Abstract Background: Systemic sclerosis (SSc) Is a clinically complex and challenging disease, that leads to skin fibrosis. Its most frequent complication is interstitial lung disease (ILD), which leads to a worse prognosis. In this situation, cyclophosphamide is considered the gold standard for its treatment, despite the controversies regarding its efficacy and toxicity. However, studies using rituximab (RTX) have shown that this drug may be a promising therapeutic option. Objectives: This paper objective was to analyze the scientific evidence on the RTX effects on SSc. Methods: A systematic review (SR) was performed including clinical trials (CTs) on the use of RTX in SSc, published up to May 2020. The studies were identified through systematic searches in bibliographic databases using a predefined search strategy. The following databases were used: PUBMED, SCOPUS, SCIELO, LILACS, SCIENCE DIRECT, WEB OF SCIENCE, COCHRANE, WHOLIS, PAHO and EMBASE. Also, a manual search was performed. The methodological quality of the studies was determined using Jadad scale, Risk of Bias Tool (RoB 2.0) and Risk of Bias in Non-Randomized Studies - of Interventions tool (ROBINS-I). A meta-analysis of the randomized CTs was performed, using Review Manager. Results: Ten CTs were included in this SR. Of these, three were randomized and seven were non-randomized. Five showed a statistically significant improvement in forced vital capacity (FVC) at some time during follow-up. Regarding the skin, eight studies showed statistically significant improvements according toa the modified Rodnan skin score. The meta-analysis found positive effects of RTX in SSc, with a statistical significance for lung disease. Conclusion: Rituximab is a promising strategy for the SSc-associated ILD and cutaneous fibrosis treatment. PROSPERO registration number: CRD42019132018.

ABSTRACT Aim Conduct a Failure Mode and Effect Analysis (FMEA) to prospectively identify the risks related to the preparation and dispensation of chemotherapy drugs at an outpatient unit of a reference center in oncology. Methods The first six stages of Failure Mode and Effect Analysis were used to identify dangerous situations and assemble a team; define the process to be analyzed and describe it graphically; apply a host of ideas to identify failure modes; prioritize failure modes and conduct risk analysis; identify potential causes of failure modes and redesign the process. Results Seventeen failure modes were identified, two of which were classified as high risk: changing the output window for the drug and miscalculating the intrathecal drug dose. Conclusions The possible failure modes related to the process analyzed were identified; in addition, it was possible to define potential causes of these risks.

RESUMO Objetivo Realizar uma Análise Multimodal de Falhas e Efeitos para identificar prospectivamente os riscos relacionados à fase do preparo e dispensação de medicamentos quimioterápicos em uma unidade ambulatorial de um centro de referência em oncologia. Métodos Foram utilizadas as seis primeiras etapas da Análise Multimodal de Falhas e Efeitos: identificar as situações perigosas e montar uma equipe; definir o processo a ser analisado descrevendo graficamente; aplicar chuva de ideias buscando identificar modos de falhas; priorizar os modos de falhas e realizar análise dos riscos; identificar causas potenciais dos modos de falha e redesenhar o processo. Resultados Foram identificados dezessete modos de falha, sendo dois classificados como de alto risco: trocar a janela de saída do medicamento e cálculo errado da dose de medicamento intratecal. Conclusões Foram identificados os possíveis modos de falha que se relacionavam ao processo analisado, além disso, foi possível definir causas potenciais para a existência desses riscos.

RESUMEN Objetivo Realizar un Análisis Multimodal de fallas y efectos para identificar prospectivamente los riesgos relacionados a la fase de la preparación y dispensación de medicamentos quimioterápicos en una unidad ambulatoria de un centro de referencia en oncología. Métodos Se utilizaron las seis primeras etapas del Análisis Multimodal de fallas y Efectos: identificar las situaciones peligrosas y montar un equipo; definir el proceso a ser analizado describiendo gráficamente; aplicar lluvia de ideas buscando identificar modos de fallas; priorizar los modos de fallas y realizar análisis de riesgos; identificar las causas potenciales de los modos de fallo y volver a dibujar el proceso. Resultados Se identificaron diecisiete modos de falla, siendo dos clasificados como de alto riesgo: cambiar la ventana de salida del medicamento y cálculo erróneo de la dosis de medicamento intratecal. Conclusiones Se identificaron los posibles modos de falla que se relacionaban al proceso analizado, además, fue posible definir causas potenciales para la existencia de esos riesgos.

Resumo Objetivos: adaptar culturalmente e validar o Safe Childbirth Checklist (SCC) da OMS para os hospitais brasileiros. Métodos: realizou-se uma pesquisa metodológica com técnicas de consenso e etapas de adaptação transcultural. O SCC original passou por três etapas de adaptação e validação: 1- grupo nominal com painel de especialistas; 2- conferência de consenso em duas maternidades escolas, em reuniões com profissionais que utilizariam a lista; 3- pré-teste com questionário estruturado aos profissionais de saúde das duas maternidades (n=40) após 30 dias de sua utilização. Critérios de validação contemplaram as validades de face e conteúdo, adequação aos protocolos nacionais, terminologia e viabilidade no contexto local. Resultados: o SCC adaptado para o Brasil foi denominado Lista de Verificação para o Parto Seguro - Brasil (LVPS-BR), contendo 49 itens. Na primeira etapa, os 29 itens do SCC original foram aprovados com algumas adaptações (ex.: CD4 substituído por Teste Rápido para HIV). Na segunda etapa, ocorreram ajustes em alguns dos 29 itens e acrescentaram-se 24 itens. Na terceira etapa, excluíram-se três itens, agruparam-se dois e acrescentou-se um. Conclusões: o processo de validação disponibilizou uma LVPS potencialmente útil para o contexto brasileiro, apresentando indícios de validade e viabilidade para o contexto nacional.

Abstract Objectives: to culturally adapt and validate the WHO Safe Childbirth Checklist (SCC) in Brazilian hospitals. Methods: a methodological study was carried out with consensus techniques and cross-cultural adaptation stages. The original SCC underwent three adaptation and validation stages: 1- nominal group with a panel of experts; 2- consensus conference at two maternity schools, in meetings with professionals who would use the list; 3- pre-test with a structured questionnaire for health professionals from both maternities (n=40) after 30 days of using the checklist. Validation criteria contemplated the content validity, adequated to Brazilian protocols, terminology and feasibility for local context. Results: the adapted SCC in Brazil was called the Lista de Verificação para o Parto Seguro - Brasil (LVPS-BR) (Checklist for Safe Childbirth -Brazil) and included 49 items. In the first stage, the 29 items of the original SCC were approved with some adaptations (e.g. CD4 was replaced by the Rapid HIV Test). In the second stage, some of the 29 items were adjusted and added 24 items more. In the third stage, three items were excluded, two were grouped and one more was added. Conclusions: the validation process provided a potentially useful LVPS for the Brazilian context, presenting validity and feasibility evidences for the Brazilian context.