One of the post-IOM controversies consuming advocates at the moment is the concern that SEID criteria are non-specific and will include people who do not have our disease. The failure to list exclusionary conditions, including psychological disorders, has drawn criticism from some advocates and at least one expert clinician. This is a legitimate concern because if the SEID criteria capture people who do not actually have it, then we are simply perpetuating the problems with the Oxford and Fukuda definitions, both of which have been demonstrated to include people who have fatigue that is not caused by our distinct disease. But will the SEID criteria open the floodgates to people who have only depression or anxiety or other fatiguing illnesses? The answer is no, if the SEID criteria are correctly applied.
Correct diagnosis is critical for clinical care and research. Overly broad groups of subjects can produce misleading research results, and incorrect diagnoses harm patients. For years, advocates and experts alike have pointed to post-exertional malaise as the symptom that distinguishes our disease from other fatiguing illnesses. PEM was a focus of the Voice of the Patient report from FDA, and is also one of the core symptoms identified by Dr. Leonard Jason’s research as essential for diagnosis. The IOM agreed, and made PEM mandatory for diagnosis with SEID.
The IOM report described PEM as:
worsening of a patient’s symptoms and function after exposure to physical or cognitive stressors that were normally tolerated before disease onset. Subjective reports of PEM and prolonged recovery are supported by objective evidence, including failure to normally reproduce exercise test results (2-day CPET) and impaired cognitive function. These objective indices track strongly with the presence, severity, and duration of PEM. (p. 86)
The IOM also found PEM to be a characteristic symptom of ME/CFS:
The existence of PEM can help physicians confirm a diagnosis of ME/CFS earlier rather than only after extensive exclusion of other conditions. Several studies have found that PEM best distinguishes ME/CFS from idiopathic chronic fatigue and may help distinguish it from other fatiguing conditions with a lower frequency of PEM. (p. 85-86)
The IOM report cites several papers finding PEM in major depressive disorder and multiple sclerosis, but interpreted them with caution because the prevalence of PEM depends on how it is defined and assessed. If these papers did not define PEM as the exacerbation of multiple symptoms after physical or cognitive exertion, then the findings would not be applicable given how IOM defined PEM.
Unlike the Canadian and International Consensus Criteria, the IOM lists no exclusionary conditions. Many people seem to have interpreted this to automatically mean the criteria are too broad. But the IOM explained that people can have SEID and other diseases, whether it is obesity, hypothyroidism, or cancer. Under Fukuda, any of those diseases would preclude diagnosis with CFS, but comorbidities are a fact of life.
For example, I have obstructive sleep apnea that arose after my diagnosis under Fukuda. Technically, this should disqualify me from diagnosis under those criteria. However, my sleep apnea is perfectly controlled by use of a CPAP machine. The data from the machine show that I do not have sleep apnea when I am using the machine (which I do, every single night). Yet I am still sick. So why should having sleep apnea, especially if it is well-controlled, exclude me from diagnosis? Certainly, the sleep apnea should be taken into account if I participate in a research study, and could possibly disqualify me from some studies. But it should not exclude me from diagnosis with the disease.
The same is true of other comorbidities. Why should someone with hypothyroidism which is being adequately treated be denied diagnosis with SEID if they have PEM, sleep problems and cognitive dysfunction? If someone has PEM, severe fatigue that prevents them from working, unrefreshing sleep and orthostatic intolerance, what difference does it make if they also have depression? Doesn’t that person deserve treatment for depression as well as management of SEID?
In my opinion, comorbidities are not the concern. The legitimate concern is whether SEID would, like Oxford and Fukuda, be applied to patients who have only depression or only anxiety (or only other fatiguing illnesses). Research has shown that Oxford and Fukuda both erroneously include people with “just” depression (and I do not mean to minimize the suffering of depression) and not the distinct disease described by ME or SEID criteria. This would be a fatal flaw of SEID criteria, because we know that studies like PACE have included high numbers of people with fatigue but not our disease, and this could account for the small signal of CBT and GET effectiveness reported in PACE (notwithstanding all the other legitimate criticisms of how PACE was conducted and analyzed).
But unlike Oxford and Fukuda, SEID requires the hallmark characteristic of PEM. If post-exertional malaise is unique to our illness, then correctly applied SEID criteria should not misdiagnosis people with other fatiguing illnesses as having SEID. Why? Because if a patient does not have PEM, they would not be diagnosed with SEID. And if a person has PEM and the other core SEID symptoms, then they have our disease regardless of what other conditions they may have. Therefore, if a person has only clinical depression or only hypothyroidism or only multiple sclerosis, that person does not qualify for SEID because he/she would not have PEM and the other core symptoms.
The IOM committee is staking the position that PEM is so distinct that no differential diagnosis is required, because differential diagnoses are needed only when multiple diseases present with similar symptoms. Once a clinician has established that a patient not only has severe debilitating fatigue, but also has PEM, unrefreshing sleep, and cognitive dysfunction and/or orthostatic intolerance, there is no need to exclude other conditions. This is a distinct symptom presentation, and will not – if correctly applied – result in people who do not have the disease being included in the patient population. Remember that Dr. Jason’s research identified PEM, unrefreshing sleep and cognitive dysfunction as the core symptoms of the disease, especially when frequency and severity cutoffs are applied (as IOM also recommended).
The real issue, in my mind, is whether these criteria will be correctly applied. Chapter 7 of the IOM report and the materials for clinicians both include questions and tests to determine if a person has PEM. However, given the misinformation already extant about our disease, and the outright prejudice among some in the medical profession, we cannot take it as a given that healthcare professionals will suddenly be able to recognize PEM correctly. That is why the educational recommendations of the IOM report are so critical, and why I believe we should be vigilant about whatever materials HHS ends up creating as part of an education campaign. It is unquestionable that many healthcare professionals need remedial education, and CDC’s current education materials are grossly inadequate. But this is a different problem from the fear that the SEID criteria themselves are not sufficiently specific to exclude those who do not have the disease.
Excellent! I agree completely!
Well done Jennie.
I do think some criteria comparison research is warranted (which was mentioned in the report) – although as you say above, Dr. Jason has spent a lot of time publishing evidence on this very subject (see for example his presentation to P2P about existing criteria and their inherent problems – including a propensity to select psychiatric conditions: https://www.youtube.com/watch?v=TeOK1res5YM). He also has just published another paper this week:
CFS/ME Towards an Empirical Case Definition: http://www.tandfonline.com/doi/abs/10.1080/21642850.2015.1014489#.VO44CeFV0nh
“Our study found a small number of core symptoms that have good sensitivity and specificity, and these included fatigue, post-exertional malaise, a neurocognitive symptom, and unrefreshing sleep. Outcomes from these analyses suggest that using empirically selected symptoms can help guide the creation of a more reliable case definition.”
I have yet to read the above in full, but it might as well have been written for the IOM Report by the looks of it – as does his other work.
Like you, I have comorbid conditions, and most developed in the 16 years since my diagnosis: and in year 15 I too was diagnosed with sleep Apnea for which I am treated, but around the same time as my diagnosis of ME, I was diagnosed with Epilepsy for which I also receive treatment.
Depression – for which most people seem to have a focus – has been again identified for me as a comorbid condition, during those periods when I have had it. It can be difficult when we talk – or doctors prescribe – anti-depressants even for ME/CFS, to always separate the two: but anti-depressant medication is not always about treating depression of course: some with ME/CFS find it does indeed help them overcome sleep difficulties.
Until we are able to develop specific treatment for the actual disease(s) underlying ME/CFS or ME/SEID or SEID (all this debate over naming does make my laugh as personally I don’t give a fig what it is called), we are only ever going to get help for symptoms – either through symptom relief drugs or illness management approaches.
High time our disease was recognised as a stand-alone condition. I think this new criteria – which isn’t really that new (check out NICE) just more specific which was needed: will help more readily identify the 80+% of people who are out there without a diagnosis.
Not only will this be helpful to them, it will also swell our ranks lending power – finally – to this often unrecognised disease.
Obviously, I believe that the criteria are very important. Thank you for your discussion of them, Jennie.
However, I disagree that concern about the criteria means that we should not focus on the name at all. It also is important.
Therefore, I have put together a survey allowing people to evaluate the proposed name “SEID.”
http://paradigmchange.me/wp/name-evaluation/
More than 700 people have responded so far. A report of the results will be sent to HHS, CFSAC and other government agencies for their consideration, as well as to the media.
Regardless of your opinion regarding what the name should be, please participate to have your voice heard! The deadline for responses is March 1.
Thanks much ,
Lisa Petrison, Ph.D.
Paradigm Change
I am glad you are doing this survey, Lisa. But I have to point out that the IOM panel asked for community input, and cited the fact that input they received did not overwhelmingly favor ME. I wish more people had spoken up earlier, but I’m glad they are doing so now at least.
I took her survey. And there is a place to express your thought that there was enough opportunity for patients to have input. So, I think the survey can be useful because she gives a range of options on even patient involvement.
I took this survey, and thought it was very well-constructed. I surprised myself by answering “I’m not sure” if patients should be involved in a disease name in general, but the other survey questions brought out other ways to communicate my reasons for personally disliking the new name (in addition to the box for comments at the end).
I add that I did also send in a written submission to IOM (and expressed a preference for ME). I also emphasized that if the panel was considering recommending a brand new name, it was critical that any such name not be vague and/or potentially trivializing [to the non-expert].
Well said and analyzed. Your points are solid. My only “wish” would be that SEID patients actually get CPET test to correctly diagnose as well as correctly identify the number of patients afflicted. Both important points for the patient and statistical analysis of effected patients.
The IOM, the FDA, the CDC have all opined that SEID (ME/CFS) is a severely disabling disease. Cutting corner by not using an objective Vo2 max test opens up diagnosis and patient numbers afflicted to human error.
The cost and rightly covered insurance to pay/co-pay this test is much lower than an MRI or even certain lab costs. CPET are done in most cardiovascular setting in almost every area of the country. Tech notions just need to be trained on Vo2max for SEID/ME. This should be a required test for such a disabling disease. SEID needs the same objective diagnostics as any other physiologic illness. This testing cuts out physician error/ prejudice and gives the government the much needed correct data to start putting real dollars into research and treatments. Cutting corners by using a patient history delivers sloppy data and more wasted time to a severely disabled population.
My only concern, Mike, is that there are patients who cannot completely two day CPET because they are too ill. But those patients should be studied and a surrogate marker could be identified.
I agee Jennie. My thoughts as well on ancillary test for those that cannot tolerate CPET!
Thank you for a very good analysis!
I’m concerned about those who are too ill, and I am also concerned about those who have delayed PEM. A two day test could miss those whose PEM doesn’t start until day three or four. Also, re those who are too ill, I am afraid that if this test became more widely used w/o some other way of verifying PEM in that grp, it might be forced on them anyway in order to prove disability.
Some of “our experts” have said that the 2-day CPET is contrary to the Hippocratic oath. So they prefer the gene or immune system markers. I tried in my metropolitan city to find someone who would do a 2-CPET for clinical use. Exercise research center at university does the test, but for research only. Another university did it for the public (at a very cheap price) for teaching their students. But they just stopped offering it due to personnel cut backs a few months before I contacted them. (The website had not yet been changed to reflect that.) I found one pulmonologist who does the test for clinical use, but only on Tuesdays. he was not willing to do it two days in a row because he saw patients in his office on the other days. I found lots doing the exercise test, but only a few doing it with the metabolic cart.
Now, I’m one to say that shouldn’t stop it being in the criteria. It will become more available if there is demand for it, and the demand would be created if it is in a diagnostic criteria for a common disease. But, the American Heart Association has said that heart doctors are not using that test as much as they should. It’s underappreciated and underused in that discipline, also.
But, I must admit there needs to be more research into it. Three studies in very small groups is just not enough to extrapolate to all folks. And, it needs to be further tested in similar diseases. Considering the concern of exacerbating patient symptoms long-term, I don’t see money coming for a larger cohort study in that.
I believe the IOM Report cited cost as a factor also here. I was speaking to a friend in the States the other evening, whose partner (also with ME/CFS), paid $1500 for this 2-day test.
My concern is also that this test must surely have a life-span. If you were able to complete the test, during a relapse, and then took it again 6 months later during a period of relative calm: the results will surely differ.
So whilst I welcome the report’s chapter on PEM and it’s preeminence in the criteria, I can understand why the 2-Day test is not yet able to be recommended for clinical assessment.
Also, the IOM seemed confident the diagnosis could be ascertained through the methods laid out and relative questions asked.
But as I said above, it will be interesting for Jason to review these new criteria against others in due course.
Op-ed in today’s (Feb. 25) NY Times by Julie Rehmeyer who says she has this disease. She is for objective testing, including CPED test and spinal fluid test. She says many doctors are not taking the IOM report seriously that this is a physiologically based illness, it’s real, disabling, etc.
I do know that many of us won’t be able to travel to get a CPED test and won’t be
able to perform it on Day 1 or not very well and certainly not on Day 2, which many
of us won’t be able to even get to if we’re wrecked from the Day 1 test.
The main point — and Rehmeyer makes it — is that the NIH has to fund
research on causes and treatments and fast.
I agree. While the 2-day CPET is good, although low numbers, is good science. I hope it is explored more. But it may not be ideal for diagnostic use for many reasons. More research in larger dollar amounts will open up many other options. I appreciate the strong words IoM committee used in talking about the small amount of research.
I agree with your summary as above.
I am not worried about people claiming they have ME/CFS or SEID who don’t have it.
I really don’t think people will do that, and if a few do, so what?
And, certainly, many of us have other ailments and health problems concurrent with our main disease — and those should not rule us out from having the ME/CFS or SEID diagnosis. And that includes people with anxiety or depression or a long list of physical illnesses. It also includes cancer and heart disease; as people age, the rates of these diseases rise and many of us have or will get these ailments.
This illness has caused me to have hyperinsomnia badly, terrible allergies and chemical sensitivities, asthma, bad muscle pain, especially when exhausted, vision
problems. I also have osteoporosis, and have broken bones, which are related to the main disease because I fell, fainted or tripped when suffering from related exhaustion.
I think your summary is on target. I hope the medical professional gets it. I hope HHS and NIH get it and put up research funds, although I am dismayed that the IOM committee suggests revisiting the data in five years!
I’m not worried about people who don’t have the disease being diagnosed with it.
I agree. Depression is usually helped with exercise, endorphins, you know. Also, is true for MS. So while they may have a form of PEM, it is clearly different or to a much lesser degree in those diseases. Patients have for years said PEM identifies this disease. The patient advocacy push before the committee report was a concern that the IoM committee would not require PEM. Not only did they require it, they made it the identifying, hallmark symptom, so strong that our disease is named after it. So why the complaints now?
And it is about time our disease join other diseases in being it’s own entity and not a different kind of depression. To say you can’t have regular depression and SEID would only make sense if regular depression and SEID are two different forms of the same illness, like there are four forms of MS. If you have one form of MS, you don’t have another, although people do transition from one form to another. But relapsing and remitting MS is different from the malignant progressive form of MS, so you wouldn’t have both at the same time. So I think it emphasizes it’s not a form of depression because it says you can have both, that’s two diseases.
Many are also missing that the recommendation to docs is to do a full workup, regular investigation of possible causes of the symptoms. I would expect it would include exploring hypothyroidism, sleep apnea or narcolepsy, depression, diabetes, cancer, cardiovascular or neurological conditions, etc. So what’s hopefully going to change? That SEID is added to the possible conditions to be considered as the doctor and patient go through a process of figuring it out, which may take some weeks or longer.
Honestly, thinking like a physician, these others are easier to diagnose in general and do have a treatment. So I would explore these others first by tests or even trying treatments to see if the symptoms improve. And while I see some disadvantages to the six-month requirement for SEID, it will likely provide for the doctor to consider other conditions as an option first, which I think the algorithm tells the doctor to do that if symptoms have not been in the last six months to a medium or sever degree and experienced at least half the time.
I had a year of on and off respiratory infection symptoms and brief periods of depression symptoms (like a day or two then free for weeks). I didn’t see a doctor about the symptoms because respiratory infections are healed by the body and the depression was brief spurts. Then those symptoms stopped, and I started having severe menstrual symptoms. So, I went to my gyno. We kept working over a period of two and a half years trying to figure out what was going on with my hormones. Fatigue, cognitive problems, hypersomnia and unrefreshing sleep symptoms gradually developed and got worse in those two years, but so gradually that I attributed them to stressful job, overwork, getting older, etc. I didn’t mention them to my gyno. Then, one night, the sharp pains started. (I was already suspecting something was wrong beyond menstrual/hormone problems because the symptoms were becoming more and more disruptive). It was then I knew something was wrong. Sharp rotating pains starting as a sudden wave is not from lack of sleep or stressful job. My gyno saw me and said, “I think you have more than hormones going on; I think you have chronic fatigue syndrome or fibromyalgia.” What’s my point? For many of us, getting to the diagnosis is a process that takes time. So I don’t see a bunch of doctors quickly diagnosing depression folks with SEID. It’s more likely the doctor will explore depression first. And when the meds don’t make a person better, and the symptoms develop more, the diagnosis becomes more clear. Same thing is very common in MS.
I do believe our PEM is different. First, it can be delayed, as much for me as 48 hours. Also, it isn’t always equal. Also, the “M” in “PEM” is an unusual set of symptoms, that is flu-like (absent the respiratory part for most of us). In fact, marathon runners have a form of post-exertion symptoms within 24 hours of their exertion. But it’s far different from what we have.
I spoke to a doctor how had been involved in GWI and mentioned to her that GWI abnormalities show after an exercise challenge and explained the 2-day CPET in our disease. She looked at me quizzically and said, “Isn’t that odd?” In a world where exercise is always good, I really appreciate the IoM committee emphasizing our exertion intolerance in the criteria and name as a wake up call to docs: Hey, this is different than what you think about all other fatiguing diseases.
I do think it would be helpful if the physician’s’ guide included a few tips for distinguishing between other diseases with similar presentations, including depression. For depression, it could be handled through questions. But it could also be handled through low dose antidepressants.
Though probably not realistic, the IOM really should have considered some type of listing of “approved” clinicians. The devil is in the details in the “PEM” assessment. In some patients, it’s almost certainly clear in others it may be very subtle. In my case, I’ve had top clinicians disagree. I think it’s highly possible that “PEM” is present but not a clear enough problem to discern for a portion of the population. IMO, the 2 day CPET should be recommended for those who are borderline or “difficult” cases so that patients aren’t un-necessarily stuck in waste bin hell.
Thank you for that excellent analysis, Jennie! It helped me to better understand the criteria, and from all that I have heard so far, I feel that the IOM report is a real step forward. I know some patients don’t care for the name SEID but I actually like it a lot. It has already helped me to better explain my illness to several important people in my life.
For example, today I visited my psychologist, who specializes in chronic illness and chronic pain patients. He has always taken my diagnosis of CFS seriously and shown compassion, but I also sensed that his understanding of it was limited. As soon as I sat down this afternoon, he said, “I have something really exciting to tell you! The name CFS is no more! I saw it in the New York Times.” I then offered him a JAMA article I had printed out about the IOM report and he took it eagerly. He seemed genuinely interested and enthusiastic and we proceeded to have the best discussion we have ever had about what this illness is really like. When I described PEM and how it is the exact opposite of what many depression patients experience, I could tell that a light bulb went on for him.
I know that not everyone is happy with the report and I think that healthy debate and dialog is a good thing. But I’m really bothered by the level of vitriol directed at the committee by some in the patient community. This is a moment when our illness is receiving unprecedented media attention and I know how much the media likes stories of conflict and controversy. I would hate for the media narrative to change from “CFS is a real and serious illness” to “CFS patients very angry about new name, new criteria, etc.” I think that would be a real tragedy.
That’s really great to hear Rachel. I hope your psychologist’s reception of the report is reflected by others who help patients with their management of this disease.
I generally agree with Jennie’s analysis. I do think how the definition is applied is the most problematic issue. I also have grave doubts about the capacity to educate the wider medical community. Three decades of trying to educate the medical community has largely failed, it would take a massive effort to address this adquately, and I am not sure that will be forthcoming.
I would like to ask a question though. Consider Oxford or Fukuda CFS definitions, the CCC and the ICC. Will most doctors get diagnoses under these right most of the time? I think doctors routinely fail to apply definitions properly, though that is hard to prove. What is claimed is misdiagnosis rates vary from 40% to 90%. Even existing definitions fail us.
I have previously suggested that a study looking into the reliability of the SEID definition, with comparison to (for example) Fukuda, CCC, and ICC, should be a priority.
Yet again you take the words right out of my mouth, Jennie. I had just started reading yesterday’s Co-Cure digest where someone started in on this issue and I immediately thought, please tell me Jennie has just posted on why PEM makes a differential diagnosis list irrelevant…(which tells you the level of trust I have that you’re going to write what I’m thinking — a tiny bit frightening in a way lol!).
Well, ask and you shall receive. 😉
One clinically troubling aspect of CDC/Fukuda is that it excludes people with any diagnosis that includes some sort of fatigue like bipolar disease or obesity or your examples of OSA or hypothyroidism. To be sure, for research purposes (which is what Fukuda was strictly supposed to be) that was a good thing to help specify what we were researching. For clinical purposes, it reinforced that CFS was just fatigue and had the whiff of psychiatric diagnosis. You can get bipolar disease and diseases that cause fatigue like heart disease. You can get depression and diseases that cause fatigue like heart disease. So why can’t you have biopolar disease and a “physical” disease that causes fatigue like CFS, unless CFS is just medicalized (and possibly psychogenic) fatigue?
Reading the IOM report along with Dr. Jason’s work, I’ve been surprised at just how well the data backs up what we have been saying intuitively all along: PEM is the defining characteristic of this disease. If you have depression but also have PEM, you then have co-morbid SEID because PEM is just that specific for this our disease. If you have bipolar disease and PEM, you then have co-morbid SEID because nothing else can cause PEM other than SEID. And if you have lupus or MS and PEM, you then have co-morbid SEID because lupus or MS cannot cause PEM. It removes this disease from the CFS (and at this point, ME) fatigue-only wastebasket and puts it squarely back onto the “real” “physical” organic disease category. It’s what makes the IOM report a radical departure from Oxford and Fukuda. So radical, in fact, that some patients (and I’m sure plenty of medical providers to come) are struggling to wrap their heads around the idea that our disease is not just a disease of exclusion anymore.
“I believe we should be vigilant about whatever materials HHS ends up creating as part of an education campaign.”
THIS is what we should all be obsessing about right now (along with SHOW US THE MONEY!). We need to make certain that HHS and CDC get PEM right in their materials educating clinicians about SEID and PEM, assisted by work like that of Dr. Jason that Firestormm mentioned above, specifically his et. al paper on the problems of diagnosing PEM. We’ve been asking that PEM be the focus of federal efforts on this disease for a long time. Instead of getting distracted and shifting to obsessing about the name SEID (which, btw, was also a huge win for us even if it’s not very sexy) or nit-picking over the IOM report because we didn’t like the appalling way HHS handled the contract, we need to keep the focus on PEM (and the MONEY) and use this IOM report as the cudgel we’ve needed to beat back the prejudice that is leaving so many of us (myself included) wasting away in bedrooms all over this country.
Well said, Michelle!
I think this is a very interesting and complex issue. Like Jennie, I also have a diagnosis which currently prevents me from having a diagnosis of ME/CFS, with my issue being thyroid problems. The thing is that I started feeling cold while in class when I was still a senior in high school in 1996, and I started specifically going to doctors for feeling ‘unwell’ in 2000-2001 or so. However my TSH didn’t come back as being elevated until at least 2004 and to top it all off, any kind of thyroid hormone makes me much worse by taking all of my symptoms and turning them up to 11! So is my thyroid problem properly excluding from a ME/CFS diagnosis or is thyroid dysfunction a part of whatever gradual onset subtype of ME/CFS that I have? It’s like I remember Mary Schweitzer saying, how can you ever find any pathology associated with ME/CFS if you start out by excluding anyone with any pathology? I think they do the same thing with inflammation, don’t they? Ie if you have too much inflammation, like CRP or something, then don’t they exclude you from being in ME/CFS studies? I don’t think this issue gets enough attention.
I agree that PEM is the defining symptom of our disease but there are a few major problems with saying PEM by itself can let doctors diagnosis this disease (whatever you choose to call it). I have several objections this concept but, to keep things simple, let me just focus on the 2-day test.
The 2 day test isn’t magic. It doesn’t make all the problems disappear — “Just do the 2 day and all will be fine.” I don’t mean it doesn’t show PEM starkly — it does. I mean that it isn’t a perfect solution even though it is a great start.
Some are simply too sick to take it. Some specialists have apparently said it goes against the Hippocratic Oath to do the test (the concept of “First, do no harm”), though I have not personally seen those comments. That stance, however, makes sense because patients can be seriously set back, potentially permanently. If you were a doctor, would you want to be responsible for a mild patient becoming housebound or a housebound patient becoming bedbound? If the diagnosis can be reached another way, it makes sense to do that first.
With cardiac patients, you can see a problem developing and stop the test; with us, the point of the test is to evoke the problem which, realistically, will be even worse on day 3 after testing is over. Stopping isn’t an option if you want the results (though Snell’s lab, Workwell, in fact does stop if it is called for). Unfamiliar doctors may think that they do treadmill tests all the time and the patients are just fine so why stop if the patient isn’t having serious cardiac abnormalities? And even after testers learn the signs of overload, there remains the question of what happens if neither the patient or physician understands how seriously it can affect those with this disease. It is almost certain people will be hurt during the national/international learning curve.
The biggest problem, though (and this is huge), is exactly who is supposed to be giving all these tests? I’ve not seen this discussed anywhere. Yes, the testing facilities are everywhere but then why aren’t more people doing it now? Obviously the demand is there because patients fly in from all over the country to the few current testing facilities. I put this question directly to Dr. Snell directly while at the IACFS/ME conference last spring because my doctor (who has the equipment) said he would do the test if I could bring him a very specific protocol. Dr. Snell politely sidestepped the question a few times at seminars and in private conversations but, when pressed, finally explained to me that the test is extremely difficult to calibrate. Workwell calibrates their equipment every single day using only the same person.
They have worked with others who do this test and apparently have met with the attitude of, “Hey, we calibrate every month or two and it is enough.” That, apparently, doesn’t cut it. They have also encountered disbelief that the day 2 could be that different, with some saying day 2 must be an equipment failure when they see the results. Some of whom Workwell has tried, and failed, to teach would surprise you. Highly competent 1 day testing parties, who administer this test every day, and who are interested and directly involved with Workwell, have been unsuccessful. Any bets on how well the average local doctor with no special training or instructions will fare?
I am for the 2 day test and for PEM as a criteria but I believe that a more complete description such as in CCC or ICC is needed, too. The problems with the 2 day will eventually be overcome but don’t mistake the 2-day as a quick-fix to the problem of determining who has PEM and therefore this disease. It’s not.
I don’t think 2day CPET is any kind of quick fix, especially having put myself through it, and you list a number of potential pitfalls. I just want to clarify that I did not say that PEM alone is sufficient to diagnose this disease. Jason’s research identifies a core symptom set which includes PEM. The IOM SEID criteria also require more than just PEM. It’s that core presentation that is unique enough to exclude those who only have other diseases.
I believe I could deal with my other comorbidities better if I didn’t have PEM. It interferes with every aspect of my life. So much so that even typing a few remarks causes extreme fatique/malaise/pain. Please, let’s find the cause/treatment for this disease. Thanks to all.
As your post title alludes, the key to these issues is the move from a diagnosis of exclusion to one of differential diagnosis – I think this is proving very difficult for many patients who are inured with decades of ‘exclusion’ to come to terms with. There are seem to be few easy accessible sources that fully explain differential diagnosis – this one is probably sufficient despite annoying adverts: http://www.wisegeek.com/what-is-differential-diagnosis.htm
Differential Diagnosis underlies most modern clinical practice, it achieves ‘exclusion of false inclusion’ by a clinical process, not by a prior listing of what is in and what is out. So ingrained is differential diagnosis in day to day medicine that it’s actually supported by standardised methodologies http://bestpractice.bmj.com/best-practice/monograph/301/diagnosis/differential-diagnosis.html and by dedicated software http://www.isabelhealthcare.com/home/default . Of course it would be wrong to fetishise differential diagnosis as being the ‘answer’, it is only as good as the doctor using it and has the limitations of any process that by definition can not be of infinite scope. Nevertheless it is a major part of how medicine happens and frankly that is where we need our illness(es) to be. If differential diagnosis is used properly, there is no reason why depression, anxiety or any other illness would be diagnosed as SEID. We have to accept that anyone presenting with what the medics determined was simple depression would almost certainly be sent down the CBT/GET style route – the important thing there would be for practitioners to be geared to recognise co-morbid or undiagnosed SEID at an early stage, and certainly we need to be concerned about that given the reluctance of some deliverers of those therapies to accept the reality of physical impairment. But the central point is that rather than the criteria being the pivotal issue, it is the correct application of differential diagnosis on which the value of SEID hangs– and that is a basic clinical issue not one of arcane specialist understanding. Having criteria that adequately describe a disease is obviously necessary but so long as the criteria are set within the context of differential diagnosis, then the chances of misdiagnosis are reduced as the treating physician is by weight of process encouraged to bring all relevant investigative methods to bear, rather than coming to pre-judged conclusions based on prior artificial exclusions.
One analogy for “differential diagnosis” might be to think about how a detective goes about solving a case of murder for example. The detective would go about interviewing people, collecting clues (e.g. the club, the blood, etc.).
An “exclusionary” process would be like eliminating the maid because she was observed to be in the kitchen at the time and the murder took place in the garage or the son because he is too young to hit the victim with the force needed. An “inclusionary” process would be like suspecting the driver did it because his hand size is the same as the blood-soaked glove found in the garage, he is tall enough to hit the victim over the head, he was seen near the garage despite being off work that day, etc. Eventually, the detective takes together these pieces of data, eliminates/ adds suspects, and concludes the driver did it.
Similarly, physicians interview patients, do tests, etc. to come to a diagnosis. The process of diagnosing ME/CFS, especially as viewed by doctors not specializing in ME/CFS, has been mostly exclusionary. Diseases A, B, C,…….Z must be eliminated for diagnosis to occur. This can take a lot of time/ effort/ resources and the doctor may never feel comfortable enough making a diagnosis. So what the SEID criteria are trying to do is to say, “If you have symptom A, B, C + D/E, you are more likely to have SEID.” Just like the driver and his characteristics. Why confine ourselves to only an ‘exclusionary” process when using both processes may help us get to the answer faster/ more accurately?
[And yes, I am a fan of mysteries and the game of Clue.]
“If these papers did not define PEM as the exacerbation of multiple symptoms after physical or cognitive exertion, then the findings would not be applicable given how IOM defined PEM.”
This is one key to diagnosing PEM along with the onset and duration of symptoms. While many illnesses present with symptoms after exertion — pain with arthritis, shortness of breath with heart disease, wheezing with asthma — the constellation of symptoms in SEID are different, as described in the document. Additionally, I can feel fine while doing an activity but with severe PEM sometimes 1-2 days later, not immediately, and the duration is long and out of proportion to the activity. I’ve been homebound for a few days after a shopping trip. The post-exertional symptoms of other diseases tend to occur while the activity is ongoing or immediately after and resolve relatively quickly, not taking hours and days.
“I can feel fine while doing an activity but with severe PEM sometimes 1-2 days later, not immediately, and the duration is long and out of proportion to the activity. I’ve been homebound for a few days after a shopping trip. ”
I have had the same experience many times, Anonymous! This one of the things I love about connecting with other SEID patients. We have experiences that people in our lives can’t understand (even if they sympathize) and it helps so much to communicate with those who do understand.
Jennie,
A very fine analysis of the PEM issue.
Two reasons not to push for a universally required CPET test: (1) some simply cannot or will not take it because of justifiable fear that they will be made significantly worse; and that fear would be raised to a level of desperation if (2) taking it were made a requirement for getting approved for Social Security Disability reimbursements. The latter is certainly a possibility. Can you imagine the SSD exams if a 2-day CPET was required and was being administered by the doctors who give those exams? Truly frightening thought.
Jennie, I’d like to know if you have an interpretation of the term “primary psychiatric disorders,” as stated as an exclusion in both CCC and ICC.
I’m wondering how their definition of a “primary psychiatric disorder” is different than just a plan unspecified “psychiatric disorder,” for instance.
(Or if it’s no different, why they bothered to put the word “primary” in there.)
As an example, generalized anxiety disorder is an extremely common condition. To my understanding, it is characterized merely as follows: “GAD is diagnosed when a person worries excessively about a variety of everyday problems for at least 6 months.”
Worrying is not even listed as a symptom of ME or ME/CFS in those definitions. So the idea that excessive worrying (if not “under control”) would rule out a diagnosis of ME or ME/CFS, even if the person otherwise amply qualified, does not make a lot of sense to me.
(After all, the idea that psychiatric problems can result in all these ME symptoms is what most of us are fighting staunchly against!)
Personally, I do not believe that these definitions were intended to exclude such individuals. But I’ve not yet talked to any panel members about it.
So I’m wondering if you have any direct knowledge about what the panels intended, or if you have an opinion of your own on how this should be interpreted.
Thanks.
I am not at all worried about psychiatric conditions being mistaken for SEID. The “PEM differential” indeed does the job! However weakening a major depressive disorder may be, those who suffer from it do not “crash” following exertion, they may be weaker, but nothing that would last days or keep on worsening 5 hours after the exertion at hand. – I am more concerned about multiple sclerosis, type 2 diabetes, heart and lung diseases and a few other conditions which all have some form of PEM. PEM may be a ME hallmark, but I feel the concept has to be refined. I am not sure how. The saying “When in doubt take an extreme case” would certainly apply: spectacular “crashes” or relapses lasting for years following a minor event is something you would never see in those other conditions. THAT is a 100% proof differential! But you can’t always count on such dramatic PEMs to occur and be witnessed by a doctor… So, it’s tricky. But it’s the best differential criteria we’ve got, it seems. We’ve dwelled incredibly on the accuracy of the name SEID, or lack thereof, but we should spend more time on specifying ever more the nature of PEM.
My knowledge/ experience of various diseases is that they do not present with PEM in the way it does in this disease. There are post-exertional symptoms in many conditions but the type of symptoms and their nature is different.
Among the diseases you mentioned, Type 2 diabetes, without co-morbid heart disease or other conditions, does not have symptoms with exertion as part of it. I have family members with Type 2 diabetes. The 76-yr. old enjoys competitive ballroom dancing while the 81-yr. old (even with heart disease) hikes twice a week in the mountains.
There are limited studies but they do seem to indicate the PEM in ME/CFS is different. For example, the Lights looked at gene expression in ME/CFS versus healthy people and people with MS after an exercise challenge. They found that the people with ME/CFS had increased/ different expression of particular genes that the other groups did not. See Fig. 2 and 3 below link. Also the MS subjects recovered within 24-48 hrs. if not sooner while the ME/CFS subjects had not:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3256093/
http://www.cortjohnson.org/blog/2014/11/06/fatigue-disorder-multiple-sclerosis-taught-us-chronic-fatigue-syndrome/
On the other side, re: the 2-day CPET, studies show that other diseases do not evidence the drop in multiple values on day 2. For example, this study on sarcoidosis, an autoimmune disease with fatigue as a prominent symptom:
http://www.ncbi.nlm.nih.gov/pubmed/23727274
“Fatigue in sarcoidosis patients cannot be objectified by reduction of exercise capacity after repeated maximal exercise testing, ”
I agree with you though that much more work needs to be done investigating PEM.
I am right now having post-exertional relapse; it is not malaise. That is a misnomer.
This is because I had too much to do on the computer earlier this week and then
last night had to clean dust in my bedroom because it was aggravating allergies.
I am now totally worn to the bone and am having trouble typing and moving around.
There is no way I could drag myself to any test, CPET or otherwise. And when I
think about doing day 1 of this test and knowing I probably could not go far, I
think I couldn’t do day 2 unless the test providers sent someone to help me
get dressed and transport me to the test site.
So, I wouldn’t be able to get there.
I agree that post-exertional relapse is a better term , Kathy. I’ve never cared for the word malaise. It sounds so vague and subjective and like it is more about emotions than physical symptoms. Here are some definitions I found online for malaise:
a general feeling of discomfort, illness, or uneasiness whose exact cause is difficult to identify. synonyms: unhappiness, uneasiness, unease, discomfort, melancholy, depression, despondency, dejection, angst, ennui; More (Google)
a feeling of general discomfort or uneasiness, of being “out of sorts”, often the first indication of an infection or other disease. (Wikipedia)
an indefinite feeling of debility or lack of health often indicative of or accompanying the onset of an illness, a vague sense of mental or moral ill-being (Merriam-Webster)
More food for thought:
http://slightlyalive.blogspot.com/2015/02/the-iom-report-on-mecfs-seid.html
Thank you Jennie for another insightful article. I agree that the PEM criteria, when properly applied, will make all the difference in distinguishing SEID. And, as you said, we have to be vigilant about these education materials that will be given to doctors. IF doctors will learn what this truly means, I really think we have a fighting chance of getting somewhere. A document created by the Institute of Medicine should gain us much needed credibility.
I agree, Kristina!
There is an article posted at the New Yorker blog about ME/CFS by someone who has the disease, Meghan O’Rourke, dated Feb. 27.
And here is a link to a study just releated by Columbia researchers Dr. Mady Hornig, et al., about what they discovered involving biomarkers and cytokines.
http://www.mailman.columbia.edu/news/scientists-discover-robust-evidence-chronic-fatigue-syndrome-biological-illness
I wonder if HHS and NIH can continue to ignore our very real disease and not fund research about it and treatments.
Here is the link to the study information by Drs. Mady Hornig, et al.,
http://advances.sciencemag.org/content/1/1/e1400121