IOM’s Redefinition of ME Invites Over-Diagnosis and Risks Inclusion of Primary Psychiatric Disorders

[SOC]

I believe patients are scared that these patients will 'pollute' the cohort. I very much disagree and I believe that we will find that with emergence of precise testing and biomarkers such as 2days CPET, viral markers at disease onset, tilt table test, there will be patients who suffer from both mental and physical illness.

My only concern about "pollution" of research cohorts is that patients with primary psychiatric conditions, but without ME/CFS, are included in research studies. Including people without the condition in research studies -- and it has been done extensively, particularly by the BPS school -- leads to indeterminate, or worse, completely incorrect research conclusions. We already have seen how much harm that can do to the progress of knowledge about the condition.

That said, it is absolutely necessary to have clean cohorts in the early stages of research. Confounding factors must be eliminated in order to get at the fundamentals of the condition. Once the basics of the condition are understood, it is possible to include patients with confounding factors to see how those confounding factors affect symptoms, progression, treatment, and so on. No, the earliest research does not fully describe the condition in all it's ugly glory. It never does. Look at the early HIV research. It (unintentionally) did not include the majority of HIV-positive patients. The purpose of the earliest research is to hunt down the core features, which are most likely to be found found in the most severe and unconfounded patients.

Eliminating confounding factors is not prejudice, it's sound research -- as is carefully exploring the impact of confounding factors once you know more about the condition.

 

[Kati]

My only concern about "pollution" of research cohorts is that patients with primary psychiatric conditions, but without ME/CFS, are included in research studies. Including people without the condition in research studies -- and it has been done extensively, particularly by the BPS school -- leads to indeterminate, or worse, completely incorrect research conclusions. We already have seen how much harm that can do to the progress of knowledge about the condition.

That said, it is absolutely necessary to have clean cohorts in the early stages of research. Confounding factors must be eliminated in order to get at the fundamentals of the condition. Once the basics of the condition are understood, it is possible to include patients with confounding factors to see how those confounding factors affect symptoms, progression, treatment, and so on. No, the earliest research does not fully describe the condition in all it's ugly glory. It never does. Look at the early HIV research. It (unintentionally) did not include the majority of HIV-positive patients. The purpose of the earliest research is to hunt down the core features, which are most likely to be found found in the most severe and unconfounded patients.

Eliminating confounding factors is not prejudice, it's sound research -- as is carefully exploring the impact of confounding factors once you know more about the condition.

However this definition we are talking about is a clinical one, not a research one. Correct me if I'm wrong.
Regardless the criteria necessitates major physical symptoms which features front and center post-Exertional relapse. Good researchers will ensure that these conditions are met. It is my hope that journal reviewers will be critical of poorly designed, poorly selected cohorts, because anyways patients will be

 

[SOC]

However this definition we are talking about is a clinical one, not a research one. Correct me if I'm wrong.
Regardless the criteria necessitates major physical symptoms which features front and center post-Exertional relapse. Good researchers will ensure that these conditions are met. It is my hope that journal reviewers will be critical of poorly designed, poorly selected cohorts, because anyways patients will be

I agree that the SEID criteria are clinical criteria and consequently should be broad to avoid excluding any patients with the condition from treatment. Making the criteria inclusionary instead of exclusionary should be a big help in better diagnosis of all patients, including those with additional conditions.

I don't see many patients objecting to people with ME/SEID and psychiatric conditions being properly diagnosed and treated. What I'm hearing is that patients object to people with primary psychiatric conditions and NOT ME/SEID being diagnosed with ME/SEID, especially if those patients are used in biomedical research and epidemiological studies.

Everyone deserves to be properly diagnosed and treated. That means diagnosed with the right condition and receiving the appropriate treatment for that condition. Treating all PWME with psych meds is wrong. Treating MDD patients without ME with ME treatments is wrong. It's as simple as that.

 

[beaker]

My only concern about "pollution" of research cohorts is that patients with primary psychiatric conditions, but without ME/CFS, are included in research studies. Including people without the condition in research studies -- and it has been done extensively, particularly by the BPS school -- leads to indeterminate, or worse, completely incorrect research conclusions. We already have seen how much harm that can do to the progress of knowledge about the condition.

That said, it is absolutely necessary to have clean cohorts in the early stages of research. Confounding factors must be eliminated in order to get at the fundamentals of the condition. Once the basics of the condition are understood, it is possible to include patients with confounding factors to see how those confounding factors affect symptoms, progression, treatment, and so on. No, the earliest research does not fully describe the condition in all it's ugly glory. It never does. Look at the early HIV research. It (unintentionally) did not include the majority of HIV-positive patients. The purpose of the earliest research is to hunt down the core features, which are most likely to be found found in the most severe and unconfounded patients.

Eliminating confounding factors is not prejudice, it's sound research -- as is carefully exploring the impact of confounding factors once you know more about the condition.

I have seen applications for past studies that have questions about co-morbid psych illness. ( They may ask direct q's about dx or they may try to fish it out w/ some of those long standard questionnaires. A good researcher tries to eliminate those w/ other things going on that will muddy the waters. Or they will sub-group the subjects in the final analysis to see if there is any significant discrepancies .
Also, any study I have been in, if it wasn't my own doc, the leading clinician has interviewed and examed the study participants. For a well defined study I don't think it would be a problem.
Of course, there are a lot of crappy studies out there. But if you take them apart you can see the issues. Perhaps there is away to have greater oversight to make sure study design has enough filters so as to not waste funding OR that publication reviewers are well versed to catch it.

 

[Valentijn]

The IOM recommended that the U.S. Department of Health and Human Services develop a toolkit for screening and diagnosing patients with ME/CFS.

This is where it could go wrong.

Yes, the IOM report has been a success. But HHS now has the chance to try to screw us over in the implementation process.

 

[Valentijn]

Look, people with mental illness are people too. They too get sick with the flu and all other illnesses including cancer, diabetes and heart diseases.

I agree completely. The only people I want out of the ME/SEID clinical diagnosis are the people who don't have ME/SEID at all. They can get (better) help without being inaccurately labeled, and then maybe we won't see them in news stories gushing on about how changing their diet or treating their thyroid completely cured their "fatigue".

There's no reason for ME/SEID to exclude patients who also have psychiatric issues, especially now that 1) PEM is the core symptom, and 2) it isn't a diagnosis of exclusion.

 

[Hope123]

Including patients with this disease and depression can help tease out the effects of each. For example, Benjamin Natelson is one of the few researchers to examine co-morbidities in this illness. In one study, he found that people with Fukuda-definition CFS and NO depression were more cognitively impaired than people with CFS+ depression. An intuitive expectation was that those with both CFS and depression would be more cognitively impaired but the result was the opposite. The results of that study help provide evidence that CFS causes cognitive issues independent of depression and is not the same as depression.

 

[Sidereal]

I'm glad that SEID is now considered a physical illness and that every kind of comorbidity is permitted including psychiatric. Depression and anxiety disorders are common problems in chronic illness and this one is no exception. Many people seem at first to have primary depression, whatever that is, and then develop a neurological illness later on. Some illnesses like Parkinson's disease can start with depression and sleep problems in the prodromal phase and these problems can predate the onset of motor symptoms by many years.

The whole issue of "primary" depression is total nonsense really, a historical artefact from the first real attempts in psychiatry to come up with standardised, reliable diagnostic criteria for various conditions. You're talking 1970s-1980s conceptualisations of the problem - Feighner criteria, Research Diagnostic Criteria (RDC), DSM-III. The same goes for the whole issue of endogenous vs. reactive depression. These concepts were once very popular but were not ultimately shown to be useful for delineating research samples or predicting response to treatment so have been abandoned by most people in the field. Of course some doctors who went to medical school in the 1970s when these psychoanalysis-inspired concepts were still in vogue are stuck in a time warp. In actuality, all depression is accompanied by changes in the brain (and peripheral immune markers) and it doesn't matter if it's deemed by the doctor to be a "reaction" to a physical illness or some other stressful life event, or if it's considered to be happening for no obvious environmental reason i.e. "endogenous". To paraphrase that towering intellect T. Chalder ( ), at the end of the day it's all in the brain.

The problem with fatigue-based criteria like Oxford and Fukuda was that if you have depression alone without ME/SEID you could meet those criteria. That's why all studies based on Oxford criteria are trash; we have no idea how many people in those studies actually had ME/SEID. But now that we have a PEM-led definition, having a long list of psychiatric exclusions would only reinforce the view that this illness is easily mistaken for depression which is not helpful. In my opinion this illness is easily mistaken for depression only if the clinician has no idea how to diagnose PEM and OI issues or how to ask the right questions about what happens to the patient if he/she tries to exert themselves. Or if the doctor is a nasty ignorant moron who thinks the patient is lying about not feeling depressed or is subconsciously converting emotional distress into physical symptoms (=somatising). Some clinicians especially GPs have no idea what depression is; they think it's some trash heap diagnosis for every problem they are unable to understand so they just prescribe SSRIs for everything that seems "unexplained".

 

[A.B.]

The problem with fatigue-based criteria like Oxford and Fukuda was that if you have depression alone without ME/SEID you could meet those criteria.

One of Jason's studies showed that a portion of healthy population would meet Fukuda criteria too. Frequency and severity of unspecific common symptoms such as fatigue and unrefreshing sleep need to be taken into account because who doesn't feel fatigued, or has bad mornings from time to time?

I just hope with SEID they get PEM right.

 

[lansbergen]

It is my hope that journal reviewers will be critical of poorly designed, poorly selected cohorts,

You can hope

 

[anciendaze]

Look, people with mental illness are people too. They too get sick with the flu and all other illnesses including cancer, diabetes and heart diseases...
A good clinician will be able to see the nuances. Everyone deserves competent care not just the mentally healthy.

Couldn't agree more, but I have to point out that studies showing around 10% of existing patients with serious mental illness have undiagnosed and untreated physiological disease -- under existing medical standards -- have been around for quite some time. The causes of these diseases do not have to be tiny viruses seen only with electron microscopes. On the other hand, mental patients may be lucky to have escaped treatment. (Note the venue for that last publication.)

Physicians who genuinely want to do something about this terrible situation do not have to do so in the context of newly proposed diagnostic criteria for disputed diseases of unknown etiology.

 

[Hope123]

One aspect I did not remember until now. Some people are concerned that the IOM criteria do not have enough symptoms to diagnosed patients accurately. But the reverse -- having too many symptoms in any case definition -- can also potentially label too many people erroneously that have ONLY a psychiatric/ psychological illness.

For instance, Holmes 1988 CFS criteria required fatigue and eight out of 11 symptoms = minimal 9 symptoms. The reason why it was changed to the 1 major/ 4 minor = minimal 5 symptoms of Fukuda were studies showed Holmes might pull in too many non-CFS, psychiatrically affected subjects. Similarly Lenny Jason had two studies examining the rate of psychiatric illness among patients fitting the CCC, ME-ICC, Revised ME, and Fukuda. Surprisingly, the data suggested that the other case definitions included MORE people, up to two-three times more people, with psychiatric disease than Fukuda.

http://www.cortjohnson.org/blog/201...oth-may-select-for-more-psychiatric-patients/

https://www.questia.com/library/jou...rasting-case-definitions-the-me-international
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658447/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3658447/

This led Jason to advocate for lesser but more specific symptoms.

 

[Valentijn]

Surprisingly, the data suggested that the other case definitions included MORE people, up to two-three times more people, with psychiatric disease than Fukuda.

I'm pretty sure that was the fault of the standard psychiatric diagnostic processes, where "physical symptoms wot I don't understand" = "crazy patient". But generally I agree - as long as PEM is a core symptom, it's not necessary to require a list of other symptoms.

 

[Ember]

However this definition we are talking about is a clinical one, not a research one. Correct me if I'm wrong.

IOM’s Redefinition of ME: Farewell LTD Benefits, Hello Diluted Research Cohorts
Posted on February 15, 2015

And here it is, hot off the press from the IOM (page 225 of the IOM report):

“Future diagnostic research will be most instructive when protocols include patients identified using the committee’s proposed diagnostic criteria for ME/CFS ….”

There it is in black and white. The IOM recommends that their criteria be used for future research.

 

[Hope123]

I'm pretty sure that was the fault of the standard psychiatric diagnostic processes, where "physical symptoms wot I don't understand" = "crazy patient". But generally I agree - as long as PEM is a core symptom, it's not necessary to require a list of other symptoms.

You make a good point except this is a Jason study and he is well aware of the limitations of such questionnaires being a psychologist. In his studies, psychiatric diagnosis was not done with the usual scales but with the accepted gold standard diagnostic the SCID-1, which requires extensive interview by a trained clinician. The SCID-1 is often not used because it is more time-consuming/ labor-requiring/ more expensive/ a burden on subjects but is the standard.
[http://en.wikipedia.org/wiki/Structured_Clinical_Interview_for_DSM-IV]

I'd also add that some psychiatric/ psychological questionnaires DO take into account the effect of medical symptoms on diagnosis. For example, the HADS was designed to decrease erroneous labelling of medically ill subjects with depression or anxiety.
http://en.wikipedia.org/wiki/Hospital_Anxiety_and_Depression_Scale

 

[Hope123]

IOM’s Redefinition of ME: Farewell LTD Benefits, Hello Diluted Research Cohorts
Posted on February 15, 2015

You know, if someone is going to take a decidedly negative interpretation of something, there's no stopping them.

Elsewhere on this forum, CBS wrote about whether the SEID criteria would be validated. Well, how else is the case definition of SEID (or for that matter, ME-ICC, CCC, etc.) going to be validated if someone doesn't test it (yes, :use it in research)? Also, the report doesn't say that this should be the only definition used in research.

Really, the way this disease has been treated deviates from the rest of the medical/ scientific world. (Not surprising to many of you, I am sure.) For most medical conditions, case definitions are generated and then they are tested to see if they work well. The same should occur for this illness. We've been plagued by definitions that haven't been tested well.

Second, there is no distinction between "research" and "clinical" case definitions for most illnesses. The "research" definition is often the same/ similar as the clinical although individual research groups might decide to concentrate on a specific subgroup. For example, there is no difference between how a clinician diagnoses someone with breast cancer and how a researcher diagnoses someone (e.g. based on pathology of breast lump); the difference is the researcher might decide their study will be on say younger women who smoke so they will make their study case definition "breast cancer + under age 40 + current/ past smoker." That will be the "research case definition" for this one study. However, if researchers do this, they recognize their results will NOT apply to everyone with breast cancer but only their selected subgroup. Similarly, clinicians will not apply this one study's findings to women with breast cancer over 40 or younger women who never smoked.

 

[Valentijn]

You make a good point except this is a Jason study and he is well aware of the limitations of such questionnaires being a psychologist. In his studies, psychiatric diagnosis was not done with the usual scales but with the accepted gold standard diagnostic the SCID-1, which requires extensive interview by a trained clinician. The SCID-1 is often not used because it is more time-consuming/ labor-requiring/ more expensive/ a burden on subjects but is the standard.

SCID-1 (DSM-IV) allows the psychiatrist to attribute physical symptoms toward a psychiatric diagnosis, if the patient doesn't have a biological diagnosis which explains the symptoms. At least one of his studies had the interview done by psychiatrists who had not been informed of a biological diagnosis, and that's where a lot of psychiatric diagnosing was done with a CCC/ICC patient group. Though my impression was that he he understood very well where much of the problem was

 

[WillowJ]

You have also brought in the problem which turned up when Leonard Jason ran a group of very carefully diagnosed patients with major depressive disorder past a group of doctors who had been given the material used to train doctors for an actual study based on the Reeves "empirical definition"; 38% of them were immediately classified as having CFS.

This situation is not analogous to the new criteria, or even to the original Fukuda criteria.

Chronic Fatigue Syndrome – A clinically empirical approach to its definition and study
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1334212/

We defined substantial reduction in occupational, educational, social, or recreational activities as scores lower than the 25th percentile of published US population [11] on the physical function (≤ 70), or role physical (≤ 50), or social function (≤ 75), or role emotional (≤ 66.7) subscales of the SF-36.

We defined severe fatigue as ≥ medians of the MFI general fatigue (≥ 13) or reduced activity (≥ 10) scales.

Finally, subjects reporting ≥ 4 symptoms and scoring ≥ 25 on the Symptom Inventory Case Definition Subscale were considered to have substantial accompanying symptoms.

...

Finally, the Symptom Inventory assesses the occurrence, frequency and intensity of 19 symptoms over the preceding month. For this study, we used the Symptom Inventory Case Definition Score defined as the sum of the product of the frequency and intensity scores of the 8 CFS case defining symptoms [14].

Note: exclusions in this study--

Medical and psychiatric exclusions
We identified 29 people with newly documented medical conditions considered exclusionary because they could account for fatigue and accompanying symptoms [9,10]. Medical exclusions included active and inadequately treated thyroid disease (n = 6), neurological disease (n = 6), inflammatory disease (n = 4), C-reactive protein levels 2 to 4 times normal (n = 3), severe anemia (n = 2), uncontrolled diabetes (n = 2), cardiac disease (n = 2), renal disease (n = 2), breast cancer post-treatment (n = 1) and liver disease (n = 1). We also identified 4 persons with exclusionary psychiatric conditions; 3 had bipolar disorders (1 person with a bipolar disorder was also medically excluded because of severe anemia), and 1 alcohol abuse. Finally, 5 subjects could not be classified because DIS data were missing. These 37 people were not considered further in this report.

Twelve fatigued and two control subjects (among the remaining 190 participants) presented with newly identified melancholic depression. However, 34 (73.9%) of the 46 subjects enrolled because they had been classified during the surveillance study as melancholic depression no longer had evidence of the condition. Following recommendations of the International CFS Study Group, only current MDDm was considered exclusionary for CFS. Thus, the remainder of this paper discusses only the 164 participants with no medical or psychiatric exclusionary conditions.

 

[beaker]

IOM’s Redefinition of ME: Farewell LTD Benefits, Hello Diluted Research Cohorts
Posted on February 15, 2015

I posted THIS on another thread that applies to this. It is very similar to what @Hope123 wrote above
I will repost here :
I have seen applications for past studies that have questions about co-morbid psych illness. ( They may ask direct q's about dx or they may try to fish it out w/ some of those long standard questionnaires. A good researcher tries to eliminate those w/ other things going on that will muddy the waters. Or they will sub-group the subjects in the final analysis to see if there is any significant discrepancies .
Also, any study I have been in, if it wasn't my own doc, the leading clinician has interviewed and examed the study participants. For a well defined study I don't think it would be a problem.
Of course, there are a lot of crappy studies out there. But if you take them apart you can see the issues. Perhaps there is away to have greater oversight to make sure study design has enough filters so as to not waste funding OR that publication reviewers are well versed to catch it.

I'd rather stand by those who are sick and have a psych dx then leave them in the lurch.
We need to all be in this together. There's a big divide and conquer going on and it makes me beyond sad.
I remember ( but too tired to find the references) that at some point along the way there was an agreement by the CCC docs that it was ok to have co-morbid psych issues.
I know one major ME/CFS specialist who said he/she had no trouble dxing people w/ this illness regardless of those issues. That he/she did not think it was a dx of exclusion if you knew what you were looking at.
True, not everyone is as experienced in this illness. But there will always be crappy docs for any illness ( I know this as an advocate for my parents ) and good docs that will be smart and able to figure it out.
We need a more rigorous training program, not excluded patients.

 

[halcyon]

IOM’s Redefinition of ME: Farewell LTD Benefits, Hello Diluted Research Cohorts
Posted on February 15, 2015

Isn't this kind of moot with the 2 day CPET test that proves disability?