36 resultados para Anvisas prior consent
Resumo:
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.
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Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
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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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The aim of this study was to analyze the influence of aerobic fitness on the effects of prior exercise on VO2response during subsequent moderate-intensity exercise. After determination of the lactate threshold (LT) and maximal VO2 (VO2max). 14 untrained subjects (UG) and 14 well-trained cyclists (TG) performed on different days and in random order, rest to moderate-intensity exercise transitions (6 minutes at 80% of LT), preceded by either no prior exercise or prior supramaximal exercise (PSE: two bouts of 1 minute at 120% of VO2max, with a 1-minute rest in between). Baseline VO2 was significantly increased (p<0.05) by PSE in both groups (UG: 0.39 ± 0.06 vs. 0.51 ± 0.15 L·min -1;TG: 0.37 ± 0.06 vs. 0.58 ± 0.14 L·min -1). In the TG group, the steady state VO2 was significantly increased by PSE (TG: 2.21 ± 0.38 vs. 2.07 ± 0.27 L·min-1, p<0.05; UG: 1.60 ± 0.27 vs. 1.60 ± 0.29 L· min-1, p>0.05). It can be concluded that aerobic fitness level influences the effects of PSE on VO2 response during moderate-intensity exercise. [J Exerc Sci Fit • Vol 7 • No 1 • 48-54 • 2009].
Resumo:
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.