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IOM Process - four stages explained

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Nielk, Nov 4, 2013.

  1. Ember

    Ember Senior Member

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    When DHHS first announced its intention to award the IOM contract, I asked the same question: “Why is a clear distinction needed between a clinical definition and a research case definition? The International Consensus Panel argues that 'it is imperative that research for ME be carried out on patients who actually have ME.'”

    Patients may have themselves to blame, however, for this development. At the June 2102 CFSAC meeting, PANDORA lobbied for the development of two case definitions:
    As a result of Dr. Susan Levine's argument at that CFSAC meeting, Dr. Lee began to focus on a broader clinical definition:
    In its September and October statements, PANDORA modified its position: “At least three different definitions are needed: a clinical definition, a more narrow research definition, and a clinical pediatric definition, and these should be developed together from the same initiative.” The September statement argues, “Numerous researchers tell us that a research definition should be narrower than the clinical definition. A narrower research definition ensures a more pure cohort, which will more likely lead to more biomarker discoveries.” PANDORA's statements ignore, however, the experts' position:
    PANDORA ignores too the fact that the ICC is both a clinical and a research definition.
     
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  2. Ember

    Ember Senior Member

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    Having the CCC operationalized has been Dr. Jason's hobbyhorse. In 2010, he took it upon himself to “revise” the CCC, concluding:
    Steve Krafchick has lobbied CFSAC on Dr. Jason's behalf, and the IOM is directed now to include the 2010 "Revised" Canadian ME/CFS Definition in its review. The CAA has taken this position: “We feel that the Canadian Clinical Consensus* can be optimized as a clinical case definition by applying a standardized methodology of execution, through validation of criteria, and a nationwide dissemination to health professionals.”
     
    Last edited: Nov 9, 2013
  3. Ecoclimber

    Ecoclimber Senior Member

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    Narrow for research, I would assume be close to the CCC definitions. Broad for clinicians means bringing in somatization disorders.

    In reference to the VA IOM panel’s report, unless an illness can be determined by verifiable evidence –based criteria( meaning lab tests results), it would fall into the category of psychogenic disorders. This is where the condition of CFS and CMI landed.

    From a clinical perspective, there are no medical lab test results that definitively state one has ME/CFS. Research using MRI or CFS taps, would not be considered normal routine procedures in a clinical setting. ME/CFS still need biomarkers to determine if a person has this illness. There are indications that there may even be subsets but until it falls under the heading of evidence-base criteria, I suspect is why they are insisting on the requirement of two definitions, one for research and one for clinical.

    There is evidence which was stated in one of my prior posts and in the IOM Panel Reports attachments on what the IOM considers as evidence-based criteria. You can look it up in VA IOM Report on the specific language and meaning used.
     
    Last edited: Nov 8, 2013
  4. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    MRIs are used to diagnose MS. As I understand it, an MRI is more useful in diagnosing MS than ME, because, though the rate of patients with brain lesions is a bit lower in MS than ME, the appearance of the lesions in MS are characteristic of that disease, while the ones in ME may not be. But maybe, in conjunction with other tests, or using SPECT or evoked EEG instead of MRI, a diagnosis could be made based on biomarkers at a reasonable cost (comparable to that of MS, say). In MS, if MRI is not positive, spinal taps and evoked EEG are done. We should get the same cost considerations in diagnosis and tx as MS and other disease patients!
     
  5. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Hasn't CCC already been validated by Jason?

    Is there a difference between operationalizing and validating? Do both need to be done before a definition is accepted for use? Has CCC been operationalized? Im not clear on what that means.

    Is CAA really supporting CCC or is it using the provisos of validation and "a standardized methodology of execution" as an excuse to avoid adopting CCC? And what does "a standardized methodology of execution" mean and has that been done yet?

    If someone knows, Pls respond, this seems important to me.
     
  6. Ecoclimber

    Ecoclimber Senior Member

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    The key operative words are "validation of criteria." According to the 2013 VA IOM report, CFS could not be validated by verifiable evidence based medical results.
     
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  7. alex3619

    alex3619 Senior Member

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    My understanding is that this is NOT the case. CFS has no specific designation under social security benefits. Nor does ME, which probably gets automatically considered as CFS. Its based on the impact something has on functional capacity.

    What might be the case is that with decreased testing and increased prejudgement it will be harder to get doctors to support development of a case for social security benefits.

    A lot of this has been explained at length during CFSAC meetings over the years.

    However in some places there is a tendency to revisit a case, and require further evidence. That might be harder to obtain.

    Maybe someone who has been through the process can give us their thoughts?
     
  8. Ember

    Ember Senior Member

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    Yes, Dr. Jason has provided validation for the CCC. Dr. Carruthers writes, “In his study of the Reeves criteria for Chronic Fatigue Syndrome, Jason et al found that only 10% of patients identified as having CFS actually had ME, and confirmed the efficacy of the Canadian criteria in separating out this 10% subset.(J Disabil Pol Studies 2009; 20: 91-100).”

    But the Jason et al. (2010) “Revised” Canadian ME/CFS Definition seeks to address reliability issues. The abstract reads in part: “The provision of operationally explicit, objective criteria on specific key symptoms might reduce criterion variance as a source of unreliability. In addition, the use of structured interview schedules will ensure that symptoms are assessed in a consistent way across settings.” Accordingly, the authors recommend structured interview schedules:
    The DePaul Symptom Questionnaire has been derived in part from the ME/CFS Fatigue Types Questionnaire (MFTQ), developed earlier by Dr. Jason's group:
    Dr. Jason explains that “these five PEM items have been included in a new diagnostic measure: the DePaul Symptom Questionnaire (DSQ), developed by our group at DePaul University to help classify people with all the major case definitions.” Notably, Dr. Jason argues that exercise testing alone isn't enough: “PEM cannot be definitively established without the inclusion of the patients’ self-reported symptoms.” To meet the criteria for PEM, "one of these items needs to be endorsed at sufficient frequency and severity (2 or greater on a scale of 0 – 4)."

    A definition is accepted for use when it is used. Reeves (2005) operationalized Fukuda (1994), but who would argue now that the definition for CFS was thereby improved?
     
    Last edited: Nov 9, 2013
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  9. Firestormm

    Firestormm Guest

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    @Ember Thanks for digging all of this out in your recent posts. Very helpful indeed :)
     
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  10. Ren

    Ren Primum Non Nocere

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    Yes, thank you!
     
  11. WillowJ

    WillowJ Senior Member

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    There are special rules for CFS under SSA. It is not a Listed disease (like ESRD, which automatically qualifies), but a directive was devised probably because they had been having issues proving that CFS was a "medically determinable impairment". A footnote in the 1999 directive states:

    http://www.cfids.org/advocacy/ssa-ruling.asp
    http://www.masscfids.org/disability

    because most people don't have the opportunity to have NK cell function tests, SPECT or PET scans, tilt table testing, advanced tests which would show memory and concentration problems, tests for infections, and so on and so forth. These are expensive (if insurance isn't involved for whatever reason, including that this isn't approved for ME or CFS) and most doctors have no idea to order them (or how to order them even if they wanted to).

    However, it's still probably easier if you can show some kind of laboratory or imaging evidence. Everybody hates an uncorroborated disease with floppy diagnostic criteria. SSA thinks every applicant it has to evaluate is probably a faker anyway, and one of us is even worse (doesn't matter which poorly-defined uncorroborated disease).

    However a 2001 publication fails to repeat this note.
    http://www.ssa.gov/disability/professionals/cfs-pub063.htm
     
    Last edited: Nov 10, 2013
  12. Andrew

    Andrew Senior Member

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    My understanding is also that it's based on impairment, not biological proof. You can get disability for mental disorder.
     
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  13. Firestormm

    Firestormm Guest

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    That would fit with the situation in the UK. Benefits are paid based on an assessment (a controversial assessment) of the degree to which a disability affects a person, be it generally in terms of living, or specifically in terms of ability to work. The actual diagnosis - or proof - has little really to do with it once a diagnosis has been established.
     
  14. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    That's interesting. Can you Pls expand on and explain that in Laymans terms? I know very little about this type of thing.
     
  15. Ember

    Ember Senior Member

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    Validity and Reliability of Measurements

    “All measurements may contain some element of error; validity and reliability concern the amount and type of error that typically occurs, and they also show how we can estimate the amount of error in a measurement. “
     
  16. Andrew

    Andrew Senior Member

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    Unless they field test their new criteria they have zero evidence that can differentiate ME/CFS patients. Therefore, they cannot say it is an evidence based criteria. All they have is an evidence based hypotheses.
     
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  17. Ember

    Ember Senior Member

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    The ME Primer uses repeat exercise testing to operationalize PENE. Given that the IOM committee is directed to review both the ICC and data from the ongoing CDC Multi-site Clinical Study of CFS, we must keep pressuring Dr. Unger to use the 2-day exercise test. Wildaisy provides two sample letters here. Erica Verillo's template letter is here.
     
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  18. Nielk

    Nielk

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    I posted this on Jennie's blog:


    Jennie,


    I see a major problem in integrity of this HHS/IOM process. The ‘process’ is claimed to be totally independent and from the IOM website statement; ‘The Academies provide independent advice; external sponsors have no control over the conduct of a study once the statement of task and budget are finalized.

    You state:

    The Federal Advisory Committee Act prohibits any U.S. government agency from using recommendations from committees created by the IOM at the request of the government unless certain conditions are met, including several conditions regarding committee membership. First, no individual can have a conflict of interest relevant to the committee (with one exception explained below). Second, the committee membership must be fairly balanced. Third, the final report must be the result of the IOM’s independent judgment. In order for HHS to use the IOM’s conclusions on a clinical case definition for ME/CFS, the IOM has to ensure that these conditions were fulfilled, including no conflicts of interest among the committee members.

    Yet, on a previous blog, ‘Which paddle’, you state:

    .., even if we could force the rescission of this contract – what then? I know many advocates believe that the Experts’ Letter calling for immediate adoption of the Canadian Consensus Criteria is the solution. But I heard from a highly placed source at HHS that the government will not accept a definition without their own thorough assessment, if not influence. HHS will want to get its hands on any definition before accepting it, and they will not accept CCC as is. So even if we get the contract rescinded, we will be back where we started except everyone on both sides will be even more pissed off.

    HHS does not want to adopt the CCC, at the risk of acting against the medical experts in the field, because they want to control the outcome. Yet, they are willing to spend a million dollars to contract with an independent organization where legally, they will not be able to control the outcome once the process has started? Does this make any sense to anyone?

    In addition, the Statement of Work states; Contractor shall meet with the NIH Task Leader and HHS personnel within 30 days of the effective date of the order as a kick-off meeting. The Contractor shall communicate with the NIH Task Leader and HHS personnel on a monthly basis to discuss the status of the study.

    This seems to be in direct violation of the IOM process of study as stated above.

    The Statement of Work further elaboratesthat the IOM panel will coordinate with NIH’s Evidence-based Methodology Workshop to “assure that relevant information is shared and key messages are coordinated.” This will give HHS the mechanism to strongly influence what literature is considered as evidence for this broad set of conditions

    It is obvious to me that HHS is very confident that they will be able to influence the outcome of this process. That is why we need to fight this till the end. It is not too late. Are we to give up our fight at such an early date, just because the process has begun? Do you think that any civil demonstration/protest should be given up at the first show of disinterest? Should we give up because the government has never canceled an IOM contract before so therefore they will not this time? Should Rosa Parks not have insisted on sitting in the front of the bus because others have not done it before? I’m sorry but, these arguments do not hold for me, personally.

    I feel that my civil rights have been violated. The government/HHS has high jacked this disease and is trying to control the outcome of this study to come up with diagnostic criteria for ME/CFS. Why have they not done so with other diseases? (Except GWI – of course) Is my illness as a U.S. citizen less important than an illness of another US citizen? I feel discriminated against. Should I just sit by quietly while this is happening? Is this not the democratic country of the free and brave?

    ‘A people who extend civil liberties only to preferred groups start down the path either to dictatorship of the right or the left.’
    -- Justice William O. Douglas

    I am also concerned that there is an illusion here that the fight is over. It is not by a long shot. 117 advocates have just signed a letter of support to the letter of 50 experts. Besides, petitions, letters, tweets, calls there are many actions taking place in the background in silence (so far). There is a large group of us who will continue to fight this until the time that this contract is canceled.

    For those who would like to help in the fight to cancel the HHS/IOM contract, these are actions you can take now.

    Actions to stop the IOM contract in support of the 50 experts.

    For U.S. citizens:

    Simple instructions for e-mailing your congressional representatives HERE.

    For everyone worldwide:

    Simple instructions for e-mailing President Obama's science advisers HERE.

    Simple instructions for e-mailing president Obama and vice president Biden HERE.

    You can sign the petition to stop the IOM contract HERE.

    The petition in support of the expert's letter is HERE.

    Simple tweeting campaign to stop IOM contract HERE.
     
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  19. Firestormm

    Firestormm Guest

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    @Nielk isn't it the case that IOM will independently come up with recommendations, and then HHS will consider them?

    I may have this wrong, but to relate it to the UK situation (again - sorry), the Independent Working Group on ME/CFS prepared a huge Report to the Chief Medical Officer, which in turn was considered by NICE.

    The Guideline Development Group then took this and other evidence to form the NICE Guideline. It might be the case I suppose in the US and after investing $1 million that HHS are more likely to adopt the IOM recommendations, but I don't really know that for definite.

    It could be that HHS will open up the issue to greater discussion once the IOM Report is in front of them, but again I can't say for definite this will happen.

    Perhaps the conference-thing next month will allow some desperately needed light to be shed upon the matter: though the 30 minutes allocated are unlikely to reveal very much!

    I think we really do need to hear from the principals involved i.e. HHS and IOM. At least NICE permitted stakeholder involvement - though it was so long ago now I can't remember how much of the discussions were made available to the greater public...
     
  20. Nielk

    Nielk

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    From the Statement of Work:

    The IOM is being tasked to "develop" diagnostic criteria, not to advise. Whatever the result of this work, it will be adopted and disseminated nationwide to health professionals. Once the work is done, there is no room for discussion, as far as I understand it.
     
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