Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage: Recommendations from the Working Group on Hospital Course and Acute Therapies—Proposal of a Multidisciplinary Research Group

the Unruptured Aneurysms and SAH − CDE Project Investigators

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)36-45
Number of pages10
JournalNeurocritical care
Volume30
DOIs
StatePublished - Jun 16 2019

Fingerprint

Intracranial Aneurysm
Subarachnoid Hemorrhage
Research
National Institute of Neurological Disorders and Stroke
Brain Ischemia
Observational Studies
Aneurysm
Clinical Trials
Therapeutics
Common Data Elements
Information Dissemination
National Institutes of Health (U.S.)
Pulmonary Edema
Hydrocephalus
Nervous System Diseases
Palliative Care
Intensive Care Units
Meta-Analysis
Electroencephalography
Epilepsy

Keywords

  • Aneurysm
  • Clinical studies
  • Common Data Elements
  • Data coding
  • Data collection
  • Standardization
  • Subarachnoid hemorrhage

ASJC Scopus subject areas

  • Clinical Neurology
  • Critical Care and Intensive Care Medicine

Cite this

@article{c964ce892ba447ec9e8c8efbd6ea1e4f,
title = "Common Data Elements for Unruptured Intracranial Aneurysms and Aneurysmal Subarachnoid Hemorrhage: Recommendations from the Working Group on Hospital Course and Acute Therapies—Proposal of a Multidisciplinary Research Group",
abstract = "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.",
keywords = "Aneurysm, Clinical studies, Common Data Elements, Data coding, Data collection, Standardization, Subarachnoid hemorrhage",
author = "{the Unruptured Aneurysms and SAH − CDE Project Investigators} and {de Oliveira Manoel}, {Airton Leonardo} and {van der Jagt}, Mathieu and Sepideh Amin-Hanjani and Bambakidis, {Nicholas C.} and Brophy, {Gretchen M.} and Ketan Bulsara and Jan Claassen and Connolly, {E. Sander} and Hoffer, {S. Alan} and Hoh, {Brian L.} and Holloway, {Robert G.} and Kelly, {Adam G.} and Mayer, {Stephan A.} and Peter Nakaji and Alejandro Rabinstein and Peter Vajkoczy and Vergouwen, {Mervyn D.I.} and Henry Woo and Zipfel, {Gregory J.} and Suarez, {Jose I.} and Macdonald, {R. Loch} and Brown, {Robert D Jr.} and {de Oliveira Manoel}, {Airton Leonardo} and Derdeyn, {Colin P.} and Nima Etminan and Emanuela Keller and LeRoux, {Peter D.} and Stephan Mayer and Akio Morita and Gabriel Rinkel and Daniel Rufennacht and Stienen, {Martin N.} and James Torner and Wong, {George K.C.} and Philippe Bijlenga and Nerissa Ko 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 J. Mocco and Susanne Muehlschlegel and Tatsushi Mutoh and Paul Nyquist and Daiwai Olson and Mejia-Mantilla, {Jorge H.} and Huston, {John III}",
year = "2019",
month = "6",
day = "16",
doi = "10.1007/s12028-019-00726-3",
language = "English (US)",
volume = "30",
pages = "36--45",
journal = "Neurocritical Care",
issn = "1541-6933",
publisher = "Humana Press",

}

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

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 Jr.

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 - Huston, John III

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

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U2 - 10.1007/s12028-019-00726-3

DO - 10.1007/s12028-019-00726-3

M3 - Article

C2 - 31119687

AN - SCOPUS:85066480781

VL - 30

SP - 36

EP - 45

JO - Neurocritical Care

JF - Neurocritical Care

SN - 1541-6933

ER -