Introducing the Common Data Elements Working Group

The National Institutes of Health (NIH), in partnership with the Centers for Disease Control and Prevention (CDC), has recently launched the Common Data Element (CDE) Working Group with the intent to streamline medical and research terminology in ME/CFS. The ultimate goal of this ambitious project is to standardize the collection, analysis, and comparison of data across multiple research studies. CDEs are becoming a foundational requisite in biomedical research in any field, and this is especially true for a disease where confusion regarding case definition, inclusion criteria, and study design continue to exist.

According to program officials, the goals of the working group are to

  • Develop common definitions and standardize case report forms (CRF) and other instruments
  • Help investigators conduct clinical research through the development of uniform formats by which clinical data can be systematically collected, analyzed, and shared across the research community

The working group includes government officials with expertise in ME/CFS and volunteer clinicians, scientists, advocates, and caregivers—many of whom are well-known figures in the ME/CFS community.

Dr. Zaher Nahle, SMCI’s chief scientific officer and vice president for research, is a member of this working group. Said Dr. Nahle, “This is an important and ambitious project. The participation of dozens of disease and community experts as volunteers underscores its importance and anticipated value. Given this unique and rare opportunity, it is our belief that a definitive case definition should be adopted as part of these discussions; it is ostensibly the most confounding issue in any research investigation involving human subjects, especially ME/CFS.”

The CDE Working Group has been divided into eleven specialized subgroups/panels with a total of 74 seats, with some experts participating in more than one subgroup. The eleven subgroups that have been formed are as follows:

  • Fatigue
  • Sleep
  • Quality of Life/Functional Status (CPET Testing)/Activity
  • Immune
  • Pain
  • Baseline/Covariate Information
  • Post-Exertional Malaise (PEM)
  • Autonomic
  • Neurologic/Cognitive/CNS Imaging
  • Neuroendocrine
  • Biomarkers (EEG, cytokines, NK cell function)

This project will take place over several months, and we will update the community periodically on its progress.

February 10, 2017
  • donnajeanoue

    Hello There, It would be such a blessing if someone could find the cause and a cure for this terrible disease!!!! I’ve been sick with CFS for 24 years now and I can tell you it only gets worse as the years go by. Nothing helps my sysmptons.

    • Larry DePuy

      On june first it will be 24 years for me too. Here’s what has helped; I take Elysium Basis. It has two ingredients, the important one is nicotinamide riboside. It is taken into the cells of the body and converted to NAD+ which “feeds” the mitochondria (the cells “engines”) and helps the mitochondria repair themselves. It is essentially a B vitamin. Go for a walk two hours after you take it. If you have been only able to walk 2 blocks you will probably do four or more.
      I am also taking antivirals which have made a huge difference. I started because of the XMRV study (that later fell through), but my blood work showed a clear response. I tried AZT first and my t-cell count went from 30 to 63 and then gradually went back to 30. After 5 months I had an adverse reaction to AZT so I quit for a month and then started on Viread. My blood work did the same. The first 10 or so days I felt much worse, but then I started to improve and 2 months later I felt better than I had in years. My doctor had me take Isentress soon after. My doctor (who had been written up in Time and Newsweek for his work on HIV and other viruses) told me I should be on 3 antivirals. Sadly he passed away, and no other doctor would prescribe the additional antiviral. Then I found out about PREP (Truvada once a day) a program for HIV negative people at risk. My new doctor then prescribed Truvada, a combo of Viread and Emtricitabine.
      What I don’t understand is why I have responded to antivirals for 4 years now but no one can find the damn virus. I realize ME/CFS could be more than one disease, but if it looks like a virus and responds to anti-viral drugs…
      Either we have to get the Gilead to do a drug study or we do it ourselves. Find a doctor who will prescribe viread or Truvada, if you get worse at first and then much better or feel no effect report it here. If we all did a two month trial we could get a good idea as to what percentage of us carries a virus. Then maybe someone would take notice. The type of antivirals that we respond to might be an indicator of the type of virus and point researchers in the right direction. I will turn 70 this year and all though my health has improved a lot, I am still not heathy. I am totally fed up with the lack of progress. I have lost half my adult life to this disease. I want a cure NOW!
      Also get tested for sleep apnea. CFS/ME may cause it in some people. I am on a C-PAP machine as well and that took care of most of my mandatory afternoon naps.