SOCIAL VALUE CREATION THROUGH SOCIAL ENTREPRENEURSHIP - A QUALITATIVE APPROACH

The objective of this paper is to contribute to better understanding of the concept behind social entrepreneurship. A qualitative approach was carried out to better know the perception behind social entrepreneurs. A sample of 10 social entrepreneurs engaged in MSME sector were interviewed pertaining to the questions behind the success of social entrepreneurial activities. The questions were raised based on their success, market orientation, image and value creation and enterprise organization. The paper nally concludes that social entrepreneurs apart from their concepts, the activities are towards the welfare of the society and it improves the economic development of the country which is a boon for the society as well as country.

Doenças crônicas não transmissíveis e seus fatores de risco na população beneficiária do Programa Bolsa Família: uma revisão integrativa / Chronic non-communicable diseases and their risk factors in the bolsa família program beneficiary population: an integrative review / Enfermedades crónicas no transmisibles y sus factores de riesgo en la población que se beneficia del programa bolsa família: una revisión integradora

Objetivo: sintetizar as evidências científicas sobre a ocorrência de doenças crônicas não transmissíveis (DCNT) e seus fatores de risco (FR) na população beneficiária do Programa Bolsa Família (PBF). Métodos: trata-se de uma revisão integrativa da literatura, cuja busca por publicações de 2004 a 2020 foi feita nas seguintes bases de dados: Literatura Latino-americana e do Caribe em Ciências da Saúde (LILACS) e Indice Bibliográico Español en Ciencias de la Salud (IBECS), via Biblioteca Virtual da Saúde (BVS); Medline, via Pubmed, SCOPUS (via Portal CAPES); e Scientific Electronic Library Online - SciELO. Resultados: foram selecionados 23 artigos, os quais foram agrupados em três categorias: 1) Prevalência dos fatores de risco para DCNT em mulheres beneficiárias do PBF: as mulheres beneficiárias apresentaram piores desfechos no consumo de tabaco, menor prática de atividade física, maior prevalência de diabetes, hipertensão e obesidade; 2) Estado nutricional e insegurança alimentar em crianças, adolescentes e famílias beneficiárias do PBF: os estudos apontaram para uma elevada prevalência de obesidade e coexistência de déficit estatural em crianças beneficiárias; e 3) Consumo alimentar de beneficiários do PBF: foi identificado um padrão não saudável de alimentação. Conclusão: usuários do PBF apresentam elevadas prevalências de fatores de risco para doenças crônicas não transmissíveis e pior padrão alimentar. Esses dados reforçam a importância de o PBF estar sendo direcionado às populações mais vulneráveis, visando mitigar as imensas desigualdades sociais. No entanto, é necessário avançar em outras políticas públicas de proteção social que impactem os determinantes sociais e melhorem a qualidade de vida de extensa camada da população brasileira.(AU)

occurrence and their risk factors (RF) in the Bolsa Família Program (BFP) beneficiary population. Methods: this is an integrative literature review whose search for publications from 2004 to 2020 was carried out in the following databases: Latin American and Caribbean Literature in Health Sciences (LILACS) and Indice Bibliográico Español en Ciencias de la Salud (IBECS), via the Virtual Health Library (VHL); Medline, via Pubmed, Scopus (via Portal CAPES); and Scientific Electronic Library Online - SciELO. Results: 23 articles were selected and grouped into three categories: 1) Prevalence of risk factors for NCDs in BFP beneficiary women: beneficiary women had worse outcomes in tobacco consumption, lower physical activity, higher prevalence of diabetes, hypertension, and obesity; 2) Nutritional status and food insecurity in BFP beneficiary children, adolescents and families: the studies pointed to a high prevalence of obesity and coexistence of height deficit in beneficiary children; and 3) Food consumption of BFP beneficiaries: an unhealthy eating pattern was identified. Conclusion: BFP users have a high prevalence of risk factors for chronic non-communicable diseases and worse dietary patterns. These data reinforce the importance of the BFP being directed to the most vulnerable populations, aiming to mitigate the immense social inequalities. However, it is necessary to advance other public policies of social protection that impact the social determinants and improve the life quality of a large part of the Brazilian population.(AU)

Objetivo: sintetizar evidencias científicas sobre la ocurrencia de enfermedades crónicas no transmisibles (ECNT) y sus factores de riesgo (FR) en la población beneficiaria del Programa Bolsa Familia (PBF). Método: se trata de una revisión bibliográfica integradora, cuya búsqueda de publicaciones entre 2004 y 2020 fue realizada en las bases de datos Literatura Latinoamericana y del Caribe en Ciencias de la Salud (LILACS) e Índice Bibliográfico Español en Ciencias de la Salud (IBECS) a través de la Biblioteca Virtual en Salud (BVS), Medline a través del Pubmed, Scopus (vía Portal CAPES) y Scientific Electronic Library Online - SciELO...(AU)

New Requirements and Improvement Suggestion for the Protection of Vulnerable Groups in Ethical Review Measures for Life Science and Medical Research Involving Humans / 中国医学伦理学

In February 2023, the National Health Commission, together with the Ministry of Science and Technology, the Ministry of Education, and the State Administration of Traditional Chinese Medicine issued the Ethical Review Measures for Life Science and Medical Research Involving Humans, which emphasizes that research participants involving vulnerable groups such as children, intellectual disabilities, and mental disabilities should be given special protection. This paper expounded the current situation of protecting vulnerable groups from six aspects: inadequate protection of vulnerable groups by relevant laws and regulations, unclear definition of vulnerable groups, insufficient supervision by relevant departments, insufficient review ability of ethics committee to satisfy the protection of vulnerable groups, difficulty in fair inclusion of vulnerable groups, and the need to improve the ethical awareness of researchers and vulnerable groups. This paper also analyzed the new requirements for the protection of vulnerable groups in the Ethical Review Measures for Life Science and Medical Research Involving Humans from the following three aspects: expanding attention to potentially vulnerable research participants, paying more attention to the consent of research participants without or with limited capacity for civil conduct, and re-informed consent after the improvement of civil capacity level. Finally, suggestions on strengthening the protection of vulnerable groups were put forward from six aspects: improving the relevant legal system, clarifying the category of vulnerable groups, strengthening the implementation by regulatory departments, establishing a research participant protection system by research institutions, improving the ethical review capacity of ethics committees, formulating review guidelines by industry associations, and strengthening the education and training of all parties, so as to minimize the risk of vulnerable groups participating in clinical research and boost the quality and speed of clinical research in China.

Intervención y familias migrantes: análisis crítico de la «vulnerabilidad¼ desde los/las profesionales / Intervention and migrant families: critical analysis of "vulnerability" from professionals / Intervenção e famílias migrantes: análise crítica da "vulnerabilidade" dos profissionais

Resumen (analítico) Se indagan los significados que adquiere la noción de vulnerabilidad en la intervención social con familias migrantes en Santiago de Chile en relación con el sistema de xenofobia y racismo imperante. Se llevó a cabo una investigación cualitativa usando entrevistas semiestructuradas y un análisis de contenido, en una muestra de diez profesionales del ámbito psicosocial que trabajan con población migrante en la región metropolitana de Chile. Los resultados revelan cómo desde la intervención social se construye una noción de sujeto migrante asociado a la vulnerabilidad, en donde la matriz xenófoba y racista agudiza las dinámicas de exclusión. Asimismo, se desprenden valoraciones moralistas negativas sobre el ejercicio parental, una sobreculturalización de sus prácticas de cuidados y la verificación de formas sutiles de control, disciplinamiento y normalización de las familias migrantes.

Abstract (analytical) This paper analyzes the meanings that the notion of vulnerability acquires in social interventions with migrant families in Santiago de Chile in relation to a system that has high levels of xenophobia and racism. Qualitative research was carried out using semi-structured interviews and content analysis in a sample consisting of 10 professionals from the psychosocial field who work with the migrant population in the Metropolitan Region of Chile. The results reveal how the social intervention constructs a notion of a migrant subject strongly associated with vulnerability in which the xenophobic and racist matrix exacerbates the dynamics of exclusion. In addition, negative evaluations are expressed by participants in the study about parental practices, an over-culturalization of their care practices and the verification of subtle forms of control, discipline and normalization of migrant families.

Resumo (analítico) O artigo investiga os sentidos adquiridos pela noção de vulnerabilidade na intervenção social com famílias migrantes em Santiago do Chile em relação ao sistema vigente de xenofobia e racismo. Realizou-se uma pesquisa qualitativa por meio de entrevistas semiestruturadas e análise de conteúdo, em uma amostra composta por 10 profissionais da área psicossocial que atuam com a população migrante na Região Metropolitana do Chile. Os resultados revelam como, a partir da intervenção social, se constrói uma noção de sujeito migrante irredutivelmente associado à vulnerabilidade, onde a matriz xenófoba e racista exacerba a dinâmica da exclusão. Além disso. avaliações moralistas negativas são emitidas sobre o exercício parental, uma superculturalização de suas práticas de cuidado e a verificação de formas sutis de cuidar. derivado, controle, disciplina e normalização das famílias migrantes.

Age at Diagnosis for Autism Spectrum Disorders: Does it Differ by Place of Residence?

Background: Despite steady decline in the age of diagnosis (AOD) at the global level, it has not declined uniformly, and marked disparities are documented by income, education, race, and access to health care. Objectives: The objectives of the study are to examine the urban/rural disparities in the initial age of autism diagnosis and to understand the interplay of the underlying demographic and social factors. Methods: A retrospective case record review of all children who received their initial diagnosis of autism at the Pediatric Psychology Clinic (1997–2018) of a tertiary advanced pediatric center at Chandigarh was conducted. Astructured abstraction data form was used to extract demographic, socioeconomic, and clinical information from the files maintained at the clinic. Results: A total of 1321 case records were examined. The mean AOD was 4.62 years (standard deviation = 2.38) and children from rural communities were diagnosed at 4.87 years, nearly 0.35 years later than urban children (t = 2.47, P = 0.013). Results indicated that 31.1% of the variance in the AOD for children from rural areas was predicted by two variables, namely the number of children in the family and total Childhood Autism Rating Scale (CARS) score (F = 13.62, P = 0.001). For the urban sample, three variables emerged as significant predictors including the number of children in the family, total CARS score, and maternal education and these together explained 20.2% of the variance in the AOD (F = 19.60, P = 0.001). Conclusion: The public health system must be sensitized to the unmet needs of the marginalized socioeconomic groups to access diagnostic and management services in a timely manner.

Manejo nutricional de pacientes con infección por Covid-19 en la Unidad Técnica de Nutrición del Hospital de Especialidades Carlos Andrade Marín / Nutritional management of patients with Covid-19 infection in the Technical Nutrition Unit of the Carlos Andrade Marín Specialties Hospital

La aparición del coronavirus tipo 2 del Síndrome Respiratorio Agudo grave (SARS-CoV-2) y su afectación como nuevo Coronavirus de 2019 (Covid-19), ha sido sorprendente por su rápido contagio y progresión de la enfermedad. Todos los grupos etarios pueden ser afectados, pero la población vulnerable es aquella que tiene más de 50 años, inmunosupresión, malnutridos o enfermedades degenerativas no transmisibles como hipertensión, diabetes y enfermedades pulmonares. Aquellos pacientes con múltiples morbilidades se encuentran asociados a procesos de malnutrición y son ellos los que podrían llegar a desarrollar complicaciones por la enfermedad y necesitar de cuidados intensivos1. El correcto manejo del estado nutricional busca prevenir el riesgo de complicaciones relacionadas con el déficit calórico proteico y el aumento de la actividad catabólica; la bibliografía detalla cómo la malnutrición genera compromiso al disminuir la musculatura respiratoria, cardíaca, esquelética y coadyuvar a la falla orgánica. El reto para la nutrición en esta pandemia es poder identificar a la población en riesgo y crear un soporte nutricional adecuado para cada paciente2. Las guías de manejo proporcionan recomendaciones útiles y rápidas para el diagnóstico y tratamiento nutrioterapéutico especializado.

The emergence of the severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2), and its affectation as the new Coronavirus of 2019 (Covid- 19), has been surprising due to its rapid transmission and disease progression. All age groups can be affected, but the vulnerable population is those over 50 years of age, immunosuppression, malnourished or non-communicable degenerative diseases such as hypertension, diabetes and pulmonary diseases. Those patients with multiple morbidities are associated with malnutrition processes and they are the ones who could develop complications due to the disease and require intensive care1. The correct management of nutritional status seeks to prevent the risk of complications related to protein caloric deficit and increased catabolic activity; the literature details how malnutrition generates compromise by decreasing respiratory, cardiac and skeletal muscle and contributing to organ failure. The challenge for nutrition in this pandemic is to identify the population at risk and create adequate nutritional support for each patient2. Management guidelines provide useful and rapid recommendations for diagnosis and specialized nutriotherapeutic treatment.

Programas de Protección Nutricional de la Agenda Venezuela / Nutritional protection programs of the Venezuela Agenda

Venezuela ha pasado a ser un país asimétrico, con grandes desigualdades y la inseguridad alimentaria familiar constituye quizás el problema nutricional más importante. En 1996, se comenzó a implementar la "Agenda Venezuela", la cual tiene un componente de protección social, que incluye 14 programas, para compensar a los grupos de población más desfavorecidos por las medidas económicas. Objetivo. Describir y analizar las fortalezas y debilidades de los programas de la Agenda, más vinculados con la situación nutricional. Materiales y métodos. Se basó en el análisis de informes presentados por los organismos ejecutores, de una encuesta de opinión realizada en Caracas, además de entrevistas a coordinadores de los programas. Se examinaron los programas: alimentos estratégicos, subsidio familiar, alimentación escolar, merienda y comedores escolares, hogares y multihogares de cuidado diario. Resultados. Las debilidades más comunes son: deficiente evaluación y apoyo educativo, escasa cobertura, solapamiento de beneficiarios, problemas de tipo logístico y presupuestario. A pesar de la fuerte inversión de recursos, el déficit nutricional en menores de seis años presenta una tendencia ascendente, lo cual reitera que los problemas nutricionales son multicausales y requieren de políticas sociales integrada, estables en el tiempo y focalizadas en los grupos más vulnerables. Conclusiones. Esta situación obliga a replantearse los programas en función a la pertinencia, factibilidad, costo-eficiencia e impacto y ha reiterado, la necesidad de un proceso de descentralización para otorgar más responsabilidad y poder de decisión a los gobiernos estatales, municipales y a la comunidad organizada y lograr un mayor impacto en la población objetivo y su contexto(AU)

Venezuela has become an asymmetric country, with great inequalities and family food insecurity is perhaps the most important nutritional problem. In 1996, the "Venezuela Agenda" began to be implemented, which has a social protection component, which includes 14 programs, to compensate the most disadvantaged population groups for economic measures. Objective. Describe and analyze the strengths and weaknesses of the Agenda programs, more linked to the nutritional situation. Materials and methods. It was based on the analysis of reports submitted by the executing agencies, an opinion poll conducted in Caracas, as well as interviews with program coordinators. The programs were examined: strategic food, family subsidy, school feeding, snack and school canteens, daily care homes and multi-homes. Results. The most common weaknesses are poor evaluation and educational support, poor coverage, overlapping beneficiaries, logistical and budgetary problems. Despite the strong investment of resources, the nutritional deficit in children under six years of age shows an upward trend, which reiterates that nutritional problems have multiple causes and require integrated social policies, stable over time and focused on the most vulnerable groups. Conclusions. This situation forces us to reconsider the programs based on their relevance, feasibility, cost-efficiency and impact and has reiterated the need for a decentralization process to grant more responsibility and decision-making power to state and municipal governments and to the organized community and achieve a greater impact on the target population and its context(AU)

Reflexiones sobre la ética de la investigación en Colombia / Reflections on Ethics of Research in Colombia

Resumen Se reflexiona en torno al diseño normativo que regula la investigación en Colombia y las prácticas de los investigadores desde un enfoque ético, abordando asuntos pro blemáticos en las ciencias de la salud, las ciencias sociales y las disciplinas ambien tales, para concluir que se necesita fortalecer el control del Estado en estos temas, la actualización de la normatividad y una mayor formación de los investigadores y miembros de Comités de Ética en investigación, especialmente en: la protección de los participantes, el cuidado de los animales, los conflictos de interés, el manejo de comunidades y de grupos vulnerables, los protocolos comunitarios, el consentimien to informado, la consulta previa, el cuidado de la biodiversidad y el acceso a recursos genéticos.

Abstract This paper reflects on the normative design, which regulates research in Colombia and the practices of researchers from an ethical approach, by addressing critical issues in the health sciences, social sciences, and environmental disciplines, to conclude that it is necessary to strengthen state control in these issues, the updating of the regulations and greater training of researchers and members of Ethics Committees in research , especially in the protection of participants, animal care, conflicts of interest, the management of communities, and vulnerable groups, community pro tocols, informed consent, prior consultation, biodiversity care, and access to genetic resources.

Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS)2016. (Parte 3 de 3) / Comparative analysis of the standards of the council of international organizations of medical sciences (CIOMS)2016. (Part 3 of 3)

El este tercer trabajo se presenta el análisis comparativo de las últimas pautas de CIOMS 2016, realizado por estudiantes de la VI Cohorte de la Maestría en Bioética como parte de la evaluación de la asignatura Bioética e Investigación. En estas pautas se abordan de forma novedosa temas tan importantes como la investigación en grupos vulnerables, en situaciones de desastre y brotes de enfermedades de orden natural o creadas por el hombre e investigaciones con conglomerados, así como la compensación por daños, manejo de datos cuando se utiliza el entorno virtual y herramientas digitales y el conflicto de interés, lo cual proporcionará a los investigadores un aporte en su formación y una rápida adaptación a la nueva propuesta CIOMS(AU)

In this third work, the comparative analysis of the latest CIOMS 2016 guidelines, carried out by students of the VI Cohort of the Master in Bioethics, as part of the evaluation of the subject Bioethics and Research is presented. These guidelines deal in a novel way with important issues such as research in vulnerable groups in situations of disaster and outbreaks of natural or man-made diseases and investigations with clusters, as well as compensation for damages, data management when the virtual environment and digital tools and the conflict of interest are used, which will provide researchers with a contribution in their training and a rapid adaptation to the new CIOMS proposal(AU)

Recomendaciones nutricionales para pacientes hospitalizados con infección respiratoria grave (IRAG) sospechosa o confirmada por COVID-19 / Nutritional recommendations for hospitalized patients with severe respiratory infection (SARS) suspected or confirmed by COVID-19

Durante estas tres décadas del cuidado continuo de pacientes hospitalizados hemos reconocido la fisiopa-tología de la respuesta metabólica al estrés y la afectación de los enfermos desde la activación molecular de la sepsis, hasta el compromiso hemodinámico y neurológico del shock, ofreciendo soporte nutricional para obtener mejores resultados para la salud y la vida de nuestros pacientes, mediante recomendaciones que han sido comprobadas en poblaciones heterogéneas con diversas presentaciones en la práctica clínica. En esta revisión de la literatura proponemos sugerencias sobre la intervención nutricional en el paciente con SARS-CoV2 o COVID-19

During last three decades of continuous care of hospitalized patients, we have recognized the pathophysiology of the metabolic response to stress and the involvement of patients, from the molecular activation of sepsis to the hemodynamic and neurological involvement of shock, offering nutritional support to obtain better results for the health and life of our patients, through recommendations that have been verified in heterogeneous populations with different presentations in clinical practice. In this literature review we propose suggestions on nutritional intervention in patients with SARS-CoV2 or COVID-19

Accidentes no fatales en población mexicana, prevalencia y factores asociados. Ensanut 2018-19 / Non-fatal unintentional injuries in Mexican population: prevalence and associated factors. Ensanut 2018-19

Resumen Objetivo: Estimar la prevalencia de lesiones accidentales no fatales en población mexicana y analizar los factores individuales, ambientales y del hogar asociados con su ocurrencia. Material y métodos: Se analizó la prevalencia de lesiones accidentales a partir de la Encuesta Nacional de Salud y Nutrición (Ensanut) 2018-19, diseñada con un muestreo probabilístico, estratificado y por conglomerados, en tres etapas. Se evaluó mediante regresión logística su asociación con distintas variables independientes. Resultados: La prevalencia de lesiones accidentales fue de 4.5% (IC95%: 4.2-4.7), equivalente a 5.6 millones de personas. De ellas, 22.3% o 1.2 millones sufrieron consecuencias permanentes en su estado de salud. La posibilidad de tener una lesión accidental fue mayor en región Norte, Centro y Ciudad de México-Estado de México, en hombres de 0 a 59 años, mujeres de 60 o más años, en personas con alguna discapacidad y en quienes reportaron sentir depresión. Conclusión: Es necesario y urgente reforzar la prevención de lesiones accidentales, especialmente en grupos vulnerables.

Abstract Objective: To estimate the prevalence of non-fatal unintentional injuries in Mexican population and to analyze individual, environmental and household factors associated with its occurrence. Materials and methods: A cross-sectional study, analyzed the prevalence of unintentional injuries from Encuesta Nacional de Salud y Nutrición (Ensanut 2018-19), which is a nationally representative health survey designed with a probability, stratified and cluster sampling, in three stages. Association with variables of interest was explored using logistic regression analysis. Results: Prevalence of non-fatal unintentional injuries was 4.5% (IC95%: 4.2-4.7), equivalent to 5.6 million people per year. Of them, 22.3% or 1.2 million suffered permanent consequences. Probability of having unintentional injuries was higher in the North and Center regions, as in Mexico City-State of Mexico; in males from 0 to 59 and females of 60 or more years of age, in people living with disabilities and those who self-reported depression symptoms. Conclusions: Strengthening unintentional injury prevention is necessary and urgent, especially within vulnerable groups of population.

População em Situação de Rua: o Papel da Educação Médica ante a Redução de Iniquidades / The Homeless Population: the Role of Medical Education to Reducing Health Disparities

Resumo: Introdução: Compreendendo a abordagem holística de saúde e considerando as desigualdades brasileiras, infere-se a discrepância dos estados de saúde entre grupos sociais, sobretudo no que concerne à população em situação de rua (PSR). Essas pessoas lidam com o desamparo institucionalizado, e a pandemia da Covid-19 expôs ainda mais essa situação. Quanto à formação dos profissionais de saúde, torna-se fundamental a abordagem do tema. Relato de Experiência: Com base na inclusão de experiências de docentes que articulavam ações de integração ensino-serviço com a equipe do Consultório na Rua de Mossoró, bem como a abordagem de temas relacionados às populações mais vulneráveis em eixo longitudinal ao curso, despertou-se o interesse dos discentes do curso de Medicina da Ufersa para ações direcionadas à PSR. Destarte, surge, em 2019, a ação "Saúde nas Ruas", em parceria com o Consultório na Rua, que fornece suporte à PSR em diversos aspectos, com a participação dos alunos do curso de Medicina. A ação, proposta a partir de iniciativa dos próprios alunos, marcou o início do planejamento da inclusão do atendimento a essa população no programa do internato do curso, bem como a criação de um projeto de extensão longitudinal para ações voltadas à PSR. Nesse processo, os discentes puderam imergir na realidade dessa população, e os usuários tiveram autonomia para compartilhar suas experiências e dores. Discussão: Mediante uma formação acadêmica que visa romper com o modelo tecnicista, os estudantes possibilitaram voz à PSR e, compreendendo essas pessoas como sujeitos do processo, refletiram sobre o agir médico na transformação da realidade em que se inserem. Conclusão: O corpo acadêmico participante potencializou em si a empatia e o desejo por uma saúde pública democrática e acessível. Ficou evidente ainda a imprescindibilidade de trabalhar temas específicos sobre populações vulneráveis, com o objetivo de fortalecer a atuação médica como forma de garantir o direito à saúde.

Abstract: Introduction: A clear discrepancy in the health status between social groups in Brazil, particularly the homeless population (HP), can be inferred from the apparent inequalities when considering health from a holistic perspective. The homeless have to deal with institutionalized abandonment, and the COVID-19 pandemic has accentuated this issue. Addressing this theme has become an essential element of the training of health professionals. Experience Report: The interest of medicine students at UFERSA in actions directed at the HP was triggered by teachers' experiences of coordinating service-learning integration actions with the street health care unit in Mossoró, and tackling issues related to the most vulnerable groups throughout the course. In 2019 the "Health on the Streets" action is therefore launched in partnership with the street health care unit, providing support to the HP in several aspects, and involving the participation of the medicine students. The action, proposed based on the students' own initiative, marked the start of the planning for including care for this group in the internship program of the course, as well as the creation of a longitudinal community outreach project for actions with the HP. The students had the opportunity to immerse themselves in the reality of this population, while the users had the autonomy to share their experiences and sufferings. Discussion: Following an academic method that aims to break away from the technicist model, the students gave voice to the HP and, understanding these people as subjects of the process, reflected on the role of medicine in transforming their reality. Conclusion: The academics who participated in this project enhanced their empathy and desire for democratic and accessible public health. It also became evident that tackling specific issues regarding vulnerable groups is indispensable, with a view to strengthening the role of the physician in guaranteeing the right to health.

III. The role of the Research Ethics Committees in the regulation of Pharma-Sponsored studies

Participants of Pharma-sponsored research are exposed to risks, benefits, and uncertainties that do not occur in other forms of clinical studies. Ethics committees represent the subjects’ first line of protection. This responsibility begins with the study review and ends after all study subjects finish the intervention. The objective of this paper is to review the most common controversial issues found in Pharma-sponsored studies. Potential solutions are proposed to prevent or resolve the polemical aspects. However, different challenges will be faced in the near future (e.g., when new therapies reach their late stage of development). All parties involved in research should work together to guarantee the protection of participants, the paramount principle on which clinical investigation is based. Pharma-sponsored research is a crucial driver to develop and implement innovative approaches to improve the informed consent process and the execution of the studies.

II. The research ethics involving vulnerable groups

Abstract Vulnerability in research occurs when the participant is incapable of protecting his or her interests and therefore, has an increased probability of being intentionally or unintentionally harmed. This manuscript aims to discuss the conditions that make a group vulnerable and the tools and requirements that can be used to reduce the ethical breaches when including them in research protocols. The vulnerability can be due either to an inability to understand and give informed consent or to unequal power relationships that hinder basic rights. Excluding subjects from research for the only reason of belonging to a vulnerable group is unethical and will bias the results of the investigation. To consider a subject or group as vulnerable depends on the context, and the investigator should evaluate each case individually.

Pré-habilitação: como preparar nossos pacientes para cirurgias abdominais eletivas de maior porte? / Prehabilitation: how to prepare our patients for elective major abdominal surgeries?

RESUMO Várias doenças da cavidade abdominal têm, na abordagem cirúrgica, sua principal forma de tratamento. Entretanto, o próprio procedimento cirúrgico é um agente estressor que pode promover efeitos adversos não relacionados com o objetivo do tratamento. A pré-habilitação emergiu como um programa multifatorial de condicionamento de saúde pré-operatório, que promove melhora na capacidade funcional e na evolução pós-operatória. O presente estudo faz uma revisão da literatura usando os bancos de dado MEDLINE, Ovid, Google Scholar e Cochrane para determinar o conceito, as indicações, os meios de seleção dos pacientes, e para sugerir as formas de implementação do programa de pré-habilitação em cirurgias abdominais de grande porte.

ABSTRACT Surgical approach is the main form of treatment for several diseases of the abdominal cavity. However, surgical procedure itself is a stressor that may lead to adverse effects unrelated to the treatment goal. Prehabilitation has emerged as a multifactorial preoperative health conditioning program, which promotes improvement in functional capacity and postoperative evolution. The present study reviews literature using MEDLINE, Ovid, Google Scholar, and Cochrane databases in order to determine the concept of prehabilitation program and the indications and means of patient selection for it, as well as to suggest ways to implement this program in cases of major abdominal surgeries.

Proteção de direitos humanos: o caso das quebradeiras de coco babaçu / Protection of human rights: the case of babaçu coconut breakers / Protección de derechos humanos: el caso de las rompedoras de coco babaçu

O presente estudo tem o objetivo analisar a proteção de direitos humanos dentro de um contexto histórico e desenvolvimentista na Amazônia, utilizando-se do caso das quebradeiras de coco babaçu. Para isso perpassou-se pelos conflitos sociais existentes na Amazônia e decorrentes desta política, analisou-se a proteção multinível e suas dimensões e a necessidade do âmbito subnacional de proteção dos direitos humanos, para, por fim, apresentar o caso das quebradeiras como exemplo de resistência e fortalecimento do protecionismo para com grupos vulnerabilizados dentro do contexto amazônico, junto à atuação em escuta e clínica ampliada, exemplificando a relação transdisciplinar entre Direito e psicologia em favor de uma atuação à proteção subnacional de direitos humanos através da abertura de novos espaços políticos para comunidades locais e movimentos sociais

The present study has the objective of analyzing the protection of human rights within a historical and developmental context in the Amazon, using the case of babaçu coconut breakers. Taking into account that the social conflicts existing in the Amazon region were the result of this strategy, the multilevel protection and its dimensions and the need for the subnational scope of protection of human rights were analyzed, in order to present the case of the breakers as an example of resistance and strengthening of protectionism towards vulnerable groups within the Amazon context, along with the performance in listening and clinical practice, exemplifying the transdisciplinary relationship between Law and Psychology, in favor of an action related to the subnational protection of human rights through the opening of new political spaces for local communities and social movements

El presente estudio tiene el objetivo de analizar la protección de derechos humanos dentro de un contexto histórico y desarrollista en la Amazonia, utilizando el caso de las rompedoras de coco babaçu. Para ello se percató por los conflictos sociales existentes en la Amazonia y derivados de esta política, se analizó la protección multinivel y sus dimensiones y la necesidad del ámbito subnacional de protección de los derechos humanos, para, por fin, presentar el caso de las quebradoras como ejemplo de resistencia y fortalecimiento del proteccionismo hacia grupos vulnerables dentro del contexto amazónico, junto a la actuación en escucha y clínica ampliada, ejemplificando la relación transdisciplinaria entre Derecho y psicología en favor de una actuación a la protección subnacional de derechos humanos a través de la apertura de nuevos espacios políticos para comunidades locales y movimientos sociales

La encuesta como método de estudio del estado nutricional de la población. El caso de los trabajadores municipales de Santiago de Chile (1936) / The Nutrition Survey as a Method of Study of Nutrition Status in a Population: The Case of Municipal Workers of Santiago of Chile (1936)

Resumen Introducción: los diagnósticos de comienzos del siglo XX daban cuenta del deterioro de las condiciones materiales de vida de la población, en particular la más pobre. Uno de los aspectos más importantes era el problema del acceso a la alimentación. El objetivo de esta reflexión fue analizar los resultados de una encuesta nutricional aplicada a los jornaleros de la Municipalidad de Santiago en 1936. Reflexión: la encuesta de la Municipalidad de Santiago de Chile ofrece información relevante sobre consumo de calorías, talla y peso. Esta encuesta permite discutir los alcances que tuvo la encuesta como técnica de investigación durante los años 1930 y 1940, y las razones de por qué se impuso frente a otros métodos como el uso de las cuentas nacionales. Conclusión: la encuesta aplicada a los trabajadores de la Municipalidad de Santiago muestra sus condiciones privilegiadas en cuanto a ingreso, consumo e Índice de Masa Corporal.

Abstract Introduction: Diagnoses in the beginning of the 20th Century showed the deterioration of material conditions of life in the general population, especially the poorest. One of the most important aspects was the problem of access to adequate food and diet. The objective of this reflection is to analyze the results of a nutrition survey applied in 1936 to the workers of the Department of Cleanliness of the Municipality of Santiago de Chile. Reflection: The survey of the Municipality of Santiago de Chile provides important information on calorie consumption, height and weight. This survey allows for discussion of the scope of the survey as a research technique during the 1930s and 1940s, and the reasons why it was imposed against other methods such as the use of national surveillance systems. Conclusion: The survey applied to the workers of the Municipality of Santiago shows their privileged conditions in regards to income, dietary intake, and Body Mass Index.

Elaboração e verificação da validade e confiabilidade de um instrumento de letramento em nutrição entre pessoas com diabetes / Elaboration and verification of the validity and reliability of a nutrition literacy instrument among people with diabetes

Resumo Introdução o letramento de pessoas com diabetes quanto à nutrição é importante, pois uma alimentação saudável pode melhorar a qualidade de vida dessas pessoas. Objetivo Objetivou-se criar um instrumento denominado Letramento Nutricional entre pessoas com Diabetes (LND) e avaliar a sua validade, confiabilidade e interpretabilidade. Método estudo metodológico com verificação da validade de conteúdo; pré-teste; estimativa da confiabilidade (consistência interna: alfa de Cronbach; reprodutibilidade: kappa-K, coeficiente de correlação intraclasse [CCI]); estimativa da validade de critério concorrente e interpretabilidade feita pela contagem dos acertos das associações de palavras com escores de 0 a 24 (corte ≤ 18) e teste de hipóteses em amostra probabilística para população infinita por meio de regressão logística; p ≤ 0,05 (OR/IC95%). Resultados a validade de conteúdo foi satisfatória. A confiabilidade (alfa = 0,68; K ≥ 0,60 e CCI = 0,68) foi boa. Quanto à validade concorrente, constatou-se correlação entre o LND e a escolaridade (rs = 0,88; p = 0,000). Dos 212 participantes, 75,8% apresentaram LND > 18. No teste de hipóteses, verificou-se que quanto maior a escolaridade, maior o LND (1,20/1,09-1,31) e o LND foi menor entre homens (0,50/0,25-1,01). Conclusão o LND foi considerado válido, confiável e de fácil interpretação, podendo ser utilizado em pesquisas futuras ou mesmo em serviços de saúde que prestam assistência às pessoas com diabetes.

Abstract Background The literacy about nutrition of people with diabetes is important since healthy eating can improve the life quality of these people. Objective The objective of this study was to create an instrument called "Nutrition Literacy among people with Diabetes (NLD)" and evaluate its validity, reliability and interpretability. Method Methodological study with verification of content validity; pre-test; reliability estimation (internal consistency: Cronbach's alpha; reproducibility: kappa-K, Intraclass Correlation Coefficient - ICC); estimation of the validity of concurrent criterion and interpretability made by counting the correct words associations with scores from 0 to 24 (cut ≤ 18) and hypothesis test in sample for infinite population through logistic regression p≤0.05; (OR / CI 95%). Results The content validity was satisfactory. Reliability (alpha = 0.68, K≥0.60 and CCI = 0.68) was good. Regarding the concurrent validity, a correlation between NLD and schooling (rs = 0.88, p = 0.000) was found. From the 212 participants, 75.8% presented NLD> 18. In the hypothesis test, it was found that the higher the schooling, the higher the NLD (1.20 / 1.09-1.31); the NLD was lower among men (0.50 / 0.25-1.01). Conclusion The NLD was considered valid, reliable and easy to interpret, and it could be used in future research or even in health services that provide assistance to people with diabetes.

Analysis of the Problem of Informed Consent in Clinical Trial / 中国医学伦理学

Objective:By observing the process of informed consent in clinical trials of one top three hospital, to disclose the non - standard phenomenon existingin the process of informed consent in clinical trials, and put for-ward that there should be special protection mechanism for vulnerable groups to participate in clinical trials. Meth-ods:Combined with the actual situation of one top three hospital, we comprehensively analyzed the problems exist-ing in the process of informed consent of clinical trials in our center, put forward strict solutions, and also formula-ted strict standards for the informed consent process of vulnerable groups. Results:Through the strict requirements of the informed consent process of vulnerable groups, the test process of vulnerable groups participating in the clini-cal trial was standardized; meanwhile the vulnerable groups were given special protection. Conclusion:Informed consent is an important guarantee that protects vulnerable groups to participate in clinical trials.

Avaliação nutricional de pacientes com câncer em atendimento ambulatorial / Nutritional assessment of cancer patients in outpatient care / Evaluación nutricional de pacientes con cáncer en atención ambulatoria

Objetivou-se analisar o aspecto nutricional de pacientes oncológicos em atendimento ambulatorial, em Joaçaba-SC. Estudo transversal, que utilizou a avaliação subjetiva global produzida pelo paciente e questionário de consumo alimentar, do Ministério da Saúde. Participaram 70 pacientes, idade média 60,3±13,9 anos, 38 (54,3%) homens, 57 (81,4%) sem acompanhamento nutricional, 48 (68,6%) com alimentação regular, 16 (22,9%) alimentação adequada e seis (8,6%) boa alimentação. O fumo teve associação com câncer de pulmão e orofaringe e o consumo de carne com câncer de intestino. A redução de peso foi elevada, 36 (52,2%) reduziram mais de 5% do peso corporal. Pessoas bem nutridas reduziram menos o peso comparado às desnutridas, tiveram melhor aceitação da dieta e menos queixas alimentares. Desnutridos totalizaram 58 indivíduos (83%), todos em estágio avançado da doença. A desnutrição teve elevada prevalência neste estudo, devendo ser implantadas estratégias de acompanhamento eficazes com equipe multiprofissional para melhorar o tratamento nutricional desta população (AU).

The objective was to analyze the nutritional aspect of cancer patients in outpatient care in Joaçaba-SC. Cross-sectional study using global subjective assessment by the patient and the food consumption questionnaire of the Brazilian Health Department. Seventy patients participated with a mean age of 60.3±13.9 years, 38 (54.3%) men, 57 (81.4%) without nutritional monitoring, 48 (68.6%) with a regular diet, 16 (22.9%) appropriate diet and (8.6%) good diet. Smoking was associated with lung and oropharyngeal cancer and meat consumption with bowel cancer. The weight reduction was high, as 36 (52.2%) lost more than 5% of their body weight. Well-nourished people lost less weight when compared to malnourished individuals, accepted the diet better and had less food complaints. In total, 58 individuals (83%) were malnourished, all of them in the advanced stage of the disease. The prevalence of malnourishment was high in this study. Effective monitoring strategies need to be implemented with a multiprofessional team to improve the nutritional treatment in this population (AU).

La finalidad fue analizar el aspecto nutricional de pacientes oncológicos en atención ambulatoria en Joaçaba-SC. Estudio transversal, que utilizó la evaluación subjetiva global producida por el paciente y cuestionario de consumo alimentario del Ministerio de la Salud brasileño. Participaron 70 pacientes, promedio de edad 60,3±13,9 años, 38 (54,3%) hombres, 57 (81,4%) sin seguimiento nutricional, 48 (68,6%) con alimentación regular, 16 (22,9%) alimentación adecuada y seis (8,6%) buena alimentación. El humo estaba asociado al cáncer de pulmón y faringe inferior y el consumo de carne con cáncer intestinal. La reducción de peso fue alta, 36 (52,2%) redujeron más del 5% del peso corporal. Personas bien nutridas redujeron menos el peso comparado a las desnutridas, aceptaron mejor la dieta y tuvieron menos quejas alimentarias. Desnutridos totalizaron 58 individuos (83%), todos en estado avanzado de la enfermedad. La prevalencia de la desnutrición fue alta en este estudio. Deben ser implantadas estrategias de seguimiento eficaces con equipo multiprofesional para mejorar el tratamiento nutricional de esta población (AU).