Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R

Completed

• Conditions: Vegetative State; Minimally Conscious State
• Interventions: Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

• Registration Number: NCT03126929
• Lead Sponsor: Hangzhou Normal University

Brief Summary

This study aims to provide, in a large sample, further psychometric data as regards the internal consistency, the test-retest reliability and the diagnostic validity of the Coma Recovery Scale-Revised (CRS-R).

Detailed Description

Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a systematic review of behavioral assessment scales for DOC has indicated that, when compared to other scales, the CRS-R meets the highest psychometric standards for the evaluation of severely brain-injured patients and may be used to assess DOC with minor reservations. However, that report mentions few evidences or studies with small sample sizes for some aspects of its reliability and validity such as its internal consistency and its test-retest reliability.The report also states that the diagnostic validity of the CRS-R remains unproven. In this study, the investigators will therefore aim to provide further psychometric data as regards those variables in a large sample of patients with DOC

Study Timeline

• Study Start: 2012-03
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2017-04
• Study First Submitted: 2017-04-17
• Study First Submitted QC: 2017-04-21
• Last Update Submitted: 2017-04-21
• Study First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• age above 18 years old
• any etiology
• pre-screening performed by the referent physician comforting the presence of a disorder of consciousness in accordance with international diagnostic criteria for VS, MCS or emergence from MCS (EMCS)

Exclusion Criteria

• neuromuscular blocking agents or sedative drugs administered within the prior 24 hours
• no documented history of a prior coma
• critical illness or unstable medical condition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimally conscious state	Coma Recovery Scale-Revised and Glasgow Coma Scale	Patients display inconsistent, but reproducible and discernible signs of awareness using CRS-R and GCS
Vegetative state	Coma Recovery Scale-Revised and Glasgow Coma Scale	patients lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R and GCS
Emergence from MCS	Coma Recovery Scale-Revised and Glasgow Coma Scale	Patients regain accurate communication and/or functional use of objects using CRS-R and GCS

Primary Outcome Measures

Name	Time	Method
Coma Recovery Scale-Revised for assess the level of consciousness	24 hours(1 day)	Rater Measured the score of Coma Recovery Scale-Revised(CRS-R) within 24h. The CRS-R consists of 23 items grouped in six subscales addressing auditory, visual, motor, oromotor, communication and arousal functions. The lowest item on each subscale represents reflexive activity while the highest items represent cognitively-mediated behaviors.