CDE

CDE standardizes data elements, definitions, and case report forms for clinical research on unruptured intracranial aneurysm (UIA) and subarachnoid hemorrhage (SAH) to harmonize data collection across studies.

Key Features:

• Comprehensive Data Elements: The CDE includes data elements covering participant characteristics, outcomes, endpoints, assessments, examinations, and treatment interventions specific to UIA and SAH clinical research.
• Standardization and Harmonization: Provides standardized definitions and guidelines to enable comparable data collection for meta-analyses, systematic reviews, and collaborative studies.
• Development Collaboration: Developed through collaboration between the National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine at the US National Institutes of Health (NIH).
• Expert Working Group and LTT Focus: An international Working Group of UIA and SAH experts reviewed existing NINDS CDEs, identified gaps, and created new elements to address long-term therapy (LTT) clinical research needs.
• Iterative Review and Public Comment: Multiple rounds of internal review by the Working Groups and steering committee, plus external public comment over a six-week period, refined the CDEs.
• Focus on Research Gaps: Identifies and includes elements addressing gaps in medication and rehabilitation parameters to support targeted investigation.

Scientific Applications:

• Clinical Trial Design: Supplies standardized case report forms and definitions to support design and endpoint specification in UIA and SAH clinical trials.
• Data Sharing and Integration: Common data elements facilitate combining and harmonizing datasets across studies for pooled analyses and collaborative research.
• Observational Studies: Supports retrospective and prospective observational studies through structured data collection that enables reliable analyses and comparisons.

Methodology:

Systematic review of existing data elements, identification of research gaps, international expert collaboration, and iterative internal review with external public comment informed the final recommendations.