Outcome registry of early intensive neurorehabilitation in patients with disorders of consciousness: study protocol of a prospective cohort study

Danielle M. F. Driessen; Cecile M. A. Utens; Gerard M. Ribbers; Willemijn S. van Erp; Majanka H. Heijenbrok-Kal

doi:10.1186/s12883-021-02099-7

Outcome registry of early intensive neurorehabilitation in patients with disorders of consciousness: study protocol of a prospective cohort study

Danielle M. F. Driessen^*, Cecile M. A. Utens, Gerard M. Ribbers, Willemijn S. van Erp, Majanka H. Heijenbrok-Kal

^*Corresponding author for this work

Rehabilitation Medicine

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Background: Prolonged disorders of consciousness (PDOC) may occur after severe brain injury. Two diagnostic entities are distinguished within PDOC: unresponsive wakefulness syndrome (UWS, previously known as vegetative state) and minimally conscious state (MCS). Patients with PDOC may benefit from early intensive neurorehabilitation (EIN). In the Netherlands, the EIN programme is provided by one designated expert rehabilitation centre and forms the starting point of a dedicated chain of specialised rehabilitation and care for this group. This study project, called DOCTOR: Disorders of Consciousness; Treatment and Outcomes Registry, sets up a registry and systematically investigates multiple short- and long-term outcomes of patients with PDOC who receive EIN.Methods: Single-centre prospective cohort study with a 2-year follow-up period. Patients with PDOC due to acute brain injury who receive EIN, aged 16 years and older are included. Measurements will take place at start EIN, in week 5, 10, and at discharge from the EIN programme (duration = max 14 weeks) and at week 28, 40, 52, and 104 after admission to the EIN programme, following patients through the health-care chain. Outcome measures are the changes over time in level of consciousness, using the Coma Recovery Scale-Revised; the frequency and type of medical complications; the mortality rate; level of disability, including the level of motor, cognitive, behavioural and emotional functioning; participation; and quality of life. Secondary outcomes include self-efficacy of caregivers, caregivers' strain and cost-effectiveness of the programme.Discussion: The DOCTOR study will provide insight in the recovery patterns and predictors of recovery for multiple outcomes in PDOC patients after following EIN. The results of the study will enable us to benchmark and improve EIN and the organisation of the health-care chain, both for patients with PDOC and for their families.Trial registration: Netherlands Trial Register, NL 8138. Retrospectively registered 6 November 2019.

Original language	English
Article number	69
Number of pages	10
Journal	BMC Neurology
Volume	21
Issue number	1
DOIs	https://doi.org/10.1186/s12883-021-02099-7
Publication status	Published - 12 Feb 2021

Bibliographical note

Funding:
The study is funded by the Dutch Brain Foundation (DR-2019-00334). The
Dutch Brain Foundation had no role in the design of the study and in
writing the manuscript. The Dutch Brain Foundation provided peer-review
for the manuscript.

Publisher Copyright:
© 2021, The Author(s).

Research programs

EMC OR-01

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Cite this

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title = "Outcome registry of early intensive neurorehabilitation in patients with disorders of consciousness: study protocol of a prospective cohort study",

abstract = "Background: Prolonged disorders of consciousness (PDOC) may occur after severe brain injury. Two diagnostic entities are distinguished within PDOC: unresponsive wakefulness syndrome (UWS, previously known as vegetative state) and minimally conscious state (MCS). Patients with PDOC may benefit from early intensive neurorehabilitation (EIN). In the Netherlands, the EIN programme is provided by one designated expert rehabilitation centre and forms the starting point of a dedicated chain of specialised rehabilitation and care for this group. This study project, called DOCTOR: Disorders of Consciousness; Treatment and Outcomes Registry, sets up a registry and systematically investigates multiple short- and long-term outcomes of patients with PDOC who receive EIN.Methods: Single-centre prospective cohort study with a 2-year follow-up period. Patients with PDOC due to acute brain injury who receive EIN, aged 16 years and older are included. Measurements will take place at start EIN, in week 5, 10, and at discharge from the EIN programme (duration = max 14 weeks) and at week 28, 40, 52, and 104 after admission to the EIN programme, following patients through the health-care chain. Outcome measures are the changes over time in level of consciousness, using the Coma Recovery Scale-Revised; the frequency and type of medical complications; the mortality rate; level of disability, including the level of motor, cognitive, behavioural and emotional functioning; participation; and quality of life. Secondary outcomes include self-efficacy of caregivers, caregivers' strain and cost-effectiveness of the programme.Discussion: The DOCTOR study will provide insight in the recovery patterns and predictors of recovery for multiple outcomes in PDOC patients after following EIN. The results of the study will enable us to benchmark and improve EIN and the organisation of the health-care chain, both for patients with PDOC and for their families.Trial registration: Netherlands Trial Register, NL 8138. Retrospectively registered 6 November 2019.",

author = "Driessen, {Danielle M. F.} and Utens, {Cecile M. A.} and Ribbers, {Gerard M.} and {van Erp}, {Willemijn S.} and Heijenbrok-Kal, {Majanka H.}",

note = "Funding: The study is funded by the Dutch Brain Foundation (DR-2019-00334). The Dutch Brain Foundation had no role in the design of the study and in writing the manuscript. The Dutch Brain Foundation provided peer-review for the manuscript. Publisher Copyright: {\textcopyright} 2021, The Author(s).",

year = "2021",

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doi = "10.1186/s12883-021-02099-7",

language = "English",

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T1 - Outcome registry of early intensive neurorehabilitation in patients with disorders of consciousness

T2 - study protocol of a prospective cohort study

AU - Driessen, Danielle M. F.

AU - Utens, Cecile M. A.

AU - Ribbers, Gerard M.

AU - van Erp, Willemijn S.

AU - Heijenbrok-Kal, Majanka H.

N1 - Funding: The study is funded by the Dutch Brain Foundation (DR-2019-00334). The Dutch Brain Foundation had no role in the design of the study and in writing the manuscript. The Dutch Brain Foundation provided peer-review for the manuscript. Publisher Copyright: © 2021, The Author(s).

PY - 2021/2/12

Y1 - 2021/2/12

N2 - Background: Prolonged disorders of consciousness (PDOC) may occur after severe brain injury. Two diagnostic entities are distinguished within PDOC: unresponsive wakefulness syndrome (UWS, previously known as vegetative state) and minimally conscious state (MCS). Patients with PDOC may benefit from early intensive neurorehabilitation (EIN). In the Netherlands, the EIN programme is provided by one designated expert rehabilitation centre and forms the starting point of a dedicated chain of specialised rehabilitation and care for this group. This study project, called DOCTOR: Disorders of Consciousness; Treatment and Outcomes Registry, sets up a registry and systematically investigates multiple short- and long-term outcomes of patients with PDOC who receive EIN.Methods: Single-centre prospective cohort study with a 2-year follow-up period. Patients with PDOC due to acute brain injury who receive EIN, aged 16 years and older are included. Measurements will take place at start EIN, in week 5, 10, and at discharge from the EIN programme (duration = max 14 weeks) and at week 28, 40, 52, and 104 after admission to the EIN programme, following patients through the health-care chain. Outcome measures are the changes over time in level of consciousness, using the Coma Recovery Scale-Revised; the frequency and type of medical complications; the mortality rate; level of disability, including the level of motor, cognitive, behavioural and emotional functioning; participation; and quality of life. Secondary outcomes include self-efficacy of caregivers, caregivers' strain and cost-effectiveness of the programme.Discussion: The DOCTOR study will provide insight in the recovery patterns and predictors of recovery for multiple outcomes in PDOC patients after following EIN. The results of the study will enable us to benchmark and improve EIN and the organisation of the health-care chain, both for patients with PDOC and for their families.Trial registration: Netherlands Trial Register, NL 8138. Retrospectively registered 6 November 2019.

AB - Background: Prolonged disorders of consciousness (PDOC) may occur after severe brain injury. Two diagnostic entities are distinguished within PDOC: unresponsive wakefulness syndrome (UWS, previously known as vegetative state) and minimally conscious state (MCS). Patients with PDOC may benefit from early intensive neurorehabilitation (EIN). In the Netherlands, the EIN programme is provided by one designated expert rehabilitation centre and forms the starting point of a dedicated chain of specialised rehabilitation and care for this group. This study project, called DOCTOR: Disorders of Consciousness; Treatment and Outcomes Registry, sets up a registry and systematically investigates multiple short- and long-term outcomes of patients with PDOC who receive EIN.Methods: Single-centre prospective cohort study with a 2-year follow-up period. Patients with PDOC due to acute brain injury who receive EIN, aged 16 years and older are included. Measurements will take place at start EIN, in week 5, 10, and at discharge from the EIN programme (duration = max 14 weeks) and at week 28, 40, 52, and 104 after admission to the EIN programme, following patients through the health-care chain. Outcome measures are the changes over time in level of consciousness, using the Coma Recovery Scale-Revised; the frequency and type of medical complications; the mortality rate; level of disability, including the level of motor, cognitive, behavioural and emotional functioning; participation; and quality of life. Secondary outcomes include self-efficacy of caregivers, caregivers' strain and cost-effectiveness of the programme.Discussion: The DOCTOR study will provide insight in the recovery patterns and predictors of recovery for multiple outcomes in PDOC patients after following EIN. The results of the study will enable us to benchmark and improve EIN and the organisation of the health-care chain, both for patients with PDOC and for their families.Trial registration: Netherlands Trial Register, NL 8138. Retrospectively registered 6 November 2019.

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DO - 10.1186/s12883-021-02099-7

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JO - BMC Neurology

JF - BMC Neurology

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ER -

Outcome registry of early intensive neurorehabilitation in patients with disorders of consciousness: study protocol of a prospective cohort study

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