CDC Multi-site Study: Heterogeneity in ME/CFS Illness Measures Not Explained by Clinical Practice, 2024, Unger et al

Heterogeneity in Measures of Illness among Patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Is Not Explained by Clinical Practice: A Study in Seven U.S. Specialty Clinics

Elizabeth R. Unger on behalf of the MCAM Study Group
Jin-Mann S. Lin 1, Yang Chen 1, Monica E. Cornelius 1, Britany Helton 1, Anindita N. Issa 1, Jeanne Bertolli 1,Nancy G. Klimas 2,3, Elizabeth G. Balbin 2, Lucinda Bateman 4, Charles W. Lapp 5, Wendy Springs 5, Richard N. Podell 6,Trisha Fitzpatrick 6, Daniel L. Peterson 7, C. Gunnar Gottschalk 7, Benjamin H. Natelson 8, Michelle Blate 8, Andreas M. Kogelnik 9, Catrina C. Phan 9, and on behalf of the MCAM Study Group

1 Division of High-Consequence Pathogens and Pathology, Centers for Disease Control and Prevention (CDC), Atlanta, GA 30329-4027, USA
2 Institute for Neuro Immune Medicine, Nova Southeastern University, Fort Lauderdale, FL 33314, USA
3 VA Medical Center, Geriatric Research and Education Clinical Center, Miami, FL 33125, USA
4 Bateman Horne Center, Salt Lake City, UT 84102, USA
5 Hunter-Hopkins Center, Charlotte, NC 28226, USA
6 Richard N. Podell Medical, Summit, NJ 07901, USA
7 Sierra Internal Medicine, Incline Village, NV 89451, USA
8 Department of Neurology, Mount Sinai Beth Israel, New York, NY 10029, USA
9 Open Medicine Clinic, Mountain View, CA 94040, USA

https://www.mdpi.com/2077-0383/13/5/1369

 

This is in the Journal of Clinical Medicine's current special issue on ME/CFS. Not sure if it's officially a CDC publication but given their involvement I'll say I'm not sure I've ever seen something like this in an MDPI journal, even taking into consideration some are better than others & we've seen a good number of ME/CFS-related papers in MDPI journals recently.

 

So the main conclusion is that the ME/CFS patient population is heterogenous but that without many differences between the cohorts at different clinics. Or as they write: "This suggests that expert clinicians are recognizing the same clinical entity, albeit one that is far from homogeneous."

Strange that only 57% of these patients met the IOM-criteria, compared to 83% for the Fukuda criteria.

 

It seems to me that it doesn’t necessarily tell us much about the patients, but that rather the clinicians admitting patients are admitting similar patients to all the clinics. Thus they must all be using similar criteria.

Whether those criteria actually correctly identify ME, is probably less certain than the fact they are all roughly agreeing on who to admit.

It might also be that clinicians admit on slightly looser criteria, in order to ensure they don’t lose patients to overly strict criteria? (Eg PEM may be difficult to ascertain in some-one newly ill, especially if the patient hasn’t yet recognised the pattern.)

Interesting all the same.

 

This must be old data and I suspect the paper is a retrospective review of the older data.

The 471 cases came from their 2017 paper. The 2017 paper lists the study length.
Thread : https://www.s4me.info/threads/multi...spective-retrospective-2017-unger-et-al.9056/

So SEVEN years to analyze this and produce a paper. Absolutely no urgency in the Federal Government organizations.

 

Here is the CDC webpage for the study.
https://www.cdc.gov/me-cfs/programs/multi-site-clinical-assessment.html

Info on the 7 sites.

 

This is just an additional paper from CDC's multi-site "MCAM" study, initiated in 2011. It's typical of CDC to dribble out papers from their studies - at least the ME studies - over many years. Maddening especially given the incredibly narrow scope of its goals.

I'm surprised that so few met IOM. In their 2017 paper on this study, they reported the following percentages of PEM, unrefreshing sleep, fatigue, and cognitive.

 

Merged - this is about an article discussing the paper that is the subject of this thread

A new CDC-funded paper includes criteria that may be leading to inaccurate prevalence rates

The stock photo . . .

https://www.medpagetoday.com/opinion/second-opinions/109274?trw=no

 

This. I consider a biomarker absolutely essential for steady research progress without relying on serendipity.

However there are three possibilities that present different issues. One, all or nearly all patients have the same disease, we just have not found the biomarker yet. It might be something yet to be even discovered as a biochemical or whatever it is. This is highly likely in my view.

Two, ME is many different diseases. In which case we are looking for many biomarkers, complicating the search. This might be right.

Three, the most disturbing, ME is not a disease in the classical sense. There IS NO biomarker. In this view ME would be a spectrum disorder or disease. If you have several hundred or thousands of the many thousands of things that can go wrong, you have ME. We might be looking for a phantom when we look for biomarkers. My conception of this view is linked to the emergency immune response idea, leading to major metabolomic changes like we find in ME, sepsis and severe burns. In this process many epigenetic and expression changes occur, and something can go wrong during this process. Then the immune challenge is cleared, such as an infection. Then we rewrite the entire response to reset to normal. Something can go wrong here too. So with thousands of things that can go wrong, in many different ways, there are potentially many thousands or even millions of types of ME. Its a spectrum, not a discrete disease entity. I hope this idea is wrong, but the unifying factor here would lead to a focus on rewriting the immune and metabolic response. Don't cure it, hit the reset switch instead.

 

The #CFS empirical case criteria (Reeves et al., 2005) are a weird operationalisation of the Fukuda criteria. I campaigned against them previously, including setting up this petition against them which people can still sign https://www.ipetitions.com/petition/empirical_defn_and_CFS_research

 

Summary article:


Disease heterogeneity among people with ME/CFS
https://www.meresearch.org.uk/disease-heterogeneity-among-people-with-me-cfs/

 

And of course now I know the date it was planned and likely done it just makes me wonder whether what they are picking up is ‘within patient’ differences due to PEM and thresholds rather than being ‘across patient’ due to something different happening.

bith are sort of possible because I wonder about types just meeting others with ME and sleep reversal being one big example that tends to come with other differences that sound like a type. But that would be down to what that eventually turns out to be and what we technically count as a different’type’

a lot could be if you define ME/CFS as something to do with pEM / reaction and recovery cycles (or not completing said cycles) to exertion. And then you’ve differences due to timings different exertion in the preceding however many days then hours has on timing of different bodily reactions or changes.

then you’ve thresholds due to severity / individual weak pints (some might be particularly light, noise, speaking or physical movements affected vs other things).

so I maybe don’t have an issue with the flagging , more if the interpretation and suggestion. If it’s within person you’re never going to get that imaginary homogeneity. Unless you are controlling for threshold, PEM, exertion or at least taking info on these so you can see if the ‘high scores’ are the night owls for a 9am test or those who had to travel by train the day before so are beginning to be in PEM etc.

But then despite all this being predictable it isn’t consistent in exact times across all of us, and then I know my body can just make itself go off-kilter and ill for no reason sometimes for example. But at least if this stuff was better studied we’d know enough maybe to spot if someone was in PEM or over-threshold from other measures.

so it to me should have been about methodology focus rather than sample. Or at least as much. I’m pretty sure studies still don’t ask people how far they travelled and waited, what they’ve had on in their preceding days (if in PEM already), their normal timings for PEM or other fatiguability. Which are pretty fundamental to know what they were actually testing in each person. You could have 5in PEM and the rest not for example.

but who knows when it was 2011-17 there could be those without PEM. Which obviously would need to be essential guest.