Rationale and design of the prospective German registry of outcome in patients with severe disorders of consciousness after acute brain injury

Abstract

Objective: To describe the rationale and design of a new patient registry (Koma Outcome von Patienten der Frührehabilitation-Register [KOPF-R; Registry for Coma Outcome in Patients Undergoing Acute Rehabilitation]) that has the scope to examine determinants of long-term outcome and functioning of patients with severe disorders of consciousness (DOC).

Design: Prospective multicenter neurologic rehabilitation registry.

Setting: Five specialized neurologic rehabilitation facilities.

Participants: Patients (N=42) with DOC in vegetative state or minimally conscious state (MCS) as defined by the Coma Recovery Scale-Revised (CRS-R) after brain injury. Patients are being continuously enrolled. The data presented here cover the enrollment period from August 2011 to January 2012.

Interventions: Not applicable.

Main outcome measures: CRS-R, FIM, and emergence from MCS.

Results: The registry was set up in 5 facilities across the state of Bavaria/Germany with a special expertise in the rehabilitation of acquired brain injury. Inclusion of patients started in August 2011. Measures include sociodemographic and clinical characteristics, course of acute therapy, electrophysiologic measures (evoked potentials, electroencephalogram), neuron-specific enolase, current medication, functioning, cognition, participation, quality of life, quantity and characteristics of rehabilitation therapy, caregiver burden, and attitudes toward end-of-life decisions. Main diagnoses were traumatic brain injury (24%), intracerebral or subarachnoid hemorrhage (31%), and anoxic-ischemic encephalopathy (45%). Mean CRS-R score ± SD at admission to rehabilitation was 5.9 ± 3.3, and mean FIM score ± SD at admission was 18 ± 0.4.

Conclusions: The KOPF-R aspires to contribute prospective data on prognosis in severe DOC.

Keywords: AIE; Anoxia; Brain injuries; CI; CRS-R; Coma Recovery Scale–Revised; DOC; Disability evaluation; EEG; ICU; KOPF-R; Koma Outcome von Patienten der Frührehabilitation– Register [Registry for Coma Outcome in Patients Undergoing Acute Rehabilitation]; LST; MCS; NSE; NTBI; Persistent vegetative state; QOL; Registries; Rehabilitation; SAH; SEPs; TBI; VS; anoxic-ischemic encephalopathy; confidence interval; disorders of consciousness; electroencephalogram; intensive care unit; life-sustaining therapy; minimally conscious state; neuron-specific enolase; nontraumatic brain injury; quality of life; somatosensory evoked potentials; subarachnoid hemorrhage; traumatic brain injury; vegetative state.