Dynamic transmission modeling of COVID-19 to support decision-making in Brazil: A scoping review in the pre-vaccine era.

Brazil was one of the countries most affected during the first year of the COVID-19 pandemic, in a pre-vaccine era, and mathematical and statistical models were used in decision-making and public policies to mitigate and suppress SARS-CoV-2 dispersion. In this article, we intend to overview the modeling for COVID-19 in Brazil, focusing on the first 18 months of the pandemic. We conducted a scoping review and searched for studies on infectious disease modeling methods in peer-reviewed journals and gray literature, published between January 01, 2020, and June 2, 2021, reporting real-world or scenario-based COVID-19 modeling for Brazil. We included 81 studies, most corresponding to published articles produced in Brazilian institutions. The models were dynamic and deterministic in the majority. The predominant model type was compartmental, but other models were also found. The main modeling objectives were to analyze epidemiological scenarios (testing interventions' effectiveness) and to project short and long-term predictions, while few articles performed economic impact analysis. Estimations of the R0 and transmission rates or projections regarding the course of the epidemic figured as major, especially at the beginning of the crisis. However, several other outputs were forecasted, such as the isolation/quarantine effect on transmission, hospital facilities required, secondary cases caused by infected children, and the economic effects of the pandemic. This study reveals numerous articles with shared objectives and similar methods and data sources. We observed a deficiency in addressing social inequities in the Brazilian context within the utilized models, which may also be expected in several low- and middle-income countries with significant social disparities. We conclude that the models were of great relevance in the pandemic scenario of COVID-19. Nevertheless, efforts could be better planned and executed with improved institutional organization, dialogue among research groups, increased interaction between modelers and epidemiologists, and establishment of a sustainable cooperation network.

Modeling the impact of child vaccination (5-11 y) on overall COVID-19 related hospitalizations and mortality in a context of omicron variant predominance and different vaccination coverage paces in Brazil.

Background: Developing countries have experienced significant COVID-19 disease burden. With the emergence of new variants, particularly omicron, the disease burden in children has increased. When the first COVID-19 vaccine was approved for use in children aged 5-11 years of age, very few countries recommended vaccination due to limited risk-benefit evidence for vaccination of this population. In Brazil, ranking second in the global COVID-19 death toll, the childhood COVID-19 disease burden increased significantly in early 2022. This prompted a risk-benefit assessment of the introduction and scaling-up of COVID-19 vaccination of children. Methods: To estimate the potential impact of vaccinating children aged 5-11 years with mRNA-based COVID-19 vaccine in the context of omicron dominance, we developed a discrete-time SEIR-like model stratified in age groups, considering a three-month time horizon. We considered three scenarios: No vaccination, slow, and maximum vaccination paces. In each scenario, we estimated the potential reduction in total COVID-19 cases, hospitalizations, deaths, hospitalization costs, and potential years of life lost, considering the absence of vaccination as the base-case scenario. Findings: We estimated that vaccinating at a maximum pace could prevent, between mid-January and April 2022, about 26,000 COVID-19 hospitalizations, and 4200 deaths in all age groups; of which 5400 hospitalizations and 410 deaths in children aged 5-11 years. Continuing vaccination at a slow/current pace would prevent 1450 deaths and 9700 COVID-19 hospitalizations in all age groups in this same time period; of which 180 deaths and 2390 hospitalizations in children only. Interpretation: Maximum vaccination of children results in a significant reduction of COVID-19 hospitalizations and deaths and should be enforced in developing countries with significant disease incidence in children. Funding: This manuscript was funded by the Brazilian Council for Scientific and Technology Development (CNPq - Process # 402834/2020-8).

Falls Suffered by Hospitalized Adult Patients: Support to the Nursing Team as the Second Victim / Caidas de pacientes adultos hospitalizados: soporte al equipo de enfermería como segunda víctima / Quedas de pacientes adultos hospitalizados: suporte à equipe de enfermagem como segunda vítima

Abstract Objective: To describe the support received by the second victim in falls suffered by hospitalized adult patients from the nursing team's perspective. Materials and Methods: This is an exploratory and descriptive study with a qualitative approach, conducted in a large general hospital in the southern region of Brazil. Data collection was carried out through semi-structured interviews with 21 nursing professionals (seven nurses and fourteen nursing technicians) selected by random sampling, who worked in the inpatient units where falls occurred with a level of harm ranging from moderate to severe during March and May of 2020. The data were submitted to content analysis from July to August of the same year. Results: On the one hand, from the nursing team's perspective, support for the second victim was considered incipient by the hospital institution. On the other, participants highlighted the support received by their families and peers in the work environment. The study followed the guidelines of the Consolidated Criteria for Reporting Qualitative Research (COREQ) . Conclusions: An institutional flow of support for the second victim needs to be formalized to mitigate the repercussions on staff.

Resumen Objetivo: describir el soporte recibido por la segunda víctima en las caídas de pacientes adultos hospitalizados desde la perspectiva del equipo de enfermería. Materiales y método: estudio exploratorio y descriptivo, con enfoque cualitativo, realizado en hospital general de gran tamaño en la región sur de Brasil. Se realizó la recolección de dados por medio de entrevista semiestructurada con 21 trabajadores de enfermería (siete enfermeros y 14 técnicos de enfermería) seleccionados por muestra aleatoria y que trabajaban en las unidades de hospitalización en que ocurrieron caídas con grado de daño comprendido de moderado a grave, de marzo a mayo de 2020. Se sometieron los datos al análisis de contenido, de julio a agosto de dicho año. Resultados: por una parte, desde la percepción del equipo de enfermería, el soporte a la segunda víctima se consideró incipiente por la institución hospitalaria. Por otra, los participantes destacan el apoyo recibido por sus familiares y pares en el entorno laboral. El estudio siguió las directrices del Consolidated Criteria for Reporting Qualitative Research (Coreq). Conclusiones: hay necesidad de formalizar un flujo institucional de soporte a la segunda víctima con el fin de mitigar las implicaciones a los trabajadores.

Resumo Objetivo: descrever o suporte recebido pela segunda vítima nas quedas de pacientes adultos hospitalizados sob a perspectiva da equipe de enfermagem. Materiais e método: estudo exploratório e descritivo, de abordagem qualitativa, realizado em hospital geral de grande porte na região sul do Brasil. A coleta de dados foi realizada por meio de entrevista semiestruturada com 21 trabalhadores de enfermagem (sete enfermeiros e 14 técnicos de enfermagem) selecionados por amostragem aleatória e que trabalhavam nas unidades de internação em que aconteceram quedas com grau de dano compreendido de moderado a grave, de março a maio de 2020. Os dados foram submetidos à análise de conteúdo, de julho a agosto do mesmo ano. Resultados: por um lado, na percepção da equipe de enfermagem, o suporte à segunda vítima foi considerado incipiente pela instituição hospitalar. Por outro, os participantes destacam o apoio recebido pelos seus familiares e por pares no ambiente de trabalho. O estudo seguiu as diretrizes do Consolidated Criteria for Reporting Qualitative Research (Coreq). Conclusões: há necessidade de formalizar um fluxo institucional de suporte à segunda vítima a fim de mitigar as repercussões sobre os trabalhadores.

Cohort study protocol of the Brazilian collaborative research network on COVID-19: strengthening WHO global data.

INTRODUCTION: With the COVID-19 pandemic, hospitals in low-income countries were faced with a triple challenge. First, a large number of patients required hospitalisation because of the infection's more severe symptoms. Second, there was a lack of systematic and broad testing policies for early identification of cases. Third, there were weaknesses in the integration of information systems, which led to the need to search for available information from the hospital information systems. Accordingly, it is also important to state that relevant aspects of COVID-19's natural history had not yet been fully clarified. The aim of this research protocol is to present the strategies of a Brazilian network of hospitals to perform systematised data collection on COVID-19 through the WHO platform. METHODS AND ANALYSIS: This is a multicentre project among Brazilian hospitals to provide data on COVID-19 through the WHO global platform, which integrates patient care information from different countries. From October 2020 to March 2021, a committee worked on defining a flowchart for this platform, specifying the variables of interest, data extraction standardisation and analysis. ETHICS AND DISSEMINATION: This protocol was approved by the Research Ethics Committee (CEP) of the Research Coordinating Center of Brazil (CEP of the Hospital Nossa Senhora da Conceicao), on 29 January 2021, under approval No. 4.515.519 and by the National Research Ethics Commission (CONEP), on 5 February 2021, under approval No. 4.526.456. The project results will be explained in WHO reports and published in international peer-reviewed journals, and summaries will be provided to the funders of the study.

Modelling the impact of school reopening and contact tracing strategies on Covid-19 dynamics in different epidemiologic settings in Brazil.

We simulate the impact of school reopening during the COVID-19 pandemic in three major urban centers in Brazil to identify the epidemiological indicators and the best timing for the return of in-school activities and the effect of contact tracing as a mitigation measure. Our goal is to offer guidelines for evidence-based policymaking. We implement an extended SEIR model stratified by age and considering contact networks in different settings - school, home, work, and community, in which the infection transmission rate is affected by various intervention measures. After fitting epidemiological and demographic data, we simulate scenarios with increasing school transmission due to school reopening, and also estimate the number of hospitalization and deaths averted by the implementation of contact tracing. Reopening schools results in a non-linear increase in reported COVID-19 cases and deaths, which is highly dependent on infection and disease incidence at the time of reopening. When contact tracing and quarantining are restricted to school and home settings, a large number of daily tests is required to produce significant effects in reducing the total number of hospitalizations and deaths. Policymakers should carefully consider the epidemiological context and timing regarding the implementation of school closure and return of in-person school activities. While contact tracing strategies prevent new infections within school environments, they alone are not sufficient to avoid significant impacts on community transmission.

A systematic review and meta-analysis assessing antiretroviral therapy for treatment-experienced HIV adult patients using an optimized background therapy approach: is there evidence enough for a standardized third-line strategy?

BACKGROUND: The World Health Organization (WHO) has identified the need for evidence on third-line antiretroviral therapy (ART) for adults living with HIV/AIDS, given that some controversy remains as to the best combinations of ART for experienced HIV-1-infected patients. Therefore, we conducted a systematic review and meta-analysis to (i) assess the efficacy of third-line therapy for adults with HIV/AIDS based on randomized controlled trials (RCT) that adopted the "new antiretroviral (ARV) + optimized background therapy (OBT)" approach and (ii) address the key issues identified in WHO's guidelines on the use of third-line therapy. METHODS: MEDLINE, EMBASE, LILACS, ISI Web of Science, SCOPUS, and Cochrane Central Register of Controlled Trials were searched for RCTs assessing third-line ARV therapy that used an OBT approach between 1966 and 2015. Data was extracted using an Excel-structured datasheet based on the Consolidated Standards of Reporting Trials (CONSORT) recommendations. The primary outcome of this meta-analysis was the proportion of patients reaching undetectable HIV RNA levels (< 50 copies/mL) at 48 weeks of follow-up. Included studies were evaluated using the Cochrane's Risk of Bias assessment tool. Summarized evidence was rated according to the GRADE approach. RESULTS: Eighteen trials assessing 9 new ARV + OBT combinations defined as third-line HIV therapy provided the efficacy data: 7 phase IIb trials and 11 phase III trials. Four of the 18 trials provided extension data, thus resulting in 14 trials providing 48-week efficacy data. In the meta-analysis, considering the outcome regarding the proportion of patients with a viral load below 50 copies/ml at 48 weeks, 9 out of 14 trials demonstrated the superiority of the new combination being studied (risk difference = 0.18, 95% CI 0.13-0.23). The same analysis stratified by the number of fully active ARVs demonstrated a risk difference of 0.29 (95% CI 0.12-0.46), 0.28 (95% CI 0.17-0.38) and 0.17 (95% CI 0.10-0.24) respectively from zero, one, and two or more active drugs strata. Nine of the 18 trials were considered to have a high risk of bias. CONCLUSIONS: Efficacy results demonstrated that the groups of HIV-experienced patients receiving the new ARV + OBT were more likely to achieve viral suppression when compared to the control groups. However, most of these trials may be at a high risk of bias. Thus, there is still not enough evidence to stipulate which combinations are the most effective for therapeutic regimens that are to be used sequentially due to documented multi-resistance.

Modelling optimal vaccination strategies against COVID-19 in a context of Gamma variant predominance in Brazil.

INTRODUCTION: Brazil experienced moments of collapse in its health system throughout 2021, driven by the emergence of variants of concern (VOC) combined with an inefficient initial vaccination strategy against Covid-19. OBJECTIVES: To support decision-makers in formulating COVID-19 immunization policy in the context of limited vaccine availability and evolving variants over time, we evaluate optimal strategies for Covid-19 vaccination in Brazil in 2021, when vaccination was rolled out during Gamma variant predominance. METHODS: Using a discrete-time epidemic model we estimate Covid-19 deaths averted, considering the currently Covid-19 vaccine products and doses available in Brazil; vaccine coverage by target population; and vaccine effectiveness estimates. We evaluated a 5-month time horizon, from early August to the end of December 2021. Optimal vaccination strategies compared the outcomes in terms of averted deaths when varying dose intervals from 8 to 12 weeks, and choosing the minimum coverage levels per age group required prior to expanding vaccination to younger target populations. We also estimated dose availability required over time to allow the implementation of optimal strategies. RESULTS: To maximize the number of averted deaths, vaccine coverage of at least 80 % should be reached in older age groups before starting vaccination into subsequent younger age groups. When evaluating varying dose intervals for AZD1222, reducing the dose interval from 12 to 8 weeks for the primary schedule would result in fewer COVID-19 deaths, but this can only be implemented if accompanied by an increase in vaccine supply of at least 50 % over the coming six-months in Brazil. CONCLUSION: Covid-19 immunization strategies should be tailored to local vaccine product availability and supply over time, circulating variants of concern, and vaccine coverage in target population groups. Modelling can provide valuable and timely evidence to support the implementation of vaccination strategies considering the local context, yet following international and regional technical evidence-based guidance.

Coping with complexity in the COVID pandemic: An exploratory study of intensive care units.

Although the COVID pandemic has challenged the resilience of health services in general, this impact has been most visible in intensive care units (ICUs). This paper presents an exploratory study of how ICUs in Brazil have coped with the complexity stemming from the pandemic. Five guidelines for coping with complexity were adopted as analytical framework. The guidelines were concerned with slack resources, diversity of perspectives, visibility, work-as-done, and unintended consequences. There were three main sources of data: (i) a survey with respondents from 33 ICUs, which indicated their agreement with 23 statements related to the use of the complexity guidelines; (ii) semistructured interviews with seven survey respondents and two public health officials; and (iii) 20 h of observations of the meetings of a municipal bed management committee. Seventy resilience practices were identified from these data sources. Most of these practices (n = 30) were related to the guideline on slack resources, which were commonly obtained from other hospital units. As for the survey data, the statement related to the availability of extra or standby human resources obtained the lowest score, reinforcing the key role of slack resources. Five lessons learned for coping with complexity in ICUs were drawn from our data; one lesson for each guideline. Furthermore, the survey questionnaire is a potential ICU assessment tool, which can be adapted to other health services.

Characteristics and outcomes of pregnant women with SARS-CoV-2 infection and other severe acute respiratory infections (SARI) in Brazil from January to November 2020.

BACKGROUND: Knowledge about COVID-19 in pregnancy is limited, and evidence on the impact of the infection during pregnancy and postpartum is still emerging. AIM: To analyze maternal morbidity and mortality due to severe acute respiratory infections (SARI), including COVID-19, in Brazil. METHODS: National surveillance data from the SIVEP-Gripe (Sistema de Informação de Vigilância Epidemiológica da Gripe) was used to describe currently and recently pregnant women aged 10-49 years hospitalized for SARI from January through November, 2020. SARI cases were grouped into: COVID-19; influenza or other detected agent SARI; and SARI of unknown etiology. Characteristics, symptoms and outcomes were presented by SARI type and region. Binomial proportion and 95% confidence intervals (95% CI) for outcomes were obtained using the Clopper-Pearson method. RESULTS: Of 945,460 SARI cases in the SIVEP-Gripe, we selected 11,074 women aged 10-49 who were pregnant (7964) or recently pregnant (3110). COVID-19 was confirmed in 49.4% cases; 1.7% had influenza or another etiological agent; and 48.9% had SARI of unknown etiology. The pardo race/ethnic group accounted for 50% of SARI cases. Hypertension/Other cardiovascular diseases, chronic respiratory diseases, diabetes, and obesity were the most common comorbidities. A total of 362 women with COVID-19 (6.6%; 95%CI 6.0-7.3) died. Mortality was 4.7% (2.2-8.8) among influenza patients, and 3.3% (2.9-3.8) among those with SARI of unknown etiology. The South-East, Northeast and North regions recorded the highest frequencies of mortality among COVID-19 patients. CONCLUSION: Mortality among pregnant and recently pregnant women with SARIs was elevated among those with COVID-19, particularly in regions where maternal mortality is already high.

[Adverse drug reaction notification forms of the pharmacovigilance systems in Brazil and twelve other Latin-American countries: a comparative analysis]. / Formulários de notificação de reações adversas a medicamento nos sistemas de farmacovigilância do Brasil e outros doze países latino-americanos: análise comparativa.

The scope of this study was to assess the forms used to report suspected adverse drug reactions (ADR) to the pharmacovigilance system in Brazil and twelve other Latin-American countries. The study comprised three stages. In the first stage, the forms were attributed a score relating to the presence of critical items to generate ADR notification. In the second stage, the variables of the forms were quantified and classified regarding feasibility to contribute to an appropriate assessment of causality. In the last stage, hierarchical clustering was used to identify similar forms. The Venezuelan form achieved the highest score (18 points). The median number of variables in the forms of each country was 41 [26 (Guatemala) to 95 (Brazil)]. Most of the variables of the form were classified as life-critical and the majority contribute as an alternative explanation to causality assessment. Four clusters were identified (1, 2, 3 and 4). The forms of Brazil and Bolivia formed two distinct groups, 1 and 3 respectively. The results of this study indicate the need to change the forms of the different countries studied or even delete some variables, making them more appropriate for the process of assessment of ADR causality.

Avaliou-se os formulários de notificação de suspeitas de reações adversas a medicamentos (RAM) do sistema de farmacovigilância do Brasil e outros doze países latino-americanos. O estudo foi composto por três etapas. Na primeira, os formulários foram pontuados em relação à presença de itens essenciais para compor uma notificação de RAM. Na segunda, as variáveis dos formulários foram quantificadas e classificadas, quanto à razoabilidade em contribuírem para a avaliação de causalidade. Na última etapa, recorreu-se à análise de agrupamento hierárquico para identificar os formulários similares. O formulário da Venezuela obteve a maior pontuação (18 pontos). A mediana das variáveis nos formulários dos países foi de 41 [26 (Guatemala) a 95 (Brasil)]. A maioria das variáveis dos formulários foram classificadas como vitais e a maior parte contribui como fator de explicação alternativo para a avaliação de causalidade. Quatro agrupamentos foram identificados (1, 2, 3 e 4). Os formulários do Brasil e da Bolívia formaram dois grupos distintos, 1 e 3 respectivamente. Há necessidade de modificação dos formulários dos países ou até mesmo exclusão de variáveis, tornando-os mais adequados ao processo de avaliação da causalidade das RAM.

Formulários de notificação de reações adversas a medicamento nos sistemas de farmacovigilância do Brasil e outros doze países latino-americanos: análise comparativa / Adverse drug reaction notification forms of the pharmacovigilance systems in Brazil and twelve other Latin-American countries: a comparative analysis

Resumo Avaliou-se os formulários de notificação de suspeitas de reações adversas a medicamentos (RAM) do sistema de farmacovigilância do Brasil e outros doze países latino-americanos. O estudo foi composto por três etapas. Na primeira, os formulários foram pontuados em relação à presença de itens essenciais para compor uma notificação de RAM. Na segunda, as variáveis dos formulários foram quantificadas e classificadas, quanto à razoabilidade em contribuírem para a avaliação de causalidade. Na última etapa, recorreu-se à análise de agrupamento hierárquico para identificar os formulários similares. O formulário da Venezuela obteve a maior pontuação (18 pontos). A mediana das variáveis nos formulários dos países foi de 41 [26 (Guatemala) a 95 (Brasil)]. A maioria das variáveis dos formulários foram classificadas como vitais e a maior parte contribui como fator de explicação alternativo para a avaliação de causalidade. Quatro agrupamentos foram identificados (1, 2, 3 e 4). Os formulários do Brasil e da Bolívia formaram dois grupos distintos, 1 e 3 respectivamente. Há necessidade de modificação dos formulários dos países ou até mesmo exclusão de variáveis, tornando-os mais adequados ao processo de avaliação da causalidade das RAM.

Abstract The scope of this study was to assess the forms used to report suspected adverse drug reactions (ADR) to the pharmacovigilance system in Brazil and twelve other Latin-American countries. The study comprised three stages. In the first stage, the forms were attributed a score relating to the presence of critical items to generate ADR notification. In the second stage, the variables of the forms were quantified and classified regarding feasibility to contribute to an appropriate assessment of causality. In the last stage, hierarchical clustering was used to identify similar forms. The Venezuelan form achieved the highest score (18 points). The median number of variables in the forms of each country was 41 [26 (Guatemala) to 95 (Brazil)]. Most of the variables of the form were classified as life-critical and the majority contribute as an alternative explanation to causality assessment. Four clusters were identified (1, 2, 3 and 4). The forms of Brazil and Bolivia formed two distinct groups, 1 and 3 respectively. The results of this study indicate the need to change the forms of the different countries studied or even delete some variables, making them more appropriate for the process of assessment of ADR causality.

Patterns of radioiodine use for differentiated thyroid carcinoma in Brazil: insights and a call for action from a 20-year database.

OBJECTIVE: This study aimed to explore the patterns of radioactive iodine (RAI) use for differentiated thyroid cancer (DTC) in Brazil over the past 20 years. METHODS: A retrospective analysis of the DTC-related RAI prescriptions, from 2000 to 2018, retrieved from the Department of Informatics of the Unified Health System (Datasus) and National Supplementary Health Agency (ANS) database was performed. RAI activities prescriptions were re-classified as low (30-50 mCi), intermediate (100 mCi), or high activities (>100 mCi). RESULTS: The number of DTC-related RAI prescriptions increased from 0.45 to 2.28/100,000 inhabitants from 2000 to 2015, declining onwards, closing 2018 at 1.87/100,000. In 2018, population-adjusted RAI prescriptions by state ranged from 0.07 to 4.74/100,000 inhabitants. Regarding RAI activities, in the 2000 to 2008 period, the proportion of high-activities among all RAI prescriptions increased from 51.2% to 74.1%. From 2009 onwards, there was a progressive reduction in high-activity prescriptions in the country, closing 2018 at 50.1%. In 2018, the practice of requesting high-activities varied from 16% to 82% between Brazilian states. Interestingly, variability of RAI use do not seem to be related to RAI referral center volume nor state socio-economic indicators. CONCLUSION: In recent years, there has been a trend towards the lower prescription of RAI, and a reduction of high-activity RAI prescriptions for DTC in Brazil. Also, significative inter-state and inter-institutional variability on RAI use was documented. These results suggest that actions to advance DTC healthcare quality surveillance should be prioritized.

Characteristics and outcomes of pregnant women with SARS-CoV-2 infection and other severe acute respiratory infections (SARI) in Brazil from January to November 2020

ABSTRACT Background: Knowledge about COVID-19 in pregnancy is limited, and evidence on the impact of the infection during pregnancy and postpartum is still emerging. Aim: To analyze maternal morbidity and mortality due to severe acute respiratory infections (SARI), including COVID-19, in Brazil. Methods: National surveillance data from the SIVEP-Gripe (Sistema de Informação de Vigilância Epidemiológica da Gripe) was used to describe currently and recently pregnant women aged 10-49 years hospitalized for SARI from January through November, 2020. SARI cases were grouped into: COVID-19; influenza or other detected agent SARI; and SARI of unknown etiology. Characteristics, symptoms and outcomes were presented by SARI type and region. Binomial proportion and 95% confidence intervals (95% CI) for outcomes were obtained using the Clopper-Pearson method. Results: Of 945,460 SARI cases in the SIVEP-Gripe, we selected 11,074 women aged 10-49 who were pregnant (7964) or recently pregnant (3110). COVID-19 was confirmed in 49.4% cases; 1.7% had influenza or another etiological agent; and 48.9% had SARI of unknown etiology. The pardo race/ethnic group accounted for 50% of SARI cases. Hypertension/Other cardiovascular diseases, chronic respiratory diseases, diabetes, and obesity were the most common comorbidities. A total of 362 women with COVID-19 (6.6%; 95%CI 6.0-7.3) died. Mortality was 4.7% (2.2-8.8) among influenza patients, and 3.3% (2.9-3.8) among those with SARI of unknown etiology. The South-East, Northeast and North regions recorded the highest frequencies of mortality among COVID-19 patients. Conclusion: Mortality among pregnant and recently pregnant women with SARIs was elevated among those with COVID-19, particularly in regions where maternal mortality is already high.

Characterization of deaths and therapeutic itineraries investigated by the Porto Alegre AIDS Mortality Committee, Brazil, in 2015. / Caracterização dos óbitos e dos itinerários terapêuticos investigados pelo Comitê Municipal de Mortalidade por Aids de Porto Alegre em 2015.

OBJECTIVE: to characterize AIDS deaths eligible for Porto Alegre AIDS Mortality Committee (AIDSMC) investigation, Brazil, in 2015, and their therapeutic itineraries. METHODS: this was a descriptive study using secondary data from surveillance information systems and AIDSMC investigation forms. RESULTS: out of 336 deaths from AIDS-related causes, 113 (33.6%) were considered avoidable, of which 52 were analyzed by AIDSMC; there was predominance of males (30/52), low schooling level (29/52 incomplete elementary education), and less than 2 years between HIV infection diagnosis and death (28/52); tuberculosis was the most frequent cause of death (17/52); and in 50/52 cases at least one therapeutic itinerary inadequacy was identified. CONCLUSION: avoidable deaths of people with AIDS occurred mostly in men, those with low education level, those with recent HIV diagnosis and most deaths were due to tuberculosis.

[Evaluation of the Performance of the Brazilian Notification System for Health Surveillance: A Tool in Brazil's Pharmacovigilance System]. / Avaliação do desempenho do Sistema Nacional de Notificações para a Vigilância Sanitária: uma ferramenta do sistema de farmacovigilância no Brasil.

The scope of this paper is to assess the performance of the Brazilian Notification System for Health Surveillance, with respect to the registration of information on adverse drug-related effects on health (Notivisa/medication) based on previously selected attributes. A cross-sectional health evaluation study was conducted between 2008 and 2013 using eight attributes established by international guidelines to assess public health surveillance systems: simplicity, acceptability, representativeness, completeness, validity, consistency, positive predictive error and timeliness. In the study period, 63,512 registrations were identified in Notivisa/medication, the majority being considered severe (60.5%). The performance of Notivisa/medication was considered satisfactory with respect to two of the eight attributes (validity and positive predictive error) and deficient in six of the remaining attributes (simplicity, acceptability, representativeness, completeness, consistency and timeliness). Quality improvement strategies to remedy the system need to be discussed and implemented in order to provide complete, timely and reliable surveillance information for different segments of Brazilian society, especially health surveillance managers.

Caracterização dos óbitos e dos itinerários terapêuticos investigados pelo Comitê Municipal de Mortalidade por Aids de Porto Alegre em 2015 / Caracterización de óbitos e itinerario terapéutico investigados por el Comité de Mortalidad por Sida de Porto Alegre, Brasil, en 2015 / Characterization of deaths and therapeutic itineraries investigated by the Porto Alegre AIDS Mortality Committee, Brazil, in 2015

Objetivo: caracterizar os óbitos por aids elegíveis para investigação pelo Comitê Municipal de Mortalidade por Aids (CMAids) de Porto Alegre, Brasil, em 2015, e seus itinerários terapêuticos. Métodos: estudo descritivo, com dados secundários de sistemas de informações de vigilância e das fichas de investigação do CMAids. Resultados: entre 336 óbitos por causas relacionadas à aids, 113 (33,6%) foram considerados evitáveis, dos quais 52 foram investigados pelo CMAids; verificou-se predomínio do sexo masculino (30/52), baixa escolaridade (29/52 casos até a 8ª série incompleta) e tempo de até 2 anos entre o diagnóstico da infecção pelo HIV e a morte (28/52); a tuberculose foi a causa de morte mais frequente (17/52); em 50/52 casos, identificou-se pelo menos uma falha no itinerário terapêutico. Conclusão: os óbitos evitáveis de pessoas com aids ocorreram, majoritariamente, em pessoas do sexo masculino, de baixa escolaridade, com diagnóstico recente de HIV e em decorrência da tuberculose.

Objetivo: caracterizar los óbitos por sida elegibles para investigación por el Comité de Mortalidad por Sida (CMSida) de Porto Alegre, Brasil, en 2015, y sus itinerarios terapéuticos. Métodos: estudio descriptivo con datos secundarios de los sistemas de información de vigilancia y formulario de investigación de CMSida. Resultados entre 336 muertes por sida, 113 (33,6%) se consideraron evitables, de las cuales 52 fueron investigadas por el CMSida; predominó el sexo masculino (30/52), el bajo nivel de educación (29/52 hasta 8º grado incompleto de primaria) y hasta 2 años entre el diagnóstico de la infección por VIH y la muerte (28/52); la tuberculosis fue la causa más frecuente de muerte (17/52); y en 50/52 casos, se identificó al menos una falla en los itinerarios terapéuticos. Conclusión: las muertes evitables de personas con sida ocurrieron principalmente en hombres, con baja escolaridad, diagnóstico reciente de VIH y debido a la tuberculosis.

Objective: to characterize AIDS deaths eligible for Porto Alegre AIDS Mortality Committee (AIDSMC) investigation, Brazil, in 2015, and their therapeutic itineraries. Methods: this was a descriptive study using secondary data from surveillance information systems and AIDSMC investigation forms. Results: out of 336 deaths from AIDS-related causes, 113 (33.6%) were considered avoidable, of which 52 were analyzed by AIDSMC; there was predominance of males (30/52), low schooling level (29/52 incomplete elementary education), and less than 2 years between HIV infection diagnosis and death (28/52); tuberculosis was the most frequent cause of death (17/52); and in 50/52 cases at least one therapeutic itinerary inadequacy was identified. Conclusion: avoidable deaths of people with AIDS occurred mostly in men, those with low education level, those with recent HIV diagnosis and most deaths were due to tuberculosis.

[Adverse drug reactions reported to the Brazilian pharmacovigilance system from 2008 to 2013: descriptive study]. / Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo.

The study aimed to analyze suspected adverse drug reactions reported to Brazil's pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries.

Analisam-se as suspeitas de reações adversas a medicamentos notificadas no sistema de farmacovigilância do Brasil (Notivisa-medicamento) entre 2008 e 2013. Trata-se de estudo descritivo cujas unidades de análises da base de dados foram as notificações e os pares medicamento-reação adversa. Foi identificado um total de 26.554 notificações, o que produziu uma taxa de notificação de 22,8 milhões de habitantes/ano. As notificações referentes ao sexo feminino (60,5%) prevaleceram, assim como a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de reações adversas a medicamentos ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 registros de pares de medicamento-reação adversa, em que prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). Os medicamentos mais frequentes nas reações adversas a medicamentos graves pertenceram aos grupos L - agentes neoplásicos e imunomodulares (32,1%) e J - anti-infeciosos gerais para uso sistêmico (27%), ao passo que o sistema-órgão-classe mais afetado foi o relacionado a afecções da pele e distúrbios afins (23,7%). O Notivisa-medicamento é relevante recurso para a produção de sinais de alertas e hipóteses sobre a segurança de medicamentos comercializados no Brasil. No entanto, a taxa de notificação por milhão de habitantes/ano mostrou-se muito inferior àquela descrita por países de média e alta renda.

El objetivo de este estudio es analizar las sospechas de reacciones adversas a medicamentos, notificadas en el sistema de farmacovigilancia de Brasil (Notivisa-medicamento), entre 2008 y 2013. Se trata de un estudio descriptivo cuyas unidades de análisis en la base de datos fueron las notificaciones y los pares medicamento-reacción adversa. Se identificaron un total de 26.554 notificaciones, generando una tasa de notificación de 22,8/ millones de habitantes/año. Las notificaciones referentes al sexo femenino (60,5%) prevalecieron, así como, la raza/color blanco (58,1%). La edad varió de 0 a 112 años (mediana = 46 años). Casi 1/3 (32,5%) de las sospechas de reacciones adversas a medicamentos ocurrieron en poblaciones vulnerables (ancianos y niños). Se evaluaron 54.288 registros de pares de medicamento-reacción adversa, donde prevalecieron las reacciones adversas graves (59,2%), destacando las que resultaron en un efecto clínicamente importante (83,1%). Los medicamentos más frecuentes en las reacciones adversas a medicamentos graves pertenecieron a los grupos L - agentes neoplásicos e inmunomoduladores (32,1%) y J - antiinfecciosos generales para uso sistémico (27%), mientras que el sistema-órgano-clase más afectado fue afecciones de la piel y disturbios afines (23,7%). El Notivisa-medicamento es una herramienta relevante para la producción de señales de alerta e hipótesis sobre la seguridad de medicamentos comercializados en Brasil. No obstante, la tasa de notificación por millón de habitantes/año se mostró muy inferior a la que está descrita en países de media y alta renta.

A predictive model for fall risk in hospitalized adults: A case-control study.

AIM: To develop and validate a predictive model for falls in hospitalized adult clinical and surgical patients, assessing intrinsic (i.e. patient-related) and extrinsic factors (i.e. care process-related). BACKGROUND: To identify factors predictive of falls and enable appropriate management of fall risk it is necessary to understand patient and environmental factors, along with care delivery processes. DESIGN: A matched case-control study. METHODS: This study was conducted in the medical and surgical wards of a Brazilian teaching hospital. The sample included 536 patients, with data collected in 2013-2014. Data analysis included descriptive statistics and conditional logistic regression. Cases of patients aged 18 years or older who fell while hospitalized were included. One patient who did not fall during hospitalization, matched by sex, ward and admission date, was selected as a control for each included case. RESULTS: The SAK Fall Scale (Severo-Almeida-Kuchenbecker) was developed and validated. The scale includes seven variables: disorientation/confusion, frequent urination, walking limitations, lack of caregiver, postoperative status, previous falls and number of medications administered within 72 hr prior to the fall. This scale showed acceptable predictive accuracy. CONCLUSIONS: The newly developed SAK Fall Scale includes five intrinsic and two extrinsic variables and differs from other predictive scales for falls. The findings of this study are broad and the scale, which is easy to apply, can be used worldwide by nurses in health services. In advanced practice, the testing of a new model for fall risk contributes to preventive interventions and thus has an impact on patient safety.

Reações adversas a medicamentos no sistema de farmacovigilância do Brasil, 2008 a 2013: estudo descritivo / Adverse drug reactions reported to the Brazilian pharmacovigilance system from 2008 to 2013: descriptive study / Reacciones adversas a medicamentos en el sistema de farmacovigilancia de Brasil, de 2008 a 2013: estudio descriptivo

Resumo: Analisam-se as suspeitas de reações adversas a medicamentos notificadas no sistema de farmacovigilância do Brasil (Notivisa-medicamento) entre 2008 e 2013. Trata-se de estudo descritivo cujas unidades de análises da base de dados foram as notificações e os pares medicamento-reação adversa. Foi identificado um total de 26.554 notificações, o que produziu uma taxa de notificação de 22,8 milhões de habitantes/ano. As notificações referentes ao sexo feminino (60,5%) prevaleceram, assim como a raça/cor branca (58,1%). A idade variou de 0 a 112 anos (mediana = 46 anos). Quase 1/3 (32,5%) das suspeitas de reações adversas a medicamentos ocorreram em populações vulneráveis (idosos e crianças). Foram avaliados 54.288 registros de pares de medicamento-reação adversa, em que prevaleceram as reações adversas graves (59,2%), com destaque para as que resultaram em efeito clinicamente importante (83,1%). Os medicamentos mais frequentes nas reações adversas a medicamentos graves pertenceram aos grupos L - agentes neoplásicos e imunomodulares (32,1%) e J - anti-infeciosos gerais para uso sistêmico (27%), ao passo que o sistema-órgão-classe mais afetado foi o relacionado a afecções da pele e distúrbios afins (23,7%). O Notivisa-medicamento é relevante recurso para a produção de sinais de alertas e hipóteses sobre a segurança de medicamentos comercializados no Brasil. No entanto, a taxa de notificação por milhão de habitantes/ano mostrou-se muito inferior àquela descrita por países de média e alta renda.

Abstract: The study aimed to analyze suspected adverse drug reactions reported to Brazil's pharmacovigilance system (Notivisa-medicamento) from 2008 to 2013. This was a descriptive study whose analytical units in the database were reports and drug-adverse reactions pairs. A total of 26,554 reports were identified, for a reporting rate of 22.8/million inhabitants/year. Reports in female patients prevailed (60.5%), as did white color/race (58.1%). Age ranged from 0 to 112 years (median = 46 years). Nearly one-third (32.5%) of suspected adverse drug reactions occurred in vulnerable populations (elderly and children). A total of 54,288 drug- adverse reactions pairs were analyzed, with a prevalence of severe adverse drug reactions (59.2%), featuring those that resulted in clinically important effects (83.1%). The most frequent drugs in severe adverse drug reactions belonged to groups L, antineoplastic and immunomodulating agents (32.1%), and J, general anti-infectious agents for systemic use (27%), while the most affected system-organ-class was conditions of the skin and related disorders (23.7%). Notivisa-medicamento is an important resource for producing warning signs and hypotheses on the safety of drugs marketed in Brazil. However, the reporting rate per million inhabitants/year was far lower than that described in middle and high-income countries.

Resumen: El objetivo de este estudio es analizar las sospechas de reacciones adversas a medicamentos, notificadas en el sistema de farmacovigilancia de Brasil (Notivisa-medicamento), entre 2008 y 2013. Se trata de un estudio descriptivo cuyas unidades de análisis en la base de datos fueron las notificaciones y los pares medicamento-reacción adversa. Se identificaron un total de 26.554 notificaciones, generando una tasa de notificación de 22,8/ millones de habitantes/año. Las notificaciones referentes al sexo femenino (60,5%) prevalecieron, así como, la raza/color blanco (58,1%). La edad varió de 0 a 112 años (mediana = 46 años). Casi 1/3 (32,5%) de las sospechas de reacciones adversas a medicamentos ocurrieron en poblaciones vulnerables (ancianos y niños). Se evaluaron 54.288 registros de pares de medicamento-reacción adversa, donde prevalecieron las reacciones adversas graves (59,2%), destacando las que resultaron en un efecto clínicamente importante (83,1%). Los medicamentos más frecuentes en las reacciones adversas a medicamentos graves pertenecieron a los grupos L - agentes neoplásicos e inmunomoduladores (32,1%) y J - antiinfecciosos generales para uso sistémico (27%), mientras que el sistema-órgano-clase más afectado fue afecciones de la piel y disturbios afines (23,7%). El Notivisa-medicamento es una herramienta relevante para la producción de señales de alerta e hipótesis sobre la seguridad de medicamentos comercializados en Brasil. No obstante, la tasa de notificación por millón de habitantes/año se mostró muy inferior a la que está descrita en países de media y alta renta.

[Analysis of the digital preference for age in the pharmacovigilance system in Brazil, 2008-2013]. / Análise da preferência digital de idade no sistema de farmacovigilância do Brasil, 2008-2013.

The scope of this article is to analyze the digital preference for the "age" variable in the database of cases of adverse drug events reported between 2008 and 2013 in the pharmacovigilance system in Brazil. The database was analyzed in three stages: 1) Initial exploration; 2) standardization of variables; and 3) duplicate records management. The digital preference for the "age" variable according to sex and grouped regions of the country, was determined using the Whipple and Myers methods and also measured by the adhesion test based on statistical χ2 at 5% significance level. The female population was predominant (60.3%), with a female/male ratio of 1.5:1 and a female majority in 8 of the 12 age groups. Throughout the period under analysis, no preference for a terminal digit was observed in the "age" variable. The ages that were registered in the database appear not to reveal any imprecision and, therefore, this information cannot be interpreted as unreliable. These results point to a good performance in collecting data and information related to the "age" variable of the Brazil's pharmacovigilance system.

Analisar a preferência digital na variável "idade" da base de dados de casos de eventos adversos a medicamentos notificados entre 2008 e 2013 no sistema de farmacovigilância do Brasil. A base de dados foi analisada em três etapas: 1) exploração inicial; 2) padronização de variáveis; e 3) manejo dos registros repetidos. A preferência digital da variável "idade", segundo sexo e regiões agrupadas do país, foi determinada usando os métodos de Whipple e Myers e medida, também, pelo teste de aderência baseado na estatística χ2 ao nível de 5% de significância.Predominou a população feminina (60,3%), perfazendo uma razão feminino/masculino de 1,5:1 e com maioria feminina em oito das 12 faixas etárias estudadas.Ao longo do período analisado não foi observado qualquer preferência de dígito terminal na variável "idade". As idades registradas nas notificações parecem não demonstrar imprecisão e, por conseguinte, esta informação pode ser interpretada como de qualidade não duvidosa. Tais resultados apontam para um bom desempenho na coleta de dados e informações relacionados à variável "idade" do sistema de farmacovigilância do Brasil.