TY - JOUR
T1 - Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage
T2 - Recommendations from the Working Group on Hospital Course and Acute Therapies—Proposal of a Multidisciplinary Research Group
AU - the Unruptured Aneurysms and SAH − CDE Project Investigators
AU - de Oliveira Manoel, Airton Leonardo
AU - van der Jagt, Mathieu
AU - Amin-Hanjani, Sepideh
AU - Bambakidis, Nicholas C.
AU - Brophy, Gretchen M.
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 G.
AU - Mayer, Stephan A.
AU - Nakaji, Peter
AU - Rabinstein, Alejandro A.
AU - Vajkoczy, Peter
AU - Vergouwen, Mervyn D.I.
AU - Woo, Henry
AU - Zipfel, Gregory J.
AU - Suarez, Jose I.
AU - Macdonald, R. Loch
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
AU - Morita, Akio
AU - Rinkel, Gabriel
AU - Rufennacht, Daniel
AU - Stienen, Martin N.
AU - Torner, James
AU - Wong, George K.C.
AU - Bijlenga, Philippe
AU - Ko, Nerissa
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 - Mocco, J.
AU - Muehlschlegel, Susanne
AU - Mutoh, Tatsushi
AU - Nyquist, Paul
AU - Olson, Daiwai
AU - Mejia-Mantilla, Jorge H.
AU - Bambakidis, Nicholas
N1 - Publisher Copyright:
© 2019, Neurocritical Care Society.
PY - 2019/6/16
Y1 - 2019/6/16
N2 - Introduction: The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations for Unruptured Aneurysms and Aneurysmal Subarachnoid Hemorrhage (SAH) CDEs. Methods: This paper summarizes the recommendations of the Hospital Course and Acute Therapies after SAH working group. Consensus recommendations were developed by assessment of previously published CDEs for traumatic brain injury, stroke, and epilepsy. Unruptured aneurysm- and SAH-specific CDEs were also developed. CDEs were categorized into “core”, “supplemental—highly recommended”, “supplemental” and “exploratory”. Results: We identified and developed CDEs for Hospital Course and Acute Therapies after SAH, which included: surgical and procedure interventions; rescue therapy for delayed cerebral ischemia (DCI); neurological complications (i.e. DCI; hydrocephalus; rebleeding; seizures); intensive care unit therapies; prior and concomitant medications; electroencephalography; invasive brain monitoring; medical complications (cardiac dysfunction; pulmonary edema); palliative comfort care and end of life issues; discharge status. The CDEs can be found at the NINDS Web site that provides standardized naming, and definitions for each element, and also case report form templates, based on the CDEs. Conclusion: Most of the recommended Hospital Course and Acute Therapies CDEs have been newly developed. Adherence to these recommendations should facilitate data collection and data sharing in SAH research, which could improve the comparison of results across observational studies, clinical trials, and meta-analyses of individual patient data.
AB - Introduction: The Common Data Elements (CDEs) initiative is a National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS) effort to standardize naming, definitions, data coding, and data collection for observational studies and clinical trials in major neurological disorders. A working group of experts was established to provide recommendations for Unruptured Aneurysms and Aneurysmal Subarachnoid Hemorrhage (SAH) CDEs. Methods: This paper summarizes the recommendations of the Hospital Course and Acute Therapies after SAH working group. Consensus recommendations were developed by assessment of previously published CDEs for traumatic brain injury, stroke, and epilepsy. Unruptured aneurysm- and SAH-specific CDEs were also developed. CDEs were categorized into “core”, “supplemental—highly recommended”, “supplemental” and “exploratory”. Results: We identified and developed CDEs for Hospital Course and Acute Therapies after SAH, which included: surgical and procedure interventions; rescue therapy for delayed cerebral ischemia (DCI); neurological complications (i.e. DCI; hydrocephalus; rebleeding; seizures); intensive care unit therapies; prior and concomitant medications; electroencephalography; invasive brain monitoring; medical complications (cardiac dysfunction; pulmonary edema); palliative comfort care and end of life issues; discharge status. The CDEs can be found at the NINDS Web site that provides standardized naming, and definitions for each element, and also case report form templates, based on the CDEs. Conclusion: Most of the recommended Hospital Course and Acute Therapies CDEs have been newly developed. Adherence to these recommendations should facilitate data collection and data sharing in SAH research, which could improve the comparison of results across observational studies, clinical trials, and meta-analyses of individual patient data.
KW - Aneurysm
KW - Clinical studies
KW - Common Data Elements
KW - Data coding
KW - Data collection
KW - Standardization
KW - Subarachnoid hemorrhage
UR - http://www.scopus.com/inward/record.url?scp=85066480781&partnerID=8YFLogxK
U2 - 10.1007/s12028-019-00726-3
DO - 10.1007/s12028-019-00726-3
M3 - Article
C2 - 31119687
AN - SCOPUS:85066480781
SN - 1541-6933
VL - 30
SP - 36
EP - 45
JO - Neurocritical Care
JF - Neurocritical Care
ER -