915 resultados para Informed consent (Medical law)
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Pós-graduação em Genética - IBILCE
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Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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Pós-graduação em Enfermagem (mestrado profissional) - FMB
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Pós-graduação em Serviço Social - FCHS
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A obesidade é uma doença crônica definida como o acúmulo de gordura anormal ou excessiva que pode prejudicar a saúde. Torna-se necessário intervir no seu combate e prevenção, especialmente entre as crianças. A literatura da área indica que, em geral, intervenções apenas com crianças ou com cuidadores, ou com ambos, apresentam resultados favoráveis. Neste estudo foram avaliados os efeitos de instruções, do treino de relato verbal (TRV) e do treino de automonitoração (TA), aplicados com e sem a participação do cuidador principal, sobre o seguimento de regras nutricionais em crianças com obesidade ou sobrepeso. Participaram duas crianças (9 e 11 anos) e suas cuidadoras primárias. O ambiente foi um consultório do ambulatório de psicologia de um hospital universitário. Foram utilizados: Prontuário dos pacientes, Roteiro de entrevista inicial, Inventário de estilos parentais (IEP), Roteiro de entrevista 2, Recordatório 24 horas, Manual informativo sobre obesidade e alimentação saudável, Teste de conhecimentos, Protocolo de orientação nutricional para crianças, Protocolo de automonitoração, Roteiro para análise do protocolo de automonitoração, jogos e brinquedos e Roteiro de entrevista final. O procedimento de coleta ocorreu em 10 sessões distribuídas em aproximadamente 15 semanas e consistiu de análise dos prontuários; entrevista no ambulatório com o cuidador e com a criança para assinatura do Termo de Consentimento Livre e Esclarecido, aplicação do roteiro de entrevista inicial e do IEP; inserção dos participantes em uma de duas condições (Condição 1, apenas a criança [P1] presente; Condição 2, tanto a criança [P2] quanto seu cuidador primário [C2] estavam presentes); aplicação do Roteiro de entrevista 2 seguido da aplicação do Recordatório 24 horas (Linha de Base 1 [LB1]); aplicação do Manual informativo sobre obesidade e alimentação saudável e do Teste de conhecimentos; TRV (Linha de Base 2 [LB2]); TA; entrevista de acompanhamento e entrevista de encerramento. Quanto aos efeitos das instruções, os resultados indicam que P1 manteve a mesma classificação em todos os itens, enquanto P2 melhorou seu desempenho nos itens conhecimento e seguimento das orientações nutricionais e C2 apresentou melhora no conhecimento sobre obesidade ao final do estudo. Os Índices de adesão à dieta obtidos por P2 foram mais elevados do que os obtidos por P1 em todas as fases da pesquisa. Comparando-se a média obtida pelos dois participantes em LB1 e LB2, observou-se aumento de 39,77% indicando mudança com significância clínica após intervenção. A combinação de variáveis nesta pesquisa mostrou-se favorável a ampliação do repertório dos participantes em relação ao comportamento alimentar, tendo como referência o próprio sujeito ao longo do estudo. Os resultados sugerem que há maior eficácia quando crianças e cuidadores são alvo de intervenção.
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Pós-graduação em Enfermagem (mestrado profissional) - FMB
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Sickle cell anemia (SCA) shows a pathophysiology that involves multiple changes in sickle cell erythrocytes, vaso-occlusive episodes, hemolysis, activation of inflammatory mediators, endothelial cell dysfunction, and oxidative stress. These events complicate treatment and culminate in the development of manifestations such as anemia, pain crises and multiorgan dysfunction. The aim of this study was to evaluate, in SCA patients, oxidative stress and antioxidant capacity markers, correlating them to treatment with hydroxyurea (HU), β-globin haplotypes and glutathione S-transferase polymorphisms (GSTT1, GSTM1 and GSTP1), in comparison to a control group (CG). The study groups were composed of 48 individuals without hemoglobinopathies (CG), SCA patients treated with HU [AF (+HU), N = 13] and untreated SCA patients [AF (-HU), N = 15], after informed consent. The groups were analyzed using cytological, electrophoretic, chromatographic and molecular methods and information from medical records. The GSTM1 and GSTT1 polymorphisms were determined by multiplex PCR, while the GSTP1 polymorphism by PCR-RFLP. Biochemical parameters were measured using spectrophotometric methods [TBARS, TEAC and catalase (CAT) and GST activities] and a chromatographic method [glutathione (GSH)]. The fetal Hb (Hb F) levels observed in the SCA (+HU) group (10.9%) confirmed the already well-described pharmacological effect of HU, but the SCA (-HU) group also had high Hb F levels (6.1%), which may have been influenced by genetic factors not targeted in this study. We found a higher frequency of the Bantu haplotype (48.2%), followed by the Benin (32.1%) and also Cameroon haplotypes, rare in our population, and 19.7% of atypical haplotypes. The presence of Bantu haplotype was related to higher lipid peroxidation levels in patients, but also, it conferred a differential response to HU treatment, raising Hb F levels in 52.6% (P = 0.03). The protective effect of Hb F was confirmed, because the increase in their levels resulted in a 41.3% decrease in lipid peroxidation levels (r = -0.74, P = 0.0156). The genotypic frequency of the GST polymorphisms observed was similar to that of other studies in the Brazilian population, and its association with biochemical markers revealed a significant difference only for the GSTP1 polymorphism, where patients with genotype V/V showed higher GSH and TEAC levels (P = 0.04 and P = 0.03, respectively) compared to patients with genotype I/I. The TBARS levels were about five to eight times higher in the SCA (+HU) and SCA (-HU) groups, respectively, compared to controls, and HU produced a 35.2% decrease in lipid peroxidation levels in the SCA (+HU) group (P < 0.0001). Moreover, the SCA (+HU) group showed higher TEAC levels when compared to CG (P = 0.002). We did not find any significant difference in GST activity between the groups studied (P = 0.76), but CAT activity was about 17 and 30% lower in SCA (+HU) and SCA (-HU) groups, respectively (P < 0.00001). Plasma GSH levels were ~2 times higher in SCA patients than in the control group (P = 0.0005) and showed a positive correlation with TBARS levels, confirming its antioxidant function. HU treatment contributed to higher CAT activity and TEAC levels and lower lipid peroxidation, and its pharmacological effect showed a “haplotype-dependent” response. These findings may contribute to elucidating the potential of HU in ameliorating oxidative stress in SCA subjects.
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Background: The intestinal microbiome (IM) has extensively been studied in the search for a link of bacteria with the cause of Crohn`s disease (CD). The association might result from the action of a specific pathogen and/or an eventual imbalance in bacterial species composition of the gut. The innumerous virulence associated markers and strategies described for adherent and invasive Escherichia coli (AIEC) have made them putative candidate pathogens for CD. IM of CD patients shows dysbiosis, manifested by the proliferation of bacterial groups such as Enterobacteriaceae and reduction of others such as Lactobacillus and Bifidobacterium. The augmented bacterial population comprising of commensal and/or pathogenic organisms super stimulates the immune system, triggering the inflammatory reactions responsible for the clinical manifestations of the disease. Considering the role played by IM in CD and the multiple variables influencing its species composition, resulting in differences among populations, the objective of this study was to determine the bacterial biodiversity in the mucosa associated microbiome of CD patients from a population not previously subject to this analysis, living in the middle west region of Sao Paulo state. Methods: A total of 4 CD patients and 5 controls subjects attending the Botucatu Medical School of the Sao Paulo State University (UNESP) for routine colonoscopy and who signed an informed consent were included in the study. A number of 2 biopsies, one from the ileum and other from any part of the terminal colon, were taken from each subject and immediately frozen at -70[degrees]C until DNA purification. The bacterial biodiversity was assessed by next generation (ion torrent) sequencing of PCR amplicons of the ribosomal DNA 16S V6 region (16S V6 rDNA). The bacterial identification was performed at the genus level, by alignment of the generated DNA sequences with those available at the ribosomal database project (RDP) website. Results: The overall DNA sequence output was based on an average number of 526,427 reads per run, matching 50 bacterial genus 16SrDNA sequences available at the RDB website, and 22 non matching sequences. Over 95% of the sequences corresponded to taxa belonging to the major phyla: Firmicutes, Bacterioidetes, Proteobacteria and Actinobacteria. Irrespective of the intestinal site analyzed, no case-control differences could be observed in the prevalence of Actinobacteria and Firmicutes. The prevalence of Proteobacteria was higher (40%) in the biopsies of control subjects as compared to that of DC patients (16%). For Bacterioidetes, the higher prevalence was observed among DC patients (33% as opposed to 14,5% in controls). The significance for all comparisons considered a p value < 0,05 in a Chi2 test. No mucosal site specific differences could be observed in IM comparisons of CD and control subjects. Conclusions: The rise in the number of Bacterioidetes observed here among CD patients seems to be in agreement with most of studies published thus far. Yet, the reduction in the number of Proteobacteria along with an apparently unaltered population of Actinobacteria and Firmicutes, which include the so called "beneficial" organisms Bifidobacterium and Lactobacillus were rather surprising. These data suggest that the analyses on the role of IM in CD should consider the multiple variables that may influence its species composition.
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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Diese Arbeit ist in ihrem Kern darum bemüht, die hochumstrittene Problematik der Haftung des Arztes für Aufklärungsfehler (insbesondere im Hinblick auf die Selbstbestimmungsaufklärung des Patienten) sachgerecht in das geltende Deliktsrechtssytem einzuordnen. Das bedeutet im Ausgangspunkt ein klares Bekenntnis zur sog. Körperverletzungsdoktrin [dazu in Teil C.) I.)] und ein Bekenntnis zur Lehre vom Erfolgsunrecht [Teil C.) III.)], in die auch der Vorwurf des Behandlungsfehlers (!) durchaus sachgerecht integriert werden kann. Unter Teil C.) IV.) wird die hochgradig kontroverse Problematik der Schadensfolgenzurechnung wegen nicht wirksam konsentierten Heilbehandlungen eingehend erörtert. Hierbei zeigt sich, daß die Lehre vom „Schutzzweck der Norm“ im Kontext des §823 I BGB bei der Haftungsausfüllung weder aus dogmatischen noch aus rein tatsächlichen Gründen anwendbar ist. Statt dessen ist die Einschränkung der Haftung des Arztes für die Schadensfolgen seines Tuns durch eine teleologische Reduktion des durch § 249 I BGB vorgegebenen und in gewissen Einzelfällen zu weit gerateten Prinzips des Totalersatzes zu erreichen. Hierbei ist nach Haftungslücken zu suchen, bei denen in besonders gelagerten Fällen eine Haftung des Arztes zu verneinen ist. Als Hilfsmittel der Lückenfüllung bietet sich in diesem Zusammenhang die Methode der Topik an. [dazu eingehend in Teil C.) IV.) 2.) d.) und e.)] In diesem Zusammenhang werden durch Vergleich verschiedenartig gelagerter Fallgruppen deren jeweilige Unterschiede herausgearbeitet und - darauf aufbauend - unterschiedliche Zurechnungsregeln herausgebildet. In Teil D.) werden die inhaltlichen, formellen und prozessualen Probleme der ärztlichen Aufklärungspflicht eingehend behandelt. Um diesbezüglich Wiederholungen zu vermeiden, wird an dieser Stelle auf die Stellungnahme zu Teil D.) in Teil D.) III.) verwiesen.
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L’elaborato propone una riflessione rispetto all’atto giuridico del consenso informato quale strumento garante dell’esercizio del diritto alla salute per i migranti. Attraverso una riflessione antropologica rispetto alla natura, alla costruzione e alla logica dei diritti universali, verranno analizzate le normative nazionali, europee ed internazionali a tutela del diritto alla salute per i migranti; l’obiettivo della ricerca è indagare l’eventuale scarto tra normative e politiche garantiste nei confronti della salute migrante e l’esistenza di barriere strutturali che impediscono un pieno esercizio del diritto alla salute. L’ipotesi di ricerca si basa sulla reale capacità performativa del consenso informato, proposto solitamente sia come strumento volto ad assicurare la piena professionalità dell’operatore sanitario nell’informare il paziente circa i rischi e i benefici di un determinato trattamento sanitario, sia come garante del principio di autonomia. La ricerca, attraverso un’analisi quanti-qualitativa, ha interrogato il proprio campo, rappresentato da un reparto di ginecologia ed ostetrica, rispetto alle modalità pratiche di porre in essere la firma nei moduli del consenso informato, con particolare attenzione alle specificità proprie delle pazienti migranti. Attraverso l’osservazione partecipante è stato quindi possibile riflettere su aspetti rilevanti, quali le dinamiche quotidiane che vengono a crearsi tra personale sanitario e pazienti, le caratteristiche e i limiti del servizio di mediazione sanitaria, le azioni pratiche della medicina difensiva. In questo senso il tema del “consenso informato”, indagato facendo interagire discipline quali l’antropologia, la bioetica, la filosofia e la sociologia, si è posto sia come lente di lettura privilegiata per comprendere le dinamiche relazionali ad oggi esistenti tra professionisti sanitari e popolazione migrante, ancora vittima di diseguaglianze strutturali, ma altresì come “innesco potenziale” di nuove modalità di intendere la relazione medico-paziente.
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L’aumento esponenziale del contenzioso medico-legale – originatosi negli USA negli anni Sessanta in proporzioni tali da far parlare di medical liability crisis, e sviluppatosi in Italia a partire dalla metà degli anni Ottanta – ha comportato e continua a comportare, unitamente ad altre conseguenze negative, il ricorso sempre più frequente dei sanitari alle pratiche di medicina difensiva, con elevatissimi costi a carico del Servizio Sanitario Nazionale dovuti alla sovrabbondanza di trattamenti e ricoveri inutili e di procedure diagnostiche invasive non necessarie, peraltro produttive di stress emotivo nei pazienti. La causa dell’aumento della litigiosità deve essere ricercata in buona parte nella relazione medico-paziente, in particolar modo con riferimento al momento informativo che precede l’acquisizione del consenso informato al trattamento clinico. In Italia, i limiti che per lo più caratterizzano gli studi riguardanti il consenso informato derivano principalmente dal fatto che essi tendono a focalizzarsi unicamente sulla componente scritta del medesimo. Il fulcro del consenso informato, invece, deve ritenersi rappresentato da una comunicazione tra sanitario e paziente relativa ad un trattamento proposto ed alle possibili alternative, alla non sottoposizione ad alcun trattamento e ai rischi e benefici di ciascuna di queste opzioni. In un tale contesto il tema della comunicazione tra il professionista e la persona assistita sta suscitando interesse poiché ci si aspetta che esso conduca a miglioramenti degli outcome dei pazienti e alla diminuzione delle denunce da parte di questi ultimi per casi di responsabilità sanitaria. La maggiore attenzione al rapporto medico - paziente ha fatto emergere il bisogno di migliorare e potenziare le abilità comunicative dei medici, in un’ottica in cui il momento comunicativo possa essere percepito dal professionista come fulcro del rapporto medico-paziente, nella prospettiva di una elaborazione di strategie di prevenzione e contrasto ai fenomeni di medicina difensiva.
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PURPOSE: To prospectively compare cartilage T2 values after microfracture therapy (MFX) and matrix-associated autologous chondrocyte transplantation (MACT) repair procedures. MATERIALS AND METHODS: The study had institutional review board approval by the ethics committee of the Medical University of Vienna; informed consent was obtained. Twenty patients who underwent MFX or MACT (10 in each group) were enrolled. For comparability, patients of each group were matched by mean age (MFX, 40.0 years +/- 15.4 [standard deviation]; MACT, 41.0 years +/- 8.9) and postoperative interval (MFX, 28.6 months +/- 5.2; MACT, 27.4 months +/- 13.1). Magnetic resonance (MR) imaging was performed with a 3-T MR imager, and T2 maps were calculated from a multiecho spin-echo measurement. Global, as well as zonal, quantitative T2 values were calculated within the cartilage repair area and within cartilage sites determined to be morphologically normal articular cartilage. Additionally, with consideration of the zonal organization, global regions of interest were subdivided into deep and superficial areas. Differences between cartilage sites and groups were calculated by using a three-way analysis of variance. RESULTS: Quantitative T2 assessment of normal native hyaline cartilage showed similar results for all patients and a significant trend of increasing T2 values from deep to superficial zones (P < .05). In cartilage repair areas after MFX, global mean T2 was significantly reduced (P < .05), whereas after MACT, mean T2 was not reduced (P > or = .05). For zonal variation, repair tissue after MFX showed no significant trend between different depths (P > or = .05), in contrast to repair tissue after MACT, in which a significant increase from deep to superficial zones (P < .05) could be observed. CONCLUSION: Quantitative T2 mapping seems to reflect differences in repair tissues formed after two surgical cartilage repair procedures. (c) RSNA, 2008.
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BACKGROUND Research ethics approvals, procedures and requirements for institutional research ethics committees vary considerably by country and by type of organisation. OBJECTIVE To evaluate the requirements and procedures of research ethics committees, details of patient information and informed consent based on a multicentre European trial. DESIGN Survey of European hospitals participating in the prospective observational study on chronic postsurgical pain (euCPSP) using electronic questionnaires. SETTING Twenty-four hospitals in 11 European countries. PARTICIPANTS From the 24 hospitals, 23 local investigators responded; 23 answers were analysed. OUTCOME MEASURES Comparison of research ethics procedures and committee requirements from the perspective of clinical researchers. Comparison of the institutions' procedures regarding patient information and consent. Description of further details such as costs and the duration of the approval process. RESULTS The approval process lasted from less than 2 weeks up to more than 2 months with financial fees varying between 0 and 575 &OV0556;. In 20 hospitals, a patient information sheet of variable length (half page up to two pages) was provided. Requirements for patients' informed consent differed. Written informed consent was mandatory at 12, oral at 10 and no form of consent at one hospital. Details such as enough time for consideration, possibility for withdrawal and risks/benefits of participation were provided in 25 to 30% of the institutions. CONCLUSION There is a considerable variation in the administrative requirements for approval procedures by research ethics committees in Europe. This results in variation of the extent of information and consent procedures for the patients involved. TRIAL REGISTRATION euCPSP in Clinicaltrials.gov identifier: NCT01467102; PAIN-OUT in Clinicaltrials.gov identifier: NCT02083835.