Standardizing the structure of stroke clinical and epidemiologic research data: the National Institute of Neurological Disorders and Stroke (NINDS) Stroke Common Data Element (CDE) project.
OBJECTIVE
The National Institute of Neurological Disorders and Stroke initiated development of stroke-specific Common Data Elements (CDEs) as part of a project to develop data standards for funded clinical research in all fields of neuroscience. Standardizing data elements in translational, clinical, and population research in cerebrovascular disease could decrease study start-up time, facilitate data sharing, and promote well-informed clinical practice guidelines.


METHODS
A working group of diverse experts in cerebrovascular clinical trials, epidemiology, and biostatistics met regularly to develop a set of stroke CDEs, selecting among, refining, and adding to existing, field-tested data elements from national registries and funded trials and studies. Candidate elements were revised on the basis of comments from leading national and international neurovascular research organizations and the public.


RESULTS
The first iteration of the National Institute of Neurological Disorders and Stroke (NINDS) stroke-specific CDEs comprises 980 data elements spanning 9 content areas: (1) biospecimens and biomarkers; (2) hospital course and acute therapies; (3) imaging; (4) laboratory tests and vital signs; (5) long-term therapies; (6) medical history and prior health status; (7) outcomes and end points; (8) stroke presentation; and (9) stroke types and subtypes. A CDE website provides uniform names and structures for each element, a data dictionary, and template case report forms, using the CDEs.


CONCLUSIONS
Stroke-specific CDEs are now available as standardized, scientifically vetted, variable structures to facilitate data collection and data sharing in cerebrovascular patient-oriented research. The CDEs are an evolving resource that will be iteratively improved based on investigator use, new technologies, and emerging concepts and research findings.
UCLA Stroke Center, 710 Westwood Plaza, Los Angeles, CA 90095, USA. jsaver@ucla.edu
Jeffrey L
JL
Saver
Steven
S
Warach
Scott
S
Janis
Joanne
J
Odenkirchen
Kyra
K
Becker
Oscar
O
Benavente
Joseph
J
Broderick
Alexander W
AW
Dromerick
Pamela
P
Duncan
Mitchell S V
MS
Elkind
Karen
K
Johnston
Chelsea S
CS
Kidwell
James F
JF
Meschia
Lee
L
Schwamm
D015415:Biomarkers; D035843:Biomedical Research; D016208:Databases, Factual; D006801:Humans; D020407:Internet; D055825:National Institute of Neurological Disorders and Stroke (U.S.); D020521:Stroke / Q000453:epidemiology / Q000235:genetics / Q000378:metabolism / Q000628:therapy; D014481:United States / Q000453:epidemiology
D015415:Biomarkers