The P2P Draft report is out

user9876

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It is unusual to go to this much trouble unless there is a specific outcome in mind. Usually, at least in bureaucratic ranks, you deliberately tailor proceedings to ensure the required outcome, much like a lot of scientific investigation into ME. So I have to ask what is being set up? And who are the beneficiaries? Patients will be a long way down the list of priorities.

I tend to think the required outcome for those comissioning the report is to be seen by their line managers and eventually politicians (perhaps Obama) to be doing something. For many bureaucrats running a process is the outcome and a sign of progress. And I think that is especially the case when they don't have a clue about how to move forward.

The question for us is how we use what is in the report to lobby for better research and more research funding.
 

Nielk

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I only skimmed through it once last night and I have to admit that this was my biggest fear. Why is that? Because they have fallen short in a big way but have given us many "crumbs" to insure patient approval of the report.

The P2P and IOM process were sprouted out of a CFSAC recommendation of 2012 - recommending convening a workshop of experts, patients and advocates in order to work on diagnostic and research criteria for ME/CFS starting with the CCC.

When we first heard of the IOM contract, 50 experts wrote a letter to the NIH urging them to stop the IOM contract and to adopt the CCC now as they have as a group. This letter was met with overwhelming support from patients and advocates who signed a letter of support to the experts.

Anything short of adopting the CCC (and working on improving in) is not acceptable to me. Anything short of accepting PEM as a cardinal and mandatory symptom of the disease is falling short. No matter how much research is done to fill the gap, if the right cohorts are not used, what is the point?

We have been abused for so many years that we jump at any "crumb" that we are given, no matter how marginal.

You might say, but this process was just to find the gaps in research, not for finding the right criteria. The truth is that the real reason for this p2p process has been murky and veiled. They kept changing it and stated that the intent was not to find research criteria, but that this might be an outcome of it.

They did mention retiring the Oxford criteria. Why not all criteria that do not demand PEM? If they are so concerned about stakeholder's input, (as they keep mentioning in their report) why did they not hear our experts and advocates as far as adopting the CCC now?

Why was this type of report my biggest fear? Because I knew that if it was terrible, like giving much weight to CBT/GET, there would be a major uproar from the stakeholders. The panel also knew that. But, because they have given us various crumbs, the thought is that this (with some minor adjustment) will be accepted my most without resistance.

Have we really waited 25+ years to be still stuck (and excited about) the CDC's Fukuda Criteria? In what way, is this report a major advancement for us?

Are we so excited that this panel of five unknowns have stated that this is not a psychological disease? Really? That makes it okay to accept the rest of it? The current CDC website does not reflects pretty much right now everything that is stated in this report. Dr, Beth Unger is doing a multi-site study based on the fact that this is a biologically based illness - not psychological.

So, what is so new in this report that make you excited about it? They do mention the co-morbidity of clinical depression a number of times. Could this be due to the fact that they have chosen the correct cohorts? Does this disease have a greater depression co-morbidity than autoimmune diseases or cancer?

They do mention the great need for further and larger scale research. The great unmet need in this patient population. Anyone involved with this disease, knows this fact only very well. Did we really have to spend close to a million dollars to have an official written report about this. We were told time and time again that there is no money for research. Will this piece of paper suddenly uncover hidden funds?

CFSAC - our own advisory committee has recommended all these stated recommendations that appear on this report for years. Which ones of these recommendations have been implemented? Do you really think that now, that this "report of the five" will come out, NIH will all of a sudden start funding this in a big way?

They have given us crumbs here:

- Stating that it is not psychological (Yet they state that clinical depression is a common co-morbidity)
- Patients should be invited to be heard and invited for consultation (Think what 10 years of CFSAC has done)
- Stating that there are measured cognitive problems (They also state there are some benefits of GET/CBT)

Why are we so willing to accept these "crumbs" and to ignore what our experts and advocates have stated?
 

RustyJ

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I actually don't see the need to mention CBT at all in the report. There is actually very little good evidence to support it is even helpful as a coping mechanism, more than anything else. And there are always questions about patient selection in those sorts of studies. I think the pervading myth of CBT is useful even if just as a coping tool, is a dangerous meme to be spreading.

They may have softened their language about CBT but it was repeatedly mentioned, while many promising areas of biomedical investigation were omitted. This of course elevates CBT.

On a lighter note, I imagine lying down would help me far more than CBT. I also feel pretty good about eating icecream, it helps me cope, till I get stomach cramps.

I also get good relief with panadol. And I definitely bet this would beat CBT hands down.
 
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RustyJ

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Stating that there are measured cognitive problems (They also state there are some benefits of GET/CBT)

Yes, some would argue cognitive problems does not exclude psychological diagnosis. Nor does inflammation, for that matter. This has all been said before.
 
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383 – 385: “Attention should be focused on providing access to high – quality, multidisciplinary care; refining assessment; and clarifying endpoints that suggest improvement and quality care. We believe there is a specific role for multimodal therapy…… ”


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Multimodal therapy (MMT) encompasses CBT, along with a whole load of other stuff that we don’t want either….
Funding for MMT research, anyone?



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http://en.wikipedia.org/wiki/Multimodal_therapy
http://en.wikipedia.org/wiki/Arnold_Lazarus

'From the late 1950s into the 1970s, at the same time that Albert Ellis and Aaron Beck were pioneering cognitive therapy, Lazarus was developing what was arguably the first form of "broad-spectrum" cognitive behavioral therapy. In 1958, he introduced the terms "behavior therapy" and "behavior therapist" into the professional literature (i.e., Lazarus, A. A. "New methods in psychotherapy: a case study". South African Medical Journal, 1958, 32, 660-664).'


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http://www.zurinstitute.com/multimodaltherapy.html


Multimodal Therapy: A Primer

By Arnold A. Lazarus, Ph.D., ABPP
Distinguished Professor Emeritus of Psychology
Rutgers University, Piscataway, NJ



It appears that most theoreticians and clinicians are now in favor of using a broad-spectrum approach to treating patients. For example, there is a current trend toward the use of holistic treatments that not only consider intraindividual, interpersonal and systemic factors, but also argue for the inclusion of a separate transpersonal (i.e., spiritual) dimension. Multimodal therapy (MMT) strives to combine a broad and interactive set of systematic strategies, and offers particular assessment tactics that enhance diagnosis, promote a focused range of effective interventions, and improve treatment outcomes.

As a psychotherapeutic approach, the theoretical underpinnings of MMT rest on a broad-based social and cognitive learning theory, while also drawing on effective techniques from many additional disciplines - without necessarily subscribing to their particular theories (i.e., it espouses technical eclecticism). MMT is based on the assumption that most psychological problems are multifaceted, multidetermined and multilayered, and that comprehensive therapy calls for a careful assessment of seven dimensions or "modalities" in which individuals operate - Behavior, Affect, Sensation, Imagery, Cognition, Interpersonal relationships and Biological processes. Given that the most common biological intervention is the use of psychotropic drugs, the first letters from the seven modalities can be combined to produce the convenient acronym "BASIC I.D." - although it must be remembered that the "D" modality actually represents a range of both medical and biological factors.

………………………


Theoretical Bases

A. Social Learning Theory

As mentioned in the introduction, MMT is based on the principles and procedures of experimental psychology, most notably social and cognitive learning theory. In essence, social learning theory states that all behaviors (normal and abnormal) are created, maintained, and modified through environmental events. While initial behavioral theories rested on animal analogues and were decidedly mechanistic (offering rather simplistic analyses of stimulus-response contingencies), the advent of what is now termed cognitive-behavior therapy (CBT) is anchored to a much more sophisticated foundation. CBT is based on the finding that cognitive processes determine the influence of external events, and can in turn be affected by the social and environmental consequences of behavior. As such, the main focus is on the constant reciprocity between personal actions and environmental consequences.


…………………………….





Multimodal Assessment And Treatment

A. The BASIC I.D.

B. Whereas many of the psychotherapeutic approaches used today are trimodal (addressing the familiar affect, cognition and behavior or "ABC"), the outcomes of several follow-up inquiries have pointed to the importance of therapeutic breadth if treatment gains were to be maintained. MMT addresses this problem by calling the clinician's attention to no less than seven discrete but interactive modalities. At base, we are all biological organisms (biochemical/neurophysiological entities), who behave (act and react), emote (experience affectiveresponses), sense (respond to tactile, olfactory, gustatory, visual and auditory stimuli), imagine (conjure up sights and sounds and other events in our mind's eye), think (hold beliefs, opinions, values and attitudes), and interact (enjoy, tolerate, or suffer various interpersonal relationships).



Thus, MMT provides clinicians with a comprehensive assessment template. By separating sensations from emotions, distinguishing between images and cognitions, emphasizing both intraindividual and interpersonal behaviors, and underscoring the biological substrate, MMT is most far-reaching. In addition, as was mentioned above, by referring to these seven modalities as Behavior, Affect, Sensation, Imagery, Cognition, Interpersonal, and Drugs/Biology, the interactive modalities can be easily recalled by taking the first letter of each one to form the acronym "BASIC I.D." Using this assessment template will help to ensure that the clinician leaves no stone unturned.


…………..


How does a clinician assess each of these modalities? Typically, through the use of a range of questions. For example, to assess the client's behavior, the clinician may ask: "What is this individual doing that is getting in the way of his or her happiness or personal fulfillment (self-defeating actions, maladaptive behaviors)?" Or perhaps, "What does the client need to increase and decrease?" Or even, "What should he/she stop doing and start doing?"


To assess the client's affect the clinician may ask: "What emotions (affective reactions) are predominant?" Or, "Are we dealing with anger, anxiety, depression, or combinations thereof, and if so, to what extent (e.g., irritation versus rage; sadness versus profound melancholy)?" The clinician may ask, "What appears to generate these negative affects - certain cognitions, images, interpersonal conflicts?" And, "How does the person respond (behave) when feeling a certain way?" Remember, however, that in addition to assessing each modality separately, it is also important to look for interactive processes that occur between and among the modalities (i.e., the impact that various behaviors have on the client's affect and vice versa).


To assess the client's sensations, the clinician may ask: "Are there any specific sensory complaints (e.g., tension, chronic pain, tremors)?" Also, "What positive sensations (e.g., visual, auditory, tactile, olfactory and gustatory delights) does the person report?" Or, staying with the notion that one must also assess interactions among modalities, the clinician may ask, "What feelings, thoughts and behaviors are connected to these negative sensations?" It should be noted that assessment of this modality should also include the individual as a sensual and sexual being and, when called for, treatment interventions should be aimed at the enhancement or cultivation of erotic pleasure.


To assess the client's imagery, the clinician may ask: "What fantasies and images are predominant?" "What is this client's self-image?" The clinician may also assess for specific success or failure images that the client holds, and will certainly want to ask whether the client experiences any negative or intrusive images (e.g., flashbacks to unhappy or traumatic experiences). Of course, as with the other modalities, the clinician will also want to assess how the client's images are connected to ongoing cognitions, behaviors, affective reactions, etc.


To assess the client's cognitions, the clinician may ask: "Can we determine the client's main attitudes, values, beliefs and opinions?" And, "Are there any definite dysfunctional beliefs or irrational ideas?" Or perhaps the clinician will assess the client's predominant "should statements" or try to detect any problematic automatic thoughts that undermine the client's functioning.


To assess the client's interpersonal functioning, the clinician may ask: "Who are the significant others in this client's life?" Or, "What does this client want, desire, expect and receive from others, and what does he or she, in turn, give to and do for them? The clinician may also ask, "What relationships give this particular client pleasures and pains?"


Finally, to assess the client's biological dimension, the clinician may ask: "Is this client biologically healthy and health conscious?" "Does he or she have any medical complaints or concerns?" And, "What relevant details pertain to diet, weight, sleep, exercise, and alcohol and drug use?"



While a client presenting for treatment may use one of the seven modalities as his or her entry point (e.g., behavior: "It's my compulsive habits that are getting to me" or interpersonal: "My wife and are not getting along"), it is more typical for people to enter into treatment with problems in two or more of the modalities (e.g., "I have all sorts of aches and pains that my doctor tells me are due to tension, I worry too much, and I feel frustrated a lot of the time. I am also very angry with my father"). Initially then, it is usually advisable to engage the client by focusing on the presenting issues, modalities, and/or areas of concern that he or she presents. To deflect the emphasis too soon onto other matters that may seem more important is only inclined to make the patient feel invalidated. Once rapport has been established, however, it is usually easy to shift to more significant problems……..


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Bob

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So we wait for another 25 years for them to begrudgingly accept ICC or CCC?
The CCC or ICC might be helpful in certain circumstances, but they aren't the answer to all our problems. Some people will be happy with nothing less then the ICC, so official adoption of the CCC isn't going to keep everyone happy anyway. And the Rituximab research suggests that CCC patients not a homogeneous group. I think that the document's proposals partly transcend the issue of the adoption of the CCC or ICC; They have proposed large-size biomedical studies, that can distinguish: different types of symptoms; different sub-groups; and different responses to treatments. And they don't rule out the use of the CCC or ICC in terms of subsetting for research purposes. This allows researchers to research the patients of their choosing, including ICC patients. And the document does place an emphasis on post-exertional malaise, and the complex nature of the illness. It even mentions that 163 symptoms are involved in ME/CFS.
 

RustyJ

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The CCC or ICC might be helpful in certain circumstances, but they aren't the answer to all our problems. Some people will be happy with nothing less then the ICC, so official adoption of the CCC isn't going to keep everyone happy anyway. And the Rituximab research suggests that CCC patients not a homogeneous group. I think that the document's proposals partly transcend the issue of the adoption of the CCC or ICC; They have proposed large-size biomedical studies, that can distinguish: different types of symptoms; different sub-groups; and different responses to treatments. And they don't rule out the use of the CCC or ICC in terms of subsetting for research purposes. This allows researchers to research the patients of their choosing, including ICC patients. And the document does place an emphasis on post-exertional malaise, and the complex nature of the illness. It even mentions that 163 symptoms are involved in ME/CFS.

Yet why didn't they suggest adopt ÏCC or CCC? Fukuda is a fatigue definition. It remains. How can you have large scale biomedical studies based on Fukuda. 'Not ruling out', is not accepting either. The language is all wrong. Its false. Classic double speak for the masses for 'We'll think about it'. They've had plenty of time to think about it. Why throw up these grand plans for studies if they haven't already got some basis for preselection? Wasn't this one of the obfuscations they used to deflate another 'not to be named' finding?
 
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Bob

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I think the the document's proposals sidestep the issue of the adoption of the CCC or ICC, and in avoiding that, it ignores the considered judgements and wishes of both the ME biomedical experts and the majority of the patients.
Agreed. But remember that, even in our community, there isn't consensus that the CCC should be adopted. Some want nothing less than the ICC.
 

alex3619

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It is these idiopathic 'cf' patients from the watered down original 'cfs' definition, which itself ignored the biological findings in the Incline Village Lake Tahoe Nevada + about 7 other communities outbreak.
I think I have read there were at least 113 outbreaks, about fifty of which were investigated, and about three of those investigated in depth. Added to this is that recent outbreaks of something are labelled post-SARS, post-Q fever etc. Then there are the various ASIA syndromes, GWI, etc. We do not understand any of these properly. Sure they are probably involving different diseases with similar syndromes, but this just emphases the need for well funded quality research.
 

Bob

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Yet why didnt they suggest adopt ÏCC or CCC?
I don't know. The report isn't perfect but, in my opinion, it's a massive step-change, and I think the positives vastly outweigh the negatives in the document. I'm viewing it in terms of its potential, and what we can get out of it. And, I think it has the potential to be transformative. If we compare this report to what went on in the Reeves era, or what's going on in the UK today, then I don't think this document compares. But, Rusty, these are just my opinions, and I respect all the different opinions that are being expressed in this thread. I really do. I don't pretend that I know best, but we all have valid and well-considered opinions. I'm listening to what you and others are saying.
 
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RustyJ

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Agreed. But remember that, even in our community, there isn't consensus that the CCC should be adopted. Some want nothing less than the ICC.

Not a suitable reason for not adopting at least one of them. I can guarantee both are considerably better than Fukuda. And if the debate is about a comparison between the three, and the focus on fatigue is the issue, then Fukuda comes a long way last. It is not a big leap from CCC to ICC, but years from Fukuda to CCC. There is no way they are going to shift on this for decades. So ideopathic fatigue will continue to confuse any research for decades.

The argument that these big scale studies are going to be the be all and end all is fraught also. PACE was such a study, and look at the manipulations and deceptions involved in that one. There is a mind set that the bigger the study, the more it is to be believed.
 
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@Bob and All


@Bob wrote: "But remember that, even in our community, there isn't consensus that the CCC should be adopted. Some want nothing less than the ICC."


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Most patients who want the ICC adopted can see that the 'ME Experts letter' asked for the CCC for tactical reasons.

If the ME Experts letter had insisted the ICC should be adopted now, the response would be the same as when the CCC was first published, and for some years after. The argument against would be that the ICC is new, not validated, not much in use for diagnosis or research. In other words, exactly the same reasons given for not using the CCC in the early years after its publication. The Experts letter states that the Criteria they propose (CCC) should be updated as new evidence comes to light, and refer to the ICC as an example ....


Here's the relevent line from the ME Experts letter:
" The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011)."
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jimells

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I believe that some patients are reading this report with some strong built-in prejudices which they must guard against.

Oh I absolutely have strong built-in prejudices, but I'm not going to guard against them. In fact, I believe they are a necessary and valuable part of the dissection and analysis of the document and the whole process that it is a part of. Just as @Bob 's and everyone else views of the document are valuable and necessary, and I continue to look forward to challenges to my analysis and conclusions. A bureaucracy full of yes-men is a significant reason why we are in this situation.


This is why they dismissed etiology of ME/CFS as not having anything to do with psycho-somatic, psychological or psychiatric disorders!

Even Wessely admits the illness starts as a non-psych disease. Then he goes on to claim that somehow the symptoms continue as a result of thinking the wrong thoughts.


Some patients feel that they didn't mention treatment by neurologists/endocrinologists/immunologists etc. but used the word physicians. In a document such as this, they use the word physicians collectively encompassing all of the fields. Good grief, they are not going to list each and every field of medicine

Good catch! Somehow I interpreted "physician" in Line 313 as "primary care physician", probably because of the report's emphasis on primary care:
191 The dissemination of diagnostic and therapeutic recommendations should focus on primary care providers.

I vaguely recall other similar statements, but I can't find them right now.


They further stated that GET graded exercise therapy often causes additional suffering,

You are taking this out of context:
135 In many cases, lack of instructions or guidance for including graded exercise therapy often causes additional suffering, creating fear of harm from a comprehensive self-management program that may include some physical activity

What do they mean by "suffering"? Is it just the "fear of harm" or the actual very serious adverse physical effects caused by GET? And the statement doesn't say GET causes suffering. It says "lack of instructions or guidance ... causes suffering" - these are very, very different. Yes I am very carefully parsing the statement. Just as the statement has been very carefully constructed.

This is a prime example of a statement that appears to say whatever anybody is hoping it says. Psychobablers can claim the statement says GET works if it's done better. Psych critics can claim the statement rejects GET. And optimists can hope it means the NIH is finally changing direction.
 

RustyJ

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@Bob and All

Most patients who want the ICC adopted can see that the 'ME Experts letter' asked for the CCC for tactical reasons.

If the ME Experts letter had insisted the ICC should be adopted now, the response woiuld be the same as when the CCC was first published, and for some years after. ie. the argument against would be that the ICC is new, not validated, not much in use for diagnosis or treatment. In other words, exactly the same reasons given for not using the CCC in the early years after its publication. Also the Experts letter states that the Criteria they propose (CCC) should be updated as new evidence comes to light, and refer to the ICC as an example ....


Here's the relevent line from the ME Experts letter:
" The expert biomedical community will continue to refine and update the case definition as scientific knowledge advances; for example, this may include consideration of the 2011 ME International Consensus Criteria (Carruthers et al, Journal of Internal Medicine, 2011)."
.

It has confused me a little about the resistance to take up ICC, when clearly from the point of defining fatigue, it was better. Your explanation clears that up. Thanks.
 
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@jimells wrote:
"This is a prime example of a statement that appears to say whatever anybody is hoping it says. Psychobablers can claim the statement says GET works if it's done better. Psych critics can claim the statement rejects GET. And optimists can hope it means the NIH is finally changing direction."


Exactly.
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Nielk

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Jennie Spotila - P2P Report: First Read

http://www.occupycfs.com/2014/12/19/p2p-report-first-read/

The P2P Panel’s draft report on advancing ME/CFS research has been published. The report is not the nightmare that many people feared, but it is also not what I had hoped for or what we need.

The advocacy chatter I’ve seen in the last 12 hours (and I have not seen everything) has been overwhelmingly positive. Words like “superb” and “justice” have been used, and it is true that there is much in the report that validates what ME/CFS experts and advocates have been saying for years.

I am in the “bah, humbug” minority, though. While there are strong recommendations in the report, many things that I considered essential for success are missing. For example, the Panel does not seem to have understood post-exertional malaise, how it is distinguishable from fatigue, and the data that show how essential it is to understanding this disease. I don’t blame the Panel for this oversight, necessarily. Given the evidence review and the agenda of the Workshop, they were not presented with much of that data. This is the Achilles heel I’ve been pointing to all year: that the Panel would not be shown the full ME/CFS landscape and therefore, their attempt to chart a course through that landscape would suffer.
Continue HERE.
 

RustyJ

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This is a prime example of a statement that appears to say whatever anybody is hoping it says. Psychobablers can claim the statement says GET works if it's done better. Psych critics can claim the statement rejects GET. And optimists can hope it means the NIH is finally changing direction.

Yes, well put. Much of the document is phrased this way.
 
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