Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project

the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
JournalNeurocritical care
DOIs
StatePublished - Jan 1 2019

Fingerprint

National Institute of Neurological Disorders and Stroke
National Library of Medicine (U.S.)
Intracranial Aneurysm
Subarachnoid Hemorrhage
Research
Common Data Elements
Information Dissemination
National Institutes of Health (U.S.)
Research Personnel

Keywords

  • Clinical trials
  • Common data elements
  • Observational studies
  • Outcomes
  • Subarachnoid hemorrhage
  • Unruptured intracranial aneurysms

ASJC Scopus subject areas

  • Clinical Neurology
  • Critical Care and Intensive Care Medicine

Cite this

@article{b92d0c81b62a4340b61925b9549baa41,
title = "Common Data Elements for Unruptured Intracranial Aneurysms and Subarachnoid Hemorrhage Clinical Research: A National Institute for Neurological Disorders and Stroke and National Library of Medicine Project",
abstract = "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.",
keywords = "Clinical trials, Common data elements, Observational studies, Outcomes, Subarachnoid hemorrhage, Unruptured intracranial aneurysms",
author = "{the Unruptured Intracranial Aneurysms and SAH CDE Project Investigators} and Jose Suarez and Sheikh, {Muniza K.} and Macdonald, {R. Loch} and Sepideh Amin-Hanjani and Brown, {Robert D.} and {de Oliveira Manoel}, {Airton Leonardo} and Derdeyn, {Colin P.} and Nima Etminan and Emanuela Keller and Leroux, {Peter D.} and Mayer, {Stephan A.} and Akio Morita and Gabriel Rinkel and Daniel Rufennacht and Stienen, {Martin N.} and James Torner and Vergouwen, {Mervyn D.I.} and Wong, {George K.C.} and Stephan Mayer and Philippe Bijlenga and Nerissa Ko and McDougall, {Cameron G.} and J. Mocco and Cameron McDougall and Werner, {Marieke J.H.} 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 Nyquist, {Paul A} and {van der Jagt}, Mathieu and Bambakidis, {Nicholas C.} and Gretchen Brophy and Ketan Bulsara and Jan Claassen and Connolly, {E. Sander} and Hoffer, {S. Alan} and Hoh, {Brian L.} and Holloway, {Robert G.} and Adam Kelly and Peter Nakaji and Alejandro Rabinstein and Peter Vajkoczy and Henry Woo",
year = "2019",
month = "1",
day = "1",
doi = "10.1007/s12028-019-00723-6",
language = "English (US)",
journal = "Neurocritical Care",
issn = "1541-6933",
publisher = "Humana Press",

}

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

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 - Mayer, Stephan

AU - Bijlenga, Philippe

AU - Ko, Nerissa

AU - McDougall, Cameron G.

AU - Mocco, J.

AU - McDougall, Cameron

AU - Werner, Marieke J.H.

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 - Nyquist, Paul A

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

AU - Woo, Henry

PY - 2019/1/1

Y1 - 2019/1/1

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

JO - Neurocritical Care

JF - Neurocritical Care

SN - 1541-6933

ER -