Health professionals ethical and legal liability on patient’s inadequate clarification in order to obtain free and informed consent

It is required that patients are provided information about therapeutic possibilities, showing the risks, benefits, prognosis and costs of each possible and indicated alternative. This is an ethical and legal resolution. However, health professionals possess the clinical/technical/scientific knowledge and determine what information will be (or not) provided. The patient in question decides to undergo a treatment, providing his/her free and informed consent on the basis of the data presented. Unfortunately, some professionals may not provide all the information necessary for making an informed decision or, after obtaining the consent of the patient, may provide him information that causes the patient to give up on the treatment initially accepted. Such information, if relevant, and not a supervening fact, should have been provided initially. However, the information may not be entirely true, and bring the patient, for instance, to decide based on inadequately presented risks. The craniofacial rehabilitation of the temporomandibular joint (TMJ) by means of TMJ prosthesis, is indicated in many situations. Often, patients in need of such prostheses have aesthetic and functional problems and the rehabilitation expectations run high. This work presents a case and discusses ethical and legal issues, including the liability of partial and inadequate information to a patient.

Perception of the informed consent form by participants in clinical trials

To understand the perception of the participants in controlled clinical trials (CCTs) about the informed consent and describe the meaning of their participation in the research. Qualitative study using the focus group technique. The sample was composed of 19 patients who participated in clinical trials about hypertension and coronary disease in a specialized cardiologic hospital located in the city of Sao Paulo. The methodological framework used was the content analysis. Some of the participants were aware of the real objective of these studies while others had misperceptions. The reading of the informed consent is not always done and, when it is done, the patient does not understand it. The lack of understanding about the term ''placebo'' was mentioned by some participants. The motivation to participate was the personal benefit. This study shows that obtaining the informed consent in CCTs is complex and that there is the need to adapt the structure and application of this document, in order to protect the participants and improve the quality of clinical trials performed in the country.

O debate bioético e jurídico sobre as diretivas antecipadas de vontade

Pós-graduação em Direito - FCHS

The importance of a good relationship between patient/dentist based on the obtaining of an informed consenr to prevent lawsuits

The increased number of law suits in the Dentistry field constitutes an international trend. Patients well informed by the media and supported by the law sue their dentists, when they judge they were victim of bad practice. Professionals even with all discussion about this subject do not have the habit of prevent themselves. It is known that for a defensive practice the best way to avoid litigation is a good relationship with patient, based on dialog and on informed consent. This relation is very important, since patients who rely on their dentists rarely take them to justice. Hence, this article discusses the importance of this relation, as well as the obtaining of informed consent in order to prevent lawsuits.

O consentimento informado: Qual o seu real valor na prática médica?

Trata-se de um artigo que comenta sobre a real importância do Termo de Consentimento Informado na prática médica. Este documento tem sido cada vez mais usado como uma prática defensiva, a fim de constituir provas para defesa de um eventual processo judicial de responsabilidade médica, desvirtuando assim a idéia original, que seria a de respeitar a autonomia do paciente e delimitar a responsabilidade médica. O documento tem como objetivo mostrar que o médico cumpriu com seu dever de informar. Seu grande valor reside nos casos onde existam riscos de danos irreversíveis ao paciente. Conclui-se, porém, que um prontuário bem elaborado onde se inclui o registro das informações que foram transmitidas, bem como o grau de participação dos pacientes e seus familiares nas decisões terapêuticas, também deve ter valor ético e jurídico semelhante do TCI.

Alcohol dehydrogenase 3 genotype as a risk factor for upper aerodigestive tract cancers

Objective: To assess alcohol dehydrogenase 3 (ADH3) polymorphism at position Ile349Val as indicator of risk factor for upper aerodigestive tract (UADT) cancer to verify its association with UADT cancer in nonalcoholic or nonsmoking individuals.Design: Cross-sectional study.Setting: Primary care or referral center.Patients: the study group consisted of 141 consecutive patients with newly diagnosed squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx admitted for surgical treatment. The comparison group consisted of 94 inpatients without cancer from the A. C. Camargo or other São Paulo (Brazil) hospital and 40 healthy individuals.Intervention: All participants were interviewed and data were collected using a structured questionnaire. After written informed consent was obtained, 20 mL of blood was collected in heparinized tubes.Main Outcome Measures: Odds ratio for ADH3 genotypes using logistic regression models.Results: After adjustment for sex, age, tobacco use, and history of cancer in first-degree family relatives, a significantly higher odds ratio for UADT cancer was observed among individuals with AA genotype and low cumulative alcohol consumption (:5 100 kg of ethanol) (odds ratio=3.8 [95% confidence interval, 1.5-9.7]). A 4-fold increase in odds ratio for UADT cancer among individuals with AA genotype and low tobacco consumption (:525 pack-years) was also found in the adjusted model.Conclusions: These results suggest that genotype AA may be a risk factor for UADT cancer, especially in individuals with low alcohol or tobacco consumption. However, further epidemiological case-control or cohort studies, preferably prospective, are needed to establish the exact role of ADH3 polymorphism and its association with the development of UADT cancers.

Panorama atual da ética em pesquisa em seres humanos

In the last decades, medical care has been increasingly permeated by the concept of evidence-based-medicine, in which clinical research plays a crucial role in establishing diagnostic and treatment. Following the improvements in clinical research, we have a growing concern and understanding that some ethical issues must be respected when the subjects are human beings. Research with human subjects relies on the principles of autonomy, beneficence, no maleficence and justice. Ordinance 196/96 from the National Health Board adds to the Brazilian legislation such renowned bioethical principles.Aim: Discuss the main ethical aspects involved in research with human subjects.Materials and Methods: Critical analysis of Ordinance 196/96 and related literature.Conclusion: Ordinance 196/96 rules research with human subjects; nevertheless, it requires more in-depth discussions regarding the informed consent, use of placebo, research with vulnerable populations and research in developing countries.

Expressão fenotípica da homozigose para hemoglobina S em relação aos haplótipos da beta globina, polimorfismos da glutationa S-transferase e enzimas de detoxificação

Pós-graduação em Genética - IBILCE

Atitudes dos profissionais de saúde frente a revelação de más notícias

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Avaliação do conhecimento, formação e capacitação do TSB e ASB no desenvolvimento das atividades no serviço público de saúde

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)

O sistema de referência e contra-referência no atendimento ao adolescente infrator: percepção dos profissionais de saúde da Fundação CASA

Pós-graduação em Enfermagem (mestrado profissional) - FMB

Perfil social das pessoas com hipertensão arterial sistêmica atendidas no Programa de Saúde da Família

Pós-graduação em Serviço Social - FCHS

Perfil de pacientes portadores de gastrostomia e o papel dos cuidadores no domicílio

Pós-graduação em Enfermagem (mestrado profissional) - FMB

Phenotypic expression of homozygous hemoglobin S in relation to β-globin haplotypes, glutathione S-transferase polymorphisms and detoxification enzymes

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.

P-233-Biodiversity of mucosa associated microbiome of Crohn's disease patients living in middle western São Paulo State, Brazil

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.