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

George K C Wong; Janis J Daly; Denise H Rhoney; Joseph Broderick; Christopher Ogilvy; Y B Roos; Adnan Siddiqui; James Torner; Unruptured Intracranial Aneurysm and SAH CDE Project Investigators

doi:10.1007/s12028-019-00727-2

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

Journal article

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

George K C Wong, Janis J Daly, Denise H Rhoney, Joseph Broderick, Christopher Ogilvy, Y B Roos, Adnan Siddiqui, James Torner and Unruptured Intracranial Aneurysm and SAH CDE Project Investigators

Neurocritical care, Vol.30(Suppl 1), pp.79-86

06/2019

DOI: 10.1007/s12028-019-00727-2

PMID: 31077078

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https://pure.amsterdamumc.nl/en/publications/dbc9c19e-532d-45f4-b9ba-0c514f632923View

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Abstract

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. 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. 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. 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.

National Library of Medicine (U.S.)

Outcome and Process Assessment, Health Care

United States

Aneurysm, Ruptured - drug therapy

Humans

Subarachnoid Hemorrhage - rehabilitation

National Institute of Neurological Disorders and Stroke (U.S.)

Intracranial Aneurysm - rehabilitation

Aneurysm, Ruptured - rehabilitation

Biomedical Research

Intracranial Aneurysm - drug therapy

Subarachnoid Hemorrhage - drug therapy

Common Data Elements

Details

Title: Subtitle: Common Data Elements for Unruptured Intracranial Aneurysm and Subarachnoid Hemorrhage Clinical Research: Recommendations from the Working Group on Long-Term Therapies
Creators: George K C Wong - Department of Surgery, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, N.T., Hong Kong. georgewong@surgery.cuhk.edu.hk
Janis J Daly - Department of Neurology, University of Florida College of Medicine, Gainesville, FL, USA
Denise H Rhoney - University of North Carolina Eshelman School of Pharmacy, Chapel Hill, NC, USA
Joseph Broderick - Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, USA
Christopher Ogilvy - Division of Neurosurgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
Y B Roos - Department of Neurology, Academic Medical Center, Amsterdam, The Netherlands
Adnan Siddiqui - Department of Neurosurgery, University of Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA
James Torner - University of Iowa College of Public Health, Iowa City, IA, USA
Unruptured Intracranial Aneurysm and SAH CDE Project Investigators
Resource Type: Journal article
Publication Details: Neurocritical care, Vol.30(Suppl 1), pp.79-86
DOI: 10.1007/s12028-019-00727-2
PMID: 31077078
NLM abbreviation: Neurocrit Care
ISSN: 1556-0961
eISSN: 1556-0961
Publisher: United States
Grant note: HHSN271201200034C / NINDS NIH HHS
Language: English
Date published: 06/2019
Academic Unit: Epidemiology; Surgery; Injury Prevention Research Center; Neurosurgery
Record Identifier: 9983995047702771

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