35 research outputs found

    A propriedade sem registro : o contrato e aquisição da propriedade imóvel na perspectiva civil-contitucional

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    Orientador : Prof. Dr. Eroulths Cortiano JuniorTese (doutorado) - Universidade Federal do Paraná, Setor de Ciências Jurídicas, Programa de Pós-Graduação em Direito. Defesa: Curitiba, 12/08/2014Inclui referênciasResumo: Esta tese objetiva uma releitura da obrigatoriedade do registro nas aquisições da propriedade imóvel, a partir do reconhecimento do contrato como dotado de função social, que realiza, igualmente, a função social como liberdade de acesso aos bens. A propriedade imobiliária no Direito Civil brasileiro está qualificada como direito real, conforme o art. 1225, I, do Código Civil, e sua transferência negocial se orienta pelo sistema da separação parcial dos planos dos direitos obrigacionais e reais, o qual prevê a necessidade do contrato de transmissão (compra e venda, doação ou permuta) com posterior registro no Cartório Imobiliário, nos termos do art. 1245 e seguintes. A Constituição Federal de 1988 garante o direito de propriedade, que deve atender à sua função social, considerando-a como direito fundamental (art. 5.o, XXII e XXIII) e como princípio geral da ordem econômica (art. 170, II e III). A necessária interação entre o Direito Civil e a Constituição, sob a supremacia hierárquica desta, conduz a entender que o direito de propriedade atual, para além da literalidade do Código Civil, deve nortear-se pela sintonia entre ambos os diplomas legais, mas a partir da observação dos princípios e dos valores constitucionais. O Direito Civil-Constitucional surge, então, como uma opção de desenvolvimento do pensamento jurídico, que visa oferecer espaço de reflexão que supere a dogmática unicamente codificada, pois, com fundamento nos princípios e na axiologia constitucional, auxilia na ressignificação de institutos clássicos, como a propriedade e o contrato. O acesso à propriedade, então, pode ser considerado para além da letra da lei, o que permite relevar o registro, com a funcionalização do contrato que, a partir de sua teleologia, da solidariedade, da alteridade e da boa-fé, pode ser o elemento constitutivo da propriedade, com base no caso concreto. A aplicação direta e imediata da Constituição nas relações interprivadas favorece a ressignificação do contrato, que alçará significado de título suficiente para garantir o direito à propriedade (acesso). A complexidade e a pluralidade das relações sociais conduzem a uma transição do modelo abstrato e individualista da propriedade para o da propriedade concreta, que se constrói na funcionalização como liberdade(s) com vistas à realização das necessidade da pessoa concretamente considerada.Abstract: The aim of this thesis is to re-read the mandatory registration on acquisition of immovable property, from the social function of contract's recognition, which also performs its social function as freedom of access to assets. The immovable property in the Brazilian Civil Law is qualified as a real right, according to art. 1225, I, Civil Code, and its negotiating transferring is guided by the partial separation between obligations and real rights, which predicts the registration of transmission's contract (sale, donation or exchange) with the state registration authority, according to art. 1245 and on Civil Code. The 1988 Federal Constitution guarantees the right to property, which must meet its social function, considering it as a fundamental right (art. 5, XXII and XXIII) and as a general principle of economic order (art. 170, II and III). The necessary interaction between the civil law and the Constitution, under the hierarchical supremacy of this leads to understand that the current property law, beyond its literal meaning of the Civil Code, shall be guided by the line between the two enactments, but from the observation of constitutional principles and values.The Civil-constitutional Law arises, then, as an option for legal thinking development, which aims to provide a reflection space that overcomes the consolidated dogmatic, therefore, on the basis of principles and the constitutional axiology, assists in reframing classical institutes, as property and contract. The access to the property can then be considered beyond the letter of the law, which allows to release the register, with the functionalization's contract which, from its teleology, solidarity, alterity and good faith, may be the constituent element of the property, based on the case. The direct and immediate constitutional applying in privates relations cooperate to the contract redefinition, which obtain the sufficient title to guarantee the right to property (access). The complexity and plurality of social relations lead to a transition from abstract and individualistic model of property to concrete one which is constructed on functionalization as freedom (s) to intending to accomplish persons needs concretely considered

    Adverse effects information in clinical guidelines on pharmacological treatment of depression in children and adolescents: a systematic review

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    Objectives To analyse to what extent clinical practice guidelines on drug treatment of depression in children and adolescents mention the risk of adverse effects, to characterise the citations in the guidelines and to assess to what extent data from a major study (Treatment for Adolescents With Depression Study, TADS) was used as basis for information about adverse effects. Design Systematic review of clinical guidelines and clinical decision support tools. Data sources PubMed, EMBASE, guideline collections, Health libraries. Eligibility criteria We included national guidelines on depression in children and adolescents from European and/or English-speaking countries, published in English, German, French or any Scandinavian language since 2008. We also included well-known, international clinical decision support tools. Data extraction and synthesis Guidelines were examined by all authors to identify and classify information on adverse effects. Citations for statements on adverse effects were extracted and classified by category. The extent of citations about suicidality risk versus other adverse effects was assessed. Results 19 guidelines were assessed. All guidelines discussed risk of suicidal behaviour connected with use of antidepressants. Most guidelines mentioned some other psychiatric adverse effects. Several guidelines did not include information on well-known and common somatic adverse effects. Most references concerned risk of suicidality. Adverse effects identified in underlying studies were not always presented. The TADS study was referred to, directly or indirectly, by 18/19 guidelines, but some only referred to TADS with regard to suicidality without citing the study’s findings of somatic adverse effects. No guideline commented on the lack of long-term adverse effects data from TADS. Conclusions Guidelines for treatment of depression in children and adolescents vary widely regarding information on adverse effects. Many guidelines do not provide information on common somatic adverse effects. There is no consensus as to what extent risks of adverse effects connected with use of antidepressants should be described in guidelines

    Critical appraisal of adverse effects reporting in the 'Treatment for Adolescents With Depression Study (TADS)'

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    To identify all publications from the ‘Treatment for Adolescents With Depression Study (TADS)’ and assess the findings regarding occurrence of any adverse effects in the treatment groups both for the short-term and long-term study stages.Descriptive analysis of TADS publications with any information on adverse effects.We identified 48 publications describing various aspects of the TADS, in which 439 adolescent patients received treatment with fluoxetine, cognitive–behavioural therapy, cognitive–behavioural therapy plus fluoxetine or placebo. Eight publications were assessed as providing some data on adverse effects. Risk of suicidal behaviour was the only adverse effect that was addressed in all publications. Several psychiatric and physical adverse effects were reported during the first 12 weeks, but not mentioned in reports from later study stages. Common adverse effects of fluoxetine, such as weight changes or sexual problems, were not identified or mentioned in the publications.The TADS publications do not present a comprehensive assessment of treatment risk with fluoxetine in adolescents, especially for more than 12 weeks of treatment. Risk of suicidality was the only adverse effect that was reported over time. Reporting of adverse effects was incomplete with regard to the long-term safety profile of fluoxetine

    Characterization of gastrointestinal adverse effects reported in clinical studies of corticosteroid therapy

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    Objectives: To examine whether 159 studies included in a previous meta-analysis reported on gastrointestinal bleeding or perforation in accordance with the CONSORT extension for reporting harms outcomes (CONSORT Harms recommendations checklist); whether differences were associated with funding source, journal, or publication year; and whether the CONSORT Harms checklist is a suitable tool for evaluation of adverse effects reporting. Study Design and Setting: Articles were assessed for fulfillment of the CONSORT Harms recommendations, funding source, publication type, and year. Agreement between reviewers was assessed by comparing scores for each study. Results: The mean CONSORT Harms score was 5.25 out of 10 (standard deviation ± 2.09). Most studies included information on participant withdrawals (133 studies, 83.6%), absolute risk of gastrointestinal bleeding or perforation (130 studies, 81.8%), and how harms-related information was collected (118 studies, 74.2%). Reporting of gastrointestinal bleeding or perforation increased with higher scores (odds ratio 1.173, P = 0.042). There was no significant association between CONSORT Harms score achieved and publication year or funding source, but there was a trend toward higher scores in studies published in the major medical journals (score difference 0.78, P = 0.052). Definitions of gastrointestinal bleeding differed between studies. Reviewer agreement was fair to moderate with large variations. Conclusion: Few studies in the systematic review received high scores using the CONSORT Harms criteria. Most studies reported on the most important criteria regarding risk of gastrointestinal bleeding or perforation. Reviewer agreement showed large variations due to imprecise texts and ambiguous criteria. Routine scoring according to fulfillment of the CONSORT Harms recommendations would be inadvisable without qualified judgment

    Estimating QUALY gains in applied studies: A review of cost-utility analyses published in 2010

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    Reimbursement agencies in several countries now require health outcomes to be measured in terms of quality-adjusted life-years (QALYs), leading to an immense increase in publications reporting QALY gains. However, there is a growing concern that the various ‘multi-attribute utility’ (MAU) instruments designed to measure the Q in the QALY yield disparate values, implying that results from different instruments are incommensurable. By reviewing cost-utility analyses published in 2010, we aim to contribute to improved knowledge on how QALYs are currently calculated in applied analyses; how transparently QALY measurement is presented; and how large the expected incremental QALY gains are. We searched Embase, MEDLINE and NHS EED for all cost-utility analyses published in 2010. All analyses that had estimated QALYs gained from health interventions were included. Of the 370 studies included in this review, 48 % were pharmacoeconomic evaluations. Active comparators were used in 71 % of studies. The median incremental QALY gain was 0.06, which translates to 3 weeks in best imaginable health. The EQ-5D-3L is the dominant instrument used. However, reporting of how QALY gains are estimated is generally inadequate. In 55 % of the studies there was no reference to which MAU instrument or direct valuation method QALY data came from. The methods used for estimating expected QALY gains are not transparently reported in published papers. Given the wide variation in utility scores that different methodologies may assign to an identical health state, it is important for journal editors to require a more transparent way of reporting the estimation of incremental QALY gains. This article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited

    What principles should govern the use of managed entry agreements?

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    BACKGROUND: To ensure rapid access to new potentially beneficial health technologies, obtain best value for money, and ensure affordability, healthcare payers are adopting a range of innovative reimbursement approaches that may be called Managed Entry Agreements (MEAs). METHODS: The Health Technology Assessment International (HTAi) Policy Forum sought to identify why MEAs might be used, issues associated with implementation and develop principles for their use. A 2-day deliberative workshop discussed key papers, members' experiences, and collectively addressed four policy questions that resulted in this study. RESULTS: MEAs are used to give access to new technologies where traditional reimbursement is deemed inappropriate. Three different forms of MEAs have been identified: management of budget impact, management of uncertainty relating to clinical and/or cost-effectiveness, and management of utilization to optimize performance. The rationale for using these approaches and their advantages and disadvantages differ. However, all forms of MEA should take the form of a formal written agreement among stakeholders, clearly identifying the rationale for the agreement, aspects to be assessed, methods of data collection and review, and the criteria for ending the agreement. CONCLUSIONS: MEAs should only be used when HTA identifies issues or concerns about key outcomes and/or costs and/or organizational/budget impacts that are material to a reimbursement decision. They provide patient access and can be useful to manage technology diffusion and optimize use. However, they are administratively complex and may be difficult to negotiate and their effectiveness has yet to be evaluated
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