Monthly multidisciplinary complex spine conference: a cost-analysis utilizing time-driven activity-based costing.

PURPOSE: To understand costs and provide an initial framework associated with conference implementation as it pertains to complication prevention. METHODS: Team members' time spent on conference preparation, presentation, and follow-up tasks was recorded and averaged to determine the time required to prepare and present one patient. Using 2022 hourly wage rates based on our urban hospital setting, wage values were calculated for each personnel type and applied to their time spent. The total cost of the conference was annualized and calculated from the time spent in the three phases of the conference multiplied by the wage rate. Published data on complication rates and associated costs before and after conference implementation were used to calculate total cost reduction. RESULTS: With 3 active spine surgeons and 108 patients per year, the total time investment was 104.04 min per patient, costing $21,791 annually. Total RN equivalent value per patient was 5.25 for all three phases. Using a historical model, this multidisciplinary approach for adult spinal deformity reduced complications by 51% at 30 days, resulting in cost savings of $418,518 per year. Thus, the model demonstrates that implementation of this approach resulted in a potential total savings of $396,726/year. CONCLUSION: Implementing a cost-saving tool for managing complex spinal disorders is a responsibility of the spine team, who should lead a multidisciplinary conference. The combination of TDABC and lean methodology can effectively demonstrate the variable costs associated with this multidisciplinary effort and models provide evidence of potential cost-savings when applied to a multidisciplinary adult spinal deformity conference. These findings should encourage clinicians and administrators to allocate resources to improve patient care by reducing complications and costs.

Post-marketing authorisation safety and efficacy surveillance of advanced therapy medicinal products in Brazil, the European Union, the United States and Japan.

BACKGROUND AIMS: Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on gene, tissues or cells. ATMPs have peculiar characteristics when compared with traditional medicines. In this regard, long-term safety and efficacy follow-up systems of individuals treated with ATMPs have become necessary and may present unique challenges, because unlike conventional drugs and biologics, these products can exert their effects for years after administration. This work seeks to assess the requirements foreseen in the regulatory frameworks for the post-marketing authorization safety and efficacy surveillance for ATMPs in Brazil, European Union (EU), Japan and United States, which are some of the members of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. METHODS: We reviewed the scientific literature and official documents of regulatory agencies (RAs) in Brazil, the EU, Japan and the United States. RESULTS AND CONCLUSIONS: RAs in the EU, US and Japan have developed regulatory guidelines for the post-marketing surveillance of ATMPs. These guidelines aim at implementing surveillance plans for monitoring adverse events, including late ones, after marketing authorization. All the ATMPs authorized by the RAs studied, submitted some type of post-marketing requirement to supplement safety and efficacy data, according to the regulations and terminology used by those jurisdictions.

A UK cost-effectiveness analysis of trifluridine/tipiracil for heavily pretreated metastatic gastroesophageal cancers.

Background: The current work was designed to estimate the cost-effectiveness of trifluridine/tipiracil (T/T) versus best supportive care (BSC) for patients with advanced stage or metastatic gastroesophageal cancer (mGC) from a UK perspective. Materials & methods: A partitioned survival analysis was undertaken using data from the phase III TAGS trial. A jointly fitted lognormal model was selected for overall survival and individual generalized gamma models were chosen for progression-free survival and time-to-treatment-discontinuation. The primary outcome was the cost per quality-adjusted life year (QALY) gained. Sensitivity analyses were undertaken to investigate uncertainty. Results: Compared with BSC, T/T was associated with a cost per QALY gained of £37,907. Conclusion: T/T provides a cost-effective treatment option for mGC in the UK setting.

Comparison of new Brazilian legislation for the approval of advanced therapy medicinal products with existing systems in the USA, European Union and Japan.

BACKGROUND AIMS: Advanced therapy medicinal products (ATMPs) are a class of biological products for human use that are based on genes, cells and tissues. The first ATMP received marketing authorization in Europe in 2009, whereas Brazil granted the first authorization in 2020. The objective of this study was to compare the regulatory models adopted by Brazil, the USA, Japan and the European Union, which comprise the member countries of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, with regard to the marketing authorization of ATMPs. METHODS: The authors performed a review of the scientific literature and official documents of the regulatory agencies in the aforementioned countries. RESULTS: The legislation and regulatory guidelines adopted by the regulatory agencies exhibit similarities and differences. It was not possible to assess whether these differences can be translated into divergent final recommendations by regulatory authorities upon a request for marketing authorization. CONCLUSIONS: In the future, it will be appropriate to start a progressive process of harmonization between these agencies in terms of terminology, legal recommendations and characterization requirements. This is particularly important for emerging countries such as Brazil. In this sense, some measures can be taken to achieve alignment between regulators.

Nível de atividade física em estudantes ouvintes e surdos de uma escola em teresina-PI / Level of physical activity in hearing and deaf students from a school in Teresina-PI

A Organização Mundial da Saúde salienta o gradativo quadro de sedentarismo e seu impacto na população. A inatividade física é considerada o quarto principal fator de risco de doença, tornando-se um dos maiores problemas de saúde pública na atualidade. Todavia, há escassez de pesquisas voltadas à investigação e descrição de saúde em algumas populações específicas, dentre essas, a comunidade surda. Considerando essa lacuna no conhecimento, o presente estudo buscou verificar e comparar o nível de atividade física entre estudantes ouvintes e surdos de uma escola pública na cidade de Teresina-PI. Trata-se de uma pesquisa de cunho quantitativo com amostra de 28 voluntários, do sexo masculino e feminino, com idades entre 12 a 30 anos, estudantes de uma Unidade Escolar na cidade de Teresina-PI. Para coleta dos dados, foi utilizado o Questionário Internacional de Atividade Física (IPAQ). O teste de Mann-Whitney, utilizado para comparação entre os grupos, mostrou que houve diferença estatística somente nas variáveis de tempo gasto por dia em atividade moderadas (p=0,011) e no número de dias na semana que praticavam atividades vigorosas (p=0,051). O teste t, aplicado para amostras independentes, não mostrou nenhuma diferença significativa para o tempo em que permaneceram sentados em um dia de semana (p=0,424). Os resultados demostraram que embora as variáveis referentes ao tempo despendido por dia em atividades moderadas e ao número de dias na semana que os voluntários praticavam atividades vigorosas tenham mostrado diferença significativas, no contexto geral a deficiência não comprometeu o nível de atividade física na amostra estudada.

The World Health Organization points the gradual pattern of inactivity and its impact on the population. Physical inactivity is considered the fourth major risk factor for disease, making it one of the greatest public health problems today. However, there is a shortage of research aimed at research and description of health in specific populations, including the deaf community. Considering this knowledge gap, the present study aimed to verify and compare the level of physical activity between hearing and deaf students in a public school in Teresina-PI. This is a quantitative research with a sample of 28 male and female volunteers aged 12 to 30 years, students at a public school in Teresina-PI. The International Physical Activity Questionnaire (IPAQ) was used to collect the data. The Mann-Whitney test used for comparison between groups showed that there was a statistical difference only in the variables of time spent per day in moderate activity (p=0.011) and in the number of days in the week that practiced vigorous activities (p=0.051). The t-test applied to independent samples did not show any significant difference to the time spent sitting on a weekday (p=0.424). The results showed that although the variables regarding the time spent per day in moderate activities and the number of days in the week that the volunteers practiced vigorous activities showed a significant difference, in the general context the deficiency does not compromise the level of physical activity of the study sample.

Description of the second juvenile stage of the blue-fingered burrowing crayfish Parastacus caeruleodactylus (Decapoda: Astacidea: Parastacidae).

This study describes and illustrates the morphology of the second juvenile stage of the blue-fingered burrowing crayfish Parastacus caeruleodactylus. One female carrying 20 juveniles was collected in January 2019 from a swamp forest in the municipality of Dom Pedro de Alcântara, state of Rio Grande do Sul, southern Brazil. Juveniles were dissected and the appendages were mounted in slides. The general morphology and the pattern of attachment of the second juvenile stage of P. caeruleodactylus correspond to that reported for other parastacids. The main differences among the co-generic species are related to the number of articles in the flagella of the antennae, the number of spines in the antennal scale, the number of setae in the articles of the appendages, the number of teeth in the mandible molar and incisor processes, the absence of segmentation in the exopod flagellum of the maxillipeds and the number of teeth in the crista dentata of the ischium of maxilliped 3.

Two new species of South American freshwater crayfish genus Parastacus Huxley, 1879 (Crustacea: Decapoda: Parastacidae).

Two new species of Parastacus Huxley, 1879 are described from material collected in the state of Rio Grande do Sul, southern Brazil: Parastacus fluviatilis sp. nov. from highland streams and Parastacus caeruleodactylus sp. nov. from wetlands. Parastacus fluviatilis sp. nov. is distinguished mainly by large chelipeds with dense setae cover on the cutting edge of fingers, telson subtriangular with two lateral blunt spines and strongly concave ventral surface of lateral process of thoracic sternites 6 and 7. Parastacus caeruleodactylus sp. nov. is distinguished mainly by blue cheliped fingers and a large gap between them, reduced abdomen, dorsal and ventral margins of dactylus, propodus and carpus of second pair of pereiopods with tufts of long setae and mid-dorsal carina of exopod of uropods unarmed. According to IUCN Red List criteria both species are considered endangered. Habitat characterization and a method for defining the shape of second abdominal pleura are also provided.

Plasmodium vivax Malaria in Pregnant Women in the Brazilian Amazon and the Risk Factors Associated with Prematurity and Low Birth Weight: A Descriptive Study.

INTRODUCTION: Plasmodium vivax is the most prevalent malaria species in the American region. Brazil accounts for the higher number of the malaria cases reported in pregnant women in the Americas. This study aims to describe the characteristics of pregnant women with malaria in an endemic area of the Brazilian Amazon and the risk factors associated with prematurity and low birth weight (LBW). METHODS/PRINCIPAL FINDINGS: Between December 2005 and March 2008, 503 pregnant women with malaria that attended a tertiary health centre were enrolled and followed up until delivery and reported a total of 1016 malaria episodes. More than half of study women (54%) were between 20-29 years old, and almost a third were adolescents. The prevalence of anaemia at enrolment was 59%. Most women (286/503) reported more than one malaria episode and most malaria episodes (84.5%, 846/1001) were due to P. vivax infection. Among women with only P. vivax malaria, the risk of preterm birth and low birth weight decreased in multigravidae (OR, 0.36 [95% CI, 0.16-0.82]; p = 0.015 and OR 0.24 [95% CI, 0.10-0.58]; p = 0.001, respectively). The risk of preterm birth decreased with higher maternal age (OR 0.43 [95% CI, 0.19-0.95]; p = 0.037) and among those women who reported higher antenatal care (ANC) attendance (OR, 0.32 [95% CI, 0.15-0.70]; p = 0.005). CONCLUSION: This study shows that P. vivax is the prevailing species among pregnant women with malaria in the region and shows that vivax clinical malaria may represent harmful consequences for the health of the mother and their offsprings particularly on specific groups such as adolescents, primigravidae and those women with lower ANC attendance.

Avaliação da presença de corantes azóicos em medicamentos para uso pediátrico comercializados no Brasil / Evaluation of the presence of azoic dye compounds in medications for pediatric use commercialized in Brazil

Os corantes são compostos empregados em formulações farmacêuticas com a finalidade de lhes conferir cor. Os corantes azóicos subdividem-se em monoazóicos e bis-azóicos. Os corantes azóicos, quando biotransformados, podem originar por separação do grupo nitrogenado,substâncias com efeito carcinogênico como a benzidina e o 1-amino-2-naftol. Avalia nas formulações de medicamentos pediátricos, comercializados no Brasil, a presença de corantes azóicos, cujo uso em medicamentos foi proibido pela Agência Nacional de Vigilância Sanitária(ANVISA), Food and Drug Administration (FDA) e Farmacopéia Brasileira IV. As informações foram coletadas durante o ano de 2001 e os dados relativos às formulações dos medicamentos pediátricos foram obtidas de 417 preparações farmacêuticas líquidas, produzidos por IndústriasNacionais (45 por cento) e Multinacionais (55 por cento). A coleta de dados foi feita nas seguintes unidades: distribuidoras e drogarias situadas no Distrito Federal (DF), Agência Nacional de Vigilância Sanitária-ANVISA, no Dicionário de Especialidades Farmacêuticas (DEF) e PR Váde Mecum. Cerca de 84 por cento dos medicamentos pesquisados não apresentavam nenhuma informação Dentre os corantes azóicos, cujo uso em medicamentos não é permitido pela Farmacopéia Brasileira. Foi encontrado o amaranto em 10 por cento dos medicamentos provenientes das indústrias nacionais e 4,5 por cento dos medicamentos provenientes de indústrias multinacionais. Existe no Brasil legislação específica regulamentando o uso destes corantes, mas os resultados demonstram o descaso das empresasem cumprir as determinações legais. Palavras-chave: Corantes azóicos, amaranto, medicamentos pediátricos.

Paciente com siliconomas e sua associação com tumores nas mamas / Patient with siliconomas and their association with breast tumors

Relatamos o caso de uma paciente que, após injeção de silicone industrial por leigos, para aumentar o volume das mamas, procurou o ambulatório de Cirurgia Plástica com quadro de algia e carcinofobia. Apresentava múltiplos siliconomas. Foi submetida a mastectomia subcutânea e implante de próteses de silicone no mesmo tempo cirúrgico. O exame anatomo-patológico revelou carcinoma lobular na mama direita, além de achado anatomopatológico compatível com siliconomas. Essa paciente, quatro meses após a cirurgia, apresentou nódulos axilares aumentados e presença de linfonodo metastático de outro tumor na axila contralateral, portanto tumores sincrônicos de mama. Aproximadamente um ano após, evoluiu com prováveis metástases retroculares e hepáticas e, atualmente, encontra-se em tratamento oncológico quimioterápico. Existem trabalhos que mostram a relação entre a injeção de silicone e formação de "siliconomas" e evolução com câncer de mama, sendo ainda assunto controverso; no entanto, não se discute a gravidade dos casos, pelo diagnóstico difícil e tardio, como nesse caso.