A Research On The Validity And Reliability Of The Chinese Version Of The Full Outline Of UnResponsiveness Score

BackgroundWith the development of the country and people’s living standards improve, traffic accidents and cerebrovascular accidents and other incidents also increased significantly, the number of patients with brain injury is also a corresponding significant increase. At the same time, the rapid development of technology intensive care, emergency medicine and other medical technologies, many critically ill patients mortality decreased significantly. However, many patients from brain injury to recover consciousness, during this period, there will be different levels of disorder of consciousness. In clinical practice, health care workers accurately assess the patient’s consciousness is the key to treatment, but also challenges faced by the international medical community. Neuroimaging (MRI) and Electrophysiology (EEG, TMS) are assisted method used by medical staff when assessed the patient’s consciousness. However, based on the behavior of the behavioral scale testing is still taken as the "gold standard" of evaluate consciousness. Consciousness assessment scale is the most commonly consciousness assessment method in medical staff. It is helpful for the patients with objective and quantitative assessment of the state of consciousness, and guide clinical treatment.The Glasgow Coma Scale (GCS) has become a widely used tool to measure the patient’s level of consciousness (LOC) in China. But the GCS cannot properly assess verbal component in intubated patients, as well as lack of clinical parameters such as brainstem reflex, breathing rhythm and mechanical ventilation which reflect the consciousness level in unconscious patients.Meanwhile, research has doubted that the lack of correlation between GCS and the outcome of traumatic brain injury. Therefore, a new coma scaling system, the Full Outline of UnResponsiveness score was developed by Mayo Clinic in 2005.It was also recommended by the latest guidelines of the European Society of Intensive Care Medicine (ESICM). The Full Outline of UnResponsiveness score has already been translated into many languages such as Italian, French, Spanish and Turkish. The Full Outline of UnResponsiveness were reported in China, but did not reported the validity and reliability of the Chinese version of the Full Outline of UnResponsiveness score.Objective1 To translate the Full Outline of UnResponsiveness score into Chinese and evaluate its reliability and validity.2 To compare the reliability and validity of the Chinese version of the Full Outline of UnResponsiveness score and the Glasgow Coma Scale among neurosurgery patients in China.Methods1 Participants150 participants were recruited from neurosurgery intensive care unit at a three-level general hospital of Guang Zhou from July 2014 to March 2015. Inclusion criteria were adult patients^18 years old diagnosed with traumatic brain injury or cerebrovascular diseases which by CT examination. Exclusion criteria were: treatment with neuromuscular junction blockers or sedatives, terminally ill or current hemodynamic instability (systolic blood pressure [BP]<80 mmHg), patients or their families who did not sign the informed consent were excluded. Pregnant women or patients with alcohol or eye injury, eye edema, facial trauma, oculomot or nerve injury were also excluded.2 Method of conscious assessmentThis research was divided into two phases, the first stage to test the validity of the Chinese version of the FOUR score.After achieve the consent from the hospital and the department, we assessed the patients consciousness of neurosurgery intensive care unit who meet eligibility criteria. All patients or patients’families have been told informed consent, patients were assessed by researcher or other raters(neurosurgery doctor or nurse) to use the Chinese version of the FOUR score.5 minutes interval, one neurosurgery residency who had more than five years work experience use the GCS to evaluate the same patients. The second stage was to test the reliability of the Chinese version of the FOUR score which the evaluation time with the first stage. One neurosurgery doctor or nurse was use the Chinese version of the FOUR score and GCS evaluate the patient.1 hours interval, another neurosurgery doctor or nurse to use the Chinese version of the FOUR score and GCS to evaluate the same patient. All raters were involved in the assessment of the training of the operation and cannot ask or discuss the results of the assessment between two raters. For patients with tracheotomy or tracheal intubation, GCS for the verbal function of defined as 1 points. One neurosurgery residency who did not participated the evaluate process records the patients one month hospital mortality and the score of Modified Rankin Scale by telephone or outpatient follow-up after 3 month.The Modified Rankin Scale scored 3-6 defined as poor outcome while 0-2 defined as good outcome.3 InstrumentsAccording to the purpose of this study, we selected the Chinese version of the FOUR score and GCS to assess the patient’s consciousness. The Modified Rankin Scale was used as a criteria for evaluating these scales prognosis ability. Researchers in refer to a large number of literature and according to the research purpose of this study design of general data questionnaire, records of the patient’s demographic characteristics and clinical data.4 Statistical analysisAll collected data will be double entry, SPSS 13.0 software package for data statistical analysis (inspection level alpha= 0.05), the general demographic data using proportions, mean and standard deviation for general descriptive statistical analysis.Count data were expressed as frequency and percentage.Internal consistency of the Chinese version of the FOUR score was evaluated by Cronbach’s a and split-half reliability. Intraclass correlation coefficient (ICC) was used to measure the inter-rater agreement and test-retest reliability.The content validity index was used analysis the content validity of the Chinese version of the FOUR score. The Spearman correlation coefficient analysis the concurrent validity of the Chinese version of the FOUR score. The receiving operating characteristic (ROC) curve were also calculated to compare the predict ability of the Chinese version of the FOUR score and GCS. Two independent sample t test was used to analysis the distinguish validity of the Chinese version of the FOUR score. Logistic regression test the relations between the Chinese version of the FOUR score, Glasgow Coma Scale and hospital mortality.Using Youden index to determine the optimal cut-off value of the Chinese version of the FOUR score and GCS, and analysis its sensitivity, specificity, statistical significance was set atp<0.05.Results1 Internal consistencyThe overall Cronbach’s a coefficient of the Chinese version of the FOUR score and GCS was 0.865 and 0.898, respectively. The split-half reliability coefficient of the Chinese version of the FOUR score was 0.844 (p＜0.01).It shows that the Chinese version of the FOUR score has a good internal consistency.2 Test-retest reliabilityRandomly selected 30 patients under the premise of not change consciousness, investigator would evaluated the same patients at the second day. This study shows that the Chinese version of the FOUR score intraclass correlation coefficient was 0.930 (p< 0.001), suggesting that the Chinese version of the FOUR score have an excellent test-retest reliability.3 Both the Chinese version of the FOUR score and Glasgow Coma Scale have a good inter-rater agreement3.1 The Chinese version of the FOUR scoreThe inter-rater agreement for the Chinese version of the FOUR score was good (ICC 0.970,95% CI:0.958-0.978). Intraclass correlation coefficients of four dimensions were 0.935,0.946,0.786 and 0.994, respectively. For intubated and non-intubated patients, the intraclass correlation coefficient was 0.951 and 0.894, respectively. For the Chinese version of the FOUR score, intraclass correlation coefficients for the alert, drowsy, stuporous, and comatose groups were 0.830,0.615, 0.847 and 0.860, respectively. For traumatic brain injury and non-traumatic brain injury patents, the intraclass correlation coefficient was 0.961 and 0.977, respectively.3.2 Glasgow Coma ScaleThe inter-rater agreement for the GCS was good (ICC0.966,95% CI: 0.953-0.975). Intraclass correlation coefficients of three dimensions were 0.906, 0.950 and 0.919, respectively. For intubated and non-intubated patients, the intraclass correlation coefficient was 0.928 and 0.898, respectively. For the GCS, intraclass correlation coefficients for the alert, drowsy, stuporous, and comatose groups were 0.777,0.672,0.753 and 0.748, respectively. For traumatic brain injury and non-traumatic brain injury patents, the intraclass correlation coefficient was 0.961and 0.969, respectively.4 Content validityScale level content validity index was used to measuare the content validity of FOUR score.The Chinese version of the FOUR score of content validity index was 0.966. It shows that has a good content validity.5 Concurrent validityThe GCS as the gold standard, a good correlation was found between the Chinese version of the FOUR score and GCS (r=0.915,p ＜0.001).6 Discriminant validityTwo independent samples t-test analysisa show that poor prognosis group of FOUR score scores were lower than the good prognosis group, the difference was statistically significant (p<0.001).7 Both the Chinese version of the FOUR score and Glasgow Coma Scale have a good predictive validity7.1 The Chinese version of the FOUR scoreThe Chinese version of the FOUR score prediction of hospital mortality and poor prognosis of the area under the ROC curve was 0.848 (95% CI:0.786-0.909) and 0.831 (95% CI:0.762-0.900), respectively. It predicted poor prognosis of optimal cut-off value was 13 scores, a sensitivity of 76% and a specificity of 79%, the best cut-off value to predict hospital mortality was 8 points, its sensitivity was 71%, specificity was 84%.7.2 Glasgow Coma ScaleArea under the ROC curve of the GCS prediction of hospital mortality and poor prognosis were 0.846 (95% CI:0.782-0.910) and 0.808 (95% CI:0.729-0.886), respectively. It predicted poor prognosis of optimal cut-off value was 10 points, its the sensitivity was 81%, specificity of 75%, the best cut-off value to predict hospital mortality was 7 score, the sensitivity was 67%, specificity of 81%.8 Relationship between the Chinese version of the FOUR score,Glasgow Coma Scale and hospital mortalityLogistic regression analysis showed that age, gender and etiology were non risk factors of this study.After adjusting for age, gender, etiology and admission state of consciousness, the logistic regression analysis showed that every 1 point increase in FOUR total score, there is an estimated 27% reductionin the odds of in-hospital mortality (odds ratio. OR=0.73,95% CI:0.62-0.87). With the GCS total score, for every 1-point increase in total score, there is an estimated 31% reduced odds of in-hospital mortality (OR=0.69,95% CI:0.55-0.85).9 Correlation between the Chinese version of the FOUR score, Glasgow Coma Scale and S-100B protein, Neuron Specific EndaseRandomly 30 cases of patients with brain damage degree of experimental index NSE and S-100B protein,for the Chinese version of the FOUR score,the correlation coefficient was-0.324 (p<0.05) with the level of neuron specific endase,-0.427 (p＜0.01) with the level of S-100B protein. For the GCS,the correlation coefficient was-0.316 (p<0.05) with the level of neuron specific endase,-0.395 (p<0.01) with the level of S-100B protein.Conclusions1 The Chinese version of the FOUR score is of 20 entries, including four dimensions. Each dimension scores in the range of 0-4 points, the total scores in the range of 0-16 points.2 The Chinese version of the FOUR scale has a good internal consistency, test-retest reliability and the reliability assessment.The Chinese version of the FOUR scale has a good content validity, discriminant validity, concurrent validity and predictive validity.3 Both the Chinese version of the FOUR score and GCS have an excellent reliability and validity, the difference was not statistically significant. Therefore, the Chinese version of the FOUR score may be another consciousness assessment tool especially for those endotracheal intubation or tracheostomy patients.