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Sensitivity analysis the effects of Glasgow outcome scale misclassification on traumatic brain injury clinical trials /Lu, Juan. January 1900 (has links)
Thesis (Ph.D.)--Virginia Commonwealth University, 2010. / Prepared for: Dept. of Epidemiology and Community Health. Title from resource description page. Includes bibliographical references.
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Prognostický význam sledování hladin markerů u poškození CNS u nemocných po poranění / Prognostic significance of levels of brain specific biochemical markers in head injury patientsHomolková, Helena January 2012 (has links)
OBJECTIVES: The S100B protein subgroup is a thermolabile acidic calcium-binding protein. S100B protein was first described in the central nervous system. Destruction of the nerve tissue results in S100B protein release from astrocytic glial cells and elevation of its levels in the cerebrospinal fluid. If the blood-brain barrier is also damaged, S100B gets into the systemic circulation and elevated blood levels of S100B are detected. Higher S100B serum levels in patients with head injury are predictive of possible development of secondary brain injury and the extent of permanent injury to the CNS. MATHERIAL AND METHODS: The authors present their results obtained in the group of 39 children aged 0 (newborns) to 17 years with isolated craniocerebral injury. RESULTS: Our group included 39 children aged 0-17 years. Excellent results (GOS - Glasgow outcome scale 4-5) were observed in 33 patients already at the time of transfer from our ICU to the neurological department. There was no death and the poor outcome group included only 6 children. Second GOS evaluation was performed 6 months later, when 36 children were in the GOS 4-5 group and only 3 children in the GOS 2-3 group. CONCLUSIONS: Due to high variability in S100B protein serum levels in children depending on age and gender, no correlation between...
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SENSITIVITY ANALYSIS – THE EFFECTS OF GLASGOW OUTCOME SCALE MISCLASSIFICATION ON TRAUMATIC BRAIN INJURY CLINICAL TRIALSLu, Juan 19 April 2010 (has links)
I. EFFECTS OF GLASGOW OUTCOME SCALE MISCLASSIFICATION ON TRAUMATIC BRAIN INJURY CLINICAL TRIALS The Glasgow Outcome Scale (GOS) is the primary endpoint for efficacy analysis of clinical trials in traumatic brain injury (TBI). Accurate and consistent assessment of outcome after TBI is essential to the evaluation of treatment results, particularly in the context of multicenter studies and trials. The inconsistent measurement or interobserver variation on GOS outcome, or for that matter, on any outcome scales, may adversely affect the sensitivity to detect treatment effects in clinical trial. The objective of this study is to examine effects of nondifferential misclassification of the widely used five-category GOS outcome scale and in particular to assess the impact of this misclassification on detecting a treatment effect and statistical power. We followed two approaches. First, outcome differences were analyzed before and after correction for misclassification using a dataset of 860 patients with severe brain injury randomly sampled from two TBI trials with known differences in outcome. Second, the effects of misclassification on outcome distribution and statistical power were analyzed in simulation studies on a hypothetical 800-patient dataset. Three potential patterns of nondifferential misclassification (random, upward and downward) on the dichotomous GOS outcome were analyzed, and the power of finding treatments differences was investigated in detail. All three patterns of misclassification reduce the power of detecting the true treatment effect and therefore lead to a reduced estimation of the true efficacy. The magnitude of such influence not only depends on the size of the misclassification, but also on the magnitude of the treatment effect. In conclusion, nondifferential misclassification directly reduces the power of finding the true treatment effect. An awareness of this procedural error and methods to reduce misclassification should be incorporated in TBI clinical trials. II. IMPACT OF MISCLASSIFICATION ON THE ORDINAL GLASGOW OUTCOME SCALE IN TRAUMATIC BRIAN INJURY CLINICAL TRIALS The methods of ordinal GOS analysis are recommended to increase efficiency and optimize future TBI trials. To further explore the utility of the ordinal GOS in TBI trials, this study extends our previous investigation regarding the effect of misclassification on the dichotomous GOS to examine the impact of misclassification on the 5-point ordinal scales. The impact of nondifferential misclassification on the ordinal GOS was explored via probabilistic sensitivity analyses using TBI patient datasets contained in the IMPACT database (N=9,205). Three patterns of misclassification including random, upward and downward patterns were extrapolated, with the pre-specified outcome classification error distributions. The conventional 95% confidence intervals and the simulation intervals, which account for the misclassification only and the misclassification and random errors together, were reported. Our simulation results showed that given a specification of a minimum of 80%, modes of 85% and 95% and a maximum of 100% for both sensitivity and specificity (random pattern), or given the same trapezoidal distributed sensitivity but a perfect specificity (upward pattern), the misclassification would have caused an underestimated ordinal GOS in the observed data. In another scenario, given the same trapezoidal distributed specificity but a perfect sensitivity (downward pattern), the misclassification would have resulted in an inflated GOS estimation. Thus, the probabilistic sensitivity analysis suggests that the effect of nondifferential misclassification on the ordinal GOS is likely to be small, compared with the impact on the binary GOS situation. The results indicate that the ordinal GOS analysis may not only gain the efficiency from the nature of the ordinal outcome, but also from the relative smaller impact of the potential misclassification, compared with the conventional binary GOS analysis. Nevertheless, the outcome assessment following TBI is a complex problem. The assessment quality could be influenced by many factors. All possible aspects must be considered to ensure the consistency and reliability of the assessment and optimize the success of the trial. III. A METHOD FOR REDUCING MISCLASSIFICATION IN THE EXTENDED GLASGOW OUTCOME SCORE The eight-point extended Glasgow Outcome Scale (GOSE) is commonly used as the primary outcome measure in traumatic brain injury (TBI) clinical trials. The outcome is conventionally collected through a structured interview with the patient alone or together with a caretaker. Despite the fact that using the structured interview questionnaires helps reach agreement in GOSE assessment between raters, significant variation remains among different raters. We introduce an alternate GOSE rating system as an aid in determining GOSE scores, with the objective of reducing inter-rater variation in the primary outcome assessment in TBI trials. Forty-five trauma centers were randomly assigned to three groups to assess GOSE scores on sample cases, using the alternative GOSE rating system coupled with central quality control (Group 1), the alternative system alone (Group 2), or conventional structured interviews (Group 3). The inter-rater variation between an expert and untrained raters was assessed for each group and reported through raw agreement and with weighted kappa (k) statistics. Groups 2 and 3 without central review yielded inter-rater agreements of 83% (weighted k¼0.81; 95% CI 0.69, 0.92) and 83% (weighted k¼0.76, 95% CI 0.63, 0.89), respectively, in GOS scores. In GOSE, the groups had an agreement of 76% (weighted k¼0.79; 95% CI 0.69, 0.89), and 63% (weighted k¼0.70; 95% CI 0.60, 0.81), respectively. The group using the alternative rating system coupled with central monitoring yielded the highest inter-rater agreement among the three groups in rating GOS (97%; weighted k¼0.95; 95% CI 0.89, 1.00), and GOSE (97%; weighted k¼0.97; 95% CI 0.91, 1.00). The alternate system is an improved GOSE rating method that reduces inter-rater variations and provides for the first time, source documentation and structured narratives that allow a thorough central review of information. The data suggest that a collective effort can be made to minimize inter-rater variation.
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Recuperação das vítimas de lesão axonial difusa e fatores associados / Outcome of diffuse axonal injury victims and associated factorsVieira, Rita de Cassia Almeida 26 February 2015 (has links)
Introdução: A lesão axonial difusa (LAD) se destaca entre os ferimentos traumáticos pela gravidade de suas consequências. Entretanto, são poucas as pesquisas que descrevem a recuperação das vítimas e os fatores associados às consequências dessa lesão. Ampliar o conhecimento nessa área e relevante para introduzir novas técnicas na assistência prestada, planejar tratamentos e monitorar a evolução das vítimas. Objetivo: Descrever a recuperação das vítimas com diagnóstico principal de LAD ate 6 meses após trauma e identificar fatores sociodemograficos e clínicos associados a óbito e dependência aos 6 meses após a lesão. Método: Estudo do tipo coorte prospectivo, com dados coletados na internação, alta hospitalar, 3 e 6 meses após a LAD. Fizeram parte do estudo vítimas de LAD com idade 18 anos e 60 anos, admitidas no Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo no período de julho de 2013 a fevereiro de 2014, com escore na escala de coma de Glasgow (ECGl) 8. A recuperação das vítimas de LAD foi analisada pelas diferenças dos resultados da aplicação da escala de Katz e escala de resultados de Glasgow ampliada (ERGA) em 3 períodos de avaliação (alta, 3 e 6 meses após LAD). Foram testadas associações entre variáveis de interesse e óbito, além de dependência até avaliação final. A regressão logística múltipla foi utilizada para identificar modelos para esses desfechos. Resultados: A casuística compôs-se de 78 vítimas com idade média de 32 anos (dp=11,9), 83,3% envolvida em acidentes de transporte e 89,7% do sexo masculino. A média do Injury Severity Score foi de 35,0 (dp=11,9) e do New Injury Severity Score (NISS), 46,2 (dp=15,9). Para a Maximum Abbreviated Injury Scale/cabeça, a média foi de 4,6 (dp=0,5). LAD leve foi observada em 44,9% das vítimas e a grave em 35,9%. Até 6 meses, 30,8% das vítimas foram a óbito e a pontuação média na ERGA dos sobreviventes evoluiu de 3,8 (dp=1,2) na alta para 2,1 (dp=1,6) aos 3 meses e 1,2 (dp=1,6) na avaliação final. Para a escala de Katz, as médias foram de 8,5 (dp=5,5) na alta, de 3,2 (dp= 5,5) aos 3 meses e 1,8 (dp=4,5) aos 6 meses. Diferenças estatisticamente significativas foram observadas na comparação dos resultados de todos os tempos. Apresentaram significância estatística no modelo de regressão logística para óbito as variáveis de gravidade da LAD com hipóxia pela SpO2 e hipotensão com NISS; para dependência, a gravidade da LAD e tempo de internação hospitalar permaneceram no modelo isoladamente. Conclusões: Foi elevada a mortalidade; entretanto, a grande maioria dos sobreviventes alcançou condições condizentes com vida independente aos 6 meses. Nesse período, a recuperação das vítimas foi expressiva, ainda que mais acentuada nos 3 primeiros meses. A LAD grave destacou-se como fator de risco para óbito e dependência. A quase totalidade das vítimas com essa lesão morreu ou estava dependente aos 6 meses após trauma. Como fatores de risco para óbito, também foram identificados o NISS, a hipóxia pela SpO2 e a hipotensão e, para dependência, o tempo de internação hospitalar / Introduction: Diffuse axonal injury (DAI) stands out from other traumatic injuries because of the severity of its consequences. However, few studies describe outcome and the factors associated to outcome of this type of injury. Enhance knowledge in this area is important to introduce new techniques in the delivery of care, treatment planning and to monitor the recovery of DAI. Objective: Describe outcome of victims with primary diagnosis of DAI 6 months after trauma and identify sociodemographic and clinical factors associated to mortality and dependence 6 months after injury. Method: Prospective cohort study with data from admission, discharge, 3 and 6 months after DAI. Participants were DAI victims aged 18 years and 60 years old, admitted to the Hospital das Clínicas da Universidade de São Paulo from July 2013 to February 2014, with a Glasgow Coma Scale (GCS) 8. The outcome of victims was analyzed by the differences found between the results of the Katz scale and the Extended Glasgow Outcome scale (GOS-E) in three different periods (discharge, 3 and 6 months after DAI). Associations between variables of interest and mortality, and dependence to final evaluation were tested. Multiple logistic regression was applied to identify models of these outcomes. Results: The sample consisted of 78 victims with an average age of 32 years (SD=11.9), 83.3% involved in traffic accidents, and 89.7% were male. The mean Injury Severity Score was 35.0 (SD=11.9) and the New Injury Severity Score (NISS) was 46.2 (SD=15.9). For the Maximum Abbreviated Injury Scale/head, the average was 4.6 (SD=0.5). Mild DAI was observed in 44.9% of the victims and severe DAI was observed in 35.9%. Up to 6 months, 30.8% of the victims died and the average score in GOS-E survivors increased from 3.8 (SD=1.2) at discharge to 2.1 (SD=1.6) at 3 months and 1.2 (SD=1.6) at the final evaluation. According to Katz scale, the average was 8.5 (SD=5.5) at discharge, 3.2 (SD=5.5) at 3 months and 1.8 (SD=4.5) at 6 months. Statistically significant differences were observed comparing the results from all periods. In the regression model for mortality the variables of DAI severity with hypoxia by SpO2 and hypotension with NISS were statistically relevant; for dependence, the DAI severity and the hospitalization period remained in the model alone. Conclusions: Besides the high mortality, the vast majority of survivors reached conditions consistent with independent living at 6 months after injury. During this period, the recovery of victims was increased, although more pronounced in the first 3 months. Severe DAI stood out as a risk factor for mortality and dependence. Almost all the victims died or were dependent six months after trauma. NISS, hypoxia by SpO2 and hypotension were also identified as risk factors related to mortality; the length of hospitalization was identified as a risk factor related to dependence on outcome
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Recuperação das vítimas de lesão axonial difusa e fatores associados / Outcome of diffuse axonal injury victims and associated factorsRita de Cassia Almeida Vieira 26 February 2015 (has links)
Introdução: A lesão axonial difusa (LAD) se destaca entre os ferimentos traumáticos pela gravidade de suas consequências. Entretanto, são poucas as pesquisas que descrevem a recuperação das vítimas e os fatores associados às consequências dessa lesão. Ampliar o conhecimento nessa área e relevante para introduzir novas técnicas na assistência prestada, planejar tratamentos e monitorar a evolução das vítimas. Objetivo: Descrever a recuperação das vítimas com diagnóstico principal de LAD ate 6 meses após trauma e identificar fatores sociodemograficos e clínicos associados a óbito e dependência aos 6 meses após a lesão. Método: Estudo do tipo coorte prospectivo, com dados coletados na internação, alta hospitalar, 3 e 6 meses após a LAD. Fizeram parte do estudo vítimas de LAD com idade 18 anos e 60 anos, admitidas no Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo no período de julho de 2013 a fevereiro de 2014, com escore na escala de coma de Glasgow (ECGl) 8. A recuperação das vítimas de LAD foi analisada pelas diferenças dos resultados da aplicação da escala de Katz e escala de resultados de Glasgow ampliada (ERGA) em 3 períodos de avaliação (alta, 3 e 6 meses após LAD). Foram testadas associações entre variáveis de interesse e óbito, além de dependência até avaliação final. A regressão logística múltipla foi utilizada para identificar modelos para esses desfechos. Resultados: A casuística compôs-se de 78 vítimas com idade média de 32 anos (dp=11,9), 83,3% envolvida em acidentes de transporte e 89,7% do sexo masculino. A média do Injury Severity Score foi de 35,0 (dp=11,9) e do New Injury Severity Score (NISS), 46,2 (dp=15,9). Para a Maximum Abbreviated Injury Scale/cabeça, a média foi de 4,6 (dp=0,5). LAD leve foi observada em 44,9% das vítimas e a grave em 35,9%. Até 6 meses, 30,8% das vítimas foram a óbito e a pontuação média na ERGA dos sobreviventes evoluiu de 3,8 (dp=1,2) na alta para 2,1 (dp=1,6) aos 3 meses e 1,2 (dp=1,6) na avaliação final. Para a escala de Katz, as médias foram de 8,5 (dp=5,5) na alta, de 3,2 (dp= 5,5) aos 3 meses e 1,8 (dp=4,5) aos 6 meses. Diferenças estatisticamente significativas foram observadas na comparação dos resultados de todos os tempos. Apresentaram significância estatística no modelo de regressão logística para óbito as variáveis de gravidade da LAD com hipóxia pela SpO2 e hipotensão com NISS; para dependência, a gravidade da LAD e tempo de internação hospitalar permaneceram no modelo isoladamente. Conclusões: Foi elevada a mortalidade; entretanto, a grande maioria dos sobreviventes alcançou condições condizentes com vida independente aos 6 meses. Nesse período, a recuperação das vítimas foi expressiva, ainda que mais acentuada nos 3 primeiros meses. A LAD grave destacou-se como fator de risco para óbito e dependência. A quase totalidade das vítimas com essa lesão morreu ou estava dependente aos 6 meses após trauma. Como fatores de risco para óbito, também foram identificados o NISS, a hipóxia pela SpO2 e a hipotensão e, para dependência, o tempo de internação hospitalar / Introduction: Diffuse axonal injury (DAI) stands out from other traumatic injuries because of the severity of its consequences. However, few studies describe outcome and the factors associated to outcome of this type of injury. Enhance knowledge in this area is important to introduce new techniques in the delivery of care, treatment planning and to monitor the recovery of DAI. Objective: Describe outcome of victims with primary diagnosis of DAI 6 months after trauma and identify sociodemographic and clinical factors associated to mortality and dependence 6 months after injury. Method: Prospective cohort study with data from admission, discharge, 3 and 6 months after DAI. Participants were DAI victims aged 18 years and 60 years old, admitted to the Hospital das Clínicas da Universidade de São Paulo from July 2013 to February 2014, with a Glasgow Coma Scale (GCS) 8. The outcome of victims was analyzed by the differences found between the results of the Katz scale and the Extended Glasgow Outcome scale (GOS-E) in three different periods (discharge, 3 and 6 months after DAI). Associations between variables of interest and mortality, and dependence to final evaluation were tested. Multiple logistic regression was applied to identify models of these outcomes. Results: The sample consisted of 78 victims with an average age of 32 years (SD=11.9), 83.3% involved in traffic accidents, and 89.7% were male. The mean Injury Severity Score was 35.0 (SD=11.9) and the New Injury Severity Score (NISS) was 46.2 (SD=15.9). For the Maximum Abbreviated Injury Scale/head, the average was 4.6 (SD=0.5). Mild DAI was observed in 44.9% of the victims and severe DAI was observed in 35.9%. Up to 6 months, 30.8% of the victims died and the average score in GOS-E survivors increased from 3.8 (SD=1.2) at discharge to 2.1 (SD=1.6) at 3 months and 1.2 (SD=1.6) at the final evaluation. According to Katz scale, the average was 8.5 (SD=5.5) at discharge, 3.2 (SD=5.5) at 3 months and 1.8 (SD=4.5) at 6 months. Statistically significant differences were observed comparing the results from all periods. In the regression model for mortality the variables of DAI severity with hypoxia by SpO2 and hypotension with NISS were statistically relevant; for dependence, the DAI severity and the hospitalization period remained in the model alone. Conclusions: Besides the high mortality, the vast majority of survivors reached conditions consistent with independent living at 6 months after injury. During this period, the recovery of victims was increased, although more pronounced in the first 3 months. Severe DAI stood out as a risk factor for mortality and dependence. Almost all the victims died or were dependent six months after trauma. NISS, hypoxia by SpO2 and hypotension were also identified as risk factors related to mortality; the length of hospitalization was identified as a risk factor related to dependence on outcome
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Análise das respostas vitais, faciais e de tônus muscular frente ao estímulo música ou mensagem em pacientes em coma, estado vegetativo ou sedado / Analysis of vital, facial and muscular responses to music or message in coma, vegetative state or sedated patientsPuggina, Ana Cláudia Giesbrecht 20 January 2011 (has links)
Coma, estado vegetativo e sedação são desordens da consciência com diferenças clínicas em que ocorrem redução generalizada ou alteração no conteúdo da consciência, somadas a deficiências no despertar. Objetivo: analisar as relações entre as respostas vitais, faciais e de tônus muscular frente ao estímulo música ou mensagem em pacientes em coma, estado vegetativo ou sedado. Método: Ensaio Clínico Controlado Transversal Unicego para o pesquisador. Local da coleta: duas Unidades de Terapia Intensiva e uma Enfermaria de um Hospital Público de Ensino e Pesquisa. Procedimento de coleta de dados: pacientes com Escala Coma de Glasgow entre 3 e 8 ou Escala de Sedação de Ramsay de 5 ou 6 foram alocados aleatoriamente em um dos três grupos (experimental música, experimental mensagem ou controle). Os familiares gravaram uma mensagem de voz e escolheram uma música de acordo com a preferência do paciente. Foram coletados os sinais vitais, eletroneurografia e expressão facial dos pacientes nos períodos basal e durante a intervenção. Duas sessões de intervenção foram realizadas no mesmo dia. Após 30-40 dias da intervenção inicial foi aplicada a Escala de Resultado de Glasgow. Resultados: a maioria dos 76 pacientes em coma, 9 estado vegetativo ou sedados eram do sexo masculino, tinham entre 18 e 36 anos e foram internados por trauma. Encontrou-se alterações estatisticamente significantes nas variáveis temperatura, expressão facial, eletroneurografia e Escala de Resultado de Glasgow nas análises realizadas nesse estudo, além de alterações mais freqüentes na sessão 2, nos pacientes em coma e estado vegetativo, no canal 1 da eletroneurografia (músculo frontal) e no grupo experimental mensagem com valores médios e porcentagem maiores do que no grupo experimental música. Conclusões: Os resultados em relação aos sinais vitais são limitados e inconclusivos, o que dificulta qualquer inferência em relação a sua influência nas respostas dos pacientes com desordens de consciência em relação aos estímulos apresentados. A expressão facial e a eletroneurografia parecem ser variáveis mais confiáveis para avaliação das respostas desses pacientes, no entanto, mais estudos são sugeridos. / Coma, vegetative state and sedation are disorders of consciousness with clinical differences where a generalized reduction or alteration occurs in the consciousness content, coupled with deficiencies in waking. Objective: to analyze the relations between the vital signs, facial expressions and muscular tonus to the music or message stimuli in coma, vegetative state or sedated patients. Method: This study was a single-blinded transversal controlled clinical trial. Data collection: two Intensive Care Units and one ward of a Public Hospital of Education and Research. Procedure: patients with Glasgow Coma Scale between 3 and 8 or Ramsay Sedation Scale of 5 or 6 being randomly placed into one of the three groups (experimental music, experimental message or control). Their relatives recorded a voice message and chose a song according to the patients preference. The vital signs, eletroneurography and facial expressions of the patients were collected both in the baseline and also during the intervention. Two intervention sessions were performed on the same day. The Glasgow Outcome Scale was applied 30-40 days after the initial intervention. Results: the majority of the 76 coma, vegetative state or 11 sedated patients were masculine, between the ages of 18 and 36 and had been interned for trauma. Statistically significant alterations were noted in the variables of temperature, facial expression, eletroneurography and Glasgow Outcome Scale in the analyses performed in this study, in addition to more frequent alterations in session 2, in the coma and vegetative state patients, in channel 1 of the eletroneurography (frontal muscle) and in the message experimental group with mean values and higher percentages than in the music experimental group. Conclusions: The results, in relation to the vital signs, are limited and inconclusive, which complicates any inference regarding their influence on the responses of patients with disorders of consciousness in relation to stimuli. Facial expressions and eletroneurography, seem to be the more reliable variables for evaluation of the responses of these patients; however, additional studies are suggested.
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Análise das respostas vitais, faciais e de tônus muscular frente ao estímulo música ou mensagem em pacientes em coma, estado vegetativo ou sedado / Analysis of vital, facial and muscular responses to music or message in coma, vegetative state or sedated patientsAna Cláudia Giesbrecht Puggina 20 January 2011 (has links)
Coma, estado vegetativo e sedação são desordens da consciência com diferenças clínicas em que ocorrem redução generalizada ou alteração no conteúdo da consciência, somadas a deficiências no despertar. Objetivo: analisar as relações entre as respostas vitais, faciais e de tônus muscular frente ao estímulo música ou mensagem em pacientes em coma, estado vegetativo ou sedado. Método: Ensaio Clínico Controlado Transversal Unicego para o pesquisador. Local da coleta: duas Unidades de Terapia Intensiva e uma Enfermaria de um Hospital Público de Ensino e Pesquisa. Procedimento de coleta de dados: pacientes com Escala Coma de Glasgow entre 3 e 8 ou Escala de Sedação de Ramsay de 5 ou 6 foram alocados aleatoriamente em um dos três grupos (experimental música, experimental mensagem ou controle). Os familiares gravaram uma mensagem de voz e escolheram uma música de acordo com a preferência do paciente. Foram coletados os sinais vitais, eletroneurografia e expressão facial dos pacientes nos períodos basal e durante a intervenção. Duas sessões de intervenção foram realizadas no mesmo dia. Após 30-40 dias da intervenção inicial foi aplicada a Escala de Resultado de Glasgow. Resultados: a maioria dos 76 pacientes em coma, 9 estado vegetativo ou sedados eram do sexo masculino, tinham entre 18 e 36 anos e foram internados por trauma. Encontrou-se alterações estatisticamente significantes nas variáveis temperatura, expressão facial, eletroneurografia e Escala de Resultado de Glasgow nas análises realizadas nesse estudo, além de alterações mais freqüentes na sessão 2, nos pacientes em coma e estado vegetativo, no canal 1 da eletroneurografia (músculo frontal) e no grupo experimental mensagem com valores médios e porcentagem maiores do que no grupo experimental música. Conclusões: Os resultados em relação aos sinais vitais são limitados e inconclusivos, o que dificulta qualquer inferência em relação a sua influência nas respostas dos pacientes com desordens de consciência em relação aos estímulos apresentados. A expressão facial e a eletroneurografia parecem ser variáveis mais confiáveis para avaliação das respostas desses pacientes, no entanto, mais estudos são sugeridos. / Coma, vegetative state and sedation are disorders of consciousness with clinical differences where a generalized reduction or alteration occurs in the consciousness content, coupled with deficiencies in waking. Objective: to analyze the relations between the vital signs, facial expressions and muscular tonus to the music or message stimuli in coma, vegetative state or sedated patients. Method: This study was a single-blinded transversal controlled clinical trial. Data collection: two Intensive Care Units and one ward of a Public Hospital of Education and Research. Procedure: patients with Glasgow Coma Scale between 3 and 8 or Ramsay Sedation Scale of 5 or 6 being randomly placed into one of the three groups (experimental music, experimental message or control). Their relatives recorded a voice message and chose a song according to the patients preference. The vital signs, eletroneurography and facial expressions of the patients were collected both in the baseline and also during the intervention. Two intervention sessions were performed on the same day. The Glasgow Outcome Scale was applied 30-40 days after the initial intervention. Results: the majority of the 76 coma, vegetative state or 11 sedated patients were masculine, between the ages of 18 and 36 and had been interned for trauma. Statistically significant alterations were noted in the variables of temperature, facial expression, eletroneurography and Glasgow Outcome Scale in the analyses performed in this study, in addition to more frequent alterations in session 2, in the coma and vegetative state patients, in channel 1 of the eletroneurography (frontal muscle) and in the message experimental group with mean values and higher percentages than in the music experimental group. Conclusions: The results, in relation to the vital signs, are limited and inconclusive, which complicates any inference regarding their influence on the responses of patients with disorders of consciousness in relation to stimuli. Facial expressions and eletroneurography, seem to be the more reliable variables for evaluation of the responses of these patients; however, additional studies are suggested.
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Sistemski prediktivni faktori ishoda lečenja kod povređenih sa teškim traumatskim moždanim oštećenjem / Systemic Predictive Factors for Treatment Outcome in Patients with Severe Traumatic Brain InjuryLazukić Aleksandra 07 September 2018 (has links)
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Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-qformat:yes;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;mso-bidi-font-family:"Times New Roman";mso-bidi-theme-font:minor-bidi;}</style><![endif]-->Uvod: Traumatsko moždano oštećenje (TMO) predstavlja globalni zdravstveni problem koji pogađa oko 10 miliona ljudi godišnje širom sveta. Teška traumatska moždana oštećenja (TTMO) čine 10% svih TMO i imaju visoku stopu mortaliteta i neizvestan oporavak. Ranije prepoznavanje sistemskih faktora koji utiču na ishod lečenja može da ima značajan uticaj na pravovremeno započinjanje terapijskih mera i smanjivanje morbiditeta i mortaliteta. Cilj istraživanja: Identifikovati sistemske faktore koji imaju značajan uticaj na ishod lečenja povređenih sa TTMO u Jedinici intenzivnog lečenja (JIL) tokom prvog dana hospitalizacije. Metodologija: Ispitivanje je sprovedeno kao retrospektivno-prospektivna studija koja je obuhvatila 115 povređenih ispitanika sa TTMO koji su hospitalizovani u JIL Urgentnog centra Kliničkog centra Vojvodine (UC KCV) u periodu od 1.01.2014.-1.10.2017. Iz medicinske dokumentacije, za svakog ispitanika uključenog u istraživanje su uzeti u razmatranje i analizu sledeći parametri u toku prvih 24 časa od momenta prijema u JIL: demografske i opšte karakteristike ispitanika od značaja za istraživanje i sistemski prediktivni faktori (sistolni i srednji arterijski pritisak- SAP/MAP, glikemija-ŠUK, telesna temperatura-TT, pH, parcijalni pritisak kiseonika-PaO2 i parcijalni pritisak ugljem dioksida- PaCO2) registrovani u pet vremenskih tačaka (0h, 6h, 12h,18h, 24h). Svi gore navedeni podaci su posmatrani i analizirani kao prediktorski faktori tj. nezavisne varijable u odnosu na zavisnu varijablu „ishod lečenja“ definisanu kao Glazgovska skala ishoda (Glasgow outcome scale-GOS) nakon otpusta povređenih iz JIL na Kliniku za neurohirurgiju KCV i GOS nakon otpusta iz Klinike za neurohirurgiju KCV i „tok lečenja“ definisan kroz dužinu boravka povređenih u JIL UC KCV, dužinu boravka na Klinici za neurohirurgiju KCV, odnosno ukupno trajanje hospitalizacije u KCV, kao i otpust kući ili u odgovarajući rehabilitacioni centar. Statistička analiza je izvršena pomoću statističkog paketa IBM SPSS 23. Podaci su predstavljeni tabelarno i grafički, a statistička značajnost određivana je na nivou p < 0,05. Prikupljeni podaci su obrađeni adekvatnim statističkim metodima. Rezultati: Sistemski faktori koji su se izdvojili kao prediktori smrtnog ishoda (GOS 1) kod povređenih sa TTMO tokom prvog dana boravka u JIL su upotreba vazoaktivne potpore i glikemija. Upotreba vazoaktivne potpore povećava verovatnoću za smrtni ishod 4,7 puta (OR=0,214; 95%CI: 0,096-0,479; p<0,05). i vrednosti glikemije > 10 mmol/l povećavaju verovatnoću za smrtni ishod u nultom satu (OR= 0,240, 95%CI: 0,087-0,662; p=0,05) i u 24 satu (OR=0,206, 95%CI: 0,037 – 0,929; p=0,05). Sa svakim porastom telesne temperature za jednu jedinicu u posmatranom intervalu raste verovatnoća za pozitivan ishod (OR =2,118 , 95%CI: 1,097 – 4,091; p<0,05) i vrednosti glikemije u intervalu od 4-8 mmol/l povećavaju verovatnoću za pozitivan ishod 2,5 puta. Sistemski faktori koji su se izdvojili u smislu predikcije ishoda lečenja ispitanika nakon otpusta iz JIL su vrednosti glikemije i telesna temperatura. Vrednost glikemije na prijemu u intervalu od 6,9 do 7,4 mmol/l povećavaju verovatnoću boljeg oporavka (GOS 4-5 vs. GOS 2-3). Niže vrednosti glikemiije u narednim vremenskim tačkama (6h, 12h, 18h) takođe povećavaju verovatnoću za bolji oporavak. Ukoliko je telesna temperatura u 6-om i 12-om satu, viša od 36,5 °C veća je verovatnoća za bolji neurološki oporavak, prilikom otpusta iz JIL, odnosno Klinike za neurohirurgiju KCV. Ispitanici koji su imali više vrednosti telesne temperature su imali duže trajanje hospitalizacije (OR=4,096; 95%CI; 0,709-7,483;p<0,05). Na dužinu boravka u JIL, kao i na otpust kući ili odgovarajući rehabilitacioni centar nije imao uticaj nijedan posmatrani sistemski faktor. Zaključak: Sistemski prediktivni faktori toka i ishoda lečenja povređenih sa TTMO su upotreba vazoaktivne potpore, glikemija i telesna temperatura.</p> / <p>Introduction: Traumatic brain injury (TBI) is a global health problem that affects about 10 million people worldwide annually. Severe traumatic brain injury (STBI) account for 10% of all TBI and has high morbidity and unreliable recovery. Early recognition of systemic factors that affect the treatment outcome can have a significant impact on the timely initiation of therapeutic measures and the reduction of morbidity and mortality. The objective of the research: to identify systemic factors that have a significant impact on the treatment outcome of the STBI patients in the Intensive Care Unit (ICU) during the first day of hospitalization. Methodology: The study was conducted as a retrospective-prospective study that included 115 injured patients with STBI who were hospitalized in the ICU, Emergency Center (EC) of the Clinical Center of Vojvodina (CCV) in the period from 01.01.2014 to 1.10.2017. From the medical documentation, for each participant involved in the research, the following parameters within the first 24 hours after the admission were considered and analyzed: demographic and general characteristics of the participants of importance for research and systemic predictive factors (systolic and mean arterial pressure-SAP / MAP, glycemia, body temperature -TT, pH, partial pressure of oxygen-PaO2 and partial pressure of carbon dioxide-PaCO2) registered at five time points (0h, 6h, 12h,18h, 24h). All of the above data were observed and analyzed as predictors, ie, independent variables in relation to the dependent variable "treatment outcome" defined as the Glasgow Outcome Scale (GOS) after the transfer from the ICU to the Clinic of neurosurgery of the CCV and GOS after discharge from a Clinic of neurosurgery and "treatment course" defined by length of stay in ICU, or the total duration of hospitalization in CCV, as well as the release to the home or the appropriate rehabilitation center. Statistical analysis was performed using the IBM SPSS 23 statistical package. The data are presented in tables and graphs, and the statistical significance was determined at p <0.05. The collected data were processed with adequate statistical methods. Results: Systemic factors that had predictive value for the lethal outcome (GOS 1) in STBI during the first day of ICU stay were the use of vasopressors and glycemia. The use of vasopressors increases the likelihood of fatal outcome 4.7 times (OR= 0,214; 95%CI: 0,096-0,479; p<0,05) and glycemic values > 10 mmol/l increase the likelihood of fatal outcome on admission (OR=0,240, 95%CI: 0,087-0,662; p=0,05) and after 24 hours (OR=0,206, 95%CI: 0,037 – 0,929; p=0,05). With each increase in body temperature for one unit in the observed interval, the probability of a positive outcome increases (OR=2,118, 95%CI: 1,097 – 4,091;p<0,05) and glycemic values in the range 4-8 mmol/l increase the probability of a positive outcome 2.5 times. Systemic factors that predict the treatment outcome of the patients after their discharge from ICU are glycemia and body temperature. The blood sugar on admission in the ICU in the range from 6.9 to 7.4 mmol/l increases the opportunity of a better recovery (GOS 4-5 vs. GOS 2-3). Lower glycemic values at the next time points (6h, 12h, 18h) also increase the opportunity of a better recovery. If the body temperature in the 6th and 12th-hour postadmission is higher than 36.5° C, the greater opportunity for better neurological improvement when the patient is discharged from ICU, or from the Clinic of neurosurgery. Participants who had higher values of body temperature had a longer duration of hospitalization (OR 4.096; 95% CI; 0.709-7.483;p<0,05). The length of the stay in ICU, as well as the release to the home or the appropriate rehabilitation center, was not affected by any observed systemic factor. Conclusion: Systemic predictive flow factors and outcome of treatment factors with STBI use of vasopressors, glycemia and body temperature.</p>
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Prognostički značaj kliničkih i parametara kompjuterizovane tomografije kod pacijenata sa hroničnim subduralnim hematomom / Prognostic importance of clinical and computed tomography parameters in patients with chronic subdural hematomaJuković Mirela 21 October 2014 (has links)
<p>Uvod: Hronični subduralni hematom (HSDH) je učestala i nezanemarljiva traumatska/netraumatska intrakranijalna lezija, naročito kod pacijenata starije životne dobi. Simptomi pacijenata sa HSDH su raznovrsni i često pogrešno protumačeni i lečeni. Zbog navedenih činjenica, HSDH predstavlja veliki izazov u dijagnostici i terapiji. Različiti autori ističu značaj radioloških parametara tokom dijagnostike ovog oboljenja i povezanost sa kliničkom slikom I neurološkim statusom pacijenta, pa je ovo istraživanje bilo usmereno u preciznoj evaluaciji pomenutih parametara, njihovoj prediktivnoj vrednosti i uticaju na prognozu ishoda lečenja. Cilj: Generalni cilj istraživanja je bio da se ispita učestalost pacijenata sa hroničnim subduralnim hematomom na teritoriji Vojvodine u periodu od tri godine; da se analizira starosna dob pacijenata, polna distribucija oboljenja, uticaj komorbiditeta ili faktora rizika na nastanak HSDH; prisustvo ili odsustvo traume koja je doprinela nastanku HSDH, vremenski interval od traume do pojave simpotoma ili znakova bolesti i da se omogući praćenje efekta terapije pacijenata sa ovim oboljenjem. Specifični ciljevi su obuhvatili: 1. Da se utvrde parametri kompjuterizovane tomografije koji imaju prediktivni značaj u pozitivnom ishodu lečenja pacijenata sa hroničnim subduralnim hematomom. 2. Da se utvrde klinički parametri koji imaju prediktivni značaj u pozitivnom ishodu lečenja pacijenata sa hroničnim subduralnim hematomom. 3. Da se dobije model sa najvećom specifičnošću i senzitivnošću za predikciju ishoda lečenja, kombinacijom kliničkih i parametrara kompjuterizovane tomografije kod pacijenata sa hroničnim subduralnim hematomom. Materijal i metode: Istraživanje je obavljeno kao prospektivna trogodišnja studija u periodu od aprila 2010. do aprila 2013. godine u Kliničkom Centru Vojvodine- Centru za radiologiju i Klinici za neurohirurgiju i obuvatila je 83 pacijenata sa dijagnozom hroničnog subduralnog hematoma. Svi ispitanici su dijagnostikovani upotrebom kompjuterizovane tomografije glave (CT) i lečeni na Klinici za neurohirurgiju KCV. Izvori podataka su celokupna medicinska dokumentacija svakog pacijenta od perioda prve hospitalizacije do njihovog otpusta, a uključuje i podatke vezane za subjektivni osećaj o zdravstvenom stanju koje su pacijenti usmeno izneli šest meseci nakon hospitalnog otpusta. Rezultati: Rezultati istraživanja pokazuju da je Glasgow Coma Scala (GCS) tj. nivo svesti pacijenta na hospitalnom prijemu jedini parametar sa visokom prediktivnom vrednošću za klinički ishod lečenja pacijenata sa HSDH procenjen preko Glasgow Outcome Scale (GOS). Preostali radiološki i klinički parametri (širina hematoma, pomeraj mediosagitalne linije, denzitet hematoma, starost pacijenta) nemaju visoku prediktivnu vrednost za klinički ishod pacijenata sa hroničnim subduralnim hematomom. Zaključak: Na osnovu grupe analiziranih pacijenata sa HSDH nije bilo moguće napraviti optimalan model za predikciju ishoda lečenja kombinujući radiološke i kliničke parametre. Pojedinačno posmatrani radiološki parametri nisu imali visoku prediktivnu vrednost za ishod lečenja pacijenata sa HSDH. Izolovan klinički parametar- GCS- je jedini visoko prediktivni faktor za ishod lečenja pacijenata sa HSDH. Kombinacija kliničkih i radioloških parametara daje visoku vrednost predviđanja kliničkog ishoda lečenja, ali samo zahvaljujući izrazito visokoj prediktivnoj vrednosti GCS. Iz svega navedenog, kompjuterizovana tomografija (CT) ima veliki značaj u ranoj dijagnostici i praćenju terapije pacijenata sa HSDH, ali CT parametri ponaosob nemaju značaj u predviđanju ishoda lečenja.</p> / <p>Introduction: Chronic subdural hematoma (CSDH) is common traumatic/no traumatic intracranial lesion, especially in older patients. Symptomatology of this disease is variable and often is misdiagnosed and treated with specially challenges in diagnostic and therapy. Different authors pointed on importance of radiological parameters during diagnostic of this disease and connections with clinic and neurological status in patients with chronic subdural hematoma (CSDH), so this thesis was directed to evaluate radiological and clinical parameters of CSDHs and to show their predictive values and their significance on patient’s outcome. Aim: General aim of this thesis was to examine frequency of patients with chronic subdural hematoma in Vojvodina, during the period of three years, to analyze the age of population with CSDHs, the gender distribution, an impact of comorbidity or risk factors for patients with CSDHs, the presence or absence of trauma which has contributed to CSDH, to determine time interval from trauma to appearance of symptoms and signs of disease, monitoring the effect of therapy. Specific aims were: 1. To determine clinical parameters with a positive predictive significance on patients outcome 2. To determine radiological parameters with a positive predictive significance on patients outcome 3. To determine optimal prognostic model with high specificity and sensitivity, using combination of radiological and clinical parameters for positive prediction outcome. Material and methods: The study was performed as three-year prospective study from April 2010 to April 2013 in Clinical Centre of Vojvodina, Centre for Radiology and Clinic of Neurosurgery and includes 83 patients with chronic subdural hematoma. All patients were diagnosed using computed tomography of the brain (CT scan) and all were treated in Clinic of Neurosurgery (KCV). Data sources included the medical records of each patient from the time of first hospitalization to period of their discharge and included data related to the subjective feeling of the health that patients verbally present six months after hospital discharge. Results: The results showed that the Glasgow Coma Scale (GCS) - a level of consciousness of the patient on the hospital admission was the only parameter with a high predictive value for clinical outcome of patients with CSDH assessed through Glasgow Outcome Scale (GOS). Other evaluated radiological and clinical parameters (width of the CSDH, mediosagital line displacement, a density of the CSDH, the age of the patient) did not have high predictive values for the clinical outcome in patients with chronic subdural hematoma. Conclusion: Based on the analyzed group of patients with CSDH it was not possible to make optimal predictive model for outcome by combining radiological and clinical parameters. Radiographic parameters did not have high predictive values for treatment outcome in patients with CSDH. Glasgow Coma Scale (GCS) is the only highly predictive factor for treatment outcome in patients with CSDH. The combination of clinical and radiological parameters gives high predictive value for clinical outcome, but only because of extremely high predictive value of GCS. Therefore, computed tomography (CT) is of great importance in early diagnosis and therapy monitoring of patients with CSDH, but CT parameters did not have the high predictive values for the patient’s clinical outcome.</p>
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Rana prognoza kvaliteta života politraumatizovanih bolesnika sa prelomima dugih kostiju / Early estimate of quality of life in polytrauma patients with multiple fractures of the long bonesGvozdenović Nemanja 06 April 2016 (has links)
<p>Pod pojmom politraume se podrazumeva teška istovremena povreda najmanje dve regije tela sa anatomskom težinom povrede AIS koja je jednaka ili veća od tri kao i ukupna izračunata anatomska težina povreda izražena ISS zbirom mora da bude veća od 15. Cilj istraživanja je da se primenom upitnika (SF36, PTSD–testa i Glazgov skale ishoda) proceni kvalitet života između politraumatizovanih pacijenata sa prelomomima dugih kostiju i politraumatizovanih bez preloma duge kosti kao i da se uoče rani pokazatelji loše prognoze kvaliteta života nakon završetka lečenja. Istraživanje je prospektivnog karaktera i obuhvatilo je 202 politraumatizovana pacijenta koji su bili povređeni u periodu 2010-2014 godine i bili lečeni u Urgentnom Centu Kliničkog Centra Vojvodine. Od 202 politraumatizovana pacijenta na kontrolne preglede se odazvalo ukupno 72 pacijenta, 37 sa prelomima dugih kostiju - ispitivana grupa i 35 politraumatizovanih pacijenata bez preloma duge kosti koji su činili kontrolnu gupu. Godinu dana nakon završetka hospitalizacije svaki ispitanik je popunjavao upitnik( SF36, PTSD test i Glazgov skala ishoda ), načinjen je klinički pregled i standardna radiografija predela preloma duge kosti. Rezultati ukazuju da ukupni kvalitet života nakon završetka lečenja se ne razlikuje značajno između ispitivanih grupa, iako politraumatizovani sa prelomima dugih kostiju imaju niži kvalitet života, odnosno značajno lošije fizički funkcionišu i imaju značajno češće psihičke poremećaje (postraumatski stresni poremećaj, depresija) u odnosu na kontrolnu grupu. Tip preloma duge kosti nije uticao na krajnji kvalitet života politraumatizovanih, dok su oni sa dva i više preloma imali značajno lošiji kvalitet života. Na osnovu dobijenih rezultata konstatovali smo da veću šansu za bolji kvalitet života imaju pacijenti mlađi od 44 godine, ukoliko su inicjalno imali vrednost ISS skora manji od 30,5 bodova, vrednosti sistolnog i dijastolnog arterijskog pritiska u referentnim vrednostima, kao i broja eritrocita i trombocita, i ukoliko su primili manje od 4 jedinica transfuzije krvi u prva 24 časa.</p> / <p>The term of polytrauma means, a patient with multiple severe injuries in at least two regions of the body with anatomical severity of trauma AIS equal or greater than three and the total calculated weight anatomical injuries expressed by ISS score must be greater than 15. The aim of our study is early estimate of quality of life in polytrauma patients with multiple fractures of the long bones and polytrauma patients without fractures of long bones as well as to detect early indicators of poor prognosis of quality of life after treatment, using questionnaires (SF 36, PTSD test and Glasgow Outcome Scale). This was prospective study and included 202 polytrauma patients who were injured during the period 2010-2014 and were treated in the Emergency Center of Clinical Center of Vojvodina. From 202 polytrauma patients, on control examinations responded 72 patients, 37 with fractures of long bones - study group and 35 polytrauma patients without fractures of long bones and they were control group. One year after the end of hospitalization each patient filled out a questionnaire (SF36, PTSD test and Glasgow Outcome Scale), made a clinical examination and standard X-rays of long bone fractures. Our results indicate that the overall quality of life after treatment is not significantly different between the groups, although polytraumatized patients with fractures have a lower quality of life and significantly worse physical functioning and have significantly more mental disorders (post-traumatic stress disorder, depression) compared to the control group. Type of long bone fractures did not affect on the final quality of life, while those patients with two or more fractures had a significantly poorer quality of life. Based on these results we concluded that greater chance for a better quality of life have patients younger than 44 years, unless they had initially ISS score less than 30.5 points, systolic and diastolic blood pressure in the reference values as well as the number of red blood cells and platelets, and if they received less than 4 units of blood transfusions in the first 24 hours.</p>
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