Disorder of Consciousness, Traumatic Brain Injury
Conditions
Brief summary
The CRS-R is a standardized and validated bedside assessment of conscious awareness. It is used routinely for diagnosis and prognosis of patients with disorders of consciousness (DOC) as well as in research settings. One limitation of the CRS-R is the lengthy administration time required to obtain a total score. Administration time can vary from approximately 15-30 minutes, depending on the patient's level of responsiveness. For this reason, the CRS-R is rarely administered in the acute hospital setting. Less time-consuming scales and metrics are used to assess conscious awareness in the acute hospital/ICU setting, but they lack specificity and sensitivity and have not been validated, increasing the potential for misdiagnosis. We have developed the CRSR-FAST and aim to test its validity, inter- and intra- rater reliability. We anticipate that, compared with the CRS-R, the CRSR-FAST will be less time-consuming to administer and score, but will maintain a high level of sensitivity to detecting signs of consciousness in severely brain injured patients.
Interventions
BEHAVIORALComa Recovery Scale-Revised
Patients will be assessed using the CRS-R and the CRSR-FAST. The CRS-R is a standardized neurobehavioral rating scale that consists of 23 items organized into six subscales that address arousal, auditory, visual, motor, oromotor/verbal, and communication systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors. Reliability and validity have been demonstrated in multiple studies. The CRSR-FAST consists of 10 items organized into 4 subscales that address arousal, visual, motor and verbal/oromotor systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors.
Sponsors
Massachusetts General Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Fluent in English * Surrogate available to provide informed consent * History of severe acquired brain injury * Sustained a traumatic brain injury (TBI, defined by damage to brain tissue caused by an external mechanical force), * Be within 3 weeks of injury * Have a total Glasgow Outcome Scale (GCS) score \<9 within the first 48 hours of injury, * Be unable to follow simple commands consistently at the time of enrollment
Exclusion criteria
* History of developmental, neurologic, or major psychiatric disorder resulting in ongoing functional disability up to the time of the current injury * Physician orders for comfort measures only
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Agreement | 48 hours | Diagnostic agreement between the Coma Recovery Scale-Revised (CRS-R) and the CRSR For Accelerated Standardized Testing (CRSR-FAST). The CRS-R is a standardized neurobehavioral rating scale used to monitor recovery of consciousness. Total scores on the CRS-R range from 0 to 23 with high scores generally indicating greater recovery. Six subscales on the CRS-R are summed to provide the total score: auditory function, visual function, motor function, oromotor/verbal function, communication and arousal. Evidence of specific behaviors on these subscales provides a diagnosis of vegetative state, minimally conscious state (MCS), or emerged from MCS. The CRSR-FAST is an abbreviated version of the CRS-R. We tested concurrent validity by comparing CRS-R and CRSR-FAST diagnostic ratings using the simple kappa coefficient; values close to 0 indicate no agreement and values close to 1 indicate almost perfect agreement. We established an a priori threshold of ≥ 0.60 to indicate substantial validity |
Other
| Measure | Time frame | Description |
|---|---|---|
| CRSR-FAST Test-Retest Reliability | 48 hours | CRSR-FAST test-retest reliability using Mak's ρ. The CRSR-FAST was administered twice by 2 blinded raters. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability |
| CRSR-FAST Interrater Reliability | 48 hours | CRSR-FAST interrupter reliability using Mak's ρ. The CRSR-FAST was administered twice by the same rater. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Severe Traumatic Brain Injury We will administer Coma Recovery Scale-Revised (CRS-R) and the Coma Recovery Scale Revised For Accelerated Standardized Testing (CRSR-FAST) to patients in the intensive care unit who have impaired level of consciousness resulting from a severe traumatic brain injury.
Coma Recovery Scale-Revised: Patients will be assessed using the CRS-R and the CRSR-FAST. The CRS-R is a standardized neurobehavioral rating scale that consists of 23 items organized into six subscales that address arousal, auditory, visual, motor, oromotor/verbal, and communication systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors. Reliability and validity have been demonstrated in multiple studies. The CRSR-FAST consists of 5 items that address visual, motor and verbal/oromotor systems. | 45 |
| Total | 45 |
Baseline characteristics
| Characteristic | Severe Traumatic Brain Injury |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 20 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 45 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 45 |
| other Total, other adverse events | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 |
Outcome results
Primary
Diagnostic Agreement
Diagnostic agreement between the Coma Recovery Scale-Revised (CRS-R) and the CRSR For Accelerated Standardized Testing (CRSR-FAST). The CRS-R is a standardized neurobehavioral rating scale used to monitor recovery of consciousness. Total scores on the CRS-R range from 0 to 23 with high scores generally indicating greater recovery. Six subscales on the CRS-R are summed to provide the total score: auditory function, visual function, motor function, oromotor/verbal function, communication and arousal. Evidence of specific behaviors on these subscales provides a diagnosis of vegetative state, minimally conscious state (MCS), or emerged from MCS. The CRSR-FAST is an abbreviated version of the CRS-R. We tested concurrent validity by comparing CRS-R and CRSR-FAST diagnostic ratings using the simple kappa coefficient; values close to 0 indicate no agreement and values close to 1 indicate almost perfect agreement. We established an a priori threshold of ≥ 0.60 to indicate substantial validity
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Severe Traumatic Brain Injury | Diagnostic Agreement | .68 Simple Kappa (SE) |
Other Pre-specified
CRSR-FAST Interrater Reliability
CRSR-FAST interrupter reliability using Mak's ρ. The CRSR-FAST was administered twice by the same rater. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Severe Traumatic Brain Injury | CRSR-FAST Interrater Reliability | 0.91 Mak's ρ |
Other Pre-specified
CRSR-FAST Test-Retest Reliability
CRSR-FAST test-retest reliability using Mak's ρ. The CRSR-FAST was administered twice by 2 blinded raters. Mak's ρ values close to 0 indicate no agreement and values close to 1 indicate almost perfect reliability. We established an a priori threshold of ≥ 0.60 to indicate substantial reliability
Time frame: 48 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Severe Traumatic Brain Injury | CRSR-FAST Test-Retest Reliability | 0.76 Mak's ρ |