Outcomes Registration of Early Intensive Neurorehabilitation in Patients With Disorders of Consciousness: Study Protocol of a Prospective Cohort Study.
Driessen, D.M.F., Utens, C.M.A., Ribbers, G.M., van Erp, W.S. & Heijenbrok-Kal, M.H.
12 February 2021Abstract
Background
Long-term disorders of consciousness (PDOC) can occur after severe brain injury. Within PDOC, two diagnostic entities are distinguished: non-responsive waking syndrome (UWS, formerly known as vegetative state) and minimally conscious state (MCS). Patients with PDOC may benefit from early intensive neurorehabilitation (EIN). The EIN programme is provided in the Netherlands by one designated expert rehabilitation centre and is the starting point of a specific chain of specialised rehabilitation and care for this group. This study project, called DOCTOR: Disorders of Consciousness; Treatment and Outcomes Register, sets up a register and systematically sets up
examines multiple short- and long-term outcomes of patients with PDOC who receive EIN.
Methods
Single-center 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 the start of the EIN, in weeks 5, 10, and at discharge from the EIN program (duration = max 14 weeks) and in weeks 28, 40, 52 and 104 after inclusion in the EIN program, where patients are followed through the care chain. Outcome measures are the changes over time in the 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, behavioral and emotional functioning; participation; and quality of life. Secondary outcomes include the self-efficacy of caregivers, the burden on caregivers, and the cost-effectiveness of the program.
Discussion
The DOCTOR study will provide insight into the recovery patterns and predictors of recovery for multiple outcomes in PDOC patients after following EIN. The results of the study will allow us to benchmark and improve EIN and the organization of the care chain, both for patients with PDOC and for their families.
Keywords
Disorders of Consciousness, Brain Injury, Outcomes, Neurorehabilitation