Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage: Recommendations from the Working Group on Hospital Course and Acute Therapies-Proposal of a Multidisciplinary Research Group

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Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage: Recommendations from the Working Group on Hospital Course and Acute Therapies-Proposal of a Multidisciplinary Research Group
 
Unruptured Aneurysms and SAH − CDE Project Investigators
(2019) Neurocritical Care, volume 30, issue Suppl 1, pp. 36 - 45
(Article)
Abstract
INTRODUCTION: The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations ... read more
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Keywords: Aneurysm, Clinical studies, Common Data Elements, Data coding, Data collection, Standardization, Subarachnoid hemorrhage, Clinical Neurology, Critical Care and Intensive Care Medicine, Research Support, Non-U.S. Gov't, Research Support, N.I.H., Intramural, Journal Article
DOI: https://doi.org/10.1007/s12028-019-00726-3
ISSN: 1541-6933
Publisher: Humana Press
Note: Funding Information: The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS) or the US Government. Funding Information: Therefore, in an effort to standardize definitions of data among clinical trials in the field of SAH, the National Institute of Health (NIH)/National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDE) Project [5] instituted the “Unruptured Aneurysm and Aneurysmal Subarachnoid Hemorrhage – Common Data Elements Project” aimed to help investigators conduct clinical research through the development of standardized naming, definitions, and data structure for clinical research variables. The CDEs will facilitate systematic clinical data collection, analysis, and sharing across the research community. Central to the project is the identification of common definitions and the standardization of case report forms and other instruments. This article summarizes the recommendations of the working group (WG) on “Hospital Course and Acute Therapies” within this project. Funding Information: Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society and the CHI Baylor St Luke’s Medical Center in Houston, TX. The development of the NINDS SAH‑CDEs was made possible thanks to the great investment of time and effort of WG members and the members of the NINDS CDE Project and NLM CDE project teams participating from 2015 to 2017. Funding Information: Dr Suarez reports being President of the Neurocritical Care Society, a mem‑ ber of the Editorial Board of Stroke Journal, and Chair of the DSMB for the INTREPID Study sponsored by BARD, outside of the submitted work. Dr Mayer reports having received personal consulting fees from Edge Therapeutics and Idorsia Pharmaceuticals outside of the submitted work. Dr Amin‑Hanjani, has nothing to disclose. Dr Vergouwen has nothing to disclose. Dr de Oliveira Manoel has nothing to disclose. Dr van der Jagt has nothing to disclose. Dr Bambakidis has nothing to disclose. Dr Brophy has nothing to disclose. Dr Bulsara has nothing to disclose. Dr Claassesn reports grants from Charles A Dana Foundation, grants from James S McDonnell Foundation, from NIH: The Stroke Hyperglycemia Insutlin Network Effort (SHINE) Trial, grants from NIH: I‑SPOT, grants from NIH: Established Status Epilepticus Treatment Trial (ESETT), grants from BARD: Intrepid, grants from NIH: Futility Study of Deferoxamine Mesylate in Intracerebral Hemorrhage (I‑DEF), grants from NIH/NLM: BIGDATA: Causal Inference in Large‑Scale Time Series with Rare and Latent Events, grants from NIH: Rhapsody (ZZ‑3K3A‑201), other from iCE Neurosystems, outside the submitted work. Dr Connolly has nothing to disclose. Dr Hoffer has nothing to disclose. Dr Hoh has nothing to disclose. Dr Holloway has nothing to disclose. Dr Kelly has nothing to disclose. Dr Nakaji has nothing to disclose. Dr Rabinstein has nothing to disclose. Dr Vajkoczy has nothing to disclose. Dr Woo has nothing to disclose. Dr Zipfel has nothing to disclose. Publisher Copyright: © 2019, Neurocritical Care Society.
(Non peer reviewed)