Abstract
Background
The recent publication of practice guidelines for management of patients with disorders of consciousness (DoC) in the United States and Europe was a major step forward in improving the accuracy and consistency of terminology, diagnostic criteria, and prognostication in this population. There remains a pressing need for a more precise brain injury classification system that combines clinical semiology with neuroimaging, electrophysiologic, and other biomarker data. To address this need, the National Institute of Neurological Disorders and Stroke launched the Common Data Elements (CDEs) initiative to facilitate systematic collection of high-quality research data in studies involving patients with neurological disease. The Neurocritical Care Society’s Curing Coma Campaign expanded this effort in 2018 to develop CDEs for DoC. Herein, we present CDE recommendations for behavioral phenotyping of patients with DoC.
Methods
The Behavioral Phenotyping Workgroup used a preestablished, five-step process to identify and select candidate CDEs that included review of existing National Institute of Neurological Disorders and Stroke CDEs, nomination and systematic vetting of new CDEs, CDE classification, iterative review, and approval of panel recommendations and development of corresponding case review forms.
Results
We identified a slate of existing and newly proposed basic, supplemental, and exploratory CDEs that can be used for behavioral phenotyping of adult and pediatric patients with DoC.
Conclusions
The proposed behavioral phenotyping CDEs will assist with international harmonization of DoC studies and allow for more precise characterization of study cohorts, favorably impacting observational studies and clinical trials aimed at improving outcome in this population.
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Change history
03 November 2023
A Correction to this paper has been published: https://doi.org/10.1007/s12028-023-01874-3
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Acknowledgements
The Curing Coma Campaign Collaborators are listed in the Supplementary Appendix.
Funding
This work was supported by grants from the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR grant numbers: 90DPTB0011, 90DPTB0027, 90DPTB0022), National Institute of Neurological Disorders and Stroke (1U01NS086090-01) and U.S. Department of Defense (W81XWH-14-2-0176, W81XWH-15-9-001). NIDILRR is a Center within the United States Administration for Community Living, Department of Health and Human Services and the VA Traumatic Brain Injury Model System. The contents of this publication do not necessarily represent the policy of NIDILRR, Administration for Community Living, and Department of Health and Human Services, and you should not assume endorsement by the United States Federal Government.
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A.Y., N.N., and J.T.G wrote the initial draft of the manuscript. B.S. provided oversight on development of the pediatric recommendations. All co-authors edited the manuscript and approved the final content. All co-authors contributed equally to the case report forms released with the article.
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Joseph T. Giacino: Senior author.
The original article has been updated to include middle initial of coauthor Yelena G. Bodien.
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Yakhkind, A., Niznick, N., Bodien, Y.G. et al. Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Behavioral Phenotyping. Neurocrit Care 40, 909–917 (2024). https://doi.org/10.1007/s12028-023-01844-9
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DOI: https://doi.org/10.1007/s12028-023-01844-9