Rationale:
Although recent preclinical SUDEP research has helped advance the understanding of potential underlying mechanisms of SUDEP, there is a consensus that preclinical SUDEP models need further characterization to assess their relevance to clinical SUDEP and to improve the rigor of preclinical SUDEP studies. Currently, the field of preclinical SUDEP research lacks a standardized data language infrastructure within which preclinical data elements can be compared and translated to the clinical setting.
To address this lack of a standard data reporting structure, and the need to better characterize and understand the clinical relevance of preclinical SUDEP models, the SUDEP Data Standardization Tools project aims to create a set of clinically relevant tools, or common data elements (CDEs) to support preclinical SUDEP data collection and reporting. The CDEs created through this project, which reflect essential variables for preclinical SUDEP research, are intended to fill gaps in already-existing CDEs for preclinical epilepsy research. The goal is to strengthen preclinical SUDEP research, making preclinical SUDEP research more relevant to clinical SUDEP, and increasing the potential for the comparison and aggregation of preclinical SUDEP data.
Methods:
CURE Epilepsy has assembled a Steering Committee and Working Groups comprised of more than 30 experts in preclinical and clinical SUDEP research. These experts were asked to create a set of case report forms containing newly identified CDEs, to aid in the collection and reporting of preclinical SUDEP research. Following multiple rounds of internal review, CDEs will be open to a period of public review, piloting, and feedback. Clinical relevance, ease of use, and sustainability are high priorities in the development of CDEs. Individual CDEs will be ranked according to priority level to provide a suggestive guide for researchers to aid in their data collection and reporting. CDEs will ultimately be converted into digital format and be available for public use by preclinical SUDEP researchers.
Results:
Initial drafts of the SUDEP CDEs have been produced in several topic areas, including core and death-related information, neurological variables, physiologic measures, pharmacology and therapeutics, neuroimaging, ex vivo electrophysiology and comorbidities. Over 100 SUDEP-specific CDEs have been created so far; efforts to refine CDEs are ongoing.
Conclusions:
Upon completion, the project will have produced a set of vetted, clinically relevant preclinical SUDEP research forms containing CDEs for standardized data collection and reporting. The SUDEP data standardization tools created through this project will aid in the standardization, transparency, rigor, and reproducibility of data. Ultimately, the goal of this project is to accelerate the translation of preclinical SUDEP research to impact the lives of those at risk for SUDEP.
Funding:
This project is supported through funding from the BAND Foundation.