Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NCT Number: NCT03549572
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Boston, Massachusetts, 02114, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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
Time frame: 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
Time frame: 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
Massachusetts General Hospital
Other
Validation and Feasibility of the Coma Recovery Scale-Revised for Accelerated Standardized Assessment (CRSR-FAST): a Brief, Standardized Assessment Instrument to Monitor Recovery of Consciousness in the Intensive Care Unit
Acronym: CRSR-FAST
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05536921
Brain Damage, Chronic, Brain Diseases
Częstochowa, Poland
View Trial DetailsNCT04921683
Anoxia, Brain, Brain Damage, Chronic
Pomona, California, United States
View Trial DetailsNCT04035655
Anoxic Brain Injury, Brain Diseases
Paris, France
View Trial DetailsNCT04442971
Brain Diseases, Brain Injuries
Hessisch Oldendorf, Germany
View Trial Details