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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 .
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients in coma | Experimental | Patients in coma were assessed by the SECONDs and CRS-R for five days. |
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| Patients in unresponsive wakefulness syndrome | Experimental | Patients in unresponsive wakefulness syndrome were assessed by the SECONDs and CRS-R for five days. |
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| Patients in minimally conscious state | Experimental | Patients in minimally conscious state were assessed by the SECONDs and CRS-R for five days. |
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| Patients in emerge from the minimally conscious state | Experimental | Patients in emerge from the minimally conscious state were assessed by the SECONDs and CRS-R for five days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplified Evaluation of CONsciousness Disorders (SECONDs) | Diagnostic Test | All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs) and Coma Recovery Scale-Revised (CRS-R) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haibo Di | International Vegetative State and Consciousness Science Institute,Hangzhou Normal University | Study Director |
| Anqi Wang | International Vegetative State and Consciousness Science Institute,Hangzhou Normal University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Vegetative State and Consciousness Science Institute, Hangzhou Normal University | Hangzhou | Zhejiang | China |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D018458 | Persistent Vegetative State |
| D014474 | Unconsciousness |
| D002493 | Central Nervous System Diseases |
| D003128 | Coma |
| D003244 | Consciousness Disorders |
| D004194 | Disease |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D001925 | Brain Damage, Chronic |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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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.
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Until the end of the protocol, all three assessors were blinded to the scores acquired by the other assessors.
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |