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This is not a figment of their imagination. This is not somaticizing. This is a common, all too common, complex disease” Dr. Ellen Clayton, Committee Chair

The proposed new name for chronic fatigue syndrome really jumped out in the IOM report but the report provides several other difference making aspects.  It proposed new clinical and research diagnostic criteria, proposed chronic fatigue syndrome should be placed in a different ICD category and more but first let’s take one more look at the name.

The Name

“It’s clear (the name) chronic fatigue syndrome does tremendous disservice to these patients” Dr. Ellen Clayton

The committee followed a protocol that proposes naming a disorder of unknown cause after the core features of the disease.

It was explained to me and others by one of the study members that none and I mean NONE of the findings in ME/CFS – as tantalizing as they are – are conclusive enough or validated well enough to be included in a name. Take natural killer cell dysfunction, something  that we all probably take for granted typifies ME/CFS.  The committee concluded that the studies on NK cell dysfunction are too small and too few to be able to confidently say that it lies at the core of ME/CFS. If they can’t say that about NK cell dysfunction I can’t imagine they can say that about anything.

foundation

The foundation for other than a physiologically based name has not been built – yet..

I’m clearly part of the problem because in my excitement I often bypass how small the studies we review are. The Japanese neuroinflammation study fits what we think about ME/CFS but it was on all of nine people.

Naming a disease is a big deal. All the ME/CFS experts on the panel – from Ron Davis to Dr. Klimas to Dr. Bateman to Dr. Lerner – would surely love to have a physiologically based name for ME/CFS, but producing a name that two years later turns out to be a big mistake would be a disaster. This disorder has had enough derision to last lifetimes.

Plus we’re simply associated with really rigorous people now.  They don’t let anything slide. Besides the fact that Ron Davis one of the most creative people on the planet – he just won yet another major award one of the reasons he is so respected is that he never goes further than the science will allow him. He actually prides himself in his  ability to poke holes in arguments. Once he moves, though you can count on it.

New Diagnostic Criteria

“This is the essence of this disorder” Dr. Ellen Clayton

Recommendation 1: Physicians should diagnose myalgic encephalomyelitis/ chronic fatigue syndrome if diagnostic criteria are met following an appropriate history, physical examination, and medical work-up. A new code should be assigned to this disorder in the International Classification of Diseases, Tenth Edition (ICD-10) that is not linked to “chronic fatigue” or “neurasthenia.”

The IOM committee proposed cutting out some symptoms in order to make the diagnostic criteria more accurate and streamlined and easier to use at the same time. If you want to blame the fact that the Committee did not recommend the Canadian or International Consensus Criteria you can blame it on Lenny Jason.  His work indicated that the diagnostic criteria  for ME/CFS could be shorter – much shorter – without sacrificing accuracy and without potentially running into the problem of emphasizing psychological issues. In medicine, if not in other places, shorter is better.

Profound fatigue – not caused by excessive exertion – and not substantially alleviated by rest – and the requirement for six months – are carryovers. My guess is that the “not lifelong” criteria is going to be removed some day – there are some people who are extremely fatigued almost from day one – but they’re probably rare.

Cognitive impairments are not required but unrefreshing sleep is, and the impairments, importantly, should be at least moderately severe at least half of the time. (Jason’s studies indicated this requirement is critical to ensure that healthy people with minor symptoms that mirror ME/CFS are not labeled  as having it.  The most important part of the new definition is that it is largely based on study evidence.

diagnostic-criteria-SEID

More streamlined diagnostic criteria for ME/CFS

 

The Committee asserted that symptoms such as postexertional malaise, orthostatic intolerance and slowed information processing—are distinctive in this disorder.  It’s not that they are not found in other disorders but that they are found more frequently and with greater severity in ME/CFS.  .

They make up the  chronic fatigue syndrome symptom gestalt. It’s their consistent appearance that probably allowed the Committee to call ME/CFS a disease. They form the core of an ME/CFS diagnosis – but they’re just the beginning of an ME/CFS diagnosis.

diagnostic algorhythm chronic fatigue

How to diagnose ME/CFS – in five steps…

They recommended that physicians particularly focus on the severity and frequency of a patients symptoms in the last month.  The report helpfully provides common descriptive terms used by patients ( “crash”, “relapse”, “I can’t find the right words anymore”, “I’m unable to relax”,”My arms and legs feel heavy” and questions that can help clue doctors into the presence of the disease. Some of the questions include:

  •  “What happens after you engage in normal physical or mental exertion?”
  • “How long does it take you to recover?”
  • “What reduces your fatigue?”
  • “How do you feel if you’ve been standing still for a minute or two?”

Subgroups

Yes, subgroups are present and the less common symptoms will probably play a role in defining them – but despite the fact they’ve been a concern for decades the report noted that the subject of subgroups has never been seriously explored in this disease.

In an indirect but to my mind a rather delicious dig at the NIH and CDC’s inaction on ME/CFS, the report referenced a statement from 1994 Fukuda definition paper urging that individuals with ME/CFS “be sub-grouped before analysis or stratified after analysis”.

Admonitions from their own researchers aside, the NIH and CDC have held on so tightly to their purse-strings through the ensuing decades that studies large enough to uncover subsets have rarely, if ever taken place.

The IOM report highlighted the meager attention paid to this disorder stating that “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.”

Remarkable is defined as something “notably or conspicuously unusual; extraordinary“, and indeed it is an extraordinary thing to have a severe, often functionally incapacitating illness strike so many people and yet get so little help ($5 million/year) in the midst of  such  largess (30 billion plus NIH budget). 

Responses to physical and cognitive stressors, brain imaging, the microbiome, virology, immune function, and gene expression provided fertile ground, the committee thought, for the uncovering of subsets.

Research Definition As Well

“There is  so much research that needs to be done….It’s just astonishing” Dr. Ellen Clayton

subsets

Will the studies needed to identify subsets finally get done

The Committee’s recommendation that “future diagnostic research will be most instructive when protocols include patients identified using the committee’s proposed diagnostic criteria for ME/CFS” suggest that they consider this both the clinical and the research definitions for ME/CFS.  It will be interesting to see if the NIH or organizations like the Chronic Fatigue Initiative, The Solve ME/CFS Initiative, Simmaron and others begin using this definition or something similar (i.e. something that requires symptom frequency and severity meet certain criteria.)

New Toolkit – New Approach

Recommendation #2:The Department of Health and Human Services should develop a toolkit appropriate for screening and diagnosing patients with myalgic encephalomyelitis/chronic fatigue syndrome in a wide array of clinical settings that commonly encounter these patients, including primary care practices, emergency departments, mental/ behavioral health clinics, physical/occupational therapy units, and medical subspecialty services (e.g., rheumatology, infectious diseases, neurology).

The committee aims for no more confused or ignorant physicians

The committee aims for no more confused or ignorant physicians

Diagnosing ME/CFS right now is just too complicated to fit into a busy practice and the committee wants that to change. They want even the busiest doctor to be able to easily and accurately diagnose people who have ME/CFS. To that end they called for the development of brief in office tests  that can detect the presence of post-exertional malaise, orthostatic intolerance and the particular kinds of cognitive problems found in this disease.

As the P2P report did, the IOM report also called for the “urgent” development of validated clinical questionnaires and  interview guides to accurately assess symptoms and other aspects of ME/CFS. (The P2P draft called for these to be developed within the frameworks of Centers of Excellence type facilities. )

Recommendation 3: A multidisciplinary group should reexamine the diagnostic criteria set forth in this report when firm evidence supports modification to improve the identification or care of affected individuals. Such a group should consider, in no more than 5 years, whether modification of the criteria is necessary. Funding for this update effort should be provided by nonconflicted sources, such as the Agency for Healthcare Research and Quality, through its Evidence-based Practice Centers process, and foundations.

“The science is  changing dramatically….We expect and hope that research  in the near future is going to allow refinement of this diagnosis.” Dr. Ellen Clayton

Disseminating the Report

The authors proposed a variety of means of disseminating the information which I am too tired  to comment on other than to note that Health Rising was not on the list of ten “organizations with strong connections to patients” that the authors suggested the DHHS contact (sigh)… (They also didn’t include Prohealth – which gets  more web traffic than anybody. Hopefully the DHHS will cast its net a bit further).

The IOM Presentation

Impact?

“We have been breathtakingly clear about the need for more research (with the agencies).” Dr. Ellen Clayton

Thanks must be given to the already very busy ME/CFS physicians and experts who took the time and energy – for no pay, if what I’m told was correct – to produce this important report. They included  Dr. Lucinda Bateman, Dr. Nancy Klimas, Ron Davis PhD, Dr. Martin Lerner. Dr. Peter Rowe, Dr. Benjamin Natelson, Lily Chu and Betsy Keller.

This report has got a lot of “ommph”. All the relevant branches of the federal government supported its production. A prestigious group (the Institute of Medicine (IOM)) that the medical profession often turns to to sort out knotty issues created it. During the year it took to produce it, the committee members  examined thousands of documents.

I think this gives advocates a tool to “act up”. Dr. Clayton

The report appears set up to make a difference but bureaucracies like the NIH are notoriously slow to change. The fact that this and the P2P reports got done is encouraging. My guess is that the people or persons who pushed for these reports knew what they were probably going to get. They want change, but the same people that have have been relegating this disorder to the back burners for decades are still there and they are going to resist change.

“It’s going to be up to all of us to come together and get to work” Dr. Lucinda Bateman

The difference this and the P2P report makes will be up to us. Can we as a community come together to push for the changes this reports propose?  Can the organizations and advocates come up with a coordinated strategy to push for change? If there’s ever been any time to do that that time is now.

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