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.
The convergence of an interdisciplinary team of neurocritical care specialists to organize the Curing Coma Campaign is the first effort of its kind to coordinate national and international research ...efforts aimed at a deeper understanding of disorders of consciousness (DoC). This process of understanding includes translational research from bench to bedside, descriptions of systems of care delivery, diagnosis, treatment, rehabilitation, and ethical frameworks. The description and measurement of varying confounding factors related to hospital care was thought to be critical in furthering meaningful research in patients with DoC. Interdisciplinary hospital care is inherently varied across geographical areas as well as community and academic medical centers. Access to monitoring technologies, specialist consultation (medical, nursing, pharmacy, respiratory, and rehabilitation), staffing resources, specialty intensive and acute care units, specialty medications and specific surgical, diagnostic and interventional procedures, and imaging is variable, and the impact on patient outcome in terms of DoC is largely unknown. The heterogeneity of causes in DoC is the source of some expected variability in care and treatment of patients, which necessitated the development of a common nomenclature and set of data elements for meaningful measurement across studies. Guideline adherence in hemorrhagic stroke and severe traumatic brain injury may also be variable due to moderate or low levels of evidence for many recommendations. This article outlines the process of the development of common data elements for hospital course, confounders, and medications to streamline definitions and variables to collect for clinical studies of DoC.
Background
The implementation of multimodality monitoring in the clinical management of patients with disorders of consciousness (DoC) results in physiological measurements that can be collected in a ...continuous and regular fashion or even at waveform resolution. Such data are considered part of the “Big Data” available in intensive care units and are potentially suitable for health care-focused artificial intelligence research. Despite the richness in content of the physiological measurements, and the clinical implications shown by derived metrics based on those measurements, they have been largely neglected from previous attempts in harmonizing data collection and standardizing reporting of results as part of common data elements (CDEs) efforts. CDEs aim to provide a framework for unifying data in clinical research and help in implementing a systematic approach that can facilitate reliable comparison of results from clinical studies in DoC as well in international research collaborations.
Methods
To address this need, the Neurocritical Care Society’s Curing Coma Campaign convened a multidisciplinary panel of DoC “Physiology and Big Data” experts to propose CDEs for data collection and reporting in this field. Results: We report the recommendations of this CDE development panel and disseminate CDEs to be used in physiologic and big data studies of patients with DoC.
Conclusions
These CDEs will support progress in the field of DoC physiologic and big data and facilitate international collaboration.
Acknowledgements The Curing Coma Campaign Collaborators are listed in the Supplementary Appendix. The Curing Coma Campaign and its Contributing Members: Venkatesh Aiyagari, Yama Akbari, Fawaz ...Al-Mufti, Sheila Alexander, Anne Alexandrov, Ayham Alkhachroum, Moshagan Amiri, Brian Appavu, Meron Awraris Gebre, Mary Kay Bader, Neeraj Badjatia2, Ram Balu, Megan Barra, Rachel Beekman, Ettore Beghi, Kathleen Bell, Erta Beqiri1, Tracey Berlin, Thomas Bleck, Yelena Bodien, Varina Boerwinkle, Melanie Boly, Alexandra Bonnel, Emery Brown, Eder Caceres, Elizabeth Carroll, Emilio G. Cediel, Sherry Chou, Giuseppe Citerio, Jan Classen, Chad Condie, Katie Cosmas, Claire Creutzfeldt, Neha Dangayach, Michael DeGeorgia, Caroline Der-Nigoghoss, Masoom Desai, Michael Diringer, James Dullaway, Brian Edlow, Ari Ercole3, Anna Estraneo, Guido Falcone, Llewellyn Padayachy, Soojin Park14, Melissa Pergakis, Len Polizzotto, Nader Pouratian, Marilyn Price Spivack, Lara Prisco, Javier Provencio, Louis Puybasset, Lindsay Rasmussen, Verena Rass, Risa Richardson, Cassia Righy Shinots, Chiara Robba, Courtney Robertson, Benjamin Rohaut, John Rolston, Mario Rosanova, Eric S. Rosenthal12, Mary Beth Russell, Gisele Sampaio Silva, Leandro Sanz, Simone Sarasso, Aarti Sarwal, Nicolas Schiff, Caroline Schnakers, David Seder, Vishank Ar Shah, Amy Shapiro-Rosen, Angela Shapshak, Kartavya Sharma, Tarek Sharshar, Lori Shutter, Jacobo Sitt, Beth Slomine, Peter Smielewski1, Wade Smith, Emmanuel Stamatakis, Alexis Steinberg, Salia Farrokh, Simona Ferioli, Davinia Fernandez-Esp, Ericka Fink, Joseph Fins, Brandon Foreman4, Jennifer Frontera, Rishi Ganesan, Ahmeneh Ghavam, Joseph Giacino, Christie Gibbons, Emily Gilmore, Olivia Gosseries, Theresa Green, David Greer, Mary Guanci, Cecil Hahn, Ryan Hakimi, Daniel F Hanley, Jed Hartings, Ahmed Hassan, Claude Hemphill, Holly Hinson, Karen Hirsch, Sarah Hocker, Peter Hu5, Xiao Hu6, Theresa Human, David Hwang, Judy Illes, Matthew Jaffa, Michael L. James, Anna Janas, Morgan Jones, Emanuela Keller, Maggie Keogh, Jenn Kim, Keri Kim, Hannah Kirsch, Matt Kirschen, Nerissa Ko, Daniel Kondziella, Natalie Kreitzer, Robert Stevens, Jose Suarez, Bethany Sussman, Shaurya Taran, Aurore Thibaut, Zachary Threlkeld, Lorenzo Tinti, Daniel Toker, Michel Torbey, Stephen Trevick, Alexis Turgeon, Andrew Udy, Panos Varelas, Chethan Venkatasubba, Paul Vespa, Walter Videtta, Henning Voss, Ford Vox, Amy Wagner, Mark Wainwright13, John Whyte, Briana Witherspoon, Aleksandra Yakhind, Ross Zafonte, Darin Zahuranec, Chris Zammit, Bei Zhang, Wendy Ziai, Lara Zimmerman, Elizabeth Zink, Julie Kromm, Abhay Kumar, Pedro Kurtz, Steven Laureys, Thomas Lawson, Nicolas Lejeune, Ariane Lewis, John Liang, Geoffrey Ling, Sarah Livesay, Andrea Luppi, Lori Madden, Craig Maddux, Dea Mahanes, Shraddha Mainali, Nelson Maldonado, Rennan Martins Ribeiro, Marcello Massimini, Stephan Mayer, Victoria McCredie, Molly McNett, Jorge Mejia-Mantill, David Menon, Geert Meyfroidt8, Julio Mijangos, Dick Moberg9, Asma Moheet, Erika Molteni, Martin Monti, Chris Morrison, Susanne Muehlschlegel, Brooke Murtaugh, Lionel Naccache, Masao Nagayama, Emerson Nairon, Girija Natarajan, Virginia Newcombe, Niklas Nielsen, Filipa Noronha-Falc‹, Paul Nyquist, DaiWai Olson, Marwan Othman, Adrian Owen. Affiliations:1Brain Physics Laboratory, Division of Neurosurgery, Department of Clinical Neurosciences, University of Cambridge, Cambridge, UK.2Program in Trauma, Department of Neurology, University of Maryland School of Medicine, Baltimore, MD, USA. 3Division of Anaesthesia, University of Cambridge, Cambridge, UK. 4University of Cincinnati, Cincinnati, OH, USA. 5Program in Trauma, Departments of Anesthesiology and Surgery, University of Maryland School of Medicine, Baltimore, MD, USA. 6School of Nursing, Emory University, Atlanta, GA, USA. 8Department and Laboratory of Intensive Care Medicine, University Hospitals Leuven and KU Leuven, Louvain, Belgium. 9Moberg Analytics, Inc, Philadelphia, PA, USA. 12Department of Neurology, Massachusetts General Hospital, Boston, MA, USA. 13Division of Pediatric Neurology, Seattle Children’s Hospital, University of Washington, Seattle, WA, USA. 14Departments of Neurology and Biomedical Informatics, Columbia University Vagelos College of Physicians and Surgeons, NewYork-Presbyterian Hospital, New York, NY, USA Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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