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

doi:10.1007/s12028-019-00729-0

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

Neurology

Research output: Contribution to journal › Article › peer-review

27 Scopus citations

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 language	English (US)
Pages (from-to)	87-101
Number of pages	15
Journal	Neurocritical Care
Volume	30
DOIs	https://doi.org/10.1007/s12028-019-00729-0
State	Published - Jun 16 2019

Funding

The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS), or the US Government. Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society, and the CHI Baylor St Luke’s Medical Center in Houston, TX. The development of the NINDS SAH CDEs was made possible thanks to the great The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS), or the US Government. Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society, and the CHI Baylor St Luke’s Medical Center in Houston, TX. The development of the NINDS SAH CDEs was made possible thanks to the great investment of time and effort of WG members and the members of the NINDS CDE Project and NLM CDE project teams participating from 2015–2017.

Keywords

Common data elements
Data standardization
Morphology
Risk factors
Unruptured intracranial aneurysms

ASJC Scopus subject areas

Critical Care and Intensive Care Medicine
Clinical Neurology

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1007/s12028-019-00729-0

Cite this

@article{83d6d8322b744ba4a03d931c73eb030b,

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 {\textquoteleft}Core,{\textquoteright} {\textquoteleft}Supplemental—Highly Recommended,{\textquoteright} {\textquoteleft}Supplemental,{\textquoteright} and {\textquoteleft}Exploratory.{\textquoteright} 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 Suarez, {Jose I.} 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 McDougall, {Cameron G.} 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 Paul Nyquist 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 Sherry Chou",

note = "Publisher Copyright: {\textcopyright} 2019, Neurocritical Care Society.",

year = "2019",

month = jun,

day = "16",

doi = "10.1007/s12028-019-00729-0",

language = "English (US)",

volume = "30",

pages = "87--101",

journal = "Neurocritical Care",

issn = "1541-6933",

publisher = "Springer",

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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. / the Unruptured Aneurysms and SAH CDE Project Investigators.
In: Neurocritical Care, Vol. 30, 16.06.2019, p. 87-101.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

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 I.

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 G.

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

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 - Chou, Sherry

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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UR - http://www.scopus.com/inward/citedby.url?scp=85066030582&partnerID=8YFLogxK

U2 - 10.1007/s12028-019-00729-0

DO - 10.1007/s12028-019-00729-0

M3 - Article

C2 - 31102238

AN - SCOPUS:85066030582

SN - 1541-6933

VL - 30

SP - 87

EP - 101

JO - Neurocritical Care

JF - Neurocritical Care

ER -

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

Funding

Keywords

ASJC Scopus subject areas

UN SDGs

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