16 resultados para Safety and quality

em Biblioteca Digital da Produção Intelectual da Universidade de São Paulo (BDPI/USP)


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OBJECTIVE: This study aimed to assess the survival and life quality evolution of patients subjected to surgical excision of oral and oropharyngeal squamous cell carcinoma. MATERIAL AND METHODS: Forty-seven patients treated at a Brazilian healthcare unit specialized in head and neck surgery between 2006 and 2007 were enrolled in the study. The gathering of data comprised reviewing hospital files and applying the University of Washington Quality of Life (UW-QOL) questionnaire previously and 1 year after the surgery. Comparative analysis used Poisson regression to assess factors associated with survival and a paired t-test to compare preoperative and 1-year postoperative QOL ratings. RESULTS: 1 year after surgery, 7 patients were not found (dropout of the cohort); 15 had died and 25 fulfilled the UW-QOL again. The risk of death was associated with having regional metastasis previously to surgery (relative risk=2.18; 95% confidence interval=1.09-5.17) and tumor size T3 or T4 (RR=2.30; 95%CI=1.05-5.04). Survivors presented significantly (p<0.05) poorer overall and domain-specific ratings of quality of life. Chewing presented the largest reduction: from 74.0 before surgery to 34.0 one year later. Anxiety was the only domain whose average rating increased (from 36.0 to 70.7). CONCLUSIONS: The prospective assessment of survival and quality of life may contribute to anticipate interventions aimed at reducing the incidence of functional limitations in patients with oral and oropharyngeal cancer.

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For the diagnosis and prognosis of the problems of quality of life, a multidisciplinary ecosystemic approach encompasses four dimensions of being-in-the-world, as donors and recipients: intimate, interactive, social and biophysical. Social, cultural and environmental vulnerabilities are understood and dealt with, in different circumstances of space and time, as the conjugated effect of all dimensions of being-in-the-world, as they induce the events (deficits and assets), cope with consequences (desired or undesired) and contribute for change. Instead of fragmented and reduced representations of reality, diagnosis and prognosis of cultural, educational, environmental and health problems considers the connections (assets) and ruptures (deficits) between the different dimensions, providing a planning model to develop and evaluate research, teaching programmes, public policies and field projects. The methodology is participatory, experiential and reflexive; heuristic-hermeneutic processes unveil cultural and epistemic paradigms that orient subject-object relationships; giving people the opportunity to reflect on their own realities, engage in new experiences and find new ways to live better in a better world. The proposal is a creative model for thought and practice, providing many opportunities for discussion, debate and development of holistic projects integrating different scientific domains (social sciences, psychology, education, philosophy, etc.)

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Aim: To evaluate the sexual functioning of breast cancer patients post mastectomy and its association with their quality of life, the personal characteristics of women and their partners, breast reconstruction, cancer staging and adjuvant therapies. Methods: A cross-sectional study was carried out in a University hospital located in the SouthEast of Brazil. A total of 100 women were included in the study. The parameters evaluated were sexual functioning, which was assessed based on the Sexual Quotient Female Version (SQ-F), quality of life (QoL), evaluated by the Medical Outcomes Study 36-item Short Form (SF-36), cancer staging, breast reconstruction, adjuvant therapies and the personal characteristics of patients (age, years of study and years of marriage) and their partners (age, years of study). Results: The majority (40.48%) of women had an unfavorable to regular SQ-F score. A significant positive correlation (p < 0.05) was found between the SQ-F score and years of education (p = 0.03), and the following SF-36 domains: functional capacity (p = 0.03), vitality (p = 0.06), emotional limitations (p = 0.00) and mental health (p = 0.03). A significant negative correlation was found between SQ-F score and the age of the partners (p = 0.03). SQ-F mean value was significantly higher (p = 0.04) among women who underwent breast reconstruction. Conclusions: Women with low educational level, who have older partners, and who did not have a breast reconstruction should receive special attention with respect to their sexuality, and the effects of mastectomy on the sexuality of patients should be assessed. Oncology nurses are best qualified to recognize issues related to sexuality and quality of life, and can offer specific and meaningful support for breast cancer patients. (C) 2010 Elsevier Ltd. All rights reserved.

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Aim. To identify the impact of pain on quality of life (QOL) of patients with chronic venous ulcers. Methods. A cross-sectional study was performed on 40 outpatients with chronic venous ulcers who were recruited at one outpatient care center in Sao Paulo, Brazil. WHOQOL-Bref was used to assess QOL, the McGill Pain Questionnarie-Short Form (MPQ) to identify pain characteristics, and an 11-point numerical pain rating scale to measure pain intensity. Kruskall-Wallis or ANOVA test, with post-hoc correction (Tukey test) was applied to compare groups. Multiple linear regression models were used. Results. The mean age of the patients was 67 +/- 11 years (range, 39-95 years), and 26 (65%) were women. The prevalence of pain was 90%, with worst pain mean intensity of 6.2 +/- 3.5. Severe pain was the most prevalent (21 patients, 52.5%). Pain most frequently reported was sensory-discriminative and evaluate in quality. Pain was significantly and negatively correlated with physical (PY), environmental (EV), and overall QOL. Compared to a no-pain group, those with pain had lower overall QOL. On multiple analyses, pain remained as a predictor of overall QOL (beta = -0.73, P = 0.03) and was also predictive of social QOL, whereas pain did not have any impact on physical, emotional, or social relationships QOL (beta = -3.85, P = 0.00) when adjusted for age, number, duration and frequency of wounds, pain dimension (MPQ), partnership, and economic status. Conclusion. To improve QOL of out-patients with chronic venous ulcers, the qualities and the intensity of pain must be considered differently.

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Marker assisted selection depends on the identification of tightly linked association between marker and the trait of interest. In the present work, functional (EST-SSRs) and genomic (gSSRs) microsatellite markers were used to detect putative QTLs for sugarcane yield components (stalk number, diameter and height) and as well as for quality parameters (Brix, Pol and fibre) in plant cane. The mapping population (200 individuals) was derived from a bi-parental cross (IACSP95-3018 x IACSP93-3046) from the IAC Sugarcane Breeding Program. As the map is under construction, single marker trait association analysis based on the likelihood ratio test was undertaken to detect the QTLs. Of the 215 single dose markers evaluated (1:1 and 3:1), 90 (42%) were associated with putative QTLs involving 43 microsatellite primers (18 gSSRs and 25 EST-SSRs). For the yield components, 41 marker/trait associations were found: 20 for height, 6 for diameter and 15 for stalk number. An EST-SSRs marker with homology to non-phototropic hypocotyls 4 (NPH4) protein was associated with a putative QTL with positive effect for diameter as also with a negative effect for stalk number. In relation to the quality parameters, 18 marker trait associations were found for Brix, 19 for Pol, and 12 for fibre. For fibre, 58% of the QTLs detected showed a negative effect on this trait. Some makers associated with QTLs with a negative effect for fibre showed a positive effect for Pol, reflecting the negative correlation generally observed between these traits.

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The citriculture in Brazil, as well as in other important regions in the world, is based on very few mandarin cultivars. This fact leads to a short harvest period and higher prices for off-season fruit. The `Okitsu` Satsuma (Citrus unshiu Marc.) is among the earliest ripening mandarin cultivars and it is considered to be tolerant to, citrus canker (Xanthomonas citri subsp. citri Schaad et al.) and to citrus variegated chlorosis (Xylella fastidiosa Wells et al.). Despite having regular fruit quality under hot climate conditions, the early fruit maturation and absence of seeds of `Okitsu` fruits are well suited for the local market in the summer(December through March), when the availability of citrus fruits for fresh consumption is limited. Yet, only a few studies have been conducted in Brazil on rootstocks for `Okitsu`. Consequently, a field trial was carried out in Bebeclouro, Sao Paulo State, to evaluate the horticultural performance of `Okitsu` Satsuma mandarin budded onto 12 rootstocks: the citrandarin `Changsha` mandarin (Citrus reticulata Blanco) x Poncirus trifoliata `English Small`: the hybrid Rangpur lime (Citrus limonia Osbeck) x `Swingle` citrumelo (P. trifoliata (L.) Raf. x Citrus paradisi Macfad.); the trifoliates (P. trifoliata (L) Raf)`Rubidoux`,`FCAV` and `Flying Dragon`(P. trifoliata var. monstrosa); the mandarins `Sun Chu Sha Kat`(C. reticulata Blanco) and `Sunki`(Citrus sunki (Hayata) Hort. ex. Tanaka); the Rangpur limes (C. limonia Osbeck) `Cravo Limeira` and `Cravo FCAV`;`Carrizo` citrange (Citrus sinensis x P. trifoliata), `Swingle` citrumelo (P. trifoliata x C. paradisi), and `Orlando` tangelo (C. paradisi x Citrus tangerina cv. `Dancy`). The experimental grove was planted in 2001, using a 6 m x 3 m spacing, in a randomized block design. No supplementary irrigation was applied. Fruit yield, canopy volume, and fruit quality were assessed for each rootstock. A cluster multivariate analysis identified three different rootstock pairs with similar effects on plant growth, yield and fruit quality of `Okitsu` mandarin. The `Flying Dragon `trifoliate had a unique effect over the `Okitsu` trees performance, inducing lower canopy volume and higher yield efficiency and fruit quality, and might be suitable for high-density plantings. The `Cravo Limeira` and `Cravo FCAV` Rangpur limes induced early-ripening of fruits, with low fruit quality. `Sun Chu Sha Kat` and `Sunki` mandarins and the `Orlando` tangelo conferred lower yield efficiency and less content of soluble solids for the latter rootstock. (C) 2009 Elsevier B.V. All rights reserved.

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Natural forest remnants have been set as seed production fields to supply seeds of native tree species for tropical forest restoration, but the effect of different forest types on seed production has not been accessed to date for palm species. In this work, we studied seed development, yield, and quality of two palm species in different tropical forest types in SE Brazil. Seed production of palmiteiro (Euterpe edulis) and queen-palm (Syagrus romanzoffiana), which are largely used in restoration efforts due to their importance for vertebrate frugivores, were studied in natural remnants of Atlantic Rainforest, Restinga Forest, Seasonally Dry Forest, and Cerrado Forest. We studied seed development, yield, size, and germination of seed lots produced in some of these forest types, including seeds harvested in 2008, 2009, and both years. Seed yield and quality, as well as seed dry mass in 2009, were higher for palmiteiro seeds produced in the Atlantic Rainforest, while queen-palm seeds produced at the Restinga Forest showed the higher mass and yield, but the lowest physiological potential. Consequently, these natural differences of seed yield and quality have to be taken into account for establishing standards for seed commercialization and analysis, seed pricing, and seedling production in forest nurseries.

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The investigation of the factors that interfere in the well-being of the elderly and their QoL can provide theoretical and methodological subsidies in structuring actions and policies in the health area, in order to fulfill the needs of that population. In this descriptive transversal study, body composition and QoL of elderly women at the UTA program in Piracicaba (Sao Paulo, Brazil) were verified. The participants were 81 women from UTA, and the general levels of physical activity were evaluated, as well as body weight (BW), height, and bodymass index (BMI). The waist circumference (WC) was measured at the level of the umbilical scar and the body composition by impedance (BIA 310e). QoL was verified by means of WHOQOL-Bref and statistical analysis developed with the SAS program. The decrease of weight, height, BMI, and fat-free mass (FFM) was observed among the several age groups, although with no significant difference. The average levels of the general QoL scores and physical, psychological and environmental domains decreased in higher age groups, but social domains showed the opposite result. This fact can be a particular characteristic of the UTA group, and factors the influence such behavior are yet to be studied. (C) 2010 Elsevier Ireland Ltd. All rights reserved.

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As a consequence of the large distribution and use of medicinal plants, the industries are producing products based on plant species in various pharmaceutical forms, which have been commercialized in pharmacies and natural products homes. However, there is no guarantee for the vast majority of these products, as to their effctiveness, safety, and quality, which may cause risks to the health of consumers. There it is important the establishment of standardized protocols of quality control for phytotherapeutic products. Tinctures of barbatimao are available in the Brazilian market proceeding from diverse manufacturers. With the purpose to evaluate the difference between the quality of tinctures of barbatimao proceeding from four manufactures, a comparative study of ph ysico-chenfical andphylocheinical characteristics was carried out. For physico-chemical analysis, the pH, density, dry residue and tannins content were evaluated. The phytochemical analysis was made using thin layer chromatography. The differences observed in physico-chemical and phytochemical characteristics had evidenced the lack of standardization in the production of these tinctures.

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Objectives: To evaluate clinical predictors of poor sleep quality and quality of life (QOL) in patients with hypertrophic cardiomyopathy (HCM). Methods: Consecutive stable patients with HCM were evaluated for the risk of obstructive sleep apnea (OSA) by the Berlin Questionnaire, daytime sleepiness by the Epworth Sleepiness Scale, sleep quality by the Pittsburgh Sleep Questionnaire Index and QOL by the Minnesota Living with Heart Failure Questionnaire. Asymptomatic subjects without HCM were used as controls. Results: We studied 84 patients with HCM and 42 controls who were similar with regard to gender (49 vs. 50% males), age [52 (38-62) vs. 47 (33-58) years] and body mass index (27 +/- 4 vs. 27 +/- 5). HCM diagnosis, high risk for OSA and female gender were independently associated with poor sleep quality in the entire population. Among patients with HCM, poor QOL was independently associated with poor sleep quality, New York Heart Association functional class and diuretic therapy. Conclusion: Poor sleep quality is very common in patients with HCM and may have a negative impact on the QOL, which in turn is an important marker of prognosis in patients with cardiomyopathies. Copyright (C) 2010 S. Karger AG, Basel

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Background-Randomized trials that studied clinical outcomes after percutaneous coronary intervention (PCI) with bare metal stenting versus coronary artery bypass grafting (CABG) are underpowered to properly assess safety end points like death, stroke, and myocardial infarction. Pooling data from randomized controlled trials increases the statistical power and allows better assessment of the treatment effect in high-risk subgroups. Methods and Results-We performed a pooled analysis of 3051 patients in 4 randomized trials evaluating the relative safety and efficacy of PCI with stenting and CABG at 5 years for the treatment of multivessel coronary artery disease. The primary end point was the composite end point of death, stroke, or myocardial infarction. The secondary end point was the occurrence of major adverse cardiac and cerebrovascular accidents, death, stroke, myocardial infarction, and repeat revascularization. We tested for heterogeneities in treatment effect in patient subgroups. At 5 years, the cumulative incidence of death, myocardial infarction, and stroke was similar in patients randomized to PCI with stenting versus CABG (16.7% versus 16.9%, respectively; hazard ratio, 1.04, 95% confidence interval, 0.86 to 1.27; P = 0.69). Repeat revascularization, however, occurred significantly more frequently after PCI than CABG (29.0% versus 7.9%, respectively; hazard ratio, 0.23; 95% confidence interval, 0.18 to 0.29; P<0.001). Major adverse cardiac and cerebrovascular events were significantly higher in the PCI than the CABG group (39.2% versus 23.0%, respectively; hazard ratio, 0.53; 95% confidence interval, 0.45 to 0.61; P<0.001). No heterogeneity of treatment effect was found in the subgroups, including diabetic patients and those presenting with 3-vessel disease. Conclusions-In this pooled analysis of 4 randomized trials, PCI with stenting was associated with a long-term safety profile similar to that of CABG. However, as a result of persistently lower repeat revascularization rates in the CABG patients, overall major adverse cardiac and cerebrovascular event rates were significantly lower in the CABG group at 5 years.

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Aim: A positive effect of liver transplantation on health-related quality of life (HRQOL) has been well documented in previous studies using generic instruments. Our aim was to re-evaluate different aspects of HRQOL before and after liver transplantation with a relatively new questionnaire the `liver disease quality of life` (LDQOL). Methods: The LDQOL and the Short Form 36 (SF-36) questionnaires were applied to ambulatory patients, either in the transplant list (n=65) or after 6 months to 5 years of liver transplant (n=61). The aetiology of cirrhosis, comorbidities, model for end-stage liver disease (MELD) Child-Pugh scores and recurrence of liver disease after liver transplantation were analysed using the Mann-Whitney and Kruskall-Wallis tests. Results: In patients awaiting liver transplantation, MELD scores >= 15 and Child-Pugh class C showed statistically significant worse HRQOL, using both the SF-36 and the LDQOL questionnaires. HRQOL in pretransplant patients was found to be significantly worse in those with cirrhosis owing to hepatitis C (n=30) when compared with other aetiologies (n=35) in 2/7 domains of the SF-36 and in 7/12 domains of the LDQOL. Significant deterioration of HRQOL after recurrence of hepatitis C post-transplant was detected with the LDQOL questionnaire although not demonstrated with the SF-36. The statistically significant differences were in the LDQOL domains: symptoms of liver disease, concentration, memory and health distress. Conclusions: The LDQOL, a specific instrument for measuring HRQOL, has shown a greater accuracy in relation to liver symptoms and could demonstrate, with better reliability, impairments before and after liver transplantation.

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Objective. Refractory, disabling pain associated with knee osteoarthritis (OA) is usually treated with total knee replacement. However, pain in these patients might be associated with central nervous sensitization rather than peripheral inflammation and injury. We evaluated the presence of hyperalgesia in patients scheduled for a total knee replacement due to knee osteoarthritis with refractory pain, and we assessed the impact of pressure pain threshold measurements (PPT) on pain, disability, and quality of life of these patients. Methods. Sixty-two female patients were compared with 22 age-matched healthy controls without reported pain for the last year. PPT was measured at the lower extremities subcutaneous dermatomes, over the vastus medialis, adductor longus, rectus femoris, vastus lateralis, tibialis anterior, peroneus longus, iliacus, quadratus lumborum and popliteus muscles and at the supraspinous ligaments from L1-L5, over the L5-S1 and S1-S2 sacral areas and at the pes anserinus bursae and patellar tendon. Results. Patients with knee OA had significantly lower PPT over all evaluated structures versus healthy control subjects (P < 0.001). Lower PPT values were correlated with higher pain intensity, higher disability scores, and with poorer quality of life, except for the role-emotional and general health status. Combined PPT values over the patellar tendon, at the S2 subcutaneous dermatome and at the adductor longus muscle were the best predictors for visual analog scale and Western Ontario and McMaster Universities Osteoarthritis Index pain scores. Conclusion. Patients with pain due to osteoarthritis who were scheduled for total knee replacement showed hyperalgesia of nervous system origin that negatively impacted pain, knee functional capacity, and most aspects of quality of life.

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Objective. To evaluate the safety and immunogenicity of varicella vaccine (VV) in susceptible patients with juvenile rheumatic diseases receiving methotrexate and corticosteroids. Methods. Twenty-five patients with juvenile rheumatic diseases (ages 2-19 years) and 18 healthy children and adolescents (ages 3-18 years) received a single dose of VV. All 25 patients were receiving methotrexate; 13 were also receiving prednisone and 5 were also receiving other disease-modifying antirheumatic drugs. None of the vaccinated patients or controls had a previous history of varicella. Anti-varicella-zoster virus IgG antibody (anti-VZV-IgG) titers were measured by enzyme-linked immunosorbent assay immediately before, 4-6 weeks after, and 1 year after vaccination. The patients were monitored prospectively for adverse reactions related to the vaccine, exposure, and occurrence of varicella. Disease activity was assessed 3 months before and 3 months after VV. Results. Twenty patients and all of the controls had negative preimmunization titers of VZV-IgG, and 5 patients had equivocal levels. Positive VZV-IgG titers were detected in 10 (50%) of 20 seronegative patients and 13 (72.2%) of 18 controls 4-6 weeks after VV (P = 0.2). One year after vaccination, 8 of 10 patients maintained positive VZV-IgG titers. No overt varicella episodes and no severe adverse reactions were observed during the followup period. No worsening of clinical parameters and no flares of juvenile rheumatic diseases or changes in doses of medications used were detected after vaccination. In fact, the number of active joints in patients with juvenile idiopathic arthritis was significantly lower after VV (P = 0.009). Conclusion. VV appears to be safe in patients with juvenile rheumatic diseases receiving methotrexate, as long as continuous prospective vigilance for side effects is performed.

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For the diagnosis and prognosis of the problems of quality of life, a multidisciplinary ecosystemic approach encompasses four dimensions of being-in-the-world, as donors and recipients: intimate, interactive, social and biophysical. Social, cultural and environmental vulnerabilities are understood and dealt with, in different circumstances of space and time, as the conjugated effect of all dimensions of being-in-the-world, as they induce the events (deficits and assets), cope with consequences (desired or undesired) and contribute for change. Instead of fragmented and reduced representations of reality, diagnosis and prognosis of cultural, educational, environmental and health problems considers the connections (assets) and ruptures (deficits) between the different dimensions, providing a planning model to develop and evaluate research, teaching programmes, public policies and field projects. The methodology is participatory, experiential and reflexive; heuristic-hermeneutic processes unveil cultural and epistemic paradigms that orient subject-object relationships; giving people the opportunity to reflect on their own realities, engage in new experiences and find new ways to live better in a better world. The proposal is a creative model for thought and practice, providing many opportunities for discussion, debate and development of holistic projects integrating different scientific domains (social sciences, psychology, education, philosophy, etc.).