NIH Clinical Study Updates via OccupyME

[Denise]

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.

 

[Simon]

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

 

[Denise]

The study FAQs have been updated also.

 

[Comet]

This sounds great. Thanks to Jennie Spotila for posting.
http://occupyme.net/2016/10/06/quick-nih-updates/:

Dr. Avi Nath is leading an ME/CFS Special Interest Group at NIH. The website says, “The ME/CFS SIG seeks to provide a forum in which to disseminate and discuss clinical and scientific information about ME/CFS. It is open to all interested intramural and extramural investigators seeking to learn more about ME/CFS and hopes to foster new research collaborations across the NIH campus.” As Dr. Nath had promised, outside experts in ME/CFS are brought in to give talks to the research team. To date, those speakers have been Dr. Anthony Komaroff, Dr. Leonard Jason, Dr. Daniel Peterson, and Staci Stevens and Dr. Mark Van Ness.

 

[Nielk]

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

To take part in the PI-ME/CFS group, you must:
□ Have been diagnosed with ME/CFS by a medical care provider
□ Have fatigue that started right after an infection, as documented in your medical records.
□ Have been having fatigue for more than 6 months, but less than 5 years at the time of study enrollment.
□ Currently have substantial and persistent fatigue and post-exertional malaise..

 

[Nielk]

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

□ You are taking any drug (including prescription, over-the-counter, or illegal drugs) that may affect the study results and that you cannot safely stop during the study, based on our evaluation. Drugs that might interfere with the study include (but are not limited to) antidepressants, mood stabilizers, pain medications, muscle relaxants, and sleeping medications.

 

[*GG*]

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

 

[taniaaust1]

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

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.

 

[Nielk]

t 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.

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.

 

[taniaaust1]

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.

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.

 

[Nielk]

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.

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

 

[viggster]

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.