Definition and prioritization of data elements for cohort studies and clinical trials on patients with unruptured intracranial aneurysms: proposal of a multidisciplinary research group
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 S...
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| Main Authors: | , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
17 May 2019
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| In: |
Neurocritical care
Year: 2019, Volume: 30, Issue: 1, Pages: 87-101 |
| ISSN: | 1556-0961 |
| DOI: | 10.1007/s12028-019-00729-0 |
| Online Access: | Verlag, Volltext: http://dx.doi.org/10.1007/s12028-019-00729-0 Verlag: https://doi.org/10.1007/s12028-019-00729-0 
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| Author Notes: | Katharina A.M. Hackenberg, Ale Algra, Rustam Al-Shahi Salman, Juhana Frösen, David Hasan, Seppo Juvela, David Langer, Philip Meyers, Akio Morita, Gabriel Rinkel and Nima Etminan in behalf of the Unruptured Aneurysms and SAH CDE Project Investigators |
| Summary: | 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. 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.’ 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. 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. |
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| Item Description: | Gesehen am 02.10.2019 |
| Physical Description: | Online Resource |
| ISSN: | 1556-0961 |
| DOI: | 10.1007/s12028-019-00729-0 |