Development of Common Data Elements for Use in Chiari Malformation Type I Clinical Research: An NIH/NINDS Project
ABSTRACT 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 limi...
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| Published in | Neurosurgery Vol. 85; no. 6; pp. 854 - 860 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
United States
Oxford University Press
01.12.2019
Copyright by the Congress of Neurological Surgeons Wolters Kluwer Health, Inc |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0148-396X 1524-4040 1081-1281 1524-4040 |
| DOI | 10.1093/neuros/nyy475 |
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| Abstract | ABSTRACT
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. |
|---|---|
| AbstractList | ABSTRACT
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. 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. 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. KEY WORDS: Chiari Malformation, Common Data Elements DOI: 10.1093/neuros/nyy475 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.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. |
| Audience | Academic |
| Author | Ashley-Koch, Allison Esposito, Kaitlyn M Luciano, Mark G Limbrick, David Ala’i, Sherita Joseph, Kristen Heiss, John Batzdorf, Ulrich Martin, Bryn A Rocque, Brandon G Odenkirchen, Joanne Esterlitz, Joy R Feldman, Robin S Kula, Roger W Riddle, Robert Poppe, Dorothy J Maher, Cormac O Bolognese, Paolo A |
| AuthorAffiliation | 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, Maryland |
| AuthorAffiliation_xml | – name: 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, Maryland – name: 5 Department of Neurosurgery, University of Michigan , Ann Arbor, Michigan – name: 9 Department of Neurosurgery, Washington University School of Medicine , St. Louis, Missouri – name: 7 Department of Biological Engineering, University of Idaho , Moscow, Idaho – name: 8 Center for Human Genetics, Duke University , Raleigh, North Carolina – name: 11 Division of Neuroscience, National Institutes of Health/National Institute of Neurological Disorders and Stroke , Bethesda, Maryland – name: 10 Chiari & Syringomyelia Foundation , Staten Island, New York – name: 12 The Emmes Corporation , Rockville, Maryland – name: 4 Department of Neurosurgery, University of Alabama , Birmingham, Alabama – name: 6 Division of Intramural Research, National Institutes of Health/National Institute of Neurological Disorders and Stroke , Bethesda, Maryland – name: 1 Department of Neurosurgery, Johns Hopkins University , Baltimore, Maryland – name: 3 Chiari Neurosurgical Center at Neurological Surgery , P.C., Lake Success, New York – name: 2 Department of Neurosurgery, University of California Los Angeles , Los Angeles, California |
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| Copyright | Copyright © 2019 by the Congress of Neurological Surgeons 2019 Copyright © by the Congress of Neurological Surgeons Copyright © 2019 by the Congress of Neurological Surgeons. COPYRIGHT 2019 Oxford University Press Copyright © 2019 by the Congress of Neurological Surgeons |
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The management of Chiari I malformation (CMI) is controversial because treatment methods vary and treatment decisions rest on incomplete understanding... The management of Chiari I malformation (CMI) is controversial because treatment methods vary and treatment decisions rest on incomplete understanding of its... |
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| SubjectTerms | Arnold-Chiari Malformation - diagnostic imaging Arnold-Chiari Malformation - epidemiology Arnold-Chiari Malformation - therapy Biomedical Research - standards Biomedical Research - trends Care and treatment Clinical trials Common Data Elements Data dictionaries Editor's Choice Health Personnel - standards Health Personnel - trends Humans Information sharing Medical research Medicine, Experimental National Institute of Neurological Disorders and Stroke (U.S.) - standards National Institute of Neurological Disorders and Stroke (U.S.) - trends Nervous system diseases Neurosurgery Outcome Assessment, Health Care - standards Outcome Assessment, Health Care - trends Retrospective Studies Special Terminology United States - epidemiology |
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| Title | Development of Common Data Elements for Use in Chiari Malformation Type I Clinical Research: An NIH/NINDS Project |
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