Decision aids for people considering taking part in clinical trials

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The Legal, Medical and Cultural Regulation of the Body: Transformation and Transgression

The regulation of the body provides an important concern in law, medical practice and culture. This volume contributes to existing research in the area by encouraging experts from a range of related disciplines to consider the legal, cultural and medical ways in which we regulate the body, further exploring how conceptions of self, liberalism, property and harm inform and influence contentious legal and ethical questions about what we can and cannot do to or with our own bodies.

Do Editorial Policies Support Ethical Research? A Thematic Text Analysis of Author Instructions in Psychiatry Journals

Introduction: According to the Declaration of Helsinki and other guidelines, clinical studies should be approved by a research ethics committee and seek valid informed consent from the participants. Editors of medical journals are encouraged by the ICMJE and COPE to include requirements for these principles in the journal's instructions for authors. This study assessed the editorial policies of psychiatry journals regarding ethics review and informed consent. Methods and Findings: The information given on ethics review and informed consent and the mentioning of the ICMJE and COPE recommendations were assessed within author's instructions and online submission procedures of all 123 eligible psychiatry journals. While 54% and 58% of editorial policies required ethics review and informed consent, only 14% and 19% demanded the reporting of these issues in the manuscript. The TOP-10 psychiatry journals (ranked by impact factor) performed similarly in this regard. Conclusions: Only every second psychiatry journal adheres to the ICMJE's recommendation to inform authors about requirements for informed consent and ethics review. Furthermore, we argue that even the ICMJE's recommendations in this regard are insufficient, at least for ethically challenging clinical trials. At the same time, ideal scientific design sometimes even needs to be compromised for ethical reasons. We suggest that features of clinical studies that make them morally controversial, but not necessarily unethical, are analogous to methodological limitations and should thus be reported explicitly. Editorial policies as well as reporting guidelines such as CONSORT should be extended to support a meaningful reporting of ethical research.

Comunicação médico-doente e consentimento informado em Portugal

Introdução – O consentimento informado (CI) para a realização de procedimentos médicos é influenciado pela comunicação entre o médico e o doente, ainda que se desconheça o impacto de alguns dos determinantes da comunicação entre estes dois intervenientes. Objetivo – Identificar e analisar os determinantes da comunicação entre o médico e o doente que influenciam o dever ético de informar para obter um CI. Métodos – Pesquisaram-se artigos de investigação originais, escritos em Portugal entre janeiro de 2005 e março de 2015, nas bases de dados eletrónicas Google Académico, PubMed, B-ON e no Repositório Científico de Acesso Aberto de Portugal, utilizando as palavras-chave ‘consentimento informado’, ‘médico’ e ‘doente‘ ou ‘informed consent’, ‘doctor’ e ‘patient’. Resultados – Identificaram-se cinco artigos que obedeciam aos critérios de inclusão e verificou-se a existência de determinantes da comunicação na relação médico-doente que influenciam o CI livre e esclarecido. Conclusão – O conhecimento da importância dos determinantes da comunicação que influenciem o CI pode ajudar na interação médico-doente e no desenvolvimento de medidas para melhorar a qualidade da prestação de cuidados de saúde.

Analysis of personality traits as a risk factor in crash related trauma.

Background: Due to increasing stress, individual personality traits are becoming a significant contributor to CRT (Crash Related Trauma). In the present study, we hypothesized that there will be no difference in personality characteristics of CRT patients and control subjects and there will be no association between trauma and personality characteristics of CRT patients. Method: A total of 119 cases and 112 controls of age >18 years were selected as per criteria decided. After obtaining ethical clearance, patients presenting to the emergency orthopedic unit were included in the study. After primary management all enrolled subjects were assessed by ICD 10 module screening questionnaire and analyzed for nine personality traits, subject to written informed consent. Results: Of all the cases enrolled 82.35% were males. Impulsive personality trait is found in 84.78% (39/46) cases. There were 46 motorcyclists out of 119 cases enrolled. Most of the personality traits showed a statistical significant association (p < 0.0003) with CRT. Conclusion: Majority of CRT victims attending orthopedic emergency unit at trauma center had impulsive and histrionic personality characteristics which accounted for 84.78% and 82.61% cases respectively. These traits showed a statistical significant association with CRT.

Identificación de infección de vías urinarias mediante examen elemental y microscópico de orina en habitantes de la comunidad de Romerillo Tambo-Cañar 2015

Antecedentes: Las infecciones de vías urinarias (IVU) constituyen un padecimiento común a nivel mundial afectando a millones de personas cada año. Representan la segunda causa de infección más frecuente, únicamente superada por las infecciones del tracto respiratorio. Objetivo: Determinar la infección de vías urinarias mediante exámen elemental y microscópico de orina en los habitantes de la comunidad de Romerillo Tambo-Cañar 2015. Metodología: Se realizó un estudio de tipo descriptivo, de corte transversal, en un universo finito de 238 habitantes de la comunidad de Romerillo del cantón Tambo, del cual se obtuvo una muestra de 150 personas. Los participantes firmaron un consentimiento/asentimiento informado y llenaron una encuesta. Se analizaron las muestras de orina mediante un exámen elemental y microscópico de orina en el laboratorio del Centro de Diagnóstico y de Investigaciones Biomédicas de la Facultad de Ciencias Médicas de la Universidad de Cuenca, aplicando normas de bioseguridad y control de calidad. Los datos obtenidos fueron analizados para la estadística descriptiva y gráfica en los programas SPSS v22 y Microsoft Excel. Resultados: De 150 muestras analizadas, 9,3% fueron positivas para IVU, de éstas el 100% corresponde a mujeres y el 85,7% pertenece al grupo de edades entre 19 y 45 años. El 78,6 % mantienen una vida sexual activa; el 28,6% retiene el deseo de orinar de 30 a 60 minutos; el 85,7% realiza su higiene íntima cada 2-4 días y el 78,6% usa ropa interior o pantalón apretados

Identificacción de infecciones de vías urinarias, agente etiológico, sensibilidad a los antimicrobianos y factores asociados en los habitantes de la Comunidad de San Francisco de Cuchocorral. El Tambo-Cañar 2015

ANTECEDENTES.- Las infecciones urinarias representan un grave problema de salud que afecta a la población en general. En El Tambo representan una de las principales causas de consulta externa y hospitalización. OBJETIVO.- Identificar la prevalencia de infecciones de vías urinarias, agente etiológico, sensibilidad a los antimicrobianos y factores asociados en los habitantes de la comunidad de San Francisco de Cuchocorral, El Tambo 2015. METODOLOGÍA.- El estudio fue descriptivo de corte transversal. El universo fue de 208 habitantes y la muestra de 160 personas de la comunidad. Se realizó el examen elemental y microscópico de orina, el urocultivo y el antibiograma. Previo a la recolección de las muestras, los participantes firmaron el consentimiento o asentimiento informado y llenaron una encuesta. Se analizaron las muestras en el laboratorio de Microbiología de la Facultad de Ciencias Médicas. Para relacionar los resultados obtenidos y las variables de estudio se utilizó el programa SPSS V22 y Excel para la estadística descriptiva. RESULTADOS.- La prevalencia de infección urinaria fue del 10%, siendo el 100% de personas con infección del sexo femenino y de ellas el 44% mujeres de 19 – 45 años. Escherichia coli fue el microorganismo más frecuente con el 87,5% y mostró resistencia para Trimetoprim sulfametoxazol y Gentamicina en un 28,6%. Proteus y Klebsiella presentaron resistencia para Ampicilina sulbactam y Fosfomicina en un 100%. CONCLUSIÓN.- Contribuimos con datos epidemiológicos sobre prevalencia de infecciones de vías urinarias, agente etiológico y sensibilidad a los antimicrobianos en los habitantes de la comunidad de San Francisco de Cuchocorral

Percepción de los graduados de la Carrera de Medicina de la Universidad de Cuenca 2003-2012, sobre la formación en la relación y comunicación médico-paciente.

Objetivo: Identificar la percepción de los médicos graduados en la Facultad de Ciencias Médicas, respecto a su formación en el tema de Relación y Comunicación Médico Paciente Diseño: es un estudio descriptivo transversal. Metodología: A través de encuesta a los médicos graduados en la Facultad de Ciencias Médicas de la Universidad de Cuenca. Se utilizó una base de datos del programa de Monitoreo de los graduados de la carrera de Medicina de la Universidad de Cuenca, 2003- 2012. Azuay. Resultados: Se realizaron 208 encuestas, 116 varones (56%) y 92 mujeres (44%), cuyas edades oscilan entre los 23 y 42 años, todos graduados de la Escuela de Medicina de la Universidad de Cuenca entre los años 2003 a 2012. El 98% de ellos residentes en el Ecuador. Respecto a la percepción sobre su formación en relación médico paciente y comunicación: para comunicación escrita, comunicación oral, entrega de noticias negativas, relación afectiva con los pacientes y participación comunitaria: la percepción es que su formación fue adecuada, en tanto aprecian como poco adecuado en manejo de situaciones de conflicto, al igual que en la aplicación del consentimiento informado

Relación de la imagen corporal percibida con el índice de masa corporal real en estudiantes de la Escuela de Tecnología Médica de la Universidad de Cuenca. Cuenca octubre 2015 – marzo 2016

OBJETIVO: Determinar la relación de la imagen corporal percibida con el índice de masa corporal real en estudiantes de la Escuela de Tecnología Médica de la Universidad de Cuenca. MATERIALES Y METODOS: Estudio transversal efectuado en estudiantes de la Escuela de Tecnología Médica, con una muestra probabilística aleatoria de 250 alumnos. Previo consentimiento informado, se encuestó a los estudiantes a través del “Cuestionario de la forma corporal” elaborado por: Cooper, Taylor y Fairburn; posteriormente se les presentó a los estudiantes el test de fotografías corporales de los autores Harris y Col., en el cual eligieron una de las figuras con las que se sentían mejor identificados; consecutivamente se procedió a la toma de las medidas antropométricas para la obtención del estado nutricional; finalmente se comparó la imagen corporal percibida con el estado nutricional de cada estudiante. La información fue analizada en el programa SPSS V22 y Excel 2013. RESULTADOS: Del total de la muestra de 251 estudiantes, el 69.7% presentaron un estado nutricional normal; el 4.4% bajo peso; el 20.7% sobrepeso y el 5.2% presentó obesidad. El 67.3% de los estudiantes presentó una adeudada percepción de su imagen corporal, el 6.8% sobrestima su peso y el 25.9% de la muestra lo subestimó. CONCLUSIONES: La mayor parte de los estudiantes universitarios presentaron una correcta percepción de su imagen corporal, al compararla con el IMC real; se evidenció un mínimo porcentaje de distorsión, donde se presentó una tendencia a la subestimación, condición que aumenta el riesgo de padecer enfermedades relacionadas con la alimentación.

Psychological Aspects in Children and Adolescents With Major Thalassemia: A Case-Control Study

Background: Thalassemia is an inherited blood disease. It is a serious public health problem throughout the Mediterranean region, the Middle East and the Indian subcontinent, as well as in Southeast Asia. Objectives: Thalassemia is an inherited blood disease. It is a serious public health problem. In this study we assessed psychological aspects in Iranian children and adolescents with thalassemia major. Patients and Methods: In this case-control study sixty healthy subjects aged 7-18 years and Sixty Patients with confirmed diagnosis of major thalassemia were enrolled. After obtaining informed consent from parents of all participating thalassemia patients and healthycontrols, we assessed psychological aspects and quality of life by Pediatric Quality of LifeTM (PedsQL™), Strengths and Difficulties Questionnaires (SDQ), State and Trait Anxiety, Children's Depression Inventory (CDI). Results: The results of this study indicate that there are significant changes in depression, anxiety, QOL and behavioral screening between children with thalassemia major compared with healthy subjects by means of both parents and children reports. According to the results, children with thalassemia major have more psychological problems than healthy ones. Patients with thalassemia have a lower QOL than their peers (P = 0.001), the rate of depression is higher in this group (P = 0.015), Also behavioral problems in these children are more than healthy subjects (P = 0.009). Conclusions: We recommend appropriate treatment and counseling procedures in addition to specific treatment of thalassemia. According to the results we suggest to establish pediatric psychiatric clinics beside thalassemic clinics to cure psychological aspects of the disease.

Financial and Criminal Responsibility for Public Funds – Protection of the Constitutional Fundamental Social Law of Health

Abstract: The implementation of Fundamental Constitutional Health and Social Rights is necessary, appropriate and proportionate, following the demands of the population. Accountability and self-responsibility play a very important role. This requires the development of constitutional principles that protect public funds against corruption and offer a constitutional right to health protection. Financial and criminal liability might provide an incentive to improve the management of public funds and reinforce fundamental constitutional principles, particularly regarding the right to health. Constitutional, administrative and criminal issues, as well as public management and administration and the science of good governance, should be articulated in a single strategy also in the health sector. In Portugal and Brazil, as examples, the Federal Court / Constitutional Court, the Supreme Court / High Court of Justice or the Court of Auditors should be considered together.

MÁS ALLÁ DEL VOTO ÉTNICO: LA PARTICIPACIÓN DE LOS PUEBLOS INDÍGENAS EN LA ADOPCIÓN DE DECISIONES. FUNDAMENTOS ANALÍTICO-CONCEPTUALES PARA SU INVESTIGACIÓN EN AMÉRICA LATINA

ResumenTradicionalmente, los estudios realizados desde la ciencia política y la sociología sobre la participación de los pueblos indígenas se han enfocado en el ámbito electoral y las movilizaciones sociales. No obstante, la observación empírica ha demostrado la necesidad de ampliar el campo de visión al análisis de la participación indígena en la adopción de decisiones factibles de afectarles enmarcando el análisis en el cumplimiento de sus derechos colectivos. De esta forma, el artículo tiene el objetivo de asentar los fundamentos analítico-conceptuales mínimos para investigar la participación de los pueblos indígenas latinoamericanos con ese enfoque. El texto se divide en tres partes. Primero, se analizan  los conceptos esenciales del tema: “pueblos  indígenas” y “participación”, reconociendo us complejidades y proponiendo elementos mínimos para su defnición. Segundo, se exploran las justifcaciones y contenidos del marco jurídico-normativo internacional de los derechos de los pueblos indígenas haciendo énfasis en la participación como derecho colectivo y revisando su situación en América Latina. Finalmente, se presenta una propuesta metodológica para la investigación sobre la participación de los pueblos indígenas que operacionaliza los derechos de consulta, consentimiento libre, previo e informado y participación en el ciclo completo de las políticas públicas.Palabras  clave:  pueblos  indígenas,  derechos  de  los  pueblos  indígenas,  participación, América Latina, políticas públicas.AbstractFrequently the felds of political science and sociological research dealing with the participation of indigenous peoples  have  focused  on  the  electoral  context  and  social mobilization. However,  empirical  observation seems to demand further analysis on the indigenous participation in decision-making on the full spectrum of matters that affect them, framing the observance in their collective rights. The present article aims to establish a minimum analytical and conceptual basis for such research on participation of Latin American indigenous peoples. The article is divided into three parts. First, it analyzes the essential concepts of the topic: “indigenous peoples” and “participation”, recognizing their complexities and proposing minimum elements for their defnition. Secondly, it explores the justifcations and contents of International Law and normative system of the rights of indigenous peoples by putting emphasis on participation as an indigenous right and by reviewing the situation of indigenous peoples in Latin America. Finally, it presents a methodological proposal to research the participation of indigenous peoples, which operationalizes the rights of consultation; the free, prior, and informed consent, and participation in the process of making of public policies.Keywords: Indigenous peoples, rights of indigenous peoples, participation, Latin America, public policies.

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.

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.