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NIH Clinical Study Updates via OccupyME

Discussion in 'Latest ME/CFS Research' started by Denise, Oct 6, 2016.

  1. Denise

    Denise Senior Member

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    On OccupyME
    Quick NIH Updates

    with links to (among other things) the clinical study and focus group consent forms.

    I am glad updates are being posted and that we are being alerted to them.
     
    AndyPR, aimossy, Hutan and 5 others like this.
  2. Simon

    Simon

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    Monmouth, UK
    IT's a very demanding study. Patients are admitted to hospital for 2-5 days, twice

    First visit - lots of test, inc evaluation to see if patient are suitable to exercise ($500 remuneration!)

    Second visit - lots more tests, linked to the exercise test ($1,100 remuneration)

    Plus up to $9 from computer simulation games :)

    I think the intensity of testing will inevitably bias the sample towards more able patients. I guess there's always a trade off between how much testing you do, and the functional status of patients. I'm sure some patients will be willing to go deep into the red for a study if they think its important enough. But some people who have severe and very long lasting/indefinite relapses might not be willing to.

    Link to download pdf of consent form http://mecfs.ctss.nih.gov/16-N-0058.1.CFS Informed consent.pdf
     
    Last edited: Oct 7, 2016
    Justin30, Artstu, trishrhymes and 8 others like this.
  3. Denise

    Denise Senior Member

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    The study FAQs have been updated also.
     
    aimossy, Simon, Sasha and 2 others like this.
  4. Comet

    Comet I'm Not Imaginary

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    This sounds great. Thanks to Jennie Spotila for posting.
    http://occupyme.net/2016/10/06/quick-nih-updates/:
     
    viggster, trishrhymes, AndyPR and 4 others like this.
  5. Nielk

    Nielk

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    It doesn't say anything about which criteria is used for diagnosis to be included in the study, The consent form states:

     
  6. Nielk

    Nielk

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    The following exclusion will severely limit those who are moderate to severe patients.

     
    actup and Wildcat like this.
  7. *GG*

    *GG* Senior Member

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    Concord, NH
    I am not Eligible:

    To take part in the PI-ME/CFS group, you must:

    □ Have been having fatigue for more than 6 months, but less than 5 years at the time of study enrollment.

    been ill 13 years now, yeah :(

    GG
     
    Wildcat likes this.
  8. taniaaust1

    taniaaust1 Senior Member

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    It sounds good to me though no matter which criteria they are using as the post exertional malaise along with with "sudden onset after infection" should be a way of picking up on the ME group of people with choosing the classical way it often starts.

    .................

    Though I wish they were also looking at longer term then just up to the 5 years group for this study but it does though make sense to me to look at a time frame of illness as i suspect this illness may be different in the early years of it then if one has had it for a very long time, so it may pay off being more specific rather then lumping everyone no matter how long they've been sick for together.
     
  9. Nielk

    Nielk

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    I disagree that fatigue and PEM alone will assure that they select ME patients and I really hope that they will not rely on this.

    Dr. Nath and Dr. Koroshetz assured us that they will use the CCC for patient selection - so I hope they will follow through with their promise.
     
    Jan and Wildcat like this.
  10. taniaaust1

    taniaaust1 Senior Member

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    You've misread my post. I agree PEM and fatigue alone wouldnt assume they would select ME patients but with the "sudden onset after infection" part they are doing too with their selection it should help pick out ME patients as that is adding in a classical ME history to their selection process.
     
    Valentijn likes this.
  11. Nielk

    Nielk

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    I didn't miss your post. It still falls short of the criteria they promised to use in selecting patients for their study.
     
    Wildcat likes this.
  12. viggster

    viggster Senior Member

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    Clinicaltrials.gov listing is here: https://clinicaltrials.gov/ct2/show/NCT02669212

    Looks like they've upped the number of subjects: 50 ME/CFS patients, 50 recovered Lyme patients, 50 healthy controls. Up to another 36 will be in the PEM focus group.

    Inclusion criteria confirm use of CCC to select patients for exercise testing.
     
    ahimsa, Solstice, Simon and 6 others like this.

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