Unintended Consequences of not Specifying Exclusionary Illnesses for SEID (Jason 2015)

[Bob]

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 experiencing high levels of fatigue after everyday activity.

@jimells, thanku for digging out that section and quoting it. It is the most basic of definitions for PEM, isn't it. It's just fatigue (or 'sickness', whatever that is) for greater than 24 hours after everyday activity. However, like you say, it's likely to be how most general doctors interpret it.

 

[Bob]

It would be interesting to see a study of who can more accurately diagnosis this illness: patients or GPs.

Now that would be a very interesting study, and possibly very useful evidence!

 

[Bob]

This certainly reflects my own experience. I have dealt with depression on and off for most of my life. I never found activity to help...

Me too. (And I now wonder if my teenage depression was an early sign that I was later going to develop ME? i.e. an immune issue that expressed itself in depressive symptoms.)

Before I had ME, I remember I ran 10 miles once (they were the days!) and found myself very annoyed that I was equally low in mood at the end of the run as I was at the beginning, despite it being a pleasant run! (People with mild to moderate depression can experience a degree of pleasure, but it's limited.) I used to do loads of exercise and activity but I never experienced an endorphin rush in my whole life, or an uplift in my underlying mood during or after exercise.

However, with the depression, I never experienced any unusual post exertional symptoms or complications. There was mild physical fatigue at times, but nothing close to the symptoms of ME, and no crashes, and no post exertional struggles. No physical incapacity or disability. No complicated physical symptoms. The occasional physical fatigue never stopped me being involved in normal physical activity. (Even if the depressive symptoms did at times.)

And I knew I had depression, just as I now know I have ME. They're different experiences. There is a slight overlap in symptoms between depression and ME. When I had depression I did wonder if I might have thyroid issues, because you can feel physically and mentally tired, and so i asked to be tested. But depression doesn't involve post exertional complications, or physical disability. It causes mood and motivational problems. You'd think that we'd be able to design a tool for clinicians so they could easily separate the two illnesses.

 

[jimells]

I think maybe I'm starting to understand why they are trying to do. There are four separate datasets, each obtained using different questionnaires, none of which were specifically designed to test SEID, so how to jam four slightly different sets of questions into one definition of PEM, one common denominator?

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
experiencing high levels of fatigue after everyday activity.

To meet the post-exertional malaise criteria, a patient needed to have 6 or more months of post-exertional malaise.

Huh? What? To have PEM one needs to have PEM?? How did reviewers miss this?

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.

To meet the post-exertional malaise criteria, a patient would need to have a frequency of at least some of the time and severity score of at least moderate to indicate prolonged levels of malaise following previously tolerated exercise.

Having all these slightly different criteria is an interesting idea, since we know that physicians and patients will have many different interpretations.

 

[worldbackwards]

I'm getting really confused now.

I usually retire from these threads long before this point.

 

[Research 1st]

Jason exposes the inadequacies of SEID, and for that should be applauded because the blind faith (by the IOM panel who created SEID) of believing SEID will change the way CFS sufferers are mistreated is most worrying.

To research ME away from CFS (even as SEID as ME), you can't include people with mental illness and allow them to dilute the ME or SEID research flock, which the SEID does and is proven to do, by Jason, who as a psychologist knows more about mental illness than most. Ergo SEID is just a massage CDC CFS, with a new label. In effect.

If a pathogen is discovered, SEID falls by the way side. To 'diagnose' a condition on not being able to do anything because it makes you worse (SEID premise), is silly, as severely affected PWME/CFS can't do anything at rest, irrespective if they do anything or not! The name SEID, confusingly promotes you are intolerant of exertion, not that you have a chronic inflammatory disease. (NB: People with inflammatory diseases are also intolerant of exertion not just PWME - example, Lupus!).

The IOM know this, but did a hatchet job on the patients with ME, by not permitting ME researchers to set the standard on what ME should be (all the renoun ME experts were prohibited from the panel).


I'm glad Jason et el, can expose the inadequacies of how SEID and demonstrate it is hardly an improvement on Fukuda CFS, if anything, it's more confusing. (A physician can't diagnose a condition using no tests, that absurd). Yet Fukuda CFS and SEID does just that.

Meanwhile, ME International Consensus Criteria could have been used to fill in the gaps until the science evolves.

Naturally, the powers that be don't want that. Perhaps science though will force ME-ICC to be used if huge leaps appear? Wishful thinking of course.

 

[jimells]

This is really good. Thank you Dr Jason for being such a forceful advocate. It can only help that this is in the "official" literature.

Even though the SEID criteria are for a clinical case definition [1], rather than a research case definition, it is likely that it will be used for research by investigators, as a similar process occurred with the clinical Fukuda et al. [2] CFS criteria.

If there are ambiguities with case definitions, like what has occurred with the Fukuda et al. [2] CFS criteria, there will be difficulties in replicating findings across different laboratories, estimating the prevalence of the illness, consistently identifying biomarkers, and determining which treatments help patients. To develop or validate a reliable case definition, we need to both provide operationally explicit inclusionary and exclusionary criteria as well as develop a consensus within the scientific community for the case definition.

These are, of course, sentiments that have been expressed here many times. It would be most interesting to have Dr Jason discuss his paper with us. But of course, I understand that he has a live outside the lab, and I'm glad that he does.

 

[barbc56]

I've only skimmed these posts but somewhere I read where FM patients don't get the phisiologcal benefits of exercise and can probably can be applied to me/cfs. This would be in addition to the other, probably more causative reasons for not getting bebefits from exercise.

I will try to find this but can't even begin to pinpoint where this info. is.

Anyone find this?

 

[Sea]

Me too. (And I now wonder if my teenage depression was an early sign that I was later going to develop ME? i.e. an immune issue that expressed itself in depressive symptoms.)

Before I had ME, I remember I ran 10 miles once (they were the days!) and found myself very annoyed that I was equally low in mood at the end of the run as I was at the beginning, despite it being a pleasant run! (People with mild to moderate depression can experience a degree of pleasure, but it's limited.) I used to do loads of exercise and activity but I never experienced an endorphin rush in my whole life, or an uplift in my underlying mood during or after exercise.

However, with the depression, I never experienced any unusual post exertional symptoms or complications. There was mild physical fatigue at times, but nothing close to the symptoms of ME, and no crashes, and no post exertional struggles. No physical incapacity or disability. No complicated physical symptoms. The occasional physical fatigue never stopped me being involved in normal physical activity. (Even if the depressive symptoms did at times.)

And I knew I had depression, just as I now know I have ME. They're different experiences. There is a slight overlap in symptoms between depression and ME. When I had depression I did wonder if I might have thyroid issues, because you can feel physically and mentally tired, and so i asked to be tested. But depression doesn't involve post exertional complications, or physical disability. It causes motivational problems. You'd think that we'd be able to design a tool for clinicians so they could easily separate the two illnesses.

I'm not so certain that they are that easily separated. My daughter has MDD. It is the correct diagnosis for her in that she is depressed, suicidal, with episodes of self harm. But... she also exhibits almost every symptom I do, even PEM. She crashes with exhaustion, lymph node swelling and pain after minor activity. She is wiped out the day after activity. She seems to have what I have plus depression, and it is not secondary depression. The depression came first, although it came after several years of less than ideal health. Whooping cough which left her with residual asthma, chronic hayfever, tonsilitis several times a year. She is an enigma, but one which I believe showcases how depression can be a result of inflammation or infection.

 

[beaker]

I think maybe I'm starting to understand why they are trying to do. There are four separate datasets, each obtained using different questionnaires, none of which were specifically designed to test SEID, so how to jam four slightly different sets of questions into one definition of PEM, one common denominator?



To meet the post-exertional malaise criteria, a patient needed to have 6 or more months of post-exertional malaise.

Huh? What? To have PEM one needs to have PEM?? How did reviewers miss this?

/QUOTE]

A bit confusing but I'll give it a shot :
I think that means you have to have PEM for 6 months ( just like they say unexplained fatigue for 6months) in order to meet the CRITERIA of MEcfs type PEM. (that is not specifically defined. Implied you push/pay for 6 months to meet the requirements)[

 

[SOC]

I'm not so certain that they are that easily separated. My daughter has MDD. It is the correct diagnosis for her in that she is depressed, suicidal, with episodes of self harm. But... she also exhibits almost every symptom I do, even PEM. She crashes with exhaustion, lymph node swelling and pain after minor activity. She is wiped out the day after activity. She seems to have what I have plus depression, and it is not secondary depression. The depression came first, although it came after several years of less than ideal health. Whooping cough which left her with residual asthma, chronic hayfever, tonsilitis several times a year. She is an enigma, but one which I believe showcases how depression can be a result of inflammation or infection.

If she has clear PEM, and it sounds like she does, there's no reason to think she can't have both depression and ME. That doesn't mean the two go hand-in-hand. People can have depression followed by cancer, or depression followed by SLE. That doesn't mean the two go together, just that having one illness (MDD) does not protect one from getting another illness (ME, cancer, SLE) as well.

 

[SOC]

I think we have a big problem with PEM in that it is not clearly defined. Perhaps CPET testing or post-exertional cytokine testing can quantify it, but we're not there yet. Most top ME/CFS clinicians can distinguish PEM (by symptoms alone) from simple fatigue after exercise and exercise intolerance from OI (or other conditions). It appears Lenny Jason cannot.

The issue with the SEID PEM criteria (or any other PEM-based criteria, for that matter) is that GPs are guaranteed not to understand what PEM really is, any more than Lenny Jason appears to. If we want GPs to diagnose PEM, we need to give them a lot more guidance.

Anyone who has really experienced post-exertional neuroimmune exhaustion knows it's more than unusual fatigue from exercise or normal activities. There's lots of things that can cause unusual fatigue, as Lenny demonstrated in this study. That doesn't mean it's the PEM described in the ICC, which is the distinguishing feature of ME.

If Lenny meant to demonstrate that the SEID criteria in the hands of untrained GPs is going to drag in a lot of non-ME patients, I think he did that. I would have guessed that without this study. What he did NOT do, imo, is demonstrate that the SEID criteria in the hands of trained and knowledgeable physicians/researchers does not clearly identify ME patients. The devil is in the details.

My memory fails me. Does anyone remember if there is a more detailed description of PEM in the IOM report? I know there's a lot more detail than just the definition, but I can't remember, and don't have the mental energy to dig up right now, whether there are details about PEM specifically.

I like Lenny, and I think he has done a lot for us, but I also know he has a lot invested in his own operationalized ME/CFS definition. This makes him rather biased in evaluating other definitions. I think his personal bias caused him to devalue PEM as a primary criteria for ME/CFS by trivializing it. That only proves that he doesn't understand PEM and it's importance to ME/CFS, not that the SEID criteria properly applied don't identify ME/CFS. His own criteria, if improperly applied, could also pull in many non-ME patients.

I imagine we can all agree that no definition is going to be properly applied by your average GP and consequently ME/CFS is going to be grossly misdiagnosed until we have some proper biomarkers.

 

[alex3619]

The issue with the SEID PEM criteria (or any other PEM-based criteria, for that matter) is that GPs are guaranteed not to understand what PEM really is, any more than Lenny Jason appears to. If we want GPs to diagnose PEM, we need to give them a lot more guidance.

I think this is the big thing. They read the name, and ignore the details. PEM is NOT exertion intolerance as commonly understood. Docs who do not differentiate, or differentiate from fatigue, will always wind up with misdiagnoses.

 

[Valentijn]

@jimells, thanku for digging out that section and quoting it. It is the most basic of definitions for PEM, isn't it. It's just fatigue (or 'sickness', whatever that is) for greater than 24 hours after everyday activity. However, like you say, it's likely to be how most general doctors interpret it.

Except there is more data later in the document, which clarifies things quite a bit.

The problem is that SEID criteria have not really been prepared for use by doctors. Jason is criticizing it for not yet implementing something it wasn't supposed to implement. NIH needs to implement it, and his efforts might obstruct that from ever happening. In which case, it's a few more decades of Fukuda CFS for Americans.

 

[Snow Leopard]

I imagine we can all agree that no definition is going to be properly applied by your average GP and consequently ME/CFS is going to be grossly misdiagnosed until we have some proper biomarkers.

Sadly this is what it comes down to in the end.

 

[Sidereal]

In Dr Jason's study, here's what he says about OI:

To meet the orthostatic intolerance criteria, a patient would need presence of at least one of the following items: dizziness, wobbling feet when getting up.

Well, this is a joke. If you redefine the standard medical definition of orthostatic intolerance to mean whatever the hell you want, then of course you can produce a study that "proves" that a bunch of depressed or autoimmune patients meet these criteria.

OI and PEM are not some random words on the page. They need to be operationalised and conveyed to doctors.

 

[Bob]

Perhaps we, as a group effort, could attempt to design a questionnaire that defines PEM, and/or a questionnaire that attempts to distinguish ME/CFS symptoms from the symptoms of affective disorders? But perhaps it wouldn't be possible, as it could be quite complex and we'd probably end up disagreeing endlessly, and waring. And it's beyond my capacity to lead any project at the moment. But it could be an increasing idea to explore if we were to do it in a small-ish group, and we agreed some ground rules. Then we could ask Lenny Jason if he would be willing to test it and validate it for us. Seeing as we have the best knowledge, we'd be the best people to do this, if we could agree a way to work together. Well, it's just a thought, and perhaps not such a practical idea.

 

[Snow Leopard]

http://www.nice.org.uk/news/article...l-help-to-save-thousands-of-lives-from-cancer

Hmm...

 

[jimells]

Most top ME/CFS clinicians can distinguish PEM (by symptoms alone) from simple fatigue after exercise and exercise intolerance from OI (or other conditions). It appears Lenny Jason cannot.

I don't think that's fair. He is analyzing data from other studies, and completely dependent on how those studies defined PEM.

If Lenny meant to demonstrate that the SEID criteria in the hands of untrained GPs is going to drag in a lot of non-ME patients, I think he did that.

Well, yeah. The title of the paper is "Unintended Consequences..." and his paper shows what they are likely to be.

 

[Valentijn]

I don't think that's fair. He is analyzing data from other studies, and completely dependent on how those studies defined PEM.

He's used similar tactics in his other studies. He used one to attack the CCC and/or ICC as being more likely to diagnose patients who were also more likely to be diagnosed with psychosomatic or mood disorders using the DSM IV. Of course, that's true if mood disorders are diagnosed based on having physical symptoms, but otherwise a pretty useless attack on a couple of very good definitions.

The questionnaires he uses regarding PEM have also generally made me want to bang my head against various firm objects.