95 resultados para observational study

em Repositório Institucional UNESP - Universidade Estadual Paulista "Julio de Mesquita Filho"


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Background: Obstructive sleep apnea (OSA) is a respiratory disease characterized by the collapse of the extrathoracic airway and has important social implications related to accidents and cardiovascular risk. The main objective of the present study was to investigate whether the drop in expiratory flow and the volume expired in 0.2 s during the application of negative expiratory pressure (NEP) are associated with the presence and severity of OSA in a population of professional interstate bus drivers who travel medium and long distances.Methods/Design: An observational, analytic study will be carried out involving adult male subjects of an interstate bus company. Those who agree to participate will undergo a detailed patient history, physical examination involving determination of blood pressure, anthropometric data, circumference measurements (hips, waist and neck), tonsils and Mallampati index. Moreover, specific questionnaires addressing sleep apnea and excessive daytime sleepiness will be administered. Data acquisition will be completely anonymous. Following the medical examination, the participants will perform a spirometry, NEP test and standard overnight polysomnography. The NEP test is performed through the administration of negative pressure at the mouth during expiration. This is a practical test performed while awake and requires little cooperation from the subject. In the absence of expiratory flow limitation, the increase in the pressure gradient between the alveoli and open upper airway caused by NEP results in an increase in expiratory flow.Discussion: Despite the abundance of scientific evidence, OSA is still underdiagnosed in the general population. In addition, diagnostic procedures are expensive, and predictive criteria are still unsatisfactory. Because increased upper airway collapsibility is one of the main determinants of OSA, the response to the application of NEP could be a predictor of this disorder. With the enrollment of this study protocol, the expectation is to encounter predictive NEP values for different degrees of OSA in order to contribute toward an early diagnosis of this condition and reduce its impact and complications among commercial interstate bus drivers.

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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

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Adalimumab is a fully-human antibody that inhibits TNF alpha, with a significant efficacy for long-term maintenance of remission. Studies with this agent in Latin American Crohn's disease patients are scarce. The objective of this study was to outline clinical remission rates after 12 months of adalimumab therapy for Crohn's disease patients. Retrospective, single-center, observational study of a Brazilian case series of Crohn's disease patients under adalimumab therapy. Variables analyzed: demographic data, Montreal classification, concomitant medication, remission rates after 1, 4, 6 and 12 months. Remission was defined as Harvey-Bradshaw Index ≤ 4, and non-responder-imputation and last-observation-carried-forward analysis were used. The influence of infliximab on remission rates was analyzed by Fischer and Chi-square tests (P<0.05). Fifty patients, with median age of 35 years at therapy initiation, were included. Remission rates after 12 months of therapy were 54% under non-responder-imputation and 88% under last-observation-carried-forward analysis. After 12 months, remission on patients with previous infliximab occurred in 69.23% as compared to 94.59% in infliximab-naïve patients (P = 0.033). Adalimumab was effective in maintaining clinical remission after 12 months of therapy, with an adequate safety profile, and was also more effective in infliximab naïve patients.

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Postoperative endoscopic recurrence (PER) occurs in nearly 80% of patients 1 year after ileocecal resection in patients with Crohn's disease (CD). Biological agents were more effective in reducing the rates of PER in comparison with conventional therapy, in prospective trials. The aim of this study was to compare the PER rates of biological versus conventional therapy after ileocecal resections in patients with CD in real-world practice. The MULTIPER (Multicenter International Postoperative Endoscopic Recurrence) database is a retrospective analysis of PER rates in CD patients after ileocecal resection, from 7 referral centers in 3 different countries. All consecutive patients who underwent ileocecal resections between 2008 and 2012 and in whom colonoscopies had been performed up to 12 months after surgery, were included. Recurrence was defined as Rutgeerts' score ≥i2. The patients were allocated to either biological or conventional therapy after surgery, and PER rates were compared between the groups. Initially, 231 patients were evaluated, and 63 were excluded. Of the 168 patients in the database, 96 received anti-tumor necrosis factor agents and 72 were treated with conventional therapy after resection. The groups were comparable regarding age, gender, and perianal disease. There was longer disease duration, more previous resections, and more open surgical procedures in patients on biologicals postoperatively. PER was identified in 25/96 (26%) patients on biological therapy and in 24/72 (33.3%) patients on conventional therapy (P=0.310). In this retrospective observational analysis from an international database, no difference was observed between biological and conventional therapy in preventing PER after ileocecal resections in CD patients.

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Introduction: Postoperative endoscopic recurrence (PER) is the initial event after intestinal resection in Crohn’s disease (CD), and after a few years most patients present with progressive symptoms and complications related to the disease. The identification of risk factors for PER can help in the optimization of postoperative therapy and contribute to its prevention. Methods: Retrospective, longitudinal, multicenter, observational study involving patients with CD who underwent ileocolic resections. The patients were allocated into two groups according to the presence of PER and the variables of interest were analyzed to identify the associated factors for recurrence. Results: Eighty-five patients were included in the study. The mean period of the first postoperative colonoscopy was 12.8 (3–120) months and PER was observed in 28 patients (32.9%). There was no statistical difference in relation to gender, mean age, duration of CD, family history, previous intestinal resections, smoking, Montreal classification, blood transfusion, residual CD, surgical technique, postoperative complications, presence of granulomas at histology, specimen extension and use of postoperative biological therapy. The preoperative use of corticosteroids was the only variable that showed a significant difference between the groups in univariate analysis, being more common in patients with PER (42.8% vs. 21%; p = 0.044). Conclusions: PER was observed in 32.9% of the patients. The preoperative use of corticosteroids was the only risk factor associated with PER in this observational analysis.

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Background and objectives Peritonitis remains as the most frequent cause of peritoneal dialysis (PD) failure, impairing patient's outcome. No large multicenter study has addressed socioeconomic, educational, and geographic issues as peritonitis risk factors in countries with a large geographic area and diverse socioeconomic conditions, such as Brazil.Design, setting, participants, & measurements Incident PD patients recruited from 114 dialysis centers and reporting to BRAZPD, a multicenter observational study, from December 2004 through October 2007 were included. Clinical, dialysis-related, demographic, and socioeconomic variables were analyzed. Patients were followed up until their first peritonitis. Cox proportional model was used to determine independent factors associated with peritonitis.Results In a cumulative follow-up of 2032 patients during 22.026 patient-months, 474 (23.3%) presented a first peritonitis episode. In contrast to earlier findings, PD modality, previous hemodialysis, diabetes, gender, age, and family income were not risk predictors. Factors independently associated with increased hazard risk were lower educational level, non-white race, region where patients live, shorter distance from dialysis center, and lower number of patients per center.Conclusions Educational level and geographic factors as well as race and center size are associated with risk for the first peritonitis, independent of socioeconomic status, PD modality, and comorbidities. Clin J Am Soc Nephrol 6: 1944-1951, 2011. doi: 10.2215/CJN.11431210

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Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

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The reproducibility of the 6-min walking test (6MWT) needs to be more solidly studied. This study aimed to investigate the reproducibility of two 6MWTs performed on subsequent days in a large and representative sample of patients with chronic obstructive pulmonary disease (COPD), and to quantify the learning effect between the two tests, as well as its determinants.In a retrospective observational study, 1,514 patients with COPD performed two 6MWTs on subsequent days. Other measurements included body composition (dual X-ray absorptiometry), dyspnoea (Medical Research Council scale) and comorbidity (Charlson index).Although the 6MWT was reproducible (intraclass correlation coefficient=0.93), patients walked farther in the second test (391 m, 95% CI 155-585 m versus 418 m, 95% CI 185-605 m; p < 0.0001). on average, the second 6MWT increased by 27 m (or 7%), and 82% of patients improved in the second test. Determinants of improvement >= 42 m in the second test (upper limit of the clinically important change) were as follows: first 6MWT < 350 m, Charlson index < 2 and body mass index < 30 kg.m(-2) (OR 2.49, 0.76 and 0.60, respectively).The 6MWT was statistically reproducible in a representative sample of patients with COPD. However, the vast majority of patients improved significantly in the second test by an average learning effect of 27 m.

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CONTEXTUALIZAÇÃO: Diagnosticar os parâmetros clínicos associados com as quedas em idosos tornou-se um grande desafio para a comunidade científica. Apesar da existência de diversos instrumentos direcionados à avaliação do equilíbrio corporal em idosos, ainda é escasso o número de trabalhos que investigaram e discutiram a concordância entre os diversos métodos. OBJETIVO: Analisar a correlação entre alguns testes usados para avaliar o equilíbrio corporal no idoso. MÉTODOS: Tratou-se de um estudo transversal, observacional, realizado com 30 voluntárias idosas comunitárias, hígidas, com diferentes níveis de condicionamento físico. Foram utilizados o Teste de Alcance Funcional Anterior (TAF), a Escala de Equilíbrio de Berg (EEB), o teste Timed Up and Go (TUG) e o Teste de Equilíbrio de Tinetti (Performance Oriented Mobility Assessment - POMA). A correlação dos dados foi realizada por meio da aplicação do Coeficiente de Correlação de Spearman, com nível de significância de 5% (p<0,05). RESULTADOS: Observou-se correlação positiva e moderada entre o TAF e a EEB (r=0,4845; p=0,0067), entre o TAF e a POMA (r=0,4136; p= 0,0231), entre a EEB e a POMA (r=0,6088; p=0,0004). CONCLUSÃO: Os testes são complementares, dado que se mostraram com particularidades e limitações distintas. Torna-se razoável, portanto, a aplicação conjunta desses instrumentos para melhor avaliar o equilíbrio de idosas.

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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

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OBJETIVO: Comparar características clínicas e evolução de pacientes com e sem injúria renal aguda adquirida em unidade de terapia intensiva geral de um hospital universitário terciário e identificar fatores de risco associados ao desenvolvimento de injúria renal aguda e à mortalidade. MÉTODOS: Estudo prospectivo observacional com 564 pacientes acompanhados diariamente durante a internação em unidade de terapia intensiva geral do Hospital das Clínicas da Faculdade de Medicina de Botucatu por 2 anos consecutivos (de maio de 2008 a maio de 2010), divididos em 2 grupos: com injúria renal aguda adquirida (G1) e sem injúria renal aguda adquirida (G2). RESULTADOS: A incidência de injúria renal aguda foi 25,5%. Os grupos diferiram quanto à etiologia da admissão em unidade de terapia intensiva (sepse: G1:41,6% x G2:24,1%, p<0,0001 e pós operatório neurológico 13,8% x 38,1%, p<0,0001), idade (56,8±15,9 x 49,8± 17,8 anos, p< 0,0001), APACHE II (21,9±6,9 x 14,1±4,6, p<0,0001), ventilação mecânica (89,2 x 69,1%, p<0,0001) e uso de drogas vasoativas (78,3 x 56,1%, p<0,0001). Com relação aos fatores de risco e às comorbidades, os grupos foram diferentes quanto à presença de diabetes mellitus, insuficiência cardíaca congestiva, insuficiência renal crônica e uso de anti-inflamatórios não hormonais (28,2 x 19,7%, p=0,03; 23,6 x 11,6%, p=0,0002, 21,5 x 11,5%, p< 0,0001 e 23,5 x 7,1%, p<0,0001, respectivamente). O tempo de internação e a mortalidade foram superiores nos pacientes que adquiriram injúria renal aguda (6,6 ± 2,7 x 12,9± 5,6 dias p<0,0001 e 62,5 x 16,4%, p<0,0001). À análise multivariada foram identificados como fatores de risco para injúria renal aguda, idade>55 anos, APACHE II>16, creatinina (cr) basal>1,2 e uso de anti-inflamatórios não hormonais (OR=1,36 IC:1,22-1,85, OR=1,2 IC:1,11-1,33, OR=5,2 IC:2,3-11,6 e OR=2,15 IC:1,1-4,2, respectivamente) e a injúria renal aguda esteve independentemente associada ao maior tempo de internação e à mortalidade (OR=1,18 IC:1,05-1,26 e OR=1,24 IC:1,09-1,99 respectivamente). À análise da curva de sobrevida, após 30 dias de internação, a mortalidade foi de 83,3% no G1 e 45,2% no G2 (p<0,0001). CONCLUSÃO: A incidência de injúria renal aguda é elevada em unidade de terapia intensiva, os fatores de riscos independentes para adquirir injúria renal aguda são idade >55 anos, APACHE II>16, Cr basal >1,2 e uso de anti-inflamatórios não hormonais e a injúria renal aguda é fator de risco independente para o maior tempo de permanência em unidade de terapia intensiva e mortalidade.

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OBJETIVO: avaliar a qualidade de vida de pacientes com osteoporose e osteopenia, acompanhadas em ambulatórios especializados em osteoporose e climatério, comparando-as com pacientes com densidade mineral óssea (DMO) normal. MÉTODOS: estudo de série de casos transversal, observacional, que se propôs a analisar, por meio do questionário Medical Outcomes Study 36 Short-Form Health Survey (SF-36), a qualidade de vida de mulheres com osteopenia e osteoporose. Foram avaliadas 124 mulheres na pós-menopausa divididas em três grupos: 55 pacientes com diagnóstico densitométrico de osteoporose, 35 com o de osteopenia e 34 que apresentavam DMO normal. Os três grupos foram comparados com relação aos dados demográficos, características clínicas e de estilo de vida e aos diferentes domínios do SF-36. RESULTADOS: as pacientes dos grupos osteopenia e DMO normal apresentaram menor idade média (56,7±7,1 e 52,9±5,4 anos), maior índice de massa corpórea (IMC) (28,6±3,7 e 30,9±5,1 kg/m²) e menor tempo de menopausa (8,4±5,9 e 5,8±4,5 anos) quando comparadas ao grupo osteoporose (61,8±10,1 anos, IMC de 25,7±5,3 kg/m², 15,5±7,5 anos, respectivamente; p<0,05). de acordo com o SF-36, não houve diferença significativa entre os grupos com relação aos domínios, à exceção do domínio vitalidade, que se mostrou superior no grupo osteoporose. Com relação à impressão pessoal sobre seu estado de saúde, das pacientes que o consideraram bom, um maior percentual pertencia ao grupo osteoporose, e entre aquelas que o consideraram ruim, um percentual menor pertencia ao grupo osteopenia. CONCLUSÃO: a qualidade de vida foi similar em mulheres com osteoporose e osteopenia, em relação às com DMO normal, à exceção do domínio vitalidade, que foi superior, paradoxalmente, nas pacientes com osteoporose.

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Many studies have demonstrated the relationship between dialysis dose and survival. Global mortality is similar among men and women; however, the influence of dialysis dose in the survival could be more intensive between women. Therefore, we conduct an observational study to evaluate the gender-related impact of single pool Kt/V (spKt/V) on the survival of patients submitted to hemodialysis in a university hospital. We found that survival was lower in groups with spKt/V smaller than 1.2 than in those with Kt/V between 1.2 and 1.4. Among female patients, spKt/V smaller than 1.2 had a more adverse effect in survival than among men with a comparable Kt/V. Otherwise, among women, the dialysis dose had an impact in survival even with Kt/V greater than 1.4. Thus, fractional urea clearance more heavily influenced the survival of females than males in hemodialysis patients.

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Intensity of dialysis dose in acute kidney injury (AKI) might benefit critically ill patients. The aim of this study was to evaluate the effect of intermittent hemodialysis (IHD) dose on mortality in patients with AKI. Methods: Prospective observational study was performed on AKI patients treated with IHD. The delivered dialysis dose per session was calculated based on single-pool Kt/V urea. Patients were allocated in two groups according to the weekly delivered median Kt/V: higher intensity dialysis dose (HID: Kt/V higher than median) and lower intensity dialysis dose (LID: Kt/V lower than median). Thereafter, AKI patients were divided according to the presence or absence of sepsis and urine output. Clinical and lab characteristics and survival of AKI patients were compared. Results: A total of 121 AKI patients were evaluated. Forty-two patients did not present with sepsis and 45 did not present with oliguria. Mortality rate after 30 days was lower in the HID group without sepsis (14.3% x 47.6%; p = 0.045) and without oliguria (31.8% x 69.5%; p = 0.025). Survival curves also showed that the HID group had higher survival rate when compared with the LID group in non-septic and non-oliguric patients (p = 0.007 and p = 0.003, respectively). Conclusion: Higher dialysis doses can be associated with better survival of less seriously ill AKI patients.

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OBJETIVO: Analisar comparativamente características clínicas e evolução de pacientes com e sem IRA adquirida em UTI geral de um hospital universitário terciário. MÉTODO: Estudo prospectivo observacional com 263 pacientes acompanhados diariamente durante a internação em UTI Geral do Hospital das Clínicas da Faculdade de Medicina de Botucatu no período de julho de 2007 a abril de 2008. RESULTADOS: A incidência de IRA foi de 31,2%. Os grupos foram semelhantes quanto ao sexo e diferiram quanto à etiologia da admissão em UTI (sepse: 31,7% x 13,1%, p < 0,0001, pós-operatório: 11% x 43%, p < 0,0001), idade (59,6 ± 18,1 x 50,2 ± 18,6 anos, p < 0,0001), APACHE II: (21 ± 11,1 x 11 ± 4,8, p = 0,002), oligúria (67,7% x 4,5%, p < 0,0001), presença de ventilação mecânica (81,7 x 57,7%, p = 0,0014), uso de drogas vasoativas (62,2 x 32,6%, p < 0,0001) e enfermaria de procedência (PS: 22 x 14,5%, p = 0,02 e centro cirúrgico: 42,7 x 62,6%, p = 0,03). Quanto às comorbidades, os grupos foram diferentes quanto à presença de HAS e IRC (42,6 x 35,9%, p = 0,005 e 15,8 x 2,1%, p = 0,04, respectivamente) e semelhantes quanto à presença de diabetes e ICC (19,5 x 11%, ns e 6 x 1,1%, ns, respectivamente). A mortalidade foi superior nos pacientes que contraíram IRA (62,1 x 16,5%, p < 0,0001). CONCLUSÃO: A incidência de IRA é elevada em UTI e presente em pacientes com parâmetros clínicos e índices prognósticos de maior gravidade, o que justifica a maior mortalidade observada neles.