Integrating real-world data from Brazil and Pakistan into the OMOP common data model and standardized health analytics framework to characterize COVID-19 in the Global South.

OBJECTIVES: The aim of this work is to demonstrate the use of a standardized health informatics framework to generate reliable and reproducible real-world evidence from Latin America and South Asia towards characterizing coronavirus disease 2019 (COVID-19) in the Global South. MATERIALS AND METHODS: Patient-level COVID-19 records collected in a patient self-reported notification system, hospital in-patient and out-patient records, and community diagnostic labs were harmonized to the Observational Medical Outcomes Partnership common data model and analyzed using a federated network analytics framework. Clinical characteristics of individuals tested for, diagnosed with or tested positive for, hospitalized with, admitted to intensive care unit with, or dying with COVID-19 were estimated. RESULTS: Two COVID-19 databases covering 8.3 million people from Pakistan and 2.6 million people from Bahia, Brazil were analyzed. 109 504 (Pakistan) and 921 (Brazil) medical concepts were harmonized to Observational Medical Outcomes Partnership common data model. In total, 341 505 (4.1%) people in the Pakistan dataset and 1 312 832 (49.2%) people in the Brazilian dataset were tested for COVID-19 between January 1, 2020 and April 20, 2022, with a median [IQR] age of 36 [25, 76] and 38 (27, 50); 40.3% and 56.5% were female in Pakistan and Brazil, respectively. 1.2% percent individuals in the Pakistan dataset had Afghan ethnicity. In Brazil, 52.3% had mixed ethnicity. In agreement with international findings, COVID-19 outcomes were more severe in men, elderly, and those with underlying health conditions. CONCLUSIONS: COVID-19 data from 2 large countries in the Global South were harmonized and analyzed using a standardized health informatics framework developed by an international community of health informaticians. This proof-of-concept study demonstrates a potential open science framework for global knowledge mobilization and clinical translation for timely response to healthcare needs in pandemics and beyond.

Vaccine effectiveness of CoronaVac against COVID-19 among children in Brazil during the Omicron period.

Although severe COVID-19 in children is rare, they may develop multisystem inflammatory syndrome, long-COVID and downstream effects of COVID-19, including social isolation and disruption of education. Data on the effectiveness of the CoronaVac vaccine is scarce during the Omicron period. In Brazil, children between 6 to 11 years are eligible to receive the CoronaVac vaccine. We conducted a test-negative design to estimate vaccine effectiveness using 197,958 tests from January 21, 2022, to April 15, 2022, during the Omicron dominant period in Brazil among children aged 6 to 11 years. The estimated vaccine effectiveness for symptomatic infection was 39.8% (95% CI 33.7-45.4) at ≥14 days post-second dose. For hospital admission vaccine effectiveness was 59.2% (95% CI 11.3-84.5) at ≥14 days. Two doses of CoronaVac in children during the Omicron period showed low levels of protection against symptomatic infection, and modest levels against severe illness.

Influence of age on the effectiveness and duration of protection of Vaxzevria and CoronaVac vaccines: A population-based study.

BACKGROUND: Aging influences COVID-19 severity and response to vaccination, but previous vaccine effectiveness (VE) analyzes lack the power to evaluate its role in subgroups within the elderly age group. Here we analyzed the impact of age on viral vector and inactivated virus vaccines' effectiveness, the main platforms used in low- and middle-income countries. METHODS: We report a retrospective longitudinal study of 75,919,840 Brazilian vaccinees from January 18 to July 24, 2021, evaluating documented infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), COVID-19-related hospitalisation, ICU admission, and death. Negative binomial regression models adjusted for sociodemographic characteristics were used for VE estimation. FINDINGS: The overall analyzes of full vaccination showed VE against hospitalisation, ICU admission, and death of 91·4% (95%CI:90·1-92·5), 91·1% (95%CI:88·9-92·9) and 92·3% (95%CI:90·5-93·7) for Vaxzevria and 71·2% (95%CI:70·0-72·4), 72·2% (95%CI:70·2-74·0) and 73·7% (95%CI:72·1-75·2) for CoronaVac, respectively. VE for all outcomes is progressively lower with age. In fully-Vaxzevria-vaccinated individuals aged <60 years, VE against death was 96.5% (95%CI:82.1-99.3) versus 68·5% (95%CI:40·0-83·4) in those ≥90 years. Among fully-CoronaVac-vaccinated individuals, VE against death was 84.8% (95%CI:77.1-89.9) in those <60 years compared to 63.5 (95%CI 58.7-67.7) for vaccinees aged 80-89 years and 48·6%; (95%CI:35·0-59·3) for individuals aged ≥90 years. Post-vaccination daily cumulative incidence curves for all outcomes showed increased risk from younger to elder decades of life. There was no increase in the incidence of hospitalisation for individuals <60 years vaccinated during the same period as those aged ≥90 years. INTERPRETATION: Although both vaccines have been effective in protecting against infection, hospitalization and death; Vaxzevria and CoronaVac demonstrated high effectiveness against severe outcomes for individuals up to 79 years of age. Our results reinforce the idea that booster doses should be carefully considered in elders. FUNDING: This study was partially supported by a donation from the "Fazer o bem faz bem" program.

Two-dose ChAdOx1 nCoV-19 vaccine protection against COVID-19 hospital admissions and deaths over time: a retrospective, population-based cohort study in Scotland and Brazil.

BACKGROUND: Reports suggest that COVID-19 vaccine effectiveness is decreasing, but whether this reflects waning or new SARS-CoV-2 variants-especially delta (B.1.617.2)-is unclear. We investigated the association between time since two doses of ChAdOx1 nCoV-19 vaccine and risk of severe COVID-19 outcomes in Scotland (where delta was dominant), with comparative analyses in Brazil (where delta was uncommon). METHODS: In this retrospective, population-based cohort study in Brazil and Scotland, we linked national databases from the EAVE II study in Scotland; and the COVID-19 Vaccination Campaign, Acute Respiratory Infection Suspected Cases, and Severe Acute Respiratory Infection/Illness datasets in Brazil) for vaccination, laboratory testing, clinical, and mortality data. We defined cohorts of adults (aged ≥18 years) who received two doses of ChAdOx1 nCoV-19 and compared rates of severe COVID-19 outcomes (ie, COVID-19 hospital admission or death) across fortnightly periods, relative to 2-3 weeks after the second dose. Entry to the Scotland cohort started from May 19, 2021, and entry to the Brazil cohort started from Jan 18, 2021. Follow-up in both cohorts was until Oct 25, 2021. Poisson regression was used to estimate rate ratios (RRs) and vaccine effectiveness, with 95% CIs. FINDINGS: 1 972 454 adults received two doses of ChAdOx1 nCoV-19 in Scotland and 42 558 839 in Brazil, with longer follow-up in Scotland because two-dose vaccination began earlier in Scotland than in Brazil. In Scotland, RRs for severe COVID-19 increased to 2·01 (95% CI 1·54-2·62) at 10-11 weeks, 3·01 (2·26-3·99) at 14-15 weeks, and 5·43 (4·00-7·38) at 18-19 weeks after the second dose. The pattern of results was similar in Brazil, with RRs of 2·29 (2·01-2·61) at 10-11 weeks, 3·10 (2·63-3·64) at 14-15 weeks, and 4·71 (3·83-5·78) at 18-19 weeks after the second dose. In Scotland, vaccine effectiveness decreased from 83·7% (95% CI 79·7-87·0) at 2-3 weeks, to 75·9% (72·9-78·6) at 14-15 weeks, and 63·7% (59·6-67·4) at 18-19 weeks after the second dose. In Brazil, vaccine effectiveness decreased from 86·4% (85·4-87·3) at 2-3 weeks, to 59·7% (54·6-64·2) at 14-15 weeks, and 42·2% (32·4-50·6) at 18-19 weeks. INTERPRETATION: We found waning vaccine protection of ChAdOx1 nCoV-19 against COVID-19 hospital admissions and deaths in both Scotland and Brazil, this becoming evident within three months of the second vaccine dose. Consideration needs to be given to providing booster vaccine doses for people who have received ChAdOx1 nCoV-19. FUNDING: UK Research and Innovation (Medical Research Council), Scottish Government, Research and Innovation Industrial Strategy Challenge Fund, Health Data Research UK, Fiocruz, Fazer o Bem Faz Bem Programme; Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro. TRANSLATION: For the Portuguese translation of the abstract see Supplementary Materials section.

Methods to evaluate COVID-19 vaccine effectiveness, with an emphasis on quasi-experimental approaches. / Métodos para avaliação da efetividade de vacinas para COVID-19 com ênfase em abordagens quase-experimentais.

The evaluation of vaccine effectiveness is conducted with real-world data. They are essential to monitor the performance of vaccination programmes over time, and in the context of the emergence of new variants. Until now, the effectiveness of COVID-19 vaccines has been assessed based on classic methods, such as cohort and test-negative case-control studies, which may often not allow for adequate control of inherent biases in the assignment of vaccination campaigns. The aim of this review was to discuss the study designs available to evaluate vaccine effectiveness, highlighting quasi-experimental studies, which seek to mimic randomized trials, by introducing an exogenous component to allocate to treatment, in addition to the advantages, limitations, and applicability in the context of Brazilian data. The use of quasi-experimental approaches, such as interrupted time series, difference-in-differences, propensity scores, instrumental variables, and regression discontinuity design, are relevant due to the possibility of providing more accurate estimates of COVID-19 vaccine effectiveness. This is especially important in scenarios such as the Brazilian, which characterized by the use of various vaccines, with the respective numbers and intervals between doses, applied to different age groups, and introduced at different times during the pandemic.

A avalição da efetividade de vacinas é feita com dados do mundo real e é essencial para monitorar o desempenho dos programas de vacinação ao longo do tempo bem como frente a novas variantes. Até o momento, a avaliação da efetividade das vacinas para COVID-19 tem sido baseada em métodos clássicos como estudos de coorte e caso controle teste-negativo, que muitas vezes podem não permitir o adequado controle dos vieses intrínsecos da alocação das campanhas de vacinação. O objetivo dessa revisão foi discutir os desenhos de estudo disponíveis para avaliação de efetividade das vacinas, enfatizando os estudos quase-experimentais, que buscam mimetizar os estudos aleatorizados ao introduzir um componente exógeno para atribuição ao tratamento, bem como suas vantagens, limitações e aplicabilidade no contexto dos dados brasileiros. O emprego de métodos quase-experimentais, incluindo as séries temporais interrompidas, o método de diferença em diferenças, escore de propensão, variáveis instrumentais e regressão descontínua, são relevantes pela possibilidade de gerar estimativas mais acuradas da efetividade de vacinas para COVID-19 em cenários como o brasileiro, que se caracteriza pelo uso de várias vacinas, com respectivos número e intervalos entre doses, aplicadas em diferentes faixas etárias e em diferentes momentos da pandemia.

Métodos para avaliação da efetividade de vacinas para COVID-19 com ênfase em abordagens quase-experimentais / Methods to evaluate COVID-19 vaccine effectiveness, with an emphasis on quasi-experimental approaches

Resumo A avalição da efetividade de vacinas é feita com dados do mundo real e é essencial para monitorar o desempenho dos programas de vacinação ao longo do tempo bem como frente a novas variantes. Até o momento, a avaliação da efetividade das vacinas para COVID-19 tem sido baseada em métodos clássicos como estudos de coorte e caso controle teste-negativo, que muitas vezes podem não permitir o adequado controle dos vieses intrínsecos da alocação das campanhas de vacinação. O objetivo dessa revisão foi discutir os desenhos de estudo disponíveis para avaliação de efetividade das vacinas, enfatizando os estudos quase-experimentais, que buscam mimetizar os estudos aleatorizados ao introduzir um componente exógeno para atribuição ao tratamento, bem como suas vantagens, limitações e aplicabilidade no contexto dos dados brasileiros. O emprego de métodos quase-experimentais, incluindo as séries temporais interrompidas, o método de diferença em diferenças, escore de propensão, variáveis instrumentais e regressão descontínua, são relevantes pela possibilidade de gerar estimativas mais acuradas da efetividade de vacinas para COVID-19 em cenários como o brasileiro, que se caracteriza pelo uso de várias vacinas, com respectivos número e intervalos entre doses, aplicadas em diferentes faixas etárias e em diferentes momentos da pandemia.

Abstract The evaluation of vaccine effectiveness is conducted with real-world data. They are essential to monitor the performance of vaccination programmes over time, and in the context of the emergence of new variants. Until now, the effectiveness of COVID-19 vaccines has been assessed based on classic methods, such as cohort and test-negative case-control studies, which may often not allow for adequate control of inherent biases in the assignment of vaccination campaigns. The aim of this review was to discuss the study designs available to evaluate vaccine effectiveness, highlighting quasi-experimental studies, which seek to mimic randomized trials, by introducing an exogenous component to allocate to treatment, in addition to the advantages, limitations, and applicability in the context of Brazilian data. The use of quasi-experimental approaches, such as interrupted time series, difference-in-differences, propensity scores, instrumental variables, and regression discontinuity design, are relevant due to the possibility of providing more accurate estimates of COVID-19 vaccine effectiveness. This is especially important in scenarios such as the Brazilian, which characterized by the use of various vaccines, with the respective numbers and intervals between doses, applied to different age groups, and introduced at different times during the pandemic.

O Desafio da Oferta de Cursos de Especialização em Atenção Básica da Universidade Aberta do Sistema Único de Saúde aos Profissionais dos Programas de Provimento / The Challenge of Offering Specialization Courses in Primary Health Care in the Open University of the Unified Health System for Professionals of the Provision Programs

RESUMO A implantação de novas políticas públicas de provimento de profissionais de saúde para a atenção básica demandou a oferta de oportunidades educacionais. O objetivo é apresentar a iniciativa do Sistema Universidade Aberta do SUS (UNA-SUS) na oferta de cursos de especialização em atenção básica aos profissionais dos programas de provimento. Participaram das ofertas 15 instituições públicas de ensino superior do Sistema UNA-SUS. Foram estudantes 41.100 profissionais de todo o Brasil, entre eles, médicos, dentistas e enfermeiros. Foram analisados os dados provenientes da Plataforma Arouca do Sistema UNA-SUS, sendo selecionados como indicadores quantitativos para análise o número de profissionais que concluíram o curso, de profissionais aguardando ingresso no curso, de estudantes cursando, de estudantes falecidos, de estudantes inativados sem ingresso e de estudantes reprovados ou que abandonaram o curso. Foi realizada ainda a análise de 2163 Trabalhos de Conclusão de Curso (TCC) que estavam disponíveis no Acervo de Recursos Educacionais em Saúde do Sistema UNA-SUS entre os meses de maio e outubro de 2017. Foi possível realizar uma análise quantitativa e qualitativa seguindo as orientações do pensamento hermenêutico-dialético. Os resultados mostraram que até o momento 20.437 profissionais dos programas de provimento concluíram os cursos de especialização em atenção básica e ainda há 8.201 cursando. Em relação ao TCC, observou-se que as doenças crônicas não transmissíveis, os tumores e os problemas relacionados à gravidez, parto e puerpério, assim como aspectos relacionados à saúde infantil e saúde do idoso foram os mais evidentes nos projetos dos profissionais. Concluiu-se que a utilização de estratégias pedagógicas inovadoras pelas instituições de ensino provocou a reflexão sobre a prática, a mudança no processo de trabalho e a troca de saberes e experiências. Os cursos ofertados prepararam os participantes dos programas de provimento para a atuação na atenção básica e demonstraram melhor conhecimento sobre o Sistema Único de Saúde e letramento digital, especialmente, os estrangeiros e os intercambistas.

ABSTRACT The implementation of new public policies in Brazil to make up the shortfall of primary health care workers requires the provision of educational opportunities as part of the core strategy. This study presents the case of the provision of specialization courses for professionals in primary health care through the Open University of the Unified Health System (UNA-SUS) in the context of two federal programs: Valuing Primary Care (Provab) and More Doctors (PMMB). The vacancies were offered by fifteen public higher education institutions of the UNA-SUS System. Forty-one thousand professionals from all over Brazil, including doctors, dentists and nurses, where enrolled as students. Quantitative data about the courses and students was collected from the Arouca Platform - the information system of UNA-SUS. The qualitative indicators selected for analysis were: the numbers of professionals waiting to enroll on the course, of students who died, of professionals who failed to enroll, and of students who enrolled, graduated and dropped out of the course. The students were also required to write a course conclusion work, and these are published in the UNA-SUS open access repository (Ares). A sample of 2163 course conclusion works where reviewed using the hermeneutic-dialectic approach. Results: It was found that to date, 20,437 graduated from basic health care specialization courses and a further 8,201 are currently taking courses. The man themes chosen for the course conclusion work were: chronic non-communicable diseases, tumors and pregnancy, childbirth and the puerperium, children's health and health of the elderly. It was concluded that the use of innovative pedagogical strategies by educational institutions led the professionals to reflect on their practice, review their work processes, and sometimes change those processes, and a broader sharing of knowledge and experiences. It seems that the courses prepared the participants for their professional activities in primary health care, improved their specific knowledge about Brazil's Unified Health System, and provided digital literacy, especially for foreign students.

[Autonomy as a central criterion in the concept of health promotion]. / Autonomia como categoria central no conceito de promoção de saúde.

This article presents the central concepts of the multiple case study "Health Promotion in Primary Care" conducted by Nescon-UFMG in 2005. Teams of the Family Health Program developed twelve health promotion experiences in different Brazilian regions. After a conceptual revision and field research, health promotion was defined as the process of improving the health of people independently of any previous disease or injury, helping them to increase control over their health. We also concluded that an increased autonomy, understood as the capacity and possibility of the persons to choose, is the central category and criterion for defining health promotion practices.

Autonomia como categoria central no conceito de promoção de saúde / Autonomy as a central criterion in the concept of health promotion

Este artigo expõe os conceitos centrais do estudo de múltiplos casos: "Promoção de Saúde na Atenção Básica". O estudo foi conduzido pelo Nescon-UFMG em 2005 em doze experiências de promoção da saúde realizadas por equipes do Programa de Saúde da Família (PSF) em diversas regiões do Brasil. Após revisão teórica e pesquisa de campo, a definição de promoção da saúde adotada foi a atuação para a melhoria da saúde, anterior e independente a qualquer patologia ou agravo, ampliando-se o controle das pessoas sobre a própria saúde. Também concluímos que a ampliação da autonomia, vista como ampliação das capacidades e possibilidades de escolha das pessoas, é a categoria central e o critério definidor da atuação em promoção de saúde.

This article presents the central concepts of the multiple case study "Health Promotion in Primary Care" conducted by Nescon-UFMG in 2005. Teams of the Family Health Program developed twelve health promotion experiences in different Brazilian regions. After a conceptual revision and field research, health promotion was defined as the process of improving the health of people independently of any previous disease or injury, helping them to increase control over their health. We also concluded that an increased autonomy, understood as the capacity and possibility of the persons to choose, is the central category and criterion for defining health promotion practices.