I'm hoping folks with better cognitive ability and medical background than myself
Not claiming either of those things, but I have read it. It's tempting to go through it section by section and pick it apart, but that would take a long time and probably wouldn't achieve much that is good.
I think it's a good document with some interesting ideas.
It's obviously a consensus document, and so the list of related diseases is wide and somewhat arguable - MCAS and EDS are in there for example. The way the research questions handle these is reasonable though e.g.
- What is the overlap between collagen/connective tissue/possible EDS? What is the role of connective tissue degeneration? What is the role of fibroblast dysfunction?
- What is the role of spinal degeneration and/or ossification? What is the role of the cervical spine?
Given the high level of acceptance of these ideas, good quality research to try to bring some answers would be helpful. It's interesting that Gulf War Illness isn't included as an associated condition.
I feel the same about the list of treatments that are given as examples. I'm not sure that I'd say some (or even any) of those have shown promise, but a lot of patient energy is being spent on them, so some good quality studies done by people with the required level of equipoise would be very useful.
Accelerate one-year clinical trials for treatments that have shown promise in the Long COVID and associated conditions patient community (e.g., anticoagulation, BC007, Low Dose Naltrexone, Ampligen, Low Dose Abilify).
This was a very interesting idea, that potentially could make the quality of Long Covid and ME/CFS research better:
Establish an Office of Complex Chronic Conditions Research (OCCCR) in the NIH Director’s Office, modeled on the Office of AIDS Research.
The one thing that I'm most disappointed about is the lack of a clear discussion of the problems of unblinded/ poorly controlled studies with subjective outcomes. To me, reducing bias from this problem is the one key thing that would improve Long Covid research. Even though there is a section on Research Design, it's not there.
Symptoms tracked should be as comprehensive as possible, as patient research has documented over 200 symptoms of Long COVID. Included among these should be the inclusion of post-exertional malaise (PEM) - a cardinal symptom of ME/CFS, cognitive symptoms, and menstrual symptoms.
Good that PEM is mentioned, but to not highlight the unblinded/uncontrolled +subjective outcomes problem makes me feel as though the Long Covid and parts of the US ME/CFS community have missed
the key lesson from the UK BPS debacle. It makes me want to yell.
It's an aspirational document. It makes a lot of ensuring diversity in trials and policy-making, which is good, even if impractical for some studies. For example, some studies may need to focus just on biological women, or just on men, or on people with a particular severity level or on people without a co-morbidity. It would be a shame if a study did not go ahead because the study question didn't fit people of every category. I liked the mention of research needing to consider menstrual cycles.
Ensure all federally-funded Long COVID studies meet recommended demographic targets for recruitment [for race/ethnicity, age, gender (including transgender and non-binary people), sex, multiple co-morbidities, disability, etc.], which may require oversampling certain populations, compensating BIPOC and LGBTQ+ patients, and conducting outreach through community health workers and organizations.
Require meaningful patient engagement in studies, which includes ensuring patients have decision-making power in every step of the research process (from ROA to publication, and as part of executive and steering committees), compensating patients for their engagement, and ensuring patient representatives are accountable to their community. In addition to requiring this of forthcoming studies, ongoing studies like RECOVER and INSPIRE should improve their patient engagement practices by adhering to these standards.
I thought the comment about compensating patients for engagement was interesting. It has struck me before, that it is the people who don't have an income and who are sick who are often the ones most expected to volunteer their time - to participate in trials, to be on patient advisory groups. I think it is right that anyone participating in research or providing advice should be paid to do that - their time is important. Perhaps if the people were paid, it would increase the respect accorded to them. If compensating participants made research more expensive, then maybe the way research is funded needs to change. It's a bit like saying the use of slave labour couldn't be stopped because it would make food production more expensive. It's controversial, of course we don't want to slow research, but the assumptions made about patients' time are worth thinking about. Perhaps less research, but research that is done really well, would get us to useful answers more quickly.
There's lot's more in there, lots more that could be said.
