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SolveCFS Biobank Beginning

Discussion in 'General ME/CFS News' started by jspotila, Mar 29, 2010.

  1. BEG

    BEG Senior Member

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    I did call the office and was asked to contact my doctor which I did. He's the pro, and I'll abide by what he says. Thanks.
  2. fred

    fred The game is afoot

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    The WPI is working with Invest in ME in the UK and NOT The ME Association.

    Invest in ME is a small, independent charity, run by ME patients and their carers, which campaigns for biomedical research into ME. It hosts an annual international conference in London.

    http://www.investinme.org/index.htm

    The funds for the WPI UK study were (allegedly) diverted from a research programme which Dr Jonathon Kerr declined to pursue after XMRV was not identfied in the second UK research study (of which he was a co-author).

    I would appreciate sight of evidence that backs the contention that the WPI receives more funding than the CAA and also that the former is being backed by pharmaceutical companies.
  3. Orla

    Orla Senior Member

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    Hi all,

    I just realised that I misunderstood the entry criteria a bit, I thought it was just post-infectious, but on re-reading it looks like either post-infectious in 48 hours, or not necessarily post-infectious over 4 weeks?? Not sure if I am correct in this.

    Hi Gracenote:

    Yes I suppose in my head I would be seeing you as essentially post-viral with possible other factors, but then you might not meet the criteria for the bank.

    I suppose part of my thinking is because of the situation in the UK. Sometimes gradual onset seems to be code for stress/psychiatric cases, so if restricting it to more acute cases cuts this out I am all for it. It is easier, I think, to make diagnostic errors with gradual onset, or to end up with some stress cases (this might not be much of an issue now, but maybe later if more doctors got involved who were not so experienced?).

    As far as I know (from UK surveys) about 80% of ME/CFS cases are post-viral, though some doctors will only diagnose it in post-viral cases so there could be a bit of circular reasoning there.

    If the entry ciriteria is stringent, even though genuine ME/CFS cases will be left out for now, at least reseachers will have a better idea of the patient population they are looking at, and so will we.

    Also some people with other factors other than viruses might be more of a mixed bag in terms of what is going on biomedically (including possible some misdiagnosed), so the results of studies might be more all over the place, and get dismissed because of this. Some of the problems resulting from this is probably in some ways more to do with the politics of the thing, but unfortunately this is the situation we are dealing with.

    I would hope that we might get higher numbers coming up positive with certain studies if the criteria are more restrictive. So this thing that some doctors/scientists do where they dismiss the findings because of mixed results (even if they there is obviously a subgroup for which an abnormality could be significant) might be less likely to happen?

    So instead of having studies with the results all over the place, which might put other researchers off exploring that area, maybe we will have higher positive results with certain studies, which might encourage further research in that area?

    So I think as a start what they are doing could be useful, so that the research might have a better chance of taking off. Once maybe it is more established they can extend the samples a bit?? Once people are properly classified maybe this will be ok then, as they could compare and contrast.

    Hi Jspotila

    That is great.

    Hi teej

    As I was typing out what I was writing I was thinking this! One problem, though which was more what I meant, is that when they say 48 hours acute, or even the 4 weeks thing, do they mean you got a virus and 48 hours/4 weeks later you have ME/CFS?? When people get sick initially, where do you draw the line between the infection and start of ME/CFS?

    The people involved in the biobank probably have guidelines for this so I am possible raising a red herring here. And basically the timelines of weeks is still pretty acute, and a lot of post-viral people would be able to fit the 4 week criteria.

    For some people they just might not be able to be very specific about the exact timelines at the beginning (though they might still be ok with the 4 weeks thing). Even if they can remember the initial infection they might be a bit hazy as to the exact timelines of the development of other symptoms. Though some people will have doctors notes on this so be able to refer back. I suppose I am just a bit fussy, and just don't trust a lot of things to memory as people make mistakes, even when they are convinced they are remembering correctly.

    Personally I could go back and check dates because I remember things I was doing that were a bit out of the ordinary (for me) and which are datable (and I have had to answer questions about it so many times that it stuck in my head a bit, and is written down in different places. My memory for dates is bad so I would still have to go back and check notes and calanders). Just some people may not have gone to the doctor for a while when they got sick initially, so might not have good initial medical notes, or they might have switched doctors so no longer have access to their original notes.

    and teej you wrote:

    The thing is, if someone had some symptoms before the deluge (so to speak) are they sudden or gradual onset? It probably depends how long they had symptoms before suddenly getting bad. And I wonder whether some people had relatively mild relapsing and remitting ME initially, so that they seem like gradual onset cases when they are more sudden onset (I am purely speculating here, and we have no way of knowing the answer to this I think until there is a test)

    Orla
  4. gracenote

    gracenote All shall be well . . .

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    Orla,

    I think your trying to sort this out explains the problem I have with this particular criteria — even in trying to be exact, it is not exact.

    I'm not sure this is correct. The psychiatric lobby recognizes that CFS often starts with an acute infection and then "the learned sickness behavior" stems from that.

    I just think we are going to end up with more confusion by trying to separate out patients by acute / gradual onset. Why not look at the markers that we know exist? Why not go by symptoms that are now present? I just don't see the logic of this particular criteria without first determining if it has any bearing on the disease ME/CFS itself.
  5. jspotila

    jspotila Senior Member

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    I encourage you to contact the office and seek guidance from them. You can find the contact info here.

    Hi Orla. The sentence in question requires "CFS initial presentation with a flu-like illness or an acute (48 hours) or subacute (four weeks) onset." I read this to mean one of the following is required: 1) flu-like illness at beginning; 2) acute (48 hours) onset; or 3) subacute (four weeks) onset. So if a potential participant has an acute onset, this criterion is met. Same if there is an initial flu-like illness, or subacute onset. The sentence can be a little confusing, especially with all the other criteria on the list. I hope this helps.
  6. Cort

    Cort Phoenix Rising Founder

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    I should hope that it will! I thought this was just for this study. If the CAA is going to represent all CFS patients then it will have to take gradual onset patients as well. I'm really surprised at this. If 20% of patients in the US have gradual onset - that's 200,000 people (and I am one of them!). That's a huge chunk of patients you're not allowing in your biobank.

    Why would anyone with gradual onset contribute to this?

    None of the doctors I've seen have ever taken special note of onset and few studies, that I recall, have found significant differences. How in the world are you going to differentiate between these two sets of patients unless you have both of them in a bio and databanks?

    I hope you can make a commitment to include these patients as funds come in.
  7. Orla

    Orla Senior Member

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    Hi Gracenote

    <Orla,

    I think your trying to sort this out explains the problem I have with this particular criteria even in trying to be exact, it is not exact. >

    That could just be my brainfog though!


    Hi Gracenote, that is their view of ME/CFS patients. They don't have a choice but to accept post-viral onset (though I have seen them try to cast doubt on it sometimes) so they just try to spin it as best they can.

    But some of these psychiatrists/doctors also misdiagnose people who have fatigue for stress reasons as having CFS. These patients fit more into their (warped) view of what ME/CFS is. But these patients basically (generally) do not have a post-viral onset, or viral-type symptoms.

    Just to be clear, I am not saying that every unclear onset case, or non viral onset, is psychiatric. But I think there is a good chance that post-viral onset cases are more likely to have strictly defined ME/CFS (or what historically was known as ME/CFS), though it is not a 100% guarantee.

    I am probably not being clear at all. Maybe one of the UK people could chip in. I have heard from numerous people that sometimes they attend these cf/cfs clinics, or even support groups, that have many attendees who don't have ME/CFS, but who have a diagnosis of CFS, based mainly on the fact that they have significant fatigue. I used to think people were exaggerating this problem, but the more I heard and saw the more I felt it really could be a problem. Admitedly these (misdiagnosed) people would not meet the Canadian, or even in many cases Fukuda criteria (if administered correctly), but I have to admit, I still feel "safer" with the extra barriers the biobank is putting in place.

    If one introduces the viral aspect to it I think there is a chance that one cuts out some of these essentially misdiagnosed people. But this is just my opinion on it, and I can see that you also have a point. Sorry if I am going on about it. I really didn't mean to! It just looks like a great plan to me, and I think as it goes on they will probably develop it, but it looks like a good start for now.
    Orla
  8. shrewsbury

    shrewsbury member

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    Well said Cort. I think the exclusion of a significant number of ME/CFS patients from the beginning is a big blot on an otherwise great project.

    This is from the Canadian Consensus Criteria Overview, pg 1

  9. jspotila

    jspotila Senior Member

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    As I have stated already, "The Association fully anticipates that the BioBank will evolve and expand over time." We see the BioBank as an essential and long-term asset for the CFS community. When we have more resources, we will expand the BioBank. It is impossible to commit to a specific timeframe for such expansions (because it is dependent on resources), and it is impossible to establish future criteria and how those might change (also dependent on resources, collaborators, and the nature of future studies). The current criteria are exactly that - current criteria at this time. The Board of Directors decided it was important to start with very specific criteria and a few collaborators because it is just that: a start.
  10. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    Biobank should only include patients diagnosed by both Canadian and Fukuda.

    I am a gradual onset person, but I don't have a big problem with the biobank excluding gradual onset people for now. Although I do think the comments of Cort, gracenote and others have merit.

    I think a much more important area for improvement would be restricting the biobank to only patients who met both the Canadian Consensus Criteria and Fukuda. Noone doing a study would turn such samples down since they would meet Fukuda (or 'Feduka' as one of our posters likes to say) and we'd be assured everyone was a real ME/CFIDS patient since they would also meet CCC. This would also go a long way to getting CCC accepted as the de facto standard definition for research and clinical use (this is extremely important). Requiring post exertional morbidity goes a long way toward ensuring the biobank's samples are from true ME patients, but why not go all the way and require CCC? This would also be less confusing as it would focus study on CCC not this new criteria of "(CCC or Fukuda) + PEM" which just makes comparing studies so much more difficult.

    Of course, I would love to see CAA promote CCC more in general.
  11. gracenote

    gracenote All shall be well . . .

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    I feel like the CAA just disenfranchised me. And Cort. And anyone else who did not have a sudden onset (or remember a sudden onset).

    You have to draw the line here? Even if we fit the Canadian criteria? Even if we would be considered some of the sickest patients? Even if we are the type of patient that the Science study was based on? Even if we are XMRV positive?

    There are plenty of ways to distinguish those of us with ME/CFS with gradual onset from psychiatric patients. If we fit the Canadian criteria (rather than Oxford or Reeves or even Fakuda), why are we excluded?

    I think this is a nonsensical move. And now it does feel personal. I am disappointed with the CAA.
  12. CBS

    CBS Senior Member

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    A really good reason to support the CAAs research efforts

    Hi Gracenote,

    I agree with your concerns about the inclusion of acute onset and not gradual onset CFS patients. I personally expect that once we understand more about CFS the distinction will not be so clear cut. As for CFS research, I understand the CAA's position and at the same time, I strongly second Cort's request that just as soon as is possible, the CAA consider adding gradual onset CFS patients to the Biobank. That said, the history of CFS research is littered with poorly defined cohorts and this is one trait that may prove useful and it needs to be documented. The CAA needs to track every trait, blood value, historical event ect. possible.

    From a statistical power perspective (closely tied to the overall cost of a study as it determines the number of patients you need, especially when looking for subtle effects), the cohorts have to be as homogeneous as possible (especially in the beginning). I am sure that the $450 plus a patient pricetag has a lot to do with each of the chosen criteria.

    I am an acute onset patient that meets all of the CAA's criteria, as well as the Fukuda and Canadian Criteria. I spoke yesterday with a CAA employee interviewing subjects. I have two very minor possibly questionable findings that might cloud the ability of a researcher to make a firm conclusion as to the specific reason for a result. I personally feel that these are not something that make me a less typical CFS patient. In fact, I feel quite strongly that they are highly consistent with CFS and are characteristic of the more prolonged and severe manifestations of CFS. However, if there are enough subjects to do the research without me, I feel that they ought to do so. Adding "noise" to the results and clouding the ability to draw conclusions isn't good for any of us. I'm not saying that onset makes one group more or less important, just that given limited finances, less homogenous cohorts reduce the power of what can be inferred from the results.

    This is something that I have expected would become an issue as some of us do and do not test positive for XMRV. I fear that the CFS community will fracture along those lines and that those without a positive XMRV test will be left with even less support than they have today. In the early stages of the BioBank (as in the early stages of XMRV testing and anything else that might come along), it is more important than ever that we support each other and at the same time advocate for the best/most efficient research practices possible.

    I agree that the addition of gradual onset CFS patients needs to happen as soon as is reasonably practical. In the mean time, I have my fingers crossed that what ever is learned (be it via the BioBank, XMRV testing, etc.) will help to unravel - what on the surface appears to be - a heterogeneous group of patients. I expect that as each "sub-group" is better understood (and possibly separated out) that the research on the other sub-groups becomes more focused. The clarification of correlation or even causality in sub-groups becomes easier to identify as the sub-groups are identified and each becomes more homogeneous (not necessarily because of different etiologies, perhaps just subgroups in different stages, with different co-infections, or some other trait that leads to a particular manifestation or level of disability associated with CFS).

    I know it feels lousy but it is good science as well as efficient use of funds. I really dont expect this to negatively impact those with gradual onset, in fact, it has a good chance of making things clearer and doing so sooner.

    Hang in there. We need you and I plan on keeping the pressure on to include a broader range of patients as soon as is feasible.
  13. Cort

    Cort Phoenix Rising Founder

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    I was concerned with this little 'may' in there. I'm glad that it will include gradual onset patients at some point - given it receives the funds it needs to expand.

    I know where Gracenote is coming from: it does feel very personal - particularly with such an exciting endeavor. I would guess that the WPI's BioBank is following the same procedure. Dr. Peterson has always focused on acute onset patients. I imagine that the study participants in their studies are also acute onset. I would be surprised if they wouldn't be - they are after all looking for viruses. So the CAA's inclusion of just those participants in the first round didn't bother or particularly surprise me either. It was that I was unclear regarding whether they would be after that.

    So long as the CAA is committed to including everybody when they can I'm certainly on board. They always been very inclusive in the past - there's no reason to think they wouldn't be now - and I think its a fantastic project. I recognize this is just the start and its a very expensive project and money is tight. We gradual onset patients will just have to be patient :)

    (We gradual onset patients just can't get any respect!!! :) So far as I can tell, the UK patient community may be wary of gradual onset patients being more 'psychiatric' but the UK medical establishment doesn't have that feeling. They think the post-viral patients are just as screwy as the gradual onset patients. IF they felt any different about that alot of ME/CFS patients in the UK would be alot happier. I don't think there's any evidence that acute onset patients are worse off either; as I remember one study suggested that a larger percentage of them got well. )

    Can you tell us how many people will have their samples deposited in the first round?
  14. CBS

    CBS Senior Member

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    One other thought - imagine a puzzle with no picture on the box. The pieces are all red, blue orange, green and yellow.

    You start by sorting the pieces by color. If green stands out for some reason you might do those first. It turns out there all evergreen trees and now when you look at the yellow, orange and red they are easier to see as trees now that you know there are other trees. Soon the whole thing starts to take shape as a fall scene with trees of all colors surrounding a lake. Starting with some like group helped all the way around but you got there with a methodical approach because there was not picture to guide you.

    I appreciate that this is a bit simplistic but it isn't far from the process that has to take place.
  15. justinreilly

    justinreilly Stop the IoM & P2P! Adopt CCC!

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    I agree. I see it unfolding this way: CAA and others have very limited funding for research. Thus, now the best allocation of resources is to fund many small pilot studies as CAA currently does rather than only one big study on some topic. More homogeneous groups allow for increased statistical validity in small studies. (Also, I think it is possible that gradual onset (which I had) pathogenesis is more heterogeneous or complicated than sudden onset.)

    As we get more funding from the govt we can then include more heterogeneity in bigger studies that carefully dissect by subgroup. In sum, I agree with CBS that starting now with more homogeneity, such as by excluding gradual onset, will accelerate good research which will benefit us all.
  16. Gerwyn

    Gerwyn Guest

    Powering a study is dependent on what the study is looking for and the magnitude of the parameter to be investigated .This would vary study by study.A homogenous cohort may or may not produce tighter confidence intervals .The generalisability of the results into a general population will of course be impossible.Such a narrow focus will always be open to attack and potentially fragment the patient population It is entirely likely that gradual and sudden onset are artificial distinctions as many viral diseases produce gradual onset or rapid onset disease
  17. fred

    fred The game is afoot

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    This is a logical premise.
  18. BEG

    BEG Senior Member

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    The sentence in question requires "CFS initial presentation with a flu-like illness or an acute (48 hours) or subacute (four weeks) onset." I read this to mean one of the following is required: 1) flu-like illness at beginning; 2) acute (48 hours) onset; or 3) subacute (four weeks) onset. So if a potential participant has an acute onset, this criterion is met. Same if there is an initial flu-like illness, or subacute onset. The sentence can be a little confusing, especially with all the other criteria on the list. I hope this helps.


    Jennie,
    To avoid confusion, here is a much clearer sentence, "Your CFS must have a post-viral onset with symptoms occuring within 48 hours (acute), or through day 28 (4 weeks, sub-acute)." This is correct? Right?

    You might suggest that it be inserted at the appropriate place on the SolveCFS BioBank webpage.
  19. CBS

    CBS Senior Member

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    Power is always greater with a more homogenous cohort regardless of the parameter under investigation. The need for greater power may be less an issue when there is a a large effect but you risk missing an effect without the greater power (and with this type of database we have no idea what we could be looking for in the future). Until more is known, why risk missing something. As for generalizability, unless you are suggesting a difference between sudden onset and gradual onset CFS, this shouldn't be an issue. If that is in fact your concern, now we're back to arguing for a larger sample size (doubling the cost) or a loss of power to detect an effect.
  20. Orla

    Orla Senior Member

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    Tighter cohorts are better in any study. I think it is good that the CAA are recognising this. My guess is is that this push came for researchers (the good ones that is), as they have been talking for years for the need for more defined cohorts.

    I think with the research, all the doctors will see is X was found in CFS. They won't know the difference between different criteria etc. so in practice, when patients are being seen and treated in a clinical setting, the results are very likely to be generalised to them (in a way this has been part of the problem with rubbish cohorts in the studies, the results get generalised to all of us.). I think as many doctors would love to have things to test for, or an explanation at least of what might be going on, that they will at least consider the possibility of the results being relevant to all with ME/CFS. If tests are available for certain problems they may run them (if they can on the public system or if the person can pay).

    People have raised many concerns on the forum about Vernon's attitude re the Oxford Criteria and so on, and to be honest I was concerned about her general thinking because she signed the "empirical"/Reeves definition, so it is something of a relief to see that the CAA are trying to do the right thing here by trying to have a tighter patient population. If people push too hard for looser entry critieria isn't there a danger that it will go the other extreme alltogether? And that would be a disaster.

    I have to admit that I feel a bit sorry for the CAA (not that I think everything they do is ok, or that some of the criticism isn't justified) but one minute they are being criticised for being too sympathetic to loose entry criteria in studies and the next they are being criticsed for being too strict. They must feel they cannot win.

    Jenny has already pointed out that this is just a beginning, they are not necessarily going to stick to the current entry criteria forever. I think it is good to start strictly and then see how it is going. They might see then where there are gaps, get feedback from researchers etc, that results in some changes.

    It is possible that some of the researchers who will be using the biobank will know little or nothing about ME/CFS so this is another advantage to what they are doing I think. There might be good scientists out there who would do research, but who don't have doctors to evaluate patients etc before including them in a study so this will be helpful for them (as well as saving a lot of time and money on trying to recruit different patients for different studies).

    These scientists might not know to look to see whether there was a difference between sudden and gradual onset, or might decide not to analyse whether there is a difference in their studies, so we could end up with a bit of a mess in terms of results if there are too many variables in the patients that are included in the studies.

    Orla

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