Discussion in 'General ME/CFS News' started by jspotila, Mar 29, 2010.
Hooray for a good start!
Well, I'd say having the Glaxo Kline XMRV research draw its ME/CFS samples from the biobank, and therefore using the Canadian Consensus Criteria in major research, (as well as using it for the other ME/CFS samples chosen) is a fantastic roll-out of the biobank!
I'm a little concerned that 1. CFS initial presentation with a flu-like illness or an acute (48 hours) or subacute (four weeks) onset will exclude a significant number of ME/CFS patients. I don't think I could answer this in a positive way. Many of us are gradual onset but wouldn't be represented in the blood bank for comparison purposes.
I hope I'm reading this wrong.
This looks like a good project. Good that neuro-cognitive impairment and post-exertional malaise (PEM) are requirements, especially the PEM. I wish PEM was a requirement for all studies.
Great news re the XMRV study.
Like Gracenote I was thinking that the first criteria is quite restrictive (and I am all in favour of being restrictive) but maybe it is good that it is like this, initially at least? All research ends up excluding patients for one reason or another, so I wouldn't worry too much at this stage so long as they can get enough samples. One problem is for people who are sick a long time they may have trouble remembering the specifics of their history re the first criteria. They may be post-viral but not quite remember timing.
But at the end of the day I would rather they be over-restrictive than over-inclusive, as being over-inclusive seems to have been a bigger problem with ME/CFS studies. It doesn't mean that the results don't apply to people who fall a bit outside of the restrictive criteria, and that these people won't benefit from the research.
Gracenote, this is the current criteria, and it does require infectious onset or acute/subacute onset with a max of four weeks. I understand that there are many patients who had gradual onset. As we have funding to expand the BioBank, we may have changes in the study criteria, and it is possible that longer onset patients will be included. I can't speculate on that any further, but I do hope we will be able to expand the BioBank to include more patients.
I'm with gracenote. This criteria does concern me. Jennie, do you have any idea why this criteria was included, and therefore excludes many PWMECFS?
Another topic - are there any plans to include patients diagnosed with ME/CFS by Dr. Bruce Carruthers, lead author of the Canadian Consensus Criteria?
The requirements are based on the needs of current collaborations.
I can't comment on any specific future plans or collaborations, I'm sorry.
I understand needing to start somewhere, but this will specifically focus on "viral" patients and will skew any results that come out of the studies. No one doing studies using BioBank blood would have access to a significant proportion of patients. We will not know if the findings would also apply to gradual onset patients. This concerns me.
It would be fantastic if you could get funding for home phlebotomy services, Jennie! Then the severe patients wouldn't be excluded! Now, that would be looking out for the bottom quartile--thank you! :Retro smile:
I agree, a study that uses viral onset patients will produce a result that may or may not be equally applicable to gradual onset patients. There is no way around that. The more variables that can be removed from a study (type of onset, no heart conditions, no primary psych diagnosis), the cleaner the result for that particular study. Then the same study can be done on another group, perhaps with a different kind of onset. If the second study gets a different result, then it's possible that type of onset is the reason. I'm not a scientist, so I hope this explanation makes sense.
The current study criteria were designed for scientific reasons, not political ones. The Association does not think gradual onset patients are not important, nor do we think gradual onset patients should not be studied. These criteria are a starting point, tied to the needs of current collaborations. When we can expand and include other patients, we will do so.
I'm absolutely not questioning the motives of CAA with this and do not think their intent is to exclude any ME/CFS patient. However, the end result will be studies that cannot be generalized to Canadian criteria CFS patients. It just seems to me that you've lost the edge for good research data before you've even started.
That's all I'm going to say. Maybe.
the 25% is probably going to be those with the highest viral titres.Generalisability is going to be a huge problem if the sample is not representative of the whole population
I think some of the more gradual onset people are also really post-viral. I saw a comment by yourself about your own history and it sounded pretty much post-viral to me (sorry if I am stepping over a line here referring to your history in this thread. I can remove it if you want. You mentioned your history in some other thread on XMRV)
Not a problem Orla. However, I don't really know what you mean by "post-viral." I definitely have viral involvement and have been helped by antivirals. I do have ongoing viral activation, but I didn't have a clear onset.
My concerns aren't personal about me (I have been and am being studied), but the fact is that patients like me would be excluded by the BioBank even though I think we are the type of patients they would want samples from. So I can't see the line that has been drawn as being useful in this type of research setting. Until there is clear research showing significant differences in the sudden and acute onset patients, I think it is premature to distinguish us in this way and will significantly impact generalizability of any results.
Help! I want to donate, but I certainly don't want to skew any results of research. My CFS did not start with an acute infectious onset. However, the symptoms of CFS hit suddenly (with severe vertigo and weakness to begin with), and in rapid-fire succession over several weeks. (It was 10 years ago -- so hard to remember.) With adjustments I continued to work my desk job for 16 months (against my doctor's wishes). It was a toxic workplace, by the way. My colleagues thought they would have to drive me home when I finally left on short-term disability. I have never been able to return to full-time employment.
So, this isn't acute onset, but is it sub-acute? Do I donate? Anyone?
I think CAA should have made this clear in their announcement that GSK is involved -- the more transparency the better and naming the funders of a research project is standard. Also, I hope the CAA enforces that results of the study be published regardless of the results as Pharma is not obligated to publish their results.
RE: generalizability. Generalizability (part of external validity) is almost always an issue with every single clinical research project and should be addressed but for an initial project, internal validity -- showing that an idea/ theory has promise -- is needed to get something off the ground.
The criteria allow acute onset (48 hrs) or sub-acute (4 weeks) without infectious onset, provided all the other requirements are met. If you have questions after reviewing the website, then please do call the office at the phone number given on the site.
From The Association's web page:
"Since we announced the SolveCFS BioBank on Monday, there has been tremendous enthusiasm about the opportunity to participate in this type of ground-breaking research . However, until all the required institutional approvals are obtained by all parties required to initiate BioBank-based studies, the CFIDS Association of America is not able to share information or comment on reports initiated by others about studies being planned. In the interim, please refer to our March 29, 2010 announcement about the SolveCFS BioBank and updated eligibility criteria. We hope that you agree that adhering to protocols established for confidentiality, privacy and the ethical conduct of research serve the interests of all of us dedicated to advancing understanding of CFS.
We regret any confusion that may have been generated and we look forward to regularly sharing news about the SolveCFS BioBank and approved studies."
In addition, researchers who use samples from the BioBank will be required to submit their findings to peer-reviewed publications.
Well I do have to say, if you have sudden onset you never forget the date it started plus you remember exactly what you were doing and thinking at the time. Many of us who are sudden onset are realizing that we had some of the symptoms before the onset incidence but we were also never the same after the incident. Many others were perfectly fine before the sudden onset.
I never heard of sub-acute onset before. That's very interesting and it's cool that they're allowing them into the Biobank right off too.
It's good that they're starting with a specific group and only using patients from 4 doctors. I'm sure they will be adding in other sub-groups as we go along. This really is very exciting.
I think the way they've chosen to start is good but I do understand why those who had gradual onset are concerned. I would say, appeal to the CAA and ask that they have plans in the future to have gradual onsets represented too. Find that out first, because my guess is that they will plan to.
Where do I fit in? I am xmrv + but I fit the criteria that was posted. Will I be able to participate in this bio bank? My diagnosis is fibromyalgia I diagnosed myself with cfs. Or do I fit in?
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