2 research outputs found
Common data elements for clinical research in mitochondrial disease: a National Institute for Neurological Disorders and Stroke project
Objectives The common data elements (CDE) project was
developed by the National Institute of Neurological
Disorders and Stroke (NINDS) to provide clinical researchers
with tools to improve data quality and allow for harmonization
of data collected in different research studies. CDEs have been
created for several neurological diseases; the aim of this project
was to develop CDEs specifically curated for mitochondrial
disease (Mito) to enhance clinical research.
Methods Nine working groups (WGs), composed of international
mitochondrial disease experts, provided recommendations
for Mito clinical research. They initially reviewed
existing NINDS CDEs and instruments, and developed new
data elements or instruments when needed. Recommendations
were organized, internally reviewed by the Mito WGs, and
posted online for external public comment for a period of eight
weeks. The final version was again reviewed by all WGs and
the NINDS CDE team prior to posting for public use