NIH seeks feedback on proposed ME/CFS common data elements (CDEs)

It's open now. This is VERY important stuff! This is about trying to come up with good standard for defining and measuring key symptoms and various aspects of ME/CFS. https://www.commondataelements.ninds.nih.gov/MECFS.aspx#tab=Data_Standards

Please be respectful if some definition is poor (ME/CFS is currently surrounded by uncertainty and misconceptions and it's easy for someone with best intentions to make mistakes). They are putting it out so we can review and provide feedback.

To develop the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) CDEs, the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome CDE Working Groups are divided into 11 subgroups to focus on identifying and defining data elements in the domains of:

  • Baseline/Covariate
  • Fatigue
  • Post-Exertional Malaise
  • Sleep
  • Pain
  • Neurologic/Cognitive/CNS Imaging
  • Autonomic
  • Neuroendocrine
  • Immune
  • QOL/Functional Status/CPET/Activity
  • Biomarkers
Click to expand...
 
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We have had good discussions about the Chalder Fatigue Scale before. Now is the perfect time to explain why it's a bad instrument. In general an important task would be to make sure that instruments and definitions based on poor science don't influence the common data elements.
 
I've just skim read the Baseline/Covariate Information Materials:
https://www.commondataelements.nind...ariate_Subgroup_CDE_Draft_Recommendations.pdf

The working group which developed it includes some well known ME/CFS experts: Anthony Komaroff, Jose Montoya, Leonard Jason, Alison Bested, Fred Friedberg, Zaher Nahle. It also included two patients and representatives from the European ME Alliance.

The medical history section is incredibly detailed. Not just the individual's medical history and history of surgeries, but also that of the individual's parents, siblings and children. It also includes the De Paul Symptom Questionnaire, as well as (sadly) the Chalder Fatigue Scale and a CDC-developed Scale which I'm not keen on. The physical examination section is also incredibly detailed and includes... a standing test!

All in all, the baseline information is incredibly thorough. I'm left with the concern that pwME/CFS will be completely wiped out just by the process of giving their baseline data to researchers. I wonder how this would be managed?
 
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This like the sort of important thing it would be good to try to influence now, but that it's easy to forget about until things go wrong, and then we have to try to fight to get them to make changes.

I wonder if we could draw attention to the inappropriateness of using certain outcomes in nonblinded trials?
 
The History and Acknowledgements page displays a very impressive line-up of experts in various subgroups.
https://www.commondataelements.ninds.nih.gov/MECFS.aspx#tab=History_and_Acknowledgements

I'm not quite sure how to approach this, though. The combined subgroups' .pdf's come out to 518 pages of what appears to be very detailed and technically challenging information. The section on Nuerologic/Cognitive/CNS Imagining is the largest at 177 pages.

As vertigo in ME/CFS is an area of interest for me, I scanned the Nuerologic/Cognitive/CNS Imagining .pdf for the words "vertigo," "balance" and "vestibular" and found this.

NIH Toolbox Overview:

The ultimate goal is to help improve communication within and between fields
of biomedical research and advance knowledge by using common data
elements. The battery will examine various cognitive (episodic memory,
language, processing speed, working memory, executive functions, attention),
emotional (negative affect, positive affect, stress and coping, social
relationships), sensory (vestibular, audition, olfaction, taste, vision) and motor
functions (dexterity, strength, locomotion, endurance, balance).
Click to expand...

So, I was glad to see it mentioned, but the task of evaluating this entire document, and the expertise needed to do so, seems so overwhelming that I fear my recommendations would be about as relevant as "Needs more cowbell."

[ Perhaps we need to organize 25 people to each go over 20 or so pages. Not ideal, since it won't follow the natural divisions of the documents, but one of those natural divisions is 70 pages long. ]
 
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