Abstract P192: National Institute of Neurological Disorders and Stroke Common Data Elements: Stroke Version 2.0 Recommendations

Abstract

Introduction: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) project provides standardized data collection formats for neuroscience clinical research. Goals are to increase harmonization, efficiency, and data quality in studies, and facilitate collaboration through data sharing and analysis. Stroke-specific CDEs were developed in 2010. The Stroke Oversight Committee (OC) reviewed Core CDEs in 2015. Subarachnoid hemorrhage and unruptured cerebral aneurysms (SAH)-specific CDEs were developed in 2017. In 2018, the Stroke OC recommended that Stroke CDEs be updated to Version 2.0. Methods: NINDS in August 2018, convened the Stroke V2.0 Working Group (WG) consisting of over 50 international subject matter experts. Each domain-specific subgroup: Biospecimens, Biomarkers, and Laboratory Tests; Hospital Course and Acute Therapies; Imaging; Long Term Therapies; Medical History and Prior Health Status; Outcomes and Endpoints; Stroke Presentation and Vital Signs; and Stroke Types and Subtypes, reviewed Stroke V1.0 and SAH CDEs relevant to their purview. Subgroups met regularly to discuss updates to existing Stroke CDEs, addition of new instruments and case report forms (CRFs), and harmonization with SAH CDEs. Draft V2.0 recommendations were posted for public review from February 26 to April 8, 2020. The WG considered public feedback before V2.0 was finalized. Results: This comprehensive review led to updates across CDEs and additions to therapies, outcomes, and imaging domains including Imaging Acquisition and SAH Surgical/Procedural Interventions CRFs and Fugl-Meyer Assessment and PROMIS-29 outcome measures. Following review of 39 V1.0 Stroke outcome measures, 11 were reclassified. Stroke V2.0 CDE recommendations include revised and new template CRFs, data dictionaries, instrument informational documents and guidance documents. Stroke V2.0 was posted to the NINDS CDE website in summer 2020. Conclusions: Updates to the NINDS CDEs based on scientific advancements and user feedback ensure they remain a useful resource. The Stroke v2.0 CDEs provide a current tool for clinical investigators across research domains. NINDS encourages CDE use to standardize research data collection across studies.