Abstracts

Rationale: The National Institute of Neurological Disorders and Stroke (NINDS) developed epilepsy-specific Common Data Elements (CDEs) in 2010 as part of an overall project to develop data standards for funded neuroscience clinical research. Through the development of these data standards, the NINDS CDE initiative strives to improve epilepsy data collection by increasing efficiency, improving data quality, reducing study start-up time, facilitating data sharing/meta-analyses and helping educate new clinical investigators. In 2011, an Oversight Committee (OC) was developed to oversee any improvements and updates as needed. These changes have been relatively minor over the last several years, including revisions to guidelines and updates to references. Some revisions have involved modifying CDE classifications (1) from ‘Core’ to ‘Supplemental.’ In 2017, the epilepsy OC worked on making more substantial changes, including important updates to the seizures and syndromes classifications for epilepsy based on the revised International League Against Epilepsy (ILAE) classification system, which needed to be reflected in the epilepsy CDEs. In addition, updates were made to the Quality of Life (QoL) recommendations and imaging documents. (1) Core CDEs are data elements that are essential to include while Supplemental CDEs are commonly collected but use depends upon study design or type of research involved. Methods: Two domain-specific epilepsy CDE working groups (WGs) were developed to consider the changes needed for seizure classification revisions and updates to QoL recommendations, while the imaging CDE updates were reviewed by members of the OC. The two WGs met via monthly teleconferences to discuss and revise the Epilepsy Seizures & Syndromes and QoL CDEs. The Seizures & Syndromes WG reviewed the updates to epilepsy seizure classifications made by the ILAE in order to map the changes to the existing epilepsy CDEs and create new CDEs. The QoL WG reviewed existing Epilepsy QoL recommendations and made revisions based on literature reviews of current adult, pediatric, and general instruments being used in current research. Results: The revised Epilepsy Seizures & Syndromes and Quality of Life CDEs were available on the NINDS CDE website in fall 2017. These updated Epilepsy CDEs and instrument recommendations incorporate revised seizure subtype classifications and a reduced number of QoL instruments. The NINDS CDE website provides the updated information, as well as guidance on the prior recommendations for studies that have already been completed.   Conclusions: The NINDS encourages the use of CDEs by the clinical research community in order to standardize the collection of research data across studies.The NINDS CDEs are a continually evolving resource, requiring updates as research advancements indicate. These newly revised Epilepsy CDEs will serve to be a valuable starting point for researchers and facilitate streamlining and sharing data. Funding: This project was funded by HHSN271201200034C.