Validity and Feasibility of the CRSR-FAST

NCT03549572 | Completed Results

• 1 other identifier: 2015P000147
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Disorder of Consciousness; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• 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

  48 hours

Other Outcomes (2)

• CRSR-FAST Test-Retest Reliability

  48 hours

• CRSR-FAST Interrater Reliability

  48 hours

Study Arms (1)

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.

Behavioral: Coma Recovery Scale-Revised

Interventions

Coma Recovery Scale-Revised BEHAVIORAL

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.

Severe Traumatic Brain Injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll adults with a impaired level of consciousness resulting from severe traumatic brain injury who are recovering in the intensive care unit.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Giacino JT, Kalmar K, Whyte J. The JFK Coma Recovery Scale-Revised: measurement characteristics and diagnostic utility. Arch Phys Med Rehabil. 2004 Dec;85(12):2020-9. doi: 10.1016/j.apmr.2004.02.033.

  PMID: 15605342 BACKGROUND

MeSH Terms

Conditions

Consciousness Disorders; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Limitations and Caveats

The full-length CRS-R was administered only one time while the CRSR-FAST was administered 3 times. Fluctuations in level of consciousness over 48 hours may have affected the full-length CRS-R assessment.

Results Point of Contact

• Title: Yelena Bodien
• Organization: Spaulding Rehabilitation Hospital

ybodien@mgh.harvard.edu

(617) 643-3956

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: August 28, 2018
• Primary Completion: December 4, 2022
• Study Completion: December 4, 2022
• Last Updated: October 26, 2024
• Results First Posted: October 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)