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OBJECTIVE.: Motivation for the study. Treatment options for HER2-positive breast cancer were evaluated, focusing on the efficacy and safety of trastuzumab-emtansine (T-DM1) compared to other anti-HER2 therapies. Main findings. Trastuzumab-deruxtecan (T-DXd) and PyroCap emerged as promising alternatives, showing substantial improvements in progression-free survival for locally advanced or metastatic breast cancer. T-DM1 showed superior efficacy to the other treatments. Implications. Our findings could inform healthcare decision-making processes to optimize strategies for HER2-positive breast cancer, and potentially improve health outcomes and quality of life. We aimed to study the efficacy and safety of trastuzumab-emtansine (T-DM1) versus other anti-HER2 therapies in HER2+ breast cancer (BC). MATERIALS AND METHODS.: We performed a network meta-analysis (NMA) of randomized controlled trials (RCTs). Our study focused on patients undergoing treatment for unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC), which included regimens involving trastuzumab and taxanes. Additionally, we considered cases within the first 6 months of treatment for HER2+ early breast cancer (EBC). RESULTS.: A total of 23 RCTs and 41 reports were included in our analysis. LABC and mBC showed no statistically significant difference in any of the comparisons of T-DM1 versus the other anti-HER2+ therapies. When assessing progression-free survival (PFS), trastuzumab-deruxtecan (T-DXd) and PyroCap demonstrated greater efficacy compared to other treatments (Hazard Ratio [HR]: 3.57; 95% confidence interval [CI]: 2.75-4.63 and HR: 1.82; 95% CI: 1.35-2.44; respectively), while T-DM1 alone exhibited superior effectiveness compared to LapCap (HR: 0.65; 95% CI: 0.55-0.77), TrasCap (HR: 0.65; 95% CI: 0.46-0.91), LapCapCitu (HR: 0.60; 95% CI: 0.33-1.10), Nera (HR: 0.55; 95% CI: 0.39-0.77), and Cap (HR: 0.37; 95% CI: 0.28-0.49). CONCLUSIONS.: NMA allows a ranking based on the comparative efficacy and safety among the interventions available. Although superior to other schemes, T-DM1 showed a lower efficacy performance in PFS and overall response rate and a trend towards worse overall survival than T-DXd.
OBJETIVO.: Motivación para realizar el estudio. Se evaluaron las opciones de tratamiento para el cáncer de mama HER-2-positivo, centrándose en la eficacia y seguridad de trastuzumab-emtansina (T-DM1) en comparación con otras terapias anti-HER-2. Principales hallazgos. Trastuzumab-deruxtecan (T-DXd)y PyroCap surgieron como alternativas prometedoras, mostrando mejoras sustanciales en la sobrevida libre de progresión para el cáncer de mama localmente avanzado o metastásico. T-DM1 mostró una eficacia superior a la de los demás tratamientos. Implicancias. Nuestros hallazgos podrían informar los procesos de toma de decisiones sanitarias para optimizar las estrategias para el cáncer de mama HER-2-positivo, y potencialmente mejorar los resultados de salud y la calidad de vida. Nuestro objetivo fue estudiar la eficacia y la seguridad de trastuzumab-emtansina (T-DM1) en comparación con otras terapias anti-HER-2 en el cáncer de mama (CM) HER-2 positivo. MATERIALES Y MÉTODOS.: Realizamos un metaanálisis de red (NMA, por sus siglas en inglés) de ensayos clínicos aleatorizados (ECA). Nuestro estudio se centró en pacientes sometidos al tratamiento para el cáncer de mama localmente avanzado no resecable (CMLA) o cáncer de mama metastásico (CMm), que incluía esquemas con trastuzumab y taxanos. Además, consideramos casos dentro de los primeros 6 meses de tratamiento para el cáncer de mama temprano (CMT) HER-2 positivo. RESULTADOS.: Se incluyeron en nuestro análisis un total de 23 ECA y 41 reportes. En CMLA y CMm, no se observaron diferencias estadísticamente significativas en ninguna de las comparaciones entre T-DM1 y otras terapias anti-HER-2 positivo. Al evaluar la sobrevida libre de progresión (SLP), trastuzumab-deruxtecan (T-DXd) y PyroCap demostraron una mayor eficacia en comparación con otros tratamientos (Hazard Ratio [HR]: 3,57; intervalo de confianza al 95% [IC 95%]: 2,75-4,63 y HR: 1.82; IC 95%: 1,35-2,44; respectivamente), mientras que T-DM1 por sí solo mostró una efectividad superior en comparación con LapCap (HR: 0,65; IC 95%: 0,55-0,77), TrasCap (HR: 0,65; IC 95%: 0,46-0,91), LapCapCitu (HR: 0,60; IC 95%: 0,33-1,1), Nera (HR: 0,55; IC 95%: 0,39-0,77) y Cap (HR: 0,37; IC 95%: 0,28-0,49). CONCLUSIONES.: Este NMA estableció un ranking basado en la eficacia y seguridad comparativas entre las intervenciones disponibles. Aunque superior a otros esquemas, T-DM1 mostró una menor eficacia en la SLP y la tasa de respuesta objetiva, y una tendencia hacia una sobrevida global peor que T-DXd.
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Ado-Trastuzumab Emtansina , Antineoplásicos Imunológicos , Neoplasias da Mama , Receptor ErbB-2 , Humanos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Ado-Trastuzumab Emtansina/uso terapêutico , Feminino , Antineoplásicos Imunológicos/uso terapêutico , Trastuzumab/uso terapêutico , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Metástase Neoplásica , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Maitansina/análogos & derivados , Maitansina/uso terapêuticoRESUMO
Abstract Interaction between severe acute respiratory coronavirus 2 (SARS-CoV-2) and IIEB remains under investigation. Objective: to compare IIEB incidence before and during COVID-19 pandemic, and assess incidence of coinfection with COVID-19 and case fatality. A cross-sectional study was performed on data from a centralized microbiology laboratory serving a network of healthcare centers comprising 713 pediatric and adult inpatient beds, expanded by 20% during the pandemic. Three periods were evaluated: (1) pre-pandemic: March 1, 2019-February 29, 2020; (2) pandemic year 1: March 1, 2020-February 28, 2021; (3) pandemic year 2: March 1, 2021-July 31, 2021. Descriptive statistical analysis was performed. 56502 samples (96% blood cultures) from 27224 patients were analyzed. Of these, 54 samples (from 54 patients) were positive for encapsulated bacteria. IIEB incidence was: 167.4, 32.6, and 50.4 per 100000 samples for periods 1, 2, and 3, respectively. Twelve IIEB episodes occurred during the pandemic period: 10 Streptococcus pneumoniae, and 2 Haemophilus influenzae, of which 7 were SARS-CoV-2/S. pneumoniae coinfections, with an incidence of 5.68 per 10000 COVID-19-related hospitalizations (0.056%). IIEB case fatality was 31%, 29%, and 60% for each period, respectively, 3/7 patients with coinfection died (43%). Case fatality for invasive pneumococcal disease (IPD) in patients without COVID-19, was 32.5%. Significant reduction in IIEB incidence was observed during the pandemic, coinciding with implementation of containment measures. The incidence of SARS-CoV-2/S. pneumoniae coinfection was low, with higher case fatality than IPD patients without COVID-19.
Resumen La interacción entre SARS-CoV-2 e infecciones invasivas por bacterias capsuladas (IIBC) continúa bajo estudio. Objetivos: comparar la incidencia de IIBC antes y durante la pandemia por COVID-19, evaluar la incidencia de coinfección con COVID-19 y la letalidad. Estudio transversal de registros de un laboratorio centralizado de Microbiología, que asiste a una red de centros asistenciales con 713 camas de internación para adultos y pediátricos, expandida 20% durante la pandemia. Tres periodos evaluados: 1) Pre-pandemia: 1-Marzo-2019 al 29-Febrero-2020; 2) Primer año de Pandemia: 1-Marzo-2020 al 28-Febrero-2021; 3) Pandemia 2021: 1-Marzo-2021 al 31-Julio-2021. Análisis estadístico descriptivo: Se analizaron 56.502 muestras (96% hemocultivos) correspondientes a 27.224 pacientes. De estas, 54 muestras (de 54 pacientes) fueron positivas para bacterias capsuladas. La incidencia de IIBC fue 167,4, 32,6 y 50,4 por cada 100.000 muestras para los periodos 1, 2 y 3, respectivamente. Doce IIBC ocurrieron durante la pandemia: 10 Streptococcus pneumoniae y dos Haemophilus influenzae, siete de ellos corresponden a coinfección SARS-CoV-2/S. pneumoniae, con una incidencia de 5,68 por cada 10.000 internaciones por COVID 19 (0,056%). La letalidad de las IIBC fue de 31, 29 y 60% para los tres periodos, respectivamente, 3/7 coinfectados fallecieron (43%). La letalidad por enfermedad neumocócica invasiva (ENI), sin COVID fue de 32,5%. Se evidenció una reducción significativa de la incidencia de IIBC luego del comienzo de la pandemia, coincidente con la implementación de las medidas sanitarias de contención de la pandemia. La incidencia de coinfección de SARS-CoV-2/S. pneumoniae fue baja y presentó mayor letalidad que las ENI sin COVID-19.
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Vacinas contra COVID-19 , COVID-19 , Complicações Infecciosas na Gravidez , SARS-CoV-2 , Humanos , Gravidez , Vacinas contra COVID-19/imunologia , Vacinas contra COVID-19/administração & dosagem , Feminino , COVID-19/prevenção & controle , Complicações Infecciosas na Gravidez/prevenção & controle , SARS-CoV-2/imunologiaRESUMO
Interaction between severe acute respiratory coronavirus 2 (SARS-CoV-2) and IIEB remains under investigation. Objective: to compare IIEB incidence before and during COVID-19 pandemic, and assess incidence of coinfection with COVID-19 and case fatality. A cross-sectional study was performed on data from a centralized microbiology laboratory serving a network of healthcare centers comprising 713 pediatric and adult inpatient beds, expanded by 20% during the pandemic. Three periods were evaluated: (1) pre-pandemic: March 1, 2019-February 29, 2020; (2) pandemic year 1: March 1, 2020-February 28, 2021; (3) pandemic year 2: March 1, 2021-July 31, 2021. Descriptive statistical analysis was performed. 56 502 samples (96% blood cultures) from 27224 patients were analyzed. Of these, 54 samples (from 54 patients) were positive for encapsulated bacteria. IIEB incidence was: 167.4, 32.6, and 50.4 per 100000 samples for periods 1, 2, and 3, respectively. Twelve IIEB episodes occurred during the pandemic period: 10 Streptococcus pneumoniae, and 2 Haemophilus influenzae, of which 7 were SARS-CoV-2/S. pneumoniae coinfections, with an incidence of 5.68 per 10000 COVID-19-related hospitalizations (0.056%). IIEB case fatality was 31%, 29%, and 60% for each period, respectively, 3/7 patients with coinfection died (43%). Case fatality for invasive pneumococcal disease (IPD) in patients without COVID-19, was 32.5%. Significant reduction in IIEB incidence was observed during the pandemic, coinciding with implementation of containment measures. The incidence of SARS-CoV-2/S. pneumoniae coinfection was low, with higher case fatality than IPD patients without COVID-19.
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COVID-19 , Coinfecção , Infecções Pneumocócicas , Adulto , Humanos , Criança , COVID-19/epidemiologia , Pandemias , Incidência , SARS-CoV-2 , Coinfecção/epidemiologia , Estudos Transversais , Streptococcus pneumoniaeRESUMO
RESUMEN Objetivo. Nuestro objetivo fue estudiar la eficacia y la seguridad de trastuzumab-emtansina (T-DM1) en comparación con otras terapias anti-HER-2 en el cáncer de mama (CM) HER-2 positivo. Materiales y métodos. Realizamos un metaanálisis de red (NMA, por sus siglas en inglés) de ensayos clínicos aleatorizados (ECA). Nuestro estudio se centró en pacientes sometidos al tratamiento para el cáncer de mama localmente avanzado no resecable (CMLA) o cáncer de mama metastásico (CMm), que incluía esquemas con trastuzumab y taxanos. Además, consideramos casos dentro de los primeros 6 meses de tratamiento para el cáncer de mama temprano (CMT) HER-2 positivo. Resultados. Se incluyeron en nuestro análisis un total de 23 ECA y 41 reportes. En CMLA y CMm, no se observaron diferencias estadísticamente significativas en ninguna de las comparaciones entre T-DM1 y otras terapias anti-HER-2 positivo. Al evaluar la sobrevida libre de progresión (SLP), trastuzumab-deruxtecan (T-DXd) y PyroCap demostraron una mayor eficacia en comparación con otros tratamientos (Hazard Ratio [HR]: 3,57; intervalo de confianza al 95% [IC 95%]: 2,75-4,63 y HR: 1.82; IC 95%: 1,35-2,44; respectivamente), mientras que T-DM1 por sí solo mostró una efectividad superior en comparación con LapCap (HR: 0,65; IC 95%: 0,55-0,77), TrasCap (HR: 0,65; IC 95%: 0,46-0,91), LapCapCitu (HR: 0,60; IC 95%: 0,33-1,1), Nera (HR: 0,55; IC 95%: 0,39-0,77) y Cap (HR: 0,37; IC 95%: 0,28-0,49). Conclusiones. Este NMA estableció un ranking basado en la eficacia y seguridad comparativas entre las intervenciones disponibles. Aunque superior a otros esquemas, T-DM1 mostró una menor eficacia en la SLP y la tasa de respuesta objetiva, y una tendencia hacia una sobrevida global peor que T-DXd.
ABSTRACT Objective. We aimed to study the efficacy and safety of trastuzumab-emtansine (T-DM1) versus other anti-HER2 therapies in HER2+ breast cancer (BC). Materials and Methods. We performed a network meta-analysis (NMA) of randomized controlled trials (RCTs). Our study focused on patients undergoing treatment for unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC), which included regimens involving trastuzumab and taxanes. Additionally, we considered cases within the first 6 months of treatment for HER2+ early breast cancer (EBC). Results. A total of 23 RCTs and 41 reports were included in our analysis. LABC and mBC showed no statistically significant difference in any of the comparisons of T-DM1 versus the other anti-HER2+ therapies. When assessing progression-free survival (PFS), trastuzumab-deruxtecan (T-DXd) and PyroCap demonstrated greater efficacy compared to other treatments (Hazard Ratio [HR]: 3.57; 95% confidence interval [CI]: 2.75-4.63 and HR: 1.82; 95% CI: 1.35-2.44; respectively), while T-DM1 alone exhibited superior effectiveness compared to LapCap (HR: 0.65; 95% CI: 0.55-0.77), TrasCap (HR: 0.65; 95% CI: 0.46-0.91), LapCapCitu (HR: 0.60; 95% CI: 0.33-1.10), Nera (HR: 0.55; 95% CI: 0.39-0.77), and Cap (HR: 0.37; 95% CI: 0.28-0.49). Conclusions. NMA allows a ranking based on the comparative efficacy and safety among the interventions available. Although superior to other schemes, T-DM1 showed a lower efficacy performance in PFS and overall response rate and a trend towards worse overall survival than T-DXd.
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Tobacco tax increases, the most cost-effective measure in reducing consumption, remain underutilized in low and middle-income countries. This study estimates the health and economic burden of smoking in Argentina and forecasts the benefits of tobacco tax hikes, accounting for the potential effects of illicit trade. Using a probabilistic Markov microsimulation model, this study quantifies smoking-related deaths, health events, and societal costs. The model also estimates the health and economic benefits of different increases in the price of cigarettes through taxes. Annually, smoking causes 45,000 deaths and 221,000 health events in Argentina, costing USD 2782 million in direct medical expenses, USD 1470 million in labor productivity loss costs, and USD 1069 million in informal care costs-totaling 1.2% of the national gross domestic product. Even in a scenario that considers illicit trade of tobacco products, a 50% cigarette price increase through taxes could yield USD 8292 million in total economic benefits accumulated over a decade. Consequently, raising tobacco taxes could significantly reduce the health and economic burdens of smoking in Argentina while increasing fiscal revenue.
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Produtos do Tabaco , Humanos , Argentina/epidemiologia , Fumar/epidemiologia , Impostos , ComércioRESUMO
INTRODUCTION: Tobacco consumption is associated with nearly 30 000 deaths annually in Nigeria alongside other adverse health and economic effects. Our objective was to estimate the health and economic implications of the current cigarette labeling policies (text-only HWs); new health warnings policies in the country (adding graphic health warnings with up to 60% coverage), and plain packaging policy as recommended by the World Health Organization. AIMS AND METHODS: We used a probabilistic state-transition individual microsimulation model, considering natural history, healthcare costs, and quality-of-life losses associated with main tobacco-attributable diseases; and the potential effects of packaging and labeling policies. We used three scenarios: (1) text-only health warnings (HWs) covering 50% of the pack, (2) introduction of graphic HWs of 50% (and later increasing to 80%) of the pack, and (3) plain packaging with HWs covering 80% of the pack. RESULTS: A total of 748 deaths are averted in the current situation; 7478 and 14 208 deaths can be averted with the new policy and with plain packaging, respectively. The number of cardiac, cerebrovascular, and cancer events that could be averted by adopting text and graphic HWs are 3093, 5093, and 1346, respectively; increasing to 5876, 9676, and 2557, respectively, with plain packaging. Up to 251 794 years were lost because of early deaths and disability, and â¦144.6 billion (USD 469 million) in health costs could be saved with HWs covering 50% to 80% of the pack over 10 years. With plain packaging and graphic HWs covering 80% of the package 478,408 years and â¦274.7 billion (USD 895 million) would be saved. CONCLUSIONS: The new cigarette labeling policy in Nigeria may yield significant health and economic benefits over 10 years. Moving the current policy to plain packaging can significantly improve these benefits. IMPLICATIONS: The new cigarette labeling policy that Nigeria is implementing should aim to achieve 100% compliance with its current regulation and the logical next step: Plain packaging with large warnings. The present study adds evidence of the potential health effects and cost savings of these levels of implementation, which is valuable for local policymakers.
Assuntos
Produtos do Tabaco , Humanos , Nigéria/epidemiologia , Embalagem de Produtos , Rotulagem de ProdutosRESUMO
Objective: To estimate the burden of disease and economic burden attributable to the consumption of sugar-sweetened beverages in El Salvador. Methods: A comparative risk model was used to estimate the effects on deaths, health events, disability-adjusted life years (DALYs), and direct medical costs attributable to the consumption of sugar-sweetened beverages. Results: A total of 520 deaths (8 per 100 000 individuals), 214 082 health events (3 220 per 100 000 individuals) and 16 643 DALYs could be attributable to the consumption of sugar-sweetened beverages in El Salvador, representing US$69.35 million in direct medical costs for the year 2020. In particular, type 2 diabetes (T2DM) events attributable to the consumption of sugar-sweetened beverages could represent more than 20% of total T2DM cases in the country. Conclusion: A high number of deaths, events, and costs could be attributed to the consumption of sugar-sweetened beverages in El Salvador.
Objetivo: Estimar a carga de morbidade e econômica atribuível ao consumo de bebidas açucaradas em El Salvador. Métodos: Foi utilizado um modelo de risco comparativo para estimar os efeitos sobre óbitos, eventos de saúde, anos perdidos devido a morte prematura ou vividos com incapacidade (AVAI) e custos médicos diretos atribuíveis ao consumo de bebidas açucaradas. Resultados: Um total de 520 mortes (8 por 100 00 indivíduos), 214 082 eventos de saúde (3 220 por 100 000 indivíduos) e 16 643 AVAI podem ser atribuídos ao consumo de bebidas açucaradas em El Salvador, o que representa US$ 69,35 milhões em custos médicos diretos para o ano de 2020. Os eventos de diabetes mellitus tipo 2 (DM2) atribuíveis ao consumo de bebidas açucaradas, em especial, podem representar mais de 20% do total de casos de DM2 no país. Conclusões: Um número elevado de mortes, eventos de saúde e custos pode ser atribuído ao consumo de bebidas açucaradas em El Salvador.
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OBJECTIVE: To investigate the tobacco-attributable burden on disease, medical costs, productivity losses and informal caregiving; and to estimate the health and economic gains that can be achieved if the main tobacco control measures (raising taxes on tobacco, plain packaging, advertising bans and smoke-free environments) are fully implemented in eight countries that encompass 80% of the Latin American population. DESIGN: Markov probabilistic microsimulation economic model of the natural history, costs and quality of life associated with the main tobacco-related diseases. Model inputs and data on labour productivity, informal caregivers' burden and interventions' effectiveness were obtained through literature review, surveys, civil registrations, vital statistics and hospital databases. Epidemiological and economic data from January to October 2020 were used to populate the model. FINDINGS: In these eight countries, smoking is responsible each year for 351 000 deaths, 2.25 million disease events, 12.2 million healthy years of life lost, US$22.8 billion in direct medical costs, US$16.2 billion in lost productivity and US$10.8 billion in caregiver costs. These economic losses represent 1.4% of countries' aggregated gross domestic products. The full implementation and enforcement of the four strategies: taxes, plain packaging, advertising bans and smoke-free environments would avert 271 000, 78 000, 71 000 and 39 000 deaths, respectively, in the next 10 years, and result in US$63.8, US$12.3, US$11.4 and US$5.7 billions in economic gains, respectively, on top of the benefits being achieved today by the current level of implementation of these measures. CONCLUSIONS: Smoking represents a substantial burden in Latin America. The full implementation of tobacco control measures could successfully avert deaths and disability, reduce healthcare spending and caregiver and productivity losses, likely resulting in large net economic benefits.
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[RESUMEN]. Objetivo. Estimar la carga de enfermedad y económica atribuible al consumo de bebidas azucaradas en El Salvador. Métodos. Se utilizó un modelo de riesgos comparativos para estimar los efectos en muertes, eventos de salud, años perdidos por muerte prematura y discapacidad (AVAD), y costos médicos directos atribuibles al consumo de bebidas azucaradas. Resultados. Un total de 520 muertes (8 cada 100 000 individuos), 214 082 eventos en salud (3 220 cada 100 000 individuos) y 16 643 AVAD podrían ser atribuibles al consumo de bebidas azucaradas en El Salvador, lo que representa $69,35 millones (dólar americano) en costos médicos directos para el año 2020. En particular, los eventos de diabetes tipo 2 (DBT2) atribuibles al consumo de bebidas azucaradas podrían llegar a representar más del 20% del total de casos de DBT2 para el país. Conclusión. Un elevado número de muertes, eventos y costos podrían atribuirse al consumo de bebidas azucaradas en El Salvador.
[ABSTRACT]. Objective. To estimate the burden of disease and economic burden attributable to the consumption of sugar-sweetened beverages in El Salvador. Methods. A comparative risk model was used to estimate the effects on deaths, health events, disabili- ty-adjusted life years (DALYs), and direct medical costs attributable to the consumption of sugar-sweetened beverages. Results. A total of 520 deaths (8 per 100 000 individuals), 214 082 health events (3 220 per 100 000 indi- viduals) and 16 643 DALYs could be attributable to the consumption of sugar-sweetened beverages in El Salvador, representing US$69.35 million in direct medical costs for the year 2020. In particular, type 2 diabetes (T2DM) events attributable to the consumption of sugar-sweetened beverages could represent more than 20% of total T2DM cases in the country. Conclusion. A high number of deaths, events, and costs could be attributed to the consumption of sugar-swee- tened beverages in El Salvador.
[RESUMO]. Objetivo. Estimar a carga de morbidade e econômica atribuível ao consumo de bebidas açucaradas em El Salvador. Métodos. Foi utilizado um modelo de risco comparativo para estimar os efeitos sobre óbitos, eventos de saúde, anos perdidos devido a morte prematura ou vividos com incapacidade (AVAI) e custos médicos dire- tos atribuíveis ao consumo de bebidas açucaradas. Resultados. Um total de 520 mortes (8 por 100 00 indivíduos), 214 082 eventos de saúde (3 220 por 100 000 indivíduos) e 16 643 AVAI podem ser atribuídos ao consumo de bebidas açucaradas em El Salvador, o que representa US$ 69,35 milhões em custos médicos diretos para o ano de 2020. Os eventos de diabetes melli- tus tipo 2 (DM2) atribuíveis ao consumo de bebidas açucaradas, em especial, podem representar mais de 20% do total de casos de DM2 no país. Conclusões. Um número elevado de mortes, eventos de saúde e custos pode ser atribuído ao consumo de bebidas açucaradas em El Salvador.
Assuntos
Bebidas Adoçadas com Açúcar , Saúde Pública , Economia de Escala na Saúde , América Latina , Bebidas Adoçadas com Açúcar , Saúde Pública , Financiamento da Assistência à Saúde , América Latina , Bebidas Adoçadas com Açúcar , Saúde Pública , Economia de Escala na SaúdeRESUMO
OBJECTIVE: Our study analyzes the cost-effectiveness of the COVID-19 vaccination campaigns in Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, and Peru. METHODS: Using a previously published SVEIR model, we analyzed the impact of a vaccination campaign (2021) from a national healthcare perspective. The primary outcomes were quality adjusted life years (QALYs) lost and total costs. Other outcomes included COVID-19 cases, hospitalizations, deaths, and life years. We applied a discount rate of 3% for health outcomes. We modeled a realistic vaccination campaign in each country (the realistic country-specific campaign). Additionally, we assessed a standard campaign (similar, "typical" for all countries), and an optimized campaign (similar in all countries with higher but plausible population coverage). One-way deterministic sensitivity analyses were performed. FINDINGS: Vaccination was health improving as well as cost-saving in almost all countries and scenarios. Our analysis shows that vaccination in this group of countries prevented 573,141 deaths (508,826 standard; 685,442 optimized) and gained 5.07 million QALYs (4.53 standard; 6.03 optimized). Despite the incremental costs of vaccination campaigns, they had a total net cost saving to the health system of US$16.29 billion (US$16.47 standard; US$18.58 optimized). The realistic (base case) vaccination campaign in Chile was the only scenario, which was not cost saving, but it was still highly cost-effective with an ICER of US$22 per QALY gained. Main findings were robust in the sensitivity analyses. INTERPRETATION: The COVID-19 vaccination campaign in seven Latin American and Caribbean countries -that comprise nearly 80% of the region- was beneficial for population health and was also cost-saving or highly cost-effective.
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OBJECTIVE: To estimate the budget impact of the potential coverage of FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) for glycemia monitoring in all type 1 diabetes mellitus (T1DM) patients and in those with type 2 diabetes mellitus (T2DM) with multiple daily insulin injections, from the social security and the private third-party payer's perspective in Argentina. METHODS: A budget impact model was developed to estimate the cost difference between the self-monitoring of blood glucose (standard of care) and FSL over 5 years. Input parameters were retrieved from local literature complemented by expert opinion. Health care costs were estimated by a micro-costing approach and reported in USD as of April 2022 (1 USD = 113.34 Argentine pesos). One-way sensitivity and scenario analyses were conducted. RESULTS: From a social security third-party payer perspective, the incorporation of FSL was associated with net savings per member per month (PMPM) of $0.026 (Year 1) to $0.097 (Year 5) and net savings PMPM of $0.002 (Year 1) to $0.008 (Year 5) for T1DM and T2DM patients, respectively. Similar findings are reported from the private third-party payer perspective. The budget impact results were more sensitive to the acquisition costs of the FSL and test strips. CONCLUSION: The potential coverage of FSL in patients with T1DM and T2DM with multiple daily insulin injections could be associated with small financial savings considering current technology acquisition costs (FSL and test strips) for social security and the private sector third-party payers in Argentina.
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Monitoramento Contínuo da Glicose , Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Custos de Cuidados de Saúde , Insulina , Humanos , Monitoramento Contínuo da Glicose/economia , Monitoramento Contínuo da Glicose/métodos , Argentina , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Insulina/administração & dosagem , Insulina/uso terapêutico , Custos e Análise de Custo , Reembolso de Seguro de Saúde/economia , Setor Privado , Previdência SocialRESUMO
BACKGROUND: Assessment of COVID-19 vaccines safety during pregnancy is urgently needed. METHODS: We conducted a systematic review and meta-analysis to evaluate the safety of COVID-19 vaccines, including their components and technological platforms used in other vaccines during pregnancy and animal studies to complement direct evidence. We searched literature databases from its inception to September 2021 without language restriction, COVID-19 vaccine websites, and reference lists of other systematic reviews and the included studies. Pairs of reviewers independently selected, data extracted, and assessed the risk of bias of the studies. Discrepancies were resolved by consensus. (PROSPERO CRD42021234185). RESULTS: We retrieved 8,837 records from the literature search; 71 studies were included, involving 17,719,495 pregnant persons and 389 pregnant animals. Most studies (94%) were conducted in high-income countries, were cohort studies (51%), and 15% were classified as high risk of bias. We identified nine COVID-19 vaccine studies, seven involving 309,164 pregnant persons, mostly exposed to mRNA vaccines. Among non-COVID-19 vaccines, the most frequent exposures were AS03 and aluminum-based adjuvants. A meta-analysis of studies that adjusted for potential confounders showed no association with adverse outcomes, regardless of the vaccine or the trimester of vaccination. Neither the reported rates of adverse pregnancy outcomes nor reactogenicity exceeded expected background rates, which was the case for ASO3- or aluminum-adjuvanted non-COVID-19 vaccines in the proportion meta-analyses of uncontrolled studies/arms. The only exception was postpartum hemorrhage after COVID-19 vaccination (10.40%; 95% CI: 6.49-15.10%), reported by two studies; however, the comparison with non-exposed pregnant persons, available for one study, found non-statistically significant differences (adjusted OR 1.09; 95% CI 0.56-2.12). Animal studies showed consistent results with studies in pregnant persons. CONCLUSION: We found no safety concerns for currently administered COVID-19 vaccines during pregnancy. Additional experimental and real-world evidence could enhance vaccination coverage. Robust safety data for non-mRNA-based COVID-19 vaccines are still needed.
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COVID-19 , Vacinas , Gravidez , Feminino , Humanos , Vacinas contra COVID-19/efeitos adversos , Alumínio , COVID-19/prevenção & controle , Vacinas/efeitos adversos , Vacinação/efeitos adversos , Adjuvantes ImunológicosRESUMO
BACKGROUND: There is an urgent need for active safety surveillance to monitor vaccine exposure during pregnancy in low- and middle-income countries (LMICs). Existing maternal, newborn, and child health (MNCH) data collection systems could serve as platforms for post-marketing active surveillance of maternal immunization safety. To identify sites using existing systems, a thorough assessment should be conducted. Therefore, this study had the objectives to first develop an assessment tool and then to pilot this tool in sites using MNCH data collection systems through virtual informant interviews. METHODS: We conducted a rapid review of the literature to identify frameworks on population health or post-marketing drug surveillance. Four frameworks that met the eligibility criteria were identified and served to develop an assessment tool capable of evaluating sites that could support active monitoring of vaccine safety during pregnancy. We conducted semi-structured interviews in six geographical sites using MNCH data collection systems (DHIS2, INDEPTH, and GNMNHR) to pilot domains included in the assessment tool. RESULTS: We developed and piloted the "VPASS (Vaccines during Pregnancy - sites supporting Active Safety Surveillance) assessment tool" through interviews with nine stakeholders, including central-level systems key informants and site-level managers from DHIS2 and GNMNHR; DHIS2 in Kampala (Uganda) and Kigali (Rwanda); GNMNHR from Belagavi (India) and Lusaka (Zambia); and INDEPTH from Nanoro (Burkina Faso) and Manhica (Mozambique). The tool includes different domains such as the system's purpose, the scale of implementation, data capture and confidentiality, type of data collected, the capability of integration with other platforms, data management policies and data quality monitoring. Similarities among sites were found regarding some domains, such as data confidentiality, data management policies, and data quality monitoring. Four of the six sites met some domains to be eligible as potential sites for active surveillance of vaccinations during pregnancy, such as a routine collection of MNCH individual data and the capability of electronically integrating individual MNCH outcomes with information related to vaccine exposure during pregnancy. Those sites were: Rwanda (DHIS2), Manhica (IN-DEPTH), Lusaka (GNMNHR), and Belagavi (GNMNHR). CONCLUSION: This study's findings should inform the successful implementation of active safety surveillance of vaccines during pregnancy by identifying and using active individual MNCH data collection systems in LMICs.
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Países em Desenvolvimento , Vacinas , Gravidez , Recém-Nascido , Criança , Feminino , Humanos , Zâmbia , Ruanda , Uganda , Vacinas/efeitos adversos , Confiabilidade dos DadosRESUMO
INTRODUCTION: Numerous vaccines have been evaluated and approved for coronavirus disease 2019 (COVID-19). Since pregnant persons have been excluded from most clinical trials of COVID-19 vaccines, sufficient data regarding the safety of these vaccines for the pregnant person and their fetus have rarely been available at the time of product licensure. However, as COVID-19 vaccines have been deployed, data on the safety, reactogenicity, immunogenicity, and efficacy of COVID-19 vaccines for pregnant persons and neonates are becoming increasingly available. A living systematic review and meta-analysis of the safety and effectiveness of COVID-19 vaccines for pregnant persons and newborns could provide the information necessary to help guide vaccine policy decisions. METHODS AND ANALYSIS: We aim to conduct a living systematic review and meta-analysis based on biweekly searches of medical databases (e.g., MEDLINE, EMBASE, CENTRAL) and clinical trial registries to systematically identify relevant studies of COVID-19 vaccines for pregnant persons. Pairs of reviewers will independently select, extract data, and conduct risk of bias assessments. We will include randomized clinical trials, quasi-experimental studies, cohort, case-control, cross-sectional studies, and case reports. Primary outcomes will be the safety, efficacy, and effectiveness of COVID-19 vaccines in pregnant persons, including neonatal outcomes. Secondary outcomes will be immunogenicity and reactogenicity. We will conduct paired meta-analyses, including prespecified subgroup and sensitivity analyses. We will use the grading of recommendations assessment, development, and evaluation approach to evaluate the certainty of evidence.
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Vacinas contra COVID-19 , COVID-19 , Recém-Nascido , Feminino , Gravidez , Humanos , Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Estudos Transversais , Bases de Dados Factuais , Feto , Metanálise como AssuntoRESUMO
OBJECTIVE: Overweight and obesity are important contributors to the non-communicable disease burden. The consumption of sugar-sweetened beverages (SSBs) has been associated with an increased risk of type 2 diabetes mellitus (T2DM), cardiovascular disease, cancer and other conditions. The objective of this study was to estimate the burden of disease attributable to the consumption of SSBs and the costs to the healthcare systems in Argentina, Brazil, El Salvador, and Trinidad and Tobago. DESIGN: Following a systematic review of models, a comparative risk assessment framework was developed to estimate the health and economic impact associated with the consumption of SSBs. SETTING: Argentina, Brazil, El Salvador, and Trinidad and Tobago. PARTICIPANTS: Overall population. PRIMARY AND SECONDARY OUTCOME MEASURES: The model estimated the effects of SSB consumption on health through two causal pathways: one mediated by body mass index (BMI) and health conditions associated with BMI and another that reflected the independent effects of SSB consumption on T2DM and cardiovascular diseases. RESULTS: The model results indicated that for all four countries, in 1 year, SSB consumption was associated with 18 000 deaths (3.2% of the total disease-related deaths), seven million disease events (3.3% of the total disease-related events), a half-million DALYs and US$2 billion in direct medical costs. This included 1.5 million cases of overweight and obesity in children/adolescents (12% of the excess weight cases) and 2.8 million cases in adults (2.8%); 2.2 million cases of type 2 diabetes (19%); 200 000 cases of heart disease (3.8%); 124 000 strokes (3.9%); 116 000 cases of musculoskeletal disease (0.2%); 102 000 cases of kidney disease (0.9%); and 45 000 episodes of asthma (0.4%). The Trinidad and Tobago population were the most affected by disease events. CONCLUSIONS: The study results indicate that the consumption of SSBs is associated with a significant burden of disease and death in Latin America and the Caribbean.
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Diabetes Mellitus Tipo 2 , Obesidade Infantil , Bebidas Adoçadas com Açúcar , Adulto , Criança , Adolescente , Humanos , Bebidas Adoçadas com Açúcar/efeitos adversos , Diabetes Mellitus Tipo 2/epidemiologia , América Latina , Sobrepeso , Efeitos Psicossociais da Doença , BebidasRESUMO
BACKGROUND: Informal care is a key element of health care and well-being for society, yet it is scarcely visible and rarely studied in health economic evaluations. This study aims to estimate the time use and cost associated with informal care for cardiovascular diseases, pneumonia and ten different cancers in eight Latin American countries (Argentina, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico and Peru). METHODS: We carried out an exhaustive literature review on informal caregivers' time use, focusing on the selected diseases. We developed a survey for professional caregivers and conducted expert interviews to validate this data in the local context. We used an indirect estimate through the interpolation of the available data, for those cases in which we do not found reliable information. We used the proxy good method to estimate the monetary value of the use of time of informal care. National household surveys databases were processed to obtain the average wage per hour of a proxy of informal caregiver. Estimates were expressed in 2020 US dollars. RESULTS: The study estimated approximately 1,900 million hours of informal care annually and $ 4,300 million per year in average informal care time cost for these fifteen diseases and eight countries analyzed. Cardiovascular diseases accounted for an informal care burden that ranged from 374 to 555 h per year, while cancers varied from 512 to 1,825 h per year. The informal care time cost share on GDP varied from 0.26% (Mexico) to 1.38% (Brazil), with an average of 0.82% in the studied American countries. Informal care time cost represents between 16 and 44% of the total economic cost (direct medical and informal care cost) associated with health conditions. CONCLUSIONS: The study shows that there is a significant informal care economic burden -frequently overlooked- in different chronic and acute diseases in Latin American countries; and highlights the relevance of including the economic value of informal care in economic evaluations of healthcare.
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Cuidadores , Assistência ao Paciente , Humanos , Doenças Cardiovasculares/terapia , Cuidadores/economia , América Latina , Neoplasias/terapia , Custos e Análise de Custo , Pneumonia/terapia , Assistência ao Paciente/economia , Assistência ao Paciente/estatística & dados numéricos , Fatores de TempoRESUMO
OBJECTIVE: To estimate the budget impact of covering the FreeStyle Libre Flash Continuous Glucose Monitoring System (FSL) for type 1 Diabetes Mellitus patients (T1DM), compared to self-monitoring of blood glucose (SMBG), from the perspective of public and private third-party payers in Chile. METHODS: A budget impact model was developed to estimate the cost difference between SMBG and FSL over five years. Two FSL coverage schemes were assessed. Input parameters were retrieved from the literature review and complemented by expert opinion. Healthcare costs were estimated by a micro-costing approach and reported in USD. RESULTS: For a public sector third-party payer, incorporating FSL implied a cost increase up to USD 0.013 per member per month (PMPM) for the fifth year under the broad coverage scheme and a net saving of 0.0001 PMPM (all years) under the restricted coverage scheme. From a private sector third-party payer, incorporating FSL implied savings up to USD 0.028 PMPM (fifth year) for the broad coverage scheme and up to USD 0.012 PMPM (fifth year) for the restricted scheme. CONCLUSION: Incorporating the FSL for T1DM patients was associated with a marginal incremental cost for the public sector third-party payer and cost savings in Chile's private healthcare sector.
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Diabetes Mellitus Tipo 1 , Humanos , Glicemia , Automonitorização da Glicemia , Chile , Custos de Cuidados de SaúdeRESUMO
BACKGROUND: Catatonia is a cluster of motor features present in multiple psychiatric and clinical diseases. It may be confused with delirium because both entities are classified according to the type and degree of psychomotor activity. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for catatonia secondary to medical conditions exclude comorbid catatonia and delirium; besides, there have been increasing reports about a comorbid presentation. This study aimed to describe the prevalence of comorbid catatonia and delirium, the therapeutic response to lorazepam, and the clinical characteristics of patients with an earlier diagnosis of delirium. METHODS: A total of 120 consecutive patients at a university hospital with an earlier diagnosis of delirium were evaluated using the Delirium Scale (confusion assessment method for the intensive care unit) and the Bush-Francis Catatonia Rating Scale for catatonia. In cases of a positive diagnosis of catatonia or catatonia/delirium, a therapeutic trial with intramuscular lorazepam was performed. FINDINGS: Thirty-one patients (26%) were positive for both catatonia and delirium, and 8 patients (7%) had catatonia. Sixty-six patients (55%) were positive only for delirium, and 5 patients (4%) were negative for delirium and catatonia. Lorazepam tests were applied on 22 patients. One in 9 patients with catatonia/delirium responded positively to lorazepam. Patients with catatonia had a 60% positive response rate. CONCLUSIONS: This is the first study on lorazepam use in catatonia-delirium patients; however, further studies are needed to determine the safety and efficacy of lorazepam in these patients. Catatonia and catatonia/delirium are underdiagnosed in inpatient wards and should be routinely assessed in patients with an altered mental status.