Introduction: Through a partnership with the Chiari & Syringomyelia Foundation (CSF), the National Institute of Neurological Disorders and Stroke (NINDS) is promoting Chiari I malformation (CMI) Common Data Elements (CDEs) as part of the NINDS project to develop standards for all funded clinical research in neuroscience. CMI CDEs strive to significantly reduce start-up time by providing standard definitions for commonly used outcome variables so that they may be used in a uniform fashion across research studies. Using CDEs ensures standard data collection, improved data sharing and meta-analyses, and education of new clinical investigators.The NINDS CMI CDE project was born out of discussion centered around the need to incorporate both patient- and clinician-reported data in a consistent format. The project began the work of developing CDEs in late 2014 with all recommendations being made available to the public in October 2016.
Methods: Working groups (WG) consisting of 40+ worldwide experts met regularly in 2015–2016 to develop a set of CMI-specific CDEs and associated case report forms, selecting among, refining, and adding to existing, field-tested data elements from national registries and studies.
Results: Version 1.0 of the NINDS CMI CDEs was released to the NINDS CDE website in October 2016 and 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 NINDS CDE website provides uniform names and structures for each data element, a data dictionary, template case report forms, guidance documents, and disease-specific recommendations.
Conclusions: The NINDS encourages the use of CDEs within and beyond the neurological clinical research community in order to standardize research data collection across studies. These newly developed CMI CDEs serve as a valuable starting point for researchers and, as an evolving resource, will be updated as research progresses.
Patient Care: The purpose of the NINDS CDE project is to significantly reduce the start-up time for clinical trial studies by providing standard definitions for commonly used outcome variables so that they may be used in a uniform fashion across research studies. This will accelerated the turn-around time of clinical trial results, to publication, and the use of these published findings to continue to advance medical treatment, and recommendations to improve patient care.
Learning Objectives: Learning Objective 1: To increase the attendees awareness of what the Chiari I Malformation CDEs are.
Learning Objective 2: To describe the process for development of the Chiari I Malformation CDEs.
Learning Objective 3: To demonstrate how to navigate the NINDS CDE website.
Learning Objective 4: To demonstrate how to use Chiari I Malformation CDEs and CRFs in a research study.