TY - JOUR
T1 - Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research
T2 - A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project
AU - the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators
AU - Suarez, Jose I.
AU - Sheikh, Muniza K.
AU - Macdonald, R. Loch
AU - Amin-Hanjani, Sepideh
AU - Brown, Robert D.
AU - de Oliveira Manoel, Airton Leonardo
AU - Derdeyn, Colin P.
AU - Etminan, Nima
AU - Keller, Emanuela
AU - Leroux, Peter D.
AU - Mayer, Stephan A.
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 - Suarez, Jose I.
AU - LeRoux, Peter D.
AU - Mayer, Stephan
AU - Bijlenga, Philippe
AU - Ko, Nerissa
AU - McDougall, Cameron G.
AU - Mocco, J.
AU - Murayama, Yuuichi
AU - Werner, Marieke J.H.
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 C.
AU - Brophy, Gretchen
AU - Bulsara, Ketan
AU - Claassen, Jan
AU - Connolly, E. Sander
AU - Hoffer, S. Alan
AU - Hoh, Brian L.
AU - Holloway, Robert G.
AU - Kelly, Adam
AU - Nakaji, Peter
AU - Rabinstein, Alejandro
AU - Vajkoczy, Peter
N1 - Publisher Copyright:
© 2019, Neurocritical Care Society.
PY - 2019/6/16
Y1 - 2019/6/16
N2 - Objectives: The goal for this project was to develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in unruptured intracranial aneurysm (UIA) and subarachnoid hemorrhage (SAH) clinical research, as part of a new joint effort between the National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine of the US National Institutes of Health. These UIA and SAH CDEs will join several other neurological disease-specific CDEs that have already been developed and are available for use by research investigators. Methods: A Working Group (WG) divided into eight sub-groups and a Steering Committee comprised of international UIA and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed and provided recommendations for UIA and SAH clinical research. The recommendations were compiled, internally reviewed by the entire UIA and SAH WG and posted online for 6 weeks for external public comments. The UIA and SAH WG and the NINDS CDE team reviewed the final version before posting the SAH Version 1.0 CDE recommendations. Results: The NINDS UIA and SAH CDEs and supporting documents are publicly available on the NINDS CDE (https://www.commondataelements.ninds.nih.gov/#page=Default) and NIH Repository (https://cde.nlm.nih.gov/home) websites. The recommendations are organized into domains including Participant Characteristics and Outcomes and Endpoints. Conclusion: Dissemination and widespread use of CDEs can facilitate UIA and SAH clinical research and clinical trial design, data sharing, and analyses of observational retrospective and prospective data. It is vital to maintain an international and multidisciplinary collaboration to ensure that these CDEs are implemented and updated when new information becomes available.
AB - Objectives: The goal for this project was to develop a comprehensive set of common data elements (CDEs), data definitions, case report forms and guidelines for use in unruptured intracranial aneurysm (UIA) and subarachnoid hemorrhage (SAH) clinical research, as part of a new joint effort between the National Institute of Neurological Disorders and Stroke (NINDS) and the National Library of Medicine of the US National Institutes of Health. These UIA and SAH CDEs will join several other neurological disease-specific CDEs that have already been developed and are available for use by research investigators. Methods: A Working Group (WG) divided into eight sub-groups and a Steering Committee comprised of international UIA and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed and provided recommendations for UIA and SAH clinical research. The recommendations were compiled, internally reviewed by the entire UIA and SAH WG and posted online for 6 weeks for external public comments. The UIA and SAH WG and the NINDS CDE team reviewed the final version before posting the SAH Version 1.0 CDE recommendations. Results: The NINDS UIA and SAH CDEs and supporting documents are publicly available on the NINDS CDE (https://www.commondataelements.ninds.nih.gov/#page=Default) and NIH Repository (https://cde.nlm.nih.gov/home) websites. The recommendations are organized into domains including Participant Characteristics and Outcomes and Endpoints. Conclusion: Dissemination and widespread use of CDEs can facilitate UIA and SAH clinical research and clinical trial design, data sharing, and analyses of observational retrospective and prospective data. It is vital to maintain an international and multidisciplinary collaboration to ensure that these CDEs are implemented and updated when new information becomes available.
KW - Clinical trials
KW - Common data elements
KW - Observational studies
KW - Outcomes
KW - Subarachnoid hemorrhage
KW - Unruptured intracranial aneurysms
UR - http://www.scopus.com/inward/record.url?scp=85066491396&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85066491396&partnerID=8YFLogxK
U2 - 10.1007/s12028-019-00723-6
DO - 10.1007/s12028-019-00723-6
M3 - Article
C2 - 31087257
AN - SCOPUS:85066491396
SN - 1541-6933
VL - 30
SP - 4
EP - 19
JO - Neurocritical Care
JF - Neurocritical Care
ER -