I particularly welcomed the comments on page 255 of the report under the heading "Areas Deserving Further Study", namely:
"the committee was struck by the relative paucity of research conducted on ME/CFS to date"
"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"
"More research is essential"
Since the lack of research funding is clearly a major obstacle to tackling this disease, is there some specific advice you can give, please, to patients and patient groups on how they can best channel their efforts from now on into ensuring, or at least maximising the chances, that the desperately needed research is in fact carried out? Since most of the limited funding is presently coming from private sources, what avenues or methods of advocacy from patients would you recommend as those with the best chance of being productive of public funding?
Atypical myalgic encephalomyelitis: meets criteria for postexertional neuroimmune exhaustion but has a limit of two less than required of the remaining criterial symptoms. Pain or sleep disturbance may be absent in rare cases.
Some patients who have ME according to the ICC and /or CCC are concerned that they don't fit the critieria for SEID. Is there, or should there be, room for an 'atypical SEID' diagnosis, just as the ICC allowed for an 'atypical ME' diagnosis?
Thank you for the opportunity to suggest questions.
1) I'm a severely-ill patient whose illness better fits the CCC criteria than the SEID criteria. Since the IOM recommended the discontinuation of previous names and diagnosis criteria for this illness, what will happen to patients now completely or partially defined out of this disease? How do we avoid having the already-marginalized severely-ill patients becoming even more marginalized?
2) It seems that the new name and criteria leave out the most severely-ill patients. Do you think that the general exclusion of severely-ill patients from CFS/ME studies affected the lack of attention to the severely-ill in the IOM report? How should this oversight be remedied, given that the most severely-ill patients are usually house or bedbound?
3) What can be done now to help severely-ill CFS/ME/SEID patients gain access to regular medical care as many of these patients can't leave the home for medical care and end up getting worse because of this limitation?
4) Although PEM is the distinguishing symptom of this illness, many patients feel very ill and disabled even if they have no exertion. Doesn't the suggested name lead to the misconception that resting patients don't still feel terribly sick? What must be done to avoid this misconception taking hold?
5) There is a brief section on pain in the IOM report. All included studies show that an overwhelming majority of patients experience pain. In the first cited study, 80% of patients experienced pain. Why wasn't pain included in the diagnostic criteria? How do we avoid having patients who have pain as a key feature of their illness now being less likely to get a diagnosis if the IOM criteria are used?
6) The suggested new name indicates that SEID is a systemic illness. But the diagnostic criteria don't include a systemic range of symptoms. Doesn't that contradiction send a confusing message about this disease, to doctors in particular?
7) Since there are systemic effects of this disease and many patients therefore first come to specialists with symptoms specific to one system (gynecologist, pain specialist, neurologist, etc.), won't the lack of immune, autonomic, neurological, gynecological, gastrointestinal, vascular etc. symptoms in the diagnostic criteria decrease the chances of those patients getting a timely diagnosis?
8) Who is responsible for implementing the IOM report's suggested changes? There hasn't been public comment by any of the relevant governmental agencies that these changes will be implemented. Has there been any internal communication between the IOM and the relevant agencies that any of these agencies are willing to and going to make the suggested changes?
9) The first step in implementing the IOM's suggested changes is to get congressional funding for the changes. Changes to the budget must come from the President and Congress. Has the IOM communicated this report to the White House and congress? Are there any planned congressional hearings on the IOM report? If not, how does that get accomplished?
10) Why was the naming process not done in a more transparent way, with consultation from a broad range of patients and practicing CFS/ME doctors? There was some input from patients, but not from a broad enough range to account for the heterogeneity of the illness.
11) It's known that the public and the medical community take illnesses with a more "medical-sounding" name more seriously. CFS has suffered from this phenomenon. Why didn't the IOM committee go with a more "medical-sounding" name?
12) Given that these two symptoms are often the earliest to appear, why were sore throat and tender lymph nodes taken out of the diagnostic criteria? Won't the omission risk patients waiting till other symptoms appear to get a diagnosis or doctors refusing to diagnose the illness at its earliest stages?
13) I have synthesized a question from Dr.Patient's post: Given that muscle weakness/asthenia is a key feature in this illness, why was it not in the diagnostic criteria?
It is with great appreciation for this opportunity that I submit my question. I am grateful for the explanation and clarification provided by Suzy Chapman for Dx Revision Watch (above) about the ICD process, and my question is this: If obtaining an ICD code for SEID will take time (at least one year or longer) won't this cause providers in the meantime to use the IOM proposed clinical diagnostic criteria to identify patients with this disease, but then force them to continue coding it as CFS, and do you see the harm in this, and how it contributes to the perpetuation of damage to patients while also diluting the research pool?
Thanks for all the work that went into the report and associated materials, and for the positive press releases. A lot of good and useful things were said in the report and associated materials, and that's great. Thank you.
Why was the delay in peak of PEM not more emphasized in the Report Guide for physicians which was posted today? Doesn't a lack of emphasis of the "post" in post-exertional malaise risk confusing the PEM of SEID with other forms of exertion intolerance such as that from POTS (which would be more immediate)? I understand that you used partly our experiences, but many of us have OI as well as SEID.
Also, will the emphasis on EBV while not naming any other infections affect SSA benefits when SSA had included HHV-6 and other infections on the list of test results which could be used to support a diagnosis of CFS?
(Some docs won't use TTT even if treating dysautonomia... and if a sleep study shows frequent wakings but no specific sleep disorder, it is considered negative and the frequent wakings may not even be communicated to the patient [I have seen this happen]... neuropsych testing is said to be expensive and to require an assessor who understands ME/SEID... not everyone can do, afford, or get to a 2-day CPET... it is unclear what kinds of tests would remain to support a diagnosis to SSA, for people who do not have EBV involvement and don't have docs willing to order aggressive or unusual testing?)
Or will the diagnosis of inclusion (rather than exclusion) sort the SSA problem of finding a medically determinable impairment?
Thank you to PR and to the IOM committee member for this opportunity.
I had a few questions regarding the clinician's guide:
1) Why are neurological symptoms (aside from cognitive dysfunction) completely excluded from this guide? Symptoms like aphasia, ataxia, numbness, sound sensitivity, light sensitivity, and sensory overload are not uncommon. Nor are the stupors of the kind Vanessa Li (and myself) have suffered from. Also absent are autonomic issues beyond OI, such as the poor temperature regulation that can sometimes go hand in hand with sensory overload. My concern is that with the new criteria and this physician's guide, I would still have been diagnosed with somatoform disorder without a clearer explication of how commonplace neurological symptoms can be, particularly for those with a more encephalitis-type presentation. I am not sure that these criteria would have protected me from the worst of the medical abuse and neglect I have experienced.
2) We are rare but there are a number of patients who fulfill the CCC and the ICC who do not fulfill the diagnostic criteria for SEID because we do not have unrefreshing sleep. I have a classic case of CCC/ICC/and Ramsay ME so I am not sure I am quite ready to accept a diagnosis of "atypical SEID"
3) I have had doctors claim in response to the new criteria that all of the symptoms listed there could be psychosomatic or psychological. How would you respond to clinicians who take that view?
4) As others have said, I worry that the emphasis on EBV might trigger old stereotypes and lead to doctors missing reactivation of other very important viruses. Are the other viruses our doctors commonly test for (HHV6, Coxsackie, CMV, etc.) not supported in the evidence enough to be included in the clinician's guide?
5) The guide seems to leave out the experiences of severely ill patients. How will it be communicated to physicians that some patients may have great difficulty even getting to their offices and that there is an entire population of people trapped in dark bedrooms who have more symptoms, more neurological symptoms, and a different presentation than the disease described in this document? Of the need for appropriate care as inappropriate care can push patients down the functional scale from mild to moderate, moderate to severe?
Under its “Comparison of Existing Diagnostic Criteria,” the IOM Report states, “While all (sic) of the criteria make clear that they are describing the same illness, some vary in the terminology used to refer to the illness or to specific symptoms." The AHRQ Evidence Report, however, finds to the contrary:
The case definitions overlap but vary greatly in their symptom set, leading to concern that they do not all represent the same disease or identify the same cohort of patients. The international ME consensus panel of experts recommends that patients meeting the International Consensus Criteria (ICC) be given the name ME, and that those meeting the criteria for CFS but not the ICC for ME be given the name CFS.
The IOM Report acknowledges that patients who fulfill the ME-ICC have “more severe functional impairment and more physical, mental, and cognitive problems than those that fulfill the Fukuda definition.” But it fails to report that the International Consensus Panel of experts recommends:
“Individuals meeting the International Consensus Criteria have myalgic encephalomyelitis and should be removed from the Reeves empirical criteria and the National Institute for Clinical Excellence (NICE) criteria for chronic fatigue syndrome;”
“Patients diagnosed using broader or other criteria for CFS or its hybrids (Oxford, Reeves, London, Fukuda, CCC, etc.) should be reassessed with the ICC. Those who fulfill the criteria have ME; those who do not would remain in the more encompassing CFS classification;” and
“Remove patients who satisfy the ICC from the broader category of CFS.... Not only is it common sense to extricate ME patients from the assortment of conditions assembled under the CFS umbrella, it is compliant with the WHO classification rule that a disease cannot be classified under more than one rubric.”
ME and CFS are classified as mutually exclusive ICD-10-CM diagnoses. Why does the IOM definition not exclude ME?
1. Institute of Medicine. Beyond Myalgic Encephalomyelitis / Chronic Fatigue Syndrome: Redefining an Illness. February 2015.
2. Smith ME Beth, Nelson, Heidi D et al. Diagnosis and Treatment of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome Evidence Report / Technology Assessment Number 219. AHRQ Publication No.15-E001-EF December 2014.
3. Carruthers BM, van de Sande MI, De Meirleir KL et al. Myalgic encephalomyelitis: International Consensus Criteria. J Intern Med 2011;270(4): 327-38. PMID: 21777306.
4. Carruthers BM, van de Sande MI, De Meirleir K, et al. Myalgic Encephalomyelitis – Adult & Paediatric: International Consensus Primer for Medical Practitioners. 2012.
It is important to note that when diagnostic criteria require any symptom on a list to classify a patient as having a disease, they risk including groups of patients that do not suffer from the same disease. For instance, the CCC provides a list of several neurological impairments. If one (sic) of these symptoms is present, the patient is considered to have fulfilled the neurological impairment requirement. For example, reduced working memory and ataxia would both indicate neurocognitive impairment, but patients presenting with memory impairment might suffer from a different entity than patients with ataxia.
The IOM core criteria consist of four symptoms. As an optional requirement, these symptoms include cognitive impairments: memory impairments, attention deficits and impaired psychomotor function. Does requiring only four criterial symptoms not increase the risk of “including groups of patients that do not suffer from the same disease?"
Post-Exertional Neuroimmune Exhaustion (PENE), the cardinal feature of ME, is described in part as a pathological inability to produce sufficient energy on demand with prominent symptoms primarily in the neuroimmune regions. ME-ICC patients are divided into four subgroups by prominent cluster: neurological, immune, metabolism/cardiorespiratory and eclectic (balanced). Does the omission of immune impairments from the IOM core criteria not risk failing to diagnose this patient subgroup?
Exclusions assist practitioners in coming to a correct diagnosis. Considering that the IOM criteria are designed to increase diagnosis, would a list of exclusions (more exhaustive than EBV mononucleosis, MS, colon cancer and primary sleep disorder) not mitigate against the potentially tragic risk of practitioners' missing alternate diagnoses?
1. Can you clarify the meaning of the term “unrefreshing sleep.” Is it being used as an umbrella term to refer to any kind of sleep disturbance/sleep related impairment? Or is it being used more narrowly to refer to e.g. “Tired upon awakening”?
2. In order for a new code to be added to a medical dictionary such as ICD, SEID needs to be placed within a particular chapter – e.g. neurological, immunological, etc. Did the IOM panel have a recommendation on where it should go? Adding onto Goodelici’s question, given the time this may take to resolve, does the panel have a recommendation on what term should be used to code SEID in the meantime so it does not become conflated with the overly broad CFS?
3. One IOM member seemed to indicate that SEID wasn’t intended to replace the name “ME” or the criteria that support ME. But the report indicated seemed to indicate that it was. Could you clarify what was intended relative to the name “ME” and the ME-ICC and CCC criteria.
4. Adding onto Scarecrow’s question on Fukuda CFS without PEM – did the committee discuss what they felt should happen to Fukuda and Empirical once SEID is pulled out? Did they expect these criteria to be disbanded?
5. Others have asked important questions on severe patients, many of whom have neurological symptoms that are not included in the criteria. With those questions in mind, did the IOM panel evaluate whether these diagnostic criteria would be reliable in the diagnosis of the most severe patients who may be bedbound and dependent on caretakers? Put another way, would doctors recognize a severely ill patient as an SEID patient based on the disease description and the criteria provided?
6. Was there a reason why selected guidance on differential diagnosis (as opposed to a list of exclusionary conditions) was not provided? For instance, particularly given the history of conflating this disease with depression, guidance on how to do a differential diagnosis between this disease and depression would help increase diagnostic reliability and avoid this becoming the new wastebin.
7. Was there any discussion of how to evaluate the validity and reliability of these new criteria for this disease prior to rollout? Same question for the diagnostic tools being recommended if they have not already been evaluated specifically for this disease. If not, shouldn’t that be done before these criteria are rolled out, especially given the lack of recommended biomarkers.
8. Was there a reason why the clinical guidelines used the term "ME/CFS (SEID)" to refer to this disease? Doesn't that risk causing additional confusion?
Thank you very much to everyone for taking part, and for submitting so many great questions.
Thank you also for having abided by the rules and guidelines, as this helped keep things simple.
I am going to ask the moderators to lock this thread now as we've reached the stated deadline for submissions. We'll work through these questions with the committee member and get the article up on the PR blog as soon as we can manage.