N/A
N=56
Validity and Feasibility of the CRSR-FAST
Disorder of Consciousness · Traumatic Brain Injury
Bottom Line
View on ClinicalTrials.gov: NCT03549572 ↗Enrolled (actual)
56
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Diagnostic Agreement — .68 Simple Kappa (SE)
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Coma Recovery Scale-Revised (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Diagnostic Agreement |
.68 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03549572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.