On February 10th, the Institute of Medicine committee will release its report Beyond ME/CFS: Redefining an Illness. The release event will be webcast at 11am Eastern. The report contents are under embargo until the release, although rumors are flying about its possible contents. HHS has already been briefed on the report, and I believe members of Congress have also been briefed (although I don’t know how many).
Good or bad, this report is likely to have a huge impact on ME/CFS advocacy. But how do we define a good or bad report? Some advocates have said that anything other than an adoption of the 2003 Canadian Consensus Criteria will be a failure. This outcome seems unlikely to me, only because it would be hard for anyone to justify spending $1 million and more than a year to simply adopt something that already exists. I think everyone would agree that a report that goes in the direction of broad Oxford-like criteria or psychogenic language will also be a complete failure. Again, this seems unlikely to me given that the committee includes a number of experts who would never agree to such a move. In fact, Dr. Klimas made comments at the P2P meeting that suggested she thinks narrow criteria would identify clean cohorts for biomarker and treatment discovery.
Until we have the report, we won’t know where it falls on the good-bad continuum. But I find it helpful to think about critical elements for success in advance, in order to more fairly judge the report on its merits (or lack thereof). So here are my personal must haves for a successful report:
Post-exertional malaise: This is nonnegotiable to me. The new definition must require PEM. The report should also explicitly define PEM, distinguish it from the single symptom of fatigue, and make suggestions on how it can be measured in clinic.
Core features: Dr. Lenny Jason has shown in multiple papers that criteria focusing on the core features of the disease are more precise, without incorporating patients with primary psychiatric disorders. Dr. Jason’s work shows that PEM, cognitive dysfunction and sleep disturbance are the three core features. Pain and autonomic dysfunction are frequently experienced by some patients but may be more useful in subsetting. So I think a successful definition should not present a laundry list of required symptoms like the 1988 Holmes or even the ME-ICC.
Frequency/Severity: Another theme of Dr. Jason’s work is setting minimum thresholds for frequency and severity in order to weed out people who do not actually have this disease. I hope the new definition will address issues like how long someone has to be sick to qualify for diagnosis, how frequently symptoms are experienced, etc.
Name: CFS or anything like it has to go. I argued in one of my memos to the IOM committee that ME was a better name, both because of evidence of inflammation in patients and because a diagnostic code already exists. I heard a rumor that ME will not be the new name, but the person who made that statement did not cite a specific source for the information. A new name will be problematic, as we may languish code-less for years, and still face the problem of the code being listed under “symptoms” instead of “neurological diseases.”
Making the diagnosis: The report should provide guidance to clinicians on how to make the diagnosis. What tests should be run? What diseases should be eliminated? Should we be referred to specialists, and which ones? Previous studies have shown that 80% of people with this disease may be undiagnosed. The report should provide recommendations on how to change that.
No psych: Any credence given to psychogenic explanations for the disease will be a failure. Agnostic statements on whether this is a psychological disorder will also be a failure.
Where To Next: Ideally, the report should make recommendations on where we go from here. Should a new prevalence study be done? Should CDC retool its multisite study? How should research on subjects that did not require PEM be interpreted going forward? How should the definition be rolled out to healthcare providers?
This may not be a comprehensive list of essential elements for success. What do you think is essential in a successful IOM report? What deal breakers would make the report a failure?
Personally, I’m confused about the view(s) regarding a psychiatric diagnosis and CFS/ME. I fully believe a person can have both.
I completely agree that a person can have both. The problem is when people who have depression or other mental health issues are misdiagnosed with CFS. Another very dangerous problem is the theory that CFS itself is caused by poor coping skills or other emotional difficulties. It’s the blurring or blending of categories that has contributed to many of the barriers to progress we face.
Hello and thanks for your reply.
Yes, I agree with you. I can see where it is possible to be misdiagnosed with CFS, when it might be severe depression, but I don’t think this happens that often, but instead, works the other way.
I think too that if doctors truly investigated the patient’s symptoms (assuming he or she has CFS/ME), as well as the length of time a person has been fatigued, that CFS would be fairly easy to distinguish from a psychiatric diagnosis (that usually being depression).
Personally, I know what both illnesses feel like and there is a huge difference! Depression doesn’t cause the debilitating type of fatigue, Post-exertional Malaise, fevers, sore throats, severe cognitive/neurological dysfunction or, as with some of us, severe pain.
A million dollars to adopt the Canadian – ludicrous!!!! Many doctors are already using it. Of course many more don’t give a rip about patients with ME. Anyway, I agree with all of the above. We should have been at this juncture a decade ago.
Thank you for this update and your recommendations. I agree with all of what you recommend here would be essential in an IOM report on ME/CFS.
I would add that the IOM should recommend more research on funding, and that
already-announced scientific studies on biomarkers, genetic expression, brain inflammation and changes (as the Stanford study) should be taken seriously,
studied closely and incorporated into the documents and body of evidence
about this disease.
Jennie, welcome back! And thanks for very helpful suggestions to keep in mind when reacting to the report when it comes out–big day! I myself would be inclined to include autonomic and immune dysfunctions within that core, particularly in view of Klimas’s reported comment on a gene expression study that first the ANS tanks, and then that takes down the immune system with it. Sleep is partly under the control of the ANS, and Julia Newton’s group has found connections between the ANS, brain hypoperfusion, and muscle build up of lactate (or was it lactic acid?)–presumably part of what we call PENE. The more the definition points to testable symptoms in physiologically describable structures and processes, rather than more easily subjectively construed words like “sleep” the better, I think? But I take Jason’s point that too many terms can be misleading and lead to undesirable outcomes.
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In Europe we use different ICD than in the USA. If IOM report brings the new name for ME and CFS, which is not included in ICD WHO, it will be the big problem. This will lead to speculations of existence of this disease.
Great peace, Jennie.
I can agree with all your remarks.
Indeed a new name will introduce another 30-30 years of confusion.
And a few core elements (Manadtaory criteria) will be sufficient.
Another breakthrough, I think, would be the use of objective measures/tests
instead of ambiguous notions, questionnaires and thresholds.
Words are interpreted by each one of us and all the others in a different way.
It doesn’t matter how a question is asked e.g. about pain or sleep dysfunction,
VAS (visual) scores etc. are not objective, should not be used and cannot be added etc.
(e.g. Do you experience pain)
What concerns me is what the community can do if the IOM fails on a number of important points, or even one or two key ones. Write letters? Talk to our Congresspeople? Nothing specific has helped much in the past. We will really be up the creek, as the IOM is going to be considered gospel. But, considering those on the panel and the wealth of knowledge about half of them have about ME, I am going to hope that it will be a breakthrough document.
Billie
The report will subsume ME/CFS into the category ‘Chronic Multisystem Illness’ along with Gulf War Syndrome and late-stage Lymes. These will be labelled ‘functional’, and treatment will be CBT and GET. The whole exercise is just window dressing for the power and influence of Wessely and P D White, who are in the pay of medical insurers and the MOD in the UK , the Veterans Administration in the US, and Swiss Re, among others. Money can be saved on disability payments if it can be labelled psychiatric, and ME/CFS is one of the most disabling, and long term illnesses. There is no intention whatever to consider the interests of the patients. The IOM and P2P exercises are just an expensive and elaborate smokescreen. I would love to be proved wrong !!
It was always going to be doubtful that the NIH would accept something termed the “Canadian Consensus” as definitional. Even if the principles of the CCC were deemed appropriate there would have had to have been sufficient re-drafting to allow US Gov. copyright. In any case there’s enough doubt about the CCC to require at least some level of contextualsation – subtyping, co-morbidities etc, so the IOM would certainly have had grist to throw into its own US centric mill.
@Nina – re: ICD. It’s important to be clear what the ICD is and, how the various national modifications are used – US isn’t the only country to have its own modification. At base the ICD is just about labelling illnesses so everyone across the world knows they are each talking about the same thing, it has no (or only very limited) diagnostic power. The US has an agreed derrogation which it uses in the US as a tool for managing health care delivery – Medicaid etc. The US is only now just moving from ICD 9 to ICD 10 and it is very unlikely this will be updated with the IOM work any time soon, given how long ICD 10 has taken to prepare. For Medicaid/Medicare purposes the bureaucratic work around in the US, for any variation that is introduced by the IOM, will simply be to have it read as being equivalent to whatever the recently published ICD-10 says.
So on balance I don’t think that IOM is problematic in principle, though we’ll have to see what it says in practice. On a wider point, ME/CFS advocacy needs to stop leaning on ICD, it’s never been the solid basis many people have claimed, and certainly isn’t a help in an evolving situation. For more the ICD – http://phoenixrising.me/archives/23892
Thank you, Jennie! Excellent post.
Do we know the IOM report will be called “Beyond ME/CFS: Redefining an Illness”?
Sorry, I found the agenda now, with the title “BEYOND MYALGIC ENCEPHALOMYELITIS/CHRONIC FATIGUE SYNDROME: REDEFINING AN ILLNESS ”
https://www.iom.edu/~/media/Files/Activity%20Files/Disease/MECFS/Public%20Briefing%20Agenda_Final%20version.pdf
Very nervous wait until 11 EST tomorrow…
NA Wright writes:
“US isn’t the only country to have its own modification. At base the ICD is just about labelling illnesses so everyone across the world knows they are each talking about the same thing, it has no (or only very limited) diagnostic power. The US has an agreed derrogation which it uses in the US as a tool for managing health care delivery – Medicaid etc.”
This is the case – in addition to the U.S., the following countries use a “clinical modification” of ICD: Canada (ICD-10-CA); Germany (ICD-10-GM); Australia (ICD-10-AM); Taiwan (ICD-10-TM); and some other countries use the Australian version.
NA Wright writes:
“The US is only now just moving from ICD 9 to ICD 10 and it is very unlikely this will be updated with the IOM work any time soon, given how long ICD 10 has taken to prepare.
The U.S. is currently scheduled to implement ICD-10-CM on October 1, 2015.
I would question your assumption that the IOM is unlikely to be updated any time soon.
As with ICD-9-CM, ICD-10-CM will be subject to annual updates and revisions via the jointly chaired NCHS/CMS ICD-10-CM Coordination and Management Committee meetings. These meetings are held in publicly twice a year, and once ICD-10-CM has implemented, the annual update and revision process will resume one year post implementation.
In May 2013, the APA’s DSM-5 was published. A number of new DSM-5 disorder categories have been proposed to be incorporated into ICD-10-CM, either with unique new ICD codes created for them, or as inclusion terms to existing ICD-10-CM codes.
Until ICD-10-CM implements, the code set is subject to partial code freeze and only limited revisions and corrections can be considered for inclusion. But once the partial code freeze lifts, in October 2016, these proposals to incorporate new DSM-5 category terms into ICD-10-CM are likely to be rubber stamped by NCHS.
For example, it is likely that the proposal to include DSM-5’s SSD as an inclusion term under ICD-10-CM’s F45.1 Undifferentiated somatoform disorder will be approved for inclusion from October 2016.
Once ICD-10-CM has implemented, there will be twice yearly opportunities for proposals from agencies, clinicians, medical professional bodies, patient groups, coding industry etc to submit formal proposals for inclusion of new terms.
The next C & M Committee meetings will be held in March and September, and in theory, IOM could propose changes or inclusions at the September meeting. (They would be too late for the March meeting as the proposal deadline has already been reached.)
Another non-negotiable – the IOM must make a definitive statement that the recommended name is not just the latest synonym for CFS, CFS/ME, ME/CFS, CFIDS, etc and the recommended definition does not describe the same disease or the same populations of patients encompassed by Fukuda, Empirical and/or Oxford.
Otherwise, regardless of what existing or new name and definition are recommended by IOM, this disease will just continue to be lumped into the “CFS” umbrella
With regard to the development of ICD-11:
The Topic Advisory Group for Neurology may be reluctant to make decisions at this point because it has been made aware of the IOM brief. Any new resulting criteria or terminology might potentially be used to inform ICD-11 decisions, though there are other potential reasons for the current absence of the three ICD-10 legacy terms within the Beta draft, which I have outlined on my site.
ICD-11 is under development with a projected date for presentation to the World Health Assembly (WHA) for approval in May 2017, with the release of ICD-11 currently planned for 2018 (though this date may, potentially, be extended if targets continue to slip).
Note that countries using ICD-10 will transition to ICD-11 at their own pace – there is no WHO mandated implementation date for the adoption of the new edition, as there is in the U.S.
As some readers will be aware, the three ICD-10 legacy terms, PVFS, BME and CFS have been absent from the Beta draft since early 2013.
At that point, CFS had been proposed to be the coded ICD Title term with BME specified as the Inclusion term to CFS.
PVFS was listed under Synonyms to CFS, along with a dozen or so other ME, CFS and PVFS related terms.
So at that point, a change of hierarchy between the terms was being proposed. (In ICD-10, PVFS is the ICD Title term, with BME coded under PVFS. CFS appears in the index only and is indexed to G93.3.)
Last year, two senior WHO ICD Revision personnel stated (via email correspondence with myself, with a UK patient org, and with a Scottish health directorate, the latter obtained by me under FOI) that the placement of ME and related conditions within the ICD-11 classification was still unresolved; that to handle this classification issue, ICD Revision would need more time and input from the relevant working groups and that it would be premature to make any statement on the subject at that point in time.
It was also stated, last year, by a senior ICD Revision project manager that there has been no proposal and no intention to include ME or other conditions such as fibromyalgia or chronic fatigue syndrome in the classification of mental disorders. That this could be made absolutely clear through the use of exclusion terms. However, exclusion terms could not be added to the relevant Mental and behavioural disorders categories (e.g. Bodily distress disorder) until the conditions that were being excluded had been restored to the Beta draft. But that at such time, he would be happy to request exclusions.
When the three terms (or any proposed potential replacement for one or more of the three terms) are restored to the Beta draft, I shall be publishing a report on my site.
Thank you for this information. We hope the neurological classification for this disease will stay in ICD-11. And also we hope it will not be any other new name for this disease in the IOM report. In our country is all medical care based on ICD-10 codes. Official authorities of our country do not accept diseases, which is not included in ICD-10. These diseases and patients do not exist for them. This is why we are afraid of the new name, which is not included in ICD. What happens in the US has the big influence on us.
@ NA Wright
The WHO’s ICD-10 edition has been subject to annual updates and revisions via the WHO-FIC Update and Revision Committee (URC) process. ICD-11 will also have an update and revision process:
http://www.who.int/entity/classifications/icd/revision/icdrevisionprocess.pdf
“ICD Revision Process: Beta Phase and Finalization
Extract (Page 10):
2. ICD Revision Process: Future Maintenance Strategy:
…After finalization, the ICD Revision mechanisms for “new proposals” and “review” may continue to serve as the basic maintenance and continuous update process. If agreed, this will replace the current “ICD-10 Update mechanism”.
In this new maintenance scheme, it is envisaged that the update proposals may come throughout the year and will be handled immediately according to a standard operating procedure. A review will be finalized by October of each year and submitted to the WHOFIC Council and a new linearization for the next year will be approved for use in the upcoming year. In this way, ICD will be named as ICD 2017, ICD 2018, ICD 2018 and so on. This mechanism will facilitate the version control with constant updates through graceful evolution ensuring stability and backward compatibility. WHO will continue to support ICD-10 Updates in a similar way for a defined period until most Member States adopt the new style. Countries who may need more frequent update cycles (e.g. twice per year) may also use the same mechanism.”
So neither the U.S. specific, ICD-10-CM, nor ICD-11 (once disseminated) will be frozen classifications.