Data Standards
Organized by domains and subdomains often used in clinical studies, data standards include:
- CDEs — Classified as Core, Supplemental–Highly Recommended, Supplemental, or Exploratory
- CRF Modules — Template forms that logically organize CDEs for data collection
- Guidance Documents — Provide further information about the CDEs
- Instrument Notice of Copyright (NOC) Documents — Include pertinent information on recommended instruments (Instrument Notice of Copyright Information)
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Start-up Resource Listing: All Core and Supplemental–Highly Recommended CDEs recommended for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome study start-up
Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Highlight Summary: Overview of all Myalgic Encephalomyelitis/Chronic Fatigue Syndrome-specific CDE recommendations as they appear on the website
ME/CFS Common Data Elements Project Frequently Asked Questions
Click Expand All to view the CDEs associated with the CRF modules, organized by domain and subdomain.
Overview
The first set of Common Data Elements (CDEs) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) was developed in partnership with the Centers for Disease Control and Prevention (CDC) in 2018.
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
Data standards include CDEs as well as case report form (CRF) Modules and Guidelines. The CRF Modules logically organize the CDEs for data collection, while the Guidelines provide further information about the CDEs. The CDEs, CRF Modules, and Guidelines presented are organized into domains which are intuitive and common in clinical research studies.
Roster
The Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) CDE Working Group is comprised of eleven different subgroups. The Working Group members have developed the CDEs for their specific subgroups. The ME/CFS CDE Working Group is supported by the NINDS/CDC CDE Team. The subgroups began meeting by teleconference in March 2017 and held calls every four to six weeks to define the CDEs for their domains and to recommend standardized, validated instruments for ME/CFS research.
Publications
A publication related to the ME/CFS CDE initiative will be written at a later date. The citation for this publication will be included on this site as soon as it is available.
Updates
Please see attached revision history document. Please contact NINDSCDE@emmes.com if you require further information or have any questions about the revision history.