Journal article
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.
- Suarez JI Division of Neurosciences Critical Care, The Johns Hopkins University School of Medicine, 1800 Orleans Street, Sheikh Zayed Building, 3014C, Baltimore, MD, 21287, USA. jsuarez5@jhmi.edu.
- Sheikh MK The Emmes Corporation, Rockville, MD, USA.
- Macdonald RL University of Toronto, Toronto, ON, Canada.
- Amin-Hanjani S University of Illinois at Chicago, Chicago, IL, USA.
- Brown RD Mayo Clinic, Rochester, MN, USA.
- de Oliveira Manoel AL University of Toronto, Toronto, ON, Canada.
- Derdeyn CP University of Iowa, Iowa City, IA, USA.
- Etminan N University of Duesseldorf, Düesseldorf, Germany.
- Keller E University of Zurich, Zurich, Switzerland.
- Leroux PD Main Line Health Care, Wynnewood, PA, USA.
- Mayer SA Henry Ford Hospital, Detroit, MI, USA.
- Morita A Nippon Medical School, Tokyo, Japan.
- Rinkel G University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
- Rufennacht D Klinik Hirslanden, Zurich, Switzerland.
- Stienen MN University of Zurich, Zurich, Switzerland.
- Torner J University of Iowa, Iowa City, IA, USA.
- Vergouwen MDI University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
- Wong GKC Chinese University of Hong Kong, Shatin, Hong Kong.
- 2019-05-16
Published in:
- Neurocritical care. - 2019
Clinical trials
Common data elements
Observational studies
Outcomes
Subarachnoid hemorrhage
Unruptured intracranial aneurysms
Biomedical Research
Common Data Elements
Guidelines as Topic
Humans
Intracranial Aneurysm
National Institute of Neurological Disorders and Stroke (U.S.)
National Library of Medicine (U.S.)
Subarachnoid Hemorrhage
United States
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1007/s12028-019-00723-6
- PMID 31087257
- Persistent URL
- https://folia.unifr.ch/unifr/documents/298817
Statistics
Document views: 24
File downloads: