Warach, Steven

Introduction: In order to increase the efficiency and effectiveness of neurovascular clinical research studies, increase data quality, facilitate data sharing, help educate new clinical investigators and reduce study start-up time, the National Institute of Neurological Disorders and Stroke (NINDS) convened a Working Group (WG) that developed Version 1.0 (published 2010) Stroke-specific Common Data Elements (CDEs). Since their initial publication, intervening advances in science and initial experience with the CDEs identified a need to update them and refine guidance on their deployment. Hypothesis/Objective: The NINDS has updated guidance on uniform data structures for use in cerebrovascular research in epidemiology, clinical trials and imaging studies in order to advance the prevention, acute treatment and recovery from cerebrovascular disease. Methods: The NINDS convened experts in research and data element design drawing strongly from investigators in the NIH StrokeNet and other NINDS clinical research projects. Results: Stroke CDE leadership developed a revised process for classifying Stroke CDEs among the four hierarchical categories of Core, Supplemental - Highly Recommended, Supplemental and Exploratory. Due to the heterogeneity of stroke conditions and study types, the classification of Supplemental - Highly Recommended was used for study type (clinical trial or observational), disease type (e.g., ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage) and disease phase (primary prevention, acute, recovery and secondary prevention). Conclusion: The second iteration of NINDS CDE recommendations for neurovascular disease is an important step towards more efficient study start-up time and improved data sharing. The updated CDEs were released on the NINDS CDE website in May 2015. The information at this meeting will include examples of how the Stroke CDEs may be used by a research study, an explanation of the new CDE classifications, and examples of navigating and selecting CDEs from the NINDS CDE website. Support: This project was funded by HHSN271201200034C.

The recent “Advanced Neuroimaging for Acute Stroke Treatment” meeting on September 7 and 8, 2007 in Washington DC, brought together stroke neurologists, neuroradiologists, emergency physicians, neuroimaging research scientists, members of the National Institute of Neurological Disorders and Stroke (NINDS), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), industry representatives, and members of the US Food and Drug Administration (FDA) to discuss the role of advanced neuroimaging in acute stroke treatment. The goals of the meeting were to assess state-of-the-art practice in terms of acute stroke imaging research and to propose specific recommendations regarding: (1) the standardization of perfusion and penumbral imaging techniques, (2) the validation of the accuracy and clinical utility of imaging markers of the ischemic penumbra, (3) the validation of imaging biomarkers relevant to clinical outcomes, and (4) the creation of a central repository to achieve these goals. The present article summarizes these recommendations and examines practical steps to achieve them.