Brexit and What It Means for Global Health.

A fiscalização de contratos administrativos, apesar da sua importância nas contratações públicas, é uma atividade que o Estado frequentemente tem dificuldades em operacionalizar e garantir aderência à legislação. Neste estudo avaliou-se qualitativamente se a introdução de acordos de níveis de serviços nos contratos administrativos e o estabelecimento da gestão de níveis de serviços (GNS) nas instituições públicas estaduais e municipais minimizariam não conformidades em suas contratações. Para tanto, os pesquisadores realizaram uma revisão sistemática na teoria da GNS e a confrontaram com os achados de uma análise de conteúdo aplicada em jurisprudências e relatórios de auditorias feitos pelo TCE/SC no período de 2006 a 2014, alicerçada por sete categorias de análise inspiradas na Lei de Licitações (Lei n. 8.666/1993). Ficou demonstrado que, para as não conformidades enquadradas nas categorias de análise, há respostas na GNS com potenciais para aprimorar as contratações públicas, desde que a sua adoção considere as particularidades da administração pública brasileira.Palavras-chave: Acordo de nível de serviço. SLA. SLM. Administração pública. Contratos administrativos. Abstract The supervision of public contracts, despite its importance in public procurement, is an activity that the state often has difficulties in operationalizing and ensuring adherence to the legislation. This study examined qualitatively whether the introduction of service level agreements in public contracts and the establishment of service level management (SLM) in state and municipal institutions would minimize nonconformities in their hiring. Therefore, the researchers underwent a systematic review of the theory of SLM and then confronted it with the findings of the content analysis applied in court decisions and audit reports performed by the Santa Catarina State Audit Court from 2006 to 2014, supported by seven categories of analysis inspired by the Brazilian Bidding Law (n. 8.666/1993). It demonstrated that, for the non-conformities classified in the categories of analysis, compelling answers exist in SLM with potential to improve public administration contracting, as long as its adoption consider the particulars of the Brazilian public administration.Keywords: Service level agreement. SLA. Public administration. Contract management

Evaluation of PIK3CA mutations in advanced ER+/HER2-breast cancer in Portugal – U-PIK Project

Background: Around 40% of ER+/HER2-breast carcinomas (BC) present mutations in the PIK3CA gene. Assessment of PIK3CA mutational status is required to identify patients eligible for treatment with PI3Kα inhibitors, with alpelisib currently the only approved tyrosine kinase inhibitor in this setting. U-PIK project aimed to conduct a ring trial to validate and implement the PIK3CA mutation testing in several Portuguese centers, decentralizing it and optimizing its quality at national level.Methods: Eight Tester centers selected two samples of patients with advanced ER+/HER2- BC and generated eight replicates of each (n = 16). PIK3CA mutational status was assessed in two rounds. Six centers used the cobas®PIK3CA mutation test, and two used PCR and Sanger sequencing. In parallel, two reference centers (IPATIMUP and the Portuguese Institute of Oncology [IPO]-Porto) performed PIK3CA mutation testing by NGS in the two rounds. The quality of molecular reports describing the results was also assessed. Testing results and molecular reports were received and analyzed by U-PIK coordinators: IPATIMUP, IPO-Porto, and IPO-Lisboa.Results: Overall, five centers achieved a concordance rate with NGS results (allele frequency [AF] ≥5%) of 100%, one of 94%, one of 93%, and one of 87.5%, considering the overall performance in the two testing rounds. NGS reassessment of discrepancies in the results of the methods used by the Tester centers and the reference centers identified one probable false positive and two mutations with low AF (1–3%, at the analytical sensitivity threshold), interpreted as subclonal variants with heterogeneous representation in the tissue sections processed by the respective centers. The analysis of molecular reports revealed the need to implement the use of appropriate sequence variant nomenclature with the identification of reference sequences (HGVS-nomenclature) and to state the tumor cell content in each sample.Conclusion: The concordance rates between the method used by each tester center and NGS validate the use of the PIK3CA mutational status test performed at these centers in clinical practice in patients with advanced ER+/HER2- BC

Gestão de níveis de serviços : um instrumento para aprimorar as contratações da administração pública de Santa Catarina

In a scenario marked by outsourcing, it is demanded from public institutions mechanisms that can increase the effectiveness and efficiency of the state. Nevertheless, the Brazilian government, in general, presents difficulties in monitoring contracted services and the complete delivery of contracted terms on schedule and with satisfactory quality. From this fact arises the research opportunity in public administration which aims to assess whether the adoption of service levels agreements (SLA) and the establishment of service level management (SLM) processes would be able to improve contract management of services of all kinds in the state of Santa Catarina, ensuring that services are performed as adjustments made and prioritizing the prevalence of public interest over private interest. During this study, the theoretical framework was built with a systematic review of the available literary collection, aspiring to know the state of art on the subject and to allow the linking of the theory with empirical evidences provided by documentary sources of data. Research procedures included a content analysis of audit reports, jurisprudences and reports of operational audits from the Santa Catarina State Audit Court (TCE/SC), in order to find empirical evidence of non-compliances committed by public agents in the follow up administrative contracts activities. The research results showed a total of 28 statements of noncompliance activities that were classified into predefined categories of analysis. Confronting these results with the raised theoretical framework has been demonstrated that, for the reported problems, compelling answers exist in the hiring model proposed by SLM, which, according to this study, has great potential to improve public outsourcing and, consequently, improve the public administration itself. Based upon the research findings, the adoption of SLA in administrative contracts of services from all over the state Executive Branch and the establishment of SLM processes to follow up the implementation of these contracts were proposed to the Santa Catarina State Treasure Office (SEF/SC) and the Santa Catarina State Administration Office (SEA/SC), in order to institutionalize a new management culture of public contracts, contributing to the state strategy that comprises the provision of public services more efficient and effective for society.Em um cenário pautado pela contratação de terceiros, é demandada das instituições públicas a utilização de mecanismos que possam aumentar a eficácia e eficiência do Estado. Apesar disso, a administração pública brasileira, de maneira geral, apresenta dificuldades em acompanhar a execução de serviços e a entrega integral de objetos contratados dentro do prazo previsto e com qualidade satisfatória. Surge daí a oportunidade de pesquisa na área de administração pública que objetiva avaliar se a adoção de acordos de níveis de serviços (do inglês service level agreement SLA) e o estabelecimento de processos de gestão de níveis de serviços (do inglês service level management SLM) contribuiriam para aprimorar a gestão de contratos de serviços de qualquer natureza nos órgãos estaduais de Santa Catarina, visando garantir que os serviços sejam realizados conforme o ajustamento efetuado e priorizar a prevalência do interesse público sobre o interesse particular. No decorrer desse estudo, o quadro teórico foi construído com uma revisão sistemática sobre o acervo literário disponível, objetivando conhecer o estado da arte sobre o tema e permitir a vinculação da teoria com as evidências empíricas providas pelas fontes documentais de dados. Os procedimentos de pesquisa compreenderam uma análise de conteúdo sobre relatórios de auditorias, jurisprudências e relatórios de auditorias operacionais do Tribunal de Contas do Estado de Santa Catarina (TCE/SC), com a finalidade de encontrar evidências empíricas de não conformidades cometidas por agentes públicos no acompanhamento de contratos administrativos. Os resultados da pesquisa demonstraram um total de 28 declarações de não conformidades que se enquadraram nas categorias de análise predefinidas. Confrontando esses resultados com o quadro teórico levantado ficou demonstrado que, para os problemas relatados, há respostas convincentes no modelo de contratação proposto pela gestão de níveis de serviços, o qual possui grande potencial para melhorar contratações públicas, e, por consequência, melhorar a própria administração pública. Embasado pelas conclusões provenientes da pesquisa, são propostos à Secretaria de Estado da Fazenda (SEF/SC) e à Secretaria de Estado da Administração (SEA/SC) de Santa Catarina a adoção de acordos de níveis de serviços em contratos administrativos de prestação de serviços de todo o Poder Executivo estadual e o estabelecimento de processos de gestão de níveis de serviços no acompanhamento da execução desses contratos, visando institucionalizar uma nova cultura de gestão de contratos administrativos, contribuindo com a estratégia estadual que compreende a prestação de serviços públicos mais eficientes e eficazes para a sociedade.Coordenação de Aperfeiçoamento de Pessoal de Nível Superio

Gestão de níveis de serviços: um instrumento para aprimorar as contratações da administração pública estadual e municipal

A fiscalização de contratos administrativos, apesar da sua importância nas contratações públicas, é uma atividade que o Estado frequentemente tem dificuldades em operacionalizar e garantir aderência à legislação. Neste estudo avaliou-se qualitativamente se a introdução de acordos de níveis de serviços nos contratos administrativos e o estabelecimento da gestão de níveis de serviços (GNS) nas instituições públicas estaduais e municipais minimizariam não conformidades em suas contratações. Para tanto, os pesquisadores realizaram uma revisão sistemática na teoria da GNS e a confrontaram com os achados de uma análise de conteúdo aplicada em jurisprudências e relatórios de auditorias feitos pelo TCE/SC no período de 2006 a 2014, alicerçada por sete categorias de análise inspiradas na Lei de Licitações (Lei n. 8.666/1993). Ficou demonstrado que, para as não conformidades enquadradas nas categorias de análise, há respostas na GNS com potenciais para aprimorar as contratações públicas, desde que a sua adoção considere as particularidades da administração pública brasileira.Palavras-chave: Acordo de nível de serviço. SLA. SLM. Administração pública. Contratos administrativos. Abstract The supervision of public contracts, despite its importance in public procurement, is an activity that the state often has difficulties in operationalizing and ensuring adherence to the legislation. This study examined qualitatively whether the introduction of service level agreements in public contracts and the establishment of service level management (SLM) in state and municipal institutions would minimize nonconformities in their hiring. Therefore, the researchers underwent a systematic review of the theory of SLM and then confronted it with the findings of the content analysis applied in court decisions and audit reports performed by the Santa Catarina State Audit Court from 2006 to 2014, supported by seven categories of analysis inspired by the Brazilian Bidding Law (n. 8.666/1993). It demonstrated that, for the non-conformities classified in the categories of analysis, compelling answers exist in SLM with potential to improve public administration contracting, as long as its adoption consider the particulars of the Brazilian public administration.Keywords: Service level agreement. SLA. Public administration. Contract management

Table1_Evaluation of PIK3CA mutations in advanced ER+/HER2-breast cancer in Portugal – U-PIK Project.DOCX

Background: Around 40% of ER+/HER2-breast carcinomas (BC) present mutations in the PIK3CA gene. Assessment of PIK3CA mutational status is required to identify patients eligible for treatment with PI3Kα inhibitors, with alpelisib currently the only approved tyrosine kinase inhibitor in this setting. U-PIK project aimed to conduct a ring trial to validate and implement the PIK3CA mutation testing in several Portuguese centers, decentralizing it and optimizing its quality at national level.Methods: Eight Tester centers selected two samples of patients with advanced ER+/HER2- BC and generated eight replicates of each (n = 16). PIK3CA mutational status was assessed in two rounds. Six centers used the cobas®PIK3CA mutation test, and two used PCR and Sanger sequencing. In parallel, two reference centers (IPATIMUP and the Portuguese Institute of Oncology [IPO]-Porto) performed PIK3CA mutation testing by NGS in the two rounds. The quality of molecular reports describing the results was also assessed. Testing results and molecular reports were received and analyzed by U-PIK coordinators: IPATIMUP, IPO-Porto, and IPO-Lisboa.Results: Overall, five centers achieved a concordance rate with NGS results (allele frequency [AF] ≥5%) of 100%, one of 94%, one of 93%, and one of 87.5%, considering the overall performance in the two testing rounds. NGS reassessment of discrepancies in the results of the methods used by the Tester centers and the reference centers identified one probable false positive and two mutations with low AF (1–3%, at the analytical sensitivity threshold), interpreted as subclonal variants with heterogeneous representation in the tissue sections processed by the respective centers. The analysis of molecular reports revealed the need to implement the use of appropriate sequence variant nomenclature with the identification of reference sequences (HGVS-nomenclature) and to state the tumor cell content in each sample.Conclusion: The concordance rates between the method used by each tester center and NGS validate the use of the PIK3CA mutational status test performed at these centers in clinical practice in patients with advanced ER+/HER2- BC.</p

Global economic burden of unmet surgical need for appendicitis

Background There is a substantial gap in provision of adequate surgical care in many low- and middle-income countries. This study aimed to identify the economic burden of unmet surgical need for the common condition of appendicitis. Methods Data on the incidence of appendicitis from 170 countries and two different approaches were used to estimate numbers of patients who do not receive surgery: as a fixed proportion of the total unmet surgical need per country (approach 1); and based on country income status (approach 2). Indirect costs with current levels of access and local quality, and those if quality were at the standards of high-income countries, were estimated. A human capital approach was applied, focusing on the economic burden resulting from premature death and absenteeism. Results Excess mortality was 4185 per 100 000 cases of appendicitis using approach 1 and 3448 per 100 000 using approach 2. The economic burden of continuing current levels of access and local quality was US $92 492 million using approach 1 and$73 141 million using approach 2. The economic burden of not providing surgical care to the standards of high-income countries was $95 004 million using approach 1 and$75 666 million using approach 2. The largest share of these costs resulted from premature death (97.7 per cent) and lack of access (97.0 per cent) in contrast to lack of quality. Conclusion For a comparatively non-complex emergency condition such as appendicitis, increasing access to care should be prioritized. Although improving quality of care should not be neglected, increasing provision of care at current standards could reduce societal costs substantially

Global economic burden of unmet surgical need for appendicitis

Background There is a substantial gap in provision of adequate surgical care in many low- and middle-income countries. This study aimed to identify the economic burden of unmet surgical need for the common condition of appendicitis. Methods Data on the incidence of appendicitis from 170 countries and two different approaches were used to estimate numbers of patients who do not receive surgery: as a fixed proportion of the total unmet surgical need per country (approach 1); and based on country income status (approach 2). Indirect costs with current levels of access and local quality, and those if quality were at the standards of high-income countries, were estimated. A human capital approach was applied, focusing on the economic burden resulting from premature death and absenteeism. Results Excess mortality was 4185 per 100 000 cases of appendicitis using approach 1 and 3448 per 100 000 using approach 2. The economic burden of continuing current levels of access and local quality was US $92 492 million using approach 1 and$73 141 million using approach 2. The economic burden of not providing surgical care to the standards of high-income countries was $95 004 million using approach 1 and$75 666 million using approach 2. The largest share of these costs resulted from premature death (97.7 per cent) and lack of access (97.0 per cent) in contrast to lack of quality. Conclusion For a comparatively non-complex emergency condition such as appendicitis, increasing access to care should be prioritized. Although improving quality of care should not be neglected, increasing provision of care at current standards could reduce societal costs substantially