Transcutaneous electrical nerve stimulation attenuates cardiac sympathetic drive in heart failure: a 123MIBG myocardial scintigraphy randomized controlled trial.

Cardiac sympathetic overdrive provides inotropic support to the failing heart. However, as myocardial insult evolves, this compensatory response impairs contractile function and constitutes an independent mortality predictor and a primary target in the treatment of heart failure (HF). In this prospective, randomized, double-blind, controlled crossover trial, we proposed cervicothoracic transcutaneous electrical nerve stimulation (CTENS) as a nonpharmacological therapy on cardiac sympathetic activity in patients with HF. Seventeen patients with HF were randomly assigned to an in-home CTENS (30 min twice daily, 80-Hz frequency, and 150-µs pulse duration) or a control intervention (Sham) for 14 consecutive days. Following a 60-day washout phase, patients were crossed over to the opposite intervention. The heart-to-mediastinum ratio (HMR) and washout rate (WR) (indexes of sympathetic innervation density and activity from planar 123iodo-metaiodobenzylguanidine myocardial scintigraphy images, respectively), as well as blood pressure (BP) and heart rate (HR), were quantified before and after each intervention. HMR, BP, and HR did not change throughout the study. Nonetheless, CTENS reduced WR (CTENS -4 ± 10 vs. Sham +5 ± 15%, P = 0.03) when compared with Sham. When allocated in two independent groups, preserved (PCSI, HMR > 1.6, n = 10) and impaired cardiac sympathetic innervation (ICSI, HRM ≤1.6, n = 7), PCSI patients showed an important attenuation of WR (-11 ± 9 vs. Sham +8 ± 19%, P = 0.007) after CTENS. Nonetheless, neither Sham nor CTENS evoked changes in WR of the ICSI patients (P > 0.05). These findings indicate that CTENS attenuates the cardiac sympathetic overdrive in patients with HF and a preserved innervation constitutes an essential factor for this beneficial neuromodulatory impact. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Identifier: NCT03354689. NEW & NOTEWORTHY We found that short-term cervicothoracic transcutaneous electrical nerve stimulation (CTENS) attenuates cardiac sympathetic overdrive in patients with heart failure and a preserved autonomic innervation may constitute an essential factor to maximize this beneficial neuromodulatory effect. CTENS then emerges as an alternative noninvasive and nonpharmacological strategy to attenuate exaggerated cardiac sympathetic drive in patients with heart failure.

A polymeric immunoglobulin-antigen fusion protein strategy for enhancing vaccine immunogenicity.

In this study, a strategy based on polymeric immunoglobulin G scaffolds (PIGS) was used to produce a vaccine candidate for Mycobacterium tuberculosis. A genetic fusion construct comprising genes encoding the mycobacterial Ag85B antigen, an immunoglobulin γ-chain fragment and the tailpiece from immunoglobulin µ chain was engineered. Expression was attempted in Chinese Hamster Ovary (CHO) cells and in Nicotiana benthamiana. The recombinant protein assembled into polymeric structures (TB-PIGS) in N. benthamiana, similar in size to polymeric IgM. These complexes were subsequently shown to bind to the complement protein C1q and FcγRs with increased affinity. Modification of the N-glycans linked to TB-PIGS by removal of xylose and fucose residues that are normally found in plant glycosylated proteins also resulted in increased affinity for low-affinity FcγRs. Immunization studies in mice indicated that TB-PIGS are highly immunogenic with and without adjuvant. However, they did not improve protective efficacy in mice against challenge with M. tuberculosis compared to conventional vaccination with BCG, suggesting that additional or alternative antigens may be needed to protect against this disease. Nevertheless, these results establish a novel platform for producing polymeric antigen-IgG γ-chain molecules with inherent functional characteristics that are desirable in vaccines.

Participation of TNF-α in Inhibitory Effects of Adipocytes on Osteoblast Differentiation.

Mesenchymal stem cells from bone marrow (BM-MSCs) and adipose tissue (AT-MSCs) are attractive tools for cell-based therapies to repair bone tissue. In this study, we investigated the osteogenic and adipogenic potential of BM-MSCs and AT-MSCs as well as the effect of crosstalk between osteoblasts and adipocytes on cell phenotype expression. Rat BM-MSCs and AT-MSCs were cultured either in growth, osteogenic, or adipogenic medium to evaluate osteoblast and adipocyte differentiation. Additionally, osteoblasts and adipocytes were indirectly co-cultured to investigate the effect of adipocytes on osteoblast differentiation and vice versa. BM-MSCs and AT-MSCs exhibit osteogenic and adipogenic potential under non-differentiation-inducing conditions. When exposed to osteogenic medium, BM-MSCs exhibited higher expression of bone markers compared with AT-MSCs. Conversely, under adipogenic conditions, AT-MSCs displayed higher expression of adipose tissue markers compared with BM-MSCs. The presence of adipocytes as indirect co-culture repressed the expression of the osteoblast phenotype, whereas osteoblasts did not exert remarkable effect on adipocytes. The inhibitory effect of adipocytes on osteoblasts was due to the release of tumor necrosis factor alpha (TNF-α) in culture medium by adipocytes. Indeed, the addition of exogenous TNF-α in culture medium repressed the differentiation of BM-MSCs into osteoblasts mimicking the indirect co-culture effect. In conclusion, our study showed that BM-MSCs are more osteogenic while AT-MSCs are more adipogenic. Additionally, we demonstrated the key role of TNF-α secreted by adipocytes on the inhibition of osteoblast differentiation. Thus, we postulate that the higher osteogenic potential of BM-MSCs makes them the first choice for inducing bone repair in cell-based therapies.

Nursing Diagnoses of hospitalized patients with heart failure: a longitudinal study.

OBJECTIVE: Identifying Nursing Diagnoses of fatigue, activity intolerance and decreased cardiac output in hospitalized patients with heart failure and verifying the association between the defining characteristics and the Nursing Diagnoses. METHOD: A longitudinal and prospective study that followed hospitalized patients with heart failure for three weeks. The data collected through interviews and physical examinations were sent to expert nurses for diagnostic inference. Descriptive and inferential statistical analyses were carried out. RESULTS: Of the 72 patients, 68.0% were male and presented the nursing diagnosis of decreased cardiac output (62.5%) in the first week, reducing to 52.8% and 38% in the second and third weeks, respectively. Fatigue only appeared in one patient. Activity intolerance was the diagnosis that had the greatest discrepancy among the experts. Decreased cardiac output was associated to the defining characteristics: dyspnea, edema, jugular venous distension and reduced ejection fraction during all three weeks of evaluation. CONCLUSION: Decreased cardiac output was more prevalent in hospitalized patients with heart failure, and the associated defining characteristics were determining factors for this nursing diagnosis. OBJETIVO: Identificar os diagnósticos de enfermagem fadiga, intolerância à atividade e débito cardíaco diminuído em pacientes com insuficiência cardíaca hospitalizados e verificar a associação entre as características definidoras e os diagnósticos de enfermagem. MÉTODO: Estudo longitudinal e prospectivo que acompanhou pacientes com insuficiência cardíaca hospitalizados por três semanas. Os dados coletados por entrevista e exame físico foram encaminhados a enfermeiros peritos para inferência diagnóstica. Realizou-se análise estatística descritiva e inferencial. RESULTADOS: Dos 72 pacientes, 68,0% eram do sexo masculino e apresentaram o diagnóstico de enfermagem débito cardíaco diminuído (62,5%) na primeira semana, reduzindo para 52,8% e 38% na segunda e terceira semana, respectivamente. Fadiga apareceu somente em um paciente. Intolerância à atividade foi o diagnóstico que teve maior discordância entre os peritos. Débito cardíaco diminuído foi associado às características definidoras dispneia, edema, distensão da veia jugular e fração de ejeção diminuída nas três semanas de avaliação. CONCLUSÃO: Débito cardíaco diminuído esteve mais prevalente em pacientes com insuficiência cardíaca hospitalizados, sendo as características definidoras associadas determinantes para este diagnóstico de enfermagem.

Effect of perceptive-auditory training on the classification of speech hypernasality. / Efeito do treinamento perceptivo-auditivo na classificação da hipernasalidade de fala.

PURPOSE: To analyze the effect of auditory-perceptual training by inexperienced speech-language pathologists in the classification of hypernasality in individuals with cleft lip and palate and compare their classification of hypernasality individually, with the gold standard evaluation, before and after this training. METHODS: Three inexperienced speech-language pathologists used a four-point scale to assess 24 high-pressure speech samples from individuals with cleft lip and palate, before and after auditory-perceptual training. The speech samples corresponded to six samples of each degree of hypernasality. The speech-language pathologists received auditory-perceptual training during the assessments. They had access to anchor samples and immediate feedback of correct answers regarding the degree of hypernasality in training. RESULTS: There was no significant difference in the overall percentage of correct answers when comparing before and after the auditory-perceptual training. There was a significant association and agreement of the three evaluators with a gold standard evaluation after training, with an increase in agreement for a single evaluator for absent and mild degrees of hypernasality. The dichotomous analysis of the data showed an increase in the Kappa Index of Agreement of this evaluator. Although there was an increase in the Index of Agreement between evaluators for absent, mild, and severe hypernasality, this increase did not reach statistical significance. CONCLUSION: The auditory-perceptual training provided did not result in a significant improvement in the hypernasality classification for the inexperienced speech-language pathologists, even though the individual data analysis showed that the training favored one of the evaluators. Further studies involving gradual and more extensive auditory-perceptual training may favor the classification of hypernasality by inexperienced SLPs.

OBJETIVO: Analisar o efeito de um treinamento perceptivo-auditivo de fonoaudiólogas sem experiência na classificação da hipernasalidade de fala de indivíduos com fissura labiopalatina e comparar a classificação da presença e grau de hipernasalidade realizadas dessas fonoaudiólogas (com a avaliação padrão-ouro), antes e depois do treinamento perceptivo-auditivo. MÉTODO: Três fonoaudiólogas sem experiência analisaram 24 amostras de fala de alta pressão de indivíduos com fissura labiopalatina, antes e depois de treinamento perceptivo-auditivo, usando escala de quatro pontos. As amostras de fala correspondiam a seis amostras de cada grau de hipernasalidade. Entre as análises, as fonoaudiólogas receberam treinamento perceptivo-auditivo. Houve acesso às amostras de referência e feedback de respostas corretas quanto ao grau de hipernasalidade no treinamento. RESULTADOS: Não houve diferença significativa na porcentagem geral de acertos entre os momentos antes e depois do treinamento perceptivo-auditivo. Houve associação e concordância significativa das três avaliadoras com avaliação padrão ouro após treinamento, com aumento da concordância para uma avaliadora (aumento de respostas corretas para os graus ausente e leve). A análise dicotômica dos dados mostrou aumento do índice de concordância Kappa dessa avaliadora. Houve aumento do índice concordância inter-avaliadores para hipernasalidade ausente, leve, e grave, porém sem significância estatística. CONCLUSÃO: O treinamento perceptivo-auditivo não resultou em melhora significativa da classificação da hipernasalidade de fala pelas fonoaudiólogas sem experiência, embora a análise individual dos dados tenha mostrado que o treinamento favoreceu uma dessas avaliadoras. Novos estudos envolvendo treinamento perceptivo-auditivo gradual e mais extenso poderão favorecer a classificação da hipernasalidade de fala por fonoaudiólogos sem experiência.

Description of a safe doppler ultrasound-guided technique for hyaluronic acid filler in the face-A method to avoid adverse vascular events.

BACKGROUND: Knowledge of facial anatomy is essential for professionals intending to inject hyaluronic acid (HA) into that region, but due to the considerable anatomical variations in region, it does not guarantee the complete safety of the procedure. Similarly, procedures widely disseminated among professionals, such as aspiration and the use of cannulas, do not ensure total safety against vascular occlusion events caused by the filler. OBJECTIVES: This article describes a technique for injecting hyaluronic acid into the face guided by Doppler ultrasonography (DUS) in order to ensure greater safety against vascular occlusion events secondary to the procedure. METHODS: We describe a Doppler ultrasound-guided filling technique, with an 18 MHZ transducer, consisting of three steps: arterial mapping, real-time ultrasound-guided filling, and assessing the perfusion. RESULTS: The described technique was performed in 480 patients and can be adopted in the routine of professionals who inject hyaluronic acid, especially in areas at high risk for vascular events. Its use results in greater safety against vascular occlusion events secondary to the procedure, without the need for prior aspiration. We conclude that there is a local vasodilation right after the filling that makes it difficult the possibility of extrinsic compression exerted by the filler on the vessel. Furthermore, the product moves to deep planes even with the bevel facing up (toward the epidermis). CONCLUSIONS: We believe that in the future the use of Doppler ultrasound-guided filling technique will be mandatory for professionals who intend to perform HA injection, to both ensure patient safety and provide legal protection for the professional.

Implications of Mycoplasma hemofelis Bacterial Load on the Hematological Parameters of Naturally Infected Cats.

Mycoplasma hemofelis is the most pathogenic hemoplasma species that affect cats. M. hemofelis may cause an acute infection that leads to hemolytic anaemia. The objective of this study was to detect and to quantify the load of M. hemofelis in cats by conventional polymerase chain reaction (PCR) and by quantitative PCR (qPCR) and to describe the possible hematological changes. M. hemofelis DNA was detected in 28.6% of the randomly selected cats (42 of 147) attended at the Veterinary Hospital of the Federal University of Mato Grosso, Brazil. The agreement between conventional PCR and qPCR was substantive (k 0.6). Females were twice as likely to acquire infection as males (odds ratio, 2.31). There was no statistically significant association (P > .05) and little/no correlation between the hematological parameters and the average of bacterial load. The results indicate that M. hemofelis infection is not related to clinical signs and bacterial blood load in cats. The agreement between conventional and quantitative PCR made it possible to detect infection by M. hemofelis in a larger number of cats.

Molecular Pharming: future targets and aspirations.

Molecular Pharming represents an unprecedented opportunity to manufacture affordable modern medicines and make these available at a global scale. The area of greatest potential is in the prevention of infectious diseases, particular in underdeveloped countries where access to medicines and vaccines has historically been limited. This is why, at St. George's, we focus on diseases such as HIV, TB and rabies, and aim to develop production strategies that are simple and potentially easy to transfer to developing countries.

Evaluation of the Relationships between Simple Anthropometric Measures and Bioelectrical Impedance Assessment Variables with Multivariate Linear Regression Models to Estimate Body Composition and Fat Distribution in Adults: Preliminary Results.

BACKGROUND: Overweight and obesity are conditions associated with sedentary lifestyle and accumulation of abdominal fat, determining increased mortality, favoring chronic diseases, and increasing cardiovascular risk. Although the evaluation of body composition and fat distribution are highly relevant, the high cost of the gold standard techniques limits their wide utilization. Therefore, the aim of this work was to explore the relationships between simple anthropometric measures and BIA variables using multivariate linear regression models to estimate body composition and fat distribution in adults. METHODS: In this cross-sectional study, sixty-eight adult individuals (20 males and 48 females) were subjected to bioelectrical impedance analysis (BIA), anthropometric measurements (waist circumference (WC), neck circumference (NC), mid-arm circumference (MAC)), allowing the calculation of conicity index (C-index), fat mass/fat-free mass (FM/FFM) ratios, body mass index (BMI) and body shape index (ABSI). Statistical analyzes were performed with the R program. Nonparametric Statistical tests were applied to compare the characteristics of participants of the groups (normal weight, overweight and obese). For qualitative variables, the Fisher's exact test was applied, and for quantitative variables, the paired Wilcoxon signed-rank test. To evaluate the linear association between each pair of variables, the Pearson correlation coefficient was calculated, and Multivariate linear regression models were adjusted using the stepwise variable selection method, with Akaike Information Criterion (p ≤ 0.05). RESULTS: BIA variables with the highest correlations with anthropometric measures were total body water (TBW), body fat percentage (BFP), FM, FFM and FM/FFM. The multiple linear regression analysis showed, in general, that the same variables can be estimated through simple anthropometric measures. CONCLUSIONS: The assessment of fat distribution in the body is desirable for the diagnosis and definition of obesity severity. However, the high cost of the instruments (dual energy X-ray absorptiometry, hydrostatic weighing, air displacement plethysmography, computed tomography, magnetic resonance) to assess it, favors the use of BMI in the clinical practice. Nevertheless, BMI does not represent a real fat distribution and body fat percentage. This highlights the relevance of the findings of the current study, since simple anthropometric variables can be used to estimate important BIA variables that are related to fat distribution and body composition.

Qualification of palliative nursing assistance in the use of the subcutaneous route.

OBJECTIVES: to describe the experience of conducting workshops for teaching the subcutaneous fluid infusion therapy in palliative care patients. METHODS: experience report based on four workshops with a workload of nine hours each, addressing the teaching, implementation of the technique, and management in the use of subcutaneous fluid infusion therapy in patients in palliative care. The host institution was a private hospital, which had two care units in the state of Rio de Janeiro. RESULTS: we identified little knowledge about the theme. Due to the dynamics used, the workshops made it possible to qualify the participants to perform and manage the subcutaneous route in palliative care environments. CONCLUSIONS: the workshops were an important means of training, qualification, and dissemination of nursing care in a palliative care environment. The resources used to enable the qualification in the execution and management of the presented technique.

Efeito do treinamento perceptivo-auditivo na classificação da hipernasalidade de fala / Effect of perceptive-auditory training on the classification of speech hypernasality

RESUMO Objetivo Analisar o efeito de um treinamento perceptivo-auditivo de fonoaudiólogas sem experiência na classificação da hipernasalidade de fala de indivíduos com fissura labiopalatina e comparar a classificação da presença e grau de hipernasalidade realizadas dessas fonoaudiólogas (com a avaliação padrão-ouro), antes e depois do treinamento perceptivo-auditivo. Método Três fonoaudiólogas sem experiência analisaram 24 amostras de fala de alta pressão de indivíduos com fissura labiopalatina, antes e depois de treinamento perceptivo-auditivo, usando escala de quatro pontos. As amostras de fala correspondiam a seis amostras de cada grau de hipernasalidade. Entre as análises, as fonoaudiólogas receberam treinamento perceptivo-auditivo. Houve acesso às amostras de referência e feedback de respostas corretas quanto ao grau de hipernasalidade no treinamento. Resultados Não houve diferença significativa na porcentagem geral de acertos entre os momentos antes e depois do treinamento perceptivo-auditivo. Houve associação e concordância significativa das três avaliadoras com avaliação padrão ouro após treinamento, com aumento da concordância para uma avaliadora (aumento de respostas corretas para os graus ausente e leve). A análise dicotômica dos dados mostrou aumento do índice de concordância Kappa dessa avaliadora. Houve aumento do índice concordância inter-avaliadores para hipernasalidade ausente, leve, e grave, porém sem significância estatística. Conclusão O treinamento perceptivo-auditivo não resultou em melhora significativa da classificação da hipernasalidade de fala pelas fonoaudiólogas sem experiência, embora a análise individual dos dados tenha mostrado que o treinamento favoreceu uma dessas avaliadoras. Novos estudos envolvendo treinamento perceptivo-auditivo gradual e mais extenso poderão favorecer a classificação da hipernasalidade de fala por fonoaudiólogos sem experiência.

ABSTRACT Purpose To analyze the effect of auditory-perceptual training by inexperienced speech-language pathologists in the classification of hypernasality in individuals with cleft lip and palate and compare their classification of hypernasality individually, with the gold standard evaluation, before and after this training. Methods Three inexperienced speech-language pathologists used a four-point scale to assess 24 high-pressure speech samples from individuals with cleft lip and palate, before and after auditory-perceptual training. The speech samples corresponded to six samples of each degree of hypernasality. The speech-language pathologists received auditory-perceptual training during the assessments. They had access to anchor samples and immediate feedback of correct answers regarding the degree of hypernasality in training. Results There was no significant difference in the overall percentage of correct answers when comparing before and after the auditory-perceptual training. There was a significant association and agreement of the three evaluators with a gold standard evaluation after training, with an increase in agreement for a single evaluator for absent and mild degrees of hypernasality. The dichotomous analysis of the data showed an increase in the Kappa Index of Agreement of this evaluator. Although there was an increase in the Index of Agreement between evaluators for absent, mild, and severe hypernasality, this increase did not reach statistical significance. Conclusion The auditory-perceptual training provided did not result in a significant improvement in the hypernasality classification for the inexperienced speech-language pathologists, even though the individual data analysis showed that the training favored one of the evaluators. Further studies involving gradual and more extensive auditory-perceptual training may favor the classification of hypernasality by inexperienced SLPs.

Bacterial endotoxin adhesion to different types of orthodontic adhesives.

OBJECTIVE: The aim of this study was to assess whether LPS adheres to orthodontic adhesive systems, comparing two commercial brands. MATERIAL AND METHODS: Forty specimens were fabricated from Transbond XT and Light Bond composite and bonding agent components (n=10/component), then contaminated by immersion in a bacterial endotoxin solution. Contaminated and non-contaminated acrylic resin samples were used as positive and negative control groups, respectively. LPS quantification was performed by the Limulus Amebocyte Lysate QCL-1000™ test. Data obtained were scored and subjected to the Chi-square test using a significance level of 5%. RESULTS: There was endotoxin adhesion to all materials (p<0.05). No statistically significant difference was found between composites/bonding agents and acrylic resin (p>0.05). There was no significant difference (p>0.05) among commercial brands. Affinity of endotoxin was significantly greater for the bonding agents (p=0.0025). CONCLUSIONS: LPS adhered to both orthodontic adhesive systems. Regardless of the brand, the endotoxin had higher affinity for the bonding agents than for the composites. There is no previous study assessing the affinity of LPS for orthodontic adhesive systems. This study revealed that LPS adheres to orthodontic adhesive systems. Therefore, additional care is recommended to orthodontic applications of these materials.

Qualification of palliative nursing assistance in the use of the subcutaneous route / Cualificación de la asistencia de enfermería paliativa en el uso de la vía subcutánea / Qualificação da assistência de enfermagem paliativista no uso da via subcutânea

ABSTRACT Objectives: to describe the experience of conducting workshops for teaching the subcutaneous fluid infusion therapy in palliative care patients. Methods: experience report based on four workshops with a workload of nine hours each, addressing the teaching, implementation of the technique, and management in the use of subcutaneous fluid infusion therapy in patients in palliative care. The host institution was a private hospital, which had two care units in the state of Rio de Janeiro. Results: we identified little knowledge about the theme. Due to the dynamics used, the workshops made it possible to qualify the participants to perform and manage the subcutaneous route in palliative care environments. Conclusions: the workshops were an important means of training, qualification, and dissemination of nursing care in a palliative care environment. The resources used to enable the qualification in the execution and management of the presented technique.

RESUMEN Objetivos: describir la experiencia de la realización de talleres para la enseñanza de la terapia de infusión de fluidos por vía subcutánea en pacientes en cuidados paliativos. Métodos: relato de experiencia basado en cuatro talleres con carga horaria de nueve horas cada, abordando la enseñanza, la ejecución de la técnica y el manejo en la utilización de la terapia de infusión de fluidos por vía subcutánea en pacientes en cuidados paliativos. La institución acogedora ha sido un hospital privado, que ha contado con dos unidades asistenciales en el estado de Rio de Janeiro. Resultados: se identificó poco conocimiento acerca de la temática. Por la dinámica utilizada, los talleres posibilitaron calificar los participantes a ejecutaren y a manejaren la vía subcutánea en ambientes de cuidados paliativos. Conclusiones: Los talleres han sido importante medio de formación, cualificación y divulgación del cuidado de enfermería en ambiente de cuidados paliativos. Los recursos utilizados posibilitan la cualificación en la ejecución y en el manejo de la técnica presentada.

RESUMO Objetivos: descrever a experiência da realização de oficinas para o ensino da terapia de infusão de fluidos por via subcutânea em pacientes em cuidados paliativos. Métodos: relato de experiência baseado em quatro oficinas com carga horária de nove horas cada, abordando o ensino, a execução da técnica e o manejo na utilização da terapia de infusão de fluidos por via subcutânea em pacientes em cuidados paliativos. A instituição sediadora foi um hospital privado, que contava com duas unidades assistenciais no estado do Rio de Janeiro. Resultados: identificou-se pouco conhecimento acerca da temática. Pela dinâmica utilizada, as oficinas possibilitaram qualificar os participantes a executarem e a manejarem a via subcutânea em ambientes de cuidados paliativos. Conclusões: as oficinas foram importante meio de formação, qualificação e divulgação do cuidado de enfermagem em ambiente de cuidados paliativos. Os recursos utilizados possibilitam a qualificação na execução e no manejo da técnica apresentada.

Efficacy and effectiveness trials have different goals, use different tools, and generate different messages.

The discussion about the optimal design of clinical trials reflects the perspectives of theory-based scientists and practice-based clinicians. Scientists compare the theory with published results. They observe a continuum from explanatory to pragmatic trials. Clinicians compare the problem they want to solve by completing a clinical trial with the results they can read in the literature. They observe a mixture of what they want and what they get. None of them can solve the problem without the support of the other. Here, we summarize the results of discussions with scientists and clinicians. All participants were interested to understand and analyze the arguments of the other side. As a result of this process, we conclude that scientists tell what they see, a continuum from clear explanatory to clear pragmatic trials. Clinicians tell what they want to see, a clear explanatory trial to describe the expected effects under ideal study conditions and a clear pragmatic trial to describe the observed effects under real-world conditions. Following this discussion, the solution was not too difficult. When we accept what we see, we will not get what we want. If we discuss a necessary change of management, we will end up with the conclusion that two types of studies are necessary to demonstrate efficacy and effectiveness. Efficacy can be demonstrated in an explanatory, ie, a randomized controlled trial (RCT) completed under ideal study conditions. Effectiveness can be demonstrated in an observational, ie, a pragmatic controlled trial (PCT) completed under real-world conditions. It is impossible to design a trial which can detect efficacy and effectiveness simultaneously. The RCTs describe what we may expect in health care, while the PCTs describe what we really observe.

Nasalance during use of pharyngeal and glottal place of production.

PURPOSE: This study obtained nasalance scores during use of compensatory articulation (CA) and compared nasalance between groups with and without hypernasality and with and without CA. METHODS: Speech samples were obtained from 43 individuals with and without velopharyngeal dysfunction during repetition of 20 phrases originating 860 audio recordings and their respective nasometric values. After excluding 143 recordings due to low quality, the remaining 717 samples were rated by three speech language pathologists (SLPs), independently, for presence or absence of hypernasality and CA. Nasalance scores for the 553 samples rated with 100% agreement among the SLPs were grouped according to the auditory-perceptual ratings: Group 1 (G1) - included samples without hypernasality and without CA (n=191); Group2 (G2) - included samples with hypernasality and without CA (n=288); Group 3 (G3) - included samples with hypernasality and with pharyngeal fricative (n=33); Group 4 (G4) - included samples with hypernasality and with glottal stop (n=41). RESULTS: Analysis of variance (ANOVA) revealed significant difference nasalance scores which were significantly higher for G2, G3, and G4 (p<0.0001) when compared to G1. The use of pharyngeal fricative (G3), particularly during /f/ (p=0.0018) and /s/ (p=0.0017) productions resulted in nasalance scores significantly higher than scores found for G2. CONCLUSION: Significantly higher nasalance values where identified during use of pharyngeal fricative.

Riscos das mídias e tecnologias na capacitação para cuidadores de idosos: estudo de caso / Risks of media and technologies in training for caregivers of elderly: a case study

Objetivou-se orientar cuidadores de idosos em um curso de capacitação no Centro de Atenção à Saúde do Idoso e seu Cuidadores, Universidade Federal Fluminense, sobre as principais carências e necessidades nutricionais requeridas pelos próprios e pelos idosos, alertando ainda sobre os riscos das tecnologias. Trata-se de um estudo de caso do estágio de docência, sobre a capacitação de cuidadores, enquanto mestrando acadêmico do Programa de Ciências do Cuidado em Saúde. A compreensão e visualização acerca da organização e planejamento das demandas cotidianas requisitadas de um profissional acadêmico em suas palestras/cursos/oficinas. Conclui-se que há necessidade de uma capacitação dos pós-graduandos nos métodos de transmissão dos conhecimentos acadêmicos, como por exemplo, a linguagem utilizada para os cuidadores, objetivando assim a compreensão de toda a turma e alertando sobre os riscos das influências tecnológicas na baixa qualidade alimentar ingerida

The aim of this study was to orient elderly caregivers in a training course at the Center for Health Care of the Elderly and its Caregivers, Federal Fluminense University, about the main needs and nutritional needs required by the elderly and the elderly, also warning about the risks of the technologies. This is a case study of the teaching stage, about the qualification of caregivers, as an academic master of the Health Care Sciences Program. Understanding and visualization about the organization and planning of the daily demands of an academic professional in their lectures/courses/workshops. It is concluded that there is a need for the training of postgraduates in the methods of transmission of academic knowledge, such as the language used for caregivers, aiming at understanding the whole class and warning about the risks of technological influences in the low food quality

Riscos das mídias e tecnologias na capacitação para cuidadores de idosos: estudo de caso / Risks of media and technologies in training for caregivers of elderly: a case study

Objetivou-se orientar cuidadores de idosos em um curso de capacitação no Centro de Atenção à Saúde do Idoso e seu Cuidadores, Universidade Federal Fluminense, sobre as principais carências e necessidades nutricionais requeridas pelos próprios e pelos idosos, alertando ainda sobre os riscos das tecnologias. Trata-se de um estudo de caso do estágio de docência, sobre a capacitação de cuidadores, enquanto mestrando acadêmico do Programa de Ciências do Cuidado em Saúde. A compreensão e visualização acerca da organização e planejamento das demandas cotidianas requisitadas de um profissional acadêmico em suas palestras/cursos/oficinas. Conclui-se que há necessidade de uma capacitação dos pós-graduandos nos métodos de transmissão dos conhecimentos acadêmicos, como por exemplo, a linguagem utilizada para os cuidadores, objetivando assim a compreensão de toda a turma e alertando sobre os riscos das influências tecnológicas na baixa qualidade alimentar ingerida

The aim of this study was to orient elderly caregivers in a training course at the Center for Health Care of the Elderly and its Caregivers, Federal Fluminense University, about the main needs and nutritional needs required by the elderly and the elderly, also warning about the risks of the technologies. This is a case study of the teaching stage, about the qualification of caregivers, as an academic master of the Health Care Sciences Program. Understanding and visualization about the organization and planning of the daily demands of an academic professional in their lectures/courses/workshops. It is concluded that there is a need for the training of postgraduates in the methods of transmission of academic knowledge, such as the language used for caregivers, aiming at understanding the whole class and warning about the risks of technological influences in the low food quality

Amostras de referência para identificação da oclusiva glotal / Reference speech samples for glotal stop identification / Muestras de referencia para la identificación dela oclusiva glótica

Objetivo: Estabelecer um banco de amostras de referência constituído por gravações de fala de indivíduos com história de fissura labiopalatina, julgadas, por múltiplos avaliadores, como representativas do uso da oclusiva glotal. Método: Três fonoaudiólogas experientes julgaram 480 frases compostas por sons oclusivos e fricativos, quanto à identificação da oclusiva glotal. As frases foram julgadas individualmente e aquelas que não apresentaram consenso inicial foram novamente julgadas de maneira simultânea pelas mesmas avaliadoras. As amostras julgadas com consenso pelas avaliadoras, com relação à presença ou ausência da oclusiva glotal durante a produção dos sons oclusivos e fricativos, foram selecionadas para estabelecer o banco de amostras de referência. Resultados: Os julgamentos realizados evidenciaram consenso das avaliadoras em 352 amostras. Destas, 120 frases eram representativas da produção adequada para os 12 sons de interesse e 232 eram representativas do uso da oclusiva glotal. Conclusão: Um banco de amostras de referência representativas da oclusiva glotal foi estabelecido a partir do consenso de avaliadores múltiplos. As amostras de referência poderão ser usadas em estudos futuros envolvendo treinamento de avaliadores e formação de fonoaudiólogos.

Objective: To establish anchor samples consisting of speech recordings of individuals with history of cleft lip and palate, rated by multiple evaluators as representative of the use of the glottal stop. Methods: A total of 480 phrases with plosive and fricative sounds were rated by three experienced speech language pathologist (SLPs) to identify use of glottal stops. The samples were rated individually and those without consensus regarding the use of glottal stops were rated simultaneously by the same evaluators. The samples rated with consensus by the evaluators, regarding the presence or absence of glottal stops during the production of plosive and fricative sounds, were selected to establish anchor samples representative of use of glottal stops. Results: A total of 352 samples were rated with consensus by all evaluators. Of these, 120 phrases were representative of the adequate place of production of plosive and fricative sounds and 232 were rated as representative of the use of the glottal stops. Conclusion: Anchor samples representative of presence and absence of glottal stops for plosive and fricative sounds were established with consensus between multiple evaluators. These anchor samples can be used in future studies involving training of evaluators and preparation of speech language pathologists.

Objetivo: Establecer un banco de muestras de referencia constituido por grabaciones de habla de individuos con historia de fisura labiopalatina, juzgadas por múltiples jueces, como representativas del uso de la oclusiva glótica. Método: Un total de 480 frases compuestas por sonidos oclusivos y fricativos fueron juzgados a respeto de la identificación de la oclusiva glótica, por tres fonoaudiólogas conexperiencia. Las frases fueron juzgadas individualmente y aquellas que no presentaron un consenso inicial fueron juzgadas nuevamente de manera simultánea por las mismas juezas. Las muestras juzgadas en consenso por las juezas, con relación a la presencia o ausencia del oclusiva glótica durante la producción de sonidos oclusivos y fricativos, fueron seleccionadas para establecer el banco de muestras de referencia. Resultados: Los juzgamientos realizados evidenciaron consenso de las juezas en 352 muestras. De estas, 120 frases eran representativas de la producción adecuada para los 12 sonidos de interés y 232 eran representativas del uso de la oclusiva glótica. Conclusión: Un banco de muestras de referencia representativas de la oclusiva glótica fue establecido a partir del consenso entre jueces múltiplos. Las muestras de referencia podrán ser usadas en futuros estudios envolviendo entrenamiento de jueces y preparo de fonoaudiólogos.

Métodos de rastreamento da depressão em pacientes ambulatoriais com insuficiência cardíaca / Methods of screening for depression in outpatients with heart failure

A depressão é uma condição clínica sindrômica subdiagnosticada em pacientes com insuficiência cardíaca. Uma variedade de instrumentos é atualmente aplicada no rastreamento da depressão. Determinar a prevalência da depressão e a concordância entre os métodos de rastreamento para depressão em pacientes com insuficiência cardíaca. Estudo transversal realizado entre março de 2015 e janeiro de 2017 com 76 pacientes ambulatoriais acompanhados em uma clínica especializada de insuficiência cardíaca. A depressão foi rastreada pela Escala de Avaliação de Depressão de Hamilton (HAM-D), pelo Inventário de Depressão de Beck-II (BDI-II) e pelo Patient Health Questionnaire-9 (PHQ-9). A concordância entre os três instrumentos foi analisada pelo coeficiente kappa de Fleiss (kF), coeficiente alfa de Krippendorff (Ck) e coeficiente alfa de Cronbach. Foram calculadas a acurácia, sensibilidade, especificidade e as taxas de resultados falso-positivos e falso-negativos dos instrumentos HAM-D e PHQ-9, considerando o instrumento BDI-II como padrão-ouro no diagnóstico da depressão. As prevalências de depressão foram de 72,4% (n = 55) pela escala HAM-D, 67,1% (n = 51) pela escala BDI-II e 40,8% (n = 31) pelo PHQ-9. A prevalência de depressão pelos três instrumentos simultaneamente foi de 28,9% (n = 22) e a concordância diagnóstica entre os três instrumentos (sobre a presença ou ausência de depressão) foi de 47,4% (n = 36). A análise revelou uma concordância superficial (kF = Ck = 0,27) e consistência moderada (↓C = 0,602, significativamente não nulo, p = 0,000). As variáveis sociodemográficas e clínicas não constituíram fatores de riscos para a depressão na amostra avaliada. Os métodos de rastreamento analisados apresentaram concordância e foram úteis na detecção da depressão entre pacientes ambulatoriais com insuficiência cardíaca

Depression is a syndromic clinical condition underdiagnosed in patients with heart failure. Several instruments are currently applied to screen for depression. To determine the prevalence of depression and the agreement among screening methods for depression in patients with heart failure. Cross-sectional study conducted between March 2015 and January 2017 including 76 outpatients following up at a clinic specialized in heart failure. Depression was screened with the Hamilton Depression Rating Scale (HAM-D), Beck Depression Inventory-II (BDI-II), and Patient Health Questionnaire-9 (PHQ-9). The agreement among the three instruments was analyzed with Fleiss' kappa coefficient (kF), Krippendorff's alpha coefficient (Ck) and Cronbach's alpha coefficient. The accuracy, sensitivity, and specificity, as well as false-positive and false-negative results of the HAM-D and PHQ-9 were calculated considering the BDI-II as the gold-standard instrument in the diagnosis of depression. The prevalence rates of depression were 72.4% (n = 55) with the HAM-D, 67.1% (n = 51) with the BDI-II, and 40.8% (n = 31) with the PHQ-9 scales. The prevalence of depression simultaneously identified by all three instruments was 28.9% (n = 22) and the diagnostic agreement (presence or absence of depression) was 47.4% (n = 36). The analysis revealed a superficial agreement (kF = Ck = 0.27) and moderate consistency ((↓C = 0.602, significantly not null, p = 0.000). Sociodemographic and clinical variables were not risk factors for depression in the evaluated sample. The screening methods analyzed showed agreement and were useful in detecting depression among outpatients with heart failure

Bacterial endotoxin adhesion to different types of orthodontic adhesives

Abstract Bacterial endotoxin (LPS) adhesion to orthodontic brackets is a known contributing factor to inflammation of the adjacent gingival tissues. Objective The aim of this study was to assess whether LPS adheres to orthodontic adhesive systems, comparing two commercial brands. Material and Methods Forty specimens were fabricated from Transbond XT and Light Bond composite and bonding agent components (n=10/component), then contaminated by immersion in a bacterial endotoxin solution. Contaminated and non-contaminated acrylic resin samples were used as positive and negative control groups, respectively. LPS quantification was performed by the Limulus Amebocyte Lysate QCL-1000™ test. Data obtained were scored and subjected to the Chi-square test using a significance level of 5%. Results There was endotoxin adhesion to all materials (p<0.05). No statistically significant difference was found between composites/bonding agents and acrylic resin (p>0.05). There was no significant difference (p>0.05) among commercial brands. Affinity of endotoxin was significantly greater for the bonding agents (p=0.0025). Conclusions LPS adhered to both orthodontic adhesive systems. Regardless of the brand, the endotoxin had higher affinity for the bonding agents than for the composites. There is no previous study assessing the affinity of LPS for orthodontic adhesive systems. This study revealed that LPS adheres to orthodontic adhesive systems. Therefore, additional care is recommended to orthodontic applications of these materials.