Evidence syntheses to support decision-making related to the Covid-19 pandemic.

The COVID-19 pandemic generated a large volume of scientific productions with different quality levels. The speed with which knowledge was produced and shared worldwide imposed on health management the challenge of seeking ways to identify the best available evidence to support its decisions. In response to this challenge, the Department of Science and Technology of the Brazilian Ministry of Health started offering a service to produce and provide scientific knowledge addressing priority public health issues in the pandemic scenario. Drug treatments, non-pharmacological measures, testing, reinfection and immunological response, immunization, pathophysiology, post-COVID syndrome and adverse events are among the topics covered. In this article, we discuss the strengths and lessons learned, as well as the challenges and perspectives that present a real example of how to offer the best scientific evidence in a timely manner in order to assist the decision-making process during a public health emergency.

Sínteses de evidências para apoio à tomada de decisões relacionadas à pandemia de covid-19 / Evidence syntheses to support decision-making related to the Covid-19 pandemic

A pandemia de covid-19 gerou um numeroso volume de produções científicas com diferentes níveis de qualidade. A velocidade com que o conhecimento era produzido e compartilhado a nível mundial impôs à gestão em saúde o desafio de buscar meios de identificar as melhores evidências disponíveis para subsidiar suas decisões. Em resposta a este desafio, o Departamento de Ciência e Tecnologia do Ministério da Saúde do Brasil estabeleceu um serviço para elaborar e disponibilizar conhecimento científico abordando questões prioritárias de saúde pública no cenário da pandemia. Entre os temas abordados estão tratamentos medicamentosos, medidas não farmacológicas, testagem, reinfecção e resposta imunológica, imunização, fisiopatologia, síndrome pós-covid e eventos adversos. Neste artigo, discute-se os pontos fortes e lições aprendidas, bem como os desafios e perspectivas que fornecem um exemplo real sobre como disponibilizar as melhores evidências científicas, em tempo hábil e de forma oportuna, para auxiliar o processo decisório durante uma emergência em saúde pública.

Incidence of Guillain-Barré syndrome in the world between 1985 and 2020: A systematic review.

Introduction: Guillain-Barré syndrome (GBS) is an acute inflammatory demyelinating polyradiculoneuropathy that affects the peripheral nervous system. The study aimed to describe the incidence of GBS in the world up to the year 2020. Methods: A systematic review was conducted. Searches were done in four databases, PUBMED, EMBASE, EBSCO and Biblioteca virtual em Saude (BVS), and in grey literature and manual search in the reference lists of eligible studies. Results: A total of 72 studies were included. The incidence of GBS among the cohort studies varied from 0.30 to 6.08 cases per 100.000 habitants and 0.42 to 6.58 cases per 100.000 person-years. Among the self-controlled studies, the risk incidence ranged from 0.072 to 1 case per 100.000 habitants and 1.73 to 4.30 cases per 100.000 person-years. Conclusions: The reported incidence of GBS in the world among the studies included in the review is slightly higher than that reported in previous studies. The highest incidence rates were associated with public health events of international concern.

Factors associated with yellow fever vaccine failure: A systematic literature review.

INTRODUCTION: Considering that vaccination with yellow fever vaccine (YFV) is the most important method to prevent and control yellow fever (YF), this study synthesized evidence on factors associated with YFV failure. METHODS: A systematic review (SR) was performed in the PubMed, Cochrane CENTRAL, Embase, and LILACS databases up to November 2019. Observational and experimental analytical epidemiological studies that analyzed the failure of YFV were included. This review followed the guidelines of the Preferred Reporting Items for Systematic Reviews and meta-Analyses. RESULTS: A total of 1,466 articles were identified after searching the databases of which 46 were included in the qualitative analysis after applying the elegibility criteria. Our findings indicated that YFV confers protective immunity in different age groups; when produced by different producers; when administered simultaneously with a range of other vaccines; when used as fractional doses and when used with prophylactic and immunosuppressive therapies. It failed to produce a protective response in some pregnant women, children under two years of age, children with Kwashiorkor and when long periods of time have passed after vaccination. For individuals with human immunodeficiency virus (HIV), the results were divergent. CONCLUSIONS: The results of this SR revealed the factors associated with the failure of the YFV, and the results can support recommendations on vaccination policies, support the safety of health professionals who work directly with immunization in the implementation of the vaccination schedule, in addition to guiding future research and enhance the credibility of YFV in the prevention of a serious disease such as YF.

Incidence of Guillain-Barré syndrome in the world between 1985 and 2020: a systematic Review

Introduction: Guillain-Barré syndrome (GBS) is an acute inflammatory demyelinating polyradiculoneuropathy that affects the peripheral nervous system. The study aimed to describe the incidence of GBS in the world up to the year 2020. Methods: A systematic review was conducted. Searches were done in four databases, PUBMED, EMBASE, EBSCO and Biblioteca virtual em Saude (BVS), and in grey literature and manual search in the reference lists of eligible studies.  Results: A total of 72 studies were included. The incidence of GBS among the cohort studies varied from 0.30 to 6.08 cases per 100.000 habitants and 0.42 to 6.58 cases per 100.000 person-years. Among the self-controlled studies, the risk incidence ranged from 0.072 to 1 case per 100.000 habitants and 1.73 to 4.30 cases per 100.000 person-years. Conclusions: The reported incidence of GBS in the world among the studies included in the review is slightly higher than that reported in previous studies. The highest incidence rates were associated with public health events of international concern.

Proposal of a Quality Assessment tool for the Evaluation of the Methodological Quality of Self-Controlled Case Series and Self-Controlled Risk Interval Study Designs / Uma proposta de instrumento para avaliação da qualidade metodológica dos desenhos de estudos autocontrolados

Self-Controlled Case Series (SCCS) and Self-Controlled Risk Interval (SCRI) study designs are types of studies where cases act as their controls. They are commonly used  by pharmacovigilance to study rare events. There is no existing tool for the assessment of the methodological quality of such studies. Critical appraisal in primary and secondary studies is crucial as it enables the reader to evaluate how the study was elaborated and take this into consideration while analyzing the evidence presented. This paper presents a proposal of an instrument that has been adapted from an already existing tool used for cohort studies and it combines the elements of this tool and the premises of the SCCS and SCRI study designs. It is expected that the tool will help researchers and readers in critically appraising SCCS and SCRI study designs.

Characterization of Guillain-Barré Syndrome in the integrated development region of the Federal District and Surrounding Areas (RIDE), Brazil, between 2017 and 2019.

INTRODUCTION: Guillain-Barré Syndrome (GBS) is an acute immune-mediated polyneuropathy that primarily affects the peripheral nerves. Following the Zika virus outbreak in Latin America, all the Latin American and Brazilian studies conducted reported an increase in the incidence of GBS. The present study aims to characterize the clinical and demographic profile of patients with GBS, according to electrophysiological estudies. METHODS: This is a clinical cohort study based on data from medical charts and interviews conducted at the homes of GBS cases identified by three data sources, admitted to and treated at a tertiary referral hospital between March 2017 and May 2019. RESULTS: There was a high level of diagnostic certainty among the 51 GBS cases monitored, with most classified as exhibiting acute inflammatory demyelinating polyneuropathy (AIDP). The majority of the individuals were of working age, with an average schooling level. Diarrhea and upper respiratory tract infection were the previous events most reported. Most cases were admitted to the hospital unable to walk and the main complication identified was aspiration pneumonia. CONCLUSION: The findings indicate the need to rethink the care of patients with GBS in order to minimize the possibility of future complications during hospitalization that may lead to unfavorable outcomes.

Burden of Disease of Guillain-Barré Syndrome in Brazil before and during the Zika virus epidemic 2014-2016.

OBJECTIVE: To estimate the burden of disease of Guillain-Barré syndrome (GBS) in Brazil in 2014, 1 year before the Zika virus epidemic, and in 2015 and 2016 during the epidemic. METHODS: The burden of disease of GBS was estimated using the summary measure of population health: Disability Adjusted Life Years (DALY), that combines both mortality (Years of Life Lost YLLs) and morbidity (Years Lived with Disability) components. The study population was composed of GBS hospitalised cases and deaths from the information systems of the Brazilian Unified Health System. RESULTS: The GBS incidence rate in 2014, 2015 and 2016 was 0.74, 0.96, 1.02/100 000 respectively, and the mortality rate in the same period was 0.08, 0.009 and 0.11/100 000 habitants. The DALYs calculated using the point estimate of GBS disability weight and its values of the confidence interval (0.198 and 0.414) were 5725.90 (5711.79-5742.89) in 2014, 6054.61 (6035.57-6077.54) in 2015 and 7588.49 (7570.20-7610.51) in 2016. The DALYs were high among the male population and in age groups between 20 and 50 years. CONCLUSIONS: The increase in DALYs in the years 2015 and 2016 compared to 2014 probably resulted from the introduction of ZIKV in Brazil, reinforcing the importance of investments in the prevention of ZIKV infection and in the care of GBS patients.

OBJECTIF: Estimer la charge de morbidité du syndrome de Guillain-Barré (SGB) au Brésil en 2014, un an avant l'épidémie du virus Zika (ZIKV) et en 2015 et 2016 pendant l'épidémie. MÉTHODES: La charge de la maladie du SGB a été estimée à l'aide de la mesure récapitulative de la santé de la population: années de vie ajustées en fonction de l'incapacité (AVCI), qui combine à la fois les composantes de la mortalité (années de vie perdues AVP) et de la morbidité (années vécues avec une incapacité). La population de l'étude était composée de cas hospitalisés du SGB et de décès provenant des systèmes d'information du système de santé unifié brésilien. RÉSULTATS: Le taux d'incidence du SGB en 2014, 2015 et 2016 était de 0,74 ; 0,96 et 1,02/100.000 respectivement et le taux de mortalité au cours de la même période était de 0,08 ; 0,009 et 0,11/100.000 habitants. Les AVCI calculées à l'aide des points d'estimation du poids de l'incapacité du SGB et de ses valeurs de l'intervalle de confiance (0,198 et 0,414) étaient de 5.725,90 (5.711,79-5.742,89) en 2014 ; 6.054,61 (6.035,57-6.077,54) en 2015 et 7.588,49 (7.570,20 - 7.610,51) en 2016. Les AVCI étaient élevés parmi la population masculine et dans les groupes d'âge entre 20 et 50 ans. CONCLUSIONS: L'augmentation des AVCI en 2015 et 2016 par rapport à 2014 résulte probablement de l'introduction du ZIKV au Brésil, renforçant l'importance des investissements dans la prévention de l'infection par le ZIKV et dans la prise en charge des patients atteints de SGB.

Pharmacological therapies for patients with human coronavirus infections: a rapid systematic review. / Terapia medicamentosa para infecções por coronavírus em humanos: revisão sistemática rápida.

This work aimed to evaluate the effects of drug therapies for coronavirus infections. Rapid systematic review with search in the MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov and International Clinical Trials Registry Platform databases. Thirty-six studies evaluating alternative drugs against SARS, SARS-CoV-2 and MERS were included. Most of the included studies were conducted in China with an observational design for the treatment of COVID-19. The most studied treatments were with antimalarials and antivirals. In antimalarial, the meta-analysis of two studies with 180 participants did not identify the benefit of hydroxychloroquine concerning the negative viral load via real-time polymerase chain reaction, and the use of antivirals compared to standard care was similar regarding outcomes. The available scientific evidence is preliminary and of low methodological quality, which suggests caution when interpreting its results. Research that evaluates comparative efficacy in randomized, controlled clinical trials, with adequate follow-up time and with the methods properly disclosed and subject to scientific peer review is required. A periodic update of this review is recommended.

Terapia medicamentosa para infecções por coronavírus em humanos: revisão sistemática rápida / Pharmacological therapies for patients with human coronavirus infections: a rapid systematic review

Resumo O objetivo deste trabalho foi avaliar efeitos de tratamentos medicamentosos para infecções por coronavírus. Revisão sistemática rápida com buscas nas bases MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov e International Clinical Trials Registry Platform. Foram incluídos 36 estudos avaliando alternativas medicamentosas contra SARS, SARS-CoV-2 e MERS. A maioria dos estudos incluídos foi conduzida na China com delineamento observacional para tratamento da COVID-19. Os tratamentos mais estudados foram antimaláricos e antivirais. Nos antimaláricos, a metanálise de dois estudos com 180 participantes não identificou benefício da hidroxicloroquina em relação à negativação da carga viral via reação em cadeia de polimerase em tempo real e o uso de antivirais comparado ao cuidado padrão foi similar em relação aos desfechos. As evidências científicas disponíveis são preliminares e de baixa qualidade metodológica, o que sugere cautela na interpretação dos dados. Pesquisas que avaliem a eficácia comparativa em ensaios clínicos randomizados, controlados, com tempo de acompanhamento adequado e com os métodos devidamente divulgados e sujeitos à revisão científica por pares são necessárias. Recomenda-se atualização periódica da presente revisão.

Abstract This work aimed to evaluate the effects of drug therapies for coronavirus infections. Rapid systematic review with search in the MEDLINE, EMBASE, Cochrane, BVS, Global Index Medicus, Medrix, bioRxiv, Clinicaltrials.gov and International Clinical Trials Registry Platform databases. Thirty-six studies evaluating alternative drugs against SARS, SARS-CoV-2 and MERS were included. Most of the included studies were conducted in China with an observational design for the treatment of COVID-19. The most studied treatments were with antimalarials and antivirals. In antimalarial, the meta-analysis of two studies with 180 participants did not identify the benefit of hydroxychloroquine concerning the negative viral load via real-time polymerase chain reaction, and the use of antivirals compared to standard care was similar regarding outcomes. The available scientific evidence is preliminary and of low methodological quality, which suggests caution when interpreting its results. Research that evaluates comparative efficacy in randomized, controlled clinical trials, with adequate follow-up time and with the methods properly disclosed and subject to scientific peer review is required. A periodic update of this review is recommended.

Systematic review of factors associated with the development of Guillain-Barré syndrome 2007-2017: what has changed?

OBJECTIVE: The objective of this study was to describe the factors associated with the development of Guillain-Barré syndrome, both infectious and non-infectious, during and after the A(H1N1) influenza pandemic in 2009 and the recent Zika virus epidemic in the Americas. METHOD: Systematic review of literature on factors associated with the development of the Guillain-Barré syndrome published between 2007 and 2017 listed in EBSCO, MEDLINE and LILACS databases. The quality of the studies was evaluated using the Newcastle Ottawa Scale. RESULTS: Thirty-four articles met inclusion criteria and were selected for analysis. Their quality was considered good in relation to most of the items evaluated. Many aetiological agents had the results of association with Guillain-Barré syndrome, among them Campylobacter jejuni, influenza vaccine - both pandemic and seasonal vaccines, respiratory infection, gastrointestinal infection among others. The aetiological agents found are, in most part, the same reported prior to the study period. The association with surgeries, chikungunya virus (CHIKV), Zika virus and quadrivalent human papillomavirus vaccine stand out as new aetiological agents in the list of the various possible agents that trigger Guillain-Barré syndrome reported in the study period. There were no Brazilian studies identified during this period. CONCLUSIONS: The results of the review reaffirmed C. jejuni as the major trigger of GBS, whereas the association of influenza vaccines and GBS is less clear; Zika virus infection in association with GBS was found in only one study.

Revisão Rápida para informar a Política Nacional de Medicamentos Biológicos no SUS / Rapid review to inform the National Policy on Biological Medicines in SUS

Contexto: O gasto elevado com medicamentos biológicos ameaça a sustentabilidade dos serviços de saúde. O objetivo da presente revisão rápida foi embasar a discussão da Política Nacional de Medicamentos Biológicos no âmbito do Sistema Único de Saúde (SUS), por meio da identificação de barreiras de acesso a esses medicamentos. Metodologia: Revisão rápida da literatura nas fontes de informação Medline via PubMed, EMBASE, Biblioteca Cochrane e Center for Review and Dissemination (CRD). Resultados: Foram incluídos nove estudos com delineamento transversal. No contexto do usuário, as barreiras foram a falta de conhecimento sobre o medicamento, a distância entre a moradia e o serviço de saúde, os longos períodos de espera por atendimento e a passividade sobre decisão de tratamento.