Petition to ask government agencies adopt ICC

By the way, I read recently that there wasn’t info in ICC about how PENE would be assessed including how many elements of it would be required for someone to be classed as having the symptom.

 

Exactly what I have said elsewhere.

 

There was that recent paper that tried to characterize PEM more carefully, so that's a current effort.

 

The CDC's website promotes IOM criteria right now, which requires PEM. We may not like that this is the criteria chosen, but it's impossible to say out of one side of our mouth that CDC supports IOM criteria only, that it lists the others as 'historical', and that this is terrible...

...and then, out of the other side of our mouths claim that the CDC as an organization finds any and all criteria acceptable.

How does that even work?

It doesn't.

 

Just to clarify - CDC's website is dealing with clinical criteria. My comment was referring to research case definitions and the Common Data Elements (CDE) initiative.

In Dr. Collins response to the MEAction request to drive consensus on research case definition and case ascertainment methods, he talked about the CDE effort as though that would solve the problem. But it wont in a timescale that matters. The NIH specified criteria for the center grants and has tight criteria for the intramural but not the rest of funded research. The CDE effort states that any definition can be used and was not scoped to address the methods used to assess criteria. The PEM subgroup of the CDE initiative did attempt to establish an initial method to get tighter alignment on how PEM was identified but this was not done across the board.

 

Thank you for the clarification, @Medfeb -- the comment above was not directed to you per se, but because I see some people spreading misinformation. It burns my biscuits. We have to be a lot more careful about our claims because we're a marginalized group, and the stupid stuff one of us does, the public will feel we ALL do. It might be unfair, but it's the case.

I just wish people would be more careful.

 

I doubt we will fully fix these issues without a better diagnostic method for PEM than the two day CPET protocol. Biomarker discovery is how the next generation of research will move forward faster.

I have said elsewhere that even if a study uses the ICC, which is good, we still need to pay attention to its operationalization. We saw in the PACE trial that operationaliztion of the London criteria resulted in a nonsense definition, not recognised by two of the authors of that criteria. While I think our better researchers are not likely to fall into this kind of trap, it always pays to look into operationalization details.

Another example, many clinical and research definitions add additional exclusion criteria for their cohort, depending on what they are looking for. While its a lot of work even a clinical definition might be used in research, such as SEID, by adding exclusion criteria. I am not sure why they would bother though, when the ICC already has much of that worked out. However there is nothing to stop them from just using ICC exclusion lists, and adding additional ones based on study requirements, to make SEID more appropriate for research.

I do wonder how successful a CDE database will be to allow alternative diagnostic criteria to be applied on data sets. I hope this is being addressed. I have not been closely following the common data elements development.

 

Totally agree that biomarkers are the answer. But we have a catch-22 since getting biomarkers requires fairly well characterized cohorts and as you note, for that we need better operationalization of how the core symptoms are assessed. While our best researchers may do a reasonable job, as you know, this lack of operationalization makes it difficult to effectively bring new people into the field and ensure comparability. And that will throttle the speed at which we can accelerate progress, get pharma involved, increase funding, etc

I think their ability to do that will be quite limited. For one, the CDEs are not a database - its just a list of instruments and in some places data elements that researchers can choose from. And even if you were to get data sets from researchers, the lack of operationalization will impact the ability to compare across sets

 

For me the main value in a CDE would be allow integration of data across studies, or in other words to allow creation of a multiple study database that can be mined. Its less clear to me if it would be of major use if this is not the intent. Standardisation of data elements is what allows integrated databases to happen. Without that it is very hard to do.

 

Yes, I agree. To me, CDE is at best a step toward aligning on particular instruments that might be used to assess different domains. But most of them are not mandatory - e.g. researchers have a list to choose from. And many - I'm guessing most - do not have what I would think of in terms of defined data elements as seen in a database. So even if two researchers use the same instrument, its not clear that both would necessarily collect the same data associated with that instrument. And there's also the issue of different methods of assessing particular criteria that you highlighted earlier.

 

Yes, and it potentially undermines a CDE. Its really useful to be able to compare studies, and right now that always entails potential bias. Having one single research diagnostic criteria is a start, but only a start. Right now its all over the place.

 

I don't consider ICD as scientific. It's economical, political and legal. For research ICD is not important.

 

35 plus Researchers wrote a letter in September 2013 that they have consensus about using the CCC as case definition for research and clinician purpose.

Why did they not propose the ICC, which where already there. They even mention them in their letter.
Does anyone know why the did not go directly for the ICC?

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A different question:

Here in the ICC primer ( http://sacfs.asn.au/download/me_international_consensus_primer_for_medical_practitioners.pdf) the following is said:

"Operational Notes: For a diagnosis of ME, symptom severity must result in a significant reduction of a patient’s premorbid activity level. Mild (meet criteria, significantly reduced activity level), Moderate (an approximate 50% reduction in pre-illness activity level), severe (mostly housebound), or very severe (mostly bedridden and needs help with basic functions)."

Why is the original article in the journal saying something different? https://onlinelibrary.wiley.com/doi/epdf/10.1111/j.1365-2796.2011.02428.x

"Operatonal Notes:
For a diagnosis of ME, symptom severity must result in a significant reduction of a patient’s premorbid
activity level. Mild (an approximate 50% reduction in pre-illness activity level), moderate (mostly housebound), severe (mostly
bedridden) or very severe (totally bedridden and need help with basic functions)."

Is the difference that the first one is for clinical purpose and the second for research purpose?

 

Sorry I did not make clear in my post I was referring to Medfeb sharing the HHS are using any criteria for research. A bit harsh to indirectly imply I am stupid. Also ICC could be used for both diagnostic and research, CDC are choosing not to do this promoting IOM SEID for diagnostic. Some of you on here believe we should accept that for the time being. I don’t. I am trying to follow all of this because I am also incredibly concerned that criteria such as IOM SEID will be used for research causing the same problems as when Fukuda were used.

Talking of people sharing information, it has been said a lot on here that Jason found ICC to select more psychiatric complaints. I have wondered about this before and asked someone for their response. I thought it was very good, so will share it here:

“Jason in a study implies there is a defect in the ICC because the criteria select "significantly greater rates of psychiatric comorbidity."

"Findings indicated that the ME-ICC identified a subset of patients with more functional impairments and physical, mental, and cognitive problems than the larger group of patients who met the Fukuda CFS criteria. However, the patients who met the ME-ICC also had significantly greater rates of psychiatric comorbidity. Jason et al. [19] also compared the ME-ICC to the Fukuda CFS criteria. In general, participants who met the ME-ICC were more functionally impaired than those with Fukuda-defined CFS." https://www.researchgate.net/public...atigue_syndrome_and_Myalgic_Encephalomyelitis

In the first place, this research hasn't been independently replicated, so the results may be inaccurate. Jason's sample used in the above study may not be representative of all people with ME.

Additionally, it is hardly surprising that people with ME, having an inflammatory disease of the brain, would also have psychiatric symptoms. These psychiatric symptoms produced by ME would be considered secondary resulting from the neurological pathology of ME, rather than a diagnosable primary psychiatric disorder. Primary psychiatric disorders determined to be the sole cause of a patient's symptoms are excluded by the ICC. Secondary psychiatric disorders are considered as comorbid with ME.

Ramsay and Dowsett's 1990 study found 98% of 420 ME subjects had symptoms of "emotional lability," which the study adds "includes frustration, elation, depression." Acheson also noted "emotional disturbances in convalescence." These symptoms could be misinterpreted as "psychiatric comorbidity" from questionnaire responses.

Also, it may actually be the case that people with ME have higher rates of comorbid depression and other psychiatric disorders subsequent to developing the disease because of the severe disability, isolation, and poverty caused by ME and the lack of understanding by the medical community and the public.

In either case, what Jason is implying as a defect of the ICC could simply mean that the ICC do a better job of selecting patients with the neurological disease ME than less specific fatigue-based criteria. It's really an issue for medical doctors experienced with diagnosing ME, such as were on the ICC panel, to decide.

It must be remembered that this alleged defect of the ICC is in contrast to the CDC/IOM criteria allowing primary psychiatric disorders, and also unrelated medical disorders, to be diagnosed as SEID (CDC ME/CFS), confounding treatment for everyone given a SEID diagnosis.”

 

Yes, i agree it was a nonsense study, but that is the point is it not that the IOM SEID can be open to being applied very badly.

Edit: I note Medfeb says this could happen with any criteria if not operationalised properly not only IOM, fair point. However, as icc has neuro and immune symptoms, perhaps less chance say in this sleep study if had been used.

 

@adambeyoncelowe, reading the study again, I agree with your interpretation.

 

If this was directed towards me, I certainly didn't mean to. As I said to @Medfeb, I'm a bit exasperated with misinformation floating around, but it isn't on you!

 

Some of the older descriptions do mention this, but conversely, others have found no higher prevalence of psychiatric symptoms than in other diseases. Which is correct?

Older descriptions also represent mild to very severe patients, though, and I think ICC specifically excludes mild patients in at least the original paper (which requires 50% reduction in function; whereas the later primer merely says 'significant') and in the number of symptoms required (which may be less frequent in milder patients).

 

Can you please let me know how you know this? e.g. a link to where this appears. (thank you)

 

See here: https://www.meassociation.org.uk/20...ate-its-guideline-on-mecfs-20-september-2017/

They include all the relevant documents and stakeholder responses. The IOM criteria and the subsequent CDC removal of GET/CBT (influenced by the IOM report) are listed as key evidence against the current recommendations.