Abstract
Background: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDEs) have been generated to standardize and define terms used by the scientific community. The widespread use of these CDEs promotes harmonized data collection in clinical research. The aim of the NINDS Unruptured Intracranial Aneurysms (UIA) and Subarachnoid Hemorrhage (SAH), and Subject Characteristics working group (WG) was to identify, define, and classify CDEs describing the characteristics of patients diagnosed with an UIA and SAH. Thus, “Participant/Subject characteristics” is a set of factors defining a population of selected individuals and allowing comparisons with a reference population and overtime. Methods: Based on standard terms defined by the United States’ Census Bureau, CDEs previously defined by several (Stroke, Epilepsy and Traumatic Brain Injury) NINDS CDE working groups literature and expert opinion of the WG, the “Participant/Subject characteristics” domain has been defined. Results: A set of 192 CDEs divided in 7 subsections: demographics (8 CDEs), social status (8 CDEs), behavioral status (22 CDEs), family and medical history (144 CDEs), pregnancy and perinatal history (8 CDEs), history data source reliability (3 CDEs), and prior functional status (3 CDEs) was defined. SAH is characterized by 6 core elements, all classified in the “Participant/Subject characteristics” domain. Four exploratory elements out of the 39 for SAH overall are in the “Participant/Subject characteristics” domain, and all remaining 182 CDEs in the “Participant/Subject characteristics” domain are classified as Supplemental-Highly Recommended elements. Conclusions: These CDEs would allow the development of best practice guidelines to standardize the assessment and reporting of observations concerning UIA and SAH.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 20-27 |
| Number of pages | 8 |
| Journal | Neurocritical Care |
| Volume | 30 |
| DOIs | |
| State | Published - Jun 16 2019 |
Funding
Dr. Bijlenga and Dr. Morel have received research grants from SystemsX.ch a Swiss initiative for Systems Biology and evaluated by the Swiss National Science Foundation. Dr Morita has nothing to disclose. Dr Brown has nothing to disclose. Dr Mocco reports grants and other from Stryker, grants and other from Penumbra, grants and other from Medtronic, grants and other from Microvention, personal fees and other from Imperative Care, personal fees and other from Cerebrotech, personal fees and other from Viseon, personal fees and other from Endostream, personal fees and other from Rebound Therapeutics, personal fees and other from Vastrax, personal fees and other from Blink TBI, personal fees and other from Serenity, personal fees and other from NTI, personal fees and other from Neurvana, personal fees, and other from Cardinal Consulting, outside the submitted work. Dr Wermer has nothing to disclose. Dr Ko reports grants from National Institutes of Health/NINDS, other from Edge Therapeutics, during the conduct of the study. Dr Murayama reports grants and personal fees from Stryker Neurovascular, grants from Siemens Healthcare, and personal fees from Kaneka Medics, during the conduct of the study. 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. Logistical support for this project was provided in part through NIH Contract HHSN271201200034C, the Intramural Research Program of the NIH, NLM, The Neurocritical Care Society and the CHI Baylor St Luke’s Medical Center in Houston, TX. The development of the NINDS SAH CDEs was made possible thanks to the great investment of time and effort of WG members and the members of the NINDS CDE Project and NLM CDE project teams participating from 2015 to 2017.
Keywords
- Common Data Elements
- Intracranial aneurysm
- Participant/Subject characteristics
- Subarachnoid Hemorrhage
ASJC Scopus subject areas
- Critical Care and Intensive Care Medicine
- Clinical Neurology