Assessment of Oxidative Stress Markers in Hypertensive Patients under the Use of Renin-Angiotensin-Aldosterone Blockers.

As in other fields, chronotherapy applied to arterial hypertension (AHT) may have implications on oxidative stress. We compared the levels of some redox markers between hypertensive patients with morning and bedtime use of renin-angiotensin-aldosterone system (RAAS) blockers. This was an observational study that included patients older than 18 years with a diagnosis of essential AHT. Blood pressure (BP) figures were measured using twenty-four-hour ambulatory BP monitoring (24-h ABPM). Lipid peroxidation and protein oxidation were assessed using the thiobarbituric acid reactive substances (TBARS) and reduced thiols assays. We recruited 70 patients with a median age of 54 years, of whom 38 (54%) were women. In hypertensive patients with bedtime use of RAAS blockers, reduced thiol levels showed a positive correlation with nocturnal diastolic BP decrease. TBARS levels were associated with bedtime use of RAAS blockers in dipper and non-dipper hypertensive patients. In non-dipper patients, bedtime use of RAAS blockers was also associated with a decrease in nocturnal diastolic BP. Chronotherapy applied to bedtime use of some BP-lowering drugs in hypertensive patients may be linked to a better redox profile.

Assessment of oxidative stress markers in elderly patients with SARS-CoV-2 infection and potential prognostic implications in the medium and long term.

We aimed to evaluate the correlation of plasma levels of thiobarbituric acid reactive substances (TBARS) and reduced thiols with morbidity, mortality and immune response during and after SARS-CoV-2 infection. This was an observational study that included inpatients with SARS-CoV-2 infection older than 65 years. The individuals were followed up to the twelfth month post-discharge. Plasma levels of TBARS and reduced thiols were quantified as a measure of lipid and protein oxidation, respectively. Fatal and non-fatal events were evaluated during admission and at the third, sixth and twelfth month post-discharge. Differences in oxidative stress markers between the groups of interest, time to a negative RT-qPCR and time to significant anti-SARS-CoV-2 IgM titers were assessed. We included 61 patients (57% women) with a mean age of 83 years old. After multivariate analysis, we found differences in TBARS and reduced thiol levels between the comparison groups in fatal and non-fatal events during hospital admission. TBARS levels were also correlated with fatal events at the 6th and 12th months post-discharge. One year after hospital discharge, other predictors rather than oxidative stress markers were relevant in the models. The median time to reach significant anti-SARS-CoV-2 IgM titers was lower in patients with low levels of reduced thiols. Assessment of some parameters related to oxidative stress may help identify groups of patients with a higher risk of morbidity, mortality and delayed immune response during and after SARS-CoV-2 infection.

Biofilms in Diabetic Foot Ulcers: Impact, Risk Factors and Control Strategies.

Diabetic foot ulcers (DFUs) are a serious complication from diabetes mellitus, with a huge economic, social and psychological impact on the patients' life. One of the main reasons why DFUs are so difficult to heal is related to the presence of biofilms. Biofilms promote wound inflammation and a remarkable lack of response to host defences/treatment options, which can lead to disease progression and chronicity. In fact, appropriate treatment for the elimination of these microbial communities can prevent the disease evolution and, in some cases, even avoid more serious outcomes, such as amputation or death. However, the detection of biofilm-associated DFUs is difficult due to the lack of methods for diagnostics in clinical settings. In this review, the current knowledge on the involvement of biofilms in DFUs is discussed, as well as how the surrounding environment influences biofilm formation and regulation, along with its clinical implications. A special focus is also given to biofilm-associated DFU diagnosis and therapeutic strategies. An overview on promising alternative therapeutics is provided and an algorithm considering biofilm detection and treatment is proposed.

Performance of 30 commercial SARS-CoV-2 serology assays in testing symptomatic COVID-19 patients.

We report evaluation of 30 assays' (17 rapid tests (RDTs) and 13 automated/manual ELISA/CLIA assay (IAs)) clinical performances with 2594 sera collected from symptomatic patients with positive SARS-CoV-2 rRT-PCR on a respiratory sample, and 1996 pre-epidemic serum samples expected to be negative. Only 4 RDT and 3 IAs fitted both specificity (> 98%) and sensitivity (> 90%) criteria according to French recommendations. Serology may offer valuable information during COVID-19 pandemic, but inconsistent performances observed among the 30 commercial assays evaluated, which underlines the importance of independent evaluation before clinical implementation.

Private health insurance coverage-related lawsuits.

OBJECTIVES: to analyze lawsuits brought by beneficiaries of health insurance operators. METHODS: this was a cross-sectional descriptive study carried out in a large-capacity private health insurance operator using data collected by the company from 2012 to 2015. RESULTS: ninety-six lawsuits were brought by 86 beneficiaries regarding medical procedures (38.5%), treatments (26.1%), examinations (14.6%), medications (9.4%), home care (6.2%), and other types of hospitalization (5.2%). The procedures with the highest number of lawsuits were percutaneous rhizotomy; chemotherapy; treatment-related positron-emission tomography scans; and for medications relative to antineoplastic and Hepatitis C treatment. CONCLUSIONS: the lawsuits were filed because of the operators' refusal to comply with items not established in contracts or not regulated and authorized by the Brazilian National Regulatory Agency for Private Health Insurance and Plans, refusals considered unfounded.

Private health insurance coverage-related lawsuits / Acciones judiciales relacionadas con la cobertura de prestaciones en la salud complementaria / Ações judiciais relacionadas às coberturas assistenciais na saúde suplementar

ABSTRACT Objectives: to analyze lawsuits brought by beneficiaries of health insurance operators. Methods: this was a cross-sectional descriptive study carried out in a large-capacity private health insurance operator using data collected by the company from 2012 to 2015. Results: ninety-six lawsuits were brought by 86 beneficiaries regarding medical procedures (38.5%), treatments (26.1%), examinations (14.6%), medications (9.4%), home care (6.2%), and other types of hospitalization (5.2%). The procedures with the highest number of lawsuits were percutaneous rhizotomy; chemotherapy; treatment-related positron-emission tomography scans; and for medications relative to antineoplastic and Hepatitis C treatment. Conclusions: the lawsuits were filed because of the operators' refusal to comply with items not established in contracts or not regulated and authorized by the Brazilian National Regulatory Agency for Private Health Insurance and Plans, refusals considered unfounded.

RESUMEN Objetivos: analizar las acciones judiciales iniciadas por beneficiarios de planes de salud de prepago. Métodos: estudio descriptivo, transversal, desarrollado en importante operadora de planes de salud de prepago, utilizando datos recopilados por la empresa entre 2015 y 2015. Resultados: fueron impulsadas 96 acciones judiciales por parte de 86 beneficiarios, referentes a procedimientos médicos (38,5%), tratamientos (26,1%), estudios (14,6%), medicación (9,4%), Home Care (6,2%) y 5,2% por otros tipos de internación. La mayoría de acciones por procedimientos correspondió a rizotomía percutánea; en tratamientos, a quimioterapia; en estudios, a tomografía por emisión de positrones; en medicamentos, a antineoplásicos y para tratar la hepatitis C. Conclusiones: motivaron las acciones judiciales interpuestas la negativa de la operadora de planes de salud a cubrir prestaciones no incluidas en el alcance del plan contratado por el beneficiario, así como asuntos no reglados y autorizados por la Agencia Nacional de Salud Complementaria, considerándose, en consecuencia, improcedentes.

RESUMO Objetivos: analisar as ações judiciais demandadas por beneficiários de uma operadora de plano de saúde. Métodos: estudo descritivo de corte transversal desenvolvido em uma operadora de plano privado de saúde de grande porte, utilizando dados compilados pela empresa no período de 2012 a 2015. Resultados: foram movidas 96 ações judiciais por 86 beneficiários, referentes a procedimentos médicos (38,5%), tratamentos (26,1%), exames (14,6%), medicamentos (9,4%), Home Care (6,2%) e 5,2% a outros tipos de internações. O maior número de ações dentre os procedimentos foi rizotomia percutânea; para tratamentos, a quimioterapia; exames solicitados de tomografia por emissão de pósitrons; para medicamentos, os antineoplásicos e para tratamento de Hepatite C. Conclusões: a razão para as demandas judiciais impetradas foi a negativa da operadora em atender os itens não pertencentes ao escopo do que foi contratado pelo beneficiário ou itens não regulamentados e autorizados pela Agência Nacional de Saúde Suplementar, portanto sendo consideradas improcedentes.

Fitness benefits and costs of floral advertising traits: insights from rayed and rayless phenotypes of Anacyclus (Asteraceae).

PREMISE OF THE STUDY: Ray flowers commonly observed in daisies' flowering heads are a well-known example of advertising structures for enhancing pollinator attraction. Despite this, ray loss has occurred in multiple lineages, which still rely on pollinators, suggesting that rayless phenotypes could also be adaptive for animal-pollination. Here, we investigate the benefits and costs of these specialized floral advertising structures by comparing rayed and rayless phenotypes in two hybridizing closely related species. METHODS: We assessed the advantages and costs of ray production in terms of floral visitor's attraction, pollen limitation, and female reproductive success using the broad natural variation on ray size and number at the contact zone of A. clavatus (rayed) and A. valentinus (rayless). In addition, we experimentally explored the effect of rays under controlled neighborhoods and the effect of ray removal on fruit production. KEY RESULTS: In sympatry, rayed phenotypes attracted significantly more visitors than rayless plants, in which seed production was pollen limited. However, rayed phenotypes did not show higher fruit set or seed production than rayless phenotypes. Fruit set and seed production benefited from denser neighborhood displays and larger individual floral displays, respectively. The removal of ray florets did not appear to enable resource reallocation to fruit production. CONCLUSIONS: Rayless heads compensated their lower visitation rate by means of a higher number of flowers per head achieving similar fecundity levels to rayed plants. The larger size of rayless heads might thus indicate an inflorescence-level trade-off between attraction and fertility.

Advancing biological hazards risk assessment.

This paper focusses on biological hazards at the global level and considers the challenges to risk assessment (RA) from a One Health perspective. Two topics - vector-borne diseases (VBD) and antimicrobial resistance (AMR) - are used to illustrate the challenges ahead and to explore the opportunities that new methodologies such as next-generation sequencing can offer. Globalisation brings complexity and introduces drivers for infectious diseases. Cooperation and the application of an integrated RA approach - one that takes into consideration food farming and production systems including social and environmental factors - are recommended. Also needed are methodologies to identify emerging risks at a global level and propose prevention strategies. AMR is one of the biggest threats to human health in the infectious disease environment. Whereas new genomic typing techniques such as whole genome sequencing (WGS) provide further insights into the mechanisms of spread of resistance, the role of the environment is not fully elucidated, nor is the role of plants as potential vehicles for spread of resistance. Historical trends and recent experience indicate that (re)-emergence and/or further spread of VBD within the EU is a matter of when rather than if. Standardised and validated vector monitoring programs are required to be implemented at an international level for continuous surveillance and assessment of potential threats. There are benefits to using WGS - such as a quicker and better response to outbreaks and additional evidence for source attribution. However, significant challenges need to be addressed, including method standardisation and validation to fully realise these benefits; barriers to data sharing; and establishing epidemiological capacity for cluster triage and response.

The Montreal Cognitive Assessment (MoCA) as a screening test for cognitive dysfunction in multiple sclerosis.

This study investigates the utility of the Portuguese version of Montreal Cognitive Assessment (MoCA) as a screening-method for identifying cognitive dysfunction (CD) in multiple sclerosis (MS). The 118 participants with comprehensive neuropsychological assessment were divided into two subgroups: (I) MS group (n = 59) and (II) control group (n = 59). The MS patients were classified as cognitively intact (n = 26) or impaired (n = 33, 56%). The results indicated that the MoCA is a psychometrically valid instrument in assessment of MS patients. The Multiple Linear Regression analyses highlighted the significant influence of Modified Fatigue Impact Scale and Irregular Word Reading Test on MoCA performance. The MoCA total score showed a good discriminative capacity between cognitively impaired and cognitively intact subjects. In addition, there were significant differences in MoCA cognitive domain scores between groups. The MoCA total score cut-off point for identifying CD in MS patients was a score below 26 points (AUC = 0.837, CI = 0.736-0.937). A proposed EM-MoCA-Subscore for identifying the MS-related cognitive impairment (max. score = 19 points, cut-off <17 points, AUC = 0.871, CI = 0.784-0.958), can reduce administration time for cognitive screening in clinical settings. The MoCA is a useful and sensitive instrument to identify the MS-related cognitive impairment.

Ações judiciais demandadas por beneficiários de uma operadora de plano de saúde / Legal actions demanded by beneficiaries of a health plan operator

A judicialização da saúde tem sido fenômeno em crescimento na área da saúde e assunto relevante da pauta de gestores. Muitos estudos produzidos nos últimos anos, tanto no campo do Direito como no da Saúde, indicam um predomínio no sistema público. Essa pesquisa teve por objetivo analisar as ações judiciais relacionadas as coberturas assistenciais na saúde suplementar. Estudo descritivo e de corte transversal realizado em uma operadora de plano privado de saúde em um município de grande porte do interior do estado de São Paulo, que presta assistência a mais de cem mil beneficiários. Foram analisadas 158 demandas judiciais ajuizadas e recebidas pela operadora e registradas em banco de dados da empresa do período de 2012 a 2015, movidas por 152 beneficiários. As ações foram classificadas em dois grandes grupos, com subgrupos constituídos, a saber: ações relacionadas a coberturas assistenciais, que envolveram procedimentos médicos, tratamentos, exames, medicamentos, home care/internação domiciliar, outros tipos de internações; e ações de outra natureza, referentes a liminares de outras operadoras para cumprimento da operadora estudada, manutenção do plano de saúde, reajustes, perícia médica, retirada do nome do Serasa, isenção de carências e outros motivos. As ações pleiteadas para realização de procedimentos médicos responderam por 57% das demandas, com destaque para rizotomia percutânea (27%). Tratamento de quimioterapia em serviços não credenciados pela operadora, exames de PET SCAN em não conformidade com rol de procedimentos autorizados pela ANS, além de medicamentos antineoplásicos e para tratamento de Hepatite C, que não integravam a relação de medicamentos registrados pela ANVISA foram destaque nas análises realizadas. A Lei 9.656/1998 foi determinante para os beneficiários recorrerem ao Judiciário por coberturas assistenciais, impactando de maneira significativa na gestão das operadoras de planos privado. Deve-se considerar legítima a discussão sobre o tema e a realização desse estudo possibilitou aprofundar a análise dos efeitos da judicialização na realidade da operadora pesquisada, abarcando seus limites e responsabilidades

The judicialization of health has been a growing phenomenon in the area of health and a relevant subject of the managers' agenda. Many studies that have been produced in recent years, both in the field of Law and Health, indicate predominance in the public system. The objective of this research was to analyze the legal actions that are related to health care coverage in supplementary health care. A descriptive and cross-sectional study was conducted in a private health care operator in a large municipality / in a big city in the interior of the state of São Paulo, which provides assistance to more than 100,000 beneficiaries. We have analyzed 158 lawsuits that were filed and received by the operator and registered in the company's database for the period from 2012 to 2015, filed by 152 beneficiaries. The actions were classified into two large groups, with constituted subgroups, namely: actions that were related to care coverage, involving medical procedures, treatments, examinations, medications, home care / other hospitalizations; and actions of other nature, relating to injunctions of other operators to comply with the operator that was studied, maintenance of the health plan, readjustments, medical expertise, removal of the name of Serasa (Brazilian credit protection organization), exemption from deficiencies and other reasons. The actions that were requested to perform medical procedures were accounted for 57% of the demands, with emphasis on percutaneous rhizotomy (27%). The treatment of chemotherapy in services that were not accredited by the operator, SCAN PET examinations in non-compliance with ANS-authorized procedures, in addition to antineoplastic drugs and for treatment of Hepatitis C, which were not part of the list of medicines that were registered by ANVISA were highlighted in the analyzes which were carried out. The Law 9,656 / 1998 was decisive for beneficiaries to appeal to the Judiciary for assistance coverage, having a significant impact on the management of the private plan operators. The discussion on the topic should be considered legitimate and the realization / execution of this study made it possible to deepen the analysis of the effects of the judicialization on the reality of the surveyed operator, encompassing its limits and responsibilities

Ações judiciais demandadas por beneficiários de uma operadora de plano de saúde / Legal actions demanded by beneficiaries of a health plan operator

A judicialização da saúde tem sido fenômeno em crescimento na área da saúde e assunto relevante da pauta de gestores. Muitos estudos produzidos nos últimos anos, tanto no campo do Direito como no da Saúde, indicam um predomínio no sistema público. Essa pesquisa teve por objetivo analisar as ações judiciais relacionadas as coberturas assistenciais na saúde suplementar. Estudo descritivo e de corte transversal realizado em uma operadora de plano privado de saúde em um município de grande porte do interior do estado de São Paulo, que presta assistência a mais de cem mil beneficiários. Foram analisadas 158 demandas judiciais ajuizadas e recebidas pela operadora e registradas em banco de dados da empresa do período de 2012 a 2015, movidas por 152 beneficiários. As ações foram classificadas em dois grandes grupos, com subgrupos constituídos, a saber: ações relacionadas a coberturas assistenciais, que envolveram procedimentos médicos, tratamentos, exames, medicamentos, home care/internação domiciliar, outros tipos de internações; e ações de outra natureza, referentes a liminares de outras operadoras para cumprimento da operadora estudada, manutenção do plano de saúde, reajustes, perícia médica, retirada do nome do Serasa, isenção de carências e outros motivos. As ações pleiteadas para realização de procedimentos médicos responderam por 57% das demandas, com destaque para rizotomia percutânea (27%). Tratamento de quimioterapia em serviços não credenciados pela operadora, exames de PET SCAN em não conformidade com rol de procedimentos autorizados pela ANS, além de medicamentos antineoplásicos e para tratamento de Hepatite C, que não integravam a relação de medicamentos registrados pela ANVISA foram destaque nas análises realizadas. A Lei 9.656/1998 foi determinante para os beneficiários recorrerem ao Judiciário por coberturas assistenciais, impactando de maneira significativa na gestão das operadoras de planos privado. Deve-se considerar legítima a discussão sobre o tema e a realização desse estudo possibilitou aprofundar a análise dos efeitos da judicialização na realidade da operadora pesquisada, abarcando seus limites e responsabilidades

The judicialization of health has been a growing phenomenon in the area of health and a relevant subject of the managers' agenda. Many studies that have been produced in recent years, both in the field of Law and Health, indicate predominance in the public system. The objective of this research was to analyze the legal actions that are related to health care coverage in supplementary health care. A descriptive and cross-sectional study was conducted in a private health care operator in a large municipality / in a big city in the interior of the state of São Paulo, which provides assistance to more than 100,000 beneficiaries. We have analyzed 158 lawsuits that were filed and received by the operator and registered in the company's database for the period from 2012 to 2015, filed by 152 beneficiaries. The actions were classified into two large groups, with constituted subgroups, namely: actions that were related to care coverage, involving medical procedures, treatments, examinations, medications, home care / other hospitalizations; and actions of other nature, relating to injunctions of other operators to comply with the operator that was studied, maintenance of the health plan, readjustments, medical expertise, removal of the name of Serasa (Brazilian credit protection organization), exemption from deficiencies and other reasons. The actions that were requested to perform medical procedures were accounted for 57% of the demands, with emphasis on percutaneous rhizotomy (27%). The treatment of chemotherapy in services that were not accredited by the operator, SCAN PET examinations in non-compliance with ANS-authorized procedures, in addition to antineoplastic drugs and for treatment of Hepatitis C, which were not part of the list of medicines that were registered by ANVISA were highlighted in the analyzes which were carried out. The Law 9,656 / 1998 was decisive for beneficiaries to appeal to the Judiciary for assistance coverage, having a significant impact on the management of the private plan operators. The discussion on the topic should be considered legitimate and the realization / execution of this study made it possible to deepen the analysis of the effects of the judicialization on the reality of the surveyed operator, encompassing its limits and responsibilities

Risk assessment in fish welfare, applications and limitations.

The Treaty of Amsterdam, in force since 1 May 1999, has established new ground rules for the actions of the European Union (EU) on animal welfare. It recognizes that animals are sentient beings and obliges the European Institutions to pay full regard to the welfare requirements of animals when formulating and implementing Community legislation. In order to properly address welfare issues, these need to be assessed in a scientific and transparent way. The principles of risk assessment in terms of transparency and use of available scientific data are probably well suited for this area. The application of risk assessment for terrestrial and aquatic animal welfare is a relatively new area. This paper describes the work developed in the context of the European Food Safety Authority (EFSA) opinions on the application of a risk assessment methodology to fish welfare. Risk assessment is a scientifically based process that seeks to determine the likelihood and consequences of an adverse event, which is referred to as a hazard. It generally consists of the following steps: (i) hazard identification, (ii) hazard characterisation, (iii) exposure assessment and (iv) risk characterisation. Different approaches can be used for risk assessments, such as qualitative, semi-quantitative and quantitative approaches. These are discussed in the context of fish welfare, using examples from assessments done to aquaculture husbandry systems and stunning/killing methods for farmed fish. A critical review of the applications and limitations of the risk methodology in fish welfare is given. There is a need to develop appropriate indicators of fish welfare. Yet, risk assessment methodology provides a transparent approach to identify significant hazards and support recommendations for improved welfare.