdle, well before incurring the cost to go to Bethesda. This could (and should?) have been done in a phone or even on-line survey, and/or confirmed by one of the six (?) clinicians recommending patients.

Regardless, it is interesting to see what processes that entails, and which investigators comprise this stage. It is concerning, too.

If the wrong individuals are admitted to the study, the results could set us back years, or worse.

This last sentence of yours explains why they are doing thorough assessments in person. I think if NIH chose patients based on phone interviews you and many others (including me) would find that problematic.

 

[duncan]

This last sentence of yours explains why they are doing thorough assessments in person. I think if NIH chose patients based on phone interviews you and many others (including me) would find that problematic.

It takes five minutes to confirm if someone satisfies the CCC.

I am still left scratching my head about all the psych variables, and the 2.5 hour meeting with an occupational/rehabilitation therapist, and a dietician...

Be honest: Odds are the NIH knows if someone meets CCC criteria well before they arrive in Bethesda. So I am concerned.

 

[duncan]

The team will then look at results and an adjudication committee will determine if patients meet Canadian Consensus Criteria

Could you please refresh my memory? Are there any bonafide patients on this team and committee?

 

[viggster]

Could you please refresh my memory? Are there any bonafide patients on this team and committee?

I have a hard time believing that you would be OK with NIH deciding who met CCC via a 5-minute phone call.

From here: https://mecfs.ctss.nih.gov/faq.html

Who are members of the adjudication committee?
Committee members are recognized experts in ME/CFS. The initial members include: Lucinda Bateman, Andy Kogolnik, Tony Komaroff, Benjamin Natelson, and Daniel Peterson. The chair of the adjudication panel is the Principal Investigator, Dr. Avindra Nath (http://irp.nih.gov/pi/avindra-nath).

 

[duncan]

I have a hard time believing that you would be OK with NIH deciding who met CCC via a 5-minute phone call.

Fair enough. But I am also not ok with all the psych crap and the unexplained rehab specialist and the dietician. And OI aside, just how much time, and how many ME.CFS "experts", does it take to conclude one meets with the CCC?

Thank you for the list of committee members. The adjudication committee is very impressive as it currently stands. Obviously, it will have to approve or disapprove only those who pass this first series of tests in Maryland, as it were.

So there are currently zero ME/CFS patients on either the team or the committee, unless I am mistaken. If so, please correct me.