Research considerations for prospective studies of patients with coma and disorders of consciousness

the Curing Coma Campaign collaborators

doi:10.1093/braincomms/fcae022

Research considerations for prospective studies of patients with coma and disorders of consciousness

the Curing Coma Campaign collaborators

Biomedical Engineering Department

Research output: Contribution to journal › Review article › peer-review

1 Citation (Scopus)

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.

Original language	English
Article number	fcae022
Journal	Brain Communications
Volume	6
Issue number	1
DOIs	https://doi.org/10.1093/braincomms/fcae022
Publication status	Published - 2024

Keywords

coma
design
disorders of consciousness
outcomes
prospective studies

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/braincomms/fcae022

Cite this

@article{169adbe7f905432da8fcb7689f6f1d4d,

title = "Research considerations for prospective studies of patients with coma and disorders of consciousness",

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.",

keywords = "coma, design, disorders of consciousness, outcomes, prospective studies",

author = "{the Curing Coma Campaign collaborators} and Lorenzo Tinti and Thomas Lawson and Erika Molteni and Daniel Kondziella and Verena Rass and Tarek Sharshar and Bodien, {Yelena G.} and Giacino, {Joseph T.} and Mayer, {Stephan A.} and Moshgan Amiri and Susanne Muehlschlegel and {Venkatasubba Rao}, {Chethan P.} and Vespa, {Paul M.} and Menon, {David K.} and Giuseppe Citerio and Raimund Helbok and Molly McNett",

note = "Funding Information: Y.G.B. receives funding from National Institutes of Health—National Institute of Neurological Disorders and Stroke (U01 NS1365885 and U01-NS086090), National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR), and Administration for Community Living (90DPTB0027 and 90DP0039). Publisher Copyright: {\textcopyright} The Author(s) 2024. Published by Oxford University Press on behalf of the Guarantors of Brain.",

year = "2024",

doi = "10.1093/braincomms/fcae022",

language = "English",

volume = "6",

journal = "Brain Communications",

issn = "2632-1297",

publisher = "Oxford University Press",

number = "1",

}

TY - JOUR

T1 - Research considerations for prospective studies of patients with coma and disorders of consciousness

AU - the Curing Coma Campaign collaborators

AU - Tinti, Lorenzo

AU - Lawson, Thomas

AU - Molteni, Erika

AU - Kondziella, Daniel

AU - Rass, Verena

AU - Sharshar, Tarek

AU - Bodien, Yelena G.

AU - Giacino, Joseph T.

AU - Mayer, Stephan A.

AU - Amiri, Moshgan

AU - Muehlschlegel, Susanne

AU - Venkatasubba Rao, Chethan P.

AU - Vespa, Paul M.

AU - Menon, David K.

AU - Citerio, Giuseppe

AU - Helbok, Raimund

AU - McNett, Molly

N1 - Funding Information: Y.G.B. receives funding from National Institutes of Health—National Institute of Neurological Disorders and Stroke (U01 NS1365885 and U01-NS086090), National Institute on Disability, Independent Living and Rehabilitation Research (NIDILRR), and Administration for Community Living (90DPTB0027 and 90DP0039). Publisher Copyright: © The Author(s) 2024. Published by Oxford University Press on behalf of the Guarantors of Brain.

PY - 2024

Y1 - 2024

N2 - 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.

AB - 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.

KW - coma

KW - design

KW - disorders of consciousness

KW - outcomes

KW - prospective studies

UR - http://www.scopus.com/inward/record.url?scp=85184828791&partnerID=8YFLogxK

U2 - 10.1093/braincomms/fcae022

DO - 10.1093/braincomms/fcae022

M3 - Review article

AN - SCOPUS:85184828791

SN - 2632-1297

VL - 6

JO - Brain Communications

JF - Brain Communications

IS - 1

M1 - fcae022

ER -

Research considerations for prospective studies of patients with coma and disorders of consciousness

Abstract

Keywords

UN SDGs

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