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Abstract Background Biosimilar etanercept presents itself as an innovative therapeutic opportunity for inflammatory and autoimmune diseases, however, its efficacy, safety, and immunogenicity in relation to the reference biological agent for the treatment of rheumatoid arthritis is still questioned. With this in mind, this study aimed to verify the efficacy, safety, and immunogenicity of the use of the biosimilar etanercept in relation to the reference biologic in patients over 18 years of age with rheumatoid arthritis. Methods A systematic review with meta-analysis was performed in accordance with the parameters of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) selecting only Phase III randomized clinical trials. The search strategy was constructed with the MeSH terms “Etanercept”, “Biological Products”, “Arthritis, Rheumatoid”, “Biosimilar Pharmaceuticals” and was performed in Medline via PubMed, Embase, the Cochrane Library, Web of Science, EBSCO and Lilacs in January 2023. The analysis measures were relative risk (RR) for dichotomous data and mean difference (MD) for continuous data. The statistical analysis for preparing meta-analyses was developed by the Review Manager 5.1.4 software. Results This systematic review selected 6 eligible studies with a sample population of n = 2355. The main efficacy outcomes showed that both drugs did not present statistically significant differences in ACR20, ACR50, and ACR70 responses within 6 months (RR 1.00; 95% CI = 0.94 to 1.07; RR 1.09; 95% CI = 0.94 to 1.26; RR 1.04; 95% CI = 0.82 to 1.31, respectively), with I 2 ranging from 55 to 63% and 0.04 ≤ P ≥ 0.08. Adverse events were mostly mild or moderate, and serious adverse events were not statistically significant. Regarding immunogenicity, only 5.4% of the ADA-positive biosimilar group had positive neutralizing antibodies. Conclusions Thus, this review found that biosimilar etanercept had efficacy, safety, and immunogenicity similar to those for the biological reference. Systematic review registration This systematic review was registered on the PROSPERO platform under number CRD42020166610.

Abstract Background The implementation of clinical practice guidelines (CPGs) is a cyclical process in which the evaluation stage can facilitate continuous improvement. Implementation science has utilized theoretical approaches, such as models and frameworks, to understand and address this process. This article aims to provide a comprehensive overview of the models and frameworks used to assess the implementation of CPGs. Methods A systematic review was conducted following the Cochrane methodology, with adaptations to the "selection process" due to the unique nature of this review. The findings were reported following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) reporting guidelines. Electronic databases were searched from their inception until May 15, 2023. A predetermined strategy and manual searches were conducted to identify relevant documents from health institutions worldwide. Eligible studies presented models and frameworks for assessing the implementation of CPGs. Information on the characteristics of the documents, the context in which the models were used (specific objectives, level of use, type of health service, target group), and the characteristics of each model or framework (name, domain evaluated, and model limitations) were extracted. The domains of the models were analyzed according to the key constructs: strategies, context, outcomes, fidelity, adaptation, sustainability, process, and intervention. A subgroup analysis was performed grouping models and frameworks according to their levels of use (clinical, organizational, and policy) and type of health service (community, ambulatorial, hospital, institutional). The JBI’s critical appraisal tools were utilized by two independent researchers to assess the trustworthiness, relevance, and results of the included studies. Results Database searches yielded 14,395 studies, of which 80 full texts were reviewed. Eight studies were included in the data analysis and four methodological guidelines were additionally included from the manual search. The risk of bias in the studies was considered non-critical for the results of this systematic review. A total of ten models/frameworks for assessing the implementation of CPGs were found. The level of use was mainly policy, the most common type of health service was institutional, and the major target group was professionals directly involved in clinical practice. The evaluated domains differed between the models and there were also differences in their conceptualization. All the models addressed the domain "Context", especially at the micro level (8/12), followed by the multilevel (7/12). The domains "Outcome" (9/12), "Intervention" (8/12), "Strategies" (7/12), and "Process" (5/12) were frequently addressed, while "Sustainability" was found only in one study, and "Fidelity/Adaptation" was not observed. Conclusions The use of models and frameworks for assessing the implementation of CPGs is still incipient. This systematic review may help stakeholders choose or adapt the most appropriate model or framework to assess CPGs implementation based on their specific health context. Trial registration PROSPERO (International Prospective Register of Systematic Reviews) registration number: CRD42022335884. Registered on June 7, 2022.

Introduction This study aims to identify early stimulation strategies in the care of children with cerebral palsy, from 0 to 3 years old, involving families, health services, schools,community and support from the social protection network. Methods This is an overview of systematic reviews was structured in accordance with the parameters of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and registered on the PROSPERO international platform (CRD42020185596) increasing the credibility of the analyzed data. The research was carried out in the following databases: PubMed via MedLine, EMBASE, Health Systems Evidence, Centre for Reviews and Dissemination, PDQ Evidence, Cochrane Library and Effective Health Care Research Consortium, in June 2020 and updated in July 2022. Results Eleven systematic reviews evaluating 19 types of early stimulation were included. No interventions were identified in the school, community and social protection network. The interventions resulted in significant improvements in child development, body functions and structures, and functional abilities of activities and participation, such as locomotor movements, gait pattern, postural control, balance, muscle tone, joint mobility, visual and auditory functions, fine and gross motor skills, execution of activities of daily living, self-initiated movements, self-care, visual perception, interaction, face-to-face contact, vocalization and communication. Discussion e conclusions Early stimulation that has training and qualification of family members showed emotional improvements in parents, with the gain of confidence and autonomy to perform stimulus interventions for babies.It is concluded that the application of strategies should consider the evaluation of the singularities of each child, in order to indicate the best strategy for early stimulation

Introdução A Avaliação de Tecnologias em Saúde (ATS) é o processo contínuo de análise e síntese dos benefícios e das consequências do emprego das tecnologias em saúde. Além da própria ATS e de sua incorporação no sistema de saúde, faz parte da Política Nacional de Gestão de Tecnologias no Sistema Único de Saúde (SUS) a racionalização de sua utilização. Isso é garantido por meio de diretrizes clínicas aplicadas ao perfil de saúde nacional e avaliadas periodicamente (1). A avaliação periódica e o monitoramento da implementação das diretrizes clínicas são parte de um processo complexo que visa a avaliar se, uma vez desenvolvida e divulgada, a diretriz está sendo seguida na prática clínica e se os resultados e os impactos esperados ou desejados estão sendo alcançados. Atualmente, embora existam diretrizes metodológicas para o desenvolvimento e implementação das diretrizes clínicas no SUS (2), o processo de avaliação e monitoramento da implementação ainda não é realizado de forma contínua e padronizada. Consequentemente, há pouca informação disponível sobre a implementação de diretrizes no contexto brasileiro. Assim, uma importante estratégia é a utilização de modelos para orientar e padronizar os processos avaliativos. Esses modelos têm o potencial de qualificar e promover maior eficiência na gestão das diretrizes clínicas e das tecnologias em saúde. O objetivo desse trabalho é mapear os modelos usados mundialmente para avaliar a implementação de diretrizes clínicas. Métodos Foi realizada uma revisão sistemática, com buscas estruturadas em bases de dados científicos (MEDLINE, Embase, PsycINFO, Web of Science, GlobalHealth, The Cochrane Library, Health Systems Evidence, CRD, Epistemonikos, PDQ-Evidence, Scopus, CINAHL, Rx for Change e BVS salud), e complementada por buscas em literatura cinzenta e em sites de instituições reconhecidas mundialmente na área de desenvolvimento de diretrizes. Foram selecionados estudos publicados até março de 2023 que abordavam “avaliação da implementação de diretrizes clínicas” e apresentavam “modelos” ou “frameworks” para orientar esse processo. O processo de triagem foi realizado de forma independente, em duplicata, por duas duplas de pesquisadores. A extração dos dados foi realizada por dois pesquisadores. Foi produzida uma síntese qualitativa com uma abordagem agregativa, sem meta-análise, dos resultados. Resultados Foram identificados 16.416 registros e 16 diretrizes. Após triagem, foram incluídos 15 documentos. Estes documentos descrevem experiências desenvolvidas em países da América do Norte (5), Europa (4), Oceania (4) e Ásia (2). Foram incluídos artigos científicos (11) e diretrizes metodológicas internacionais sobre o tema (4). Foram encontrados 12 modelos para avaliar a implementação de diretrizes clínicas, sendo os mais utilizados: Theoretical Domains Framework (TDF) (2); Promoting Action on Research Implementation in Health Systems (PARiHS) framework (2); e Consolidated Framework for Implementation Research (CFIR) (2). Discussão e Conclusões Os resultados preliminares apontam o uso incipiente de modelos para avaliar a implementação de diretrizes clínicas. Espera-se auxiliar os stakeholders na escolha do modelo mais adequado a ser utilizado em pesquisas e em processos avaliativos da implementação de diretrizes clínicas, a partir da identificação e caracterização de modelos existentes na literatura.

RESUMO O Transtorno do Espectro do Autismo (TEA) é um transtorno do neurodesenvolvimento que compromete a comunicação e as habilidades sociais. Este estudo teve como objetivo analisar os recursos educacionais utilizados por profissionais de nível técnico e superior que lidam com alunos com TEA. Essa revisão foi registrada no PROSPERO CRD42020212986 e seguiu as recomendações da lista de verificação Standards for Reporting Qualitative Research (SRQR). As bases científicas utilizadas na busca foram Medline via PubMed, Embase, Web of Science e Lilacs. Dez artigos foram selecionados para a revisão. Os recursos educacionais que se destacaram ao longo do percurso foram: a formação em competências sociais e organizacionais; apoio e acompanhamento educacional/profissional; artefatos tecnológicos para interação audiovisual; e ferramentas de avaliação com capacidade educacional. Entende-se que a melhoria dos recursos educacionais, enfatizando a comunicação clara e objetiva, bem como a sociabilidade das aulas se torna fundamental para promover um ambiente educacional mais eficaz e estimulante para o aprendizado dos estudantes autistas.

It is important to prioritize intersectoral action at schools to prevent the use of alcohol and other drugs. This strategic act should be organized with multidisciplinary learning characteristics and with the involvement of different stakeholders. The aim of a recent scoping review was to identify the factors that benefit and hinder intersectoral actions at school resulting from the elaboration of policies to prevent drug use. It seems like the research study was a scoping review that used the P-population, C-context, and C-concept structure. The study searched for information in various databases like Embase, Proquest, Lilacs, Medline via Pubmed, PsycInfo, WHO-Iris, and PAHO-Iris on April 17, 2023. According to the results, there were 5 studies that were eligible to answer the research question. One of the advantages of intersectoral actions is the role of schools in creating a support network with different social actors, particularly with family involvement. On the other hand, one of the challenges is inconsistencies in legal regulations, which do not provide enough guidance to schools on how to prevent alcohol and drug use. While public and private schools may be affected differently by social and economic factors, it is essential to invest in developing policies that focus on drug prevention for children and adolescents who are learning in schools.

Introdução: O linfoma anaplásico de células grandes (ALCL) é um tipo raro de linfoma não Hodgkin e alguns relatos têm apontado possível associação entre a sua ocorrência e a implantação de próteses mamárias, especialmente as texturizadas. Contudo até o momento, pouco se sabe sobre o processo da doença e sua relação com os implantes mamários. Objetivo: Identificar se há associação entre o uso de implantes mamários e o desenvolvimento de ALCL. Método: Foi feita uma revisão de literatura com busca sistemática nas bases de dados: Medline via PubMed, Cochrane Library, Embase e Biblioteca Virtual em Saúde (BVS) em fevereiro de 2019, utilizando os termos Breast Implantation e anaplastic large-cell lymphomas. Resultados: Ao todo foram identificados 797 estudos, dos quais 12 foram selecionados e incluídos no presente trabalho: dois estudos de caso-controle, cinco registros retrospectivos de banco de dados, um estudo de coorte prospectiva e quatro revisões sistemáticas de relatos de casos. Os estudos de caso-controle apontaram aumento da chance de ocorrência de ALCL nas pacientes com implante mamário. Nos casos de ALCL relatados, a maioria relaciona-se a implantes de superfície texturizada, entretanto os dados podem estar enviesados já que este é o tipo de prótese mais vendida em todo o mundo. Grande parte dos procedimentos foram realizados por motivos estéticos, seguidos de reconstrução mamária após câncer de mama e mastectomia. Nesses casos, não se sabe se a reconstrução é um fator de risco ou agravante para o desenvolvimento de ALCL. Os dados foram provenientes de estudos realizados nos Estados Unidos da América, Holanda, Suécia, Reino Unido e Itália. Conclusões: Até o momento, os dados apontaram associação entre o implante mamário e o desenvolvimento de ALCL, entretanto não há como se estabelecer relação causal.