Research considerations for prospective studies of patients with coma and disorders of consciousness
Author:
Tinti Lorenzo1, Lawson Thomas2ORCID, Molteni Erika3ORCID, Kondziella Daniel45ORCID, Rass Verena6, Sharshar Tarek7, Bodien Yelena G89, Giacino Joseph T9, Mayer Stephan A1011, Amiri Moshgan4, Muehlschlegel Susanne12, Venkatasubba Rao Chethan P13, Vespa Paul M1415, Menon David K16ORCID, Citerio Giuseppe1718, Helbok Raimund619ORCID, McNett Molly20, , Agarwal Sachin, Aiyagari Venkatesh, Akbari Yama, Albertson Asher, Alexander Sheila, Alexandrov Anne, Alkhachroum Ayham, Al-Mufti Fawaz, Amiri Moshagan, Appavu Brian, Gebrewold Meron Awraris, Ayounb Marc, Badenes Rafael, Bader Mary Kay, Badjiata Neeraj, Balu Ram, Barlow Brooke, Barra Megan, Beekman Rachel, Beghi Ettore, Beqiri Erta, Berlin Tracey, Bilotta Federico, Bleck Thomas, Bodien Yelena, Boerwinkle Varina, Boly Melanie, Bonnel Alexandra, Brazzi Luca, Brown Emery, Bulic Sebina, Caceres Eder, Caceres Adrian, Cafiero Tullio, Carroll Elizabeth, Cediel Emilio G, Chou Sherry, Citerio Giuseppe, Claassen Jan, Condie Chad, Conti Alfredo, Cosmas Katie, Costa Paolo, Creutzfeldt Claire, Dangayach Neha, Dauri Mario, Debicki Derek, DeGeorgia Michael, Der-Nigoghossian Caroline, Desai Masoom, Dhar Rajat, Diringer Michael, Durr Emily, Edlow Brian, Ercole Ari, Estraneo Anna, Falcone Guido, Farrokh Salia, Ferguson Adam, Fernandez-Espejo Davinia, Fink Ericka, Fins Joseph, Foreman Brandon, Franchi Federico, Frontera Jennifer, Ganesan Rishi, Gaspard Nicolas, Ghavam Ahmeneh, Giacino Joseph, Gibbons Christie, Gilmore Emily, Glustein Chavie, Gosseries Olivia, Green Theresa, Greer David, Guanci Mary, Gupta Deepak, Hahn Cecil, Hakimi Ryan, Hammond Flora, Hanley Daniel F, Hartings Jed, Hassan Ahmed, Helbok Raimund, Hemphill Claude, Da Cunha Arthur Henrique Galvão Bruno, Hinson Holly, Hirsch Karen, Hocker Sarah, Hu Peter, Hu Xiao, Human Theresa, Hwang David, Illes Judy, Jaffa Matthew, James Michael L, Janas Anna, Johnson Susan, Jones Morgan, Jox Ralf J, Kalanuria Atul, Keller Emanuela, Kennedy Lori, Kennelly Megan, Keogh Maggie, Kim Jenn, Kim Keri, Kirsch Hannah, Kirschen Matthew, Ko Nerissa, Kondziella Daniel, Kreitzer Natalie, Kromm Julie, Kumar Abhay, Kurtz Pedro, Laureys Steven, Lawson Thomas, Lejeune Nicolas, Lewis Ariane, Liang John, Ling Geoffrey, Livesay Sarah, Luppi Andrea, MacDonald Jennifer, Maddux Craig, Mahanes Dea, Mainali Shraddha, Maldonado Nelson, Ribeiro Rennan Martins, Mascia Luciana, Massimini Marcello, Mathur Rohan, Mayer Stephan, McCredie Victoria, McNett Molly, Mejia-Mantilla Jorge, Mendoza Michael, Menon DavidORCID, Meyfroidt Geert, Mijangos Julio, Moberg Dick, Moheet Asma, Molteni Erika, Montalenti Elisa, Monti Martin, Morrison Chris, Muehlschlegel Susanne, Munar Marina, Murtaugh Brooke, Naccache Lionel, Nagayama Masao, Nairon Emerson, Nakagawa Thomas, Naldi Andrea, Narenthiran Ganesalingam, Natarajan Girija, Nemetsky Esther, Newcombe Virginia, Nielsen Niklas, Niznick Naomi, Noronha-Falcão Filipa, Nyquist Paul, Olson DaiWai, Othman Marwan, Owen Adrian, Padayachy Llewellyn, Pajoumand Mehrnaz, Park Soojin, Pergakis Melissa, Perry Heidi, Polizzotto Len, Pouratian Nader, Spivack Marilyn Price, Prisco Lara, Provencio Javier, Puglises Francesco, Puybasset Louis, Rao Chethan, Rasmussen Lindsay, Rass Verena, Rasulo Frank, Ray Bappaditya, Ricci Zaccaria, Richardson Risa, Shinotsuka Cassia Righy, Robba Chiara, Robertson Courtney, Rohaut Benjamin, Rolston John, Romagnoli Stefano, Rosanova Mario, Rosenthal Eric, Rowe Shaun, Rubin Michael, Russell Mary Beth, Silva Gisele Sampaio, Sanz Leandro, Sarasso Simone, Sarwal Aarti, Schiff Nicolas, Schnakers Caroline, Seder David, Shah Vishank Arun, Shapiro-Rosenbaubm Amy, Shapshak Angela, Sharma Kartavya, Sharma Kumar Ajay, Sharshar Tarek, Shutter Lori, Sitt Jacobo, Slomine Beth, Smetana Keaton, Smielewski Peter, Smith Wade, Stamatakis Emmanuel, Steinberg Alexis, Stevens Robert, Suarez Jose, Sung Gene, Sussman Bethany, Taran Shaurya, Mazzeo Anna Teresa, Thibaut Aurore, Thompson David, Threlkeld Zachary, Tinti Lorenzo, Toker Daniel, Torbey Michel, Tosto Jenna, Trevick Stephen, Tsaousi Georgia, Turgeon Alexis, Udy Andrew, Varelas Panos, Vespa Paul, Videtta Walter, Voss Henning, Vox Ford, Wagner Amy, Wahlster Sarah, Wainwright Mark, Whyte John, Witherspoon Briana, Yakhkind Aleksandra (Sasha), Yeager Susan, Young Michael, Zafar Sahar, Zafonte Ross, Zahuranec Darin, Zammit Chris, Zhang Bei, Ziai Wendy, Zimmerman Lara, Zink Elizabeth
Affiliation:
1. Department of Neuroscience, Istituto di Ricerche Farmacologiche Mario Negri IRCCS , Milan 20156 , Italy 2. Critical Care, The Ohio State University Wexner Medical Center , Columbus, OH 43210 , USA 3. Biomedical Engineering Department, School of Biomedical Engineering and Imaging Sciences, King’s College London , London SE1 7EU , UK 4. Department of Neurology, Rigshospitalet, Copenhagen University Hospital , Copenhagen 2100 , Denmark 5. Department of Clinical Medicine, University of Copenhagen , Copenhagen 2200 , Denmark 6. Department of Neurology, Neuro-Intensive Care Unit, Medical University of Innsbruck , Innsbruck 6020 , Austria 7. Neuro-Intensive Care Medicine, Anaesthesiology and ICU Department, GHU-Psychiatry and Neurosciences, Pole Neuro, Sainte-Anne Hospital, Institute of Psychiatry and Neurosciences of Paris, INSERM U1266, Université Paris Cité , Paris 75006 , France 8. Department of Neurology, Harvard Medical School, Massachusetts General Hospital , Boston, MA 02114 , USA 9. Department of Physical Medicine and Rehabilitation, Harvard Medical School, Spaulding Rehabilitation Hospital , Charlestown, MA 02129 , USA 10. Department of Neurology, New York Medical College , Valhalla, NY 10595 , USA 11. Department of Neurosurgery, New York Medical College , Valhalla, NY 10595 , USA 12. Department of Neurology and Anesthesiology/Critical Care Medicine, Johns Hopkins University School of Medicine , Baltimore, MD 21205 , USA 13. Division of Vascular Neurology and Neurocritical Care, Baylor College of Medicine and CHI Baylor St Luke’s Medical Center , Houston, TX 77030 , USA 14. Department of Neurology, David Geffen School of Medicine at UCLA , Los Angeles, CA 90095 , USA 15. Department of Neurosurgery, David Geffen School of Medicine at UCLA , Los Angeles, CA 90095 , USA 16. Division of Anaesthesia, University of Cambridge , Cambridge CB2 1TN , UK 17. NeuroIntensive Care, IRCSS Fondazione San Gerardo dei Tintori , Monza 20900 , Italy 18. School of Medicine and Surgery, Università Milano Bicocca , Milan 20854 , Italy 19. Department of Neurology, Johannes Kepler University , Linz 4040 , Austria 20. College of Nursing, The Ohio State University , Columbus, OH 43210 , USA
Abstract
Abstract
Disorders of consciousness are neurological conditions characterized by impaired arousal and awareness of self and environment. Behavioural responses are absent or are present but fluctuate. Disorders of consciousness are commonly encountered as a consequence of both acute and chronic brain injuries, yet reliable epidemiological estimates would require inclusive, operational definitions of the concept, as well as wider knowledge dissemination among involved professionals. Whereas several manifestations have been described, including coma, vegetative state/unresponsive wakefulness syndrome and minimally conscious state, a comprehensive neurobiological definition for disorders of consciousness is still lacking. The scientific literature is primarily observational, and studies-specific aetiologies lead to disorders of consciousness. Despite advances in these disease-related forms, there remains uncertainty about whether disorders of consciousness are a disease-agnostic unitary entity with a common mechanism, prognosis or treatment response paradigm. Our knowledge of disorders of consciousness has also been hampered by heterogeneity of study designs, variables, and outcomes, leading to results that are not comparable for evidence synthesis. The different backgrounds of professionals caring for patients with disorders of consciousness and the different goals at different stages of care could partly explain this variability. The Prospective Studies working group of the Neurocritical Care Society Curing Coma Campaign was established to create a platform for observational studies and future clinical trials on disorders of consciousness and coma across the continuum of care. In this narrative review, the author panel presents limitations of prior observational clinical research and outlines practical considerations for future investigations. A narrative review format was selected to ensure that the full breadth of study design considerations could be addressed and to facilitate a future consensus-based statement (e.g. via a modified Delphi) and series of recommendations. The panel convened weekly online meetings from October 2021 to December 2022. Research considerations addressed the nosographic status of disorders of consciousness, case ascertainment and verification, selection of dependent variables, choice of covariates and measurement and analysis of outcomes and covariates, aiming to promote more homogeneous designs and practices in future observational studies. The goal of this review is to inform a broad community of professionals with different backgrounds and clinical interests to address the methodological challenges imposed by the transition of care from acute to chronic stages and to streamline data gathering for patients with disorders of consciousness. A coordinated effort will be a key to allow reliable observational data synthesis and epidemiological estimates and ultimately inform condition-modifying clinical trials.
Funder
National Institutes of Health—National Institute of Neurological Disorders and Stroke National Institute on Disability Independent Living and Rehabilitation Research NIDILRR Administration for Community Living
Publisher
Oxford University Press (OUP)
Cited by
1 articles.
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