A combined score test for binary and ordinal endpoints from clinical trials

There is growing interest, especially for trials in stroke, in combining multiple endpoints in a single clinical evaluation of an experimental treatment. The endpoints might be repeated evaluations of the same characteristic or alternative measures of progress on different scales. Often they will be binary or ordinal, and those are the cases studied here. In this paper we take a direct approach to combining the univariate score statistics for comparing treatments with respect to each endpoint. The correlations between the score statistics are derived and used to allow a valid combined score test to be applied. A sample size formula is deduced and application in sequential designs is discussed. The method is compared with an alternative approach based on generalized estimating equations in an illustrative analysis and replicated simulations, and the advantages and disadvantages of the two approaches are discussed.

The Usefulness of Caries Frequency, Depth, and Location in Determining Cariogenicity and Past Subsistence: A Test on Early and Later Agriculturalists From the Peruvian Coast

Dental markers have been used to unravel particularities of paleodiet, subsistence, social structure, and health. This article aims to compare oral pathology among four pre-Columbian groups with different degrees of agricultural and socio-cultural development but comparable ecological conditions who lived on the coastal desert of Peru. Three of these groups are assigned to distinct phases of the Formative Period (2500-1 BC), a time critical for our understanding of the development of agriculture and social complexity. The fourth group corresponds to the Late Intermediate Period (1000-1470 AD), when agriculture had its apogee and society was highly stratified. In this study we test whether there is an increase (1) in the frequency of carious lesions and (2) in caries depth, and (3) if there is a shift from occlusal to extra-occlusal caries locations with the development of agriculture. Therefore, we analyze the frequencies of carious lesions and antemortem tooth loss (AMTL), the caries distributions by age, sex, and type of tooth, as well as the tissues affected by, and the location of the carious lesions. Since there are no significant differences in the frequencies of carious lesions and AMTL between the groups, we reject hypothesis 1. In contrast, caries depth does increase, and caries location changes from occlusal to extra-occlusal sites with agricultural development. However, we can only corroborate hypothesis 2 and 3 when taking into consideration dental wear. Thus, we recommend that caries depth and locations should be used with evaluations of dental wear to reconstruct subsistence in ancient populations. Am J Phys Anthropol 143:75-91, 2010. (C) 2010 Wiley-Liss, Inc.

In vivo assessment of DNA damage and protective effects of extracts from Miconia species using the comet assay and micronucleus test

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

Cocaine mutagenicity and hepatocarcinogenicity evaluations in rodents

The mutagenicity (clastogenicity) and the carcinogenicity (promoting potential) of cocaine were evaluated, respectively, by the mouse bone marrow micronucleus test (study I) and by the initiated rat liver bioassay (study II). In study I, two administration routes (i.p. and i.v.) and two sampling times (24 and 48 hours) after cocaine treatment were studied. Swiss male mice were treated with cocaine at doses of 0, 18, 37, and 75 mg/kg and 0, 2, 4, and 8 mg/kg by i.p. and i.v. routes, respectively. No significant differences were observed between treated and negative control groups regarding the frequencies of micronuclei and the polichromatic/normochromatic erythrocyte (PCE/NCE) ratios. In study II, the development of putative preneoplastic foci of hepatocytes expressing the enzyme glutathione S-transferase placental form (GST-P+) was utilized as the end-point marker in a 8-week rat liver bioassay. The animals were initiated for carcinogenesis by a single i.p. sub-carcinogenic dose of diethylnitrosamine (DEN). After a 6-week exposure to 5 or 10 mg/kg of cocaine i.v. twice a week there was no enhancement of GST-P+ foci development above the values of the control DEN-only treated animals. Also, cocaine did not induce any toxicity as evidenced by the absence of alterations of rat body and liver weights and of liver biochemical function and morphology. The results suggest that cocaine does not have a mutagenic effect on the mouse bone marrow cells or promoting activity on the rat hepatocarcinogenesis process. Teratogenesis Carcinog. Mutagen. 18:199-208, 1998. (C) 1998 Wiley-Liss, Inc.

Criteria for peanut seed pre-conditioning for the tetrazolium test

The staining pattern of peanut (Arachis hypogaea L.) seeds with a tetrazolium solution was evaluated to determine the adequate conditions of seed quality evaluations. Three seed lots with different vigour levels and similar moisture content were pre-conditioned using the combination of five periods of time (4, 8, 12, 16 and 20 hours) and four temperatures (20, 25, 30 and 35 degrees C) and then exposed to a 1.0% tetrazolium solution for three hours. The moisture content levels of seeds conditioned for 8 hours at the temperatures of 25, 30 or 35 degrees C, for 12 hours at 20 or 25 degrees C and for 16 hours at 20 degrees C, were above 30%. In this range of moisture level, the staining in tetrazolium was clear and uniform, reflecting an appropriate conditioning of the seeds. However, under a practical point of view, the period of 16 hours at 20 degrees C showed to be the best option, since it allows to start the pre-conditioning an late afternoon of one day and submit the seeds for staining in the following morning.

Neurohormonal, hemodynamic, and electrocardiographic evaluations of healthy dogs receiving long-term administration of doxorubicin

Objective - To evaluate diagnostic testing that could be used to establish an early diagnosis of cardiotoxicosis induced by long-term administration of doxorubicin. Animals - 13 adult mixed-breed dogs. Procedures - 7 dogs were administered doxorubicin chloride (30 mg/m2, IV, q 21 d for 168 days [cumulative dose, 240 mg/m2]), and 6 dogs received saline (0.9% NaCl) solution (5 mL, IV, q 21 d for 168 days; control group). Echocardiography, ECG, arterial blood pressure, plasma renin activity (PRA), and plasma concentrations of norepinephrine and brain natriuretic peptide (BNP) were assessed before each subsequent administration of doxorubicin and saline solution. Results - Dogs that received doxorubicin had a significant decrease in R-wave amplitude, compared with values for the control group, from 30 to 210 mg/m2. Doxorubicin-treated dogs had decreases in fractional shortening and left ventricular ejection fraction evident as early as 30 mg/m2, but significant differences between groups were not detected until 90 mg/m2 was reached. There was also a significant increase in PRA (≥ 120 mg/m2) and left ventricular end-systolic and end-diastolic dimensions (≥ 60 and ≥ 180 mg/m2, respectively). Systemic arterial pressure, remaining echocardiographic variables, and concentrations of norepinephrine and BNP had significant variations, but of no clinical importance, during doxorubicin administration. Conclusions and clinical relevance - Doxorubicin-induced cardiotoxicosis developed at 120 mg/m2, but there were no clinical signs of dilated cardiomyopathy or congestive heart failure. Echocardiography and determination of PRA were able to detect early cardiac alterations during the development of dilated cardiomyopathy, despite apparently differing degrees of sensitivity to development of doxorubicin-induced cardiotoxicosis.

Test-day model for milk yield of dairy buffaloes in colombia

The test-day model is the preferred method for genetic evaluations in dairy cattle. For this study, 28372 test-day records of 1220 lactations from 1997 to 2009 were used. The (co)variance components for milk in test-day were estimated using a Uni and multiple-traits repeated animal model with the Restricted Maximum Likelihood method (REML). The Contemporary Group (herd, year, and season of parity) and the age of parity (linear and quadratic) fixed effects, and the additive genetic, permanent environmental, and residual random effects were included in the model. The heritabilities ranged between 0.06 and 0.45 during lactation. The genetic correlations were greater than 0.93. In conclusion, the test-day model is appropriate for the genetic evaluation of dairy buffaloes in Colombia.

Tetrazolium test for assessment of seed viability of atemoya (Annona cherimola Mill. x A. squamosa L.)

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

Test-retest reliability of electromyographic variables of masseter and temporal muscles in patients with cerebral palsy

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Phenotypic and functional evaluations of peripheral blood monocytes from chronic-form paracoccidioidomycosis patients before and after treatment

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

Toothpick test: a methodology for the detection of RR soybean plants

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

Body posture evaluations in subjects with internal temporomandibular joint derangement

The aim of this study was to verify possible relationships between global body posture and temporomandibular joint internal derangement (TMJ-id), by comparing 30 subjects presenting typical TMJ-id signs to 20 healthy subjects. Body posture was assessed using the analysis of muscle chains on several photographs. Results show a higher frequency of lifted shoulders (p=0.04) and of changes in the antero-internal hip chain (p=0.02) in the test group, but no further differences were found significant between the control and test groups. The test group was then divided into three subgroups according to the Helkimo index of temporomandibular disorder severity. Again, no significant differences were found between the subgroups. However, there was a trend noticed in the group with the most severe dysfunction, to present a forward head and shoulders posture. Results are discussed in light of previous studies using the same sample.

One-repetition maximum test and isokinetic leg extension and flexion: correlations and predicted values

The most typical maximum tests for measuring leg muscle performance are the one-repetition maximum leg press test (1RMleg) and the isokinetic knee extension/flexion (IKEF) test. Nevertheless, their inter-correlations have not been well documented, mainly the predicted values of these evaluations. This correlational and regression analysis study involved 30 healthy young males aged 18-24y, who have performed both tests. Pearson's product moment correlation between 1RMleg and IKEF varied from 0.20 to 0.69 and the more exact predicted test was to 1RMleg (R2 = 0.71). The study showed correlations between 1RMleg and IKEF although these tests are different (isotonic vs. isokinetic) and provided further support for cross determination of 1RMleg and IKEF by linear and multiple linear regression analysis.

Quantifying the influence of bone density and thickness on resonance frequency analysis: an in vitro study of biomechanical test materials

PURPOSE: Resonance frequency analysis (RFA) offers the opportunity to monitor the osseointegration of an implant in a simple, noninvasive way. A better comprehension of the relationship between RFA and parameters related to bone quality would therefore help clinicians improve diagnoses. In this study, a bone analog made from polyurethane foam was used to isolate the influences of bone density and cortical thickness in RFA. MATERIALS AND METHODS: Straumann standard implants were inserted in polyurethane foam blocks, and primary implant stability was measured with RFA. The blocks were composed of two superimposed layers with different densities. The top layer was dense to mimic cortical bone, whereas the bottom layer had a lower density to represent trabecular bone. Different densities for both layers and different thicknesses for the simulated cortical layer were tested, resulting in eight different block combinations. RFA was compared with two other mechanical evaluations of primary stability: removal torque and axial loading response. RESULTS: The primary stability measured with RFA did not correlate with the two other methods, but there was a significant correlation between removal torque and the axial loading response (P < .005). Statistical analysis revealed that each method was sensitive to different aspects of bone quality. RFA was the only method able to detect changes in both bone density and cortical thickness. However, changes in trabecular bone density were easier to distinguish with removal torque and axial loading than with RFA. CONCLUSIONS: This study shows that RFA, removal torque, and axial loading are sensitive to different aspects of the bone-implant interface. This explains the absence of correlation among the methods and proves that no standard procedure exists for the evaluation of primary stability.

Implicit and explicit evaluations: a declaration of dependence

This section presents abstracts of three studies on how consumer choices can be influenced by the name letter effect of brands without decision makers being aware of this influence. The first paper examined whether making brand names similar to consumers' names increases the likelihood that consumers will choose the brand. One prediction is that people will prefer and be more likely to choose products or services whose names prominently feature the letters in their own first or last names. The results showed that subjects' preference rankings and evaluations of name letter matching brands were higher than those of non-name letter matching brands. The second paper tested the possibility of using subliminal priming to activate a concept that a persuasive communicator could take advantage of. To examine the idea, two experiments were presented. In the first experiment, participants' level of thirst were manipulated and then subliminally presented them with either thirst-related words or control words. While the manipulations had no effect on participants' self-reported, conscious ratings of thirst, there was a significant interactive effect of the two factors on how much of the drink provided in the taste test was consumed. In a second, follow up experiment, thirsty participants were subliminally presented with either thirst-related words or control words after which they viewed advertisements for two new sports beverages. In conclusion, the research demonstrates that under certain conditions, subliminal printing techniques can enhance persuasion. The third paper hypothesized that the lack of correlations between implicit and explicit evaluations is due to measurement error.