Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）

Study Overview
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Brief Summary
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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
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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

Official Title
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Chinese Validation of the Simplified Evaluation of CONsciousness Disorders（SECONDs）

Conditions
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Brain Diseases, Vegetative State, Unconsciousness, Central Nervous System Diseases

Intervention / Treatment
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* Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)


Participation Criteria
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Eligibility Criteria
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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: None

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each patient was assessed by three distinct assessors who were experienced and trained to use the CRS-R. All assessments were completed within two weeks (i.e., five CRS-R to obtain a reliable diagnosis [17], and 7 SECONDs performed by 3 different assessors in the 2 weeks) in five different sessions. Session 1 included one evaluation with the CRS-R performed by one assessor (i.e., concurrent validity) and three evaluations with the SECONDs performed by two assessors (i.e., intra-rater reliability and inter-rater reliability). The other sessions (2 to 5) each included one evaluation with the SECONDs and one evaluation with the CRS-R (i.e., concurrent validity) performed by two assessors. Each SECONDs was performed alternatively either before or after the CRS-R assessment. To avoid fatigue effects and reduce the impact of within-day fluctuations of vigilance, a break of 30 to 80 min between each assessment was taken.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients in coma<br>Patients in coma were assessed by the SECONDs and CRS-R for five days. | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>* All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)<br>|
| Experimental: Patients in unresponsive wakefulness syndrome<br>Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days. | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>* All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)<br>|
| Experimental: Patients in minimally conscious state<br>Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days. | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>* All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)<br>|
| Experimental: Patients in emerge from the minimally conscious state<br>Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days. | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>* All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the reliability and validity of the Chinese version of the SECONDs | 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 | Within 10 days | 
| Diagnose the level of consciousness in patients through SECONDs and CRS-R | 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). | Within 10 days | 
| Diagnose the level of consciousness in patients through CRS-R | 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). | Within 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coma, disorder of consciousness, behavioral scale, rehabilitation, diagnosis