To all those with an interest: a letter from the PANDORA Org president.
IOM's response to patients' concerns about panel selection
- Thread starter Nielk
- Start date
". We are glad to see that five of the intended committee members are ones we nominated. "
Well that wont be a help at all if its decided that there isnt enough evidence for abnormalities in ME due to all the crappy "CFS" studies out there watering it down too much..
I dont think none of the "evidence" out there I dont think is currently strong enough to carry much impact, due to the mixing of the diverse groups of ME/CFS peple and this contract will not be looking at ME but rather a very diverse group of people. So what is these intended committee members meant to do when they cant include what they know is right due to that.... their hands will be tied with nothing they can do.
I know pandora intents well but i do think its got its head in the sand, its very disturbing to see our advocacy groups be conned.
The only way this whole thing would have any hope of going well at all is if the different subgroups of ME/CFS were being looked at separately with different recommendations being given for the different ones. You just cant put all that evidence together and look at it together to come up with something. Its completely foolish.
Well that wont be a help at all if its decided that there isnt enough evidence for abnormalities in ME due to all the crappy "CFS" studies out there watering it down too much..
I dont think none of the "evidence" out there I dont think is currently strong enough to carry much impact, due to the mixing of the diverse groups of ME/CFS peple and this contract will not be looking at ME but rather a very diverse group of people. So what is these intended committee members meant to do when they cant include what they know is right due to that.... their hands will be tied with nothing they can do.
I know pandora intents well but i do think its got its head in the sand, its very disturbing to see our advocacy groups be conned.
The only way this whole thing would have any hope of going well at all is if the different subgroups of ME/CFS were being looked at separately with different recommendations being given for the different ones. You just cant put all that evidence together and look at it together to come up with something. Its completely foolish.
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It should be viewed as a conflict of interest of having anyone who has worked for the CDC on that panel as far as ME/CFS goes, its a conflict of interest when one thinks of how poorly the CDC has treated ME/CFS people over the years.
When we spoke to an IoM study director for a study for another disease, we were told they prefer larger studies and double blind for clinical trials. I thought we were screwed. But when I asked her how many is a larger trial, she said 60-70. Well, we have lots of good studies on that. Smaller ones, with numbers of 30-40 are considered if there aren't any ones studying same thing with bigger numbers. The committee will also hear presentations from experts and patients and already have position papers (including the first one from PANDORA Org) that will be given to the committee members.
I wanted to reply to this post just to see this posted again, the above is how things should be for ME. So will those who have ME be treated the same... nope!!
thanks
but can they base any of their decisions of presentations from patients? is that evidence based enough? It means nothing unless they can base their decisions on what they hear even if it ended up going against some of those crap studies.
How will what patients speak be choosen?
The thing which worries me is that most of the studies, nearly all.. have biased towards CFS rather then ME (according to CCC and International ME definitions). So there will be biased there from the start so how is this going to be properly counteracted?
but can they base any of their decisions of presentations from patients? is that evidence based enough? It means nothing unless they can base their decisions on what they hear even if it ended up going against some of those crap studies.
How will what patients speak be choosen?
The thing which worries me is that most of the studies, nearly all.. have biased towards CFS rather then ME (according to CCC and International ME definitions). So there will be biased there from the start so how is this going to be properly counteracted?
if they consider overseas studies then the griffith uni cfs research would be classed as large studies, maybe this can get nk function into the criteria and make it a main stream lab test??
I don't have 18 more months to spare of pain, exhaustion, suffering, financial ruin, progressing physical debility, and isolation just to get a definition, no less one that could be just okay, or even terrible.
This is just totally unacceptable when there are *two* definitions available right now, one of them handed on a silver platter by almost every single expert in the field.
This is just totally unacceptable when there are *two* definitions available right now, one of them handed on a silver platter by almost every single expert in the field.
Unfortunately this is happening right when we possibly were at the verge of maybe soon having something like the International consensus defination becoming more known and used more (things take time to become known and used). Its interesting that that happened .. we finally had something good and finally had some stronger ME advocacy going on past few years, more of us working together.. and now this. dragging us all worldwide away from where we may of headed up in the near future.
With its timing.. it is really going to delay things for us (could that all be part of a plan).
With its timing.. it is really going to delay things for us (could that all be part of a plan).
Are those studies big enough to be counted as larger trial?
and are there other studies using crap defination people to counteract?
and are there other studies using crap defination people to counteract?
The study I was In had 160 people. They used fukuda criteria. Another thread here mentions another recent study they did using the CCC and nk results weren't that different??? Plus there are studies they have done that arent released yet, maybe soon??? I hope.
We need to distinguish between a clinical trial and a diagnostic review, or examination of a diagnostic test. This is a review of diagnosis, not a review of clinical treatment trials.
We have I think ONE paper that fulfills the requirements of looking at a diagnostic test, the 2 day CPET. Most of the others were exploratory studies. Many of the findings are contradicted by other studies. When two studies at about the same evidence grade give wildly different results, then both have their evidence grade decreased.
The want double blinded RCTs for treatment studies, good evidence of specificity and sensitivity for tests, and prospective cohorts for diagnostic studies.
So, we have NO tests at a high grade of evidence. We have NO diagnostic studies at a high grade of evidence. We have NO RCTs that seem to be consistent enough to be considered a high grade of evidence, though without going through all the studies I cannot be sure.
We are in the process of getting some of that with current studies. In particular the phase 3 Rituximab trial may be out in a few years, I think its scheduled to commence January or something.
Further I don't think it would take much to do a study, if funding is available, to substantiate that the 2 day CPET is diagnostic. Once we have that then any CFS definition or cohort will be clearly divided into two groups - those with abnormal CPET results, and those who do not.
PS I am just starting to read the Cochrane handbook online: http://handbook.cochrane.org/
We have I think ONE paper that fulfills the requirements of looking at a diagnostic test, the 2 day CPET. Most of the others were exploratory studies. Many of the findings are contradicted by other studies. When two studies at about the same evidence grade give wildly different results, then both have their evidence grade decreased.
The want double blinded RCTs for treatment studies, good evidence of specificity and sensitivity for tests, and prospective cohorts for diagnostic studies.
So, we have NO tests at a high grade of evidence. We have NO diagnostic studies at a high grade of evidence. We have NO RCTs that seem to be consistent enough to be considered a high grade of evidence, though without going through all the studies I cannot be sure.
We are in the process of getting some of that with current studies. In particular the phase 3 Rituximab trial may be out in a few years, I think its scheduled to commence January or something.
Further I don't think it would take much to do a study, if funding is available, to substantiate that the 2 day CPET is diagnostic. Once we have that then any CFS definition or cohort will be clearly divided into two groups - those with abnormal CPET results, and those who do not.
PS I am just starting to read the Cochrane handbook online: http://handbook.cochrane.org/
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Is the 2 day test going to be able to be done by someone who is bedridden. I think they would be best to persue a blood test of some kind as the sickest would be excluded from any type of physical test.
Obviously not everyone can do the test as usual, especially not the most severe. However some might be able to use a supine bike or hand crank. The real issue is whether or not it is wise to do so. On the other hand I suspect the most severe will need only one test - day one will show disability.
The only large studies I know of are the exercise studies don't in England using phony ME/CFS criteria.
How rheumatoid arthritis diagnostic criteria came about might interest you. Good model, excellent documentation:
ARA=American Rheumatism Association, renamed ACR=American College of Rheumatology
EULAR=European League Against Rheumatism
Series of published RA diagnostic criteria each incorporating new research developments over time:
ARA RA Diagnostic Criteria 1956
Revised ARA RA Diagnostic Criteria 1958
Revised revised ARA RA Diagnostic Criteria 1987
ACR/EULAR RA Diagnostic Criteria 2010
Of interest: composition of the 1987 ARA RA Diagnostic Criteria committee of 18 members:
16 of the 18 committee members (90% of the total committee) were MD rheumatologists(14) or
immunologists(2) specializing in RA;
1 of the 18 committee members (5% of the total committee) was an MD Professor of Pathology; and
1 of the 18 committee members(5% of the total committee) was a PhD specialist in biostatistics/immunology.
The RA experts were pioneers & leaders in the field.
Process: Diagnostic Criteria are reviewed & approved by the ACR Board of Directors & EULAR Executive Committee before being released/adopted.
Evidence: "the Criteria set has been quantitatively validated using patient data and it has undergone validation using an external data set."
ACR is an independent, professional, medical & scientific society.
http://www.rheumatology.org/Practic...assification_Criteria_for_Rheumatic_Diseases/
ARA=American Rheumatism Association, renamed ACR=American College of Rheumatology
EULAR=European League Against Rheumatism
Series of published RA diagnostic criteria each incorporating new research developments over time:
ARA RA Diagnostic Criteria 1956
Revised ARA RA Diagnostic Criteria 1958
Revised revised ARA RA Diagnostic Criteria 1987
ACR/EULAR RA Diagnostic Criteria 2010
Of interest: composition of the 1987 ARA RA Diagnostic Criteria committee of 18 members:
16 of the 18 committee members (90% of the total committee) were MD rheumatologists(14) or
immunologists(2) specializing in RA;
1 of the 18 committee members (5% of the total committee) was an MD Professor of Pathology; and
1 of the 18 committee members(5% of the total committee) was a PhD specialist in biostatistics/immunology.
The RA experts were pioneers & leaders in the field.
Process: Diagnostic Criteria are reviewed & approved by the ACR Board of Directors & EULAR Executive Committee before being released/adopted.
Evidence: "the Criteria set has been quantitatively validated using patient data and it has undergone validation using an external data set."
ACR is an independent, professional, medical & scientific society.
http://www.rheumatology.org/Practic...assification_Criteria_for_Rheumatic_Diseases/
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@Gemini It's very interesting to see the panel makeups for various diseases. The number of disease experts on the panel seems to correlate well with how good of a definition was produced.
RA and MS - 90%+ experts - good definition
GWI - 20% or less experts - bad definition
ME/CFS - about 50% experts - ???? - something in the middle, but not as bad as GWI - about like Fukuda? (and if this is the case, what's the point in this whole exercise anyway - to just end up back where we started?)
This doesn't include what influence the IOM contract might have on the panel. Given the panel makeup, 50% is about as good as we can expect under the best circumstances. Depending on the terms of the contract, it could be worse than that.
RA and MS - 90%+ experts - good definition
GWI - 20% or less experts - bad definition
ME/CFS - about 50% experts - ???? - something in the middle, but not as bad as GWI - about like Fukuda? (and if this is the case, what's the point in this whole exercise anyway - to just end up back where we started?)
This doesn't include what influence the IOM contract might have on the panel. Given the panel makeup, 50% is about as good as we can expect under the best circumstances. Depending on the terms of the contract, it could be worse than that.
Hear the manta: If its not evidence based it doesn't count. If its not evidence based it doesn't count. If its not evidence based it doesn't count.
Expect to hear it more and more often.
Government health organizations are infatuated with EBM.
Expect to hear it more and more often.
Government health organizations are infatuated with EBM.
And isn't just darling how absence of "evidence" = somatoform.
Interesting how that works.
Interesting how that works.
My new line is strictly a reverse of theirs. There is no objective evidence of psychogenic disorder so it must be physical.
If its a rational claim for them, its a rational claim for us. Of course I regard it as highly irrational. This is what is called a counter-example. Were it a rational claim, then clearly the logic could not be used to derive the opposite result.
If its a rational claim for them, its a rational claim for us. Of course I regard it as highly irrational. This is what is called a counter-example. Were it a rational claim, then clearly the logic could not be used to derive the opposite result.