TY - JOUR
T1 - Development of Common Data Elements for Use in Chiari Malformation Type i Clinical Research
T2 - An NIH/NINDS Project
AU - Luciano, Mark G.
AU - Batzdorf, Ulrich
AU - Kula, Roger W.
AU - Rocque, Brandon G.
AU - Maher, Cormac O.
AU - Heiss, John
AU - Martin, Bryn A.
AU - Bolognese, Paolo A.
AU - Ashley-Koch, Allison
AU - Limbrick, David
AU - Poppe, Dorothy J.
AU - Esposito, Kaitlyn M.
AU - Odenkirchen, Joanne
AU - Esterlitz, Joy R.
AU - Ala'i, Sherita
AU - Joseph, Kristen
AU - Feldman, Robin S.
AU - Riddle, Robert
N1 - Funding Information:
Logistics support for this project was provided in part through NIH Contract HHSN271201200034C. The CMI CDE project was made possible from financial contributions of the Chiari & Syringomyelia Foundation. 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. Dr Rocque receives other support from NIH Grant 1KL2TR001419. Dr Martin receives other support from NIH NIGMS Grants P20 GM103408, 4U54GM104944-04, NIH NIMH Grant 1R44MH112210-01A1 and NASA Grant NNX16AT06G. The authors have no personal, financial, or institutional interest in any of the drugs, materials, or devices described in this article.
Funding Information:
ABBREVIATIONS: CDE, Common Data Elements; CMI, Chiari malformation; CRF, case report form; CSF, Chiari & Syringomyelia Foundation; MRI, magnetic resonance imaging; NIH, National Institutes of Health; NINDS, National Institute of Neurological Disorders and Stroke; WG, working group
Funding Information:
∗Department of Neurosurgery, Johns Hopkins University, Baltimore, Maryland; ‡Department of Neurosurgery, University of California Los Angeles, Los Angeles, California; §Chiari Neurosurgical Center at Neurological Surgery, P.C., Lake Success, New York; ¶Department of Neurosurgery, University of Alabama, Birmingham, Alabama; ||Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan; #Division of Intramural Research, National Institutes of Health/National Institute of Neurological Disorders and Stroke, Bethesda, Maryland;∗∗Department of Biological Engineering, University of Idaho, Moscow, Idaho; ‡‡Center for Human Genetics, Duke University, Raleigh, North Carolina; §§Department of Neurosurgery, Washington University School of Medicine, St. Louis, Missouri; ¶¶Chiari & Syringomyelia Foundation, Staten Island, New York; ||||Division of Neuroscience, National Institutes of Health/National Institute of Neurological Disorders and Stroke, Bethesda, Maryland; ##The Emmes Corporation, Rockville,
Publisher Copyright:
© 2019 by the Congress of Neurological Surgeons.
PY - 2019/12/1
Y1 - 2019/12/1
N2 - The management of Chiari I malformation (CMI) is controversial because treatment methods vary and treatment decisions rest on incomplete understanding of its complex symptom patterns, etiologies, and natural history. Validity of studies that attempt to compare treatment of CMI has been limited because of variable terminology and methods used to describe study subjects. The goal of this project was to standardize terminology and methods by developing a comprehensive set of Common Data Elements (CDEs), data definitions, case report forms (CRFs), and outcome measure recommendations for use in CMI clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health. A working group, comprising over 30 experts, developed and identified CDEs, template CRFs, data dictionaries, and guidelines to aid investigators starting and conducting CMI clinical research studies. The recommendations were compiled, internally reviewed, and posted online for external public comment. In October 2016, version 1.0 of the CMI CDE recommendations became available on the NINDS CDE website. The recommendations span these domains: Core Demographics/Epidemiology; Presentation/Symptoms; Co-Morbidities/Genetics; Imaging; Treatment; and Outcome. Widespread use of CDEs could facilitate CMI clinical research trial design, data sharing, retrospective analyses, and consistent data sharing between CMI investigators around the world. Updating of CDEs will be necessary to keep them relevant and applicable to evolving research goals for understanding CMI and its treatment.
AB - The management of Chiari I malformation (CMI) is controversial because treatment methods vary and treatment decisions rest on incomplete understanding of its complex symptom patterns, etiologies, and natural history. Validity of studies that attempt to compare treatment of CMI has been limited because of variable terminology and methods used to describe study subjects. The goal of this project was to standardize terminology and methods by developing a comprehensive set of Common Data Elements (CDEs), data definitions, case report forms (CRFs), and outcome measure recommendations for use in CMI clinical research, as part of the CDE project at the National Institute of Neurological Disorders and Stroke (NINDS) of the US National Institutes of Health. A working group, comprising over 30 experts, developed and identified CDEs, template CRFs, data dictionaries, and guidelines to aid investigators starting and conducting CMI clinical research studies. The recommendations were compiled, internally reviewed, and posted online for external public comment. In October 2016, version 1.0 of the CMI CDE recommendations became available on the NINDS CDE website. The recommendations span these domains: Core Demographics/Epidemiology; Presentation/Symptoms; Co-Morbidities/Genetics; Imaging; Treatment; and Outcome. Widespread use of CDEs could facilitate CMI clinical research trial design, data sharing, retrospective analyses, and consistent data sharing between CMI investigators around the world. Updating of CDEs will be necessary to keep them relevant and applicable to evolving research goals for understanding CMI and its treatment.
KW - Chiari Malformation
KW - Common Data Elements
UR - http://www.scopus.com/inward/record.url?scp=85074612848&partnerID=8YFLogxK
U2 - 10.1093/neuros/nyy475
DO - 10.1093/neuros/nyy475
M3 - Article
C2 - 30690581
AN - SCOPUS:85074612848
SN - 0148-396X
VL - 85
SP - 854
EP - 859
JO - Clinical Neurosurgery
JF - Clinical Neurosurgery
IS - 6
ER -