Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project

Objectives: The goal for this project was to develop a comprehensive set of common data elements (CDEs), data defnitions, case report forms and guidelines for use in unruptured intracranial aneurysm (UIA) and subarachnoid hemorrhage (SAH) clinical research, as part of a new joint efort between the National Institute of Neurological Dis‑ orders and Stroke (NINDS) and the National Library of Medicine of the US National Institutes of Health. These UIA and SAH CDEs will join several other neurological disease-specifc CDEs that have already been developed and are avail‑ able for use by research investigators. Methods: A Working Group (WG) divided into eight sub-groups and a Steering Committee comprised of interna‑ tional UIA and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed and provided recommendations for UIA and SAH clinical research. The recommendations were compiled, inter‑ nally reviewed by the entire UIA and SAH WG and posted online for 6 weeks for external public comments. The UIA and SAH WG and the NINDS CDE team reviewed the fnal version before posting the SAH Version 1.0 CDE recommendations. Results: The NINDS UIA and SAH CDEs and supporting documents are publicly available on the NINDS CDE (https ://www.commondataelements.ninds.nih.gov/#page=Default) and NIH Repository (https://cde.nlm.nih.gov/home) websites. The recommendations are organized into domains including Participant Characteristics and Outcomes and Endpoints. Conclusion: Dissemination and widespread use of CDEs can facilitate UIA and SAH clinical research and clinical trial design, data sharing, and analyses of observational retrospective and prospective data. It is vital to maintain an international and multidisciplinary collaboration to ensure that these CDEs are implemented and updated when new information becomes available.

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