ME and cfs to be classified as seperate illnesses

[Angela Kennedy]

Bob said:

"It would mean that Jonathan Kerr in the UK, for example, would not have been turned down for research grants because he insisted on selecting his patients with criteria which were tighter than the official criteria. So, if he was allowed to use the CCC, then he could have carried out meaningful research on a well defined cohort of ME patients."

Bob, would you mind providing evidence for this claim please?

 

[Bob]

Bob, would you mind providing evidence for this claim please?

Hi Angela,
Do you mean about Jonathan Kerr's funding applications being turned down due to his proposed selection criteria?
I can provide anecdotal evidence for that, but it'll take me a while to dig it out.


BTW, in the first sentence, my assertion was too strong, and 'would' should be read as 'might', and the second sentence is obviously open to discussion.

 

[oceanblue]

Thanks to Bob and Mark for those extensive posts, which really got me thinking.

I think that, right now, the most important thing our entire community needs to be pushing for is for a separation of ME from other fatiguing illnesses.

I think that all of our patient organisations need to come together to organise a big, single, concerted campaign to fight for the Canadian definitions, or better, to be used, so that ME can be treated as a single, distinct, disease in its own right.

I fully agree with the first point as I think it's key both to effective research and to how patients are diagnosed and treated. As for the definition we push for, it might be the 'or better' option, I think, for many reasons, including those made by Mark, Bob and WillowJ - though I agree that the CCC are the right place to start that discussion.

As Mark says, patients who don't quite meet the CCC are likely to feel cast out from the ME tribe yet certainly don't feel they they have some general chronic fatigue that the biopsychosocialists love to prey upon

Mark: Talk about being caught between the devil and the deep blue sea!

I completely agree that if we can all unite around a common view of the illness we are far more likely to make a difference.

Bob's point that people like Nancy Klimas, Judy Mikovits and Lenny Jason recognise that some of their patients would no longer fit the CCC, to me highlight one of the weaknesses of the criteria as they currently stand.

at the 2010 Invest in ME conference, Mikovits, Whittemore, Klimas and Jason confirmed that the experience they have with many of their patients was that their symptoms had changed over time, esp after employing symptom management techniques (such as pacing, and whatever other medical tools they used to get better). The four speakers at the round table discussion seemed to be under agreement that their patients' symptoms changed over time, and that they expressed quite different symptoms, and levels of symptoms over the course of their illness. They said that some of their patients would not necessarity fit the Canadian consensus criteria (CCC) now, whereas they would have done when they were first ill.

As these participants and Bob suggest, we could broaden the definition of CCC to evaluate patients over the course of the illness. Or do as Lenny Jason does (pointed out by Dolphin) by having several levels of CCC criteria. It's certainly possible, but my concern about this approach is that it takes a complex definition, and when it doesn't quite give the right answers, adds yet more complexity until it does.

There's an Albert Einstein quote that I think very relevant:

Everything should be made as simple as possible, but not one bit simpler

The Oxford Criteria to me fail the second part of this test: by focusing just on mental and physical fatigue they too broad to be useful, sweeping up a whole mish-mash of patients many of whom have primarily psychological problems with fatigue as a secondary factor.

On the other hand, I seriously wonder if the enormously complex Canadian Criteria meet the 'as simple as possible' test (which is much the same as Occam's Razor). Have you read the CCC document? It lists so many requirements that in lots of different places I couldn't help wondering - are we sure this is the exact place to draw the line between ME and not-ME?

As Mark put it:

if the line is going to be drawn at the CCC, if you want to achieve that separation, then firstly you need some damn good evidence that sharply distinguishes that condition from anything that falls just short of it

It turns out that is a key principle in defining diseases in general (bonus points to Mark ) - if the people who meet the cirteria look very much like those that just fail to meet them, then you probably haven't defined a discrete illness.

Digression to main thread topic There's a really interesting paper about the validity of psychological diagnoses which concludes that most psychological illnesses are not valid disease entities ie that the current DSM-IV is full of diseases that aren't really valid specific diseases at all! Never mind DSM-V proposals... Maybe that's why psychologists are so comfortable with definitions of CFS that don't tie down a discrete illness?

The key point that the paper makes (it's not just talking about psychological disease) that I think is relevant to ME is:

Diagnostic categories defined by their syndromes should be regarded as valid only if they have been shown to be discrete entities with natural boundaries that separate them from other disorders.

My concern is that there might not be a natural boundary between those that meet the CCC and those that just miss out.

What would help here is empirical evidence (no relation to the dodgy CDC 'empirical criteria') to find where, if anywhere, the natural boundaries exist ie the point Mark made above. My guess would be that there are natural boundaries with CCC inside the boundaries but with them quite a lot of patients who have things like PEM but don't currently meet every last CCC criteria.

But I have no evidence for that hunch and I think evidence is what's really needed to move this forward. Evidence would have the huge advantage of moving the debate from 'this is what physicians and patients recognise and believe describes the illness' to 'here's the evidence that this definition describes a unique group of people with a common illness, clearly distinguishable from other forms of chronic fatigue'. It might turn out to be the CCC exactly as they are described now, it might be something a little broader - but at least any refined defintion would be based on how well it identifies unique patients in the real world. The experiment would be something like take a big bunch of chronically fatigued patients, collect a mass of data on them including lab test, demographics and everything required for the CCC, then use data analytical techniques such as Factor Analysis to see if groups of patients cluster together.

It may be that if you specify just a few symptoms e.g. PEM, Post-exertional Fatigue and mental concentration/memory problems a discrete cluster will emerge that will include all the CCC patients as well as others who don't quite meet CCC. We won't know unless someone does the experiment.

Bob's proposal's

1. The first is to evaluate the patient's symptoms over the entire course of the illness, from the very beginning to the present time

That would certainly be one way to do it, though I'm sure there would be objections from some to a diagnosis based on symptoms that may not have been present for 15 years

2. The second solution would be to use the CCC only for research purposes, and not in a clinical setting.

Again, I think this is one way forward, but I have 2 concerns. The first is practical: because of the need for a full medical evaluation it's expensive/time consuming to screen patients, which is presumably why so many studies are so thin on patients. Using highly restrictive criteria will make recruitment even harder but not necessarily better. The second isn't an objection as such, but if there were empirical evidence for the criteria it would be a whole lot easier to persuade researchers that these criteria are the way to go.

3. The third solution would be to have different levels/grades of ME,

Unreservedly agree that sub-grouping would be useful! Though as bob notes, the more you sub-group, the less generally applicable the findings.

4. The fourth, is that if we all agree that ME has to have post exertional malaise (PEM) as a symptom

Agree with this one too, as does WillowJ, it seems. But it isn't currently mandatory in CCC, which only require PEM OR post-exertional fatigue.

Summary
Phew, this has gone on a bit! Here's what I've been trying to say:

1. I agree that getting everyone behind a case definition that separates ME from general chronic fatigue is incredibly important. I also agree that the CCC are a good place to start but as they are currently defined they do seem to exclude a lot of people, potentially alientating many patients and the exclusions may not work as intended all of the time (as observed by Klimas, Jason, Mikovits).

2. I think some empirical research might resolve these problems. We could see if the CCC defines an discrete illness with natural boundaries or if some of the CCC boundaries are artificial and need tweaking. It's just possible that the CCC could be made even better.

 

[Bob]

Great stuff oceanblue, thanks for engaging with this... your post is really interesting, and helpful...

I think your very last point, 2., about refining the CCC, is a good point, but maybe it is something that we would strive for in an ideal world.
If we were to ask for the CCC to be changed and improved, that would take years of research in itself, and it probably wouldn't happen at all.

So I'm trying to understand what changes we, as a community, could push for immediately, that most of our community would be happy to go along with...
So, I'd really like to see if we could all work out a way to employ current knowledge, and the current diagnostic tools, in such a way that we could all agree on a way forwards... so then we could all push for (i.e. campaign for, or advocate for) changes that we could all agree on as a community, with one voice.

oceanblue, you've helped with this already, by addressing my points, 1 to 4... So thanks very much for addressing those points...

It's really useful to get some opinions on this, and have the discussion...
I hope other people will share their opinions on this too...
Although, I appreciate that not everyone will agree with what i'm trying to do here.

Thanks again,
Bob

 

[taniaaust1]

My own experience of ME is that the illness is a fluctuating condition, which is sometimes severe, and sometimes allows for a certain amount of activity, and alongside this, there are sometimes weird and not so wonderful complications and associated symptoms. This experience fits in exactly with all the people I know locally, who have all had almost identical experiences as I have, since we've become ill. There are also some patients locally who are permanently bed bound, who obviously who don't meet others so often.

My personal opinion is that ME has all levels of symptoms, from no symptoms at all (i.e. remission or xmrv carriers), to severe bed-bound levels of illness, and that all the unusual and neurological and immunological symptoms can flare up or diminish at any time, in some patients. And I recognise that many patients do not ever experience any remission, and are in a permanent state of having severe symptoms.

At a round table discussion, at the 2010 Invest in ME conference, Mikovits, Whittemore, Klimas and Jason confirmed that the experience they have with many of their patients was that their symptoms had changed over time, esp after employing symptom management techniques (such as pacing, and whatever other medical tools they used to get better). The four speakers at the round table discussion seemed to be under agreement that their patients' symptoms changed over time, and that they expressed quite different symptoms, and levels of symptoms over the course of their illness. They said that some of their patients would not necessarity fit the Canadian consensus criteria (CCC) now, whereas they would have done when they were first ill. So, to deal with this, they said that when using the Canadian consensus criteria (CCC) to make a diagnosis, that the patients' symptoms should be evaluated over the entire course of the illness, and not purely a snapshot of their symptoms at the present time, as this could result in the patient not receiving a diagnosis using the CCC.
(I'm pretty certain that I have captured the jist of this conversation correctly, and not misrepresented the proceedings.)

I agree with Bobs quote above... I too think there is a big range of different degrees of illness with ME with some recovering some or if its XMRV some not showing full blown symptoms.

The issue is we cant have things so broad that other illnesses are getting mistaken for it, that isnt fair on those who do have other serious medical issues to which they possibly may be getting treatment for if their doctors get off their butts and work out what is wrong with them. The only way for our illness to be taken seriously and keep on being taken seriously, is to have cut off points. ME shouldnt be a diagnoses in which patients are just being thrown into due to doctors not doing the right tests or having no real idea what is wrong with them. ME shouldnt be a waste basket diagnoses.

I think there needs to be different catagories of diagnoses.. strict CC CFS/ME diagnoses (which the diagnoses is held even if symptoms improve some at a later point), and a separate one which thought to be probable CFS/ME diagnoses (eg not full blown ME but most probable). Then of cause there is the old just idopathic fatigue as a third diagnoses (thou who only have fatigue and dont have a symptom complex). So basically what there is now I do agree with the catagories, the only issue is the CC CFS/ME defination needs to be accepted worldwide...

most here if the CC CFS/ME defination was accepted would be moving up to the CC CFS/ME group bringing a lot larger numbers there, so one would think more serious recognition and research.

No matter where one draws the line.. some are going to be left out, it cant be helped if this illness does come in all kinds of severity esp before any big crash. (this illness can have periods of remission!).

 

[WillowJ]

oceanblue, yes, I agree that PEM should be required in any case. I think that's one of the important things that distinguishes ME/CFS from other fatiguing diseases.

I also agree with Tania, we do have to have a line, or else there is no point in having a disease class. Fukuda the way it is doesn't work. Oxford and Empirical are clearly not even under consideration.

Whoever gets "left out", and it shouldn't be anyone with PEM, but whoever it is, we have to insist that they get full evaluations for diagnosable diseases from MDD to vit D deficiency to sleep studies. Oh, well, "a lot of people are tired" (I seriously was told this by a doctor who did next to nothing for me, prior to my having any diagnosis, after I had complained that I could not do basic personal care and chores) is not a conscionable way to treat anyone. If, after full evaluation, doctors still don't know what's wrong with a group of people, they need to get IF (idiopathic fatigue) funded and studied--and given a better name (and divided into various classes if they can find any logical divisions).

So, for us though, we have a more-or-less-Canadian-criteria and not-so-much-Canadian-criteria crowd. Is there something we can all meet on?

How about PEM, infectious manifestation(s), and/or neurological manifestation(s)? Do we need the and or the or? Would some people who don't meet CCC but do have PEM please chime in?

And this would be an interim measure, until we can get something more like how MS and Lupus are diagnosed requiring the pattern of both clinical signs and symptoms plus diagnostic testing results (NK cell profile, for instance, PET scan, maybe XMRV); like Lupus and MS, the testing results would help establish diagnosis (which would pretty much require the doc to run them in order to make the diagnosis--yay!) but any particular result would not be positively required for the diagnosis (as they don't seem to be 100% universal, at least not 100% of the time, and neither are laboratory techniques always 100% accurate).

 

[Angela Kennedy]

Hi Angela,
Do you mean about Jonathan Kerr's funding applications being turned down due to his proposed selection criteria?
I can provide anecdotal evidence for that, but it'll take me a while to dig it out.

Thank you Bob, that would be great if you could dig it out.

 

[Bob]

Thank you Bob, that would be great if you could dig it out.

Here's the info Angela...

At the 2007 Invest in ME Conference, Dr Kerr repeated his message:

We have applied several times to the MRC and on each occasion we were invited to submit those applications and on each occasion we got scores typically of 9, 8 and 3 the 3 score was obviously from a psychiatrist who was complaining about our way of enrolling the patients, the criteria we had etcDavid Tyrell told me the MRC will never fund biomedical research in CFS because they are in the thrall of the psychiatrists so far, he has been right.

http://www.meactionuk.org.uk/The-MRC-secret-files-on-ME.htm

 

[Bob]

Hi tania and Willow,

Thanks for your input, and the interesting points you've covered... I really appreciate this discussion...
If you have the energy, could you please have a look at my points 1 to 4 that I posted earlier, and see if you think any of these possible solutions might work for our community, in your opinion? (I know you've both already covered some of these points.)

I'll post them again, here:

I think there maybe a few possible solutions to the issues we've been discussing...

1. The first is to evaluate the patient's symptoms over the entire course of the illness, from the very beginning to the present time, and to use all of this information in an evaluation when using the Canadian consensus criteria (CCC).
Mikovits, Whittemore, Klimas and Jason promoted this approach when they had their very interesting round table discussion at the 2010 Invest in ME conference, as they said that many of their patients would not fit the CCC after managing their illness and seeing their symptoms improve.

2. The second solution would be to use the CCC only for research purposes, and not in a clinical setting. This would satisfy me personally, to a great extent, especially as a first step towards improving our lives. It would mean that ME researchers would then be able to carry out meaningful research on a homogeneous group of patients. It would mean that Jonathan Kerr in the UK, for example, would not have been turned down for research grants because he insisted on selecting his patients with criteria which were tighter than the official criteria. So, if he was allowed to use the CCC, then he could have carried out meaningful research on a well defined cohort of ME patients.
And I'm not so certain that using the CCC in a clinical setting would be very useful to us anyway, esp here in the UK, because doctors are still just going to look blankly at us and say that there's nothing they can do for us, as there is no treatment.

3. The third solution would be to have different levels/grades of ME, as Leonard Jason suggests; Grading ME, depending on the current severity, and types, of symptoms that a patient is expressing. This way, every patient would keep the ME label, but researchers would be able to work with homogeneous groups of patients whether it was a severe group or a mild group. This would be the researchers choice which group they worked with. This would only work if it was absolutely clear which patient type each researcher was working with, as only then would their research would be replicable. I believe that this would definitely be a big improvement on where we are now. (Although, if psych researchers started to try to confuse the government and the public by conflating the results of different patient types, then this would not be an improvement. But we would be able to reject their lack of scientific rigour more easily than we do now.)

4. The fourth, is that if we all agree that ME has to have post exertional malaise (PEM) as a symptom, then this should, at the very least, have to be included in any new diagnostic criteria used to diagnose ME. I think that PEM is a non-negotiable for diagnosing ME, and in some ways, if all that happened, was that PEM was added to the current criteria as a prerequisite for a diagnosis, then that would go a long way to separating ME patients from other fatiguing illnesses.


Any thoughts on all of these points and suggestions? Which would you accept, and reject, as a way forwards for our community, and why?

 

[Angela Kennedy]

Here's the info Angela...

thank you very much for this Bob.

 

[WillowJ]

Bob, sure, and thanks for re-posting them here...

1) The problem I see with this is early diagnosis and epidemiology. Not everyone starts with a full complement of signs and symptoms. I understand that this is a problem with other diseases such as Lupus, so maybe it's not an insurmountable problem. However, in a disease that has a possibility of occurring in outbreaks, I would think you would want to be able to make a prompt diagnosis so you would know if an outbreak were occurring, but maybe a sudden lot of "probable ME" patients would suffice.

2) Using CCC for research but not for clinical is very interesting. It would ensure a more homogeneous cohort in research while not excluding people unnecessarily from clinical diagnosis. However I think you brought up a valid concern, that doctors might have difficulty translating research to clinical application, when the criteria is different. Perhaps with an official guideline "CCC research applies to Fukuda-plus-PEM patients" it might work out, but I don't know.

3) I do like the different levels/grades or even subsets (without necessarily designating a severity level). However this would require a large sample size for any research--we would have to be assured of large amounts of funding before making this step, and it might exclude some private practice clinics from having large enough samples. Still, I love the idea of subsets and I'm convinced subsets exist.
I think we should wait until a larger percent of us are diagnosed (Jason's latest says only 10% are diagnosed (2009)... if we legitimize the disease and give doctors better tools, we should step that up a lot, which may reduce the "not enough patients for subsets" problem) before making subsets official as required diagnostic/research criteria (although we should move to have subsets recoginized as optional research criteria, and as promoted to doctors for treatment purposes)

4) Simply adding PEM as an absolute requirement is a basic step that should be taken in any case. This is the least we should do. It may be the best answer as an interim measure until we can get biomarkers sorted out. It would at least exclude the accidental (and purposeful) inclusion of MDD, vitamin D deficiency, thyroid problems, Lupus, and everything else that currently slips into Fukuda. And it would prevent us from being confused with TATT.

In connection with any of this, we do need a name change. Preferably myalgic encephalomyelitis, but really anything that is serious, medical, and doesn't contain any of the words chronic, fatigue, syndrome, or encephalopathy [which means a syndrome located in the brain].

But I still like PEM plus requiring neurological and/or immunological manifestations. That's as simple as it needs to be and no simpler.

 

[Bob]

That's really helpful, Willow. Thanks very much for addressing those points. You make some really helpful and interesting observations.

My suggestion no 1. wouldn't have any impact on diagnosis if someone has become ill recently, so I think your concerns (as I understand them) about that point are misplaced. There wouldn't have to be a period of waiting to make a diagnosis after someone initially got ill, anymore than there is already (i.e. three or six months, or whatever it is.) This suggestion was only relevent for people who have been ill for some time, so that the entire history of their illness is taken into account when making a diagnosis, including their symptoms at the beginning of their illness. (I hope I interpreted what you said correctly).

Thanks for all your comments.

 

[Bob]

So does anyone not agree with the following suggestions, with regards to improving the diagnostic criteria for ME?...

A). Post exertional malaise (PEM) should be a prerequisite for a diagnosis of ME.

B). A patient's symptoms should be assessed over the entire course of the illness, to date, and not just a snapshot of the symptoms, when making a diagnosis.

C). Canadian consensus criteria (CCC) should be promoted to be used for researching ME (i.e. it should be an official criteria that is permitted for research purposes.)

 

[Bob]

I'd really like to attract new participants to this discussion, in order to canvas a wide selection of viewpoints and opinions...
Can anyone suggest how we could copy all of the posts from my post #234, onwards, to a brand new discussion topic? (my brain's not working tonight, so I can't think for myself right now!)

 

[WillowJ]

That's really helpful, Willow. Thanks very much for addressing those points. You make some really helpful and interesting observations.

My suggestion no 1. wouldn't have any impact on diagnosis if someone has become ill recently, so I think your concerns (as I understand them) about that point are misplaced. There wouldn't have to be a period of waiting to make a diagnosis after someone initially got ill, anymore than there is already (i.e. three or six months, or whatever it is.) This suggestion was only relevent for people who have been ill for some time, so that the entire history of their illness is taken into account when making a diagnosis, including their symptoms at the beginning of their illness. (I hope I interpreted what you said correctly).

Thanks for all your comments.

Let me try to explain better... my concern is about the subgoup that starts with fewer signs and symptoms and gets more later. I would not have quite met CCC during the first year or so of my disease. I remember no sleep disturbance at first. Don't remember for sure, but I may also have been missing another category or two. What could they have diagnosed me with under the "evaluate the entire course of my (so far relatively short) disease" guideline when I didn't yet meet CCC?

Then again, perhaps I had a different postviral disease first, and got ME later? But that doesn't meet Occam's Razor (it makes the explanation more complicated). However, it might mean that at that early point, maybe I would not have been a good pick for a research study, so using CCC for research might be best. I'm just not sure CCC for clinical diagnosis picks up everyone who will eventually meet CCC. Again, though, they have this same problem with Lupus, MS... diseases like this develop over time and it might take 2 years to get diagnosed properly.

 

[WillowJ]

I'd really like to attract new participants to this discussion, in order to canvas a wide selection of viewpoints and opinions...
Can anyone suggest how we could copy all of the posts from my post #234, onwards, to a brand new discussion topic? (my brain's not working tonight, so I can't think for myself right now!)

ask Mark; I saw him do that on another thread (which I thought was an amazing feat, btw)

 

[WillowJ]

So does anyone not agree with the following suggestions, with regards to improving the diagnostic criteria for ME?...

A). PEM should be a prerequisite for a diagnosis of ME.

B). A patient's symptoms should be assessed over the entire course of the illness, and not just a snapshot of the symptoms, when making a diagnosis.

C). CCC should be promoted to be used for researching ME (i.e. it should be an official criteria that is permitted for research purposes)

I agree with all of those.

However, any sign-and-symptom criteria, including CCC, should be noted that it's an interim measure until we get one that is sign-and-symptom-and-diagnostic-testing like MS and Lupus are currently diagnosed.

 

[Bob]

Dolphin, Willow, tania and oceanblue...

If I ask Mark to copy our latest posts to a brand new thread, to encourage more discussion on this specific subject, would you all be happy for your recent posts to be copied to the new thread, under a new title?

 

[Dolphin]

Dolphin, Willow, tania and oceanblue...

If I ask Mark to copy our latest posts to a brand new thread, to encourage more discussion on this specific subject, would you all be happy for your recent posts to be copied to the new thread, under a new title?

No problem with me, Bob. Thanks for asking.

 

[oceanblue]

So does anyone not agree with the following suggestions, with regards to improving the diagnostic criteria for ME?...

A). Post exertional malaise (PEM) should be a prerequisite for a diagnosis of ME.

B). A patient's symptoms should be assessed over the entire course of the illness, to date, and not just a snapshot of the symptoms, when making a diagnosis.

C). Canadian consensus criteria (CCC) should be promoted to be used for researching ME (i.e. it should be an official criteria that is permitted for research purposes.)

Hi Bob - yes, I agree and think that would definigely be an improvement on what we have now.

In terms of effectiveness, it might be best to get some researchers on board, eg Lenny, on the assessing over entire course of the illness, so that patients are pushing for something that has already been backed by some researchers. Just a thought.

High Noon showdown. I take your point about not wanting to wait for further research to refine case definitions. However, I do think we should be asking/demanding for more research investment in this area, because ultimately empirical evidence on what works best will be the most powerful force for getting a new case definition adopted by all researchers. (OK, biomarkers is the ultimate goal, but nailing the right case definition will probably help with that too).

The CDC are still supposed to be organising an international conference on case defintion, though what is really going to advance things is research showing which definitions work best at identifying a unique group of patients: ME vs Chronic Fatigue. I'd love to see a head to head of, say, CDC Empirical vs CCC - which really defines a discrete disease? The same research could also tweak any boundaries on CCC as appropriate. So I think we should be asking for this kind of research alongside adoption of the modified CCC as the best definition for now. CDC don't like the patients' suggestion (which they won't)? Fine, then they can put up the money for a head to head test.

Well, I've had my say. good luck with your initiative.