Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms

Proposal of a Multidisciplinary Research Group

the Unruptured Aneurysms and SAH CDE Project Investigators

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Pages (from-to)87-101
Number of pages15
JournalNeurocritical care
Volume30
DOIs
StatePublished - Jun 16 2019

Fingerprint

Intracranial Aneurysm
Cohort Studies
Clinical Trials
Subarachnoid Hemorrhage
Research
National Institute of Neurological Disorders and Stroke
National Institutes of Health (U.S.)
Aneurysm
Meta-Analysis
Outcome Assessment (Health Care)
Therapeutics

Keywords

  • Common data elements
  • Data standardization
  • Morphology
  • Risk factors
  • Unruptured intracranial aneurysms

ASJC Scopus subject areas

  • Clinical Neurology
  • Critical Care and Intensive Care Medicine

Cite this

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

In: Neurocritical care, Vol. 30, 16.06.2019, p. 87-101.

Research output: Contribution to journalArticle

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title = "Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group",
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.",
keywords = "Common data elements, Data standardization, Morphology, Risk factors, Unruptured intracranial aneurysms",
author = "{the Unruptured Aneurysms and SAH CDE Project Investigators} and Hackenberg, {Katharina A.M.} and Ale Algra and Salman, {Rustam Al Shahi} and Juhana Fr{\"o}sen and David Hasan and Seppo Juvela and David Langer and Philip Meyers and Akio Morita and Gabriel Rinkel and Nima Etminan and Jose Suarez and Macdonald, {R. Loch} and Sepideh Amin-Hanjani and Brown, {Robert D.} and {de Oliveira Manoel}, {Airton Leonardo} and Derdeyn, {Colin P.} and Emanuela Keller and LeRoux, {Peter D.} and Stephan Mayer and Daniel Rufennacht and Stienen, {Martin N.} and James Torner and Vergouwen, {Mervyn D.I.} and Wong, {George K.C.} and Philippe Bijlenga and Nerissa Ko and Cameron McDougall and J. Mocco and Yuuichi Murayama and Werner, {Marieke J.H.} and Rahul Damani and Joseph Broderick and Raj Dhar and Jauch, {Edward C.} and Kirkpatrick, {Peter J.} and Martin, {Renee H.} and Susanne Muehlschlegel and Tatsushi Mutoh and Nyquist, {Paul A} and Daiwai Olson and Mejia-Mantilla, {Jorge H.} and {van der Jagt}, Mathieu and Nicholas Bambakidis and Gretchen Brophy and Ketan Bulsara and Jan Claassen and Connolly, {E. Sander} and Hoffer, {S. Alan} and Hoh, {Brian L.}",
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T1 - Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms

T2 - Proposal of a Multidisciplinary Research Group

AU - the Unruptured Aneurysms and SAH CDE Project Investigators

AU - Hackenberg, Katharina A.M.

AU - Algra, Ale

AU - Salman, Rustam Al Shahi

AU - Frösen, Juhana

AU - Hasan, David

AU - Juvela, Seppo

AU - Langer, David

AU - Meyers, Philip

AU - Morita, Akio

AU - Rinkel, Gabriel

AU - Etminan, Nima

AU - Suarez, Jose

AU - Macdonald, R. Loch

AU - Amin-Hanjani, Sepideh

AU - Brown, Robert D.

AU - de Oliveira Manoel, Airton Leonardo

AU - Derdeyn, Colin P.

AU - Keller, Emanuela

AU - LeRoux, Peter D.

AU - Mayer, Stephan

AU - Rufennacht, Daniel

AU - Stienen, Martin N.

AU - Torner, James

AU - Vergouwen, Mervyn D.I.

AU - Wong, George K.C.

AU - Bijlenga, Philippe

AU - Ko, Nerissa

AU - McDougall, Cameron

AU - Mocco, J.

AU - Murayama, Yuuichi

AU - Werner, Marieke J.H.

AU - Damani, Rahul

AU - Broderick, Joseph

AU - Dhar, Raj

AU - Jauch, Edward C.

AU - Kirkpatrick, Peter J.

AU - Martin, Renee H.

AU - Muehlschlegel, Susanne

AU - Mutoh, Tatsushi

AU - Nyquist, Paul A

AU - Olson, Daiwai

AU - Mejia-Mantilla, Jorge H.

AU - van der Jagt, Mathieu

AU - Bambakidis, Nicholas

AU - Brophy, Gretchen

AU - Bulsara, Ketan

AU - Claassen, Jan

AU - Connolly, E. Sander

AU - Hoffer, S. Alan

AU - Hoh, Brian L.

PY - 2019/6/16

Y1 - 2019/6/16

N2 - 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.

AB - 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.

KW - Common data elements

KW - Data standardization

KW - Morphology

KW - Risk factors

KW - Unruptured intracranial aneurysms

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U2 - 10.1007/s12028-019-00729-0

DO - 10.1007/s12028-019-00729-0

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EP - 101

JO - Neurocritical Care

JF - Neurocritical Care

SN - 1541-6933

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