Journal article
Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group
Neurocritical care, Vol.30(Suppl 1), pp.87-101
06/2019
DOI: 10.1007/s12028-019-00729-0
PMID: 31102238
Abstract
Introduction
Variability in usage and definition of data characteristics in previous cohort studies on unruptured intracranial aneurysms (UIA) complicated pooling and proper interpretation of these data. The aim of the National Institute of Health/National Institute of Neurological Disorders and Stroke UIA and Subarachnoid Hemorrhage (SAH) Common Data Elements (CDE) Project was to provide a common structure for data collection in future research on UIA and SAH.
Methods
This paper describes the development and summarization of the recommendations of the working groups (WGs) on UIAs, which consisted of an international and multidisciplinary panel of cerebrovascular specialists on research and treatment of UIAs. Consensus recommendations were developed by review of previously published CDEs for other neurological diseases and the literature on UIAs. Recommendations for CDEs were classified by priority into ‘Core,’ ‘Supplemental—Highly Recommended,’ ‘Supplemental,’ and ‘Exploratory.’
Results
Ninety-one CDEs were compiled; 69 were newly created and 22 were existing CDEs. The CDEs were assigned to eight subcategories and were classified as Core (8), Supplemental—Highly Recommended (23), Supplemental (25), and Exploratory (35) elements. Additionally, the WG developed and agreed on a classification for aneurysm morphology.
Conclusion
The proposed CDEs have been distilled from a broad pool of characteristics, measures, or outcomes. The usage of these CDEs will facilitate pooling of data from cohort studies or clinical trials on patients with UIAs.
Details
- Title: Subtitle
- Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group
- Creators
- Katharina A M Hackenberg - Department of Neurosurgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany. katharina.hackenberg@umm.deAle Algra - Brain Center Rudolph Magnus, Department of Neurology and Neurosurgery, and the Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The NetherlandsRustam Al-Shahi Salman - Centre for Clinical Brain Sciences, University of Edinburgh, Chancellor's Building, Edinburgh, UKJuhana Frösen - Department of Neurosurgery, Kuopio University Hospital, Kuopio, FinlandDavid Hasan - University of Iowa, NeurosurgerySeppo Juvela - Department of Clinical Neurosciences, University of Helsinki, Helsinki, FinlandDavid Langer - Department of Neurosurgery, Hofstra Northwell School of Medicine, and Northwell Health, Lenox-Hill Hospital, New York, NY, USAPhilip Meyers - Departments of Neurosurgery and Radiology, Columbia University Medical Center, New York, NY, USAAkio Morita - Department of Neurological Surgery, Nippon Medical School, Bunkyo-ku, Tokyo, JapanGabriel Rinkel - Brain Center Rudolf Magnus, Department of Neurology and Neurosurgery and Center of Excellence for Rehabilitation Medicine, University Medical Center Utrecht, Utrecht, The NetherlandsNima Etminan - Department of Neurosurgery, University Hospital Mannheim, University of Heidelberg, Mannheim, Germany
- Resource Type
- Journal article
- Publication Details
- Neurocritical care, Vol.30(Suppl 1), pp.87-101
- DOI
- 10.1007/s12028-019-00729-0
- PMID
- 31102238
- NLM abbreviation
- Neurocrit Care
- ISSN
- 1541-6933
- eISSN
- 1556-0961
- Publisher
- United States
- Grant note
- HHSN271201200034C / NINDS NIH HHS
- Language
- English
- Date published
- 06/2019
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Neurosurgery; Otolaryngology
- Record Identifier
- 9984040342002771
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