Validation of the Chinese Version of the SECONDs

Study Overview
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Brief Summary
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The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version

Detailed Description
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The assessment is of great importance for the management and treatment in patients with disorders of consciousness. The Simplified Evaluation of CONsciousness Disorders is a useful tool to assess consciousness of DOC patients in bedside. The aim of this study was to translate the SECONDs from English into Chinese and determine the validity of this Chinese version. To test internal reliability and inter-rater reliability, both rater A and rater B assess the perception of pain on day 1; and to obtain test-retest reliability, rater A assessed all patients repeatedly on day 2.

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

Conditions
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Minimally Conscious State, Vegetative State

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: age ≥ 16 years old; no administration of neuromuscular blockers or sedation within the 24 hours of enrolment; the presence of periods of eye opening (indicating wakefulness and rest cycles); a diagnosis of VS or MCS, based on more than 4 times behavioral assessment performed using the Coma Recovery Scale-Revised within 2 weeks. Exclusion Criteria: Coma; documented history of prior brain injury; psychiatric or neurologic illness; 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; upper limb contusions, fractures (based on the imaging examination) or flaccid paralysis (by using noxious stimuli to upper limbs, motor sub-scale scores <1).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The order of the administration was randomly selected. All patients' total scores assessed by rater A were recorded to test the internal consistency of SECONDs (A1). Meanwhile, to assess the concurrent validity, the scores of the CRS-R were recorded together with SECONDs by rater A on day 1. In order to analyze the test-retest reliability, rater A complete the second evaluation of SECONDs on day 2 (A2).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with vegetative state<br>Patients with vegetative state were assessed by the SECONDs and CRS-R for two days. | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>* All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>|
| Experimental: Patients with minimally conscious state<br>Patients with minimally conscious state were assessed by the SECONDs and CRS-R for two days. | Diagnostic Test: Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>* All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of consciousness in DOC patients | All patients were classified as the MCS and VS by the Coma recovery scale-revised | Within 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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disorders of consciousness, vegetative state, minimally conscious state, consciousness