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ABSTRACT Objective: To update the recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. Methods: Experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. Results: Twenty-one recommendations were generated, including strong recommendations for the use of corticosteroids in patients using supplemental oxygen and conditional recommendations for the use of tocilizumab and baricitinib for patients on supplemental oxygen or on noninvasive ventilation and anticoagulants to prevent thromboembolism. Due to suspension of use authorization, it was not possible to make recommendations regarding the use of casirivimab + imdevimab. Strong recommendations against the use of azithromycin in patients without suspected bacterial infection, hydroxychloroquine, convalescent plasma, colchicine, and lopinavir + ritonavir and conditional recommendations against the use of ivermectin and remdesivir were made. Conclusion: New recommendations for the treatment of hospitalized patients with COVID-19 were generated, such as those for tocilizumab and baricitinib. Corticosteroids and prophylaxis for thromboembolism are still recommended, the latter with conditional recommendation. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and to promote resource economy.

RESUMO Objetivo: Atualizar as recomendações para embasar as decisões para o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. Métodos: A elaboração desta diretriz foi feita por especialistas, incluindo representantes do Ministério da Saúde e metodologistas. O método utilizado para o desenvolvimento rápido de diretrizes baseou-se na adoção e/ou adaptação de diretrizes internacionais existentes (GRADE ADOLOPMENT) e contou com o apoio da plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. Resultados: Chegaram-se a 21 recomendações, incluindo recomendações fortes quanto ao uso de corticosteroides em pacientes em uso de oxigênio suplementar e recomendações condicionais para o uso de tocilizumabe e baricitinibe, em pacientes com oxigênio suplementar ou ventilação não invasiva, e de anticoagulantes, para prevenção de tromboembolismo. Devido à suspensão da autorização de uso, não foi possível fazer recomendações para o tratamento com casirivimabe + imdevimabe. Foram feitas recomendações fortes contra o uso de azitromicina em pacientes sem suspeita de infecção bacteriana, hidroxicloroquina, plasma convalescente, colchicina e lopinavir + ritonavir, além de recomendações condicionais contra o uso de ivermectina e rendesivir. Conclusão: Foram criadas novas recomendações para o tratamento de pacientes hospitalizados com COVID-19, como as recomendações de tocilizumabe e baricitinibe. Ainda são recomendados corticosteroides e profilaxia contra tromboembolismo, esta em caráter condicional. Vários medicamentos foram considerados ineficazes e não devem ser usados, no intuito de proporcionar o melhor tratamento segundo os princípios da medicina baseada em evidências e promover a economia de recursos.

https://doi.org/10.5935/2965-2774.20230136-en

Mixed-effects model: a useful statistical tool for longitudinal and cluster studies Mixedeffects Mixed effects model
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Silveira, Leda Tomiko Yamada da

; Ferreira, Juliana Carvalho

; Patino, Cecilia Maria

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 2 elocation e20230137

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

https://doi.org/10.36416/1806-3756/e20230137

Crafting a research protocol: a stepwise comprehensive approach protocol
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Figueiredo, Ricardo Gassmann

; Patino, Cecilia María

; Ferreira, Juliana Carvalho

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 6 elocation e20230371

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https://doi.org/10.36416/1806-3756/e20230371

Dealing with confounding in observational studies
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Fumo-dos-Santos, Cristiane

; Ferreira, Juliana Carvalho

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 4 elocation e20230281

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

https://doi.org/10.36416/1806-3756/e20230281

Fragility index and fragility quotient in randomized clinical trials
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Garcia, Marcos Vinicius Fernandes

; Ferreira, Juliana Carvalho

; Caruso, Pedro

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 1 elocation e20230034

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https://doi.org/10.36416/1806-3756/e20230034

The MECOR program: almost three decades inspiring and improving respiratory clinical research in Brazil and across the globe program
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Ferreira, Juliana Carvalho

; Pizzichini, Marcia M M

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 3 elocation e20230213

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https://doi.org/10.36416/1806-3756/e20230213

Losing your fear of using R for statistical analysis
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Shimizu, Iara

; Ferreira, Juliana Carvalho

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 3 elocation e20230212

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https://doi.org/10.36416/1806-3756/e20230212

Twelve tips to manage a research project-advice for the young investigator
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Fernandes, Flavia Fonseca

; Ferreira, Juliana Carvalho

; Patino, Cecilia Maria

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 5 elocation e20230336

Abstract: En Pt | Text: En Pt | PDF: En | PDF: Pt

https://doi.org/10.36416/1806-3756/e20230336

Use of elexacaftor+tezacaftor+ivacaftor in individuals with cystic fibrosis and at least one F508del allele: a systematic review and meta-analysis
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Silva Filho, Luiz Vicente Ribeiro Ferreira da

; Athanazio, Rodrigo Abensur

; Tonon, Carolina Rodrigues

; Ferreira, Juliana Carvalho

; Tanni, Suzana Erico

Jornal Brasileiro de Pneumologia

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2023, Volume 49 N. 6 elocation e20230187

Abstract: En Pt | Text: En Pt | PDF: En | PDF: Pt

ABSTRACT Objective: To evaluate the effect of treatment with the combination of three cystic fibrosis transmembrane conductance regulator (CFTR) modulators-elexacaftor+tezacaftor+ivacaftor (ETI)-on important clinical endpoints in individuals with cystic fibrosis. Methods: This was a systematic review and meta-analysis of randomized clinical trials that compared the use of ETI in individuals with CF and at least one F508del allele with that of placebo or with an active comparator such as other combinations of CFTR modulators, following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations and the Patients of interest, Intervention to be studied, Comparison of interventions, and Outcome of interest (PICO) methodology. We searched the following databases: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov from their inception to December 26th, 2022. The risk of bias was assessed using the Cochrane risk-of-bias tool, and the quality of evidence was based on the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Results: We retrieved 54 studies in the primary search. Of these, 6 met the inclusion criteria and were analyzed (1,127 patients; 577 and 550 in the intervention and control groups, respectively). The meta-analysis revealed that the use of ETI increased FEV1% [risk difference (RD), +10.47%; 95% CI, 6.88-14.06], reduced the number of acute pulmonary exacerbations (RD, −0.16; 95% CI, −0.28 to −0.04), and improved quality of life (RD, +14.93; 95% CI, 9.98-19.89) and BMI (RD, +1.07 kg/m2; 95% CI, 0.90-1.25). Adverse events did not differ between groups (RD, −0.03; 95% CI, −0.08 to 0.01), and none of the studies reported deaths. Conclusions: Our findings demonstrate that ETI treatment substantially improves clinically significant, patient-centered outcomes.

RESUMO Objetivo: Avaliar o efeito do tratamento com a combinação de três moduladores da proteína cystic fibrosis transmembrane conductance regulator (CFTR, reguladora de condutância transmembrana em fibrose cística) - elexacaftor + tezacaftor + ivacaftor (ETI) - sobre desfechos clínicos importantes em indivíduos com fibrose cística. Métodos: Revisão sistemática e meta-análise de ensaios clínicos randomizados que compararam o uso de ETI em indivíduos com fibrose cística com pelo menos um alelo F508del com o uso de placebo ou de um comparador ativo como outras combinações de moduladores da CFTR. O estudo foi realizado seguindo as recomendações Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) e a metodologia Patients of interest, Intervention to be studied, Comparison of interventions, and Outcome of interest (PICO). Foram realizadas buscas nos seguintes bancos de dados: MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials e ClinicalTrials.gov, desde a sua criação até 26 de dezembro de 2022. O risco de viés foi avaliado por meio da ferramenta de risco de viés da Cochrane, e a qualidade das evidências foi determinada com base no sistema Grading of Recommendations Assessment, Development and Evaluation (GRADE). Resultados: Foram identificados 54 estudos na busca primária. Destes, 6 preencheram os critérios de inclusão e foram analisados (1.127 pacientes: 577 pacientes intervenção e 550 pacientes controle). A meta-análise revelou que o uso de ETI aumentou o VEF1 em porcentagem do previsto [diferença de risco (DR): +10,47%; IC95%: 6,88-14,06], reduziu o número de exacerbações pulmonares agudas (DR: −0,16; IC95%: −0,28 a −0,04) e melhorou a qualidade de vida (DR: +14,93; IC95%: 9,98-19,89) e o IMC (DR: +1,07 kg/m2; IC95%: 0,90-1,25). Os eventos adversos não diferiram entre os grupos (DR: −0,03; IC95%: −0,08 a 0,01), e nenhum dos estudos relatou óbitos. Conclusões: Nossos achados demonstram que o tratamento com ETI melhora substancialmente os desfechos clinicamente significativos centrados no paciente.

https://doi.org/10.36416/1806-3756/e20230187

10.

Diretrizes Brasileiras para o tratamento farmacológico de pacientes hospitalizados com COVID-19: Diretriz conjunta da Associação Brasileira de Medicina de Emergência, Associação de Medicina Intensiva Brasileira, Associação Médica Brasileira, Sociedade Brasileira de Angiologia e Cirurgia Vascular, Sociedade Brasileira de Infectologia, Sociedade Brasileira de Pneumologia e Tisiologia e Sociedade Brasileira de Reumatologia
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Falavigna, Maicon

; Stein, Cinara

; Amaral, José Luiz Gomes do

; Azevedo, Luciano Cesar Pontes de

; Belli, Karlyse Claudino

; Colpani, Verônica

; Cunha, Clóvis Arns da

; Dal-Pizzol, Felipe

; Dias, Maria Beatriz Souza

; Ferreira, Juliana Carvalho

; Freitas, Ana Paula da Rocha

; Gräf, Débora Dalmas

; Guimarães, Hélio Penna

; Lobo, Suzana Margareth Ajeje

; Monteiro, José Tadeu

; Nunes, Michelle Silva

; Oliveira, Maura Salaroli de

; Prado, Clementina Corah Lucas

; Santos, Vania Cristina Canuto

; Silva, Rosemeri Maurici da

; Sobreira, Marcone Lima

; Veiga, Viviane Cordeiro

; Vidal, Ávila Teixeira

; Xavier, Ricardo Machado

; Zavascki, Alexandre Prehn

; Machado, Flávia Ribeiro

; Carvalho, Carlos Roberto Ribeiro de

Revista Brasileira de Terapia Intensiva

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mar 2022, Volume 34 N. 1 Pages 1 - 12

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

RESUMO Objetivos: Há diversas terapias sendo utilizadas ou propostas para a COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é elaborar recomendações para subsidiar decisões sobre o tratamento farmacológico de pacientes hospitalizados com COVID-19 no Brasil. Métodos: Um grupo de 27 membros, formado por especialistas, representantes do Ministério da Saúde e metodologistas, integra essa diretriz. Foi utilizado o método de elaboração de diretrizes rápidas, tomando por base a adoção e/ou a adaptação de recomendações a partir de diretrizes internacionais existentes (GRADE ADOLOPMENT), apoiadas pela plataforma e-COVID-19 RecMap. A qualidade das evidências e a elaboração das recomendações seguiram o método GRADE. Resultados: Foram geradas 16 recomendações. Entre elas, estão recomendações fortes para o uso de corticosteroides em pacientes em uso de oxigênio suplementar, para o uso de anticoagulantes em doses de profilaxia para tromboembolismo e para não uso de antibacterianos nos pacientes sem suspeita de infecção bacteriana. Não foi possível fazer uma recomendação quanto à utilização do tocilizumabe em pacientes hospitalizados com COVID-19 em uso de oxigênio, pelas incertezas na disponibilidade e de acesso ao medicamento. Foi feita recomendação para não usar azitromicina, casirivimabe + imdevimabe, cloroquina, colchicina, hidroxicloroquina, ivermectina, lopinavir/ ritonavir, plasma convalescente e rendesivir. Conclusão: Até o momento, poucas terapias se provaram efetivas no tratamento do paciente hospitalizado com COVID-19, sendo recomendados apenas corticosteroides e profilaxia para tromboembolismo. Diversos medicamentos foram considerados ineficazes, devendo ser descartados, de forma a oferecer o melhor tratamento pelos princípios da medicina baseada em evidências e promover economia de recursos não eficazes.

ABSTRACT Objective: Several therapies are being used or proposed for COVID-19, and many lack appropriate evaluations of their effectiveness and safety. The purpose of this document is to develop recommendations to support decisions regarding the pharmacological treatment of patients hospitalized with COVID-19 in Brazil. Methods: A group of 27 experts, including representatives of the Ministry of Health and methodologists, created this guideline. The method used for the rapid development of guidelines was based on the adoption and/or adaptation of existing international guidelines (GRADE ADOLOPMENT) and supported by the e-COVID-19 RecMap platform. The quality of the evidence and the preparation of the recommendations followed the GRADE method. Results: Sixteen recommendations were generated. They include strong recommendations for the use of corticosteroids in patients using supplemental oxygen, the use of anticoagulants at prophylactic doses to prevent thromboembolism and the nonuse of antibiotics in patients without suspected bacterial infection. It was not possible to make a recommendation regarding the use of tocilizumab in patients hospitalized with COVID-19 using oxygen due to uncertainties regarding the availability of and access to the drug. Strong recommendations against the use of hydroxychloroquine, convalescent plasma, colchicine, lopinavir + ritonavir and antibiotics in patients without suspected bacterial infection and also conditional recommendations against the use of casirivimab + imdevimab, ivermectin and rendesivir were made. Conclusion: To date, few therapies have proven effective in the treatment of hospitalized patients with COVID-19, and only corticosteroids and prophylaxis for thromboembolism are recommended. Several drugs were considered ineffective and should not be used to provide the best treatment according to the principles of evidence-based medicine and promote economical resource use.

https://doi.org/10.5935/0103-507x.20220001-pt

11.

Impact of prone positioning on patients with COVID-19 and ARDS on invasive mechanical ventilation: a multicenter cohort study
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Cunha, Marieta C A

; Schardong, Jociane

; Righi, Natiele Camponogara

; Lunardi, Adriana Claudia

; Sant’Anna, Guadalupe Nery de

; Isensee, Larissa Padrão

; Xavier, Rafaella Fagundes

; Brambatti, Kaciane Roberta

; Pompeu, José Eduardo

; Frâncio, Fabiano

; Faria, Luiza Martins

; Cardoso, Rozana Astolfi

; Silva, Antonio Marcos Vargas da

; Dorneles, Camila de Christo

; Werle, Roberta Weber

; Ferreira, Juliana Carvalho

; Plentz, Rodrigo Della Méa

; Carvalho, Celso R F

Jornal Brasileiro de Pneumologia

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2022, Volume 48 N. 2 elocation e20210374

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

RESUMO Objetivo: Identificar fatores que levam a uma resposta positiva da oxigenação e fatores preditivos de mortalidade após a pronação. Métodos: Estudo de coorte retrospectivo multicêntrico envolvendo sete hospitais brasileiros. Os critérios de inclusão foram idade > 18 anos com diagnóstico suspeito ou confirmado de COVID-19, ventilação mecânica invasiva, relação PaO2/FIO2 < 150 mmHg e pronação. Após a primeira sessão de pronação, uma melhora de 20 mmHg na relação PaO2/FIO2 foi definida como resposta positiva. Resultados: O estudo envolveu 574 pacientes, dos quais 412 (72%) apresentaram resposta positiva à primeira sessão de pronação. A regressão logística múltipla mostrou que os respondedores apresentaram menores pontuações no Simplified Acute Physiology Score III (SAPS III) e no SOFA e menores níveis de dímero D (p = 0,01; p = 0,04; e p = 0,04, respectivamente). Sugeriu-se que a pontuação no SAPS III e a PaO2/FIO2 iniciais seriam preditores da resposta da oxigenação. A taxa de mortalidade foi de 69,3%. Maior risco de mortalidade foi associado à idade (OR = 1,04 [IC95%: 1,01-1,06]), tempo até a primeira sessão de pronação (OR = 1,18 [IC95%: 1,06-1,31]), número de sessões (OR = 1,31 [IC95%: 1,00-1,72]), porcentagem de comprometimento pulmonar (OR = 1,55 [IC95%: 1,02-2,35]) e imunossupressão (OR = 3,83 [IC95%: 1,35-10,86]). Conclusões: Nossos resultados mostram que a maioria dos pacientes de nossa amostra apresentou resposta positiva da oxigenação após a primeira sessão de pronação. No entanto, a taxa de mortalidade foi elevada, provavelmente em virtude do estado de saúde e número de comorbidades dos pacientes e da gravidade de sua doença. Nossos resultados também sugerem que a pontuação no SAPS III e a PaO2/FIO2 inicial predizem a resposta da oxigenação; além disso, idade, tempo até a primeira sessão de pronação, número de sessões, comprometimento pulmonar e imunossupressão podem predizer mortalidade.

ABSTRACT Objective: To identify factors that lead to a positive oxygenation response and predictive factors of mortality after prone positioning. Methods: This was a retrospective, multicenter, cohort study involving seven hospitals in Brazil. Inclusion criteria were being > 18 years of age with a suspected or confirmed diagnosis of COVID-19, being on invasive mechanical ventilation, having a PaO2/FIO2 ratio < 150 mmHg, and being submitted to prone positioning. After the first prone positioning session, a 20 mmHg improvement in the PaO2/FIO2 ratio was defined as a positive response. Results: The study involved 574 patients, 412 (72%) of whom responded positively to the first prone positioning session. Multiple logistic regression showed that responders had lower Simplified Acute Physiology Score III (SAPS III)/SOFA scores and lower D-dimer levels (p = 0.01; p = 0.04; and p = 0.04, respectively). It was suggested that initial SAPS III and initial PaO2/FIO2 were predictors of oxygenation response. The mortality rate was 69.3%. Increased risk of mortality was associated with age (OR = 1.04 [95 CI: 1.01-1.06]), time to first prone positioning session (OR = 1.18 [95 CI: 1.06-1.31]), number of sessions (OR = 1.31 [95% CI: 1.00-1.72]), proportion of pulmonary impairment (OR = 1.55 [95% CI: 1.02-2.35]), and immunosuppression (OR = 3.83 [95% CI: 1.35-10.86]). Conclusions: Our results show that most patients in our sample had a positive oxygenation response after the first prone positioning session. However, the mortality rate was high, probably due to the health status and the number of comorbidities of the patients, as well as the severity of their disease. Our results also suggest that SAPS III and the initial PaO2/FIO2 predict the oxygenation response; in addition, age, time to first prone positioning, number of sessions, pulmonary impairment, and immunosuppression can predict mortality.

https://doi.org/10.36416/1806-3756/e20210374

12.

Why should noninferiority clinical trials be performed?
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Maskin, Patricio

; Ferreira, Juliana Carvalho

; Patino, Cecilia María

Jornal Brasileiro de Pneumologia

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2022, Volume 48 N. 1 elocation e20220055

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

https://doi.org/10.36416/1806-3756/e20220055

13.

Brazilian guidelines for the treatment of outpatients with suspected or confirmed COVID-19. A joint guideline of the Brazilian Association of Emergency Medicine (ABRAMEDE), Brazilian Medical Association (AMB), Brazilian Society of Angiology and Vascular Surgery (SBACV), Brazilian Society of Geriatrics and Gerontology (SBGG), Brazilian Society of Infectious Diseases (SBI), Brazilian Society of Family and Community Medicine (SBFMC), and Brazilian Thoracic Society (SBPT)
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Falavigna, Maicon

; Belli, Karlyse Claudino

; Barbosa, Alexandre Naime

; Zavascki, Alexandre Prehn

; Nastri, Ana Catharina de Seixas Santos

; Santana, Christiane Machado

; Stein, Cinara

; Gräf, Débora Dalmas

; Cadegiani, Flavio Adsuara

; Guimarães, Hélio Penna

; Monteiro, José Tadeu

; Ferreira, Juliana Carvalho

; de Azevedo, Luciano Cesar Pontes

; Magri, Marcelo Mihailenko Chaves

; Sobreira, Marcone Lima

; Dias, Maria Beatriz Gandra de Souza

; de Oliveira, Maura Salaroli

; Corradi, Mirian de Freitas Dal Ben

; Rosa, Regis

; Heinzelmann, Ricardo Souza

; da Silva, Rosemeri Maurici

; Belfort Junior, Rubens

; Cimerman, Sergio

; Colpani, Verônica

; Veiga, Viviane Cordeiro

; de Carvalho, Carlos Roberto Ribeiro

Brazilian Journal of Infectious Diseases

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2022, Volume 26 N. 2 elocation 102347

Abstract: En | Text: En | PDF: En

ABSTRACT Background Several therapies have been used or proposed for the treatment of COVID-19, although their effectiveness and safety have not been properly evaluated. The purpose of this document is to provide recommendations to support decisions about the drug treatment of outpatients with COVID-19 in Brazil. Methods A panel consisting of experts from different clinical fields, representatives of the Brazilian Ministry of Health, and methodologists (37 members in total) was responsible for preparing these guidelines. A rapid guideline development method was used, based on the adoption and/or adaptation of recommendations from existing international guidelines combined with additional structured searches for primary studies and new recommendations whenever necessary (GRADE-ADOLOPMENT). The rating of quality of evidence and the drafting of recommendations followed the GRADE method. Results Ten technologies were evaluated, and 10 recommendations were prepared. Recommendations were made against the use of anticoagulants, azithromycin, budesonide, colchicine, corticosteroids, hydroxychloroquine/chloroquine alone or combined with azithromycin, ivermectin, nitazoxanide, and convalescent plasma. It was not possible to make a recommendation regarding the use of monoclonal antibodies in outpatients, as their benefit is uncertain and their cost is high, with limitations of availability and implementation. Conclusion To date, few therapies have demonstrated effectiveness in the treatment of outpatients with COVID-19. Recommendations are restricted to what should not be used, in order to provide the best treatment according to the principles of evidence-based medicine and to promote resource savings by aboiding ineffective treatments.

https://doi.org/10.1016/j.bjid.2022.102347

14.

How to write a curriculum vitae - advice for young researchers
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Ferreira, Juliana Carvalho

Jornal Brasileiro de Pneumologia

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2022, Volume 48 N. 2 elocation e20220144

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

https://doi.org/10.36416/1806-3756/e20220144

15.

Intercurrent events in clinical research: the norm, not the exception
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Rojas-Saunero, L. Paloma

; Patino, Cecilia María

; Ferreira, Juliana Carvalho

Jornal Brasileiro de Pneumologia

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2022, Volume 48 N. 4 elocation e20220310

Abstract: Pt En | Text: Pt En | PDF: Pt | PDF: En

https://doi.org/10.36416/1806-3756/e20220310

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