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Validity and Feasibility of the CRSR-FAST

Completed
Conditions
Traumatic Brain Injury
Disorder of Consciousness
Interventions
Behavioral: Coma Recovery Scale-Revised
Registration Number
NCT03549572
Lead Sponsor
Massachusetts General Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
56
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Severe Traumatic Brain InjuryComa Recovery Scale-RevisedWe 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.
Primary Outcome Measures
NameTimeMethod
Diagnostic Agreement48 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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Massachusetts General Hospital

🇺🇸

Boston, Massachusetts, United States

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