Active-control trials with binary data: a comparison of methods for testing superiority or non-inferiority using the odds ratio

This paper considers methods for testing for superiority or non-inferiority in active-control trials with binary data, when the relative treatment effect is expressed as an odds ratio. Three asymptotic tests for the log-odds ratio based on the unconditional binary likelihood are presented, namely the likelihood ratio, Wald and score tests. All three tests can be implemented straightforwardly in standard statistical software packages, as can the corresponding confidence intervals. Simulations indicate that the three alternatives are similar in terms of the Type I error, with values close to the nominal level. However, when the non-inferiority margin becomes large, the score test slightly exceeds the nominal level. In general, the highest power is obtained from the score test, although all three tests are similar and the observed differences in power are not of practical importance. Copyright (C) 2007 John Wiley & Sons, Ltd.

Conjugated linoleic acid and human health: a critical evaluation of the evidence

Purpose of review: This review critically evaluates studies investigating the effects of conjugated linoleic acid on human health, including effects on body composition, blood lipids, liver metabolism, insulin sensitivity and immune function. It focuses mainly on human intervention studies, but includes some reference to animal and cellular studies which provide insight into potential molecular mechanisms of action of conjugated linoleic acid. Recent findings: Human studies continue to report inconsistent effects of conjugated linoleic acid on human health. Some of these reports are based on overinterpretation of marginal effects of supplementation. Recent data suggest that the effects of the substance may be isomer dependent and that cis-9, trans-11 and trans-10, cis-12 conjugated linoleic acids have opposing effects on blood lipids and on metabolism in adipocytes and hepatic cells. Summary: Claims that conjugated linoleic acid is beneficial for health remain as yet unconvincing. Human studies investigating the effects of conjugated linoleic acid supplements have tended to use mixtures of isomers and have been inconsistent. More recent studies have attempted to use relatively pure preparations of single isomers and these studies suggest that the effects of conjugated linoleic acid may be isomer-specific. These recent data suggest a relative detrimental effect of trans-10, cis-12 conjugated linoleic acid on blood lipids. There appears to be little effect of conjugated linoleic acid on immune function and the effects on insulin sensitivity remain unclear.

Heat kernel smoothing via Laplace-Beltrami eigenfunctions and its application to subcortical structure modeling

We present a new subcortical structure shape modeling framework using heat kernel smoothing constructed with the Laplace-Beltrami eigenfunctions. The cotan discretization is used to numerically obtain the eigenfunctions of the Laplace-Beltrami operator along the surface of subcortical structures of the brain. The eigenfunctions are then used to construct the heat kernel and used in smoothing out measurements noise along the surface. The proposed framework is applied in investigating the influence of age (38-79 years) and gender on amygdala and hippocampus shape. We detected a significant age effect on hippocampus in accordance with the previous studies. In addition, we also detected a significant gender effect on amygdala. Since we did not find any such differences in the traditional volumetric methods, our results demonstrate the benefit of the current framework over traditional volumetric methods.

Sample size considerations in active-control non-inferiority trials with binary data based on the odds ratio

This paper presents an approximate closed form sample size formula for determining non-inferiority in active-control trials with binary data. We use the odds-ratio as the measure of the relative treatment effect, derive the sample size formula based on the score test and compare it with a second, well-known formula based on the Wald test. Both closed form formulae are compared with simulations based on the likelihood ratio test. Within the range of parameter values investigated, the score test closed form formula is reasonably accurate when non-inferiority margins are based on odds-ratios of about 0.5 or above and when the magnitude of the odds ratio under the alternative hypothesis lies between about 1 and 2.5. The accuracy generally decreases as the odds ratio under the alternative hypothesis moves upwards from 1. As the non-inferiority margin odds ratio decreases from 0.5, the score test closed form formula increasingly overestimates the sample size irrespective of the magnitude of the odds ratio under the alternative hypothesis. The Wald test closed form formula is also reasonably accurate in the cases where the score test closed form formula works well. Outside these scenarios, the Wald test closed form formula can either underestimate or overestimate the sample size, depending on the magnitude of the non-inferiority margin odds ratio and the odds ratio under the alternative hypothesis. Although neither approximation is accurate for all cases, both approaches lead to satisfactory sample size calculation for non-inferiority trials with binary data where the odds ratio is the parameter of interest.

Essays on health care reform, wealth inequality, and demography

This thesis contains three chapters. The first chapter uses a general equilibrium framework to simulate and compare the long run effects of the Patient Protection and Affordable Care Act (PPACA) and of health care costs reduction policies on macroeconomic variables, government budget, and welfare of individuals. We found that all policies were able to reduce uninsured population, with the PPACA being more effective than cost reductions. The PPACA increased public deficit mainly due to the Medicaid expansion, forcing tax hikes. On the other hand, cost reductions alleviated the fiscal burden of public insurance, reducing public deficit and taxes. Regarding welfare effects, the PPACA as a whole and cost reductions are welfare improving. High welfare gains would be achieved if the U.S. medical costs followed the same trend of OECD countries. Besides, feasible cost reductions are more welfare improving than most of the PPACA components, proving to be a good alternative. The second chapter documents that life cycle general equilibrium models with heterogeneous agents have a very hard time reproducing the American wealth distribution. A common assumption made in this literature is that all young adults enter the economy with no initial assets. In this chapter, we relax this assumption – not supported by the data – and evaluate the ability of an otherwise standard life cycle model to account for the U.S. wealth inequality. The new feature of the model is that agents enter the economy with assets drawn from an initial distribution of assets. We found that heterogeneity with respect to initial wealth is key for this class of models to replicate the data. According to our results, American inequality can be explained almost entirely by the fact that some individuals are lucky enough to be born into wealth, while others are born with few or no assets. The third chapter documents that a common assumption adopted in life cycle general equilibrium models is that the population is stable at steady state, that is, its relative age distribution becomes constant over time. An open question is whether the demographic assumptions commonly adopted in these models in fact imply that the population becomes stable. In this chapter we prove the existence of a stable population in a demographic environment where both the age-specific mortality rates and the population growth rate are constant over time, the setup commonly adopted in life cycle general equilibrium models. Hence, the stability of the population do not need to be taken as assumption in these models.

Estimação de fatores de correção do perímetro escrotal para idade e peso corporal em touros jovens da raça Nelore

Neste trabalho foram estudados os efeitos de idade e peso sobre o perímetro escrotal (PE) de touros jovens da raça Nelore e estimados os fatores de correção (FC) do PE para esses efeitos. As informações utilizadas pertencem aos Registros de Produção da Associação Paraguaia dos Criadores de Nelore, obtidos entre 1986 e 1997, de 110 criatórios, totalizando 7458 observações. Os coeficientes de regressão que permitiram o cálculo dos FCs para o PE foram estimados pelo método dos quadrados mínimos, empregando-se um modelo que considerou o grupo contemporâneo (animais nascidos no mesmo ano, estação, rebanho, avaliados na mesma data e do mesmo grupo de manejo alimentar na desmama e no sobreano), o efeito linear da idade em dias e os efeitos linear e quadrático do peso aos 570 dias de idade (P570). O efeito da idade sobre o PE foi igual a 0,0383(±0,0024) cm/dia e do P570 sobre o PE corrigido para essa idade, 0,0708(±0,0049) cm/kg, efeito linear, e -0,0000413(±0,0000074) cm/kg², efeito quadrático. A idade e o peso do animal foram importantes fontes de variação a serem removidas do PE, como indicativo da precocidade sexual de touros de sobreano.

Cinética da fermentação e taxas de degradação de forrageiras tropicais em diferentes idades de corte estimadas pela técnica de produção de gases in vitro

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

Caste Asymmetries in the Neotropical Swarm-Founding Wasp Polybia (Trychothorax) ignobilis (Hymenoptera, Vespidae, Epiponini)

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Castes and asynchronous colony cycle in Polybia bistriata (Fabricius) (Hymenoptera: Vespidae)

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

Influência da idade no comportamento da pressão intraocular em uma população da região Sul-brasileira

OBJETIVO: Verificar influência da idade no comportamento da pressão intraocular (PIO) em população acima de 40 anos. MÉTODOS: Neste estudo observacional transversal realizado no município de Piraquara - PR, a PIO foi aferida através da tonometria de Goldmann. Todos os indivíduos foram submetidos a exame de triagem, sendo os suspeitos de glaucoma ou hipertensão ocular encaminhados ao atendimento de retorno para realização de exame oftalmológico completo. Para fins de análise estatística, os pacientes foram divididos em grupos etários (40-49; 50-59; 60-69 e acima de 70 anos). Posteriormente todos os pacientes portadores de glaucoma ou suspeita, hipertensão arterial sistêmica (HAS) ou Diabetes mellitus (DM) foram excluídos. RESULTADOS: Avaliaram-se 3360 indivíduos com média de idade de 54,04 ± 10,52 anos, sendo 59,79% do sexo feminino. Não se observou diferença estatisticamente significativa entre a média da PIO nos diferentes grupos etários (p=0,19; teste ANOVA). da mesma forma, não foi observada correlação significativa entre a PIO e a idade (p = 0,11; correlação linear de Pearson). Após exclusão dos indivíduos portadores de HAS (1671), DM (n=360), glaucoma ou suspeita de glaucoma (n=161) não se observou diferença estatisticamente significativa entre a média da PIO e a idade (p=0,17; teste ANOVA). No entanto, uma fraca correlação negativa, porém significativa, foi encontrada entre PIO e idade (p=0,03; R=-0,055, correlação linear Pearson). CONCLUSÃO: Na presente amostra, não foi observada influência significativa da idade na PIO, entretanto, após a exclusão de indivíduos com glaucoma, HAS e DM, observou-se uma fraca correlação linear negativa e significativa entre as duas variáveis.

NEST REUSE AND COMMUNAL NESTING IN MICROTHURGE-CORUMBAE (HYMENOPTERA, MEGACHILIDAE), WITH SPECIAL REFERENCE TO NEST DEFENSE

Observations on the nesting activities of Microthurge corumbae, carried out at the University Campus of Ribeirao Preto, São Paulo, Brazil, from 1977 to 1981, indicated that 61.9% of nests were re-used by succeeding generations. Re-use by one generation was more frequent than by two generations, and re-use by a third was observed only once. Nests were re-used by one or several females. Single females were more frequently in the first re-use. In these cases nest re-use did not differ essentially from the solitary foundation of a new nest, except for the adoption of a pre-existing nest without excavation. In multifemale nests, analysis of relative age (wing wear), ovarian and spermathecal conditions of associated females and the content of nests at excavation indicated that the social pattern in such colonies is communal. There is some evidence that the associated females are relatives. The chalcidoid wasp Leucospis was the principal nest parasite, and ants of the genus Crematogaster were nest predators. In multifemale nests, the rate of parasitism was significantly lower than in solitary nests, indicating that nest-sharing resulted in improved nest defense. on the other hand. The absence of predation on immatures of the first generation of M. corumbue in multifemale nests suggests that such nests are also more resistant to attack by predators.

Modelo para o estudo da dinâmica evolutiva dos aspectos fisiográficos dos pantanais

This paper studies the applicability of a model to the evolutive dynamics of Pantanal physiography. The Miranda-Aquidauana Pantanal has developed as a pre-existent fluvial plain in the beginning, from Paraguay river, whose ancient marks, recognized by weathering alteration volumes, show components that make possible its relative age determination and consequently permit the comprehension of the ancient and recent dynamic evolutions, that are responsible for the present physiographic form.

Morphological caste differences in three species of the Neotropical genus Clypearia (Hymenoptera: Polistinae: Epiponini)

Clypearia is a rare genus of swarm-founding Neotropical wasp whose biology is very little known. Morphological castes differences, condition of ovaries, relative age, and color pattern differences were analyzed in three species of Clypearia. Physiological differences and low morphometric differentiation between queens and workers were present in all species studied, indicating that these species are characterized by physiological caste only. We suggest that caste determination in the three Clypearia species studied is postimaginal. © 2010 Giovanna Tocchini Felippotti et al.

Nitrogênio e idade de corte na qualidade da biomassa de capimelefante para fins agroenergéticos cultivado em Latossolo

Nowadays one of the major challenge for research is the production of alternative agrifuels energy material derived from plant biomass. Allied to this, the proper management of nitrogen, becomes fundamental for productivity gains and improvement in quality of elephant grass biomass. Thus, the objective was to evaluate the effect of nitrogen fertilization and plant age effect on the quality of elephant grass biomass for energy purposes. The experiment was performed with genotype Paraíso, grown in a dystrophic Oxisol in the southern state of Tocantins. The design was randomized blocks with subdivided plots, situating plots as nitrogen rates (0, 50, 100 and 150 kg ha-1) and the subplots cutting age (120, 150 and 180 days after planting ) four replicates. We evaluated the relationship carbon/nitrogen (C:N) and leaf/stem (L:S), levels of neutral detergent fiber (NDF) and ash contents in dry biomass produced. The application of nitrogen increased by 12% to C:N ratio of the plant. The advanced age of cut forage was increased 9% in the C:N plant, however, decreased by 12 and 14% levels of ash produced in the stem and leaves, respectively. The production of elephant grass for agrifuels is feasible with management system proposed, quality characteristics desirable, such as high C:N ratio, above 40% and higt fiber content, above 50%.

Detecção de Crateras de Impacto em Imagens Digitais. Estudo de caso: Superfície de Marte

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)