Ember
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Diagnostic criteria for myalgic encephalomyelitis/chronic fatigue syndrome: Background and charge to the IOM Committee
Thanks so much for the opportunity to speak to you today. This first meeting of the committee is the culmination of a year-long effort at the Department of Health and Human Services (HHS) to support development of clinical diagnostic criteria for myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS).
In 2012, the Chronic Fatigue Syndrome Advisory Committee (CFSAC) recommended to the Secretary of HHS that she convene a workshop to reach a consensus for research and clinical case definitions for ME/CFS. Because of the considerable need for faster and more accurate diagnosis for patients, HHS asked the IOM to use its well-established and well-regarded consensus process to provide guidance to the broader medical community on how to identify and diagnose ME/CFS in the clinical setting.
HHS envisions that the recommendations from this study will reach health care providers likely to see patients who may have ME/CFS but haven’t yet been diagnosed. This would include primary care providers, as well as some specialty groups.
HHS has asked that four specific tasks be addressed, which I will walk you through now. For the purposes of this study, HHS uses ME/CFS to refer to conditions that include: Myalgic Encephalomyelitis, Chronic Fatigue Syndrome, Chronic Fatigue and Immune Dysfunction Syndrome, Neuroendocrine Immune Disorder, as well as other terminologies. These may be distinct disease entities, part of a spectrum, or a similar phenotypic response to a variety of external or internal assaults on the individual.
Task 1 - Conduct a study to identify the evidence for various diagnostic clinical criteria of ME/CFS using a process with stakeholder input, including practicing clinicians and patients.
The first task focuses on reviewing available scientific literature regarding signs, symptoms and diagnosis of ME/CFS. This review would include:
• Published peer-reviewed research on ME/CFS, including proven and potential biomarkers; the pathophysiology, natural history, and epidemiology of ME/CFS; and neurologic, immunologic, infectious, cardiovascular, and endocrine aspects of the disease.
• The review would also include literature describing the symptomatology of ME/CFS. We ask that you consider the variety and range of symptoms, including disease severity.
• It is also important to consider the distinction between generalized chronic fatigue with known etiology, unexplained chronic fatigue without associated multisystem illness, and the more specific syndrome of myalgic encephalomyelitis.
As the committee reviews the literature, we ask that you consider the existing definitions and criteria for ME/CFS, and build upon them as appropriate. As you probably know, there has been support from a number of advocates and experts in the field for the 2003 ME/CFS Canadian Consensus Definition. Some of the members of this committee have gone on the record as supporting these clinical criteria.
The CFSAC recommendation made in 2012 that I mentioned at the beginning of my presentation asked that the reexamination of the ME/CFS case definition process “begin with the 2003 Canadian Consensus Definition.” Perhaps some of the stakeholders speaking later today will discuss why this definition is preferred over the 2010 Revised Canadian version.
HHS believes that it is of prime importance to get stakeholder input into the evidence collection process. We are pleased that representatives from the advocate and patient community are on today’s agenda. We are also pleased that your committee includes individuals with long-standing experience in ME/CFS, both professional and personal.
Task 2 - Develop evidence-based clinical diagnostic criteria for ME/CFS for use by clinicians, using a consensus-building methodology.
HHS asks that as you develop your recommendations, you:
• Evaluate clinical diagnostic criteria to determine: 1) whether existing criteria are adequate for medical practitioners to diagnose the individual patient with ME/CFS; 2) whether criteria need to be revised; or 3) whether new criteria are needed.
• The criteria should account for the various and distinct subpopulations of individuals with ME/CFS. One subpopulation to consider is children.
• The committee may well decide that different criteria are needed for different disease entities that fall under the broad umbrella of ME/CFS. This could help health care providers distinguish between these different conditions.
• Notably, there is debate whether ME and CFS are distinct entities or different names for the same or similar syndrome.
• As you develop your recommendations, please consider the specificity, sensitivity and reliability of the clinical criteria.
• HHS would also like to have recommendations on a process for revising and updating the criteria in the future as needed.
Task 3 - Recommend whether new terminology for ME/CFS should be adopted.
For the third Task, we ask that you:
• Review the various terminologies that refer to ME/CFS, identify the clinical distinctions among them, if any, and make recommendations for clinical diagnostic criteria for the distinct entities. These terminologies include, but are not limited to neuroendocrine immune disorder; myalgic encephalomyelitis; chronic fatigue syndrome; and chronic fatigue immune deficiency syndrome.
• If the committee decides new terminology is needed for the condition(s), provide recommendations for the new terminology(ies). Different names may be warranted.
Please know that there are many people - scientists, clinicians, advocates – who believe that the name chronic fatigue syndrome does harm to patients. I agree.
Task 4 - Develop an outreach strategy to disseminate the definition nationwide to health professionals.
Lastly, HHS asks that you
• Recommend strategies to disseminate these criteria nationwide to enhance awareness and responsiveness to ME/CFS patients.
• If the committee recommends name changes, incorporate that recommendation in the dissemination plan.
• We ask that you recommend strategies to increase the number of primary and specialty health care professionals who recognize and diagnose ME/CFS, and can distinguish between other conditions causing neuroendocrine immune dysfunction, generalized chronic fatigue and ME/CFS.
We recognize that making a diagnosis is just a first step, and that many of the health care providers who make the diagnosis will not have sufficient knowledge and experience to manage their patient’s complex condition. We also recognize that there are too few providers in the US with expertise in managing ME/CFS. HHS has not asked the committee to address this problem, however.
Pushing out the criteria to a wide audience of health professionals is a critical need. As you know, the 2003 Canadian Consensus criteria are widely embraced by many ME/CFS experts and patient advocates. But they are not well-known beyond these groups. Whatever the committee develops needs to get into textbooks and widely-read journals and be at the top of a Google search. For example, the lead article in the November 6, 2013 issue of JAMA was a summary of a new IOM report on improving quality of cancer care in the elderly. Perhaps, an article about ME/CFS diagnostic criteria will be the lead in JAMA in a couple of years!
To close, HHS has requested that the IOM committee coordinate with two ongoing HHS efforts concerning ME/CFS in order to minimize overlap and maximize synergy. You will be hearing more details from Drs. Unger and Maier today.
HHS is most grateful for your willingness to take on this challenging task. I have been working with CFSAC for 2½ years. From that position I understand how important it is that all ME/CFS patients have health care providers that know about this serious condition, can make, or at least suspect the diagnosis, and if appropriate, refer to providers experienced in managing their disease. This is a desperate situation for so many, and my hope is that this study will be a major step in improving the clinical care and lives of these patients.
Another benefit is that widely accepted and widely disseminated clinical diagnostic criteria will facilitate the research efforts that are needed to understand and to treat ME/CFS.
We recognize that coming up with diagnostic criteria may not be easy. We can only hope ongoing and future research efforts will soon make diagnosis much easier. But patients and providers need help and guidance now. We need to go forward with what we know.
Thanks again for what you are doing for the patients with ME/CFS, and their families and friends.
I am happy to answer any questions you may have.
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