18 research outputs found
Comparison of Teen Driver Fatality Rates by Vehicle Type in the United States
Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/74622/1/j.aem.2007.06.038.pd
The National Institute of Neurological Disorders and Stroke and Department of Defense Sport-Related Concussion Common Data Elements Version 1.0 Recommendations
Aim: Through a partnership with the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), and Department of Defense (DoD), the development of Sport-Related Concussion (SRC) Common Data Elements (CDEs) was initiated. The aim of this collaboration was to increase the efficiency and effectiveness of clinical research studies and clinical treatment outcomes, increase data quality, facilitate data sharing across studies, reduce study start-up time, more effectively aggregate information into metadata results, and educate new clinical investigators. Materials/Methods: The SRC CDE Working Group consisted of 34 worldwide experts in concussion from varied fields of related expertise, divided into three Subgroups: Acute (3 months post-concussion). To develop CDEs, the Subgroups reviewed various domains, and then selected from, refined, and added to existing CDEs, case report forms and field-tested data elements from national registries and funded research studies. Recommendations were posted to the NINDS CDE Website for Public Review from February 2017 to April 2017. Results: Following an internal Working Group review of recommendations, along with consideration of comments received from the Public Review period, the first iteration (Version 1.0) of the NINDS SRC CDEs was completed in June 2017. The recommendations include Core and Supplemental ? Highly Recommended CDEs for cognitive data elements and symptom checklists, as well as other outcomes and endpoints (e.g., vestibular, oculomotor, balance, anxiety, depression) and sample case report forms (e.g., injury reporting, demographics, concussion history) for domains typically included in clinical research studies. Interpretation: The NINDS SRC CDEs and supporting documents are publicly available on the NINDS CDE website https://www.commondataelements.ninds.nih.gov/. Widespread use of CDEs by researchers and clinicians will facilitate consistent SRC clinical research and trial design, data sharing, and metadata retrospective analysis
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Abstract WP332: Updating the Structure of Stroke Clinical Research Data: Version 2 of the Stroke Common Data Elements From the National Institutes of Health/National Institute of Neurological Disorders and Stroke
Introduction:
In order to increase the efficiency and effectiveness of neurovascular clinical research studies, increase data quality, facilitate data sharing, help educate new clinical investigators and reduce study start-up time, the National Institute of Neurological Disorders and Stroke (NINDS) convened a Working Group (WG) that developed Version 1.0 (published 2010) Stroke-specific Common Data Elements (CDEs). Since their initial publication, intervening advances in science and initial experience with the CDEs identified a need to update them and refine guidance on their deployment.
Hypothesis/Objective:
The NINDS has updated guidance on uniform data structures for use in cerebrovascular research in epidemiology, clinical trials and imaging studies in order to advance the prevention, acute treatment and recovery from cerebrovascular disease.
Methods:
The NINDS convened experts in research and data element design drawing strongly from investigators in the NIH StrokeNet and other NINDS clinical research projects.
Results:
Stroke CDE leadership developed a revised process for classifying Stroke CDEs among the four hierarchical categories of Core, Supplemental - Highly Recommended, Supplemental and Exploratory. Due to the heterogeneity of stroke conditions and study types, the classification of Supplemental - Highly Recommended was used for study type (clinical trial or observational), disease type (e.g., ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage) and disease phase (primary prevention, acute, recovery and secondary prevention).
Conclusion:
The second iteration of NINDS CDE recommendations for neurovascular disease is an important step towards more efficient study start-up time and improved data sharing. The updated CDEs were released on the NINDS CDE website in May 2015. The information at this meeting will include examples of how the Stroke CDEs may be used by a research study, an explanation of the new CDE classifications, and examples of navigating and selecting CDEs from the NINDS CDE website.
Support:
This project was funded by HHSN271201200034C