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

NCT ID: NCT03126929

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 169 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2017-03-31

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

Conditions

Minimally Conscious State; Vegetative State

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Vegetative state

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

Coma Recovery Scale-Revised and Glasgow Coma Scale

Intervention Type: DIAGNOSTIC_TEST

Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Minimally conscious state

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

Coma Recovery Scale-Revised and Glasgow Coma Scale

Intervention Type: DIAGNOSTIC_TEST

Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Emergence from MCS

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

Coma Recovery Scale-Revised and Glasgow Coma Scale

Intervention Type: DIAGNOSTIC_TEST

Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Interventions

Coma Recovery Scale-Revised and Glasgow Coma Scale

Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 86 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hangzhou Normal University

OTHER

Sponsor Role: lead

Responsible Party

Ying Zhang

nurse-in-charge

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

2012/026/B

Identifier Type: -

Identifier Source: org_study_id