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IOM Process - four stages explained

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

  1. Ren

    Ren Deep breath - lots of deep breaths...

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    In Jennie's "IOM Process Check" post (1), there are links for IOM's "statement of task" (Activity Description) (2) and HHS' Statement of Work (3). As others have pointed out, the Social Security Administration is also funding the IOM consensus study.

    I have, superficially at least, searched for a statement from SSA but couldn't find anything. Shouldn't SSA give an explanatory statement as well?? Other questions include, Is SSA in the habit of funding studies? Did SSA fund the GWI IOM (consensus?) study?

    The PACE study was funded by the UK Dept of Work and Pensions, right? And to my understanding, this was the first time this dept had funded such a study. Is SSA repeating this UK example?

    (1) http://www.occupycfs.com/2013/11/04/iom-process-check/
    (2) http://www.iom.edu/activities/disease/diagnosismyalgicencephalomyelitischronicfatiguesyndrome.aspx
    (3) https://dl.dropboxusercontent.com/u/57025850/MECFS IOM SOW.pdf
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  2. alex3619

    alex3619 Senior Member

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    Were the DWP involved in funding the NICE guidelies for CFS in the UK? If so, is there a pattern here?
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  3. jspotila

    jspotila Senior Member

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    Really excellent questions. To my knowledge, SSA has not issued a statement about the study. The VA funded the case definition effort for GWI/CMI, which is still ongoing. I don't know anything about how often SSA funds studies through IOM. And you are right to raise the potential similarity with the UK approach.
  4. Ren

    Ren Deep breath - lots of deep breaths...

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    "Were the DWP involved in funding the NICE guidelies for CFS in the UK? If so, is there a pattern here?" Don't know, but we can try to find out.

    Re the question of a statement from SSA - and just as an added note of justification - IOM's website (1) defines consensus study as such:

    "A consensus study is the result of an IOM consensus committee’s deliberations in regard to a specific request from the study’s sponsor. After discussing the issue of concern, the committee addresses those issues in a consensus report."

    Forgive repeats of info, etc. Normally, I'd just read and read and try to play catch-up on understanding the beaurocratic history and all, before blurting out whatever. But since time is sensitive, I thought it's better to blurt things out and let those with more experience respond/ignore accordingly. :)

    (1) http://www.iom.edu/About-IOM/Study-Process/Activities.aspx
  5. Firestormm

    Firestormm Content Team Lead

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    @jspotila @Ren The DWP in UK were funding part of the PACE Trial I think, but I can't recall they had anything to do with the NICE Guideline. I could be wrong of course.
  6. Ecoclimber

    Ecoclimber Senior Member

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    Remember, I asked this under above on "exclusions for medicare and medicaid" which is under SSA with the OIG.
    I felt it strange that SSA is involved.

    I find it interesting that part of the IOM is involved in lobbying for changes in health policy by embedding health policy fellows within Congressional Offices to influnence Congressional members.

    http://iom.edu/Global/News Announcements/2013-RWJF-Policy-Fellows.aspx
    "The fellows were chosen in a national competition for highly accomplished health professionals and behavioral and social scientists who have an interest in health policy. Their experiences in Washington will enrich their understanding of public policy formation and the ways federal and state government relate to the mission of their home institutions and local communities. The fellows will undertake a three-month orientation program, followed by a nine-month assignment in a congressional office or in the executive branch where they will be involved in health legislation and programs. After their Washington assignment, fellows will continue to receive support to sustain their development as health policy leaders."
    Ren likes this.
  7. Andrew

    Andrew Senior Member

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    This is an important point because the contract excludes validation testing. It also seems to imply that they must come up with new criteria, even if their analysis shows the contract methodology does not justify this kind of affirmation.

    This is why I'm worried about this process being a quicksand for experts. If they follow the contract, they must act against their own recommendations. Well, unless there are dissenting opinions allowed, in which case they could state that the new criteria comes from substandard methodology and must never be used. But those group processes often seduce people into détente at the expense of what is scientifically the best.
    Last edited: Nov 7, 2013
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  8. Ecoclimber

    Ecoclimber Senior Member

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    Last edited: Nov 7, 2013
  9. jspotila

    jspotila Senior Member

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    Well, there is a single request from the study sponsor here. HHS and SSA put up the money, but they didn't make separate requests. The SOW I detailed on my blog is the document, as far as I can tell:

    http://www.occupycfs.com/2013/09/30/the-statement-of-work/
  10. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Andrew, what do you mean here, that they can't just adopt the CCC if they want to? Are you saying something else. and can you expand on this point?
    Last edited: Nov 10, 2013
  11. Firestormm

    Firestormm Content Team Lead

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    I must admit - and I have only been following this saga from the sidelines really - I thought IOM were charged with producing recommendations. That it would be HHS who would adopt something. So, IOM could therefore, recommend CCC as a means of diagnosis; but that would not be the end of their recommendations brief. There is more to it than recommending a set of criteria, the criteria need 'operationalising'.

    I suspect the IOM will review all criteria currently in use in a similar fashion to the review by NICE.

    @jspotila Jennie you might be interested in this bit. I say 'might' ;)

    See Full NICE Guideline, Chapter 5, for the review completed by the Clinical Guideline Group, who also considered a similar process completed in New Zealand:

    http://www.nice.org.uk/nicemedia/live/11824/36191/36191.pdf

    From pp. 124 you can see/read the review they completed of the recommended tests for example, and the criteria including the criteria advanced by the Independent Working Group on CFS/ME who forwarded a Report to the Chief Medical Officer in 2002. A report that is referred to throughout the NICE Guideline, and was formed in association with 'stakeholders' including patients.

    Anyway, you can read for yourselves what they thought of the criteria such as existed at the time...

    Bottom line was that many of the criteria were not robust enough and the same applied to the various tests advanced - including those that might now be used for exclusionary diagnoses.

    You might also like to remind yourselves of the NICE Criteria. Some seem to think it doesn't include PEM, some might think PEM needs to be more specific:

    Page 7: http://www.nice.org.uk/nicemedia/live/11824/36190/36190.pdf

    It is not my intention to argue over the merits of the NICE Guideline. I do think however, that advocates in the US need to turn their focus to considerations about how your preferred CCC might get past the IOM review i.e. how you can 'operationalise' it. And how the CCC might now appeal when in 2005-2007 it didn't appeal at least to the NICE Guideline Development Group.

    I also don't think the Canadian Criteria will be adopted in full, without at least a change in name. Perhaps it is easier in the UK because we have a National Health Service, so a standard set of Clinical Guidelines can be rolled out in the way that NICE have done.

    But, if the IOM recommend something to HHS, and HHS adopt the recommendation, will it then be rolled out across the US? Will all US Physicans be obliged to assess, test, diagnose and treat patients in line with the HHS Clinical Guideline?

    How does it work? In the UK for example, a GP is still able to treat his patient as an individual. For example - NICE does not mandate any pharmaceutical symptom management - well beyond I think the one drug it mentions. A GP and/or consultant attached to an ME Service can prescribe based on the individual.

    Until such time as more research can go into assessing effectiveness of existing non-ME specific drugs, and/or new ME drugs, I doubt if any drugs will feature in a set of Clinical Guidelines: which is a shame I think.

    In terms of treatment and the proposed HHS Clinical Guideline, I realise you are all concerned it will contain no more than GET, CBT and Activity Management i.e. be reflective of the NICE Guideline. I tend to think of Activity Management as being similar to 'Pacing' unless of course you want to argue a particular 'line' or expert opinion about Pacing.

    Will IOM/HHS be able/or even consider, rolling out Specialist ME Centres across America? NICE went to quite some lengths to consider costings in terms of delivery of care and treatment when writing and then publishing its Guideline.

    Would specialist centres - for assessment, diagnosis, onward referral, and treatment - be something you chaps would consider advocating for? Would it be something that should form part of any Guideline consideration?

    It's hard for me to look at the UK and compare to the US when I know so little about your system of healthcare delivery.

    I would though recommend to any advocate in America, that they set aside some time to properly read through the full NICE Guideline and accompanying documents.

    I'd be interested in hearing some more discussion about how a national clinical guideline could be rolled out in the US and how it might affect things over there - good and bad.

    Of course, in the UK, we did have a headstart I suppose, before NICE was published I think, in that £7 million was granted for the establishment of those specialist centres. Trouble has been holding on to the good ones. Funding is so tight - we have to really fight to retain the expert staff and the service itself...

    Edit: Link added to Independent Working Group Report to Chief Medical Officer 2002.
    Last edited: Nov 8, 2013
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  12. alex3619

    alex3619 Senior Member

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    I could be wrong, but my memory says the CCC has indeed been operationalized already. However the ICC hasn't. Does anyone recall specific documentation on this?

    I don't think its about operationalization. The IOM could surprise us and adopt the CCC,. but there is no basis for thinking this likely. The ICC on the other hand needs more development work.

    We now have a decade's worth of experience at using the CCC both in research and clinically. That is why I think the experts and many advocates preferred it. Such a track record is much more appealing to conservative sources than a new and unproven definition.

    One thing that was brought up at a CFSAC meeting some time ago (I don't recall when) is that HHS etc cannot adopt a definition that has not been vetted by government. However if they were interested in doing this for the CCC they would have made a point of it I think. We would already be clear that was what they were looking at, and the whole concern over the IOM would be very much less.
  13. Andrew

    Andrew Senior Member

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    Andrew, what do you mean here, that they can't just adopt the CCC if they want to? Are you saying something else. and can you expand on this point?[/quote]

    I can't explain it more except to say read the wording and see if you think it conveys an expectation of a new criteria. I'm not really clear myself.
  14. Ren

    Ren Deep breath - lots of deep breaths...

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    Before reading through the new posts, I looked again at the Statement of Work and jotted down some thoughts. And I'm also concerned that the SOW, as Andrew said, "conveys an expectation of a new criteria."

    From the Statement of Work, SOW, (1) as shared by Jennie (2) - with bold added by me:
    "In collaboration with CFSAC ex officio agencies (including NIH) HHS will request that the IOM develop consensus clinical diagnostic criteria for this disorder. A widely accepted clinical definition and a clear distinction from clinical trials and research case definitions would aid in advancing clinical care, drug development, and basic and translational research for ME/CFS."

    The second sentence above, "A widely accepted clinical definition..." is repeated in both the Background section and the Task Description section of the SOW.

    Now, I thought existing definitions, such as CCC/ICC/etc, were used for both clinical AND research purposes. For example, what I understand to be the initial ICC paper (3) states:

    "Criterial symptoms are supported by a study of more than 2500 patients that determined which symptoms had the greatest efficacy to identify patients with ME."

    So with regard to the SOW again - How is having a clinical definition which is seperate from a clinical trials and research definition going to "advance" clinical care?? And how especially will this "advance" drug development? This especially seems illogical to me. Shouldn't drug developement be tied to the clinical trials and research diagnosis??

    It seems then that according to the SOW, the IOM has been charged with creating a NEW entitity that is specifically seperate from (existing) research criteria.

    Also, the SOW Background section states,
    "Clinicians and medical professionals disagree on many aspects of ME/CFS, ranging from frank disbelief in the illness to confusion about the application of clinical diagnostic criteria."

    In my opinion, this isn't a very far-ranging reflection of physician intellect. To me (and what I fear is that) this statement pretty much says that physicians are bumbling idiots, and we in power are going to kindly dumb down this pesky research criteria for them.

    In regard to above posts, I'm sorry I don't really understand what is meant by CCC being "operationalized". I have to read about this term.

    (1) https://dl.dropboxusercontent.com/u/57025850/MECFS%20IOM%20SOW.pdf
    (2) http://www.occupycfs.com/2013/09/30/the-statement-of-work/
    (3) http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
  15. alex3619

    alex3619 Senior Member

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    I suspect, but could be wrong, that clinical definitions can modify research outcomes. First, its will be the basis for determining general understanding of the disease, and hence support for research. Second, in translating fundamental research based on a research definition into clinical care, I think a clinical definition will be used. Research definitions produce results that have to be translated to the patient population, and it seems to me that clinical definitions are a part of that.

    To go back to something else, they want to include investigation of CFS and allied terms. That is so broad it will include Oxford, Reeves, even the Australian Definition. So it will include papers based on that. Oxford was an attempt, or at least that is my understanding, to make CFS maximally useful to clinicians. Don't know whats wrong? Has prolonged severe fatigue? Don't worry, its just CFS. There is a reason that the Oxford definition can lead to a 40-70+% misdiagnosis rate.

    Now if the IOM panel does decide to strictly subcategorize patients, that could be interesting. For example, if you qualify for ME you don't have CFS. If you qualify for CFS, you don't have ICF (Ideopathic Chronic Fatigue). There would be some justification for that. I just don't see most potential panels taking that path. There is even some justification for an even stricter label, Epidemic Myalgic Encephalomyelitis as a separate subgroup.

    Now if they take related terminology to the ultimate extent, all of a sudden they will add neurasthenia, somatization, and even hysteria and mass hysteria. People have been overlooking the issue that ME has widely been regarded as mass hysteria following the 1970 McEvedy and Beard paper, regardless of the complete lack of substantive evidence in that paper. So a very broad interpretation brings the whole thing back to the broadest base, which is psychogenic diagnoses.
  16. Ren

    Ren Deep breath - lots of deep breaths...

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    Re NICE guidelines funding, I found... "NICE commissioned the National Collaborating Centre for Primary Care to develop this guideline..." (p. 38) http://www.nice.org.uk/nicemedia/live/11824/36193/36193.pdf

    I haven't explored the (more detailed) info Firestormm shared. (Thanks for the links.)

    Thanks, Jennie for sharing the SOW. I personally am still suspicious of SSA. I glanced recently at SSA requirements for assistance for individuals with "CFS/CFIDS" - the terms used by SSA. http://www.ssa.gov/disability/professionals/cfs-pub063.htm

    Just superficially skimming these requirements, I noticed the emphasis on lab findings. For example, "Although you may reach a diagnosis of CFS on the basis of your patient's symptomatology (after ruling out other disorders), the Social Security law requires that a disabling impairment be documented by medically acceptable clinical and laboratory findings."

    From the above, it seems that SSA should advocate for a definition which is most closely tied to biomarkers. But the HHS SOW (to which we assume SSA is tied) seems to be distancing itself from the biomedical info we have as represented by definitions such as CCC/ICC. Does that make sense? That the concern is that HHS is seeking a vague "consensus" while SSA holds the patient community responsible for biomedical evidence?
    Last edited: Nov 8, 2013
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  17. Ren

    Ren Deep breath - lots of deep breaths...

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    I guess I need to read for a better understanding of clinical criteria and research criteria. Maybe this seems kind of chicken-and-the-egg to me - that I don't understand which defintion comes first, or is most important, or how they affect each other. Seems like they should develop hand-in-hand, but I'm (obviously probably) not a science person...
  18. Ecoclimber

    Ecoclimber Senior Member

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    ANOTHER IMPORTANT FACTOR TO CONSIDER: WILL YOU LOSE YOU SOCIAL SECURITY BENEFITS UNDER A NEW RULING?

    As in the VA IOM Panel concluded from their policy of evidence based criteria, that GWS including CFS could not be defined as a result of a medical condition, it was relabelled and moved to the category of a symptom-based psychogenic disorder treatable by ony psychiatric modalities such as CBT/GET, talk therapy, St. Johns wort, etc. As one Gulf War Veteran stated in testimony: Being told by VA doctors that they, and I quote, “WE DO NOT TREAT GULF WAR RELATED ILLNESSES, BUT WE CAN REFER YOU TO PSYCHOLOGY.”

    If the medical or psychiatric condition(s) that caused your disability, improves or moved into another category, the SSA could find that you are no longer disabled, making your benefit payments stop. This applies the same in both SSDI and SSI claims.

    Briefly, the SSA periodically reviews the case of all beneficiaries (usually in 3 or 7 year increments) to determine if they are still disabled.

    So if the SSA benefits was awarded for a medical condition which is now considered a psychogenic disorder, SSA may review your case for a change in benefits. Medical treatment may not be available. SSDI for psychogenic disorders usually must fall under the category as life threatening.

    Under the VA IOM, veterans were no longer able to receive medical treatment other than the treatment protocol recommended by the IOM Panel.

    Under ACA, medical insurance benefits may be further impacted.

    Something to take in consideration that you could lose significant SSA benefits depending upon how the IOM Panel rules. This is why I thought it was interesting they brought in the SSA as a participatory funding partner!

    If you are currently receiving SSDI, SSI, Medicare or Medicaid Benefits, please consult with an attorney who specializes in SSA disability law.
    Last edited: Nov 8, 2013
  19. Nielk

    Nielk

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    I guess now it makes sense why Social Security Administration (SSA), is the sponsor of this work. They are willing to spend a million dollars now in order to save billions in disability payments.
  20. Ecoclimber

    Ecoclimber Senior Member

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    Yes, it makes sense now. I couldn't figure the SSA angle. The VA IOM operates under an entirely different structure administered by the Veteran Administration, Department of Veterans Affairs, veterans disability benefits. However this does not preclude veterans apply for and receiving SSDI as well. However, the two programs are out of sync. and this may be the reason why HHS brought in SSA to sync up both programs.

    From September 12, 2012 Research Service Report 7-5700 www.crs.gov R41289
    "Both SSA and the VA have faced challenges in the administration of benefits and have been criticized for a lack of interagency coordination, processes that are “out-of-sync” with modern conceptions of disability, and extensive processing delays for claims and appeals. These are a few issues which led, in part, to a Government Accountability Office (GAO) investigation and determination of federal disability programs as “high risk.” Both agencies have made efforts to address issues surrounding pending claims and appeals, but differ in their responses to other recommendations"
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