TY - JOUR
T1 - Definition and Prioritization of Data Elements for Cohort Studies and Clinical Trials on Patients with Unruptured Intracranial Aneurysms: Proposal of a Multidisciplinary Research Group
AU - Hackenberg, Katharina A. M.
AU - Algra, Ale
AU - Salman, Rustam Al-Shahi
AU - Frosen, 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., Jr.
AU - Manoel, Airton Leonardo de Oliveira
AU - Derdeyn, Colin P.
AU - Etminan, Nima
AU - Keller, Emanuela
AU - LeRoux, Peter D.
AU - Mayer, Stephan
AU - Morita, Akio
AU - Rinkel, Gabriel
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 - Mayer, Stephan
AU - Suarez, Jose I.
AU - Damani, Rahul
AU - Broderick, Joseph
AU - Dhar, Raj
AU - Jauch, Edward C.
AU - Kirkpatrick, Peter J.
AU - Martin, Renee H.
AU - Mocco, J.
AU - Vergouwen, Mervyn D. I.
AU - Ruigrok, Ynte
AU - Rinkel, Gabriel
AU - Rinkel, Gabriel
AU - Algra, Ale
AU - Vergouwen, Mervyn D. I.
AU - Visser-Meily, Johanna
N1 - Funding Information:
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
Funding Information:
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.
Publisher Copyright:
© 2019, Neurocritical Care Society.
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 - Unruptured intracranial aneurysms
KW - Risk factors
KW - Morphology
KW - Data standardization
UR - http://www.scopus.com/inward/record.url?scp=85066030582&partnerID=8YFLogxK
U2 - 10.1007/s12028-019-00729-0
DO - 10.1007/s12028-019-00729-0
M3 - Article
C2 - 31102238
SN - 1541-6933
VL - 30
SP - 87
EP - 101
JO - Neurocritical Care
JF - Neurocritical Care
IS - Sup 1
ER -