Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Assess the reliability and validity of the Chinese version of the SECONDs
Study Overview
Brief Summary
The aim of this study was to translate the SECONDs from French into Chinese and assess the validity and reliability of the Chinese version of the SECONDs .
Detailed Description
To promote accurate assessments of DoC patients and the development of clinical research on DoC in China, we here propose and validate a version of the SECONDs translated into Mandarin Chinese. Hence, this study aims to assess the concurrent validity (compared with the CRS-R which has already been translated and validated in Mandarin), intra-rater reliability, and inter-rater reliability of the Chinese version of the SECONDs
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Masking Description
Until the end of the protocol, all three assessors were blinded to the scores acquired by the other assessors.
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days);
- •Age: 18-85 years old;
- •No history of other neurological or psychiatric deficits;
- •Ability to speak Chinese fluently;
- •Medical stability (e.g., absence of mechanical ventilation, sedation, infection)
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Assess the reliability and validity of the Chinese version of the SECONDs
Time Frame: Within 10 days
The reliability and validity of the Chinese version of the SECONDs were evaluated by calculating the weighted Cohen's Kappa and Spearman coefficients of the differences between SECONDs and CRS-R in the diagnosis of MCS and UWS patients
Diagnose the level of consciousness in patients through SECONDs and CRS-R
Time Frame: Within 10 days
Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Simplified Evaluation of CONsciousness Disorders (SECONDs).
Diagnose the level of consciousness in patients through CRS-R
Time Frame: Within 10 days
Detect acute (longer than 14 days, less than 28 days) or prolonged DoC (following severe acquired brain injury, longer than 28 days) patients through Coma Recovery Scale-Revised (CRS-R).
Secondary Outcomes
No secondary outcomes reported
Investigators
Haibo Di
professor
Hangzhou Normal University