SolveCFS Biobank Beginning

jspotila

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Jennie,
To avoid confusion, here is a much clearer sentence, "Your CFS must have a post-viral onset with symptoms occuring within 48 hours (acute), or through day 28 (4 weeks, sub-acute)." This is correct? Right?
I'm going to get clarification on this from staff, because this is not how I read the sentence in question.
 

fred

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Tighter cohorts are better in any study. I think it is good that the CAA are recognising this. My guess is is that this push came for researchers (the good ones that is), as they have been talking for years for the need for more defined cohorts.
Is type of onset the only or most relevant variable that can be used to produce 'tighter cohorts'?
 

Hope123

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For the record, Peterson stated during last years CFSAC meeting that a weakness of prior studies of CFS was the lack of emphasis on the flu-like aspects of the illness so I am glad that the CAA is focusing on this in their criteria. I've jumped on the CAA for other reasons but not on this one.
 

CBS

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Is type of onset the only or most relevant variable that can be used to produce 'tighter cohorts'?
Fred,

The CAA has used a number of different and important "variables" to keep the cohort clean. They provided their own list of qualifications (such as the requirement of an acute onset) in addition to the requirement that subjects have to meet either the Fukuda or Canadian Criteria and they were also very clear that for both Dx Criteria there were several disqualifying conditions. They have also significantly limited the list of doctors from which they are willing to accept the CFS diagnosis.

This will be, by far, the most tightly and explicitly defined CFS cohort ever. I know we all want to feel represented and being excluded can create some angst. However, I can guarantee that there are enough of us suffering from this disease that - at this time - excluding as many potentially confounding conditions will only help everyone.

Shane
 

fred

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I have no agenda with this question. It is a simple one which remains unanswered: is type of onset the most effective limiting variable?
 

CBS

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I have no agenda with this question. It is a simple one which remains unanswered: is type of onset the most effective limiting variable?
Hi Fred,

I had not assumed an agenda. My apologies if I left that impression. My response was intended to emphasize that, at least from where I sit, there isn't one most effective limiting variable but rather the cohort needs to be well characterized and explicitly defined and that involves some tough decisions. In this regard I think the CAA did an admirable job (and as has been stated by myself and others, when resources are available an expansion would be most welcome).
 

gracenote

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For the record, Peterson stated during last years CFSAC meeting that a weakness of prior studies of CFS was the lack of emphasis on the flu-like aspects of the illness so I am glad that the CAA is focusing on this in their criteria. I've jumped on the CAA for other reasons but not on this one.
I don't think "flu-like aspects" and sudden onset are the same thing. I have a "flu-like illness" but not sudden onset (and I don't think I'm the only one). That's the point I've been trying to make.

TESTIMONY DR. DAN PETERSON AT THE CFSAC MEETING OCTOBER 2009

So again the CDC-criteria are well-known to everybody and I point out that even as early as 88 and 94 with the revision, there was an emphasis in this case-definition for flu-like illness, or symptoms that suggest the possibility of a viral onset and perpetuation of this syndrome. Of course weve been troubled by the fact that its obviously heterogeneous, highly dependent on case-definition and highly dependent on the observer in order to define the cohort thats being studied and its been said many, many times that that has to be clarified in all studies that are done. And the concept of clinical networking I think is absolutely critical to perceive, particularly if we have an agent like this that could be studied across regional borders.

What intrigued me for many, many years was the fact that if you study the literature on patients severely affected with CFS, certain things stick out. For example the RNASE-L dysfunction in the antiviral pathway has been reported by researchers from all around the world. The same finding with low NK-cell numbers and function. Very reliable researchers such as Dr Klimas have reported this over and over. And there is abnormalites of the innate immune system with activated T-cells and production of inflammatory cytokines. And most everybody who has looked at this has reproduced those particular findings.
Just saw your post Shane.

The CAA has used a number of different and important "variables" to keep the cohort clean.
"Sudden onset" just seems arbitrary to me. This particular criteria does not seem relevant to keeping "the cohort clean." It's based on patient report and not on any measurable laboratory findings.

Why not begin to use criteria like these that have been "reported by researchers from all around the world," that Dr. Klimas has "reported over and over"? And that "most everybody who has looked at this has reproduced those particular findings"? Why not these types of criteria?

And we're not talking about a single study, or several studies, but a BioBank from where all studies will get their samples. I think the cohort would be better defined by Peterson's "certain things stick out" criteria.

I know we all want to feel represented and being excluded can create some angst.
My continuing difficulty with this has nothing to do with angst (who me, feel left out? :eek:), but with the quality of the data that will be produced by these studies. I think they're starting off on the wrong foot.

Just my opinion. And (for now) I'm sticking to it. :innocent1:

If I'm mistaken, I will learn and sing everybody this song. ;)


 

justinreilly

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Powering a study is dependent on what the study is looking for and the magnitude of the parameter to be investigated .This would vary study by study.A homogenous cohort may or may not produce tighter confidence intervals .The generalisability of the results into a general population will of course be impossible.Such a narrow focus will always be open to attack and potentially fragment the patient population It is entirely likely that gradual and sudden onset are artificial distinctions as many viral diseases produce gradual onset or rapid onset disease
Wow! I learn so much from you, Gerwyn! Thanks.
 

justinreilly

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Oxford Definition is Invalid. Period.

I think with the research, all the doctors will see is X was found in CFS. They won't know the difference between different criteria etc. so in practice, when patients are being seen and treated in a clinical setting, the results are very likely to be generalised to them (in a way this has been part of the problem with rubbish cohorts in the studies, the results get generalised to all of us.). I think as many doctors would love to have things to test for, or an explanation at least of what might be going on, that they will at least consider the possibility of the results being relevant to all with ME/CFS.
Excellent point!

People have raised many concerns on the forum about Vernon's attitude re the Oxford Criteria and so on, and to be honest I was concerned about her general thinking because she signed the "empirical"/Reeves definition, so it is something of a relief to see that the CAA are trying to do the right thing here by trying to have a tighter patient population. If people push too hard for looser entry critieria isn't there a danger that it will go the other extreme alltogether? And that would be a disaster.

I have to admit that I feel a bit sorry for the CAA (not that I think everything they do is ok, or that some of the criticism isn't justified) but one minute they are being criticised for being too sympathetic to loose entry criteria in studies and the next they are being criticsed for being too strict. They must feel they cannot win...

Orla
I disagree strongly.

It is hard to be anyone involved in ME/CFIDS in any capacity! I think CAA has done a great job with the biobank and the criteria for inclusion. I don't think there is really anything to criticize about it (except it would be incredibly great if the criteria for inclusion were each patient meeting 'both Fukuda and Canadian definitions' rather than '[Fukuda or Canadian] + PEM').

That said, it is inexcusable for CAA or its scientific director to give any credibility whatsoever to the Belgian study. Moreover, it should be a top priority for CAA to expose what a fraud the Oxford definition is. The formulation and use of the Oxford definition continues to be the biggest problem in the science of ME. Additionally it is Exhibit A in the case against Wessely et al. for scientific fraud.

Do I sound like a broken record? Well, imitation is the sincerest form of flattery, Cort. I think a little of your OCD/ autism has rubbed off on me. (is it possible for XMRV to rub off on someone? OK, truth be told, I was like this before I 'met' you Cort.):Retro smile:
 

jspotila

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Jennie,
To avoid confusion, here is a much clearer sentence, "Your CFS must have a post-viral onset with symptoms occuring within 48 hours (acute), or through day 28 (4 weeks, sub-acute)." This is correct? Right?

You might suggest that it be inserted at the appropriate place on the SolveCFS BioBank webpage.
I double-checked with the office about this question. Here is clarification of the criterion:

CFS initial presentation characterized by one of the following: a flu-like illness, an acute (48 hours) onset or a subacute onset (over a period of up to four weeks).

A potential BioBank donor needs one of those three options (in addition to meeting the other criteria, of course). I apologize for any confusion caused by the original wording. This new language will go up on the website, as well. Thanks to Brown-eyed Girl and the others who asked for clarification!
 

CBS

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I don't think "flu-like aspects" and sudden onset are the same thing. I have a "flu-like illness" but not sudden onset (and I don't think I'm the only one). That's the point I've been trying to make.
Gracenote, I read this in the way you did. I've had long standing and fluctuating flu-like aspects over the years but the day this all started for me, I had one hell of a lymph node enlarge (according to one doc it was "plum-sized") within a matter of hours and 24 hours later I was laid out with a 104 degree fever. Definitely not one in the same.

Just saw your post Shane.

"Sudden onset" just seems arbitrary to me. This particular criteria does not seem relevant to keeping "the cohort clean." It's based on patient report and not on any measurable laboratory findings.

Why not begin to use criteria like these that have been "reported by researchers from all around the world," that Dr. Klimas has "reported over and over"? And that "most everybody who has looked at this has reproduced those particular findings"? Why not these types of criteria?

And we're not talking about a single study, or several studies, but a BioBank from where all studies will get their samples. I think the cohort would be better defined by Peterson's "certain things stick out" criteria.

My continuing difficulty with this has nothing to do with angst (who me, feel left out? :eek:), but with the quality of the data that will be produced by these studies. I think they're starting off on the wrong foot.

Just my opinion. And (for now) I'm sticking to it. :innocent1:

If I'm mistaken, I will learn and sing everybody this song. ;)
I probably wouldn't use the term arbitrary myself but it was definitely a judgment call and there is plenty of room to argue for this as an unnecessary exclusion.

Gracenote - I'm glad you're sticking to your opinion. I've always found it well considered and enlightening (perhaps especially so when you're disagreeing with me). I'd love to hear you sing some day but no need to do so on this issue no matter what happens (and as I stated earlier, I personally expect that down the road the distinction will prove to be of minimal use).

I don't know how many subjects that the CAA is finding meet their criteria. I did find this bit particularly encouraging:

CFS patients will be preferentially selected if they have been diagnosed by the Canadian clinical criteria or have documented abnormal NK cell laboratory results.
I wonder what percentage of the BioBank sample will consist of patients with "abnormal NK cell laboratory results?"

Jennie, Does the CAA have a target or limit to the number of patients that will be included in the BioBank? I imagine they must if for no other reasons than minimum statistical power and financial constraints. And secondly, are there contingency plans if the minimum number of necessary patients is not met using the original criteria.
 

jspotila

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Jennie, Does the CAA have a target or limit to the number of patients that will be included in the BioBank? I imagine they must if for no other reasons than minimum statistical power and financial constraints. And secondly, are there contingency plans if the minimum number of necessary patients is not met using the original criteria.
Ultimately, the only limit on the number of patients in the BioBank will be the Association's ability to afford it! Response to the announcement this week has been very strong, and so I don't think we are in danger of not having enough patients using the current criteria. More details about this whole process will be addressed in the upcoming CFIDS Link and a webinar (don't have a date for that yet, sorry). I don't think I can comment more specifically on the targets, etc. until after all the required institutional approvals are obtained.
 

CBS

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Ultimately, the only limit on the number of patients in the BioBank will be the Association's ability to afford it! Response to the announcement this week has been very strong, and so I don't think we are in danger of not having enough patients using the current criteria. More details about this whole process will be addressed in the upcoming CFIDS Link and a webinar (don't have a date for that yet, sorry). I don't think I can comment more specifically on the targets, etc. until after all the required institutional approvals are obtained.
That was quick! Thanks.
 

CBS

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I double-checked with the office about this question. Here is clarification of the criterion:

CFS initial presentation characterized by one of the following: a flu-like illness, an acute (48 hours) onset or a subacute onset (over a period of up to four weeks).

A potential BioBank donor needs one of those three options (in addition to meeting the other criteria, of course). I apologize for any confusion caused by the original wording. This new language will go up on the website, as well. Thanks to Brown-eyed Girl and the others who asked for clarification!
Just to be clear here, the CAA is talking about the initial presentation.
 

Orla

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Hi Jenny, thanks for that clarification. That is much clearer now.

And Justin and all, just to clarify I think the Oxford Criteria is rubbish and should never be used. I found Vernon's comments on the criteria disappointing and worrying (in her comment about the Belgain trial), which is why I was pleasantly surprised when I saw the strict entry criteria for the biobank. Part of my thinking on the biobank is that I would hope that it might mark an attitude of looking for more stringent criteria in research, I think it should be encouraged. It might also encourage other researchers to adopt more strict criteria (even if they don't go with exactly the same model). I think it is great that PEM will be a requirement, as I think this should be a requirement for all ME/CFS studies.

The US biobank might also serve as an example for others thinking of establishing a biobank (I known they were looking into something like this for the UK).

And I'd better shut up now for the night before I stamp on anyone else's toes!

(Fred I don't have the energy to answer right now, but will think about what you said.)
Orla
 

gracenote

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I double-checked with the office about this question. Here is clarification of the criterion:

CFS initial presentation characterized by one of the following: a flu-like illness, an acute (48 hours) onset or a subacute onset (over a period of up to four weeks).

A potential BioBank donor needs one of those three options (in addition to meeting the other criteria, of course). I apologize for any confusion caused by the original wording. This new language will go up on the website, as well. Thanks to Brown-eyed Girl and the others who asked for clarification!
Thanks jspotila. I appreciate you sorting this out for us.

Just in case, I'll start practicing that song now. I've realized, belatedly, that it has no words. I may end up having to yodel it. That would not be good.
:eek:
 

CBS

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Thanks jspotila. I appreciate you sorting this out for us.

Just in case, I'll start practicing that song now. I've realized, belatedly, that it has no words. I may end up having to yodel it. That would not be good.
:eek:
I do hope that we'll all be yodeling together very soon (and yes, I did read in the Dr. Yes thread about men not being able to yodel - or something along those lines :sad:)!
 

justinreilly

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I double-checked with the office about this question. Here is clarification of the criterion:

CFS initial presentation characterized by one of the following: a flu-like illness, an acute (48 hours) onset or a subacute onset (over a period of up to four weeks).

A potential BioBank donor needs one of those three options (in addition to meeting the other criteria, of course). I apologize for any confusion caused by the original wording. This new language will go up on the website, as well. Thanks to Brown-eyed Girl and the others who asked for clarification!
I thought ME/CFIDS always presented as a flu-like illness (even when gradual onset).
 
K

_Kim_

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I do hope that we'll all be yodeling together very soon (and yes, I did read in the Dr. Yes thread about men not being able to yodel - or something along those lines :sad:)!
Oh CBS, men are quite capable of yodeling ;)
We just don't want to watch
male-orgasm..jpg