Informed consent in clinical research: do patients understand what they have signed?

Informed consent is an essential element of research, and signing this document is required to conduct most clinical trials. Its aim is to inform patients what their participation in the study will involve. However, increasingly, their complexity and length are making them difficult to understand, which might lead patients to give their authorization without having read them previously or without having understood what is stated. In this sense, the Ethics Committees for Clinical Research, and Pharmacists specialized in Hospital Pharmacy and Primary Care in their capacity as members of said committees, play an important and difficult role in defending the rights of patients. These Committees will review thoroughly these documents to guarantee that all legal requirements have been met and, at the same time, that they are easy to understand by the potential participants in a clinical trial.

Up-regulation Of Dnam-1 And Nkp30, Associated With Improvement Of Nk Cells Activation After Long-term Culture Of Mononuclear Cells From Patients With Ovarian Neoplasia.

This study aimed at evaluating the functional activation and activating receptors expression on resting, short- and long-term NK and NK-like T cells from blood of ovarian neoplasia patients. Blood from patients with adnexal benign alterations (n = 10) and ovarian cancer (grade I-IV n = 14) were collected after signed consent. Effector cells activation was evaluated by the expression of the CD107a molecule. Short-term culture was conducted overnight with IL-2 and long-term culture for 21 days, by a method designed to expand CD56(+) lymphocytes. Short-term culture significantly increased NK cells activation compared to resting NK cells (p<0.05), however, the long-term procedure supported an even higher increase (p<0.001). Resting NK-like T cells showed poor activation, which was not altered by the culture procedures. The long-term culture effectively increased the expression of the activating receptors on NK and NK-like T cells, either by increasing the number of cells expressing a given receptor and/or by up-regulating their expression intensity. As a conclusion, the long-term culture system employed, resulted in a high number of functional NK cells. The culture system was particularly efficient on the up-regulation of NKp30 and DNAM-1 receptors on NK cells.

Transtorno do déficit de atenção e hiperatividade: proposta de avaliação neuropsicológica para diagnóstico

Attention deficit hyperactivity disorder (ADHD) is characterized by a persistent pattern of inattention and/or hyperactivity/impulsivity. The aim of this research was to contribute more precisely to the diagnosis of ADHD, to propose a battery of neuropsychological assessment and to analyze the contribution of each test. We studied 10 matched pairs of children with ADHD and normal controls (7 to 11 years). Inclusion criteria were: presence of ADHD typical behavior, positive diagnosis of ADHD based on DSM-IV, normal IQ, normal neurological examination and parental consent. We used extensive neuropsychological battery. The results showed differential sensitivity for detection of attentional problems in children with ADHD, although most tests did not reach statistical significance. The item, errors, of WCST revealed statistically significant difference between the two groups: ADHD performance was inferior to controls . In conclusion the neuropsychological assessment battery used in this research contributed to the diagnosis of ADHD.

Programação esportiva na TV Brasil : a influência da ideologia e indústria cultural

Universidade Estadual de Campinas . Faculdade de Educação Física

Creatina quinase e dor muscular tardia na musculação : estudo experimental em adultos e jovens com o "circuit weight training" e o "multiple set system"

Universidade Estadual de Campinas . Faculdade de Educação Física

Efeito residual no triathlon : como nadar influência nas etapas seguintes

Universidade Estadual de Campinas. Faculdade de Educação Física

Protocolo de lesão esportiva no esporte paralímpico (PLEEP) : proposta para a coleta de dados

Universidade Estadual de Campinas . Faculdade de Educação Física

Termo de consentimento livre e esclarecido aos usuários de clínicas odontológicas brasileiras: aspectos éticos e legais

O consentimento do paciente antes do início de qualquer procedimento é uma condição a ser respeitada pelos profissionais da odontologia, sem nenhuma exceção. É necessário que o paciente esteja ciente de seu status de saúde, de suas necessidades específicas, do propósito de cada tratamento, conheça os planejamentos alternativos (incluindo o não tratamento), saiba do seu prognóstico, riscos, consequências, limitações e se conscientize das suas responsabilidades e as do seu cirurgião-dentista, proporcionando o sucesso do tratamento. O termo de consentimento livre e esclarecido (TCLE) visa fortalecer e esclarecer a posição do paciente, estabelecendo os direitos e deveres de ambas as partes paciente e profissional. O conhecimento integral do tratamento diminuirá a ansiedade do paciente e as complicações de tratamento, promoverá maior qualidade dos serviços odontológicos e maior satisfação do dentista e do paciente. Entretanto, no Brasil, poucos artigos são encontrados e existem alguns problemas éticos envolvendo as clínicas odontológicas, no que diz respeito a este documento de esclarecimento para o paciente. Diante disso, este trabalho tem por objetivo realizar uma revisão crítica sobre o tema abordado, demonstrando a importância do TCLE na clínica odontológica brasileira e na vida profissional dos cirurgiões-dentistas.

Avaliação de solventes de extração por ultrassom usando-se cromatografia líquida de alta eficiência para a determinação de hidrocarbonetos policíclicos aromáticos em solos contaminados

A method using ultrasonication extraction for the determination of 17 polycyclic aromatic hydrocarbons (PAHs), selected by the USEPA and NIOSH as "consent decree" priority pollutants, in soil by High Performance Liquid Chromatography (HPLC) was studied. Separation and detection were completed in 20 min with a C18 columm, acetonitrile-water gradient elution and ultraviolet absorption and fluorescence detections. The detection limits, for a 10 µL of solution injection, were less than 9,917 ng/g in UV detection and less than 1,866 ng/g in fluorescence detection. Several organic solvents were tested for extraction of the 17 PAHs from soils. Acetone was the best solvent among the three solvents tested, and the order of the extraction efficiencies was: acetone>methanol>acetonitrile. Ultrasonication using acetone as solvent extraction was used to evaluate the biodegradation of those compounds in contaminated soil during a vermicomposting process.

Street children and their relationship with the police

Background: This paper explores and analyses the experiences of school-age street children. It specifically addresses the relationship of the street children who live on the streets of Sao Paulo (a large Brazilian metropolis), in relation to their experiences, with the policemen. Methods: The paper is a secondary analysis of date previously collected in 1999. The data were collected through individual semi-structured interviews, with 14 school-age children frequenting two city public refuges, with their legal guardians` consent. The text from transcribed interviews was organized according to the validity norms of `thematic analysis`, a technique of contents analysis method. The decomposing and reconstructing process of that analysis gave rise to thematic categories (among which `the police category`) that represented the reconstruction of the difficulties faced by the children in their development. Results and discussion: The children portrayed the police as an enemy, a fearful figure and one of the most agonizing street experiences. Rarely did the police have a positive image to them. According to the children, police violence occurs in three forms: through systematic police persecution in an effort to remove the children from the streets against their will; actions that had the deliberate intent to humiliate them with verbal or physical aggression; and through alleged sexual abuse, revealed by the children in a veiled manner. The authority that is supposedly intended to protect them is portrayed as one of the most feared social agents. Conclusion: The reported hostile behaviour of the policemen shows the state of vulnerability of those children living on the street. This situation must be focused like a health problem because it causes injury to development of children. Nurses can help them through organizing assistance to children in situation of personal and social risk in the school nursing and health institution.

A comparative study of speed expressed by the number of throws between heavier and lighter categories in judo

Objective. - The objective of this work was to verify if there was a difference in throwing speed performance between heavier and lighter weight categories in judo. Methods and subjects. - Sixteen (16) judoists 18 +/- 3 years old, eight considered in the lightweight category (< 66 kg) and eight considered in the heavyweight (> 73 kg) category, participated in the study after signing a term of informed consent. A force-velocity test was used to determine the anaerobic power, strength, and pedal speed for each subject. In addition, three trials of Nage-komi exercise, each comprised of a set of Osoto-gari (15s), Uchi-mata (15s) and Seoi-nage (15s) throws were performed by each subject to ascertain throwing speed. Throws within the sets were intersected by one period of three minutes passive rest, while the trials were separated by one period of 10 minutes passive rest. Heart rate and the greatest number of throws within each set were measured for three trials. One-way analysis of variance (Anova) was used to compare the number of throws between the two weight categories and a ""Student"" test when the difference was significant. A correlation was used to examine the link between the different parameters. Results. - The force-velocity test did not show a significant difference in pedal speed between the two categories. However, there was a significant difference between the two categories when throwing speed was measured by the number of throws (p < 0.05) executed during the Seoi-nage (p < 0.01) and Uchi-mata (p <0.05) techniques. There was however, no significant difference between the two categories in Osoto-gari technique. Conclusion. - The throwing speed of judoists represented by the number of throws is significantly different between the two categories. The lighter category has more speed than the heavier category using the arm technique (Seoi-nage), while the heavier category has more speed using the leg technique with half turn of the attacker`s body (Uchi-mata). As a result, throwing speed is related to the type of technique used and not weight category. (C) 2007 Elsevier Masson SAS. All rights reserved.

Design of the multicenter Australian study of epidural anesthesia and analgesia in major surgery: The MASTER Trial

The Multicenter Australian Study of Epidural Anesthesia and Analgesia in Major Surgery (The MASTER Trial) was designed to evaluate the possible benefit of epidural block in improving outcome in high-risk patients. The trial began in 1995 and is scheduled to reach the planned sample size of 900 during 2001. This paper describes the trial design and presents data comparing 455 patients randomized in 21 institutions in Australia, Hong Kong, and Malaysia, with 237 patients from the same hospitals who were eligible but not randomized. Nine categories of high-risk patients were defined as entry criteria for the trial. Protocols for ethical review, informed consent, randomization, clinical anesthesia and analgesia, and perioperative management were determined following extensive consultation with anesthesiologists throughout Australia. Clinical and research information was collected in participating hospitals by research staff who may not have been blind to allocation. Decisions about the presence or absence of endpoints were made primarily by a computer algorithm, supplemented by blinded clinical experts. Without unblinding the trial, comparison of eligibility criteria and incidence of endpoints between randomized and nonrandomized patients showed only small differences. We conclude that there is no strong evidence of important demographic or clinical differences between randomized and nonrandomized patients eligible for the MASTER Trial. Thus, the trial results are likely to be broadly generalizable. Control Clin Trials 2000;21:244-256 (C) Elsevier Science Inc. 2000.

A randomized trial of a problem-based learning approach for teaching epidemiology

Purpose. To conduct a controlled trial of traditional and problem-based learning (PBL) methods of teaching epidemiology. Method. All second-year medical students (n = 136) at The University of Western Australia Medical School were offered the chance to participate in a randomized controlled trial of teaching methods fur an epidemiology course. Students who consented to participate (n = 80) were randomly assigned to either a PBL or a traditional course. Students who did not consent or did not return the consent form (n = 56) were assigned to the traditional course, Students in both streams took identical quizzes and exams. These scores, a collection of semi-quantitative feedback from all students, and a qualitative analysis of interviews with a convenience sample of six students from each stream were compared. Results. There was no significant difference in performances on quizzes or exams between PBL and traditional students. Students using PBL reported a stronger grasp of epidemiologic principles, enjoyed working with a group, and, at the end of the course, were more enthusiastic about epidemiology and its professional relevance to them than were students in the traditional course. PBL students worked more steadily during the semester but spent only marginally more time on the epidemiology course overall. Interviews corroborated these findings. Non-consenting students were older (p < 0.02) and more likely to come from non-English-speaking backgrounds (p < 0.005). Conclusions. PBL provides an academically equivalent but personally far richer learning experience. The adoption of PBL approaches to medical education makes it important to study whether PBL presents particular challenges for students whose first language is not the language of instruction.