Abstract
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.
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Change history
06 December 2023
A Correction to this paper has been published: https://doi.org/10.1007/s12028-023-01894-z
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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
Funding
Erta Beqiri is supported by supported by the Medical Research Council (grant no.: MR N013433-1) and by the Gates Cambridge Scholarship. Xiao Hu is supported by NIH OT2 OD032701-01. Geert Meyfroidt is funded by the research foundation Flanders (FWO) as senior clinical investigator (1843123), KU Leuven Industrial Research Fund, Pfizer Global Medical Grants. Dick Moberg received funding for data harmonization provided by the U.S. Army MRAA (W81XWH1920013). Eric S. Rosenthal is supported by NIH OT2 OD032701-01 and DOD/US Army W81XWH-18-DMRDP-PTCRA. Soojin Park is supported by NIH R01NS129760 and R01NS131606.
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E.B. and S.P. wrote the initial draft of the manuscript. All co-authors edited the manuscript and approved the final content. All co-authors contributed to the case report forms released with the manuscript.
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Erta Beqiri MD: None. Neeraj Badjatia MD MSc: None. Ari Ercole MD PhD: None. Brandon Foreman MD: Speaker for UCB Pharma, Scientific Advisory and Site PI for Marinus Pharmaceuticals, Scientific Advisory for SAGE Therapeutics, Lecturer for Natus Medical Inc. Peter Hu PhD: None. Xiao Hu PhD: Patents US10811141B2, US8634677, US10357169B2, USb8510126, US9600990B2, US20100049082, US8805703B2, US8688459; Advisory Board and Stock or stock options in Brain4Care. Kerri LaRovere MD MMSc: Patent for Emboli Detection Methods to Identify Mechanisms of Brain Injury in Susceptibe Adults and Children (Thomas Heldt et al. No: US-2022-0181008-A1). Geert Meyfroidt MD PhD: consultant to Codman Integra. Dick Moberg: President of Moberg Analytics, Inc. Chiara Robba MD PhD: Speaker for Masimo and Edwards. Eric S. Rosenthal MD: consultant to UCB Pharma; patent planned application 125141.03491. Peter Smielewski PhD: receives part of the licensing fees for ICM+ software, licensed by Cambridge Enterprise Ltd, University of Cambridge, Cambridge. Mark S. Wainwright MD PhD: Member, Neurology Clinical Advisory Board for Sage Therapeutics. Soojin Park MD: Board Trustee, Neurocritical Care Foundation; Associate Editor, Neurocritical Care.
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Beqiri, E., Badjatia, N., Ercole, A. et al. Common Data Elements for Disorders of Consciousness: Recommendations from the Working Group on Physiology and Big Data. Neurocrit Care 39, 593–599 (2023). https://doi.org/10.1007/s12028-023-01846-7
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DOI: https://doi.org/10.1007/s12028-023-01846-7