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.