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IACFSME speaks up about the IOM report

Discussion in 'Institute of Medicine (IOM) Government Contract' started by Kati, Mar 6, 2015.

  1. Kati

    Kati Patient in training

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    IACFS/ME Board Response to:
    Institute of Medicine Report on Chronic Fatigue Syndrome:
    Case Definition Issues and Future Directions

    A well-validated diagnosis of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is essential for research and clinical care. To that end, the US Department of Health and Human Services (DHHS) tasked the highly respected Institute of Medicine (IOM) to develop “evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology”, to “recommend whether new terminology for ME/CFS should be adopted”, and to create plans for disseminating these conclusions to clinicians [1]. IOM recommendations are often accorded high credibility by the US Congress as well as the DHHS and can have a significant impact on funding of federal grant programs. Given the minimal US research funding for the illness, this report may hold promise for new grant initiatives.

    In early February, 2015 the IOM released its prepublication report [2] which appropriately emphasized the seriousness of CFS/ME as a debilitating and under-served illness condition. Their recommendations included a new name for CFS/ME as well as a somewhat different case definition in comparison to existing definitions. The new name, Systemic Exertion Intolerance Disease (SEID), requires that the patient have a substantial reduction in pre-illness functioning (occupational, educational, personal activities) for 6 or more months accompanied by new onset of fatigue not alleviated by rest. At least three symptoms are also required: post-exertional malaise, unrefreshing sleep, and either cognitive impairment or orthostatic intolerance. The full IOM report (free download) may be found at: http://www.nap.edu/download.php?record_id=19012#
    The advantage of the new name is that it captures the scientific and clinical consensus (with growing empirical confirmation [e.g., 3]) on the importance of the key distinguishing symptom of post-exertional malaise (PEM). Given that this illness name is new, we have no data to guide our evaluation of it. The existing illness name, ME/ CFS, is to be replaced with SEID. Although both the ME and CFS terms are problematic (ME has little evidence behind it and CFS is trivializing), abandoning these terms presents another set of problems.

    ME and CFS vs. SEID: Why the differences matter
    Both the ME and CFS terms have long histories in the medical literature and capture somewhat different symptom patterns. Also the current definitions (particularly Fukuda et al. [4]) have been specifically linked to significant pathophysiological findings in a number of areas such as energy metabolism, immunology, and neuroendocrinology. Any change in the definition, in this case to SEID, is likely to alter the characteristics of the samples that are studied, the findings that are generated, and the level of comparability with published data. Given the well-known difficulties in replication of findings across studies (even when the same case definition is used), this is more than a minor issue. It remains to be seen if the new illness definition will be adopted in research studies. An official name change, if it occurs, would be made by the US Centers for Disease Control.

    Required symptoms in the new definition:
    How inclusive/exclusive of ill patients?
    In contrast to the broadly inclusive Fukuda et al. definition of CFS which folds in many individuals who are not as severely ill (e.g., cases who do not also meet ME criteria), the new IOM definition (SEID) may narrow the criteria so much that a number of true cases may be excluded. For instance, the requirement of unrefreshing sleep indicates that a patient will be excluded from the IOM definition in the absence of poor sleep. Thus, if an individual with fatigue, PEM, and cognitive impairment does not have poor sleep, he/she would not be diagnosed with the illness. We have no data on the new definition to know how much of a problem this might be.

    In support of SEID, empirical studies suggest that the core symptoms distinguishing ME/CFS from controls are PEM, fatigue, unrefreshing sleep, and fatigue [e.g., 3]. Specifically, each SEID-listed symptom occurs in 80-90+% of CFS and/or ME-diagnosed patients. However, when we look at how many patients have two SEID symptoms, the percent will either be the same, or (probably) lower. So with each additional required symptom, more cases are likely to be excluded. This opens up the possibility of potentially inappropriate exclusions of ill individuals -- another perhaps unintended consequence of the new definition.

    Importance of uniform standards for case definition assessment
    The issue of case definition assessment, although mentioned in the IOM recommendations chapter, was not given the priority that we think it deserves. Importantly the committee did recommend operationalizing the proposed diagnostic criteria so that clinicians have explicit guidance during their assessment of the patient. “The development of clinical questionnaire or history tools that are valid across populations of patients should be an urgent priority.” (IOM report, p. 223) To this end, we support new assessment research on a case definition (whichever one is ultimately used) to create reliable diagnostic guidelines which we do not have now.

    To assess symptom domains with consistency, a number of challenges remain. No matter what the case definition is or will be, we still do not have uniform assessment across laboratories or practitioners’ offices. Thus one researcher’s (or clinician’s) method of symptom assessment may be substantively different from another’s. This may be one reason why CFS/ME biomedical studies are so varied and inconsistent in their findings. These are significant concerns that require targeted research to solve.

    Uniform assessments for self-report measures of fatigue, pain and other symptoms across illnesses have been developed in a (US) National Institutes of Health funded program called “PROMIS” (Patient Reported Outcomes Measurement Information System) [5]. This project encompassed large scale cooperative efforts across multiple study sites. Similarly, for CFS/ME, multi-site field trials would be needed to establish standard assessment criteria with adequate reliability that can then be adopted by the research and clinical communities. Once such standards are in place, findings are more likely to be replicated and prevalence figures will be more trustworthy. Uniform assessment standards have been proposed for CFS/ME [6].

    Conclusion and Future Directions
    In sum, we hope that the heightened recognition of CFS/ME expressed in the IOM report will lead to new federal grant initiatives that support substantively increased levels of biomedical research on this illness. Key areas for future research, in our view, are the development of an empirically derived case definition of the illness as well as uniform assessments of definitional symptoms with adequate specificity and sensitivity. Achieving these critical endpoints would represent an important advance at the ground level of CFS/ME science with implications for diagnosis, biomarkers, and effective interventions.

    More generally, current levels of federal funding are simply not sufficient to meet the challenges of this multifaceted and complex illness. As stated in the IOM report: “Remarkably little research funding has been made available to study the etiology, pathophysiology, and effective treatment of this disease, especially given the number of people afflicted” (page 225). We hope that our federal health agencies will respond positively to this overarching concern.

    Fred Friedberg, PhD
    Staci Stevens, MA
    Rosamund Vallings, MB, MS
    Steven Krafchick, MPH, JD
    Julia Newton, MD, PhD
    Jon Kaiser, MD



    References

    1. Clayton, E. W. (2015). Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: An IOM Report on Redefining an illness. JAMA. Published online February 10, 2015. doi:10.1001/jama.2015.1346

    2. Institute of Medicine. Beyond Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Redefining an Illness. Washington, D.C.: The National Academies Press; 2015. Retrieved from http://www.iom.edu/mecfs

    3. Abigail A. Brown & Leonard A. Jason (2014) Validating a measure of myalgic encephalomyelitis/chronic fatigue syndrome symptomatology, Fatigue: Biomedicine, Health & Behavior, 2:3, 132-152.

    4. Fukuda, K., Straus, E., Hickie, I., Sharpe, M.C., Dobbins, J.G., & Komaroff, A. (1994). The Chronic Fatigue Syndrome: A comprehensive approach to its definition and study. Annals of Internal Medicine, 121, 953-959.

    5. U.S. Department of Health and Human Services. (2009). Food and drug administration guidance for industry on patient reported outcome measures: Use in medical product development to suppose labeling claims. Federal Register.

    6. Jason, Unger, Dimitrakoff et al; (2012) Minimum data elements for research reports on CFS. Brain Behav Immun. 2012 Mar;26(3):401-6. doi: 10.1016/j.bbi.2012.01.014. Epub 2012 Jan 28.


    Source: National MEFM Action Network on Facebook
     
  2. Ember

    Ember Senior Member

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    “In support of SEID, empirical studies suggest that the core symptoms distinguishing ME/CFS from controls are PEM, fatigue, unrefreshing sleep, and fatigue [e.g., 3].” Freudian slip?:oops:
     
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  3. Kati

    Kati Patient in training

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    i disagree that the CDC should choose the name. they had their chance once and that didn't go too well. :(

    (Edited)
     
    Last edited: Mar 7, 2015
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  4. WillowJ

    WillowJ คภภเє ɠรค๓թєl

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    WA, USA
    I think what they were saying is that CDC is one of the agencies in charge of coding. All clinical modification coding changes have to go through the (3?) US agencies/organizations that handle this on a country level. To get a new ICD-CM code, as was suggested in the IOM document. More or less (they will need an ICD-10-CM code, as the US should be, finally, changed over to this by, idk, the fall of this year?).

    A name cannot be used officially by doctors unless it has an ICD code. Otherwise it's just a nickname for the illness.
     
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  5. Dolphin

    Dolphin Senior Member

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    The specific "unrefreshing sleep" question was answered by 92% at the required threshold.
    But the cumulative figure would likely be higher as other things can satisfy as unrefreshing sleep in the IoM definition e.g. 68% reported difficulties falling asleep, 58% reported problems staying asleep, etc.

    This is a problem I wrote to Lenny Jason about when his paper (Jason et al. 2013 - source of tables in IoM report) came out: the paper should have given cumulative figures for a group of related questions.

    Another example is cognitive functioning:
    The highest response was 80% for problems remembering. However, more than 80% likely have cognitive problems when one brings in other items e.g. difficulty expressing thoughts: 73%; Difficulty paying attention: 69%, etc.

    The problem the IoM had, and anyone has, is the evidence base is not great.
     
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  6. Kati

    Kati Patient in training

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    It's a tough question to answer when responding to DePaul type of questionnaires when they ask ' in the last month have you had problems falling asleep.' Well, I don't with my usual drug cocktail. And 'have you had unrefreshing sleep?' - and my answer is that I don't quite remember what it feels like to feel refreshed in the morning, ready to conquer the world.

    Things will get much easier with biomarkers. Subjective questionnaires are just horrible.
     
  7. SOC

    SOC

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    I've wondered ever since I've had to answer such questionnaires -- Why do they assume you're getting no treatment? With symptomatic treatment our symptom profile may look very different, which skews the perception of what actual symptoms exist in ME/CFS. If they want to know what symptoms are part of ME/CFS, they need to ask which symptoms we had before treatment, or what symptoms we've ever had with the illness (since the symptoms change over time).

    Agreed. Subjective questionnaires are horrible. The only time I'll answer them now is when the purpose is to learn how my symptom profile is changing with treatment, ie, what treatments are working and what symptoms still need to be addressed.
     
  8. Ember

    Ember Senior Member

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    The figures used to validate the core symptoms in the IOM's Report Guide for Physicians are based on Jason et al. (2013b), a study that applies the DePaul Symptom Quesionnaire (DSQ) to a SolveCFS BioBank population. According to @Simon:
    Dr. Bateman confirms:
    Dr. Unger has used the DSQ and NIH-funded PROMIS questionnaires in her CDC multi-site study; she reports in her interim analysis:
    Are we expected to wait another three to five years for Dr. Unger's expanded study?
     
    Last edited: Mar 8, 2015
  9. Ember

    Ember Senior Member

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    Again, according to Simon:
     
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  10. alex3619

    alex3619 Senior Member

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    Logan, Queensland, Australia
    Yes, and with the rules of evidence used by the IOM a lot of evidence, useful evidence, will be ruled out. On the flip side this is in part why they can say its very clear there is an inadequate research base, we need more research, and hence more funding.
     
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  11. Nielk

    Nielk

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    I would think that just the fact that the NIH has been spending an average of 5 million dollars a year for research and that it has not resulted in any treatment for a severely effected population with a burden on the economy in th etens of billions would be enough evidence that there is a astronomical lack of funding for research?
     
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  12. alex3619

    alex3619 Senior Member

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    Yes, to us. At a burden of probably nearly a hundred billion a year the world spends chump change. This is tantamount to deciding the world would rather lose a fortune than do anything about it. Yet its not so obvious to many.

    Some will likely cite the 9000 or so papers and say is that not enough? Yet when you look for the kinds of studies that make a real difference under EBM views there are almost none. Further, most of our studies are too small, too limited in scope, and a host of other problems.

    As advocates we have been aware of this for many many years. Yet in an environment when large numbers of doctors do not believe this is even a subject worthy of study, what then? When even Lipkin gets a study rejected because "CFS is psych" then you know there is a problem.

    I think our leading docs and researchers are also well aware of this.

    What the IOM and P2P do is state the bleeding obvious. So in a sense they are a waste of money. CFSAC has been doing that for a long time too. Yet they state the obvious in a very loud voice.

    I am still struggling to deal with irrationality in government and especially bureaucracy. I guess I always will. Government is often inept, its politicians are the group that often thinks ineptly , and its bureaucracy is the arm that does the inept things. It does not matter which country, or which party, or what political leanings either. Yet there are many many reasons for this. Nobody said politics was easy. When its easy you should probably be very suspicious.
     
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  13. Ember

    Ember Senior Member

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    The IACFSME now supports the development of more questionnaires:
    Rather than calling for comparative testing of existing criteria, the IACFSME calls for the development of an empirically derived case definition: “Key areas for future research, in our view, are the development of an empirically derived case definition of the illness as well as uniform assessments of definitional symptoms with adequate specificity and sensitivity.”

    Why not call for comparative testing of existing criteria, using existing criteria, not using the DSQ algorithm as a stand-in for existing criteria with an added ICC-adjusted mock-up? The DSQ was developed prior to the publication of the ICC. It's promoted for reliability rather than for validity.
     
  14. Ember

    Ember Senior Member

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    This new Jason et al. (2015) study is consistent with IACFSME's promoting, as a key area for future research, “the development of an empirically derived case definition of the illness:”

    Chronic fatigue syndrome and myalgic encephalomyelitis: towards an empirical case definition
     
    Last edited: Mar 8, 2015
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