Common Data Elements for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage Clinical Research: Recommendations from the Working Group on Long-Term Therapies

the Unruptured Intracranial Aneurysm and SAH CDE Project Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Objectives: The goal for the long-term therapies (LTT) working group (WG) of the Unruptured Intracranial Aneurysm (UIA) and Subarachnoid Hemorrhage (SAH) common data elements (CDEs) was to develop a comprehensive set of CDEs, data definitions, case report forms, and guidelines for use in UIA and SAH LTT 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 other neurological disease-specific CDEs already developed and available for use by research investigators. Methods: The eight LTT WG members comprised international UIA, and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed, and provided recommendations for future LTT clinical research. The recommendations were compiled, internally reviewed by the all UIA and SAH WGs and steering committee members. The NINDS CDE team also reviewed the final version before posting the SAH Version 1.0 CDE recommendations on the NINDS CDE website. Results: The NINDS UIA and SAH LTT 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 subcommittee members discussed and reviewed various parameters, outcomes, and endpoints in UIA and SAH LTT studies. The following meetings with WG members, the LTT WG’s recommendations are incorporated into the disease/injury-related events, assessments and examinations, and treatment/intervention data domains. Conclusions: Noting gaps in the literature regarding medication and rehabilitation parameters in UIA and SAH clinical studies, the current CDE recommendations aim to arouse interest to explore the impact of medication and rehabilitation treatments and therapies and encourage the convergence of LTT clinical study parameters to develop a harmonized standard.

Original languageEnglish (US)
Pages (from-to)79-86
Number of pages8
JournalNeurocritical care
Volume30
DOIs
StatePublished - Jun 16 2019

Fingerprint

Intracranial Aneurysm
Subarachnoid Hemorrhage
National Institute of Neurological Disorders and Stroke
Research
Therapeutics
Group Psychotherapy
Common Data Elements
Rehabilitation
Committee Membership
National Library of Medicine (U.S.)
National Institutes of Health (U.S.)
Research Personnel
Guidelines

Keywords

  • Cerebral aneurysm
  • Clinical research
  • Common data elements
  • Endpoint
  • Long-term therapy
  • Medication
  • Outcome
  • Rehabilitation
  • Subarachnoid Hemorrhage

ASJC Scopus subject areas

  • Clinical Neurology
  • Critical Care and Intensive Care Medicine

Cite this

Common Data Elements for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage Clinical Research : Recommendations from the Working Group on Long-Term Therapies. / the Unruptured Intracranial Aneurysm and SAH CDE Project Investigators.

In: Neurocritical care, Vol. 30, 16.06.2019, p. 79-86.

Research output: Contribution to journalArticle

@article{f44d30f8965740ffa13415f7930645f0,
title = "Common Data Elements for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage Clinical Research: Recommendations from the Working Group on Long-Term Therapies",
abstract = "Objectives: The goal for the long-term therapies (LTT) working group (WG) of the Unruptured Intracranial Aneurysm (UIA) and Subarachnoid Hemorrhage (SAH) common data elements (CDEs) was to develop a comprehensive set of CDEs, data definitions, case report forms, and guidelines for use in UIA and SAH LTT 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 other neurological disease-specific CDEs already developed and available for use by research investigators. Methods: The eight LTT WG members comprised international UIA, and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed, and provided recommendations for future LTT clinical research. The recommendations were compiled, internally reviewed by the all UIA and SAH WGs and steering committee members. The NINDS CDE team also reviewed the final version before posting the SAH Version 1.0 CDE recommendations on the NINDS CDE website. Results: The NINDS UIA and SAH LTT 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 subcommittee members discussed and reviewed various parameters, outcomes, and endpoints in UIA and SAH LTT studies. The following meetings with WG members, the LTT WG’s recommendations are incorporated into the disease/injury-related events, assessments and examinations, and treatment/intervention data domains. Conclusions: Noting gaps in the literature regarding medication and rehabilitation parameters in UIA and SAH clinical studies, the current CDE recommendations aim to arouse interest to explore the impact of medication and rehabilitation treatments and therapies and encourage the convergence of LTT clinical study parameters to develop a harmonized standard.",
keywords = "Cerebral aneurysm, Clinical research, Common data elements, Endpoint, Long-term therapy, Medication, Outcome, Rehabilitation, Subarachnoid Hemorrhage",
author = "{the Unruptured Intracranial Aneurysm and SAH CDE Project Investigators} and Wong, {George K.C.} and Daly, {Janis J.} and Rhoney, {Denise H.} and Joseph Broderick and Christopher Ogilvy and Roos, {Y. B.} and Adnan Siddiqui and James Torner and Suarez, {Jose I.} and {Loch Macdonald}, R. and Sepideh Amin-Hanjani 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 McDougall, {Cameron G.} and J. Mocco and Yuuichi Murayama 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 Susanne Muehlschlegel and Tatsushi Mutoh and Paul Nyquist and Daiwai Olson and Mejia-Mantilla, {Jorge H.} and {van der Jagt}, Mathieu and Nicholas Bambakidis and Gretchen Brophy and Ketan Bulsara and Jan Claassen and {Sander Connolly}, E. and {Alan Hoffer}, S. and Alejandro Rabinstein and Huston, {John III}",
year = "2019",
month = "6",
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volume = "30",
pages = "79--86",
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TY - JOUR

T1 - Common Data Elements for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage Clinical Research

T2 - Recommendations from the Working Group on Long-Term Therapies

AU - the Unruptured Intracranial Aneurysm and SAH CDE Project Investigators

AU - Wong, George K.C.

AU - Daly, Janis J.

AU - Rhoney, Denise H.

AU - Broderick, Joseph

AU - Ogilvy, Christopher

AU - Roos, Y. B.

AU - Siddiqui, Adnan

AU - Torner, James

AU - Suarez, Jose I.

AU - Loch Macdonald, R.

AU - Amin-Hanjani, Sepideh

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 - McDougall, Cameron G.

AU - Mocco, J.

AU - Murayama, Yuuichi

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 - Muehlschlegel, Susanne

AU - Mutoh, Tatsushi

AU - Nyquist, Paul

AU - Olson, Daiwai

AU - Mejia-Mantilla, Jorge H.

AU - van der Jagt, Mathieu

AU - Bambakidis, Nicholas

AU - Brophy, Gretchen

AU - Bulsara, Ketan

AU - Claassen, Jan

AU - Sander Connolly, E.

AU - Alan Hoffer, S.

AU - Rabinstein, Alejandro

AU - Huston, John III

PY - 2019/6/16

Y1 - 2019/6/16

N2 - Objectives: The goal for the long-term therapies (LTT) working group (WG) of the Unruptured Intracranial Aneurysm (UIA) and Subarachnoid Hemorrhage (SAH) common data elements (CDEs) was to develop a comprehensive set of CDEs, data definitions, case report forms, and guidelines for use in UIA and SAH LTT 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 other neurological disease-specific CDEs already developed and available for use by research investigators. Methods: The eight LTT WG members comprised international UIA, and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed, and provided recommendations for future LTT clinical research. The recommendations were compiled, internally reviewed by the all UIA and SAH WGs and steering committee members. The NINDS CDE team also reviewed the final version before posting the SAH Version 1.0 CDE recommendations on the NINDS CDE website. Results: The NINDS UIA and SAH LTT 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 subcommittee members discussed and reviewed various parameters, outcomes, and endpoints in UIA and SAH LTT studies. The following meetings with WG members, the LTT WG’s recommendations are incorporated into the disease/injury-related events, assessments and examinations, and treatment/intervention data domains. Conclusions: Noting gaps in the literature regarding medication and rehabilitation parameters in UIA and SAH clinical studies, the current CDE recommendations aim to arouse interest to explore the impact of medication and rehabilitation treatments and therapies and encourage the convergence of LTT clinical study parameters to develop a harmonized standard.

AB - Objectives: The goal for the long-term therapies (LTT) working group (WG) of the Unruptured Intracranial Aneurysm (UIA) and Subarachnoid Hemorrhage (SAH) common data elements (CDEs) was to develop a comprehensive set of CDEs, data definitions, case report forms, and guidelines for use in UIA and SAH LTT 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 other neurological disease-specific CDEs already developed and available for use by research investigators. Methods: The eight LTT WG members comprised international UIA, and SAH experts reviewed existing NINDS CDEs and instruments, created new elements when needed, and provided recommendations for future LTT clinical research. The recommendations were compiled, internally reviewed by the all UIA and SAH WGs and steering committee members. The NINDS CDE team also reviewed the final version before posting the SAH Version 1.0 CDE recommendations on the NINDS CDE website. Results: The NINDS UIA and SAH LTT 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 subcommittee members discussed and reviewed various parameters, outcomes, and endpoints in UIA and SAH LTT studies. The following meetings with WG members, the LTT WG’s recommendations are incorporated into the disease/injury-related events, assessments and examinations, and treatment/intervention data domains. Conclusions: Noting gaps in the literature regarding medication and rehabilitation parameters in UIA and SAH clinical studies, the current CDE recommendations aim to arouse interest to explore the impact of medication and rehabilitation treatments and therapies and encourage the convergence of LTT clinical study parameters to develop a harmonized standard.

KW - Cerebral aneurysm

KW - Clinical research

KW - Common data elements

KW - Endpoint

KW - Long-term therapy

KW - Medication

KW - Outcome

KW - Rehabilitation

KW - Subarachnoid Hemorrhage

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