Response to Critique of "The Insignificance of Thresholds in Environmental Impact Assessment: An Illustrative Case Study in Canada".

Our paper, "The Insignificance of Thresholds in Environmental Impact Assessment: An Illustrative Case Study in Canada" received a critique that challenged us on a number of grounds. Namely, that we defame EIA practitioners, that we advocate EIAs to become a scientific enterprise, that we do not recognize the complexity inherent in EIA, and that EIA undergo an independent assessment by regulators. We respond to all of these points, and argue that conflict of interest is an institutional issue (not one of corrupt practitioners), and that we critique the science that forms the basis of evidence in EIA. Further, we show that the complexity and uncertainty in the critique cannot explain the findings from our paper that all cases of impact threshold exceedance were determined to be not significant in EIA. Finally, we compare the significance determinations in proponent reports to final regulator decisions and determine that they are overwhelmingly identical (93-95%). Regulators are financially independent of proponents, but their decisions on significant are heavily dependent on the information and analysis provided by the proponent reports. As regulators rely on these reports, environmental impact assessments must be based on rigorous and transparent analysis.

The Insignificance of Thresholds in Environmental Impact Assessment: An Illustrative Case Study in Canada.

Environmental assessment is the process that decision-makers rely on to predict, evaluate, and prevent biophysical, social, and economic impacts of potential project developments. The determination of significance in environmental assessment is central to environmental management in many nations. We reviewed ten recent environmental impact assessments from British Columbia, Canada and systematically reviewed and scored significance determination and the approaches used by assessors, the use of thresholds in significance determination, threshold exceedances, and the outcomes. Findings of significant impacts were exceedingly rare and practitioners used a combination of significance determination approaches, most commonly relying upon reasoned argumentation. Quantitative thresholds were rarely employed, with less than 10% of the valued components evaluated using thresholds. Even where quantitative thresholds for significance were exceeded, in every case practitioners used a variety of rationales to demote negative impacts to non-significance. These reasons include combinations of scale (temporal and spatial) of impacts, an already exceeded baseline, model uncertainty and/or substituting less stringent thresholds. Governments and agencies can better protect resources by requiring clear and defensible significance determinations, by making government-defined thresholds legally enforceable and accountable, and by requiring or encouraging significance determination through inclusive and collaborative approaches.

Obesity Paradox in Atrial Fibrillation and its Relation with the New Oral Anticoagulants.

Obesity, a chronic disease established as a global epidemic by the World Health Organization, is considered a risk factor for atrial fibrillation (AF), the most common sustained cardiac arrhythmia, which has high morbidity and mortality. Although both obesity and AF are diseases associated with negative outcomes, studies have shown the presence of an obesity paradox, in which patients with a high body mass index (BMI) and AF have a better prognosis than patients with a normal BMI. Despite the fact that the mechanisms that lead to this paradox are still uncertain, adequate anticoagulation in obese patients seems to play an important role in reducing adverse events in this group. In this perspective article, the authors discuss the relationship between new oral anticoagulants (NOACs), namely, apixaban, edoxaban and rivaroxaban (factor Xa inhibitors) and dabigatran (direct inhibitor of thrombin), and the obesity paradox, seeking to deepen the understanding of the mechanism that leads to this paradox.

SARS-CoV-2 genomic surveillance in Rondônia, Brazilian Western Amazon.

SARS-CoV-2 has spread rapidly around the world, with Brazil currently considered an epicenter of the pandemic. The Northern region has the second highest incidence coefficient, as well as the third highest mortality rate in the country. This study aimed to investigate information about the evolutionary history of epidemic spread and genetic aspects of strains isolated on the Western Amazon, in the State of Rondônia, Brazil. It was possible to detect a total of 22 mutations. Some of these alterations may possibly be related to effects on transmissibility, the fidelity of RNA replication, the ability of cancer patients to respond to infection, beyond a mutation that emerged after the introduction of SARS-CoV-2 in Rondônia. At least two events of introduction were detected, corresponding to the B.1 and B.1.1 European lineages. An introduction was observed possibly through Argentina, where strains originated that circulated in the Minas Gerais and Ceará Brazilian states, prior to Rondônia (B.1.), as well as through the Minas Gerais state and the Federal District, which gave rise to strains that spread to Rondônia, from the capital to more rural parts of the state (B.1.1.). The findings show the need to monitor the genetic epidemiology of COVID-19, in order to surveil the virus's evolution, dispersion and diversity.

Development of a quantitative one-step multiplex RT-qPCR assay for the detection of SARS-CoV-2 in a biological matrix.

INTRODUCTION: Coronavirus disease-2019 (COVID-19) is a disease caused by Severe Acute Respiratory Syndrome Virus 2 (SARS-CoV-2) that emerged in China in late 2019. The rapid viral spread has made the disease a public health emergency of worldwide concern. The gold standard for diagnosing SARS-CoV-2 is reverse transcription followed by qualitative real-time polymerase chain reaction (RT-qPCR); however, the role of viral load quantification has not been thoroughly investigated yet. OBJECTIVE: The aim of this study was to develop a high-precision quantitative one-step RT-qPCR reaction using the association of the viral target and the human target in the same reaction. METHODS: The assay standardization involved the absolute quantification method, with serial dilutions of a plasmid with the N gene in a biological matrix to build a standard curve. RESULTS AND DISCUSSION: The results demonstrated the possibility of quantifying as few as 2.5 copies/reaction and an analysis of 244 patients with known results selected by cross-section that revealed 100% agreement with a qualitative RT-qPCR assay registered by Anvisa. In this population, it was possible to quantify patients with between 2.59 and 3.5 × 107 copies per reaction and negative patients continued to indicate the same result. CONCLUSION: This assay can be a useful tool for a proper patient management, because the level and duration of viral replication are important factors to assess the risk of transmission and to guide decisions regarding the isolation and release of patients; an accurate diagnosis is critical information, whereas the current COVID-19 pandemic represents the biggest current global health problem.

Caderno Eletrônico de Laboratório como instrumento de sinergia, inovação e sustentabilidade científica / Electronic Laboratory Notebook as an instrument of synergy, innovation and scientific sustainability

Esta é uma dissertação profissional, desenvolvida sobre um tema de pesquisa com potencial de aplicação na Fiocruz. Parte da percepção que a geração e a transformação dos dados de pesquisa contemporâneos estão, crescentemente, em formato digital. Leva ainda em consideração a importância de um completo ciclo de vida dos dados, que pode ser facilitado com a inclusão de ferramentas eletrônicas de registro e guarda, conhecidas por Cadernos Eletrônicos de Laboratório (ELN), que assumam parte da tarefa de preservar as informações de maneira adequada de acordo com as Boas Práticas de Pesquisa. A busca pelo tema ganha força ao avaliar que há uma grande quantidade de Cadernos Eletrônicos de Laboratório disponíveis no mercado em contraponto à baixa adesão no meio acadêmico mundial. Como pressuposto de que os Cadernos Eletrônicos de Laboratório podem contribuir na qualidade das informações das pesquisas, desempenhando papel importante na cadeia de desenvolvimento da ciência e da tecnologia, como objetivo geral, buscamos propor parâmetros para a construção de um Caderno Eletrônico de Laboratório voltado aos laboratórios de pesquisa da Fiocruz, embasados nas necessidades identificadas da área de pesquisa biomédica da Fiocruz para a adoção de registro nestas ferramentas digitais. Situado pelo arcabouço teórico e por poucos estudos ou iniciativas sobre o tema na Fiocruz, foi feito um recorte para nosso trabalho, encontrando no Programa de Pesquisa Translacional uma diversidade que representa a pesquisa biomédica institucional, e foi considerado, para alcançar o objetivo principal, as necessidades das áreas de pesquisa, buscando conhecer como são realizadas as coletas, os registros dos dados de pesquisa e os maiores problemas enfrentados para manutenção das informações nos laboratórios. Como conclusão, esta pesquisa, apesar de não ser exaustiva, descreveu os melhores parâmetros e as principais dificuldades para a adoção de Cadernos Eletrônicos de Laboratório para a pesquisa biomédica na Fundação Oswaldo Cruz. Com o conhecimento alcançado, sugerimos algumas estratégias para institucionalização dos ELN na Fiocruz.