869 resultados para 290309 Safety and Quality


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This dissertation examines the effect of regulations, resource and referral agencies, and subsidies on price and quality of care in child care centers. This research is based on a carefully developed conceptual framework that incorporates the factors affecting the demand and supply of child care. The first step in developing this framework is sketching out the structural equations. The structural equations help us understand the underlying behavior of individuals and firms making a decision. The exogenous variables are vector of attributes relating to family characteristics, child characteristics, regulations, subsidy, community characteristics and prices of inputs. Based on the structural equations, reduced form equations are estimated to find the effect of each of the exogenous variables on each of the endogenous variables. Reduced form equations help us answer public policy questions. The sample for this study is from the 1990 Profile of Child Care Settings (PCCS) data in which 2,089 center based programs were interviewed.^ Child/Staff Ratio (Group Level). Results indicate that among subsidies, only the state subsidy per child in poverty has a significant effect on the child/staff ratio at the group level. Presence of resource and referral agencies also increase the child/staff ratio at the group level. Also when the maximum center group size regulation for 25-36 months becomes more stringent, the child/staff ratio at the group level decreases.^ Child/Staff Ratio (Center Level). When the regulations for the maximum child/staff ratio for age groups 13-24 months and 37-60 months become lax, the child/staff ratio for the center increases. As the regulation for maximum group size for infants becomes stringent, the child/staff ratio decreases. An interesting finding is that as the regulations for maximum group size for age groups 13-24 months and 25-36 months become stringent, the child/staff ratio for the center increases. Another significant finding is that when a center is located in a rural area the child/staff ratio is significantly lower.^ Center Weighted Average Hourly Fees. Maximum group size regulations for age groups 25-36 months and 37-60 months have a negative effect on center hourly fee. Maximum child staff regulations for age groups 13-24 months and 37-60 months have a negative effect on center hourly fee. Maximum child staff regulations for age groups 0-12 months and 25-36 months have a positive effect on center hourly fee. Findings also indicate that the center average hourly price is lower when there is a resource and referral agency present. Cost adjusted prekindergarten funds and JOBS child care subsidies have a negative effect on average hourly fee. Cost adjusted social services block grant and state subsidy per child in poverty have a positive effect on the average hourly price. A major finding of this dissertation is the interaction of subsidy and regulatory variables.^ Another major finding is that child/staff ratio at the group level is lower when there is an interaction between geographic location and nature of center sponsorship. ^

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The present study tested a nomological net of work engagement that was derived from its extant research. Two of the main work engagement models that have been presented and empirically tested in the literature, the JD-R model and Kahn's model, were integrated to test the effects that job features and personal characteristics can have on work engagement through the psychological conditions of meaningfulness, safety, and availability. In this study, safety refers to psychological perceptions of safety and not workplace safety behaviors. The job features that were tested in this model included person-job fit, autonomy, co-worker relations, supervisor support, procedural justice, and interactional justice, while the personal characteristics consisted of self-consciousness, self-efficacy, extraversion, and neuroticism. Thirty-four hypotheses and a conceptual model were tested in order to establish the viability of this nomological net of work engagement in which it was expected that meaningfulness would mediate the relationships between job features and work engagement, safety would mediate the relationships that job features and personal characteristics have with work engagement, and availability (physical, emotional, and cognitive resources) would mediate the relationships that personal characteristics have with work engagement. Furthermore, analyses were run in order to determine the factor structure of work engagement, assess whether or not it exhibits differential validity from organizational commitment and job satisfaction, and confirm that it is positively related to the outcome variable of organizational citizenship behavior (OCB). The final sample consisted of 500 workers from an online labor market who responded to a questionnaire composed of measures of all constructs included in this study. Findings show that work engagement is best represented as a three-factor construct, composed of vigor, dedication and absorption. Furthermore, support was found for the distinction of work engagement from the related constructs of organizational commitment and job satisfaction. With regard to the proposed model, meaningfulness proved to be the strongest predictor of work engagement. Results show that it partially mediates the relationships that all job features have with work engagement. Safety proved to be a partial mediator of the relationships that autonomy, co-worker relations, supervisor support, procedural justice, interactional justice, and self-efficacy have with work engagement, and fully mediate the relationship between neuroticism and work engagement. Findings also show that availability partially mediates the positive relationships that extraversion and self-efficacy have with work engagement, and fully mediates the negative relationship that neuroticism has with work engagement. Finally, a positive relationship was found between work engagement and OCB. Research and organizational implications are discussed.

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In this thesis, we proposed the use of device-to-device (D2D) communications for extending the coverage area of active base stations, for public safety communications with partial coverage. A 3GPP standard compliant D2D system level simulator is developed for HetNets and public safety scenarios and used to evaluate the performance of D2D discovery and communications underlying cellular networks. For D2D discovery, the benefits of time-domain inter-cell interference coordi- nation (ICIC) approaches by using almost blank subframes were evaluated. Also, the use of multi-hop is proposed to improve, even further, the performance of the D2D discovery process. Finally, the possibility of using multi-hop D2D communications for extending the coverage area of active base stations was evaluated. Improvements in energy and spectral efficiency, when compared with the case of direct UE-eNB communi- cations, were demonstrated. Moreover, UE power control techniques were applied to reduce the effects of interference from neighboring D2D links.

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This dissertation examines the effect of regulations, resource and referral agencies, and subsidies on price and quality of care in child care centers. This research is based on a carefully developed conceptual framework that incorporates the factors affecting the demand and supply of child care. The first step in developing this framework is sketching out the structural equations. The structural equations help us understand the underlying behavior of individuals and firms making a decision. The exogenous variables are vector of attributes relating to family characteristics, child characteristics, regulations, subsidy, community characteristics and prices of inputs. Based on the structural equations, reduced form equations are estimated to find the effect of each of the exogenous variables on each of the endogenous variables. Reduced form equations help us answer public policy questions. The sample for this study is from the 1990 Profile of Child Care Settings (PCCS) data in which 2,089 center based programs were interviewed. Child/Staff Ratio (Group Level): Results indicate that among subsidies, only the state subsidy per child in poverty has a significant effect on the child/staff ratio at the group level. Presence of resource and referral agencies also increase the child/staff ratio at the group level. Also when the maximum center group size regulation for 25-36 months becomes more stringent, the child/staff ratio at the group level decreases. Child/Staff Ratio (Center Level): When the regulations for the maximum child/staff ratio for age groups 13-24 months and 37-60 months become lax, the child/staff ratio for the center increases. As the regulation for maximum group size for infants becomes stringent, the child/staff ratio decreases. An interesting finding is that as the regulations for maximum group size for age groups 13-24 months and 25-36 months become stringent, the child/staff ratio for the center increases. Another significant finding is that when a center is located in a rural area the child/staff ratio is significantly lower. Center Weighted Average Hourly Fees: Maximum group size regulations for age groups 25-36 months and 37-60 months have a negative effect on center hourly fee. Maximum child staff regulations for age groups 13-24 months and 37-60 months have a negative effect on center hourly fee. Maximum child staff regulations for age groups 0-12 months and 25-36 months have a positive effect on center hourly fee. Findings also indicate that the center average hourly price is lower when there is a resource and referral agency present. Cost adjusted prekindergarten funds and JOBS child care subsidies have a negative effect on average hourly fee. Cost adjusted social services block grant and state subsidy per child in poverty have a positive effect on the average hourly price. A major finding of this dissertation is the interaction of subsidy and regulatory variables. Another major finding is that child/staff ratio at the group level is lower when there is an interaction between geographic location and nature of center sponsorship.

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Objectives To evaluate the change in masticatory efficiency and quality of life of patients treated with mandibular Kennedy class I removable partial dentures (RPDs) and maxillary complete dentures at the Department of Dentistry of the Federal University of Rio Grande do Norte. Materials and methods A total of 33 Kennedy class I patients were rehabilitated with maxillary complete dentures, and mandibular RPDs were selected for this non-randomized prospective intervention study. The patients had a mean age of 59.1 years. Masticatory efficiency was evaluated by colorimetric assay using fuchsin capsules. The measurements were conducted at baseline and 2 and 6 months after prosthesis insertion. Quality of life was evaluated using the Oral Health Impact Profile (OHIP-14) at baseline and 6 months after denture insertion. The Kolmogorov-Smirnov normality test was applied. Masticatory efficiency was evaluated by repeated measures ANOVA. Oral health-related quality of life was compared using the paired t test. Results There was no statistically significant difference in masticatory efficiency after denture insertion (p = 0.101). Significant differences were found (p = 0.010) for oral health-related quality of life. A significant improvement in psychological discomfort (p < 0.01) and psychological disability (p < 0.01) was observed. Mean difference value (95 % confidence interval) was 6.8 (3.8 to 9.7) points, reflecting a low impact of oral health on quality of life, considering the 0–56 range of variation of the OHIP-14 and a Cohen’s d of 1.13. Conclusion According to the results of the present study, rehabilitation with Kennedy class I RPDs and complete dentures did not influence masticatory efficiency but improved oral health-related quality of life. Clinical relevance The association between the patient’s quality of life and the masticatory efficiency is important for treatment predictability.

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The condition and quality of cultured blue mussels (Mytilus edulis) are affected by various environmental characteristics including temperature, salinity, food concentration, composition and year-to-year variability, waves, tides, and currents. Mussels are a keystone species in the ecosystem, affecting the surrounding environment through filtration, biodeposition and nutrient recycling. This study evaluated the effects of culture depth and post-harvest handling on cultured blue mussels in Newfoundland, Canada. Depth was examined over two years; three shallow water (5 m depth) and three deep water sites (15 m depth) were compared for environmental characteristics, mussel physiological stress response, growth, and biochemical composition. The area examined presented complex hydrodynamic characteristics; deep water sites appeared to be located more often near or within the pycnocline than shallow water sites. Deep water sites presented lower temperatures than shallow sites from spring to fall. Physiological stress response varied seasonally, but was unaffected by culture depth. In Year 1 shallow and deep water mussels presented similar growth, while in Year 2 deep water mussels showed better final condition. Lipid and glycogen showed seasonal variation, but no significant differences between shallow and deep water were noted. Fatty acid profiles showed a higher content of omega-3s PUFA in deep water sites at the end of Year 2. Under extreme weather conditions, deep water appeared to provide a more stable environment for mussel growth than shallow water. Harvested mussels were kept under ambient live-holding conditions for one month during the fall, winter, and spring seasons. They were compared to freshly harvested mussels for condition, biochemical profile and palatability. A progressive loss of dry tissue weight and an increase in water content were shown over the holding period during the fall and spring seasons, when compared to field controls. The biochemical analysis suggested seasonal changes; differences in triacylglycerol content were found in the spring season when compared with controls. The palatability data indicated that the panellists were unable to determine a difference between mussels kept in holding and those freshly harvested from the site. This study presents new knowledge for mussel farming, especially in terms of environmental interactions and deep water culture.

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Acknowledgements: Thanks go to the participants of the ‘Health and Work’ Organised Session (2011) of the Scottish Economic Society 2011 Annual Conference, Perth, Scotland, for helpful comments. The authors are also grateful to the editor Franco Peracchi and the referees of this journal for helpful comments and suggestions. The financial support of the European Commission is gratefully acknowledged (HEALTHatWORK Project) — 7th Framework Programme THEME [HEALTH-2007-4.2-3] Grant Agreement No: 200716.

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Acknowledgements: Thanks go to the participants of the ‘Health and Work’ Organised Session (2011) of the Scottish Economic Society 2011 Annual Conference, Perth, Scotland, for helpful comments. The authors are also grateful to the editor Franco Peracchi and the referees of this journal for helpful comments and suggestions. The financial support of the European Commission is gratefully acknowledged (HEALTHatWORK Project) — 7th Framework Programme THEME [HEALTH-2007-4.2-3] Grant Agreement No: 200716.

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Acknowledgements This study was funded by the Chief Scientist Office of the Scottish Government, grant CZH_4_495.

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Acknowledgments The VIVIANE study was funded and coordinated by GlaxoSmithKline Biologicals SA, which also covered all costs associated with development and publication of this report. We thank all study participants and their families. We gratefully acknowledge the work of the central and local study coordinators, and staff members of the sites who participated in this study. Writing support services were provided by Mary Greenacre (An Sgriobhadair, Isle of Barra, UK), on behalf of GSK Vaccines; editing and publication coordination services were provided by Jérôme Leemans (Keyrus Biopharma, Lasne, Belgium), Stéphanie Delval (XPE Pharma and Science, Wavre, Belgium), and Matthieu Depuydt (Business Decision Life Sciences, Brussels, Belgium), on behalf of GSK Vaccines

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With the cell therapy industry continuing to grow, the ability to preserve clinical grade cells, including mesenchymal stem cells (MSCs), whilst retaining cell viability and function remains critical for the generation of off-the-shelf therapies. Cryopreservation of MSCs, using slow freezing, is an established process at lab scale. However, the cytotoxicity of cryoprotectants, like Me2SO, raises questions about the impact of prolonged cell exposure to cryoprotectant at temperatures >0 °C during processing of large cell batches for allogenic therapies prior to rapid cooling in a controlled rate freezer or in the clinic prior to administration. Here we show that exposure of human bone marrow derived MSCs to Me2SO for ≥1 h before freezing, or after thawing, degrades membrane integrity, short-term cell attachment efficiency and alters cell immunophenotype. After 2 h's exposure to Me2SO at 37 °C post-thaw, membrane integrity dropped to ∼70% and only ∼50% of cells retained the ability to adhere to tissue culture plastic. Furthermore, only 70% of the recovered MSCs retained an immunophenotype consistent with the ISCT minimal criteria after exposure. We also saw a similar loss of membrane integrity and attachment efficiency after exposing osteoblast (HOS TE85) cells to Me2SO before, and after, cryopreservation. Overall, these results show that freezing medium exposure is a critical determinant of product quality as process scale increases. Defining and reporting cell sensitivity to freezing medium exposure, both before and after cryopreservation, enables a fair judgement of how scalable a particular cryopreservation process can be, and consequently whether the therapy has commercial feasibility.

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This paper discusses the difficulties involved in managing knowledge-intensive, multinational, multiorganisational, and multifunctional project networks. The study is based on a 2-year quasi-ethnography of one such network engaged in the design and development of a complex new process control system for an existing pharmaceutical plant in Ireland. The case describes how, drawing upon the organisational heritage of the corporations involved and the logic implicit within their global partnership arrangements, the project was initially structured in an aspatial manner that underestimated the complexity of the development process and the social relations required to support it. Following dissatisfaction with initial progress, a number of critical management interventions were made, which appeared to contribute to a recasting of the network ontology that facilitated the cultivation and protection of more appropriate communicative spaces. The case emphasises the need to move away from rationalistic assumptions about communication processes within projects of this nature, towards a richer conceptualisation of such enterprises as involving collective sensemaking activities within and between situated ‘communities’ of actors. Contrary to much contemporary writing, the paper argues that space and location are of crucial importance to our understanding of network forms of organising.

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Sildenafil is a phosphodiesterase type-5 inhibitor approved for treatment of pulmonary arterial hypertension (PAH) in adults. Data from pediatric trials demonstrate a similar acute safety profile to the adult population but have raised concerns regarding the safety of long-term use in children. Interpretation of these trials remains controversial with major regulatory agencies differing in their recommendations - the US Food and Drug Administration recommends against the use of sildenafil for treatment of PAH in children, while the European Medicines Agency supports its use at "low doses". Here, we review the available pediatric data regarding dosing, acute, and long-term safety and efficacy of sildenafil for the treatment of PAH in children.

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UNLABELLED: Black patients chronically infected with genotype 1 hepatitis C virus (HCV) have historically had lower rates of response to interferon-based treatment than patients of other races. In the phase 3 ION program, the single-tablet regimen of the NS5A inhibitor ledipasvir and NS5B nucleotide polymerase inhibitor sofosbuvir was shown to be safe and highly effective in the general population. The aim of this study was to evaluate the safety and efficacy of ledipasvir/sofosbuvir in black patients using data from the three open-label ION clinical trials, which evaluated the safety and efficacy of 8, 12, and 24 weeks of ledipasvir/sofosbuvir with or without ribavirin for the treatment of treatment-naïve and treatment-experienced patients with genotype 1 HCV, including those with compensated cirrhosis. The primary endpoint was sustained virologic response at 12 weeks after the end of therapy (SVR12). For our analysis, rates of SVR12, treatment-emergent adverse events, and graded laboratory abnormalities were analyzed in black versus non-black patients. Of the 1949 patients evaluated, 308 (16%) were black. On average, black patients were older, had higher body mass index, were more likely to be IL28B non-CC, and had a lower serum alanine aminotransferase at baseline than non-black patients. Overall, 95% of black and 97% of non-black patients achieved SVR12. The rate of relapse was 3% in black patients as compared with 2% in non-black patients. The most common adverse events included fatigue, headache, nausea, and insomnia. The majority of adverse events occurred more frequently in the ribavirin-containing arms of the studies. No differences were observed in overall safety by race. CONCLUSION: A once-daily dosage of ledipasvir/sofosbuvir was similarly effective in black and non-black patients with genotype 1 HCV infection. The addition of ribavirin did not appear to increase SVR12 but was associated with higher rates of adverse events.

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Background and Objectives: Mobility limitations are a prevalent issue in older adult populations, and an important determinant of disability and mortality. Neighborhood conditions are key determinants of mobility and perception of safety may be one such determinant. Women have more mobility limitations than men, a phenomenon known as the gender mobility gap. The objective of this work was to validate a measure of perception of safety, examine the relationship between neighborhood perception of safety and mobility limitations in seniors, and explore if these effects vary by gender. Methods: This study was cross-sectional, using questionnaire data collected from community-dwelling older adults from four sites in Canada, Colombia, and Brazil. The exposure variable was the neighborhood aggregated Perception of Safety (PoS) scale, derived from the Physical and Social Disorder (PSD) scale by Sampson and Raudenbush. Its construct validity was verified using factor analyses and correlation with similar measures. The Mobility Assessment Tool – short form (MAT-sf), a video-based measure validated cross-culturally in the studied populations, was used to assess mobility limitations. Based on theoretical models, covariates were included in the analysis, both at the neighborhood level (SES, social capital, and built environment) and the individual level (age, gender, education, income, chronic illnesses, depression, cognitive function, BMI, and social participation). Multilevel modeling was used in order to account for neighborhood clustering. Gender specific analyses were carried out. SAS and M-plus were used in this study. Results: PoS was validated across all sites. It loaded in a single factor, after excluding two items, with a Cronbach α value of approximately 0.86. Mobility limitations were present in 22.08% of the sample, 16.32% among men and 27.41% among women. Neighborhood perception of safety was significantly associated with mobility limitations when controlling for all covariates, with an OR of 0.84 (CI 95%: 0.73-0.96), indicating lower odds of having mobility limitations as neighborhood perception of safety improves. Gender did not affect this relationship despite women being more likely to have mobility limitations and live in neighborhoods with poor perception of safety. Conclusion: Neighborhood perception of safety affected the prevalence of mobility limitations in older adults in the studied population.