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

Hangzhou Normal University

Status: Completed

Conditions: Vegetative State; Minimally Conscious State

Treatments: Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

Study type: Observational

Funder types: Other

Identifiers

NCT03126929

2012/026/B

Details and patient eligibility

About

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).

Full 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

Enrollment: 169 patients

Sex: All

Ages: 18 to 86 years old

Volunteers: No Healthy Volunteers

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

Trial design

169 participants in 3 patient groups

Vegetative state

Description:

patients lack awareness of self and environment even in the presence for eye-opening and sleep-wake cycles using CRS-R and GCS

Treatment:

Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

Minimally conscious state

Description:

Patients display inconsistent, but reproducible and discernible signs of awareness using CRS-R and GCS

Treatment:

Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale

Emergence from MCS

Description:

Patients regain accurate communication and/or functional use of objects using CRS-R and GCS

Treatment:

Diagnostic Test: Coma Recovery Scale-Revised and Glasgow Coma Scale