NIH post-infectious CFS study

Denise

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@A.B. - thanks for posting this.


(bolding is original to NIH post, not added by me)
"-Meet the 2005 Reeves standardized case definition of chronic fatigue syndrome. This includes:

--Having greater than or equal to 4 symptoms set forth in the 1994 Fukuda criteria.

--Severe fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of greater than or equal to 13 on the general fatigue subscale or greater than or equal to 10 on the reduced activity subscale.

--Functional impairment as determined using the Short-Form 36 (SF-36): score of greater than or equal to 70 physical function subscale, or greater than or equal to 50 on role physical subscale, or greater than or equal to 75 on social function subscale, or greater than or equal to 66 on emotional subscale.

--Symptom validity as determined using the Centers for Disease Control Symptom Inventory: score of greater than or equal to 25 on the Symptom Inventory Case Definition subscale.

-fatigue onset greater than 6 months but less than 5 years prior to enrollment."



---- 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).

Additional edit - @Bob pointed out that the Reeves 2005 definition used "less than" (as opposed to "greater than" so it is possible there is an error in the posted protocol.
 
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duncan

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I am a bit confused about their Lyme qualifications. Their emphasis appears to be on fatigue, but if you've had Lyme, you can only participate if you DON'T suffer from fatigue?

And then, out of all the diseases that might cause a post-infectious condition, the one they seem most concerned with is Lyme? Not a herpes or enterovirus?

How do they distinguish between a post-infectious condition caused by Lyme, and PTLDS?

I wish I were a fly on the wall when (if?) this group discussed Lyme overlap with Marques and company (NIH Lyme Research Director).
 

Scarecrow

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Additional inclusion criteria for participants with PI-CFS:

-A self-reported illness narrative of the development of persistent fatigue as the consequence of an acute infection. The persistent fatigue may have an acute onset or become progressively worse over 6 months.

-Documentation of fatigue starting after an infection by a physician in their medical records.

-Meet the 2005 Reeves standardized case definition of chronic fatigue syndrome. This includes:
--Having greater than or equal to 4 symptoms set forth in the 1994 Fukuda criteria.

--Severe fatigue as determined using the Multidimensional fatigue Inventory (MFI): score of greater than or equal to 13 on the general fatigue subscale or greater than or equal to 10 on the reduced activity subscale.

--Functional impairment as determined using the Short-Form 36 (SF-36): score of greater than or equal to 70 physical function subscale, or greater than or equal to 50 on role physical subscale, or greater than or equal to 75 on social function subscale, or greater than or equal to 66 on emotional subscale.

--Symptom validity as determined using the Centers for Disease Control Symptom Inventory: score of greater than or equal to 25 on the Symptom Inventory Case Definition subscale.
-fatigue onset greater than 6 months but less than 5 years prior to enrollment.
So they are using the empirical criteria. PEM not a requirement.

Interesting that they have gone for max 5 year illness duration. I would have liked to have seen a longer minimum duration.
 

Scarecrow

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Additional inclusion criteria for functional movement disorders group:

-A self-reported illness narrative of the development of persistent, paroxysmal, or episodic motor symptoms as the consequence of an acute event or exposure or occurring with an acute onset.

-Diagnosis of clinically definite FMD utilizing Fahn and Williams criteria.
--Documented psychogenic movement disorder: persistent relief by psychotherapy, suggestion or placebo, or observed without the movement disorder when unobserved.
--Clinically established psychogenic movement disorder: inconsistent over time or incongruent with a classical movement disorder, plus other false neurological signs, multiple somatizations, obvious psychiatric disturbances, distractibility, or deliberate slowness.
-The diagnosis of FMD must be made by a neurologist and documented in their medical records.
 

Bob

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They need to diagnose using CCC as well as Reeves 2005. Or drop Reeves completely.

Apart from the totally unhelpful choice of diagnostic criteria, it looks like a useful and comprehensive study.

It even includes a two day CPET test. And a Lumber puncture.

Edit: I wonder if Ron Davies might be able to give them a nudge about the diagnostic criteria.
 
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Bob

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I am a bit confused about their Lyme qualifications. Their emphasis appears to be on fatigue, but if you've had Lyme, you can only participate if you DON'T suffer from fatigue?
They only want ex-Lyme patients who have been successfully treated for Lyme, and don't have any lingering fatigue symptoms. They don't want people with current Lyme symptoms.
 

Scarecrow

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Apart from the unhelpful choice it diagnostic criteria, it looks like a useful and comprehensive study.
Hard to tell without the full protocol. Are they testing any hypotheses or are they data mining? I agree with you about the exercise test but, on the other hand, that's not the cohort I would have picked for this study.
 

duncan

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@Bob, then how do these patients who have been cured of Lyme qualify for a CFS study that does not include PEM? What symptoms of CFS are not found in Lyme patients, or PTLDS patients if you believe that creature exists?
 

Bob

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@Bob, then how do these patients who have been cured of Lyme qualify for a CFS study that does not include PEM? What symptoms of CFS are not found in Lyme patients, or PTLDS patients if you believe that creature exists?
I'm not sure if I've understood your question properly, but ex-Lyme patients are being used as a control group.
 

duncan

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I cannot imagine how a Lyme patient who has supposedly "recovered", but still has symptoms of any sort, would not be categorized under Post-Treatment Lyme Disease Syndrome.

Do you sense the arbitrary inclusion criteria here?

Oh, I see your note about control group. Thank you, @Bob, for pointing that out to me.

But can anyone explain THIS logic to me? Why single out recovered Lyme patients? Aren't they going out of their way to attract "recovered" Lyme patients as controls?

I guess my point is, one way or another, for a CFS study, and out of all the diseases that can result in post-infectious conditions, why place so much emphasis on Lyme, even when using "recovered" patients as controls?
 
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Bob

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Hard to tell without the full protocol. Are they testing any hypotheses or are they data mining?
My very vague understanding (and I might be wrong) is that they are data mining. I think they are using the NIH's state-of-the-art equipment to look for biological differences e.g. in immune cells etc. I don't know the full extent of their investigations.

I agree with you about the exercise test but, on the other hand, that's not the cohort I would have picked for this study.
Agreed, but it would be very easy for them to add a CCC diagnosis to the study, e.g. using the De Paul symptom questionnaire. Let's hope we can persuade them.
 

Marco

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Oh, I see your note about control group. Can anyone explain THIS logic to me? Why single out recovered Lyme patients? Aren't they going out of their way to attract "recovered" Lyme patients as controls?
Seems reasonable to me. They're going specifically after 'post-infection' (assumed) patients and using symptom free post-Lyme (presumably confirmed as Lyme infection by whatever means) they can compare one post-infective group without symptoms with another group with. Why choose Lyme? - substantial symptom overlap?
 

Scarecrow

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Why single out recovered Lyme patients?
A useful comparison to the healthy controls and the PI-CFS group.

Notice that the same 6 month to 5 year period applies to the asymptomatic Lyme group, i.e. antibiotic treatment more than 6 months but less than 5 years before inclusion.
 

Scarecrow

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My very vague understanding (and I might be wrong) is that they are data mining. I think they are using the NIH's state-of-the-art equipment to look for biological differences e.g. in immune cells etc. I don't know the full extent of their investigations.
I think you are correct based on my vague recollection of previous reports. But then, why include the FMD group?
 

Bob

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Oh, I see your note about control group. Can anyone explain THIS logic to me? Why single out recovered Lyme patients? Aren't they going out of their way to attract "recovered" Lyme patients as controls?
It's not an investigation of Lyme disease. So they don't need to include any Lyme patients. If an ex-Lyme patient now has a CFS diagnosis then I think they might be eligible to enrol as a CFS patient. But I'm not certain about that. It does seem a bit arbitrary to include ex-Lyme patients as a control, but I think it's a useful control.
 

Aurator

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They forgot to mention where you live being an inclusion/exclusion factor.

I'm also perplexed by this exclusion criterion:
"History of head injury with loss of consciousness, or history of head injury with amnesia lasting greater than a few seconds".

As a schoolboy I used to play rugby at county level and was knocked unconscious several times. The last time it happened (thirty years ago now) I had amnesiac episodes for up to a year. I had several brain scans, which were "normal". My current ME/CFS symptoms started abruptly after an URT infection three years ago. Why on earth should my historic episodes of unconsciousness be an exclusion factor? Are they saying all my current flu-like symptoms etc. may be a result of some delayed and hitherto undetected neurological damage?
 
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jimells

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The "Functional Movement Disorder" rubbish is very troubling. I doubt MS studies would include this make-believe disease as a comparison group. And then there is the way they continue to operate behind closed doors. How about a press release or press conference to blow their own horn and give us a chance to ask questions? Oh right... they don't want anybody to question their actions.