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IOM Bias: "The Cause(s) of Chronic Multisymptom Illnesses Following the First Gulf War"

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Ren, Nov 14, 2013.

  1. Andrew

    Andrew Senior Member

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    There are a bunch of CR/LF there. Go to the bottom of the void with your cursor. Hold down the backspace key until your cursor is at the end of your text.

     
    Ren likes this.
  2. Ren

    Ren Primum Non Nocere

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    It's magic! :) Thanx, Andrew!
     
  3. beaker

    beaker CFS/ME 1986

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    Somatoform disorders : " <snip> no organic findings"
    I guess they haven't looked very hard at the research. *sigh*

    and
    "Chronic Fatigue Syndrome : <snip> fatigue and 4/8"minor" criteria"

    Nothing "minor" about the rest of the symptoms/criteria for me. Using Fukuda, CCC or ICC.
    No one gets it.
     
    justinreilly likes this.
  4. Ecoclimber

    Ecoclimber Senior Member

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    Gulf War Veterans: Treating Symptoms and Syndromes
    http://www.nap.edu/catalog/10185.html

    Appendix C
    Unique Considerations in Chronic Fatigue Syndrome


    Although fatigue is a common symptom, it is also one that is vague, imprecise, and nonspecific. One of the essential problems in the study and measurement of fatigue, either as a singular entity or as a component of a more well-defined disorder, is the failure to differentiate various types of fatigue. In Chronic Fatigue and Its Syndromes (Wessely et al. 1998), the authors challenge the reader to try a “thought experiment” that clearly illustrates the dilemma encountered in defining and assessing fatigue.

    Below, their experiment has been expanded and modified; however, the message regarding the problems encountered in defining fatigue remains intact.

    • You run 5 miles under adverse conditions; even before starting you feel weak and daunted at the prospect. After completing only a portion of the course, you stop; the next day you are sore and tired.

    • You are asked to carefully check the references for a 600-page book on fatigue. You feel overwhelmed and really just want to ride your bike. After a few hours your eyes hurt, you are weary, your concentration diminishes, and you are making many mistakes.

    • It’s flu season and you are feeling achy and weak. Your nose is running, your throat is sore, and all you want to do is go to bed.

    • You have just been up for two days finishing a grant proposal, then had to take a “red eye” and deliver the application in person to make the grant deadline.

    • You have been driving in your car for an hour. The landscape is boring and you can hardly keep your eyes open. All you want to do is sleep. You also often feel like this when at home watching TV.

    • Climbing stairs has become progressively, though subtly, more difficult over the last two years.

    • Although at first, exertion is not bothersome, after 10–15 minutes, you experience constant cramping in your extremities.

    These examples illustrate the multidimensionality of fatigue. Fatigue can occur in anticipation of a task and be influenced by both physical (e.g., the length of the run) and psychological factors (e.g., how rewarding it will be). Fatigue can also be interpreted as a sense of effort needed to perform a task, and both physical and mental tasks may result in fatigue.

    In conjunction with the sensation or perception of fatigue, the effort associated with a task may be manifested as a change in behavior, especially a decrement in performance (e.g., information processing declines when one feels tired). Fatigue is also most often acute, and in such cases typically resolves after completion of the task.

    In cases in which fatigue is more chronic and pervasive, it is frequently associated with illness, stress, and sleep disturbances.

    Finally, as the last two vignettes illustrate, fatigue must be distinguished from sleepiness or drowsiness and true muscle weakness since these symptoms are associated with a different array of conditions, usually primary sleep and muscle disorders.

    Thus, it is clear that a simple question regarding “fatigue” is not likely to be very informative or precise. Yet elements of fatigue can be ascertained if care is taken in questioning an individual or in constructing an instrument. However, complicating matters even more is the fact that patients often have additional meanings for fatigue.

    Sometimes, the word fatigue is used as a synonym for other complaints while at other times it becomes a general term to encompass an array of symptoms that occur together.

    Patients will often equate fatigue with weakness, dizziness, lack of coordination or stamina, feeling “spacey,”poor concentration/cognitive abilities, having “rubber legs,” boredom, lack of motivation, malaise, or feeling blue or depressed.

    Despite the further ambiguity introduced by these descriptors, it is clear that fatigue has distinct physical and mental aspects that must be considered in measurement.

    Copyright © National Academy of Sciences. All rights reserved.

    In this report, conditions of unknown etiology for which treatments are examined include chronic fatigue syndrome (fatigue, headache, cognitive dysfunction, and other symptoms), depression (fatigue, loss of memory and other general symptoms, cognitive dysfunction, and sleep disturbances), fibromyalgia (muscle pain, sleep disturbances, fatigue), and irritable bowel syndrome (diarrhea, constipation, abdominal pain, nausea, vomiting, and other gastrointestinal symptoms). Other diagnoses such as headache and panic disorder are included in the report because they involve symptoms similar to those reported by Gulf War veterans.

    Evidence of symptoms is self-report

    Treatment efficacy is the benefit produced by a given treatment in tightly controlled, perhaps artificial, study conditions in which patients are carefully selected and may be more frequently observed, tested, and monitored than is typically the case in routine practice. A number of study designs can provide varying levels of evidence of treatment efficacy. They include, from strongest to weakest: conditions in which patients are carefully selected and may be more frequently observed, tested, and monitored than is typically the case in routine practice. A number of study designs can provide varying levels of evidence of treatment efficacy.
    They include, from strongest to weakest:

    • Multiple well-designed randomized controlled trials (RCTs);

    • Single well-designed RCTs or multiple small RCTs;

    • Cohort study, particularly one with “multiple on/off” features;

    • Case-control study; and

    • Series of clinical observations or anecdotes. (My Comments: This where most of the ME/CFS clinicians observations, treatment protocols and anecdotal information is obtained. It is considered at the low end for consideration for treatment efficacy for ME/CFS patients)

    In addition to the above designs, there is the technique of meta-analysis. Meta-analysis was developed to fit the situation in which study results are not fully consistent or there are multiple studies of differing degrees of design rigor. In meta-analysis the results of multiple studies are combined to yield an overall cross-study estimate of effectiveness.

    In its review of clinical studies, the U.S. Preventive Health ServicesTask Force (USPHSTF) used strict criteria for selecting admissible evidence of effectiveness in grading the quality of evidence (see Table ES-1).

    The task force gave greater weight to those study designs that, for methodological
    reasons, are less subject to bias and inferential error (USPHSTF 1996).

    In evaluating treatments for Gulf War veterans, the committee

    TABLE ES-1 Quality of Evidence

    Level Evidence

    I Evidence obtained from at least one properly randomized controlled trial.
    (CBT/ GET PACE ?)


    II-1 Evidence obtained from well-designed controlled trials without randomization.

    II-2 Evidence obtained from well-designed cohort or case-control analytical studies, preferably from more than one center or research group.

    II-3 Evidence obtained from multiple time series with or without the intervention. Dramatic results in uncontrolled experiments (such as the results of the introduction of penicillin treatment in the 1940s) could also be regarded as this type of evidence.

    III Opinions of respected authorities, based on clinical experience, descriptive studies, and case reports, or reports of expert committees. (ME/CFS Clinicians)


    Treatment effectiveness studies, including the largest and most comprehensive outcomes studies, emphasize external validity often at the expense of internal validity. They may involve very large samples that are fully representative of the patients seen in routine clinical practice, but the studies may include confounding factors that weaken the inferences about cause-and-effect relationships.

    The committee believes the results of a single, well-designed outcomes study (e.g., a cohort study or variation of care and outcome study) should be considered to be as compelling as the results of a single, well controlled randomized trial in determining treatment effectiveness.

    An outcomes study will have few concerns about the generalizability of its findings to real-world settings (external validity) but perhaps some concerns about internal validity; RCTs will have the opposite pattern of

    The randomized controlled trial (RCT) is the most reliable methodology for assessing the efficacy of treatments in medicine. In such a trial a defined group of study patients is assigned to either receive the treatment or not, or to receive different doses of the treatment, through a formal process of randomization.

    TABLE 3-1 Hierarchy of Evidence

    Emphasis on Efficacy Emphasis on Effectiveness (My Comments: Determination base on this critieria and selecting the top critieria as being the best treatment option after reviewing research papers on clinical trial treatments)

    Level I Systematic Review (e.g., meta- Systematic Review (e.g., meta analysis) of Several Well-Controlled analysis) of Several Well-Randomized Trials—consistent results Designed Outcome Studies or “Effectiveness RCTs”—consistent results (CBT/ GET PACE ?)

    Level II Single, Well-Controlled Single, Well-Designed Randomized Trial Outcomes Study or
    “Effectiveness RCT”

    Level III Consistent Findings from Multiple Cohort, Case-Control, or Observational Studies*

    Level IV Single Cohort, Case-Control, or Observational Study (ME/CFS Clinicians)

    Level V Uncontrolled Experiment, Unsystematic Observation, Expert Opinion (ME/CFS Clinicians)

    Document Attached

    This is probably very close to the analysis that ME/CFS IOM Panel will generate using this as a basis for selection and establishing treatment protocols: This involves not only Chronic Fatigue Syndrome but Neurological (cognitive dysfunction, loss of memory, and sleep disturbances), irritable bowel syndrome (diarrhea, constipation, abdominal pain, nausea, vomiting, and other gastrointestinal symptoms),fibromyalgia (muscle pain, sleep disturbances, fatigue)

    Eco
     

    Attached Files:

    Last edited: Nov 19, 2013
    Ren likes this.
  5. beaker

    beaker CFS/ME 1986

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    complete confusion of fatigue as a symptom and the entity of ME/CFS.
    And done intentionally.
    I wish they would stop this. I wish someone w/ some sort of influence would point this out or at least admit to it.
    grrrrr
     
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  6. alex3619

    alex3619 Senior Member

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    I have recently come to the tentative conclusion that ME does not require chronic fatigue as a symptom. A well managed mild patient, which means pacing as well as other things, or a pre-clinical (short of the formal criteria, or very mild) patient who can still hold down a full time job, might only have temporary or limited fatigue. The issue is fatiguability, not fatigue, and if they are managing well then they might not have chronic fatigue. Its the more severe patients, and the ones who have not learned to pace and do other things as necessary in their case, who have chronic fatigue. Its a secondary effect of ME, not a primary one.
     
  7. Snowdrop

    Snowdrop Senior Member

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    I agree. Some people will manage to carry on with some sort of life where they are managing perhaps without realizing that they are pacing themselves within a smaller energy context than what might be considered average.

    This brings out the issue of stress as a cause or not. With the above in mind it seems to me that stress isn't a causative factor, the way a virus might be but for a person with a mild and managed ME stress could 'reveal' the underlying illness. The longer one is ill then the longer one has opportunities for significant stress and therefore 'revelation' of the underlying illness.
     
  8. WillowJ

    WillowJ Senior Member

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    PACE and most other CBT/GET trials are not usually controlled. They would probably put them in Level II "Well-Designed Randomized Trial Outcomes Study", but this isn't correct as they are not typically well-designed (Lancet and BMJ publication with "endless rounds of peer review" or no).

    However they'd still go in Level III Consistent Findings from Multiple Observational Studies (unless someone was really sharp and realized many of these shouldn't qualify to be included at all)
     
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  9. alex3619

    alex3619 Senior Member

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    It is also NOT the case that the highest class of evidence is an RCT, unless it is also double blinded. No psycho- or begavioural therapy can be double blinded. The patients and treating practitioners know what therapy they are receiving.

    The PACE trial is so full of holes its icon should be swiss cheese, or perhaps a large holed cheese grater. These holes are methodological, statistical, and rhetorical ... claims are made that cannot be substantiated.

    I also seriously question whether highly subjective "evidence" of a small improvement can ever be considered the highest class of evidence. It is easily within the expected bias.
     
  10. Roy S

    Roy S former DC ME/CFS lobbyist

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    Blasphemy is punishable by CBT for eternity...
     
  11. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    I think it's funny that they don't list 'depressed mood' as a symptom of depression. This just highlights their ridiculous method/strategy of comparing the unweighted list of symptoms of several illnesses like depression, ME and Fibro and saying they're basically the same thing since many of the symptoms are the same; totally ignoring the unique presentation and symptom constellation of each illness.
     
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  12. WillowJ

    WillowJ Senior Member

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    PS, we have Level III evidence from that last table for low NK cell function, or Level II from the ES-1 table
     
    Last edited: Nov 19, 2013
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  13. WillowJ

    WillowJ Senior Member

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    If that's so, then lupus and cancer are also the same. Oh wait, they have lab tests. And funding.

    Major Premise: diseases with funding are legitimate disease entities, while diseases with no funding are all the same disease (because.... we haven't yet established diagnostic biomarkers--oh, except for Parkison's, Alzheimer's, Autism, and some of the Ehlers-Danlos Syndrome types.... but they have... um.... I give up. Not all of those even have good funding, though all are better funded than us.)
     
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  14. alex3619

    alex3619 Senior Member

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    What you don't want me indoctrinating them for eternity? So they escape their punishment?
     
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  15. alex3619

    alex3619 Senior Member

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    Their listing of the evidence hierarchy is for a heirarchy that is old, and possibly extremely obsolete. I will see if I can get a good example of a modern hierarchy. I tried to find a good one, but they are all either too simple, or too technical.
     
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  16. alex3619

    alex3619 Senior Member

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    It is not what I am looking for, exactly, this is a sports medicine article on levels of evidence here. To demonstrate how bad the hierarchy is, it is unclear where the CCC or ICC fit, or indeed any of our definitions. That is because there is insufficient clarity in the research itself. Is the CCC level 5? Or is the CCC level 3?

    Please note EBM can include economic or decision models.
     
    Last edited: Nov 19, 2013
  17. alex3619

    alex3619 Senior Member

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    This is another here. SR is systematic review. Most of the charts are of this level of complexity, or higher. The silly one the IOM used is really dumbed down.

    Please note that investigational science, and consensus criteria based on clinical practice, investigations, and basic investigational science, do not fit neatly into any category. That would include both the ICC and CCC, but most definitely include anything the IOM would produce.The IOM will try to claim level 2a evidence though, but I am doubtful it could qualify.

    EBM guidelines are not ideally suited to this kind of diagnostic criteria development.

    If we had a validated, replicated diagnostic test, either to rule in or rule out ME for example, it would be level 1c evidence.

     
    Last edited: Nov 19, 2013
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  18. alex3619

    alex3619 Senior Member

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    I changed my search question a little, using "evidence based formulation diagnostic criteria" and came up with this 21 page document:

    http://www.farestaie.com.ar/proyecto/FORO_SMF/archivos/material_aportado/nicola/Formulating and Using EBG.pdf

    This article discusses the general diagnostic criteria process, but it appears to be biased toward diseases with diagnostic biomarkers. It essentially covers much of the IOM process, but its not a perfect match, and we have no idea if the IOM will do something close to this.

    The use of RCTs in deciding upon diagnostic criteria can be considered a category error. These are interventional and not diagnostic studies.

    There is such a dearth of information on all this, that I suspect that GWS and now ME are the guinea pigs.
     
    Last edited: Nov 19, 2013
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  19. lnester7

    lnester7 Seven

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    Question: @Ecoclimber

    If we submit an organized list categorized by levels of studies so they cannot say they didn't have the data, of all the physiological studies and we classify them based on this criteria. Is this acceptable by the IOM committee??? Is there something like submit evidence stage???
     
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  20. alex3619

    alex3619 Senior Member

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    @lnester7, there will be opportunities to submit comments etc. later. I would rather not get to later, but if we can at least identify the 20 or so most important studies for diagnostics, and rank them, then the 10 or so most imporant studies for psychobabble, and rank them with criticisms, it would be a start.

    Most important would be a list of studies that rank very low in psychobabble despite high claims. This includes ALL the interventional studies, i.e. CBT/GET. The diagnostic CBT/GET studies are all rank 5, the lowest, because not only are they based on psychiatric first principles, they are based on subjective evidence. There is no objective basis for the claims. I think this theme can be worked on and polished more than a little.
     
    Last edited: Nov 19, 2013
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