Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Methods. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia. governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. Conclusions. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy. (C) 2003 International Association for the Study of Pain.

Tentativas e perspectiva de forma????o de uma burocracia p??blica no Brasil

An??lise da quest??o da forma????o da burocracia p??blica no Brasil, desde a cria????o do Conselho Federal do Servi??o P??blico Civil em 1936 at?? as condi????es dadas pela Constitui????o Federal de 5 de outubro de 1988. Perspectivas e dificuldades de sua consolida????o na situa????o atual. As experi??ncias ocorridas no per??odo: o Estado Novo, o processo de Redemocratiza????o de 1946, o governo Kubitschek, o Movimento de 1964 e as grandes reformas sob o Decreto-Lei n?? 200, de 1967, a crise dos anos 80, a Constitui????o de 1988 e a Administra????o P??blica sob a Carta atual. Discuss??o dos temas em debate no momento sobre a quest??o da Administra????o P??blica: estabilidade, regime jur??dico, concurso p??blico, previd??ncia.

Bone mineral density of rat femurs after hindlimb unloading and different physical rehabilitation programs

Bone weakening can occur due to the absence of load on the skeleton or even short periods of decreased physical activity. Therefore, musculoskeletal diseases that involve temporary immobilization by casts, inactivity or tension increases the risk of fractures. Physical activity is the most studied procedure both to prevent damage and to restore bone structure. The present study aimed at evaluating, by bone densitometry on rat femurs, the influence of hindlimb unloading and later running activity on treadmill or free movement. Sixty-four Wistar rats were used, aged 65 days with a mean corporal mass of 316.11g, randomly divided into eight experimental groups: group 1, the suspended control with seven animals under hindlimb unloading regimen for 28 days, then euthanized; groups 2 and 3, the trained suspended comprising of 7 and five animals, respectively, subjected to hindlimb unloading for 28 days, followed by treadmill exercise for 28 days (group 2) or 56 days (group 3), then euthanized; groups 4 and 5, designated free suspended, comprised of 7 animals each under hindlimb unloading regimen for 28 days followed by free activity in cages for 28 days (group 4) or 56 days (group 5), then euthanized; groups 6, 7 and 8, negative controls, each with 8 animals allowed to free activity in cages and euthanized at the ages of 93, 121 and 149 days, respectively. Bone mineral density (BMD) of the left femur was analyzed by bone densitometry. Unloading by tail-suspension decreased BMD while treadmill training and free activity in cages promoted its recovery in a similar way and over time.

Anotação ao Acórdão do Supremo Tribunal de Justiça (Português), de 25 de Janeiro de 2011 - o contrato de franquia e a resolução

Resumo: 1 – Sumário do Acórdão do Supremo Tribunal de Justiça, de 25 de Janeiro de 2011; 2 – Texto completo do Acórdão do Supremo Tribunal de Justiça, de 25 de Janeiro de 2011, Juiz Conselheiro Garcia CALEJO (Relator), Juiz Conselheiro Hélder ROQUE e Juiz Conselheiro Sebastião PÓVOAS: cfr. http://www.dgsi.pt , 21 de Abril de 2011; 3 – Anotação; 3.1 – Introdução à anotação; 3.2 – A questão da resolução em termos gerais; 3.3 – A questão da resolução no «contrato atípico de franquia»; 4 – Conclusões; § Abstract: 1 - Summary of the Sentence of the Supreme Court of Justice, 25 of January of 2011; 2 - Complete text of the Sentence of the Supreme Court of Justice, 25 of January of 2011, Advising Judge Garcia CALEJO (Reporter), Advising Judge Hélder ROQUE and Advising Juiz Sebastião PÓVOAS: cfr. http://www.dgsi.pt , 21 of April of 2011; 3 - Notation; 3.1 - Introduction to the notation; 3.2 - The question of the resolution in general terms; 3.3 - The question of the resolution in the «atypical contract of franshise»; 4 - Conclusions;

Lições de Direito dos Contratos

1 – Importância e actualidade do instituto. 2 – Noção de contrato. Sua disciplina no Código Civil. 3 – Relações contratuais de facto. 4 – Princípios fundamentais do regime dos contratos. 5 – Princípio da liberdade contratual. 6 – Princípio do consensualismo. 7 – Princípio da boa fé. A responsabilidade pré-contratual. 8 – Princípio da força vinculativa. 9 – Contratos unilaterais ou não sinalagmáticos e bilaterais ou sinalagmáticos. Contratos gratuitos e onerosos. Contratos cumulativos e aleatórios. 10 – Contratos mistos. União de contratos ou coligação de contratos. 11 – Contrato-promessa. 12 – Pacto de preferência. 13 - Alguns problemas e “contratos em especial”, a título enunciativo, relacionados com as actividades de Gestão, Banca e Seguros: “aspectos contratuais” de direito civil e de direito comercial. § 1 - Importance and actuality of the institute. 2 - Contract notion. Its disciplines in the portuguese Civil Code. 3 – Contractual relations of fact. 4 - Basic principles of the regimen of contracts. 5 - Principle of the contractual freedom. 6 - Principle of “consensualism”. 7 - Principle of the "good faith". The pre-contractual liability. 8 - Principle of the obligatory force (binding). 9 - Unilateral or not bilateral contracts. Free and onerous contracts. Cumulative and random contracts.

Anotação ao Acórdão do Supremo Tribunal de Justiça (Português), de 25 de Janeiro de 2011 - a resolução e o contrato de franquia

É importante chamar a atenção das possíveis diferenças entre o contrato de franquia e o contrato de agência no que diz respeito também ao problema da resolução em termos mais gerais ou em termos mais concretos; 1 – Sumário do Acórdão do Supremo Tribunal de Justiça, de 25 de Janeiro de 2011; 2 – Texto completo do Acórdão do Supremo Tribunal de Justiça, de 25 de Janeiro de 2011, Juiz Conselheiro Garcia CALEJO (Relator), Juiz Conselheiro Hélder ROQUE e Juiz Conselheiro Sebastião PÓVOAS: cfr. http://www.dgsi.pt , 21 de Abril de 2011; 3 – Anotação; 3.1 – Introdução à anotação; 3.2 – A questão da resolução em termos gerais; 3.3 – A questão da resolução no «contrato atípico de franquia»; 4 – Conclusões; Abstract: is important to draw attention to potential differences between the franchise agreement and agency agreement with regard also to the resolution problem in more general terms or in more concrete terms; 1 - Summary of the Sentence of the Supreme Court of Justice, 25 of January of 2011; 2 - Complete text of the Sentence of the Supreme Court of Justice, 25 of January of 2011, Advising Judge Garcia CALEJO (Reporter), Advising Judge Hélder ROQUE and Advising Juiz Sebastião PÓVOAS: cfr. http://www.dgsi.pt , 21 of April of 2011; 3 - Notation; 3.1 - Introduction to the notation; 3.2 - The question of the resolution in general terms; 3.3 - The question of the resolution in the «atypical contract of franshise»; 4 - Conclusions;

Anotação ao Acórdão do Supremo Tribunal de Justiça (Português), de 25 de Janeiro de 2011 - a resolução e o contrato de franquia

is important to draw attention to potential differences between the franchise agreement and agency agreement with regard also to the resolution problem in more general terms or in more concrete terms; 1 - Summary of the Sentence of the Supreme Court of Justice, 25 of January of 2011; 2 - Complete text of the Sentence of the Supreme Court of Justice, 25 of January of 2011, Advising Judge Garcia CALEJO (Reporter), Advising Judge Hélder ROQUE and Advising Juiz Sebastião PÓVOAS: cfr. http://www.dgsi.pt , 21 of April of 2011; 3 - Notation; 3.1 - Introduction to the notation; 3.2 - The question of the resolution in general terms; 3.3 - The question of the resolution in the «atypical contract of franshise»; 4 - Conclusions;

O recurso ao outsourcing na prestação de cuidados de saúde

Nos últimos anos verificou-se uma alteração das condições e modo de funcionamento de empresas e instituições, privadas e públicas, muitas delas através da introdução de novas ferramentas de gestão. De entre elas, podemos destacar o outsourcing, que apesar de não ser um fenómeno actual, é ainda em Portugal uma ferramenta recente e pouco explorada, que pode contribuir de forma decisiva para a modernização, flexibilidade e competitividade das empresas. O presente estudo pretende abordar a contratação de serviços externos nos serviços de saúde públicos, também conhecido como outsourcing, mediante uma análise prática da realidade de uma instituição hospitalar com sete serviços em regime de outsourcing, com recolha dos dados durante o triénio 2008-2010. No Serviço de Urgência durante 2010 o principal prestador recebeu mais 104,28% acima do valor referência/hora, no Serviço de Oftalmologia no ano de 2010 o prestador recebeu um valor superior em 24,91%, no Serviço de Limpeza, Higiene e Conforto é pago ao prestador durante o ano de 2010 um valor superior em 13,85%, no Serviço de Vigilância e Segurança o prestador recebeu durante o ano de 2010 um valor superior em 27,5%, caso a instituição hospitalar optasse por contratar, para os serviços atrás referidos, profissionais para o quadro de pessoal. Ainda em relação ao Serviço de Urgência foi pago mais 21,38% acima do valor de referência publicado por Despacho governamental. Em relação aos Serviços de Lavandaria e de Tratamento de Resíduos Sólidos, não foi possível recolher os dados necessários que pudessem levar a uma conclusão válida sobre os custos pagos pela instituição hospitalar. Pode-se concluir que a contratação de prestadores externos, para os serviços de saúde, essenciais e não essenciais, em regime de outsourcing, revela-se na maioria dos casos analisados a opção menos económica, com custos bastantes elevados.

Determination of pharmocotherapeutical complexity in institutionalized elderly

The phenomenon of aging is nowadays society as acquired the status of a social problem, with growing attention and concern, leading to an increase number of studies dedicated to the elderly. The lack of domestic, familiar or social support often lead elderly to nursing homes. Institutionalization is in many cases the only opportunity to have access to health care and life quality. Aging is also associated with a higher prevalence of chronic diseases that require long term medication sometimes for life. Frequently the onset of multiple pathologies at the same time require different therapies and the phenomenon of polypharmacy (five ou more drugs daily) can occur. Even more, the slow down of physiological and cognitives mechanisms associated with these chronic diseases can interphere, in one hand, with the pharmacocinetic of many medications and, on the other hand, with the facility to accomplish the therapeutical regimen. All of these realities contribute to an increase of pharmacotherapeutical complexity, decreasing the adherence and effectiveness of treatment. The pharmacotherapeutical complexity of an individual is characterized by the conciliator element of different characteristics of their drug therapy, such as: the number of medications used; dosage forms; dosing frequency and additional indications. It can be measured by the Medication Regimen Complexity Index (MRCI), originally validated in English.

Drug therapy complexity: the importance of pharmacotherapeutic follow-up

Nowadays, the phenomenon of population ageing represents an worldwide problem, which assumes particular significance in Portugal. As they get older, individuals present more comorbidities and consequently consume an increasing number of drugs, which contributes to a growing drug therapy complexity. The institutionalized elders are particularly affected by this occurrence. Drug therapy complexity is defined as the conciliator of several characteristics of the pharmacotherapy and can affect patient’s safety and medication adherence. It can be measured with Medication Regimen Complexity Index (MRCI). This study aims to determine the drug therapy complexity of institutionalized elders in order to assess the need of pharmacotherapeutic follow-up.

Retreatment in leprosy: a case-control study

OBJECTIVE: To assess risk factors for retreatment of leprosy patients. METHODS: A case-control study with patients from two reference care units in Recife, northeastern Brazil, in 2003. The case group included retreated patients (N=155) and the control group comprised those patients who were not retreated (N=155) matched by year of diagnosis and health care unit. Univariate and multivariate analyses were conducted to test the associations and odds ratios and related 95% confidence intervals were estimated. RESULTS: The following factors were found to be significantly associated (p<0.05) with retreatment: occurrence of adverse immunological reactions after treatment completion (OR=2.3; 95% CI=1.18;4.83), final bacterial index > 1 (OR=6.43; 95% CI=1.67;24.74), therapeutic regimen consisting of sulfone monotherapy (OR=10; 95% CI=0.01;0.78) and reports of household contacts (OR=2.2; 95% CI=0.24;0.85). CONCLUSIONS: The study findings reinforce that the use of dapsone monotherapy should be discontinued, and highlight the need for epidemiological monitoring of specific groups of leprosy patients after treatment completion through periodical clinical and laboratory evaluation. Further studies to explore the association between final bacterial index and retreatment are strongly recommended.

Polio inactivated vaccine costs into routine childhood immunization in Brazil

OBJECTIVE To analyze the costs of vaccination regimens for introducing inactivated polio vaccine in routine immunization in Brazil.METHODS A cost analysis was conducted for vaccines in five vaccination regimens, including inactivated polio vaccine, compared with the oral polio vaccine-only regimen. The costs of the vaccines were estimated for routine use and for the “National Immunization Days”, during when the oral polio vaccine is administered to children aged less than five years, independent of their vaccine status, and the strategic stock of inactivated polio vaccine. The presented estimated costs are of 2011.RESULTS The annual costs of the oral vaccine-only program (routine and two National Immunization Days) were estimated at US$19,873,170. The incremental costs of inclusion of the inactivated vaccine depended on the number of vaccine doses, presentation of the vaccine (bottles with single dose or ten doses), and number of “National Immunization Days” carried out. The cost of the regimen adopted with two doses of inactivated vaccine followed by three doses of oral vaccine and one “National Immunization Day” was estimated at US$29,653,539. The concomitant replacement of the DTPw/Hib and HepB vaccines with the pentavalent vaccine enabled the introduction of the inactivated polio without increasing the number of injections or number of visits needed to complete the vaccination.CONCLUSIONS The introduction of the inactivated vaccine increased the annual costs of the polio vaccines by 49.2% compared with the oral vaccine-only regimen. This increase represented 1.13% of the expenditure of the National Immunization Program on the purchase of vaccines in 2011.

In vitro susceptibility of Paracoccidioides brasiliensis yeast form to antifungal agents

A study was conducted to determine the susceptibility of P. brasiliensis yeast form to amphotericin B (A), ketoconazole (K), 5-fluorocytosine (5-FC) and rifampin (R). The three isolates tested produced minimal inhibitory concentrations (MICs) (mcg/ml) in the following range: A: 0.09-0.18; K: 0.001-0.007; 5-FC: 62.5-250 and R: 40-80. The minimal fungicidal concentrations (MFC) were several times higher than the corresponding MICs. Precise MFC for 5-FC were not obtained (> 500 mcg/ml). Combination of K plus A proved synergic, with the fractional inhibitory concentration (FIC) indices revealing synergy when the drugs were combined at the 1 to 1 and 1 to 5 MIC ratios. R (40 mcg/ml) appeared to antagonize K. These results indicate promise for the combined use of K plus A as a therapeutical regimen.

Contributo das tecnologias de informação na gestão do regime terapêutico no diabético

A diabetes é a doença do seculo XXI, atinge mais de um milhão de portugueses cada vez mais jovens em idades trabalhadoras, e já custa mais de 1% do PIB, além dos enormes danos que pode causar às pessoas e à sociedade. Segundo o Relatório Anual do Observatório Nacional da Diabetes, em 2011, cerca de um quarto da população portuguesa integrada no escalão etário dos 60 aos 79 tem Diabetes. Um estudo realizado pelo Lisbon Internet and Networks Institute (LINI), em 2010, diz-nos que “a internet é um recurso para a informação e educação para a saúde”. Em 2010 49% dos lares portugueses possuem acesso à internet e 44% da população é utilizadora (acréscimo significativo relativamente aos 29% em 2003). Destes, dois terços têm entre os 15 e os 24 anos. Os idosos representam 1,6%, dos quais os reformados e pensionistas representam 5%, as domésticas representam 11% e os trabalhadores manuais 22%, sendo estes os menos utilizadores. Um terço da restante população procura informação sobre saúde semanalmente, cerca de 16%. Face à atual conjuntura económica, com restrições orçamentais, nomeadamente na área da saúde, devem-se encontrar meios para prevenir e lidar com a Diabetes numa perspetiva de custo-benefício, isto porque a Diabetes pode reduzir as oportunidades de emprego e de aprendizagem. O atual diretor da Organização para a Cooperação e Desenvolvimento Económico (OCDE) Yyes Leterme diz que “Prevenir e tratar a Diabetes e as suas complicações custa cerca de 90 mil milhões de euros anualmente na Europa”. Atualmente, não é muito utilizado nem explorado o potencial das tecnologias de informação e as ferramentas web ao serviço da saúde, quer por profissionais de saúde, quer por utentes na gestão ao regime terapêutico na doença crónica, mais precisamente na gestão adequada da Diabetes. Potenciar uma visão integrada dos diferentes recursos de comunicação e a sua utilização conjugada com a promoção da saúde e prevenção da doença poderá enfatizar em termos de eficácia e eficiência a minimização de recursos das organizações de saúde e promover a gestão adequada da Diabetes. Tendo por base esta problemática, este estudo pretende abordar e refletir o possível contributo das tecnologias de informação e das ferramentas web na gestão adequada ao regime terapêutico da Diabetes.

Aerosolised pentamidine for Pneumocystis carinii pneumonia in patients with acquired immunodeficiency syndrome

The goal of this study was to evaluate inhaled pentamidine for the treatment of patients with mild and moderate Pneumocystis carinii pneumonitis. Eight adults with AIDS and pneumocystis pneumonia (4 with a first episode and 4 with a repeat pneumocystosis) received daily inhalations of aerosol pentamidine isethionate for 21 days. Six patients were treated with doses of 300 mg of pentamidine and the remaining 2 received 600 mg every day. In the 300 mg treatment group, 2 individuals showed discrete and transient neutropenia. However, both subjects that received 600 mg of aerosol pentamidine daily developed leukopenia. One of them had major toxicity (overall severe intolerance of 12.5%) that required drug discontinuation and did not allow any analysis of the treatment efficacy. Of the 7 evaluable patients, 6 (88%) completed the treatment successfuly. One subject of the 300 mg regimen experienced an early recurrence. In conclusion, inhaled pentamidine is an effective treatment for mild and moderate cases of P. carinii pneumonia. It is less toxic than standard anti-pneumocystis therapy and is suitable for outpatient use.