844 resultados para approval for medical research
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A adesão ao tratamento ocorre quando o conselho médico ou de saúde coincide com o comportamento do indivíduo, ao uso de medicamentos, cumprimento da dieta e mudanças no estilo de vida, não sendo, portanto, um ato não passivo do paciente. Em pacientes com hipertensão arterial sistêmica a adesão ao tratamento pode ser definida como o grau de cumprimento das medidas terapêuticas indicadas, sejam elas medicamentosas ou não, com o objetivo de manter a pressão arterial em níveis pressóricos normais. A não adesão em pacientes com doenças crônicas em tratamento a longo prazo em países desenvolvidos é em média de 50%, revelando a importância de serem avaliados os motivos que levam a esse comportamento. O estudo teve como objetivo avaliar a não adesão em idosos hipertensos de uma unidade pública de saúde de Ribeirão Preto - SP. Trata-se de um estudo de corte transversal, desenvolvido com uma amostra de 196 pessoas. A coleta de dados ocorreu entre agosto de 2014 até junho de 2015, após aprovação do Comitê de Ética em Pesquisa. Para essa etapa foram utilizados os instrumentos Brief Medication Questionnaire, Medical Outcomes Studies 36-item Short Form Survey, Escore de Risco Global e Escore de Risco pelo Tempo de Vida. Após a coleta dos dados, as entrevistas foram codificadas, os dados foram tabulados e foi realizada a análise estatística descritiva e de correlação. Como resultado, constatou-se que houve predomínio de mulheres, com idade média de 69,4 anos, casados/união estável, não moravam sozinhos, com 1,85 pessoas na casa em média, de cor branca, com ensino fundamental incompleto, renda de até dois salários mínimos e aposentados/pensionistas, atendidos pelo SUS. Apresentaram hábitos de vida razoáveis, sem predomínio de consumo de bebidas alcoólicas, tabagismo, uso excessivo de sal e sedentarismo. A mais frequente comorbidade associada à HAS foi a dislipidemia. Foi observado elevado predomínio de fatores de risco cardiovasculares como obesidade abdominal, obesidade geral, comorbidades, razão de lipídeos e fatores agravantes como proteína c reativa ultrassensível, microalbuminúria e síndrome metabólica. A maioria da amostra foi classificada como sendo portador de risco cardiovascular alto após estratificação do risco. A percepção da qualidade de vida relacionada à saúde foi considerada baixa na maioria principalmente devido a limitações emocionais. A não adesão esteve presente em quase metade dos idosos, relacionada principalmente à complexidade da farmacoterapia e dificuldade em lembrar sobre o uso de seus medicamentos. Não foi observada correlação entre a não adesão e as variáveis estudadas. Conclui-se que o comportamento de não adesão observado não esteve relacionada às variáveis estudadas nessa amostra e que são necessárias intervenções urgentes para reduzir o risco cardiovascular e prevenir doenças cardiovasculares e mortalidade, bem como melhora da percepção da qualidade de vida relacionada à saúde.
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"Project no. NM 008 015.08"
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"May 1987."
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Shipping list no.: 95-0133-P.
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Mode of access: Internet.
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Title from collective t.p. issued subsequently.
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Mode of access: Internet.
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Provides information on ethics committee approval. Importance of research ethics committee; Application to the relevant local research ethics committee; Information on obtaining ethical approval.
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Objective: To report on strategies for, and outcomes of, evaluation of knowledge (publications), health and wealth (commercial) gains from medical research funded by the Australian Government through the National Health and Medical Research Council (NHMRC). Design and methods: End-of-grant reports submitted by researchers within 6 months of completion of NHMRC funded project grants which terminated in 2003 were used to capture self-reported publication number, health and wealth gains. Self-reported gains were also examined in retrospective surveys of grants completed in 1992 and 1997 and awards primarily supporting people (“people awards”) held between 1992 and 2002. Results: The response rate for the 1992 sample was too low for meaningful analysis. The mean number of publications per grant in the basic biomedical, clinical and health services research areas was very similar in 1997 and 2003. The publication output for population health was somewhat higher in the 2003 than in the 1997 analysis. For grants completed in 1997, 24% (31/131) affected clinical practice; 14% (18/131) public health practice; 9% (12/131) health policy; and 41% (54/131) had commercial potential with 20% (26/131) resulting in patents. Most respondents (89%) agreed that NHMRC people awards improved their career prospects. Interpretation is limited by the relatively low response rates (50% or less). Conclusions: A mechanism has been developed for ongoing assessment of NHMRC funded research. This process will improve accountability to the community and to government, and refine current funding mechanisms to most efficiently deliver health and economic returns for Australia.
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Background Qualitative research makes an important contribution to our understanding of health and healthcare. However, qualitative evidence can be difficult to search for and identify, and the effectiveness of different types of search strategies is unknown. Methods Three search strategies for qualitative research in the example area of support for breast-feeding were evaluated using six electronic bibliographic databases. The strategies were based on using thesaurus terms, free-text terms and broad-based terms. These strategies were combined with recognised search terms for support for breast-feeding previously used in a Cochrane review. For each strategy, we evaluated the recall (potentially relevant records found) and precision (actually relevant records found). Results A total yield of 7420 potentially relevant records was retrieved by the three strategies combined. Of these, 262 were judged relevant. Using one strategy alone would miss relevant records. The broad-based strategy had the highest recall and the thesaurus strategy the highest precision. Precision was generally poor: 96% of records initially identified as potentially relevant were deemed irrelevant. Searching for qualitative research involves trade-offs between recall and precision. Conclusions These findings confirm that strategies that attempt to maximise the number of potentially relevant records found are likely to result in a large number of false positives. The findings also suggest that a range of search terms is required to optimise searching for qualitative evidence. This underlines the problems of current methods for indexing qualitative research in bibliographic databases and indicates where improvements need to be made.
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Background: The Framework Method is becoming an increasingly popular approach to the management and analysis of qualitative data in health research. However, there is confusion about its potential application and limitations. Discussion. The article discusses when it is appropriate to adopt the Framework Method and explains the procedure for using it in multi-disciplinary health research teams, or those that involve clinicians, patients and lay people. The stages of the method are illustrated using examples from a published study. Summary. Used effectively, with the leadership of an experienced qualitative researcher, the Framework Method is a systematic and flexible approach to analysing qualitative data and is appropriate for use in research teams even where not all members have previous experience of conducting qualitative research. © 2013 Gale et al.; licensee BioMed Central Ltd.
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Background: To date debate concerning the relative merits of social and medical sciences has been largely academic. Aims: To outline and critically appraise a utilitarian approach to mental health research that reflects a critical realist perspective. Method: Consideration of the relative utility of differing approaches to illustrative ‘‘psychiatric’’ disorders, and recent policy initiatives. Results: Socially relevant outcomes of Bipolar Affective Disorder are determined by influences that operate independently of the characteristic instability of mood. There is now a highly specific and effective psychological treatment for Panic Disorder. Its benefits are still not fully exploited because of continuing lay and professional focus upon the condition’s social manifestations. Great numbers of people presenting in primary care are unhelpfully caused to adopt the role of ‘‘patient’’ due to practices limiting the professional response to a medical one. Such practices reflect public and professional perceptions of the nature of ‘‘mental health difficulties’’ much more than they do the achievements of medicine. Recent policy-supporting initiatives influencing UK NHS mental health services are much more likely to be supported by social sciences than by medical research. Conclusions: There is considerable scope for a contribution to applied mental health research from frameworks and methodologies that are rooted in a social sciences perspective.
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Background The problem of silent multiple comparisons is one of the most difficult statistical problems faced by scientists. It is a particular problem for investigating a one-off cancer cluster reported to a health department because any one of hundreds, or possibly thousands, of neighbourhoods, schools, or workplaces could have reported a cluster, which could have been for any one of several types of cancer or any one of several time periods. Methods This paper contrasts the frequentist approach with a Bayesian approach for dealing with silent multiple comparisons in the context of a one-off cluster reported to a health department. Two published cluster investigations were re-analysed using the Dunn-Sidak method to adjust frequentist p-values and confidence intervals for silent multiple comparisons. Bayesian methods were based on the Gamma distribution. Results Bayesian analysis with non-informative priors produced results similar to the frequentist analysis, and suggested that both clusters represented a statistical excess. In the frequentist framework, the statistical significance of both clusters was extremely sensitive to the number of silent multiple comparisons, which can only ever be a subjective "guesstimate". The Bayesian approach is also subjective: whether there is an apparent statistical excess depends on the specified prior. Conclusion In cluster investigations, the frequentist approach is just as subjective as the Bayesian approach, but the Bayesian approach is less ambitious in that it treats the analysis as a synthesis of data and personal judgements (possibly poor ones), rather than objective reality. Bayesian analysis is (arguably) a useful tool to support complicated decision-making, because it makes the uncertainty associated with silent multiple comparisons explicit.
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The commercialisation of therapeutic products containing regenerative human tissue is regulated by the common law, statute and ethical guidelines in Australia and England, Wales and Northern Ireland. This article examines the regulatory regimes in these jurisdictions and considers whether reform is required to both support scientific research and ensure conformity with modern social views on medical research and the use of human tissue. The authors consider the crucial role of informed consent in striking the balance between the interests of researchers and the interests of the public.