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

Publication ,  Journal Article
Hackenberg, KAM; Algra, A; Al-Shahi Salman, R; Frösen, J; Hasan, D; Juvela, S; Langer, D; Meyers, P; Morita, A; Rinkel, G; Etminan, N ...
Published in: Neurocrit Care
June 2019

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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Published In

Neurocrit Care

DOI

EISSN

1556-0961

Publication Date

June 2019

Volume

30

Issue

Suppl 1

Start / End Page

87 / 101

Location

United States

Related Subject Headings

  • United States
  • Neurology & Neurosurgery
  • National Library of Medicine (U.S.)
  • National Institute of Neurological Disorders and Stroke (U.S.)
  • Intracranial Aneurysm
  • Humans
  • Common Data Elements
  • Cohort Studies
  • Clinical Trials as Topic
  • Biomedical Research
 

Citation

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Hackenberg, K. A. M., Algra, A., Al-Shahi Salman, R., Frösen, J., Hasan, D., Juvela, S., … Unruptured Aneurysms and SAH CDE Project Investigators, . (2019). Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group. Neurocrit Care, 30(Suppl 1), 87–101. https://doi.org/10.1007/s12028-019-00729-0
Hackenberg, Katharina A. M., Ale Algra, Rustam Al-Shahi Salman, Juhana Frösen, David Hasan, Seppo Juvela, David Langer, et al. “Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group.Neurocrit Care 30, no. Suppl 1 (June 2019): 87–101. https://doi.org/10.1007/s12028-019-00729-0.
Hackenberg KAM, Algra A, Al-Shahi Salman R, Frösen J, Hasan D, Juvela S, et al. Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019 Jun;30(Suppl 1):87–101.
Hackenberg, Katharina A. M., et al. “Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group.Neurocrit Care, vol. 30, no. Suppl 1, June 2019, pp. 87–101. Pubmed, doi:10.1007/s12028-019-00729-0.
Hackenberg KAM, Algra A, Al-Shahi Salman R, Frösen J, Hasan D, Juvela S, Langer D, Meyers P, Morita A, Rinkel G, Etminan N, Unruptured Aneurysms and SAH CDE Project Investigators. Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group. Neurocrit Care. 2019 Jun;30(Suppl 1):87–101.
Journal cover image

Published In

Neurocrit Care

DOI

EISSN

1556-0961

Publication Date

June 2019

Volume

30

Issue

Suppl 1

Start / End Page

87 / 101

Location

United States

Related Subject Headings

  • United States
  • Neurology & Neurosurgery
  • National Library of Medicine (U.S.)
  • National Institute of Neurological Disorders and Stroke (U.S.)
  • Intracranial Aneurysm
  • Humans
  • Common Data Elements
  • Cohort Studies
  • Clinical Trials as Topic
  • Biomedical Research