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Hunting down the cause of ME/CFS & other challenging disorders - Lipkin in London
In a talk to patients in London on 3rd September, Dr. W. Ian Lipkin described the extraordinary lengths he and his team are prepared to go to in order to track down the source of an illness, with examples ranging from autism to the strange case of Kawasaki disease.
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CDC Multi-site Study - An interview with Beth Unger

Discussion in 'Phoenix Rising Articles' started by Phoenix Rising Team, Jan 31, 2014.

  1. Phoenix Rising Team

    Phoenix Rising Team

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    The CDC multi-site clinical assessment of CFS/ME is now underway, and Bob took the opportunity to interview Dr Beth Unger, the lead scientist in charge. The outcomes of this significant study are likely to be widely influential and the means by which the CDC employ objective measures has become something of a hot potato, especially in relation to exercise testing...

    [​IMG]
    Elizabeth, R. Unger, PhD, MD
    Chief, Chronic Viral Disease Branch

    The CDC department that oversees chronic fatigue syndrome, under the leadership of Dr Beth Unger, has begun a large study using data from 450 ME/CFS patients, collected at seven well known clinical sites across America (see below).

    The CDC website describes the study as a "multi-site clinical assessment of chronic fatigue syndrome (CFS) to characterize patients with CFS or myalgic encephalomyelitis (ME) in clinical practices of clinicians with expertise in CFS/ME."

    "The study started in 2012 and aims to enrol 450 patients. Any patient (aged 18 – 70 years) that is managed or diagnosed with CFS, post-infective fatigue (PIF) or myalgic encephalomyelitis (ME) at any of seven participating clinical sites is eligible for participating in the study."

    No specific official clinical criteria (such as the Fukuda CFS criteria or the Canadian Consensus Criteria for ME) are required for patient recruitment. Instead, the participating clinicians are asked to use their own clinical judgement to include CFS/ME/PIF patients in the study.

    The CDC website says: "The study will examine the differences and similarities between CFS/ME patients in the clinical practices of experienced CFS clinicians." "The data collected using a standardized approach from expert clinical practices will be used to address the CFS case definition. Ultimately, this study aims to improve how we measure illness domains of CFS. This may allow patients to be sub-grouped to improve therapy and allow the underlying biology to be discovered."

    On paper, the CDC seems fairly ambitious in its aims:

    "CDC is fully committed to working with the CFS Advisory Committee (CFSAC) and DHHS to develop consensus about the case definition and name of this devastating illness. The need is not only for a case definition but also for reproducible standardized approaches to applying it, as well as for biomarkers to refine subgroups within the overall CFS patient population."

    The first stage of the study collected subjective measures from the patients, including clinical assessments and medical histories.​

    Dr Unger has said that 'biologic' measures are crucial to further characterize and sub-group patients, and has indicated that the early stages needed to be self-report measures in order to test the logistics of such a large study. She has said that the logistics were found to be successful in the first stage, and that they are now moving on to the second stage.

    The second stage will enroll paediatric/adolescent CFS patients, as well as recruiting the controls (healthy people and people ill with other fatiguing illnesses), as comparison groups.​

    The devil is in the detail...

    Dr Unger seems to be taking a robust evidence-based approach to defining the illness, illnesses, or subsets. If the study is done well, it could turn out to be a ground-breaking project, but if done badly, it could be worse than meaningless. If objective biological tests are not included in the long-term, then this might turn out to be a large but very shallow study, costing a lot of money and not providing any ground-breaking answers.

    Depending on its ultimate design, and its implementation, this large study could potentially be ground-breaking. Extensive objective and biological measures are not yet included in the study, but the study is evolving, and Dr Unger explains that the current study may pave the way to, and enable, future biological testing in better defined cohorts.

    However, strong feelings of discontent have been expressed - by patients and advocates - over Dr Unger's decision not to include extensive objective or biological testing from the start. One such objective test that has been called for, is a two-day cardio-pulmonary exercise test (CPET), which seeks to measure cardio-pulmonary efficiency (by measuring values such as: effort, energy expenditure, oxygen intake, and heart rate) when patients use an exercise bicycle in two separate tests on consecutive days.

    [​IMG]
    Hooked up for a CPET

    In small studies by Dr Christopher Snell and colleagues, CFS/ME patients were seen to have fairly similar CPET results to sedentary healthy controls on the first day's test. But, significantly, for one of the efficiency measures, the healthy controls improved in performance in the second day's test, whereas the performance among the CFS/ME patients was substantially worse on the same test.

    This has been seen as a means of objectively demonstrating the symptom of post-exertional malaise - considered a key symptom of CFS/ME - and Dr Snell has said that this abnormal response to exercise is something he has seen only in these patients (see: Repeat Test Reveals Dramatic Drop in Exercise Capacity).

    Dr Snell's latest research study was small, but these intriguing initial results, if replicated by larger studies, may well confirm that 2-day CPET testing is a useful biomarker for the disease.

    Members of the Chronic Fatigue Sydrome Advisory Committee (CFSAC) have suggested that Dr Unger contact Dr Snell to discuss the merits of a two-day CPET, which she has now done. We do not know the extent to which they discussed his research, or what will occur as a result, but Dr Snell has hinted that Dr Unger appeared to be open minded to including such a test at some stage in the future - indeed she does not rule it out in the answers provided to my questions (below).

    The plans for the CDC's study currently include a one-day CPET test, along with 48-hour post-exertional cognitive tests and post-exertional self-reported illness and symptom scores. Dr Snell has indicated that he believes there may be merit in using the proposed post-exercise cognitive tests and post-exercise symptom scores. It is possible that these measures may demonstrate post-exertional symptom exacerbation unique to CFS/ME patients, or a subgroup of CFS/ME patients.

    But it seems clear that Dr Snell and many patients are of the opinion that a two-day CPET should be included. The CDC study is of such significance that it seems a wasted opportunity not to do so.

    Interviewing Dr Unger

    There is limited official information available about the study, so I recently put some questions to the CDC. In reply, Dr Unger explained that she considers it important to first of all collect a comprehensive range of subjective data that will enable, stimulate, and pave the way for further studies using biological testing.

    The questions and answers are quoted below, exactly as they were asked and responded to. The answers were received on December 19th, 2013.

    1. What are you ultimately hoping to achieve from your study e.g. to create a new clinical or research diagnostic criteria, to determine biomarkers, to define subsets, to discover any research leads?

    We hope that this study will help determine the best measures of the major illness domains of CFS. These include measures of function, pain, fatigue, sleep, and additional symptoms cited in various case definitions. These measures are needed in order to determine if patient subsets can be identified that will correlate with biologic measures that could guide therapy.

    These measures are also important to assist researchers in selecting patients that are better defined, a feature of study design that will help the field achieve replication and validation of results. In addition, we hope that our study will contribute to developing outcome measures needed for clinical trials. The data collected in this study will be useful in evaluating current and proposed diagnostic criteria, but creating new CFS case definition criteria is not a goal.

    Our study will also provide descriptive analyses of the clinical management of CFS by the participating experts. Information on medication and other therapeutic and management tools could begin the process of developing evidence-based guidance for best practices for CFS care.

    2. What data are you collecting about the patients? What biological/objective testing are you carrying out, or are you likely to add to the study? Are you collecting any tissue samples, and if so, what tests will you perform on the samples? If you are collecting DNA, what are you looking for in the DNA e.g. genetic predisposition?

    In the first stage of the study we are collecting standardized self-reported measures of CFS illness domains. These include measures of function, pain, fatigue, sleep, and additional symptoms cited in various CFS case definitions. We are also using data abstraction forms to collect information from study participants on the history of the present illness, detailed medical history, medications, lab test results, family history, infection and immunization history, and physical examination.

    In this second stage of the study, which began November 2013, we are collecting saliva to measure the wakening cortisol response. We are also collecting blood to create a small biorepository of DNA and RNA that could be used to replicate promising findings from other groups.

    3. Is the methodology of the study evolving as you proceed i.e. are you adding more elements to the study as you feel you need to? Is the study open ended? How will you know when your study is complete i.e. what data will you have collected? what type of conclusions will you have made?

    The study methodology is evolving. Follow-up of patients involved in the first stage of the study will be continued in the second stage using a smaller set of questionnaires that will give data on disease course and on how well the instruments measure changes in their health.

    The second stage will enroll pediatric/adolescent CFS patients. In addition, we are enrolling healthy people and those ill with other illnesses that include fatigue as comparison groups. Other components that are being added in the second stage include measures of cognition and exercise capacity as well as response to exercise.

    The study is currently being conducted under a contract that allows one-year extensions for up to five years if funds are available. While data collection will end when the contracts are closed, analysis and publication of the findings will continue. The study is expected to provide data to support new initiatives throughout the CFS research community.

    4. Are you seeking to have an over-arching definition of fatiguing illnesses or is your focus on well defined subsets? Are you seeking to attempt to define subsets of the current Fukuda CFS diagnosis? Do you consider that post-exertional malaise (aka post-exertional neuro-immune exhaustion) i.e. delayed and prolonged post exertional symptom exacerbation that is not relieved by rest, could potentially define a distinct subset of Fukuda CFS? Are you actively looking for such a subset?

    A new definition of CFS is not the objective of this study. We do believe the study will help identify subsets of CFS patients, and equally important, will provide the tools for clinicians and researchers to use to identify similar subsets. An essential feature of this study is that we did not use a case definition to enroll patients. The study relies on the clinical expertise of those physicians who have extensive experience in caring for those with CFS.

    Post-exertional malaise or post-exertional neuroimmune exhaustion is an important characteristic of CFS with no currently validated measures. We believe that the data collected in our study will help identify the best options for either measuring post-exertional malaise, or for identifying measures that correlate with this characteristic.

    5. I have heard patients and advocates expressing concern that it is very important that your exercise testing is carried out over two days, but you have highlighted the practical difficulties of such a study. Could a small exploratory two-day testing program be carried out, with patients who are safely able to participate, to see how useful the results are?

    Our primary objective is to measure the exercise capacity in as many of the enrolled patients as possible using a standardized protocol, and to monitor the post-exertional response for 48 hours with online cognitive testing and visual analogue scales of fatigue, pain, and symptoms.

    Maximal cardio-pulmonary exercise testing (CPET) with one day of testing and 48-hour follow-up of cognition was developed in consultation with Dr. Gudrun Lang (cognition), and Drs. Dane Cook and Connie Sol (exercise). We chose the one-day test so that more patients could be tested at multiple sites with rigorous standardization.

    The two-day test would require an additional overnight stay for those patients who travel long distances to attend clinic, and excludes those who are most severely affected because of the heavy physical toll. In developing the protocol, we strived to find a balance between testing that would yield meaningful data in the broadest representation without placing an unnecessary burden on the patients.

    Results of the study will guide the next steps. It may be that a trial of a two-day protocol could be indicated for some patients or to explore other aspects of the illness.

    6. Over the years, the CDC has not always been popular with the ME/CFS community. Is there anything you can say that will provide patients with confidence in the CDC's current program and with your department's general attitude towards the patient population and the illness? Is the CDC making a fresh start with regards to ME/CFS?

    CDC’s CFS Program is committed to reducing the clinical morbidity associated with CFS while at the same time improving the quality of life for CFS patients and their families. We are focusing on projects addressing the most pressing needs associated with CFS. During our meetings with CFS advocacy groups, we heard repeatedly about the need for improved health care services for CFS patients.

    We currently have two types of initiatives related to this identified need. First, our study to collect data on CFS patients in multiple clinical practices; and second, developing educational materials, particularly targeted to healthcare providers, to advance the recognition and treatment of CFS.

    Additional Information:

    The seven participating clinical sites:
    • Pain and Fatigue Study Center, NY .............. (Lead clinician: Dr. Benjamin Natelson)
    • Center for Neuro-Immune Disorders, FL ..... (Lead clinician: Dr. Nancy Klimas)
    • Open Medicine Clinic, CA ............................. (Lead clinician: Dr Andreas Kogelnik)
    • Sierra Internal Medicine Associates, NV .... (Lead clinician: Dr Daniel Peterson )
    • Fatigue Consultation Clinic, UT ................... (Lead clinician: Dr Lucinda Bateman)
    • Hunter-Hopkins Center, NC .......................... (Lead clinician: Dr Charles Lapp)
    • Richard Podell Clinic, NJ ............................... (Lead clinician: Dr Richard Podell)
    Summary of Objective Tests:

    Current or proposed objective testing and biological sample taking:
    • One-day maximal cardiopulmonary exercise testing (CPET); with 48 hour post-exercise online cognitive testing (and also pain and symptom questionnaires) to attempt to identify post-exertional changes.
    • Saliva to measure morning (wakening) cortisol response
    • Blood samples to create a small bio-repository of DNA and RNA that could be used to replicate promising findings from other groups.
    • Natural Killer (NK) cell function and counts; sample for serum archive.
    • Blood sampling for gene expression changes.
    Possible future tests (i.e. tests that have not been proposed but not ruled out):
    • Two-day CPET.

    Further Reading:
    Multi-site Clinical Assessment of CFS
    CDC website (click here)


    Redefining ME/CFS? CDC Chief Reveals First Fruits Of Multi-Center Doctor Study At FDA Stakeholder Meeting
    Simon McGrath, 11 May 2013 (click here)


    Opportunity Lost
    Jennie Spotila, 10 September 2013 (click here)


    Discussion of Dr Snell's recent two day CPET study
    Repeat Test Reveals Dramatic Drop in ME/CFS Exercise Capacity
    Simon McGrath, 29 Jul 2013 (click here)


    Advocates Rebuffed: CDC Whiffs On Opportunity to Prove Reduced Exercise Capacity Present in Major Chronic Fatigue Syndrome Study
    Cort Johnson, 15 September 2013 (click here)


    Phoenix Rising Forum Discussion - New Dr Snell paper on exercise and CFS (click here)

    CFSAC committee meeting - Spring 2013
    Beth Unger discusses the CDC's multi-centre study - YouTube Video: (Click here to view video on YouTube)


    CFSAC committee meeting - Spring 2013 Stage 2 of Multi-site CFS Study - YouTube Video: (Click here to watch video on YouTube)

    Phoenix Rising is a registered 501 c.(3) non profit. We support ME/CFS and NEID patients through rigorous reporting, reliable information, effective advocacy and the provision of online services which empower patients and help them to cope with their isolation.

    There are many ways you can help Phoenix Rising to continue its work. If you feel able to offer your time and talent, we could really use some more authors, proof-readers, fundraisers, technicians etc. and we'd love to expand our Board of Directors. So, if you think you can help then please contact Mark through the Forum.

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  2. Roy S

    Roy S former DC ME/CFS lobbyist

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    Dr. Unger, if you are reading this, why can't you do at least some 2 day CPET testing to compare it to the 1 day testing? Testing their validity ASAP could be extremely useful and might salvage a little trust from the patient community. It can't be fun to be continually criticized.

    Thanks for the article, Bob.
     
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  3. lnester7

    lnester7 Seven

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    To all,

    I have had the one day testing and I am extremely active patient. I work 40h and I was in one of my best days and even though I thought I would not see anything in the one day exercise, It was fast and obvious. My AT was 115 and took 5min to reach. So I could demonstrate without too much taxing to my system.

    I am getting the 2 day one next and I will compare the differences, I will post back here to see if it is too much difference, but you will prove the disability issue with a day one.
     
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  4. Simon

    Simon

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    Thanks for a fine article, Bob. I thought you asked the questions we wanted answers to. And thanks for mentioning my article too!

    I do think this study could provide a treasure trove of data and hope it will be accessible to any researchers that want it. Wish they had taken more biological samples eg blood that could be processed in many different ways, as opposed to being restricted to DNA/RNA and NK cell function.

    I applaud the attempt to find outcome measures (questionnaire) that meaningfully measure change - self-reports are used by researchers of all persuasions but almost none of them have been shown to be good measures of change - which is actually the key thing you need in a clinical trial. Don't suppose they are using actometers as an objective measure of activity? Would be one way to validate the questionnaires.

    I also think the 48-hour follow-up on symptoms and congnitive performance after a maximal test will be valuable. The Lights found differences in gene expression (and symptoms) after a single moderate exercise test. It would be interesting to run the Snell test on a random subgroup of patients to see how well the results from the single (CDC) and double (Snell) maximal exercise test compare.
     
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  5. Firestormm

    Firestormm Guest

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    Interesting comment and experience from Els on our Facebook page: https://www.facebook.com/PhoenixRisingMECFS/posts/10152239014773384?stream_ref=10

    Especially in relation to observing PEM at 72 hours - which I think tends to apply to me in most cases - or at least between 48 and 72 hours.

    In order to take this into account, she exerted herself the day before she took the 48 hour test. However, I am not sure if this then makes a 'test' for PEM rather counter-productive or if it means we should be considering testing over a longer period to really establish the symptom.

    As a test of functionality at the time - I can see the test has merit - but as something that is diagnostic of the disease - 'a marker' - I really can't see it myself. Not until bigger and better studies are done.

    We did talk about this a lot when the Snell work was published. This need to ensure that patients doing the test were similarly exerting beforehand - maybe even having them on-site as it were the day before to all relax or at least measure and take into account what activity they had performed before testing took place e.g. distances traveled etc.

    And of course - as Unger herself says above - such a test is not suitable for all with ME. I sure as heck couldn't do the exercise bike at the moment and I consider myself more able in other respects...

    Be back later...
     
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  6. Christopher

    Christopher Senior Member

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    Our government is content to just keep slowly doing fruitless studies until we all eventually die out. Why bother caring?

    The only time the feds gave us any attention is when researchers started getting too close to the truth. It was only THEN that they decided to spend money to shut us up and move the illness to that of "autoimmunity" and "inflammation of unknown etiology" - just enough research to placate patients but not enough to get anywhere with treatment. And what, we should be overjoyed that after decades of willfully neglecting physiological research into our disease that we're finally getting some crumbs?

    We're not going to get anywhere with this ass-covering bullcrap. Why we tolerate this abuse by our government I do not understand.

    (deep breaths, Chris, deep breaths)
     
    Last edited: Jan 31, 2014
  7. AzizaJ

    AzizaJ

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    That is a very valid point. My own 2-day test was inconclusive. I even performed a little better the 2nd day. The first day I had not slept very well, and started with acidosis in my legs even before the test. The 2nd day I had had a good night's rest (at least relatively), and no acidosis when I started. I'm sure this affected the results.

    And like Els, my PEM usually hits the 2nd day after exertion (so after 48-72 hours).

    Also, I had my tests relatively close to home (only one hour of travelling). I was wondering how this is for most US patients, when they have their tests. Do they have to travel far (read exert themselves a great deal) before they are tested? How does that affect the test?
     
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  8. Kati

    Kati Patient in training

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    Once more the CDC will rely on self-report of pain and other symtoms post exercise test. The only objective value will be the cognitive test, which could in my opinion be skewed whether the patient is upright or reclinng.

    when I did my exercise test a couple of ear ago, I developped arrythmia during the test and it was still present the net day.

    I can't believe that in 2014 there is no money for patients with ME and for the CDC to perform a truly scientific study on patients who have this poorly researched disease which yanks highly functioning from payroll. This is in the light of President Obama who has announced an extra 100 millions for HIV AIDS only 2months after government shut down last fall.

    Basically what the 1day exercise will show is that we are deconditioned. dr Snell and Staci Stevens will confirm that too.

    As I am awaiting for being called into doing it, I will ask if I can 'purchase' a day 2 for myself. After a couple of medical reports saying I am refusing 'treatment' of meditation, group therapy and naturopath and yet another specialist who will say that I refuse CBT and GET, I will need to prove that indeed I am sick and doing the very best for myself.
     
  9. SOC

    SOC Senior Member

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    What (and where practicing) so-called ME/CFS specialist is using only meditation, group therapy, naturopathy, CBT and GET? Sheesh! :rolleyes: I can see ignorant GPs doing that, but "specialists"? Really? Come on folks, get into the 21st century.

    I'm sorry to hear that's the kind of "specialist" treatment you get, Kati. :hug:
     
    Last edited: Jan 31, 2014
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  10. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    I think it looks promising as they are testing known physiological problems with cfs/me such as the exercise tolerance/pem and the nk function stuff. I guess its not about finding anything new but replicating previous findings. If one day they could add the exercise tolerance test and nk function test to the CCC then i think this will definately be an improvement on diagnosing cfs/me. Im sure there are more tests they could add but this is a good start and its not just going off a list of random symptoms. Once they can narrow the group down to what truly is ME then better studies and treatments hopefully will come.
     
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  11. SOC

    SOC Senior Member

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    I'm still uncomfortable with the amount of questionnaires compared to objective measures. For a start, questionnaires are only as good as the questions asked. Bad questions give unclear or inaccurate responses. I'm not sure the CDC folks understand the illness well enough to ask appropriate questions. We don't need any more "Have you been overly fatigued in the last 6 months?" Let's hope the expert clinicians and researchers are giving the CDC lots of help with this.

    There's the possibility that something positive will come out of this study. The inclusion of our experts is highly encouraging. I won't be comfortable until I see the results, though. :p
     
  12. Bob

    Bob

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    Here is Dr Unger' s presentation to the IOM committee. It is quite a good over-view of the project but I don't think it includes any new information.

    Presentation - click here to view on YouTube.


    Q&A's - click here to view on YouTube.
     
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  13. ggingues

    ggingues $10 gift code at iHerb GAS343 of $40

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    @Christopher Couldn't agree with you more! Ready to burn this sucker down!!

    GG
     
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  14. Firestormm

    Firestormm Guest

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    Well, it makes a marvelous difference to watch and listen to a presentation from IOM that is not subject to problems with internet signal, or sound, I must say! Struggling to watch the IOM meeting the other night (day 1), led I believe to my subsequent issues experienced (day 3). Talk about PEM :ill:.

    And that wasn't unusual physical exertion of course: which brings me to another point about the CPET - it is stimulated by physical and not mental exertion: so we also need some means of measuring objective mental exertion and any affect or influence it has on PEM as a symptom (if indeed following all of these attempts to determine what PEM might be, it continues to exist as a separate symptom).

    If I over-exert mentally, to a significant extent, on Day 1, and don't rest on Day 2 but try and continue my normal routines (which include mental 'work'), then on Day 3 I will feel bad effects. Is this any different to physical exertions, and physical PEM? It may well be but perhaps we need to learn more about it. And what about the combination of physical and mental over-exertion?

    We are also no closer to determining a cause. There have been hints, but if looking at physical exertion - over and above 'a norm' - then why should we feel 'worse' after a delay? And why should that delay be different (perhaps) for each of us - could it be based on the nature and/or duration of the exertion? The 'level' of our individual disability? What factors might contribute to delaying any negative effects? And do those effects occur all the time i.e. what is the actual trigger - is there a 'level' at which an 'event' is triggered?

    I took a long time - 1-2 years - to build up to the routine I have now and baring exceptions like the flu, I can manage to do what I need to do at the level of functioning I now experience generally. But any interuption to that routine - like viewing the IOM conference the other night (which ran from 6-10pm UK Time) and was well outside of my routine - tends to screw me over but to variable degrees.

    I find it easier to pace any over-exertion on the physical front and find it easier to manage than mental exertion, but whilst I do anticipate a 'crash', I don't avoid overdoing things but instead try and plan for them. It's the unexpected or unintended events now that catch me out - or the unavoidable. Also I experience terrible sleep, and an especially 'bad night' will f**** me up in similar fashion to a bout of PEM, but it occurs almost immediately.

    I think unraveling PEM has a way to go, but I am pleased that they seem to be trying to get to grips with it - at least in part. Always was too loose a symptom for me - and for my doctors - to really place much faith in. One of the hardest I found to make others believe is real: 'Well, we all feel bad the next day, after doing too much the day before." Etc. etc. So I do hope that this CPET when properly validated can help alleviate some of this concern: though quite how practical it will be as a test in a surgery - or when it might be used - I don't know.

    It bothers me that as a 'test' it implies that at some point a level of 'pass/fail' might be employed. And what if you 'fail' at the time of taking it? ME is a fluctuating condition. I also can't help but worry, that such a test could be used by some unscrupulous Benefit Agency as a determinant for work capability...

    OK that might be wholly unrealistic, but at some point when tests become the norm for our condition (whatever that proves to be), and the results feature in medical records, then it will filter into our assessed ability to work. Might be a good thing, might not. I can't help worrying though - especially if people are overly praising of such things before they have been properly validated.
     
    Last edited: Feb 1, 2014
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  15. daisybell

    daisybell Senior Member

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    I agree with you. I find that mental exertion is in some ways worse than physical for making me feel unwell. If I am having a good spell, I can walk for over an hour (slowly) with no apparent after-effects. I recently had two weeks off work and felt great! ( that is to say I actually didn't wake up every day feeling unwell) But as soon as I am back at work which I am still trying to do, I feel unwell again. The sustained cognitive load is what seems to bring on most of my symptoms.
    If I end up not working, I can't see any dr without significant experience of ME concluding that I am not fit for work. But as soon as I work, I feel ill.
     
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  16. 5150

    5150 Senior Member

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    We Need To Find The Root Cause(s). We Need Treatments. We Don't Need Leftover Crumbs Studies.
    Unger and Sebelius: what a pair to draw. More Stonewalling.
     
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  17. biophile

    biophile Places I'd rather be.

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    Thanks Bob. I have not combed over the article yet, but the lack of 2-day testing annoyed me more than I thought it would. I understand many patients cannot do this test, I would be very reluctant to do it because of my current state (I would have been glad to do it in the earlier less-severe years of the illness), but the option should be there for a subgroup. Researchers behind the CPET test for CFS are saying there needs to be a two day test for the best data.

    Subjective questionnaires are important, and we do need large studies employing them, but part of me cannot help but see the CDC multi-site study as the sort of preliminary fluffery that should have already been done 20 years ago. So some important data should be collected, but more of the same, and a great opportunity lost, sort of like the PACE Trial adding on a whole bunch of questionnaires but then omitting one of the most important measures i.e. actigraphy by actometers.

    I think don't think a single CPET test is going to be utterly useless though. Many patients are worried that a single test will just serve an agenda to show that patients are merely deconditioned. However, what a single day test does show is that CFS patients can have similar fitness levels as healthy sedentary controls who do not experience CFS symptoms or PEM. That in itself is a convincing argument against the primary deconditioning hypothesis.

    Simon mentioned that the Lights found (biological) abnormalities corresponding to PEM after a single test. Unfortunately, the CDC multi-site study is not taking any blood samples after the exercise test either? It appears however that the methodology can be added to if there is adequate funding. So it sounds like there is hope that the CDC may not (but probably will anyway) miss a great opportunity to validate some previous clues.
     
  18. Bob

    Bob

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    Yes, I agree. This study should have been carried out 20 or 30 years ago. The way I see it is that the CDC has done next to nothing in the past, in terms of useful research. So the CDC doesn't have any useful data on ME. I think Beth Unger is starting afresh. She has to start somewhere, and I think this is a good place to start. Unfortunately it's 20 or 30 years too late, but that's not her fault. She has emphasised, repeatedly, that this is only a starting point, and that the study will evolve. But no one trusts the CDC, so they need to demonstrate their intentions with actions. But even purely using self-reports, and clinical history (inc vaccination history, and past/current pharmaceutical prescriptions), I think a large study like this may potentially give some exceptional ground-breaking info.

    A single CPET study on it's own is going to be pretty useless, I imagine, although it may contribute to determining some subsets. But I think the 48 hour post-exertional cognitive tests and self-reports may well have some merit, and may well come up with some interesting results. The reason a two-day CPET test is informative is because the second test assesses and objectively measures the post-exertion reaction. But 48 hour post-exertional cognitive tests may also measure PEM (i.e. changes as a result of a post-exertional reaction.)

    I don't think they are taking post-exertional blood samples. I haven't seen that proposed.

    It all boils down to whether Unger is honest, open-minded and competent.
    I'm hopeful that she's doing her job with good faith, but the CDC has a lot to prove.
    I think that Unger may have reset the CDC's program for CFS, which is what she needed to do.
    And if starting from scratch, I can't fault her approach of collecting large amounts of data and 'following the evidence' (i.e. without bias or prejudice), which I think is exactly what we need.

    But, yes, if she adds objective biomedical tests, then the study could be transformed into something incredibly meaningful and ground-breaking, if carried out competently and honestly.

    I'm cautiously optimistic, but I'll be sceptical until we see some meaningful results, and a solid demonstration of good faith.
     
    Last edited: Feb 24, 2014
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  19. heapsreal

    heapsreal iherb 10% discount code OPA989,

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    i think the good research is going to come from the private type researchers like kdm, montoya, dr K, dr P, need the $$ to go to those guys to get the job done.
     
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  20. Firestormm

    Firestormm Guest

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    I wonder if the following examination were to be repeated on patients with ME similar observations might be made (PEM in Gulf War Illness) June 2013:

    Not that I am saying this research was good or bad, obviously is in need of replication; but apart from the observed sub-groupings, it is I think important to note that PEM is not exclusive to ME. Maybe they should also try Snell's testing methods on GWI and also use controls from other chronic conditions (I know Snell has said that his observation in ME was unique but a study using, say, MS patients as well as healthy people, as controls, might also better enable the point from his initial research to be better established as something definitive for ME).
     
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