https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3493110/
Abstract
Background and Purpose
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 based on comments from leading national
and international neurovascular research organizations and the public.
Results
The
first iteration of the NINDS stroke-specific CDEs comprises 980 data
elements spanning nine 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 Endpoints; 8) Stroke Presentation; 9)
Stroke Types and Subtypes. A CDE website provides uniform names and
structures for each element, a data dictionary, and template case report
forms (CRFs) using the CDEs.
Conclusion
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.
The
mission of the National Institute of Neurological Disorders and Stroke
(NINDS) is “to reduce the burden of neurologic disease.” Supporting
translational, clinical, and population research in stroke is
fundamental to this mission, as stroke is the single greatest nervous
system cause of death and disability, both in the United States and
worldwide.(1, 2) (3)
Accordingly,
the NINDS supports a diverse array of translational, clinical trial,
epidemiologic, and additional patient-oriented research in
cerebrovasular disease, which have had a substantial beneficial effect
upon health policy, clinical care, and patient outcomes.(4)
However, the fullest potential benefit of these research endeavors has
not been realized due to the absence of uniform, widely-accepted formats
to characterize demographic, disease, care process, and outcome
variables. Data elements are often characterized in varying manners in
different studies, hampering cross-study comparisons, recognition of
population differences, data-sharing, and pooled analyses.
To
harmonize data collected across diverse translational, clinical, and
population studies, NINDS began the Common Data Element (CDE) Project in
2006.(5)
The project aims to standardize naming, definitions, data structure,
and response options for all variables commonly employed in NINDS-funded
patient and population research. The CDE project complements
study-level guidelines from the Enhancing the QUAlity and Transparency
Of health Research (EQUATOR) Network.(6)
However, where EQUATOR guidelines focus on the reporting of study level
results, the CDE Project focuses on the collection and reporting of
individual variable level results, providing guidance for data
collection, and facilitating data sharing, at a more granular, patient
level.
The overall CDE Project has four primary goals: 1)
disseminate standards for the collection of data from participants
enrolled in studies of neurological diseases; 2) create easily
accessible data-collection tools for investigators that are ready to use
“off the shelf”; 3) encourage focused and simplified data collection to
reduce burden on investigators and practice-based clinicians to
increase clinical research participation; and 4) improve study quality
and reduce cost of data entry, cleaning and analysis by providing
uniform data descriptions and tools across NINDS-funded clinical studies
of treatment for neurological diseases.(5, 7)
The anticipated benefits of the CDE Project are multiple, and include:
1) rapid and efficient study start-up by allowing investigators access
to appropriate data elements, definitions, and case report form
templates; 2) improved patient safety by facilitating development of
common report templates that can be submitted to oversight committees
such as Data and Safety Monitoring Boards (DSMBs); 3) enriched data
sharing and data aggregation by employing standard definitions and
common forms; and 4) wide adoption of common outcome measures (e.g.,
functional, cognitive) that may be relevant across the neurological
diseases.(5, 7)
The
CDE Project first developed a set of General CDEs commonly collected in
all neuroscience clinical studies, including demographic information,
medical history data, medication use, and data needed for safety
reporting.(8)
Next, development of disease-specific CDEs was undertaken. This paper
describes the process and outcome for the development of Stroke CDEs.
Methods
NINDS
convened a Stroke CDE Working Group consisting of 52 experts with
experience in NIH-funded cerebrovascular disease clinical and population
research or international initiatives in stroke data integration. The
Working Group comprised extramural clinical scientists, intramural NINDS
researchers, and the NINDS CDE team, supported by a contracted clinical
research organization, KAI Research Inc. (Rockville, MD). Participants
represented a broad spectrum of specialties and research domains,
including: adult and pediatric stroke; acute care and prevention;
outpatient, prehospital, emergency department, inpatient, and
neurointensive care; neurology, neurosurgery, emergency medicine,
radiology, and hematology; nursing, physicians, biostatisticians, public
health, and epidemiologists. The input of experienced research
coordinators and scientists involved with the creation of data and
specimen repositories and of an industry scientist was also solicited.
Members from diverse institutions were selected to ensure the inclusion
of different perspectives and experience. Specific federal agencies,
such as the Food and Drug Administration (FDA) and the Centers for
Disease Control (CDC), were requested to appoint representatives. The
CRO was responsible for scheduling the Working Group conference calls
and working on administrative action items such as development of the
CDE data dictionaries based on the Working Group’s content
recommendations. Wherever possible efforts were made to harmonize the
Stroke CDE work product with existing data structure recommendations,
including from the Specialized Program of Translational Research in
Acute Ischemic Stroke (SPOTRIAS) Common Clinical Database, the Centers
for Disease Control and Prevention’s Paul Coverdell National Acute
Stroke Registry (Coverdell), and the American Heart Association/American
Stroke Association Get With the Guidelines (GWTG) – Stroke national
quality improvement registry.
The final CDE products were to include:
- Listing of standardized data elements that can be incorporated into any data system
- Data Dictionary with data specifications for each element, including definition, format of response (numeric vs multiple choice vs free text), recommended response options (for multiple choice), explanations, and references
- Template study forms in Microsoft WORD and PDF format
- Manuals of Procedures (MOPs), as appropriate
- Website that facilitates access to the CDE data elements, data dictionary, forms, and MOPS (http://www.commondataelements.ninds.nih.gov/Stroke.aspx).
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