TY - JOUR
T1 - Common Data Elements for Subarachnoid Hemorrhage and Unruptured Intracranial Aneurysms
T2 - Recommendations from the Working Group on Subject Characteristics
AU - the Unruptured Cerebral Aneurysms and SAH CDE Project Investigators
AU - Bijlenga, Philippe
AU - Morita, Akio
AU - Ko, Nerissa U.
AU - Mocco, J.
AU - Morel, Sandrine
AU - Murayama, Yuichi
AU - Wermer, Marieke J.H.
AU - Brown, Robert D.
AU - Suarez, Jose I.
AU - Loch Macdonald, R.
AU - Amin-Hanjani, Sepideh
AU - de Oliveira Manoel, Airton Leonardo
AU - Derdeyn, Colin P.
AU - Etminan, Nima
AU - Keller, Emanuela
AU - LeRoux, Peter D.
AU - Mayer, Stephan
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 - 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 - Bulsara, Ketan
AU - Claassen, Jan
AU - Sander Connolly, E.
AU - Alan Hoffer, S.
AU - Hoh, Brian L.
AU - Holloway, Robert G.
AU - Kelly, Adam
AU - Nakaji, Peter
AU - Zipfel, Gregory J.
N1 - Publisher Copyright:
© 2019, Neurocritical Care Society.
PY - 2019/6/16
Y1 - 2019/6/16
N2 - Background: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) have been generated to standardize and define terms used by the scientific community. The widespread use of these CDEs promotes harmonized data collection in clinical research. The aim of the NINDS Unruptured Intracranial Aneurysms (UIA) and Subarachnoid Hemorrhage (SAH), and Subject Characteristics working group (WG) was to identify, define, and classify CDEs describing the characteristics of patients diagnosed with an UIA and SAH. Thus, “Participant/Subject characteristics” is a set of factors defining a population of selected individuals and allowing comparisons with a reference population and overtime. Methods: Based on standard terms defined by the United States’ Census Bureau, CDEs previously defined by several (Stroke, Epilepsy and Traumatic Brain Injury) NINDS CDE working groups literature and expert opinion of the WG, the “Participant/Subject characteristics” domain has been defined. Results: A set of 192 CDEs divided in 7 subsections: demographics (8 CDEs), social status (8 CDEs), behavioral status (22 CDEs), family and medical history (144 CDEs), pregnancy and perinatal history (8 CDEs), history data source reliability (3 CDEs), and prior functional status (3 CDEs) was defined. SAH is characterized by 6 core elements, all classified in the “Participant/Subject characteristics” domain. Four exploratory elements out of the 39 for SAH overall are in the “Participant/Subject characteristics” domain, and all remaining 182 CDEs in the “Participant/Subject characteristics” domain are classified as Supplemental-Highly Recommended elements. Conclusions: These CDEs would allow the development of best practice guidelines to standardize the assessment and reporting of observations concerning UIA and SAH.
AB - Background: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) have been generated to standardize and define terms used by the scientific community. The widespread use of these CDEs promotes harmonized data collection in clinical research. The aim of the NINDS Unruptured Intracranial Aneurysms (UIA) and Subarachnoid Hemorrhage (SAH), and Subject Characteristics working group (WG) was to identify, define, and classify CDEs describing the characteristics of patients diagnosed with an UIA and SAH. Thus, “Participant/Subject characteristics” is a set of factors defining a population of selected individuals and allowing comparisons with a reference population and overtime. Methods: Based on standard terms defined by the United States’ Census Bureau, CDEs previously defined by several (Stroke, Epilepsy and Traumatic Brain Injury) NINDS CDE working groups literature and expert opinion of the WG, the “Participant/Subject characteristics” domain has been defined. Results: A set of 192 CDEs divided in 7 subsections: demographics (8 CDEs), social status (8 CDEs), behavioral status (22 CDEs), family and medical history (144 CDEs), pregnancy and perinatal history (8 CDEs), history data source reliability (3 CDEs), and prior functional status (3 CDEs) was defined. SAH is characterized by 6 core elements, all classified in the “Participant/Subject characteristics” domain. Four exploratory elements out of the 39 for SAH overall are in the “Participant/Subject characteristics” domain, and all remaining 182 CDEs in the “Participant/Subject characteristics” domain are classified as Supplemental-Highly Recommended elements. Conclusions: These CDEs would allow the development of best practice guidelines to standardize the assessment and reporting of observations concerning UIA and SAH.
KW - Common Data Elements
KW - Intracranial aneurysm
KW - Participant/Subject characteristics
KW - Subarachnoid Hemorrhage
UR - http://www.scopus.com/inward/record.url?scp=85065658011&partnerID=8YFLogxK
U2 - 10.1007/s12028-019-00724-5
DO - 10.1007/s12028-019-00724-5
M3 - Article
C2 - 31077079
AN - SCOPUS:85065658011
SN - 1541-6933
VL - 30
SP - 20
EP - 27
JO - Neurocritical Care
JF - Neurocritical Care
ER -