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Enhancing sudden unexpected death in epilepsy (SUDEP) research through development of common data elements
Sloka S Iyengar, Elaine K O'Loughlin1, Lauren Harte-Hargrove1
1CURE Epilepsy, Chicago, Illinois, USA.
Epilepsia Open
|August 4, 2025
Summary
Standardized data collection tools, including Common Data Elements (CDEs) and Case Report Forms (CRFs), are crucial for advancing Sudden Unexpected Death in Epilepsy (SUDEP) research. Implementing these standardized methods will enhance rigor, transparency, and translation of preclinical findings to prevent SUDEP.
Area of Science:
- Neuroscience
- Epilepsy Research
- Biomedical Data Standardization
Background:
- Sudden Unexpected Death in Epilepsy (SUDEP) is a significant cause of mortality in epilepsy patients, with unknown underlying biological mechanisms.
- Preclinical research is vital for understanding SUDEP, but current methodologies lack standardization, hindering data translation and progress.
- A 2020 SUDEP Coalition Summit highlighted the need for standardized tools to improve research rigor, reproducibility, and translation.
Purpose of the Study:
- To develop standardized Common Data Elements (CDEs) and Case Report Forms (CRFs) for preclinical Sudden Unexpected Death in Epilepsy (SUDEP) research.
- To establish a research infrastructure that enhances data standardization, rigor, and transparency in SUDEP studies.
- To facilitate the translation of preclinical SUDEP research findings into clinical applications for SUDEP prevention.
Main Methods:
- CURE Epilepsy convened a Steering Committee and expert working groups in preclinical and clinical SUDEP research.
- Developed standardized CDEs and CRFs based on methodologies used for other epilepsy-related CDEs.
- Focused on creating a Core and Death-Related Information CRF for priority use in SUDEP preclinical studies.
Main Results:
- The Core and Death-Related Information CRF provides essential CDEs for documenting animal models, experimental details, and seizure characteristics.
- Includes CDEs for recording observations during fatal seizures, animal posture, diet, medications, and health conditions.
- The developed CDEs serve as a blueprint for consistent data collection in SUDEP preclinical research.
Conclusions:
- Systematic implementation of CDEs and CRFs in SUDEP preclinical research will improve study rigor and transparency.
- The proposed Core CDEs, along with supplemental elements, will aid collaborative efforts towards SUDEP prevention.
- Standardization of data is essential for advancing the understanding and prevention of Sudden Unexpected Death in Epilepsy.
