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临床试验/NCT03126929
NCT03126929已完成不适用

Further Psychometric Data for the Reliability and the Diagnostic Validity of the Coma Recovery Scale-Revised

Hangzhou Normal University0 个研究点目标入组 169 人开始时间: 2012年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
169
主要终点
Coma Recovery Scale-Revised for assess the level of consciousness

研究概览

简要总结

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).

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 86 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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

结局指标

主要结局

Coma Recovery Scale-Revised for assess the level of consciousness

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Hangzhou Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ying Zhang

nurse-in-charge

Hangzhou Normal University

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