Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group

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 Str...

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Vydané v:Neurocritical care Ročník 30; číslo Suppl 1; s. 87 - 101
Hlavní autori: Hackenberg, Katharina A. M., Algra, Ale, Al-Shahi Salman, Rustam, Frösen, Juhana, Hasan, David, Juvela, Seppo, Langer, David, Meyers, Philip, Morita, Akio, Rinkel, Gabriel, Etminan, Nima
Médium: Journal Article
Jazyk:English
Vydavateľské údaje: New York Springer US 01.06.2019
Springer Nature B.V
Predmet:
Aneurysms
Biomedical Research
Blood pressure
Classification
Clinical Trials as Topic
Cohort analysis
Cohort Studies
Common Data Elements
Critical Care Medicine
Demographics
Disability
Disease
Genotype & phenotype
Headaches
Humans
Hypertension
Intensive
Internal Medicine
Intracranial Aneurysm
Ischemia
Medical imaging
Medicine
Medicine & Public Health
Morphology
National Institute of Neurological Disorders and Stroke (U.S.)
National Library of Medicine (U.S.)
Neurology
Neurosurgery
Risk factors
Smoking
Special Article
Stroke
Transient ischemic attack
United States
United States
Unruptured intracranial aneurysms
Data standardization
Common data elements
Morphology
Risk factors
ISSN:1541-6933, 1556-0961, 1556-0961
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Shrnutí: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.
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ISSN:1541-6933
1556-0961
1556-0961
DOI:10.1007/s12028-019-00729-0