I suspect the most severely ill patients can't even get out of bed, let alone participate in a 2-day exercise test. It's likely that if we find out more about the disorder from those we can get data from, it can be applied to the people who have the disease to a more severe extent.Exclusion criteria for all participants includes, "Current immunologic disorder (e.g. Type 1 diabetes, rheumatoid arthritis)", yet the IOM ME/CFS Clinicians Guide lists “Immune impairment” as an "additional symptom" on page 9 of the guide/page 13 of the PDF : https://iom.nationalacademies.org/~/media/Files/Report Files/2015/MECFS/MECFScliniciansguide.pdf. This seems inconsistent and a significant contradiction. Don't many/most/all M.E. patients have some form of an immunologic disorder - at the very least, autoimmune thyroid disease? What is the scientific justification and/or reasoning to exclude M.E. patients who have a “current immunologic disorder”?
Additional exclusion criteria for participants with CFS: "Underlying illness that may cause fatigue such as thyroid dysfunction..." - see observations and questions listed just above.
Why would NIH publicly mention Reeves - to what benefit? Did they not know how Reeves is thought of by expert physicians, M.E. researchers and M.E. patients - and if not, why did NIH not know this?
"Enrollees will meet all definitions for ME/CFS, including Canadian Consensus Criteria, IOM, Fukuda and Reeves, in addition to post-infectious onset." In all honesty, their list reads like the contents of the kitchen sink. Wouldn’t the study benefit from selecting more focused criteria, say the CCC and/or ICCC? What is being said by listing all of these different criteria? (struggling to make sense of this)
Has the NIH offered a meaningful explanation as to why their initial study does not focus on – or even include (!) – severely ill M.E. patients – instead of being limited to no more than moderately ill M.E. patients?
Including all versions of the criteria really produces no problem practically or even logically speaking. As long as everyone has to conform to the strictest criteria, the lesser criteria become irrelevant to the extent that they overlap the strict criteria, and only provide additional barriers to inclusion to the extent that they don't overlap.
Regarding the immune impairment issue, people with ME/CFS are not generally recognized as having immune impairment according to traditional diagnostic categories. Again, this will just serve to weed out people who don't actually have ME/CFS, but some other diagnosable disorder.
This comment isn't necessarily directed to you and your concerns, but generally I think people just need to chill and let the researchers do their work. Of course it's important to have NIH clarify that they're using proper criteria and studying PEM, but the majority of critiques I've seen (from non-scientists, moreover) have appeared mostly to be just noise at best, counterproductive at worst. Some group on facebook is even circulating a petition demanding that NIH stop the study! Are these people insane? This will be a great study, one we desperately need. The tone of NIH in taking this seriously has been impressive, imo. I'm looking forward to Tues to hopefully silence these patient-critics. Based on past experience (e.g., with XMRV), I suspect many will just continue looking for conspiracies and criticizing NIH for including Reeves (oh, horror), even though that doesn't matter in the least as long as stricter criteria is also being included. But hopefully it will shut down at least some of the critics and let these researchers do what they need to do.