Petition to ask government agencies adopt ICC

Obviously there are others in the community who don't view it like that, which confuses me a bit.

 

It's also possible that the criteria themselves don't inherently sift out primary psych diagnoses. That means additional work has to be done to rule out other problems. But this only adds to the complexity of the CCC and ICC.

People may not realise they have psych problems, or may actively conceal them, so it's possible that CCC and ICC provide sufficient smokescreen for them to do that--knowingly or not.

Part of that is likely the complexity of the criteria, and part of that may be the time required to fill them in. Do people focus more or less if they've got a giant questionnaire to fill in, and does that make the answers more or less accurate?

If a person takes a long time filling it all in, do they have more time to think as they're answering later questions, for example? That might introduce bias in that they remember a headache they had six months ago and so go back and tick the box for that as a neurocognitive symptom.

Or does a patient with ME start getting brain fog and then forget all the details as they go along, meaning the questionnaires are less likely to record their symptoms accurately than someone without that problem?

 

One issue seems to be that IOM isn't 'neurological' enough. But I don't buy that. It's clear to me that OI and sleep issues are supposed to be ANS-related. It's just not as explicit.

Another is that PEM isn't PENE (which is generally more detailed and makes an assumption about cause in 'neuroimmune'). But neither is exactly the same as Ramsay's 'muscle fatiguability' anyway.

I prefer post-exertional deterioration, because it's more descriptive than PEM but doesn't suggest only one kind of problem. For example, if a person's PE* appears primarily metabolic in nature, should a doctor discount it because it isn't 'neuroimmune'?

 

I dont see this as an either/or issue. These studies had problems with study design and methodology AND they also used case definitions that selected patients who had other fatiguing conditions. Either alone should call into question study findings - even if the studies had been conducted perfectly but on the wrong population, the findings should be questioned. But the fact that these studies had problems with both issues only further damns the studies.

Multiple US government reports have highlighted the negative impact of overly broad definitions like Oxford and Fukuda on research and called for this issue to be addressed. It was important that this last NIH report highlighted this specific issue as well as issues with study conduct. The problem is that NIH has ignored that recommendation.

I agree as long as there's some bare minimum of required inclusion criteria - for instance, PEM/PENE and unrefreshing sleep are required by CCC, ME-ICC, and IOM but not Fukuda, which only specifically required medically unexplained fatigue - all other symptoms were optional as long as there were 4 of them from the list. The "medically unexplained" implies psychiatric and the polythetic nature of the criteria creates man-made heterogeneity that research has struggled to make sense of. For clinical use, in the US, the medical community, not CDC, decides what to use. We have a range of medical education providers and medical associations and they dont all automatically adopt what the CDC or the IOM publishes. I agree that simpler is better to get traction with that community. And the credibility of IOM helps although even with that, its not a slam-dunk. Personally, I think its more important and has a greater likelihood of success to get the US medical community to really understand key features such as PEM than it is to push them to adopt the ME-ICC.

 

This is further complicated by the fact some Fukuda studies still make PEM compulsory, so we're not always comparing like with like.

 

The main concern for me is people like Jason have done studies using data to show that SEID can diagnose even more people than under Fukuda which are too broad in my opinion.

An American advocate explained it well in this following comment:

“Data from a community‑based sample indicated that the SEID prevalence rate would be 2.8 times as great as the rate found when the Fukuda et al. criteria were applied. In addition, the erroneous inclusion of individuals with primary psychiatric conditions in SEID samples would have detrimental consequences for the interpretation of epidemiological, etiological, and treatment efficacy findings for people with this illness."

https://www.researchgate.net/public...e_IOM's_systemic_exertion_intolerance_disease

This means the majority of new SEID (ME/CFS) patients will have symptoms due to a variety of psychiatric, behavioral, and medical conditions previously excluded from Fukuda CFS. Given that not all people meeting the Fukuda criteria will also meet the SEID criteria, I calculated that about 75% of the new CDC ME/CFS (SEID) group will be people newly eligible for the diagnosis.

People with ME will be an even smaller percentage of the SEID group than currently of the Fukuda CFS group. I estimated less than about 20% of the new SEID (ME/CFS) mixed group will be people who should be diagnosed with ME.

New clinical trials of "ME/CFS" (SEID) treatments could show positive effects of exercise and CBT because a large portion of people given the new CDC ME/CFS diagnosis will actually have primary depressive disorders solely producing their symptoms.

Patients used for clinical trials are likely to be chosen from people diagnosed using the SEID criteria from clinical practices rather than subjects selected meeting more specific research criteria. The SEID criteria are already being promoted for research use by IOM panel members who claimed their broad criteria were not intended for research use. It makes no sense to have research conducted on groups of subjects differing widely from the group of patients given the diagnosis in clinical practice.

It will no longer be possible to argue that ME/CFS is a primarily physical disease because, in fact, a substantial portion of new CDC ME/CFS patients will have symptoms due to psychiatric disorders. Jason et al. found 47% of a sample of people with melancholic depression (a severe form of clinical depression excluded from Fukuda CFS) met the new CDC ME/CFS criteria.

The CDC and many prominent US CFS doctors and researchers (Montoya, Lipkin, Hornig, Bateman, and Klimas among others) are promoting the IOM criteria in research papers for diagnosis of "ME/CFS." The CDC on its website is now listing the Fukuda criteria for CFS, the CCC for ME/CFS, and the ICC for ME as "historic" criteria all replaced by the 2015 four-symptom IOM SEID criteria for what the CDC is now calling "ME/CFS."

This same person made this observation on oe

 

Re pem, this same person made this comment:

“Jason used this as a definition of PEM in his SEID research.

"To meet the post-exertional malaise criteria, a patient would need to have indicated presence of at least 1 of our two post-exertional malaise symptoms: sickness/fatigue for >24 h after exercising or experiencing high levels of fatigue after everyday activity."

He found people with many conditions reported PEM and met the SEID criteria, including 47% of a sample of people with melancholic depression.

Yes, PEM can be interpreted as a symptom similar to the PENE of the ICC. However, PEM can also mean experiencing fatigue and a prolonged recovery after exertion, which is reported by many patients with diverse conditions.

That why PEM is a double-edged sword. It can seen as a symptom of people with ME and those without ME. Even PENE is not regarded as only found in ME by the ICC. Seven other causally related symptoms are additionally required for a case of ME.”

 

I have a huge problem with so-called "psychiatric illnesses", as you know. I don't believe in the existence of a real object called psyche, and if it existed I wouldn't believe in the claim it can become sick (unless it is proven).

There's absolutely no objective proof for this.

So what remains is the same as in case of ME: a symptom list (and the feeling of a doctor).

We all know that there are a multitude of similar symptoms in depression, somatoform disorder and ME; that's the reason why many people with ME are falsely diagnosed and will never get an ME diagnosis. I always wonder how you will exclude psychiatric illnesses due to this. What will happen is that people who have some physical disease - maybe not ME - will end up with a psychiatric diagnosis with the well-known CBT/GET and "it's in your own hands" stuff.

It comes down to the following I suppose: If a doctor likes you he won't give you a psych diagnosis, if he dislikes you he will. At least, that was my observation.
I never understood how a somatoform disorder etc. can be reliably diagnosed - because it can't.

This is just really difficult.

 

To me this petition is unhelpful. The key concern relates to:
ME has appeared in 50+ outbreaks worldwide and was first named and defined by Dr. A. Melvin Ramsay after a massive outbreak in 1955 in the Royal Free Hospital in London. The disease also appears in the sporadic form and is neurological in nature with immune dysfunction, muscle weakness (including paralysis) and pain as well as affecting multiple body systems.

After listening and reading for five years I am not convinced that we know there is 'a disease' of this sort. What does it mean to be 'neurological in nature'? I agree that the brain seems to be suffering but we do not actually know why. None of the evidence for immune dysfunction seems to have held up so far. I think the evidence for muscle weakness (including paralysis) dating back to Ramsay and Acheson is questionable.

On the other hand PEM seems to be a feature that identifies a specific pattern of illness. If it also occurs in the context of lupus or other conditions I do not think that necessarily makes it less useful in categorising otherwise unexplained illness.

It seems to me a bad idea to try to persuade government health agencies to rewrite textbooks on the basis of what a group of patients want them to say, unless there is a good evidence base.

 

Hi Adam - I don’t wish to rehash the arguments about criteria but I do want to pull you up on your inference from my personal comments below the note (blog).

I did get too personal, I admit that, mea culpa. However, the comments were made *before* I knew Jen was in hospital (which I only read about on Twitter yesterday) and so seriously ill. At the time of writing the note I had only read Jen saying she was “fine but weak” after her thyroid cancer operation.

Your inference that I thought Jen used the atypical polio research as a distraction is wrong. I only meant that, instead of spending her time and energy doing that, she should have, IMO, as the figurehead of an international ME organisation, been using it to prepare a critique of the CDC guidelines. Annabel was right to pull me up on that comment.

I don’t have an axe to grind with Jen but I am bitterly disappointed at her acceptance of IOM as a valid criteria for clinical use and her disingenuous stance that it’s only her opinion, as if it carries no weight as the head of her organisation.

I’m sorry it’s made you mistrust the purpose of my note and to therefore dismiss its discussion points.

 

I love SEID criteria. It is very important in getting a clinical diagnosis. Because clinicians just will NOT use CCC or ICC and that's all there is to that. It's a bit much to bother with and I know I don't have doctors that have time to use them.

In research, I do wish they would use ICC and CCC to further "categorize" instead of just having severe patients in with mild and moderate. It could help pinpoint types and severity instead of the old phrase "there is a SUB-GROUP that is". Maybe the subgroups are screaming at everyone in the face.

I don't mind mild, moderate, and severe in the same study, I just mind that they could already be grouped using SEID, CCC, and ICC in the one study and keeping the data within those groups to see if the SUB-GROUP is found in one of those criteria.

I'm not signing this petition.

 

Thanks. I'm glad you've taken the time to comment. I've read the comments again, and some of them do feel personal. Not all of them are yours, of course, but it does make me feel uneasy.

This, to me, is the problem. PEM or PENE or PED needs to be properly defined. Everyone gets tired after exercise, so it's not that.

If 47% of SEID patients also have psychiatric illness compared to 61% of ICC, the ICC is still technically worse. These studies are both by Jason, by the way.

I think the reason many patients are reluctant to dismiss SEID is because that label has meant many have been diagnosed and given treatment. The IOM report is also one of the main reasons NICE is updating its guidelines.

An easy fix--for me--would be to expand brain fog to neurocognitive symptoms and OI to ANS symptoms. Then it would be pretty much the London criteria, and simple enough to use. Of course, PE* would have to be properly defined to work, but I believe that's true of all the criteria.

ETA: SEID is a positive diagnosis, so that may be part of the problem too. It means it's not a diagnosis of exclusion, so fewer exclusions may be done. I have mixed feelings about this, because I'd prefer a positive diagnosis.

 

On the paper by Leonard Jason that claimed that 2.8 times as many people satisfied the IoM criteria has to Fukuda, I previously wrote the following on the "other" forum:

---
In another Jason et al. (2015) paper, Unintended Consequences of not Specifying Exclusionary Illnesses for SEID (Jason 2015), definitions weren't used that were comparable to the SEID criteria:

This is what was used in that paper:

 

I agree. I am uneasy with trying to lobby government for a change that there is no valid evidence base to point to. Science doesn’t work that way. Patients don’t get to define an illness, researchers do. I think we can lobby for more research to better define the illness and insist to the researchers that our voices are listened to when coming up with definitions. I don’t believe we can simply lobby the government to demand a particular criteria.

 

“We are international medical practitioners and researchers in the field of myalgic encephalomyelitis (ME), ME advocates, patients and their supporters.”
Not just doctors and researchers.

I agree there are several different agendas and I doubt there will ever be consensus. I think what some groups are doing is potentially damaging to the patient population as a whole. I believe we need to be proactive in calling for research, and in critiquing research to ensure it is accurate, but not in demanding that a particular criteria is adopted without research that shows it is the most accurate reflection of the illness. Some of these patient groups are trying to take the place of researchers, it’s not how disease definition works.

 

He seems to do this regularly. I'm not sure it's intentional (I'm pretty sure he's just experimenting with different ways to measure or assess post-exertional symptom exacerbation to figure out which is best, because the definitions do seem to evolve), but he needs to be clear about the problems this causes in the research.

The limited evidence we do have seems to indicate that well defined post-exertional problems is the key to diagnosis. The problem is with how we define it in the first place to make it an accurate diagnostic tool.

 

Jason did poor work criticizing the IOM criteria. He used vague definitions of PEM and then finds that lots of other illnesses have PEM too. I am not sure asking patients about fatigue after exercise or activities tells us much about PEM.

That said, we don't have a good questionnaire to determine whether PEM is present or not. What we would need is to develop a questionnaire that can distinguish between people that objectively show PEM on repeat CPET from those who don't.

It may turn out to be the case that PEM is not unique (I would want high quality studies before accepting this), but even if presence of PEM narrowed down the number of possible diagnoses down to a few that would be very helpful.