USA - NCHS/CDC Proposal for ICD-10-CM - adding SEID

It's also worth bearing in mind that the authors specifically quote Carruthers et al. when describing PEM. This is pretty much the same description in the CCC and ICC, but presented without assumptions of causation.

In fact, the report details PEM on pages 78-86, which means they devote a whole nine pages to describing it in detail. They list the evidence for PEM too.

If I'm remembering correctly, there was also a study that showed the only important criterion for accurately diagnosing patients was PEM. Anything else is just icing on the cake. But you have to get PEM right or even the most detailed criteria can select the wrong patients.

 

Even with the exclusion criteria, ME can be diagnosed whilst having treatment for other conditions that do not fully resolve with treatment or even a condition where there is no treatment. It depends on the clinical judgement of the doctor whether a patient's symptoms are primarily the result of a depressive disorder or another disease. ME and any other condition both of course need to be treated. For example, the CCC say about exclusionary criteria that “if a potentially confounding medical condition is under control, then the diagnosis of ME/CFS can be entertained if patients meet the criteria otherwise.” Obviously some illnesses will never be under control but it is recognised that a person can have other conditions.

The lack of exclusionary crtieria in IOM criteria is about misdiagnosing major depressive disorder (MDD) as SEID or considering a patient has co-morbid SEID because the symptoms of MDD or another condition overlap with the nonspecific SEID symptoms.

For example, a recent study at the Sleep Center at Emory University School of Medicine, “Systemic exertion intolerance disease/chronic fatigue syndrome is common in sleep centre patients with hypersomnolence: A retrospective pilot study,” found 21% of 187 patients with hypersomnolence (excessive daytime sleepiness) met the criteria for SEID.

The study authors interpreted the results of the study to mean that SEID is a common co-morbidity in the hypersomnolent population. An alternate interpretation is that the SEID criteria do not distinguish between patients with a hypothesized exertion intolerance disease and those whose symptoms are associated with a more appropriate existing diagnosis.

As mentioned briefly to Strategist, in addition research by Leonard Jason's group found 48% of subjects with a clear medical reason for their fatigue met the SEID criteria. 27% of a group diagnosed with MDD met the SEID criteria. 47% of group with a severe form of depression, melancholic depression, met the SEID criteria and could have been given a diagnosis of co-morbid SEID to add to their difficulties.

Sorry I don’t know how to multiquote so will bold the rest of your comments:

“Not sure what you are referring to so maybe I am missing something. But the IOM report based its definition of PEM on at the CCC and stated that PEM was associated with not only an exacerbation of some or all of a patients symptoms but also a further reduction in function.

The IOM report may have given more detail on the nature of the PEM but the IOM clinician’s guide which is what doctors will be using says simply PEM with an asterisk that expands it to say ‘Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS (SEID) should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity. In the clinicians guide further on from the box with the core criteria it expands a bit further and says PEM is worsening of a patient’s symptoms and function after exposure to physical or cognitive stressors that were normally tolerated before disease onset

The meaning of such subjective terms as "profound, prolonged, moderate, substantial, or severe intensity" are open to a variety of interpretations. The IOM criteria allow PEM of "moderate intensity" to be used for diagnosis.

The CDC CFS Toolkit for years defined PEM as "Postexertional malaise (extreme, prolonged exhaustion and sickness following physical or mental activity). Also the term "malaise" has been used by doctors for years to describe a vague feeling of discomfort reported by patients. If the IOM report wanted the symptom of PEM to mean something unique to SEID and more specific, they would have been better using a different term than the Fukuda term PEM (I know CCC used the term PEM too. ICC obviously tried to make it more specific) which had already been defined as stated above and is nonspecific, being commonly reported in many medical and psychiatric conditions.

“I appreciate that the ICC had not been out for long at the time of the CFSAC recommendation or the letter to HHS from 50 experts calling for the CCC to be used. But I've been at a number of research meetings in the last year or two and many of the researchers stated they are still using CCC, including some who signed that letter. That suggests to me that it was not just a timing issue.“

I don’t doubt that but I would support advocates pushing for more researchers to use ICC which the ICC authors, some of whom were part of the CCC, clearly said were supposed to be the follow on of CCC. I know one of the Australian Team’s use ICC, can’t remember name Sonya-Marshall? and Japanese team Nakatomi use ICC. However, the biggest concern as said is the chance IOM SEID will creep into being used for research which there are already signs of happening.

@Inara, sorry I see you have asked a question and @adambeyoncelowe you have just posted quoting me, but I am wiped out so will have to stop for today. I will try and come back and respond when hopefully more rested.

 

I am not convinced that lack of specificity (of IOM criteria or others) is as much of a problem as is believed. It is a simple elegant explanation to explain why studies arrive at inconsistent results or fail to find anything at all. But we do not have a gold standard for determining ME/CFS and so we cannot know if this is true or not. I suspect that there are many reasons for inconsistent results, and that the solution is not as easy.

Tightening the criteria might very well be a search strategy that works, but is it because the criteria approximate reality or is it because they select patients that are sicker with a stronger and more easily identifiable illness process?

Sicker patients could also be sicker because they have multiple problems at once (like mast cell issues or POTS). This would make it harder, not easier to figure out what the problem really is.

There are also other search strategies that could work, for example focusing on recent onset patients.

(I do generally support stricter criteria in research, but think competence of the researchers and funding are more important)

I'm also getting the impression that much of the desire to see strict criteria in research is an attempt to get away from the BPS model. "They didn't have ME" is also used to explain away positive results from CBT/GET studies and the like. Now we know that these positive results are most likely an artifact of bad methodology that amplifies biased reporting of symptoms and (by incompetence or intention) conflates it with successful treatment.

I write so much about this because it's really important to avoid becoming a victim of our own assumptions of what the illness is. We could lose decades of research by trying to confirm our own incorrect assumptions.

 

Do you have details about any of them? Do any of them base their education on the IC Primer?

Historically what we have seen leaves those of us who are low moderate, severe, and very severe without any medical support. No information about immune abnormalities, paralysis, the serious neurological issues that doctors don't believe are real, cardiac abnormalities, etc Many of us have stopped bothering with going to doctors at all because the information they have worked from is so harmful.

Any education that is going to work for the population who fits the ICC first has to "uneducate" the doctors. I've not heard that any of the ones working on this are focused on this level of care.

 

And now I fully understand the crux of this miscommunication if you are sure ME does not include immune abnormalities. I have immune abnormalities.. of that there is no doubt. So are you saying I must have a different disease? This also explains why you would not consider the ICC a viable criteria for ME as that criteria clearly describes a disease that has immune dysfunction.

My immune symptoms fit the Th1 Th2 imbalance exactly. Having been at this 29 years... and living in a body that does NOT have any normal immune responses, I am absolutely positive I do have immune abnormalities. I don't have a normal response to colds and flus that go around. I don't tolerate vaccines... attributed to immune dysfunction. I had EBV reactivated... attributed to immune dysfunction.

I could go on, but it sounds like you have set your mind that ME is not an immune dysfunction disease.
So I either have a different disease. Or you and I think ME is something very different.

I'm in many groups with patients who have immune dysfunction and consider themselves to have ME.
If this group does not agree that ME includes immune dysfunction, I'm clearly in the wrong place.

 

At this point of time, PEM is subjective. Researchers depend on what the patients tell them about PEM, and we all know how hard it is to describe PEM, even for us who experience it.

I think most diseases have severity degrees. Why shouldn't people with "mild" PEM and other mild ME symptoms be diagnozed with ME? ME is not only the very severe spectrum. My impression was that even "mild" ME is pretty disabling. Also I think we shouldn't do "severity battling".

(Otherwise, I liked your post, obviously, it's interesting.)

 

I'm not sure this document:

...is any more helpful than this:

...in isolation.

Both documents on their own are ripe for misinterpretation and abuse. That's why each has a report attached to it which explains in detail what each criterion means. We should judge the entirety of each criteria, not just a cheatsheet that vastly summarises an approach.

For instance, the ICC summary doesn't explain whether each characteristic of PENE is needed or just one. Each of the symptom domains also include things which may not be anything to do with the domain they're included under (is pain always neurological, for instance?) and offer 'soft' options that are too generic (headaches, GI problems, dizziness) without qualification. All it takes is a person with lots of non-specific issues and a doctor who doesn't understand PENE from that document, and hey presto! Misdiagnosis!

The ICC document also has a lot of things to check off, so there's a danger that in trying to fill it out doctors will 'fish' for answers. The longer you're asked to recall symptoms, the more you start to remember.

So a person who went in complaining of fatigue might be provoked to recall the headaches they occasionally get, the bloating they had the other week, or the dizziness they got that one time in the supermarket. Yet these things may have been caused by dehydration, a bad curry and an inner ear infection, respectively.

All it takes is that doctor thinking that, like the others on the cheatsheet, PENE is a multi-option symptom, and you've got a problem. They might say they get more fatigued after exercise (who doesn't?) and that's that.

I think you missed the 'demonstrable' part. A few cytokines here and there (sometimes conflicting ones) doesn't demonstrate this conclusively. Things like a 'Th1/Th2' shift are very woolly and may be equally due to recall bias. It's also worth pointing out that Ron Davis has found fewer viruses in patients than in controls so far. The evidence here is all over the place.

Jo has talked numerous times about how people with lax understanding of immunology have overstated the case for immune involvement in ME (and in other diseases). That's not to say the immune system isn't involved, but it is to say that the evidence we have so far is very poor quality and full of pet theories that don't go anywhere.

A faggot fallacy is 'a belief that multiple pieces of evidence, each independently being suspect or weak, provide strong evidence when bundled together' (see here). I think that the science around ME has been particularly prone to faggot fallacies on all sides of the debate.

Realising that evidence is poor or lacking is not the same as agreeing with the BPS school, though, or not sticking up for ME. In fact, it's precisely because we want to stick up for ME that we want the discussion to be as accurate as possible.

I realise that this is getting off-topic, but in short, we should discuss this based on what's actually there in the criteria, and not overstate weak evidence or cling to some sacred cow or other.

 

How do you exclude somatoform disorder anyway? It's essentially defined as multiple unexplained symptoms. I think it might just exist to give doctors an exit option in the case of patients that can't be helped but refuse to give up.

 

Please note I am referring to ME and CFS from the perspective of being in the US.

I believe patients should educate themselves about the issues surrounding a CFS diagnosis that leads doctors to treat with CBT and GET. We have doctors here who use the term CFS but treat the immune abnormalities, cardiac issues, neurological issues appropriately as per the ICC. We have doctors who call the disease ME and send people for cognitive and physical therapy with no grasp of the dangers.

Many of us here in the US have asked our doctors to use the G93.3 code and given them the IC primer as well as the latest information about these abnormalities which has led to us getting MUCH better respect and care for our needs.

I do NOT think patients can "enforce" anything. Educating our doctors is key to getting better treatment.

 

You may not be aware, but this is probably the place on the internet with the highest concentration of experts on the CBT/GET/PACE controversy. Several authors of the PACE reanalysis paper and other prominent critics of CBT/GET participate in discussions.

The reason CFS is treated with CBT/GET has nothing to do with case definitions. It is because a group of researchers succeeded in convincing society that CBT/GET are a good treatment. If an immune abnormality was found tomorrow that explained the illness, the CBT/GET people would still insist that CBT/GET is useful as rehabilitation treatment. They would quietly de-emphasize or change the false illness beliefs part of their model but otherwise continue as before.

 

I am aware there are experts in this group. Which is why I joined in the first place.

I disagree that CBT/GET has nothing to do with case definitions. If the case definition specifically states the danger of exertion leads to damage of the patient, then the case definition would most certainly stop exercise therapy. Because patients (in the US) would be able to sue for malpractice if a doctor insists a patient exercises.

That is one area SEID falls short. We now know that doctors are seeing exertion intolerance the same way they view food intolerance. Gradually increasing will overcome the intolerance. As mentioned before, it is of high importance that all medical education about ME "uneducate" doctors first.

I have seen in some of the articles about the cytokine findings that CBT is a treatment for cytokine abnormalities. (I don't have those links at hand).

 

A biomarker can't be found if vague and imprecise case definitions are used. Experts who had seen thousands of patients and had a good handle on recognizing this specific population created the CCC and then the ICC. This was done so researchers would stop looking at the wrong patient populations described by the vague Fukuda and Oxford definitions.

The concern remains that researchers are still not selecting a patient population that is recognized as ME as per the ICC. That would explain researchers seeing a lack of immune system abnormalities that are experienced by the ME community. We know that many patients need antivirals for reactivated viruses, low NK cell function is prevalent, IVIG is also needed. Many of us with immune system issues are seeing improvement using low dose naltrexone (immune system modulator).

Here is an example of a study that used ICC as the criteria for selection of patients.

A Preliminary Comparative Assessment of the Role of CD8+ T Cells in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis and Multiple Sclerosis. (2016) Brenu, Broadley, Nguyen, Johnston, Ramos, Staines, Marshall-Gradisnik https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4736227/

Conclusion from that study: "In summary, these preliminary findings provide new insight into the possibility of hyper activated inflammatory CD8+ T cell profile in untreated MS patients while CFS/ME patients may display an exhausted profile which permits viral prevalence and persistence. The above data may suggest that the differential expressions of receptors and adhesion molecules in MS patients are in response to imbalances in neuroimmune homeostasis. In comparison to CFS/ME patients, MS patients may have more severe immune dysregulation. Nevertheless it is likely that impairments in CD8+ T cells in CFS/ME patients relate to abnormal levels of adhesion and migratory molecules and these abnormalities may contribute to the persistent immune dysregulation observed and warrant further validation in a larger sample size

 

I wasn't specifically referring to CBT and GET. Sorry that was not clear. I was referring to treatments being based on patients changing their behavior instead of doctor intervention.

I'm referring to the CDC recommendations that is all about "living with ME/CFS"... nothing about actually treating the disease.

From the website:

"

• Professional counseling: Talking with a therapist to help find strategies to cope with the illness and its impact on daily life and relationships.
• Balanced diet. A balanced diet is important for everyone’s good health and would benefit a person with or without any chronic illness.
• Nutritional supplements. Doctors might run tests to see if patients lack any important nutrients and might suggest supplements to try. Doctors and patients should talk about any risks and benefits of supplements, and consider any possible interactions that may occur with prescription medications. Follow-up tests to see if nutrient levels improve can help with treatment planning.
• Complementary therapies. Therapies, like meditation, gentle massage, deep breathing, or relaxation therapy, might be helpful.

Important note: Patients should talk with their doctors about all potential therapies because many treatments that are promoted as cures for ME/CFS are unproven, often costly, and could be dangerous."

 

This thread is specifically about the US has proposed giving ME, CFS, and SEID three different ICD codes. So this isn't my argument about "what is what". This is a discussion trying to clarify how to address the proposal that is being put forth that makes all three of these separate diseases which would necessitate three separate diagnostic criteria.

The discussion's aim was to give input about how to address this specific issue.

My input was that ME as per the ICC describes a specific disease that includes immune dysfunction. That has turned into a separate discussion.

Your comment about "we won't know until we have biomarkers" is valid. Unfortunately, the ICD coding in the US is not waiting for that to happen. So we are stuck having this discussion now.