Registering transparency: the making of the international clinical trial registry platform by the world health organization (2004-2006).

BACKGROUND: This paper examines the events and conditions that led to the creation of the International Clinical Trials Registry Platform (ICTRP) in 2006 by the World Health Organization (WHO), and how the WHO addressed the issue of transparency in global pharmaceutical research. Using historical textual analysis, I trace the scientific debates that advocated for the establishment of official clinical trial registries in medical journals, and the sequence of actions following the GSK Paxil scandal in 2004, identifying the major ethical and scientific arguments that led to the involvement of the WHO as a key actor in trial registration in the context of the Big Pharma business model. RESULTS: Through the questions "Why register?" and "Why registries?" as a roadmap, I examine the issues of publication bias and selective reporting by the industry, scrutinizing two ways in which the practice of publication bias damaged transparency in industry-sponsored research. The first involved ethical concerns regarding human subject exploitation and concealing of negative results. The second addresses the deterioration of the certainty of evidence due to incomplete access to trials results. By reviewing the series of events that occurred between 2004 and 2006 -between the Paxil scandal and the launch of the ICTRP-, I analyze the actions taken by the different actors involved: (1) the International Committee of Medical Journal Editors (ICMJE) and the creation of the Ottawa Group; (2) the WHO, beginning with the Ministerial Summit on Health Research held in November of 2004, and (3) the responses of the pharmaceutical industry and specifically GSK to the call for transparency and trial registration. CONCLUSIONS: The history of trial registration through the ICTRP as a dataveillance apparatus shows the difficulty of regulating a health enterprise turned into a global business. Moreover, it shows the challenges of globalization and how easier and faster it is to globalize business compared to good practices, raising the question of why it has been so hard to undo these trends. Indeed, the history of the movement for trial registration is not a history of regulation success, or at least not yet.

Factors influencing the implementation of shared decision-making in breast cancer care: protocol for a mixed-methods study.

INTRODUCTION: Chile is committed to actively involving patients in their healthcare. However, little is known about how this is translated into clinical encounters. Breast cancer (BC) is the first cause of cancer-related death in Chilean women. National policy guarantees standard care, and treatment decisions should be made along this process that can have long-term consequences for women. So, BC is a particularly well-suited case study to understand the complexity of patient participation in decision-making. OBJECTIVE: To identify the factors that affect the active involvement of patients in the BC treatment decision-making process, considering the perspectives and practices of health professionals and women facing the disease. METHOD AND ANALYSIS: We will conduct a mixed-method study through a convergent parallel design in three stages: (1) A qualitative study: non-participant observation of the tumour board (TB) meetings; semi-structured interviews with key informants from TBs; documentary analyses; semi-structured interviews with women facing BC; and non-participant observations of clinical encounters; (2) a cross-sectional study with 445 women facing BC stages I-III from three hospitals in Santiago, Chile. We will measure the level of expected participation, experienced participation, decisional conflict, quality of life (QoL) and satisfaction with healthcare. Descriptive analysis will be performed, and multivariable binary logistic regression models will be adjusted to identify factors associated with high levels of QoL or satisfaction; (3) an integration study will bring together the data through a joint display technique. ETHICS AND DISSEMINATION: The study has been conceived and will be conducted according to international and local agreements for ethical research. Ethical approval has been granted by two Ethics Committees in Chile.The results will be disseminated to scientific and lay audiences (publications in scientific journals and conferences, seminars and a website for plain language dissemination).

What is needed to effectively communicate risk during a health crisis? A qualitative study with international experts based on the COVID-19 pandemic.

OBJECTIVE: To identify a framework for risk communication during health crises by using the current pandemic as a case study. DESIGN: A qualitative study based on individual interviews. SETTING: Different countries with diverse levels of perceived success on risk communication during the COVID-19 health crisis. PARTICIPANTS: International experts with experience in health crisis management or risk communication. ANALYSIS: A thematic analysis was performed supported by Atlas.ti. RESULTS: Four men and six women took part in the study (three from Europe, two from Latin America, two from North America, one from Asia and two from Oceania). Three major themes emerged from the data: (1) institutionalising the communication strategy; (2) defining the problem that needs to be faced; (3) developing an effective communication strategy. CONCLUSION: Risk communication during a health crisis requires preparation of governments and of health teams in order to produce and deliver effective messages as well as to help communities to make informed and healthy decisions. This is particularly relevant for slow disasters, such as COVID-19, as the strategy must innovate to avoid information fatigue of the audience. The findings of this article could inform guidelines to best equip countries for a clear communication strategy for future crises. PROSPERO REGISTRATION NUMBER: CRD42021234443.

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)

Facilitators and barriers perceived by health professionals in the implementation of Managing Cancer and Living Meaningfully (CALM) psychotherapy in Santiago.

INTRODUCTION: Palliative care (PC) for advanced cancer is guaranteed by law in Chile, but the formal training for it is insufficient. Training models have emerged internationally that enable professionals to be better prepared for the provision of psychotherapy in PC. The objective of this study is to explore health professionals' perceptions of the 'Managing Cancer and Living Meaningfully' (CALM) psychotherapy and the perceived barriers and facilitators to its implementation, based on a theoretical training. METHODS: A qualitative study was carried out with health professionals working in oncology and/or PC and participating in a CALM training. A focus group was conducted after to explore the experience of CALM training and the perceived barriers and facilitators to its implementation. A thematic analysis of the content and an analysis of the facilitators and barriers to the implementation of mental health services were carried out. RESULTS: Twenty four professionals participated in the training, six of whom were part of the subsequent focus group. There was a consensus that the training was a positive professional experience and that it is a culturally sensitive and feasible intervention for application in Chile. The barriers identified include institutional bureaucracy as resistance to change, the excess workload of the clinical teams and the absence of spaces for more in-depth training. CONCLUSIONS: CALM is a useful and relevant framework for the training of health professionals working in oncology and PC. In Chile, there is a need for training spaces on this topic. Future research and organisational studies should evaluate professionals' beliefs about, and resistance to, adopting evidence-based psychotherapeutic interventions.

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

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.

Validación del instrumento Informed Choice para medir la decisión informada de mamografía en mujeres chilenas usuarias de atención primaria / Validation of the Informed Choice instrument for Chilean women facing a mammography decision in primary care

Objetivo: Adaptar y validar el instrumento Informed Choice (IC) para la decisión de mamografía al contexto chileno. Diseño: Estudio transversal, analítico, de adaptación y validación psicométrica. Emplazamiento: Centro de atención primaria del sector sur oriente de Santiago de Chile. Métodos: 1) traducir y contra-traducir IC; 2) realizar un grupo focal para la relevancia cultural/lingüística; 3) examinar la validez del contenido; 4) pilotar el instrumento; 5) aplicar para validación. Para la consistencia interna se usó el alfa de Cronbach, prueba de esfericidad de Bartlett y la medida de Kaiser-Meyer-Olkin para determinar correlaciones entre las variables y análisis factorial. Resultados: Se construyeron 3 versiones del IC, modificándose según la opinión de usuarios y expertos. La validación se llevó a cabo en una muestra de 70 mujeres. La edad media fue de 54,4 años, el 47,1% de educación secundaria completa y el 92,9% al menos se había realizado alguna vez una mamografía. Se realizó análisis factorial del IC y se eliminó uno de sus ítems. El alfa de Cronbach final fue 0,79. Conclusión: El uso de instrumentos de medición requiere de su validación previa ya que la versión original puede variar de acuerdo al contexto cultural donde será aplicado y las necesidades locales particulares. El proceso de validación del IC permite contar con un instrumento confiable para medir la decisión de las mujeres que deben realizarse la mamografía en la dimensión conocimiento, actitud e intención hacia el examen.(AU)

Objective: To adapt and validate for the Chilean context the instrument Informed Choice (IC) to measure informed decision for mammography. Location: Primary Health Care Center in southeast Santiago, Chile. Design: Individual, transversal, analytical and psychometric adaptation and validation study. Methods: We 1) translated and back-translated IC; 2) conducted a focus group for cultural/linguistic relevance; 3) reviewed content validity; 4) piloted the instrument; 5) applied IC for validation. Analysis was performed by using Cronbach alpha, correlation, Bartlett's test of sphericity, Kaiser-Meyer-Olkin measure and factor analysis. Results: Three versions of the IC were developed, which included changes according to the views of users and experts. Validation was conducted in a sample of 70 women. Mean age was 54,4 years, 47,1% had completed secondary school and 92,9% have had at least one mammography. After factor analysis item 1 was removed and the final Cronbach Alpha was 0,79. Conclusions: The Chilean IC is reliable to measure decision women for mammography, this evaluate knowledge, attitude and intention towards the screening. The validation of an instrument to the cultural context is necessary and may have any variations to the original version according to local needs.(AU)

[Validation of the Informed Choice instrument for Chilean women facing a mammography decision in primary care]. / Validación del instrumento Informed Choice para medir la decisión informada de mamografía en mujeres chilenas usuarias de atención primaria.

OBJECTIVE: To adapt and validate for the Chilean context the instrument Informed Choice (IC) to measure informed decision for mammography. LOCATION: Primary Health Care Center in southeast Santiago, Chile. DESIGN: Individual, transversal, analytical and psychometric adaptation and validation study. METHODS: We 1) translated and back-translated IC; 2) conducted a focus group for cultural/linguistic relevance; 3) reviewed content validity; 4) piloted the instrument; 5) applied IC for validation. Analysis was performed by using Cronbach alpha, correlation, Bartlett's test of sphericity, Kaiser-Meyer-Olkin measure and factor analysis. RESULTS: Three versions of the IC were developed, which included changes according to the views of users and experts. Validation was conducted in a sample of 70 women. Mean age was 54,4 years, 47,1% had completed secondary school and 92,9% have had at least one mammography. After factor analysis item 1 was removed and the final Cronbach Alpha was 0,79. CONCLUSIONS: The Chilean IC is reliable to measure decision women for mammography, this evaluate knowledge, attitude and intention towards the screening. The validation of an instrument to the cultural context is necessary and may have any variations to the original version according to local needs.

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.

Validation of the Death and Dying Distress Scale (DADDS-Sp) in a population with advanced cancer in Chile.

INTRODUCTION: Developing instruments to screen for relevant aspects of advanced illness is key to identifying palliative needs and evaluating the effectiveness of interventions in this population. The objective of this project is to validate the Death and Dying Distress Scale in Spanish (DADDS-Sp) for screening anxiety about death and evaluating psychometric properties for people with advanced cancer. METHODS: DADDS is a 15-item self-administered questionnaire that assesses thoughts and feelings related to death and the process of dying. A cross-sectional, descriptive, psychometric validation study was conducted in two cancer centres in Santiago de Chile. Included were patients over 18 years of age with incurable and/or metastatic cancer, fluent in Spanish, and a life expectancy of more than 3 months. Reliability was analysed using Cronbach's alpha, and confirmatory factor analysis was performed following the model of the original scale. RESULTS: Seventy four patients participated in the study. The median age was 63 years. Of the sample, 59% identified themselves as women. On average, participants reported low anxiety about death (mean = 21, SD = 18). Women have more death anxiety. The reliability analysis yielded a value of α = 0.93 (IC = 0.91-0.95). Factor analysis with a one-factor structure yielded Comparative Fit Index (CFI) = 0. 0.972, Root Mean Square Error of Approximation (RMSEA) = 0.092, Standardized Root Mean Square Residual (SRMR) = 0.085 and Tucker-Lewis Index (TLI) = 0.968. The model with a two-factor structure yielded CFI = 0.989, RMSEA = 0.059, SRMR = 0.075 and TLI = 0.987, suggesting that the two-factor model has a better fit for the data studied. CONCLUSIONS: DADDS-Sp is psychometrically valid for use in a Spanish-speaking population, yielding high reliability and internal consistency. A majority of the Chilean patients reported a low level of anxiety about death although about 10% presented with severe anxiety, so their identification for adequate clinical management is fundamental.

International validation of the revised European Organisation for Research and Treatment of Cancer Head and Neck Cancer Module, the EORTC QLQ-HN43: Phase IV.

BACKGROUND: We validated the new European Organisation for Research and Treatment of Cancer Quality of Life Head and Neck Module (EORTC QLQ-HN43). METHODS: We enrolled 812 patients with head and neck cancer from 18 countries. Group 1 completed the questionnaire before therapy, and 3 and 6 months later. In group 2 (survivors), we determined test-retest reliability using intraclass correlation coefficients (ICC). Internal consistency was assessed using Cronbach's Alpha, the scale structure with confirmatory factor analysis, and discriminant validity with known-group comparisons. RESULTS: Cronbach's alpha was >0.70 in 10 of the 12 multi-item scales. All standardized factor loadings exceeded 0.40. The ICC was >0.70 in all but two scales. Differences in scale scores between known-groups were >10 points in 17 of the 19 scales. Sensitivity to change was found to be sufficient in 18 scales. CONCLUSIONS: Evidence supports the reliability and validity of the EORTC QLQ-HN43 as a measure of quality of life.

Effective interventions to improve the health literacy of cancer patients.

Health literacy (HL) refers to the cognitive and social abilities that are determinants in the motivation and capacity of the individual to access, understand and use information for the care of one's own health. In oncology, increased survival, navigation of the healthcare system, the many different forms of treatment and the management of adverse effects/outcomes make HL a critical factor in patient care. The objective of this study is to identify the structure, content and effectiveness of interventions to improve HL in cancer patients. MATERIALS AND METHODS: A literature review was performed using the '(health literacy OR Cancer Literacy) AND Cancer AND Intervention' strategy on seven multidisciplinary databases. Studies that intervened in subjects diagnosed with cancer and treating HL explicitly as a variable to be measured were included. RESULTS: One thousand two hundred and thirty-six abstracts were retrieved. Eight studies met the inclusion criteria. Research focused on patients diagnosed with breast cancer or prostate cancer. Interventions used multimedia resources and face-to-face interactions. No study defined HL. HL was usually a secondary outcome. There is high variability in the design of studies and interventions and in the instruments used to measure HL. The effectiveness of the interventions varied between studies, with improvements that were diminished over time or insufficient in participants with initial low literacy. CONCLUSION: The evidence to date in interventions oriented to study HL in patients with cancer is focused on other constructs, leaving HL as a phenomenon difficult to define both conceptually and clinically. Variability in designs and measurements makes comparison between interventions difficult. Defining and operationalizing HL is critical to design and measure effective interventions, which must be adapted to patients' needs.

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.

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

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.

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

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.

[Clinical implications of the "war against cancer"]. / ¿Contra qué se lucha cuando se lucha? Implicancias clínicas de la metáfora bélica en oncología.

This article discusses the origin and implications of the "war on cancer" metaphor. Commonly present in mass media, the "war on cancer" notion circulates also among patients, their loved ones, their support networks, and oncological multidisciplinary teams. In our view when cancer is uprooted of its illness status, and conceptualized as an "enemy", myths about disease and those who suffer it (especially the idea of psychogenesis) are strengthened. Two topics in which the war metaphor is particularly problematic in the clinical context, are analyzed in depth. The first one is the relationship between the oncologic patient and his or her loved ones and support networks. When patients are insistently prompted to fight the disease and think positive, the expression of emotions associated to the adaptive process of receiving a diagnosis of cancer may be inhibited. Secondly, the war metaphor promotes an authoritarian view among the health teams and on the physician-patient relationship, undermining the patent's autonomy in the decision-making process, which may affect his global quality of life. Also, it encourages emotional isolation, concealment of psychiatric symptoms and conspiracies of silence. It is concluded that public policies to avoid the "war on" notion are required. Instead, education of the general population about wrong beliefs about cancer should be encouraged.