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

doi:10.1007/s12028-019-00723-6

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

Research output: Contribution to journal › Article › Academic

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 language	English
Pages (from-to)	4-19
Number of pages	16
Journal	Neurocritical Care
Volume	30
Issue number	Suppl 1
DOIs	https://doi.org/10.1007/s12028-019-00723-6
Publication status	Published - 16 Jun 2019

Keywords

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

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@article{7fef04bda6414ea7a3607002ab160736,

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 = "Suarez, {Jose I} 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}",

note = "Funding Information: The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS) or the US Government. The development of the NINDS SAH CDEs was made possible thanks to the great investment of time and effort of WG members and the members of the NINDS CDE Project and NLM CDE project teams participating from 2015 to 2017. Funding Information: 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 Dis‑ orders 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 avail‑ able for use by research investigators. Funding Information: Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society and the CHI Baylor St Luke{\textquoteright}s Medical Center in Houston, TX. Publisher Copyright: {\textcopyright} 2019, Neurocritical Care Society.",

year = "2019",

month = jun,

day = "16",

doi = "10.1007/s12028-019-00723-6",

language = "English",

volume = "30",

pages = "4--19",

journal = "Neurocritical Care",

issn = "1541-6933",

publisher = "Humana Press",

number = "Suppl 1",

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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 - 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

N1 - Funding Information: The views expressed here are those of the authors and do not represent those of the National Institutes of Health (NIH), the National Institute of Neurological Disorders and Stroke (NINDS) or the US Government. The development of the NINDS SAH CDEs was made possible thanks to the great investment of time and effort of WG members and the members of the NINDS CDE Project and NLM CDE project teams participating from 2015 to 2017. Funding Information: 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 Dis‑ orders 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 avail‑ able for use by research investigators. Funding Information: Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society and the CHI Baylor St Luke’s Medical Center in Houston, TX. 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

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U2 - 10.1007/s12028-019-00723-6

DO - 10.1007/s12028-019-00723-6

M3 - Article

C2 - 31087257

SN - 1541-6933

VL - 30

SP - 4

EP - 19

JO - Neurocritical Care

JF - Neurocritical Care

IS - Suppl 1

ER -

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

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Keywords

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