Accurately determining the level of consciousness in patients with severe brain injury is essential for treatment planning, prognosis, and ethical decision-making. Clinically, levels of consciousness are differentiated into coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Conscious State (MCS) based on behavioral signs. Although behavioral assessment is considered the clinical gold standard, it is prone to misclassification. Research has shown that a substantial proportion of patients initially diagnosed with UWS may actually show signs of minimal consciousness, which is associated with better cognitive abilities and a more favorable prognosis.
The Coma Recovery Scale-Revised (CRS-R) is internationally recommended for diagnosing disorders of consciousness, but it is time-consuming and not free from diagnostic error. Repeated assessments can significantly improve diagnostic accuracy. To enhance feasibility in routine clinical practice, a shorter and more time-efficient assessment tool, the Simplified Evaluation of CONsciousness Disorders (SECONDs), was developed. This scale focuses on the behavioral signs most strongly associated with MCS and uses optimized testing procedures while maintaining high diagnostic accuracy.
The aim of this study is to further evaluate diagnostic approaches for assessing consciousness in patients with severe brain injury and to improve the reliability and clinical applicability of these assessments.
Admission to an intensive care unit (ICU) or intermediate/high-dependency care unit
Underlying etiology of brain injury: anoxic, traumatic, or vascular
Time since index event < 90 days
Early Rehabilitation Barthel Index (ERBI) score < 30 points
History of prior brain injury
Pre-existing major psychiatric disorder
Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)
Ongoing sedation at the time of assessment
The study population consists of adult patients with severe acquired brain injury admitted to a neurological early rehabilitation program. Eligible participants present with a disorder of consciousness in the subacute phase (within 90 days after the index event) and require intensive or monitored medical care. Underlying etiologies include anoxic, traumatic, or vascular brain injury. Patients are characterized by severe functional impairment, as reflected by a low Early Rehabilitation Barthel Index score at admission.
Cohort
Prospective
Simplified Evaluation of CONsciousness Disorders (SECONDs)
BehavioralThe Simplified Evaluation of CONsciousness Disorders (SECONDs) is a structured behavioral assessment tool designed for the rapid evaluation of patients with disorders of consciousness.
Coma Recovery Scale-Revised (CRS-R)
BehavioralThe Coma Recovery Scale-Revised (CRS-R) is a standardized behavioral assessment tool used to evaluate the level of consciousness in patients with severe brain injury. It consists of six subscales assessing auditory, visual, motor, oromotor/verbal, communication, and arousal functions.
Agreement Between the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) and the "Coma Recovery Scale-Revised" (CRS-R; Range: 0-23)
Categorical agreement in clinical classification of level of consciousness (Unresponsive Wakefulness Syndrome \[UWS\], Minimally Conscious State \[MCS\], Emerged from Minimally Conscious State \[eMCS\], No Disorder of Consciousness \[non-DoC\]) between the Simplified Evaluation of CONsciousness Disorders (SECONDs) and the Coma Recovery Scale-Revised (CRS-R).
Diagnostic Stability in Patients Initially Classified as UWS
Rate of diagnostic reclassification following repeated behavioral assessment on two consecutive days in patients initially diagnosed with Unresponsive Wakefulness Syndrome (UWS). Misdiagnosis rate is defined as the proportion of patients whose level of consciousness is reclassified into a different diagnostic category (e.g., from UWS to Minimally Conscious State \[MCS\]) upon repeat measurement.
Prognostic Validity of the "Simplified Evaluation of CONsciousness Disorders" (SECONDs; Range: 0-8) for Long-Term Functional Outcome
Predictive value of baseline classification using the Simplified Evaluation of CONsciousness Disorders (SECONDs; ; Range: 0-8) for functional outcome at 12 months after admission, as measured by the Glasgow Outcome Scale-Extended (GOSE; Range: 1-8).
Feasibility of the Simplified Evaluation of CONsciousness Disorders (SECONDs)
Assessment of clinical feasibility of SECONDs in a neurological rehabilitation setting, including test completion rate, administration time per assessment, and occurrence of premature test termination or technical/practical difficulties.
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