Chiari I Malformation Common Data Element Project: The National Institute of Neurological Disorders and Stroke (NINDS) Chiari I Malformation Common Data Elements (CDE) Recommendations Version 1.0 Website Release (P2.058)

Objective: The purpose of the Chiari I Malformation common data element (CDE) project is to facilitate research data collection by providing standard definitions for commonly used, research variables in order that they may be used in a uniform fashion across research studies. Use of CDEs it is a critical step to ensure that data housed within a database would be of better quality, significantly reduce the study start-up time, improve data sharing and meta-analyses and help educate new clinical investigators. Background: In 2013, the National Institute of Neurological Disorders and Stroke (NINDS) Chiari I Malformation CDE project was born out of discussion for the need to incorporate both patient-reported and clinician-reported data in a consistent format. Design/Methods: Working groups (WG) consisting of 40+ worldwide experts met regularly in 2014–2016 to develop a set of Chiari I Malformation specific CDEs and associated case report forms, selecting among, refining, and adding to existing, field-tested data elements from national registries and studies. Results: Released on the NINDS CDE website in October 2016, version 1.0 Chiari I Malformation CDE recommendations span the following domains: Core Demographics Database, Epidemiology; Presentation, Natural History, Signs Symptoms; Co-morbidities, Risk Factors, Genetics; Spinal Anomaly, Stability/Imaging; Treatment; and Outcome. The latest information provided at this meeting will include examples of how Chiari I Malformation CDEs may be used by a research study and how to navigate and select CDEs from the NINDS CDE website. Conclusions: These newly developed Chiari I Malformation CDEs serve as a valuable starting point for researchers. The NINDS encourages the use of CDEs by the clinical research community in order to standardize the research data collection across studies. The CDEs are an evolving resource that is constantly being updated as research progresses. Study Supported by: This project was funded by HHSN271201200034C. Disclosure: Dr. Feldman has nothing to disclose. Dr. Alai has nothing to disclose. Dr. Odenkirchen has nothing to disclose. Dr. Joseph has nothing to disclose. Dr. Esposito has nothing to disclose. Dr. Poppe has nothing to disclose.