Implementación de ensayos clínicos y acceso posensayo a vacunas para la COVID-19 en Latinoamérica / Implementation of clinical trials and post-trial access to COVID-19 vaccines in Latin America

Latinoamérica fue durante noviembre de 2020 una de las regiones más afectada por la pandemia de COVID-19 en cuanto a prevalencia y muertes atribuidas al virus. Por ello, el inicio de testeo de vacunas en ciudadanos de la región fue recibido con altas expectativas sobre su efectividad. Frente a lo cual es esencial tener en cuenta ciertos principios fundamentales que deben guiar este proceso asegurando su correcta implementación. El objetivo de este artículo es ofrecer consideraciones sobre el proceso de implementación de ensayos clínicos y acceso posensayo a vacunas para COVID-19 en Latinoamérica. En particular los relacionados con el respeto a la dignidad de los participantes, las tensiones históricas globales y regionales en materia de economía política de ensayos clínicos, algunos aspectos de la gobernanza global y el rol de la Organización Mundial de la Salud en la pandemia, y la necesidad de asegurar el acceso posensayo a la vacuna. Se concluye que la pandemia es una oportunidad para estrechar lazos de cooperación y solidaridad entre países latinoamericanos. Los ensayos clínicos son una instancia clave para reforzar la gobernanza local y regional con miras a fortalecer la transparencia y la vigilancia de la correcta realización de alianzas público-privadas en el desarrollo de terapias, en los que la Organización Mundial de la Salud y la Organización Panamericana de la Salud, tienen un rol importante para la implementación de estrategias de integración y acceso a vacunas(AU)

Latin America was during November 2020 one of the most affected regions by the COVID-19 pandemic in terms of prevalence and deaths attributed to the virus. Therefore, the start of vaccine testing in citizens of the region was received with high expectations about its effectiveness. Therefore, it is essential to take into account certain fundamental principles that should guide this process ensuring its correct implementation. The objective of this article is to provide considerations on the process of implementing clinical trials and post-trial access to COVID-19 vaccines in Latin America, in particular those related to respect for the dignity of participants, the historical global and regional tensions regarding the political economy of clinical trials, some aspects of global governance and the role of the World Health Organization in the pandemic, and the need to ensure post-trial access to the vaccine. It is concluded that the pandemic is an opportunity to strengthen bonds of cooperation and solidarity between Latin American countries. Clinical trials are a key instance to strengthen local and regional governance with a view to consolidate transparency and monitoring of the correct implementation of public-private partnerships in the development of therapies, in which the World Health Organization and the Pan American Health Organization have an important role for the implementation of integration strategies and access to vaccines(AU)

Consideraciones para comunicar riesgos y beneficios de la mamografía a mujeres desde la perspectiva de los expertos / Experts' views on the communication of risks and benefits of mammography to detect breast cancer

Background: Breast cancer (BC) has a high mortality rate in developing countries due to a scarcity of early detection. Risk communication is critical to support women who face the decision to undertake BC screening. Thus, they can balance their perceived and real risk, and make informed choices. Aim: To describe experts' views on how the provision of information related to BC screening should be made. Material and Methods: A qualitative study with focus groups with national experts was conducted. Open coding was performed. Results: Four categories on the way information about BC screening should be provided emerged: to communicate about the need of the exam; the pros and cons of the test; fear as a barrier for understanding; and involving women in the decision-making process. Conclusions: These findings emphasize the need to include risk communication strategies in the patient-provider relationship and encourage and respect women's autonomy when facing the BC screening decision.

Recordar la dictadura chilena visitando lugares de memoria / Lembrar da ditadura chilena visitando locais de memória / Remembering the chilean dictatorship by visiting places of memory

Resumen En el marco de los estudios sobre lugares de memoria vinculados a las violaciones a los derechos humanos cometidas por la dictadura cívico-militar en Chile (1973-1990), este artículo presenta el análisis de visitas a dos lugares de memoria de Santiago de Chile - Villa Grimaldi y Londres 38 - realizadas por personas de distintos grupos etarios. El análisis aborda la interacción de los visitantes con el lugar, considerando los afectos y percepciones que provoca la visita, y la interpelación que estos lugares hacen a las memorias que los visitantes construyen sobre el pasado reciente. Los resultados muestran que, si bien existe acuerdo en la condena a las violaciones a los derechos humanos y la importancia de una cultura de la memoria y los derechos humanos, se produce una distancia entre las generaciones al valorar conflictos del pasado que refieren a distintos momentos históricos.

Resumo No marco dos estudos sobre os lugares de memória vinculados às violações dos direitos humanos cometidos pela ditadura cívico-militar no Chile (1973-1990), este artigo apresenta a análise de visitas a dois lugares de memória de Santiago do Chile - Villa Grimaldi y Londres 38 - realizadas por pessoas de diferentes faixas etárias. O estudo aborda a interação dos visitantes com o lugar, considerando os sentimentos e as percepções que a visita provoca e a interpelação que estes lugares fazem às memórias que os visitantes constroem sobre o passado recente. Os resultados mostram que, embora haja acordo na condenação das violações dos direitos humanos e na importância de uma cultura de memória e dos direitos humanos, um distanciamento entre as gerações aparece ao avaliar conflitos do passado que se referem a diferentes momentos históricos.

Abstract In the framework of the studies on places of memory related to human rights violations committed by the Chilean military-civic dictatorship (1973-1990), this article presents the analysis of visits to two places of memory of Santiago de Chile - Villa Grimaldi and London 38 - made by people of different age groups. The analysis addresses the interaction of the visitors with the place, considering the affections and perceptions that the visit caused, and the interpellation that these places cause to the memories that the visitors build on the recent past. The results show that, although there is an agreement on the condemnation of human rights violations and the importance of a culture of memory and human rights, there is a distance among the generations when assessing past conflicts that refer to different historic moments.

Implementación de la vacunación contra el virus papiloma humano en Chile: una mirada desde los determinantes sociales de la salud "ingreso" y "género" / HPV vaccine implementation in Chile: an appraisal from the social determinants of health model

Cervical cancer is the fourth most common neoplasm in women worldwide and its incidence is associated with profound social inequities. In Chile, it is the second cause of death in women of reproductive age. The Chilean clinical guideline identifies the vaccine against Human Papillomavirus (HPV) as the main preventive measure. Since 2014, the Ministry of Health has implemented free immunization against HPV for girls and female adolescents. This article critically analyzes this public policy from the viewpoint of health equity, using as framework the Social Determinants of Health Model. Specifically, we address the structural determinants of income and gender, which act as material and social barriers for achieving immunization, affecting protection against cervical cancer. These barriers correspond to the high cost of the vaccine, and social attitudes/cultural beliefs towards sexual behavior in Latin America and Chile that affect the acceptability of vaccination. The Social Determinants of Health Model constitutes a useful tool for identifying health inequities and understanding public policy from an equity viewpoint that complements the biomedical and epidemiological understanding of disease. In this topic, the initiative aims to strengthen the idea of health as a human right and health promotion as an essential function of public health policy.

Educando en epilepsia a escolares de enseñanza básica y secundaria: mediante un video / Video Training elementary and high school students on Epilepsy

Resumen: Existe gran desinformación sobre epilepsias; mitos, prejuicios y estigma institucionalizado en el sistema escolar. Además, dificultades de participación social en las personas con epilepsia. Todo esto produce un impacto negativo en la calidad de vida de las personas con epilepsia. El objetivo de este trabajo es probar un método para educar en Epilepsias a escolares, mediante técnicas audiovisuales adecuadas a su lenguaje, intereses, nivel de atención y comprensión. Capacitación directa de 1.000 niños. Se realiza, por expertos en epilepsia y profesionales con experiencia en material audiovisual, un guión de 4 capítulos, sobre una historia de crisis de epilepsia en un niño, representado por marionetas. Se presenta el video a establecimientos educacionales públicos y privados. Se aplica Pre y Post test de 10 preguntas, para medir nivel de conocimientos y aprendizajes básicos en epilepsias. Un año post presentación de video, se mide en una muestra de estudiantes, la persistencia de conocimientos enseñados. Hubo un total de 1.111 escolares. Las respuestas pre-test correctas, incorrectas y que no sabían fueron en un 44%, 37% y 19% respectivamente. Las respuestas post-test correctas, incorrectas y que no sabían fueron en un 94%, 5% y 1% respectivamente. El análisis estadístico con las pruebas de McNemar mostraron diferencias altamente significativas entre el pre y post test en cada una de las 10 preguntas (p<0.0001). El estudio de persistencia, un año después (2011) fueron las siguientes: Correctas: 74%. Incorrectas: 8%. No sabe: 18%.Hubo cambios significativos de adquisición de conocimientos entre el pre y post test, con niveles de persistencia de conocimientos aceptables, un año después. El mensaje que la epilepsia puede afectar a cualquier persona, se visualiza como potente para sensibilizar y mejorar las actitudes sociales. Palabras Claves: Video educacional, epilepsia, convulsiones, estigma, estudiantes de escuelas primarias

There is a lack of information on Epilepsies, myths, prejudices and stigma institutionalized in the school system. In addition, people with epilepsy face a difficult time when trying to engage socially. All these produce a negative impact on the quality of life of people with epilepsy. The objective of this study is to test a method to educate schoolchildren in elementary and high school by audiovisual techniques appropriate to their language, interests, level of care and understanding in Epilepsies. Direct training of 1,000 children was performed by epilepsy experts and professionals with experience in audiovisual material through 4 chapters on a history of epileptic seizure in a child represented by puppets. The video was screened at public and private schools. A 10-item questionnaire was applied before and after the video, to measure level of knowledge and basic learning about Epilepsies. The knowledge about epilepsy was retested one year later in a sample of students. A total of 1,111 schoolage children participated. The results before the video screening were: correct 44%, incorrect 37%, and "I don't know" 19%. After the screening, there was a marked improvement, where correct answers were 94%, incorrect 5% and "I don't know" 1%. Statistical analysis with McNemar tests showed highly significant differences between the questionnaires before and after the video screening in each of the 10 questions (p < 0.0001). The test was repeated a year later (2011), with the following results: correct: 74%. Incorrect: 8%. I don't know: 18%. There was significant acquisition of knowledge after the video screening, with persistence of knowledge at acceptable levels a year later. The message that epilepsy can affect anyone is seen as potent to raise awareness and improve social attitudes. Key Words: educational video, epilepsy, seizures, stigma, elementary school students.

Calidad de vida en pacientes chilenas sobrevivientes de cáncer de mama / Quality of life in Chilean breast cancer survivors

Background: Quality of Life (QOL) assessment may evaluate the impact of diseases and their treatment on the overall well-being of patients. Aim: To assess QOL in Chilean breast cancer survivors. Patients and Methods: Ninety one female breast cancer patients aged 60 ± 10 years, who finished their oncologic treatment at least a year prior to the assessment, who were disease free and in medical follow-up were included in the study. They completed the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 core questionnaire and the breast cancer module QLQ-BR23. Results: Forty eight percent of respondents were long term survivors (more than five years). Global QOL scores were high (73.6 ± 18.2), emotional scale had the lowest scores in QLQ-C30 functional scales (72.1). Symptoms with the highest scores were: Insomnia (= 21.2), pain (= 20.8), and fatigue (= 19.1). Body image, sexual function, and concern about the future were the most relevant problems. Body image was superior in patients with breast-conserving surgery (p = 0.008), and cognitive function was better in patients in early disease stage (p = 0.03) and in those with more than five years of survival (p = 0.04). Conclusions: Even when global QOL scores were high, some symptoms were prevalent. Awareness about these problems and symptoms should improve their diagnosis and treatment.