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.

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.

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.