Epidemiology, patient journey and unmet needs related to hemophilia in Brazil: a scoping review with evidence map.

INTRODUCTION: Brazil is one of the countries with the largest population of people with hemophilia (PwH) worldwide. In this scoping review, we aim to investigate the Brazilian context for hemophilia regarding three predefined concepts: (i) clinical-epidemiological profile, (ii) burden of disease and (iii) patient journey and unmet needs. METHODS: Three questions in each concept guided the screening of references retrieved by systematic searches carried out in MEDLINE, LILACS and the Digital Library of Theses and Dissertations. Quantitative and qualitative studies conducted in Brazil from 2002 onwards were assessed for eligibility. MAIN RESULTS: Ninety-two studies were included. A total of 66 studies addressed the concept "Clinical-epidemiological profile", 31 investigated the concept of "Burden of disease" and 26 addressed the concept "Patient journey and unmet needs". Based on these studies, pain and arthropathy affect a substantial proportion of the PwH, with physical functioning, pain and school or work being the domains of quality of life with the greatest impact. About 43 % to 82.6 % of the PwH are unemployed. Rates of inhibitor development are highly variable across studies, especially in hemophilia A. Adherence to prophylactic treatment ranges from 25 % to 72 %. The annualized bleeding rate is estimated at 2.4 ± 4.1. The barriers to treatment identified include distance to reference centers, lack of coordination of specialized and emergency care and restricted access to rehabilitation. CONCLUSIONS: Hemophilia poses a considerable burden on the PwH. Despite the available modalities of treatment, there are remaining unmet needs that should be addressed by researchers and policy makers in the future.

Insomnia symptoms during the covid-19 pandemic: a case-control study.

OBJECTIVE: To identify lifestyle-related, sociodemographic, and mental health characteristics of people with insomnia symptoms and people without insomnia during the pandemic. METHODS: A case-control study was conducted with data collected by snowball sampling using an online questionnaire. From November 2020 to April 2021, 6,360 people with a mean age of 43.5 years (SD = 14.3) participated in the survey. For this study, we considered 158 cases of insomnia disorder and 476 controls (three controls per case) randomly selected from the participants without sleep problems. RESULTS: The results of the comparative analysis between cases and controls showed that sleeping less than six hours daily (OR = 3.89; 95%CI 2.50-6.05), feeling sadness frequently (OR = 2.95; 95%CI 1.69-5.17), residing in metropolitan areas (OR = 1.71; 95%CI 1.04-2.84), being 40 years or older (OR = 1.93; 95%CI 1.22-3.06), and the interaction between occupation and poorer education (OR = 2.12; 95%CI 1.22-3.69) were predictors for symptoms of insomnia disorder during the pandemic. CONCLUSIONS: In addition to confirming the hypothesis that mental health problems are associated with insomnia symptoms, the results point to insomnia as an important outcome for studies on the effects of unemployment, vulnerability and low education of the population, especially in large cities, highlighting that the effects of the crisis on health and the economy are extremely unequally distributed.

Insomnia symptoms during the covid-19 pandemic: a case-control study / Sintomas de insônia durante a pandemia de covid-19: um estudo caso-controle

ABSTRACT OBJECTIVE To identify lifestyle-related, sociodemographic, and mental health characteristics of people with insomnia symptoms and people without insomnia during the pandemic. METHODS A case-control study was conducted with data collected by snowball sampling using an online questionnaire. From November 2020 to April 2021, 6,360 people with a mean age of 43.5 years (SD = 14.3) participated in the survey. For this study, we considered 158 cases of insomnia disorder and 476 controls (three controls per case) randomly selected from the participants without sleep problems. RESULTS The results of the comparative analysis between cases and controls showed that sleeping less than six hours daily (OR = 3.89; 95%CI 2.50-6.05), feeling sadness frequently (OR = 2.95; 95%CI 1.69-5.17), residing in metropolitan areas (OR = 1.71; 95%CI 1.04-2.84), being 40 years or older (OR = 1.93; 95%CI 1.22-3.06), and the interaction between occupation and poorer education (OR = 2.12; 95%CI 1.22-3.69) were predictors for symptoms of insomnia disorder during the pandemic. CONCLUSIONS In addition to confirming the hypothesis that mental health problems are associated with insomnia symptoms, the results point to insomnia as an important outcome for studies on the effects of unemployment, vulnerability and low education of the population, especially in large cities, highlighting that the effects of the crisis on health and the economy are extremely unequally distributed.

RESUMO OBJETIVO Identificar características relacionadas ao estilo de vida, sociodemográficas e saúde mental de pessoas com sintomas de insônia e pessoas sem insônia durante a pandemia. MÉTODOS A partir de dados coletados por amostragem em bola de neve, por meio de um questionário online foi realizado um estudo caso-controle. Durante o período de novembro de 2020 a abril de 2021, 6.360 pessoas com idade média de 43,5 anos (DP = 14,3) participaram da pesquisa. No presente estudo, foram considerados 158 casos de transtorno de insônia e 476 controles (três controles por caso) selecionados aleatoriamente dentre os participantes sem problemas de sono. RESULTADOS Os resultados da análise comparativa entre casos e controles mostraram que dormir menos de seis horas diárias (OR = 3,89; IC95% 2,50-6,05), sentir tristeza frequentemente (OR = 2,95; IC95% 1,69-5,17), residir em metrópoles (OR = 1,71; IC95% 1,04-2,84), estar com 40 anos ou mais (OR = 1,93; IC95% 1,22-3,06) e a interação entre ocupação e escolaridade mais precária (OR = 2,12; IC95% 1,22-3,69) foram fatores preditores para sintomas de transtorno de insônia durante a pandemia. CONCLUSÕES Além da confirmação da hipótese de que problemas de saúde mental estão associados a sintomas de insônia, os resultados apontam para a insônia como um desfecho importante para estudos sobre efeitos do desemprego, vulnerabilidade e baixa escolaridade da população, sobretudo nas grandes metrópoles, ressaltando que os efeitos da crise sobre a saúde e a economia são distribuídos de forma extremamente desiguais.

Teleconsultations in neurology in a universal health system amid COVID-19: a descriptive study.

OBJECTIVE: This study aimed to characterize teleconsultations in neurology executed by Regula+Brasil project in Recife, a capital city in northeastern Brazil. METHODS: A descriptive study carried out by four private hospitals, in a partnership with the Ministry of Health in Brazil. Teleconsultation was performed preferably in the video modality. Conditions eligible for teleconsultation were headache, epilepsy, and cerebrovascular disorders. Period of analysis was May to September 2020. RESULTS: A total of 243 teleconsultations were analyzed, of which 76.95% was a first appointment. In 48.97% of cases, the teleconsultation represented the first opportunity for the patient to be consulted with the specialist. Among cases of first appointment, 20.16% were further referred to a face-to-face consultation and 21.81% could be redirected to primary health care. Headache disorders were the most predominant clinical conditions. CONCLUSIONS: The implementation and development of telemedicine by Regula+Brasil during the COVID-19 pandemic represented an opportunity to assess the value of having teleconsultations added along the line of care from primary care to a medical specialty, promoting the coordination of care across different levels of complexity of care in the health system and improving access to specialized care.

Teleconsultations in neurology in a universal health system amid COVID-19: a descriptive study

SUMMARY OBJECTIVE: This study aimed to characterize teleconsultations in neurology executed by Regula+Brasil project in Recife, a capital city in northeastern Brazil. METHODS: A descriptive study carried out by four private hospitals, in a partnership with the Ministry of Health in Brazil. Teleconsultation was performed preferably in the video modality. Conditions eligible for teleconsultation were headache, epilepsy, and cerebrovascular disorders. Period of analysis was May to September 2020. RESULTS: A total of 243 teleconsultations were analyzed, of which 76.95% was a first appointment. In 48.97% of cases, the teleconsultation represented the first opportunity for the patient to be consulted with the specialist. Among cases of first appointment, 20.16% were further referred to a face-to-face consultation and 21.81% could be redirected to primary health care. Headache disorders were the most predominant clinical conditions. CONCLUSIONS: The implementation and development of telemedicine by Regula+Brasil during the COVID-19 pandemic represented an opportunity to assess the value of having teleconsultations added along the line of care from primary care to a medical specialty, promoting the coordination of care across different levels of complexity of care in the health system and improving access to specialized care.

Micro-Costing of a Remotely Operated Referral Management System to Secondary Care in the Unified Health System in Brazil.

Referral of cases from primary to secondary care in the Brazilian public healthcare system is one of the most important issues to be tackled. Telehealth strategies have been shown effective in avoiding unnecessary referrals. The objective of this study was to estimate cost per referred case by a remotely operated referral management system to further inform the decision making on the topic. Analysis of cost by applying time-driven activity-based costing. Cost analyses included comparisons between medical specialties, localities for which referrals were being conducted, and periods of time. Cost per referred case across localities ranged from R$ 5.70 to R$ 8.29. Cost per referred case across medical specialties ranged from R$ 1.85 to R$ 8.56. Strategies to optimize the management of referral cases to specialized care in public healthcare systems are still needed. Telehealth strategies may be advantageous, with cost estimates across localities ranging from R$ 5.70 to R$ 8.29, with additional observed variability related to the type of medical specialty.

Micro-Costing of a Remotely Operated Referral Management System to Secondary Care in the Unified Health System in Brazil / Microcusteio de um Sistema de Regulação Remoto para o Cuidado Especializado no Sistema Único de Saúde no Brasil

Abstract Referral of cases from primary to secondary care in the Brazilian public healthcare system is one of the most important issues to be tackled. Telehealth strategies have been shown effective in avoiding unnecessary referrals. The objective of this study was to estimate cost per referred case by a remotely operated referral management system to further inform the decision making on the topic. Analysis of cost by applying time-driven activity-based costing. Cost analyses included comparisons between medical specialties, localities for which referrals were being conducted, and periods of time. Cost per referred case across localities ranged from R$ 5.70 to R$ 8.29. Cost per referred case across medical specialties ranged from R$ 1.85 to R$ 8.56. Strategies to optimize the management of referral cases to specialized care in public healthcare systems are still needed. Telehealth strategies may be advantageous, with cost estimates across localities ranging from R$ 5.70 to R$ 8.29, with additional observed variability related to the type of medical specialty.

Resumo O encaminhamento de casos da atenção primária para a secundária no Sistema Único Brasileiro é uma das questões mais importantes a ser enfrentada. As estratégias de telessaúde têm se mostrado eficazes para evitar encaminhamentos desnecessários. O objetivo deste estudo foi estimar o custo por caso encaminhado por meio de um sistema de gerenciamento de referenciamentos operado remotamente para subsidiar a tomada de decisão sobre o tema. Análise de custo por meio da aplicação de custeio baseado em atividades orientado pelo tempo (time-driven activity-based costing ou TDABC). As análises de custo incluíram comparações entre especialidades médicas, localidades para as quais os encaminhamentos estavam sendo conduzidos e períodos de tempo. O custo por referenciamento em todas as localidades variou entre R$ 5,70 a R$ 8,29. O custo por referenciamento nas especialidades médicas variou entre R$ 1,85 a R$ 8,56. Estratégias para otimizar a gestão dos referenciamentos para a atenção especializada nos sistemas públicos de saúde ainda são necessárias. As estratégias de telessaúde podem ser vantajosas, com estimativas de custo entre as localidades variando entre R$ 5,70 a R$ 8,29, com variabilidade adicional observada relacionada ao tipo de especialidade médica.

Telehealth for Supporting Referrals to Specialized Care During COVID-19.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic led to the suspension or postponement of care for non-urgent conditions worldwide. Regula Mais Brasil is an initiative of the Unified Health System (SUS) in Brazil to optimize the management of referrals to specialized care by using telehealth. Objectives: To report the expansion of telehealth activities of Regula Mais Brasil in response to COVID-19 and to assess qualification of referrals in primary health care (PHC) units as well as the added value of teleconsultation in qualifying referral cases. Methods: Descriptive study of the teleconsultations carried out as an additional strategy to the remotely operated referral management system, responsible for navigating cases from PHC units to specialized care in Recife, Brazil, between May 6, 2020 and September 30, 2020. Teleconsultation was implemented as a tool for reducing delays in the access to health care due to COVID-19 and ultimately allowed for reclassification of the referral adequacy and priority. Changes in referral priority ratings and referral decisions after teleconsultation were analyzed. Results: A total of 622 referral cases were analyzed. Approved referrals represented 51.9% of cases. The main reason for approved referrals was the need for diagnostic resources. There was a reduction in priority ratings in 449 cases (72.2%) after teleconsultation. There was a statistically significant association between the change of priority ratings and the decision on referral (Pearson's χ2, p-value <0.0001). Results show that telemedicine had an impact on the prioritization and qualification of cases referred to specialized services. Conclusions: A need was detected to rapidly adapt tools available for telemedicine in Brazil. Our results demonstrate that teleconsultation as an additional strategy to the remotely operated referral management system has contributed toward improving equitable access to specialized services.

Qualidade metodológica das avaliações econômicas de antineoplásicos submetidas à Agência Nacional de Saúde Suplementar (ANS) na atualização do rol 2020 ­ Estudo de avaliação crítica / Methodological quality of economic assessments of antineoplastics submitted to Supplementary Health Agency in the update of the 2020 list ­ Critical assessment study

Objetivo: Descrever e analisar criticamente as avaliações econômicas de medicamentos antineoplásicos submetidas à Agência Nacional de Saúde Suplementar (ANS) durante o processo de atualização do rol de procedimentos em saúde 2020. Métodos: Estudo transversal de análise crítica dos estudos de avaliação econômica integrantes da documentação submetida à ANS com o objetivo de incorporação no rol de procedimentos. A avaliação da qualidade metodológica foi realizada por meio da ferramenta Methodology Checklist 6: Economic Evaluations Version 3.0 da Scottish Intercollegiate Guidelines Network. Resultados: Foram incluídas 49 avaliações econômicas: 22 estudos de custo-efetividade, 10 estudos de custo-utilidade, três estudos de custo-minimização e 14 estudos de custo-efetividade e custo-utilidade. A qualidade metodológica foi considerada, na maior parte (88%), como aceitável ou de baixa qualidade. Conclusão: Estudos de avaliação econômica são fundamentais no processo decisório de incorporação de tecnologias na saúde suplementar. Esta análise crítica sugere que a qualidade dos estudos econômicos apresentados dentro das propostas de incorporação de antineoplásicos durante o processo de atualização do rol 2020 da ANS foi limitada. Inconsistências metodológicas e falta de um relato transparente reduzem a validade e a aplicabilidade dos achados na tomada de decisão.

Objective: To describe and critically appraise the economic evaluations of antineoplastic drugs submitted to the ANS during the process of updating its 2020' list of procedures. Methods: Cross-sectional study of critical analysis of the economic evaluation studies included in the documentation submitted to the ANS with the aim of incorporating them into the list of procedures. The methodological quality assessment was carried out using the Methodology Checklist 6: Economic Evaluations Version 3.0 of the Scottish Intercollegiate Guidelines Network. Results: Overall, 49 economic evaluations were included: 22 cost-effectiveness studies, 10 cost-utility studies, three cost-minimization studies and 14 mixed economic studies. Methodological quality was mostly considered as acceptable or low quality. Conclusion: Economic evaluation studies are fundamental in the decision-making process of incorporating technologies into supplementary health care. This critical appraisal suggests that the quality of the economic studies presented within the proposals to incorporate antineoplastics during the process of updating the ANS 2020 roll was limited. Methodological inconsistencies and lack of transparent reporting reduce the validity and applicability of findings for decision-making

Delays and Disruptions in Cancer Health Care Due to COVID-19 Pandemic: Systematic Review.

PURPOSE: There has been noteworthy concern about the impact of COVID-19 pandemic on health services including the management of cancer. In addition to being considered at higher risk for worse outcomes from COVID-19, people with cancer may also experience disruptions or delays in health services. This systematic review aimed to identify the delays and disruptions to cancer services globally. METHODS: This is a systematic review with a comprehensive search including specific and general databases. We considered any observational longitudinal and cross-sectional study design. The selection, data extraction, and methodological assessment were performed by two independent reviewers. The methodological quality of the studies was assessed by specific tools. The delays and disruptions identified were categorized, and their frequency was presented. RESULTS: Among the 62 studies identified, none exhibited high methodological quality. The most frequent determinants for disruptions were provider- or system-related, mainly because of the reduction in service availability. The studies identified 38 different categories of delays and disruptions with impact on treatment, diagnosis, or general health service. Delays or disruptions most investigated included reduction in routine activity of cancer services and number of cancer surgeries; delay in radiotherapy; and delay, reschedule, or cancellation of outpatient visits. Interruptions and disruptions largely affected facilities (up to 77.5%), supply chain (up to 79%), and personnel availability (up to 60%). CONCLUSION: The remarkable frequency of delays and disruptions in health care mostly related to the reduction of the COVID-19 burden unintentionally posed a major risk on cancer care worldwide. Strategies can be proposed not only to mitigate the main delays and disruptions but also to standardize their measurement and reporting. As a high number of publications continuously are being published, it is critical to harmonize the upcoming reports and constantly update this review.

Methodological quality and redundancy of systematic reviews that compare endarterectomy versus stenting for carotid stenosis.

A review of systematic reviews (SRs) and a critical appraisal study was conducted at Escola Paulista de Medicina, Universidade Federal de São Paulo (Unifesp). The objectives of this review are (1) to identify all published SRs comparing the effectiveness and safety of carotid endarterectomy (CEA) versus carotid artery stenting (CAS) for carotid artery stenosis, (2) to assess their methodological quality and (3) to compare the primary studies contained in each SR. We included 17 SRs published between 2005 and 2017. None of the SRs fulfilled all items of AMSTAR-2. The overall confidence in the results was graded as critically low for 16 SRs (94%) and low for 1 SR (6%). Five items were judged inadequate in all SRs: reference to a published protocol, explanation to the selection of study design, comprehensive search of the literature, methods for statistical combination of findings and consideration of the risk of bias on the results of meta-analysis. In total, 15 randomised clinical trials (RCTs) were included at least in one SR. The number of included RCTs in each SR was inconsistent (4 to 15) and was not related to the year of publication of the SR. Our study found redundant and low methodological quality SR comparing CAS versus CEA for carotid stenosis.

Technical Procedures for Preparation and Administration of Platelet-Rich Plasma and Related Products: A Scoping Review.

INTRODUCTION: Platelet-rich plasma is widely used for different types of clinical situations, but universal standardization of procedures for its preparation is still lacking. METHODS: Scoping review of comparative studies that have assessed at least two alternatives in one or more stages of preparation, storage and/or administration of PRP or its related products. A systematic search was conducted in MEDLINE, Embase, and LILACS. Two authors screened references independently. Data extraction was performed iteratively, and results were presented for each included comparison. RESULTS: Thirty-nine studies were included after assessing full texts, focusing on the comparison of PRP to a related product, types of anticoagulants, centrifugation protocols, commercial kits, processing time, methods for activation, and application concomitantly to other substances. Only laboratory outcomes were assessed, as platelet, leukocyte and growth factor concentrations. CONCLUSION: Results showed great variability related to methods employed in different stages of PRP processing, which may explain the variability observed in clinical trials assessing the efficacy of PRP for different clinical situations.

Guidelines for the pharmacological treatment of COVID-19. The task-force/consensus guideline of the Brazilian Association of Intensive Care Medicine, the Brazilian Society of Infectious Diseases and the Brazilian Society of Pulmonology and Tisiology. / Diretrizes para o tratamento farmacológico da COVID-19. Consenso da Associação de Medicina Intensiva Brasileira, da Sociedade Brasileira de Infectologia e da Sociedade Brasileira de Pneumologia e Tisiologia.

INTRODUCTION: Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil. METHODS: A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020. RESULTS: Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively. CONCLUSION: So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence.

Guidelines for the pharmacological treatment of COVID-19. The task-force/consensus guideline of the Brazilian Association of Intensive Care Medicine, the Brazilian Society of Infectious Diseases and the Brazilian Society of Pulmonology and Tisiology

Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil. A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020. Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively. So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence.

Há diversas terapias sendo utilizadas, consideradas ou propostas para o tratamento da COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é fornecer recomendações baseadas nas evidências científicas disponíveis e em sua interpretação transparente, para subsidiar decisões sobre o tratamento farmacológico da COVID-19 no Brasil. Um grupo de 27 especialistas e metodologistas integraram a força-tarefa formada pela Associação de Medicina Intensiva Brasileira (AMIB), pela Sociedade Brasileira de Infectologia (SBI) e pela Sociedade Brasileira de Pneumologia e Tisiologia (SBPT). Foram realizadas revisões sistemáticas rápidas, atualizadas até 28 de abril de 2020. A qualidade das evidências e a elaboração das recomendações seguiram o sistema GRADE. As recomendações foram elaboradas nos dias 5, 8 e 13 de maio de 2020. Foram geradas 11 recomendações, embasadas em evidência de nível baixo ou muito baixo. Não há indicação para uso de rotina de hidroxicloroquina, cloroquina, azitromicina, lopinavir/ritonavir, corticosteroides ou tocilizumabe no tratamento da COVID-19. Heparina deve ser utilizada em doses profiláticas no paciente hospitalizado, mas não deve ser realizada anticoagulação na ausência de indicação clínica específica. Antibacterianos e oseltamivir devem ser considerados somente nos pacientes em suspeita de coinfecção bacteriana ou por influenza, respectivamente. Até o momento, não há intervenções farmacológicas com efetividade e segurança comprovada que justifiquem seu uso de rotina no tratamento da COVID-19, devendo os pacientes serem tratados preferencialmente no contexto de pesquisa clínica. As recomendações serão revisadas continuamente, de forma a capturar a geração de novas evidências

Diretrizes para o tratamento farmacológico da COVID-19. Consenso da Associação de Medicina Intensiva Brasileira, da Sociedade Brasileira de Infectologia e da Sociedade Brasileira de Pneumologia e Tisiologia / Guidelines for the pharmacological treatment of COVID-19. The task-force/consensus guideline of the Brazilian Association of Intensive Care Medicine, the Brazilian Society of Infectious Diseases and the Brazilian Society of Pulmonology and Tisiology

RESUMO Introdução: Há diversas terapias sendo utilizadas, consideradas ou propostas para o tratamento da COVID-19, muitas carecendo de apropriada avaliação de efetividade e segurança. O propósito deste documento é fornecer recomendações baseadas nas evidências científicas disponíveis e em sua interpretação transparente, para subsidiar decisões sobre o tratamento farmacológico da COVID-19 no Brasil. Métodos: Um grupo de 27 especialistas e metodologistas integraram a força-tarefa formada pela Associação de Medicina Intensiva Brasileira (AMIB), pela Sociedade Brasileira de Infectologia (SBI) e pela Sociedade Brasileira de Pneumologia e Tisiologia (SBPT). Foram realizadas revisões sistemáticas rápidas, atualizadas até 28 de abril de 2020. A qualidade das evidências e a elaboração das recomendações seguiram o sistema GRADE. As recomendações foram elaboradas nos dias 5, 8 e 13 de maio de 2020. Resultados: Foram geradas 11 recomendações, embasadas em evidência de nível baixo ou muito baixo. Não há indicação para uso de rotina de hidroxicloroquina, cloroquina, azitromicina, lopinavir/ritonavir, corticosteroides ou tocilizumabe no tratamento da COVID-19. Heparina deve ser utilizada em doses profiláticas no paciente hospitalizado, mas não deve ser realizada anticoagulação na ausência de indicação clínica específica. Antibacterianos e oseltamivir devem ser considerados somente nos pacientes em suspeita de coinfecção bacteriana ou por influenza, respectivamente. Conclusão: Até o momento, não há intervenções farmacológicas com efetividade e segurança comprovada que justifiquem seu uso de rotina no tratamento da COVID-19, devendo os pacientes serem tratados preferencialmente no contexto de pesquisa clínica. As recomendações serão revisadas continuamente, de forma a capturar a geração de novas evidências.

ABSTRACT Introduction: Different therapies are currently used, considered, or proposed for the treatment of COVID-19; for many of those therapies, no appropriate assessment of effectiveness and safety was performed. This document aims to provide scientifically available evidence-based information in a transparent interpretation, to subsidize decisions related to the pharmacological therapy of COVID-19 in Brazil. Methods: A group of 27 experts and methodologists integrated a task-force formed by professionals from the Brazilian Association of Intensive Care Medicine (Associação de Medicina Intensiva Brasileira - AMIB), the Brazilian Society of Infectious Diseases (Sociedad Brasileira de Infectologia - SBI) and the Brazilian Society of Pulmonology and Tisiology (Sociedade Brasileira de Pneumologia e Tisiologia - SBPT). Rapid systematic reviews, updated on April 28, 2020, were conducted. The assessment of the quality of evidence and the development of recommendations followed the GRADE system. The recommendations were written on May 5, 8, and 13, 2020. Results: Eleven recommendations were issued based on low or very-low level evidence. We do not recommend the routine use of hydroxychloroquine, chloroquine, azithromycin, lopinavir/ritonavir, corticosteroids, or tocilizumab for the treatment of COVID-19. Prophylactic heparin should be used in hospitalized patients, however, no anticoagulation should be provided for patients without a specific clinical indication. Antibiotics and oseltamivir should only be considered for patients with suspected bacterial or influenza coinfection, respectively. Conclusion: So far no pharmacological intervention was proven effective and safe to warrant its use in the routine treatment of COVID-19 patients; therefore such patients should ideally be treated in the context of clinical trials. The recommendations herein provided will be revised continuously aiming to capture newly generated evidence.

Efficacy of platelet-rich plasma for non-transfusion use: Overview of systematic reviews.

INTRODUCTION: Platelet-rich plasma (PRP) is a blood component therapy with a supraphysiological concentration of platelets derived from allogenic or, more commonly, autologous blood. PRP has been used in different non-transfusion indications because of its role in the promotion of tissue repair and healing, in fields such as Traumatology, Dermatology and Dentistry. OBJECTIVE: To provide a synthesis of the efficacy of PRP for different clinical situations. METHODS: Systematic searches were carried out in MEDLINE, Embase, Cochrane Library and LILACS in July 2018 to identify systematic reviews (SRs) of randomized clinical trials (RCTs) focusing on PRP for non-transfusion use. Two authors independently screened all retrieved references in two stages (titles and abstracts at a first stage and full texts at a second stage). The methodological quality of SRs that met the eligibility criteria was appraised by AMSTAR 2. Conclusions were based on the most recent SRs with highest quality. RESULTS: One thousand two hundred and forty references were retrieved. After checking the inclusion criteria, 29 SRs of RCTs related to three different fields (wound care, Orthopedics and Dentistry) were included. The results suggest the benefit of PRP for different clinical situations, such as diabetic wounds, acute lesions of musculoskeletal system, rotator cuff lesions, tendinopathies, knee and hip osteoarthritis, total knee arthroplasty, allogenic bone graft for dental implants and periodontal intrabony defects. CONCLUSION: There is low to moderate quality evidence supporting the efficacy of PRP for specific clinical situations. The low quality of the evidence limits the certainty of these findings. Well-planned and well-conducted RCTs are still needed to further assess the efficacy of PRP.

Neurodevelopmental Treatment (Bobath) for Children With Cerebral Palsy: A Systematic Review.

AIM: To assess the effects of neurodevelopmental treatment for children with cerebral palsy. METHODS: We conducted a systematic review following the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and reported in accordance to PRISMA Statement. Through a comprehensive literature search we considered all randomized clinical trials that compared neurodevelopmental treatment with conventional physical therapy for children with cerebral palsy. We used the Cochrane Risk of Bias Table to assess the risk of bias of the included randomized clinical trial, and the GRADE approach to evaluate the certainty of the body of the evidence. RESULTS: We found 3 randomized clinical trials (2 published and 1 ongoing) comprising 66 children. Published randomized clinical trials presented methodological and reporting limitations and only 1 provided data for outcomes of interest. No difference between neurodevelopmental treatment and conventional physical therapy was found for gross motor function (mean difference 1.40; 95% confidence interval -5.47 to 8.27, low certainty evidence). CONCLUSION: This review found that the effects of neurodevelopmental treatment for children with cerebral palsy are still uncertain. Further studies are required to assess the efficacy and safety of neurodevelopmental treatment for this purpose and until there, current evidence do not support its routinely use in practice. Number of protocol registration in PROSPERO database: CRD42017082817 (available from https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=82817 ).

What do Cochrane systematic reviews say about interventions for insomnia?

ABSTRACT CONTEXT AND OBJECTIVE: Insomnia is a frequent complaint that generates more than five million visits to doctors per year in the United States. This study summarizes all Cochrane systematic reviews (SRs) that evaluated interventions to treat insomnia. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A sensitive search was carried out in the Cochrane Database of Systematic Reviews to identify Cochrane SRs that assessed the effects of any type of intervention for people with insomnia. The results, main characteristics of the SRs and the certainty of the evidence obtained from them were synthesized and discussed. RESULTS: Seven SRs were included. They addressed the benefits and harm of acupuncture (n = 1), behavioral interventions (n = 1), music (n = 1), pharmacotherapy (n = 2), phototherapy (n = 1) and physical exercise (n = 1). The certainty of the evidence ranged from moderate to very low. CONCLUSION: Acupuncture, music, physical exercise, paroxetine, doxepin, trimipramine and trazodone seem to present some benefit for patients with insomnia. However, the uncertainty around these results means that no robust and definitive recommendations for clinical practice can be made until the benefits and harms from each intervention for patients with insomnia have been confirmed through further studies.

What do Cochrane systematic reviews say about the use of cannabinoids in clinical practice?

BACKGROUND: The therapeutic effects of cannabinoid compounds have been the center of many investigations. This study provides a synthesis on all Cochrane systematic reviews (SRs) that assessed the use of cannabinoids as a therapeutic approach. DESIGN AND SETTING: Review of SRs, conducted in the Discipline of Evidence-Based Medicine, Escola Paulista de Medicina (EPM), Universidade Federal de São Paulo (UNIFESP). METHODS: A broad search was conducted in the Cochrane Database of Systematic Reviews to retrieve any Cochrane SRs that assessed the efficacy and safety of cannabinoids as a therapeutic approach. The results and key characteristics of all reviews included were summarized and discussed. RESULTS: Eight SRs were included. They assessed the use of cannabinoids for the following types of conditions: neurological (two SRs), psychiatric (two SRs), rheumatological (one SR), infectious (one SR) and oncological (two SRs). There was moderate-quality evidence showing that the use of cannabinoids reduced nausea and vomiting among adults, compared with placebo. Additionally, there was moderate-quality evidence showing that there was no difference between cannabinoids and prochlorperazine regarding the number of participants who reported vomiting, in this same population. CONCLUSIONS: This review identified eight Cochrane systematic reviews that provided evidence of unknown to moderate quality regarding the use of cannabinoids as a therapeutic intervention. Further studies are still imperative for solid conclusions to be reached regarding practical recommendations.