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This study describes the cross-cultural adaptation to Brazilian Portuguese of the Adaptive Behavior Assessment System (ABAS-3), which assesses 11 skills areas within three major adaptive domains: the conceptual, social, and practical. The translation was performed by two independent translators, which was followed by the synthesis of the translations by two experts and then an analysis of the synthesis by 33 specialists from the areas of health and education (three per subscale) who were experts in the domains evaluated by ABAS-3. Of the 1121 items of the five ABAS-3 forms, 82 (7.31%) needed revision. There was good agreement between the specialists in respect of most items, with only minor adjustments being required. There was good evidence of content validity and the adequacy of the adaptation in respect of the conceptual, idiomatic, and semantic aspects of the items of the instrument. This initial process of cross-cultural adaptation was necessary because adaptive behavior is strongly influenced by environmental factors such as socioeconomic status and culture.
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Estimating durations between hundreds of milliseconds and seconds is essential for several daily tasks. Explicit timing tasks, which require participants to estimate durations to make a comparison (time for perception) or to reproduce them (time for action), are often used to investigate psychological and neural timing mechanisms. Recent studies have proposed that mechanisms may depend on specific task requirements. In this study, we conducted electroencephalogram (EEG) recordings on human participants as they estimated intervals in different task contexts to investigate the extent to which timing mechanisms depend on the nature of the task. We compared the neural processing of identical visual reference stimuli in two different tasks, in which stimulus durations were either perceptually compared or motorically reproduced in separate experimental blocks. Using multivariate pattern analyses, we could successfully decode the duration and the task of reference stimuli. We found evidence for both overlapping timing mechanisms across tasks as well as recruitment of task-dependent processes for comparing intervals for different purposes. Our findings suggest both core and specialized timing functions are recruited to support explicit timing tasks.
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Percepção do Tempo , Humanos , Percepção do Tempo/fisiologia , EletroencefalografiaRESUMO
PURPOSE: To present our real-life experience with dabrafenib and trametinib (D-T) treatment in patients with BRAF V600E-mutated ATC in Argentina. PATIENTS Y METHODS: We included five patients from four different hospitals. The median age was 70 years, and 60% were male. The performance status at diagnosis was grade 0 in 60% and grade 2 in 40% of patients. Four patients could undergo total thyroidectomy; in one of them, surgical treatment was amenable due to the indication of D-T as neoadjuvant therapy. From the total cohort, the best response to treatment was complete response in 40%, partial response in 20%, and stable disease in 20%. The median duration of response was 20 weeks, ranging from 16 to 92 weeks. All patients experienced at least one adverse event (AE). Grade ≥3 AEs were observed in two (40%) patients. They were upper gastrointestinal bleeding and subclavian vein thrombosis. The median follow-up was 20 weeks (range: 16 to 92). CONCLUSION: This report contributes to illustrate the feasibility and effectiveness of D-T treatment in five patients with loco-regionally advanced and metastatic BRAF V600E-mutated ATC in a real-life setting. A multidisciplinary approach and rapid molecular-tailored testing are essential to begin this therapeutic option.
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Carcinoma Anaplásico da Tireoide , Neoplasias da Glândula Tireoide , Humanos , Masculino , Idoso , Feminino , Carcinoma Anaplásico da Tireoide/tratamento farmacológico , Carcinoma Anaplásico da Tireoide/patologia , Proteínas Proto-Oncogênicas B-raf/genética , Argentina , Piridonas/uso terapêutico , Piridonas/efeitos adversos , Neoplasias da Glândula Tireoide/tratamento farmacológico , MutaçãoRESUMO
For registration of generic and similar drugs, it is necessary to carry out pharmaceutical equivalence (PE) tests and pharmaceutical bioequivalence (PB). To carry out these tests, duly qualified research centers are contracted, which need to be monitored by the sponsor who is legally responsible for the activities. To this end, it is the recommendation of the Document of the Americas, periodic monitoring to verify compliance with quality requirements, Standard Operating Procedures, Good Clinical Practices (GCP), Good Laboratory Practices (GLP), of the applicable regulatory framework, as well as of compliance with the study protocol. Thus, monitoring is a methodical and documented process to evaluate the degree of adhesion of the center to the planned design for the evaluation of the formulations. To this end, the implementation of a standardized and easily completed guideline is a very important tool to guarantee a consistent evaluation and maintain the organizational memory of the evaluated items by monitors designated by the sponsor, contributing to the constant improvement of the contracted centers and supporting traceability of the studies. This work provided a systemic view of the evidence process related mainly to pharmaceutical bioequivalence, with the monitoring guideline summarizing the items of greatest relevance to be verified.
Para registro de medicamentos genéricos e similares, é necessária a realização de testes de equivalência farmacêutica (EF) e bioequivalência farmacêutica (BF). Para a realização desses testes, são contratados centros de pesquisa devidamente habilitados, que precisam ser monitorados pelo patrocinador legalmente responsável pelas atividades. Há também a recomendação do Documento das Américas de realizar monitoramentos periódicos para verificar o cumprimento dos requisitos de qualidade, Procedimentos Operacionais Padrão, Boas Práticas Clínicas (BPC), Boas Práticas de Laboratório (BPL), de marco regulatório aplicável, bem como de cumprimento do protocolo do estudo. Assim, o monitoramento é um processo metódico e documentado para avaliar o grau de adesão do centro ao desenho planejado para a avaliação das formulações. Para tanto, a implantação de uma diretriz padronizada e de fácil preenchimento é uma ferramenta muito importante para garantir uma avaliação consistente e manter a memória organizacional dos itens avaliados por monitores designados pelo patrocinador, contribuindo para a melhoria constante dos centros contratados e apoiando rastreabilidade dos estudos. Este artigo forneceu uma visão sistêmica do processo de evidência relacionado principalmente à bioequivalência farmacêutica, com a diretriz de monitoramento resumindo os itens de maior relevância a serem verificados.
Para el registro de medicamentos genéricos y similares, es necesario realizar pruebas de equivalencia farmacéutica (EP) y de bioequivalencia farmacéutica (PB). Para llevar a cabo estas pruebas se contratan centros de investigación debidamente cualificados, que deben ser supervisados por el promotor, que es el responsable legal de las actividades. Para ello, es la recomendación del Documento de las Américas, el monitoreo periódico para verificar el cumplimiento de los requisitos de calidad, los Procedimientos Operativos Estándar, las Buenas Prácticas Clínicas (BPC), las Buenas Prácticas de Laboratorio (BPL), del marco regulatorio aplicable, así como del cumplimiento del protocolo del estudio. Así, la monitorización es un proceso metódico y documentado para evaluar el grado de adhesión del centro al diseño previsto para la evaluación de las formulaciones. Para ello, la implantación de una pauta estandarizada y de fácil cumplimentación es una herramienta muy importante para garantizar una evaluación consistente y mantener la memoria organizativa de los elementos evaluados por parte de los monitores designados por el promotor, contribuyendo a la mejora constante de los centros contratados y apoyando la trazabilidad de los estudios. Este trabajo proporcionó una visión sistémica del proceso de evidencia relacionado principalmente con la bioequivalencia farmacéutica, con la pauta de monitoreo que resume los ítems de mayor relevancia a ser verificados.
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Disponibilidade Biológica , Equivalência Terapêutica , Guia de Prática Clínica , Preparações Farmacêuticas , Medicamentos Genéricos , Guias de Prática Clínica como Assunto , Agência Nacional de Vigilância Sanitária , Desenvolvimento de Medicamentos , Marcos Regulatórios em SaúdeRESUMO
Background: It has been suggested that small metastatic lymph nodes (LNs) detected after initial surgery in patients with differentiated thyroid cancer (DTC) can be managed with active surveillance (AS). However, there is still concern regarding the clinical outcomes of these patients. The main aims of our study were as follows: (1) to assess the frequency of growth and the need of additional treatment in a group of patients with LN recurrences selected for AS, and (2) to determine predictive factors of LN progression. Methods: We retrospectively reviewed 856 clinical records from our DTC patient's database (May 2010 to January 2022). Eighty patients had suspicious cervical LNs on consecutive ultrasound (US) after initial surgery, but we included 50 patients with cytological confirmation of metastatic disease and at least 12 months follow-up. Exclusion criteria were as follows: any LN ≥2 cm or multiple LNs ≥1.5 cm in size, proximity to vital structures, PET-positive disease (standard uptake value ≥5), aggressive histology, and distant metastasis. Patients were followed with thyroglobulin (Tg) and thyroglobulin antibodies measurements on suppressive therapy and neck US every 6-12 months. LN growth was defined as an increase of ≥3 mm in any of its diameters. Results: A total of 50 patients had a median age of 41 years (range, 18-75). Most patients were women (80%) and had classical papillary thyroid cancer (86%). The mean size of the LNs was 10.1 ± 4.4 mm. After a median follow-up of 29 months (range, 12-144), 12 patients (24%) had an increase in size of the metastatic LN, 7 (58%) of whom were surgically removed. None of these seven patients had a structural incomplete response at the end of follow-up. The only variable that predicted an increase in LN size was a rise in Tg levels ≥0.5 ng/mL (p = 0.016). Based on a multivariate analysis, patients with increase in Tg levels ≥0.5 ng/mL had a significantly higher chance of developing LN growth (odds ratio [OR] 16.2 [confidence interval, CI 1.5-120.2], p = 0.020). The median progression-free survival rate was 6.6 years [CI 5.6-9.5]. Conclusion: AS of small LNs could be a feasible alternative to immediate surgery in properly selected patients.
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Carcinoma Papilar , Neoplasias da Glândula Tireoide , Humanos , Feminino , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Idoso , Masculino , Câncer Papilífero da Tireoide/cirurgia , Câncer Papilífero da Tireoide/patologia , Tireoglobulina/análise , Estudos Retrospectivos , Carcinoma Papilar/diagnóstico por imagem , Carcinoma Papilar/cirurgia , Carcinoma Papilar/patologia , Conduta Expectante , Metástase Linfática/patologia , Neoplasias da Glândula Tireoide/diagnóstico por imagem , Neoplasias da Glândula Tireoide/cirurgia , Neoplasias da Glândula Tireoide/patologia , Linfonodos/diagnóstico por imagem , Linfonodos/cirurgiaRESUMO
Social distancing in response to the COVID-19 pandemic brought several modifications in our daily lives. With these changes, some people have reported alterations in their feelings of how fast time was passing. In this study, we assessed whether and how social distancing and the evolution of the COVID-19 pandemic influenced participants' time awareness and production of time intervals. Participants (n = 3855) filled in the first questionnaire approximately 60 days after the start of social distancing in Brazil and weekly questionnaires for 15 weeks during social distancing. Our results indicate that time was perceived as expanded at the beginning, but this feeling decreased across the weeks. Time awareness was strongly associated with psychological factors such as loneliness, stress, and positive emotions, but not with time production. This relation was shown between participants and within their longitudinal reports. Together, our findings show how emotions are a crucial aspect of how time is felt.
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OBJECTIVE: The treatment of patients with differentiated thyroid cancer (DTC) was modified in the last decade towards a more individualized approach according to the risk of recurrence (RR). We compared the outcomes of patients with low and intermediate RR (LRR and IRR) who received or did not receive radioiodine remnant ablation (RRA) after assessing the dynamic risk. METHODS: We included 307 DTC patients with LRR and IRR submitted to total thyroidectomy. All patients were reclassified according to the dynamic risk stratification (low or high). Patients with high dynamic risk received RRA (141 patients). RESULTS: LRR patients who received RRA presented a frequency of structural incomplete response (SIR) of 5% at the end of the follow-up, compared to 2% in those who did not receive it (p=0.353). IRR patients treated with RRA had a frequency of SIR of 22%, compared to 5% in patients without RRA (p=0.008). CONCLUSION: This study demonstrates the usefulness of dynamic risk assessment to decide RRA in a cohort with a long-term follow-up. The lower prevalence of SIR at the end of the follow-up in patients who did not receive RRA highlights the adequate selection of those who would not benefit from RRA, even with an intermediate risk of recurrence.
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Radioisótopos do Iodo , Neoplasias da Glândula Tireoide , Humanos , Radioisótopos do Iodo/uso terapêutico , Recidiva Local de Neoplasia , Estudos Retrospectivos , Neoplasias da Glândula Tireoide/radioterapia , Neoplasias da Glândula Tireoide/cirurgia , Tireoidectomia , Resultado do TratamentoRESUMO
Studies investigating the neural mechanisms of time perception often measure brain activity while participants perform a temporal task. However, several of these studies are based exclusively on tasks in which time is relevant, making it hard to dissociate activity related to decisions about time from other task-related patterns. In the present study, human participants performed a temporal or color discrimination task of visual stimuli. Participants were informed which magnitude they would have to judge before or after presenting the two stimuli (S1 and S2) in different blocks. Our behavioral results showed, as expected, that performance was better when participants knew beforehand which magnitude they would judge. Electrophysiological data (EEG) was analysed using Linear Discriminant Contrasts (LDC) and a Representational Similarity Analysis (RSA) approach to investigate whether and when information about time and color was encoded. During the presentation of S1, we did not find consistent differences in EEG activity as a function of the task. On the other hand, during S2, we found that temporal and color information was encoded in a task-relevant manner. Taken together, our results suggest that task goals strongly modulate decision-related information in EEG activity.
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Eletroencefalografia/métodos , Objetivos , Percepção do Tempo/fisiologia , Adulto , Comportamento , Tomada de Decisões , Análise Discriminante , Eletrodos , Eletrofisiologia/métodos , Feminino , Humanos , Modelos Lineares , Masculino , Análise Multivariada , Reconhecimento Automatizado de Padrão , Estimulação Luminosa , Tempo de Reação/fisiologia , Reprodutibilidade dos Testes , Fatores de Tempo , Adulto JovemRESUMO
Management of contaminated sites requires application of remediation technologies to reduce environmental and human health risks, but these actions can also produce negative effects, such as energy and natural resources consumption, greenhouse gas emissions, and impacts on local communities. The tenets of sustainability can be used to select sustainable alternatives in the environmental cleanup of these areas to reduce negative consequences and seek new solutions for site reuse. The present study evaluates seven case studies of contaminated sites to identify how sustainable practices were adopted at each site and how environmental, economic and social benefits were achieved. Based on this survey, an in-depth analysis of 48 sustainable management practices was conducted to assess interim actions and institutional controls at a contaminated site located on the campus of University of Sao Paulo (USP) in the city of Sao Paulo, Brazil. The analysis involved a discussion about how future potential improvements to sustainable practices at the site could generate benefits and sustainable gains, such as improvement of quality of life of university students and surrounding communities; reduction of natural resource use, reduction of costs represented by the consumption of water and reduction of demand of potable water for society. The result of this analysis is a site-specific framework of 36 sustainable practices represented by a graphical approach with several examples that can be adopted during assessment and remediation on a case study basis, taking into account the needs and guidelines of the administration of the contaminated site. This approach can easily be adopted by the public and stakeholders who want to apply sustainable practices in other sites. The site-specific framework demonstrates how sustainable principles can be included in the process of contaminated sites management in an integrated process, meeting the needs and expectations of all affected stakeholders.
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Poluição Ambiental , Recuperação e Remediação Ambiental , Brasil , Conservação dos Recursos Naturais , Humanos , Recursos Naturais , Qualidade de VidaRESUMO
ABSTRACT Objective: The treatment of patients with differentiated thyroid cancer (DTC) was modified in the last decade towards a more individualized approach according to the risk of recurrence (RR). We compared the outcomes of patients with low and intermediate RR (LRR and IRR) who received or did not receive radioiodine remnant ablation (RRA) after assessing the dynamic risk. Materials and methods: We included 307 DTC patients with LRR and IRR submitted to total thyroidectomy. All patients were reclassified according to the dynamic risk stratification (low or high). Patients with high dynamic risk received RRA (141 patients). Results: LRR patients who received RRA presented a frequency of structural incomplete response (SIR) of 5% at the end of the follow-up, compared to 2% in those who did not receive it (p=0.353). IRR patients treated with RRA had a frequency of SIR of 22%, compared to 5% in patients without RRA (p=0.008). Conclusions: This study demonstrates the usefulness of dynamic risk assessment to decide RRA in a cohort with a long-term follow-up. The lower prevalence of SIR at the end of the follow-up in patients who did not receive RRA highlights the adequate selection of those who would not benefit from RRA, even with an intermediate risk of recurrence.