IOM Criteria to Be used in Research for NIH Center of Excellence

[duncan]

I do not see how embracing the strictest criteria for research purposes can - for ME/CFS at least - be bad here, especially in light of:

a) We have had a history of questionable research that often cast the broadest net imaginable; this is in large part what helped entangle us in the BPS mess,

b) As much as we can hope otherwise, many of us are still uncertain of the govt's agenda. I do not think it would be prudent to forget that the early NIH ME/CFS project copy that was inadvertently released had functional disorders as a control group.

 

[A.B.]

b) As much as we can hope otherwise, many of us are still uncertain of the govt's agenda. I do not think it would be prudent to forget that the early NIH ME/CFS project copy that was inadvertently released had functional disorders as a control group.

Spreading false information about NIH, IOM criteria, etc. will contribute to things going badly. Some of the false information that's circulating on social media:

IOM criteria are very broad (this seems to be a misunderstanding due to poor work Jason et al).
IOM criteria are all about fatigue.
NIH is forcing researchers to use IOM criteria.
The evil government is out to get patients (while the NIH is investing millions of dollars into excellent ME/CFS related projects).

The people engaging in this campaign do not seem to care about facts.

 

[Nielk]

Spreading false information about NIH, IOM criteria, etc. is a good way to make sure things will go badly.

You should not accuse someone of spreading false information if you do not know the details.

Nothing in the above statement is false and we have the evidence to back it up.

 

[duncan]

The evil government is out to get patients (while the NIH is investing millions of dollars into excellent ME/CFS related projects)

I suppose it's laudable to be able to trust despite history.

 

[A.B.]

I suppose it's laudable to be able to trust despite history.

It's laudable to actually look at and think about things before deciding they're fatally flawed.

 

[duncan]

Fatally flawed? Perhaps not. But flawed, arguably so. Then why not remedy the potential flaws before they become fatal? Or at the least discuss them openly. Not sure where that logic fails here...

 

[A.B.]

Jason et al claimed the IOM criteria are far broader than the Fukuda criteria and could result in frequent misdiagnosis:

The findings indicate that many individuals from major depressive disorder illness groups as well as other medical illnesses were categorized as having SEID. The past CFS Fukuda et al. prevalence rate in a community based sample of 0.42 increased by 2.8 times with the new SEID criteria.

Let's see whether the problem is in the IOM criteria or with the methods used:

To meet the post-exertional malaise criteria, a patient needed to report the occurrence of one of the following symptoms: prolonged generalized fatigue or malaise following previously tolerable levels of exercise, feeling generally worse than usual or fatigued for 24 h or more after exercise, or exercise brings on my fatigue.

A patient only needed to tick "exercise brings on my fatigue" to be considered to suffer from PEM. I doubt that the IOM criteria critics find this definition of PEM accurate, yet their criticism seem to be based in part on this study.

http://www.mdpi.com/2075-4418/5/2/272

 

[Nielk]

Jason et al claimed the IOM criteria are far broader than the Fukuda criteria and could result in frequent misdiagnosis:

Let's see whether the problem is in the IOM criteria or with the methods used:

A patient only needed to tick "exercise brings on my fatigue" to be considered to suffer from PEM. I doubt that the IOM criteria critics find this definition of PEM accurate, yet their criticism seem to be based in part on this study.

http://www.mdpi.com/2075-4418/5/2/272

I'm not sure I understand the point you are making?

 

[Nielk]

These are works of analysis by Frank Twisk regarding the IOM criteria.


Replacing Myalgic Encephalomyelitis and Chronic Fatigue Syndrome with Systemic Exercise Intolerance Disease Is Not the Way forward - https://www.researchgate.net/public...se_Intolerance_Disease_Is_Not_the_Way_forward

A critical analysis of the proposal of the Institute of Medicine to replace Myalgic Encephalomyelitis and Chronic Fatigue Syndrome by a new diagnostic entity called Systemic Exertion Intolerance Disease - https://www.researchgate.net/public...ty_called_Systemic_Exertion_Intolerance_Disea

 

[A.B.]

These are works of analysis by Frank Twisk regarding the IOM criteria.

Similarly to what Jason did, Twisk incorrectly defines PEM as "exercise intollerance" and then concludes that the IOM criteria can easily misdiagnose too many other conditions. He also cites Jason, who as we have just seen, isn't doing good work on this.

 

[Nielk]

Similarly to what Jason did, Twisk incorrectly defines PEM as "exercise intollerance" and then concludes that the IOM criteria can easily misdiagnose too many other conditions. He also cites Jason, who as we have just seen, isn't doing good work on this.

Although Twisk states PEM as per IOM is a weak describtion, this is just a very small part of his analysis and why he feels IOM criteria is not an appropriate definition of ME.

 

[A.B.]

this is just a very small part of his analysis and why he feels IOM criteria is not an appropriate definition of ME.

It revolves around the view that Ramsay ME is the true definition. This is just an assumption. There are no biomarkers for Ramsay ME or any ME or CFS definition that could prove or disprove this.

The situation is effectively that we have sick patients and we do not really know what is wrong with them. These various case definitions are attempts to make some progress. There is nothing wrong with acknowleding uncertainty. It's actually essential for real progress.

 

[Nielk]

Here is Frank Twisk's letter re Liky Chu's paper.

http://www.tandfonline.com/doi/full/10.1080/21641846.2017.1357937?scroll=top&needAccess=true

 

[Nielk]

It revolves around the view that Ramsay ME is the true definition. This is just an assumption. There are no biomarkers for Ramsay ME or any ME or CFS definition that could prove or disprove this.

So, you are saying Ramsay is not a true definition because no biomarkers, yet IOM is a true definition?

 

[Nielk]

Ramsay criteria is based on a specific outbreak in London in the 1950's. Definitely not based on a bunch of vague sick group of people. Dr. Melvin Ramsay actually treated and studies these patients and wrote a book about it.

 

[alex3619]

For me the primary problem with SEID is how a PEM diagnosis is treated. If PEM is not properly assessed then it will often be wrongly diagnosed.

However I can say the same thing about CCC or ICC.

The IOM report was flawed due to fundamentals. The research history in ME is so poor that an EBM process like that will also be flawed. Good research in ME has frequently gone unnoticed, unreplicated, and is not independently validated. How do you perform a good EBM review under those conditions? However I think the group did very well despite the flaws, but could not rise above them either. The flaws were intrinsic to the process. EBM is not suitable when the state of knowledge is very poor. All it can do is evaluate clinical therapies, and then only in a very limited way.

Everything hinges on the operationalization of PEM. So far we only have post exercise cytokine tests and the two day CPET. One or both seem to be mandatory in any study looking at deep ME and CFS research. It is entirely possible that the NIH are taking this into account, (and they are using exercise testing though I am unaware of the protocols) though we lack sufficient details to be sure, or at least I have not read them. So there is some cause for concern, but little for objection.

 

[alex3619]

So, you are saying Ramsay is not a true definition because no biomarkers, yet IOM is a true definition?

There are no true definitions, only better or worse. We really need biomarkers. A huge motivation for studies like the NIH or at centers of excellence is to find those biomarkers. They will change the whole research landscape. With good biomarkers the low grade studies will find funding difficult, and high quality studies will increase the rate at which we learn things.

Without biomarkers we have had a research landscape in which bad research can flourish. With poor medical politics we have had a situation where investigative ME research looking for biomarkers has been severely slowed.

 

[duncan]

A huge motivation for studies like the NIH or at centers of excellence is to find those biomarkers. /QUOTE]



For us. A huge motivation for the ME/CFS community. For the NIH? Hopefully.

 

[Ember]

I do not see how embracing the strictest criteria for research purposes can - for ME/CFS at least - be bad here, especially in light of:

a) We have had a history of questionable research that often cast the broadest net imaginable....

Dr. Klimas calls the IOM criteria “the heterogeneity case definition,” and she agrees that "the broad, broad net" that they cast isn't meant for use by researchers:

Our intention was to draw the broad, broad net. It was absolutely important that this not be a narrow subgroup case definition or a research case definition that was trying to reduce the heterogeneity. This was supposed to be the heterogeneity case definition. It was supposed to be the one that cast the broader net....

This is not meant to direct the way you do your science. In fact, in our research, we use the Canadian case definition because it reduces heterogeneity, and we're trying to have a smoother, cleaner group (https://www.youtube.com/watch?v=mk10dyGu6xs –- 28:30 - 30:30).

Responding to Dr. Jason's criticism, Dr. Klimas points out that the IOM criteria don't fall within “that tight, tight zone where you lost about 30 or 40 percent of the subjects by applying the Canadian case definition or the ICC.” While the IOM definition “can capture the population with more precision than Fukuda,” Dr. Klimas advises that “it does not take the place of the CCC or ICC.”