Trial Outcomes & Findings for Validity and Feasibility of the CRSR-FAST (NCT NCT03549572)

Last Updated: 2024-10-26

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

56 participants

Primary outcome timeframe

48 hours

Results posted on

2024-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	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 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.
Overall Study STARTED	56
Overall Study COMPLETED	45
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validity and Feasibility of the CRSR-FAST

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Severe Traumatic Brain Injury n=45 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Age, Continuous	44 years STANDARD_DEVIATION 20 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	40 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Outcome measures

Outcome measures
Measure	Severe Traumatic Brain Injury n=45 Participants 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 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.
Diagnostic Agreement	.68 Simple Kappa (SE)

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Severe Traumatic Brain Injury n=45 Participants 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 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.
CRSR-FAST Test-Retest Reliability	0.76 Mak's ρ

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Severe Traumatic Brain Injury n=45 Participants 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 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.
CRSR-FAST Interrater Reliability	0.91 Mak's ρ

Adverse Events

Severe Traumatic Brain Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Yelena Bodien

Spaulding Rehabilitation Hospital

Phone: (617) 643-3956

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place