Brazilian society of rheumatology methodological guide for the development of evidence-based clinical guidelines in rheumatology

Abstract Clinical practice guidelines (CPG) are developed to align standards of health care around the world, aiming to reduce the incidence of misconducts and enabling more effective use of health resources. Considering the complexity, cost, and time involved in formulating CPG, strategies should be used to facilitate and guide authors through each step of this process. The main objective of this document is to present a methodological guide prepared by the Epidemiology Committee of the Brazilian Society of Rheumatology for the elaboration of CPG in rheumatology. Through an extensive review of the literature, this study compiles the main practical recommendations regarding the following steps of CPG drafting: distribution of working groups, development of the research question, search, identification and selection of relevant studies, evidence synthesis and quality assessment of the body of evidence, the Delphi methodology for consensus achievement, presentation and dissemination ofthe recommendations, CPG quality assessment and updating. This methodological guide serves as an important tool for rheumatologists to develop reliable and high-quality CPG, standardizing clinical practices worldwide.

Decision aid for prostate cancer screening in Brazil.

OBJECTIVE: To present the development and validation processes of a decision aid for prostate cancer screening in Brazil. METHODS: Study with qualitative-participatory design for the elaboration of a decision aid for prostate cancer screening, with the participation of a group of men and physicians inserted in primary health care in 11 Brazilian states. Evidence synthesis, field testing, and use in clinical scenarios were performed to adapt the content, format, language, and applicability towards the needs of the target audience in the years 2018 and 2019. The versions were subsequently evaluated by the participants and modified based on the data obtained. RESULTS: We elaborated an unprecedented tool in Brazil, with information about the tests used in the screening, comparison of their possible benefits and harms and a numerical infographic with the consequences of this practice. We verified the decision aid usability to assist in the communication between the doctor and the man in the context of primary health care, besides identifying the need for greater discussion about sharing decisions in clinical scenarios. CONCLUSION: The tool was easy to use, objective, and has little interference in consultation time. It is a technical-scientific material, produced by research, with the participation of its main target audience and which is available free of charge for use in Brazilian clinical scenarios.

Lupus retinopathy: epidemiology and risk factors / Retinopatia lúpica: epidemiologia e fatores de risco

ABSTRACT Lupus retinopathy is a clinical manifestation of systemic lupus erythematosus in the visual system. It is generally asymptomatic; however, it can become a threatening condition. It is closely associated with the inflammatory activity and higher mortality of systemic lupus erythematosus. Lupus retinopathy has several different clinical presentations, such as lupus microangiopathy, vascular occlusion, vasculitis, hypertensive retinopathy associated with lupus nephritis, and autoimmune retinopathy. Although the prevalence and associated factors of lupus retinopathy have been well defined in some parts of the world, there are no data from Latin America, including Brazil. As lupus retinopathy is generally asymptomatic, without a routine fundoscopy, it has been probably underestimated. This review is intended to discuss the epidemiology and risk factors of lupus retinopathy.

RESUMO A retinopatia lúpica é uma manifestação clínica do lúpus eritematoso sistêmico no sistema visual. Geralmente assintomática, porém pode ser uma condição ameaçadora à visão. Está intimamente associada à atividade inflamatória do lúpus eritematoso sistêmico e ao aumento da mortalidade. A retinopatia lúpica tem diversas apresentações clínicas, como a microangiopatia lúpica, oclusão vascular, vasculite, retinopatia hipertensiva associada à nefrite lúpica e retinopatia autoimune. A prevalência e os fatores associados à retinopatia lúpica estão bem definidos em algumas partes do mundo. No entanto, esses dados são pouco conhecidos na América Latina, incluindo o Brasil. Como a retinopatia lúpica é geralmente assintomática, sem a fundoscopia de rotina, provavelmente esta é subestimada. O objetivo desta revisão é discutir a epidemiologia e fatores de risco para retinopatia lúpica.

Lupus retinopathy: epidemiology and risk factors.

Lupus retinopathy is a clinical manifestation of systemic lupus erythematosus in the visual system. It is generally asymptomatic; however, it can become a threatening condition. It is closely associated with the inflammatory activity and higher mortality of systemic lupus erythematosus. Lupus retinopathy has several different clinical presentations, such as lupus microangiopathy, vascular occlusion, vasculitis, hypertensive retinopathy associated with lupus nephritis, and autoimmune retinopathy. Although the prevalence and associated factors of lupus retinopathy have been well defined in some parts of the world, there are no data from Latin America, including Brazil. As lupus retinopathy is generally asymptomatic, without a routine fundoscopy, it has been probably underestimated. This review is intended to discuss the epidemiology and risk factors of lupus retinopathy.

Análise documental sobre decisão compartilhada nas diretrizes clínicas de câncer / Shared decision-making in clinical cancer guidelines / Análisis documental sobre la toma de decisiones compartida en las directrices clínicas para el cáncer

Resumo A decisão compartilhada é processo colaborativo que inclui preferências individuais na elaboração do plano de cuidados. Este estudo examina como esse tipo de decisão é contemplado nas diretrizes terapêuticas para o câncer do Sistema Único de Saúde, buscando nos sites do Instituto Nacional de Câncer e da Comissão Nacional de Incorporação de Tecnologias documentos que citassem a participação do paciente. Foram analisados 29 documentos e, dentre eles, dez abordavam decisão compartilhada ou ideias relacionadas. Esses textos tratavam da possibilidade de rastrear alguns tipos de câncer e estabeleciam critérios para a interrupção do tratamento. Os resultados revelaram que ainda há grandes desafios para promover a autonomia, o respeito a valores individuais e a parceria em ambientes clínicos.

Abstract Shared decision-making is a collaborative process that includes patient preferences in the care planning process. This study aimed to analyze how the shared decision-making is considered in the cancer guidelines of the Brazilian Unified Health System through a research of documents about patients' participation on the databases of the National Cancer Institute and National Commission for the Incorporation of Technologies. We analyzed 29 documents, and 10 of them presented an approach for shared decision-making or ideas related to the topic. These documents addressed the possibility of screening some types of cancer and established criteria for interrupting the treatment. The results show the great challenges that still exist to promote autonomy, and to respect individual values and partnership in clinical settings.

Resumen La toma de decisiones compartida es un proceso colaborativo que incluye preferencias individuales en la elaboración del plan de cuidados. Este estudio buscó examinar la manera en que este tipo de decisión es contemplado en las directrices terapéuticas para el cáncer del Sistema Único de Salud de Brasil, buscando, en los sitios electrónicos del Instituto Nacional del Cáncer y de la Comisión Nacional de Incorporación de Tecnologías, documentos que mencionaran la participación del paciente. Se analizaron 29 documentos y, entre ellos, diez abordaban la toma de decisiones compartida o ideas relacionadas. Estos textos abordaban la posibilidad de rastrear algunos tipos de cáncer y establecían criterios para la interrupción del tratamiento. Los resultados revelaron que aún hay grandes desafíos para promover la autonomía, el respeto por los valores individuales y la coparticipación en entornos clínicos.

Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas - BiobadaBrasil).

OBJECTIVES: To assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice. PATIENTS AND METHODS: This cohort study used data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas - BiobadaBrasil), from 01/2009 to 05/2013, encompassing 1552 treatments, including 415 with only synthetic disease-modifying anti-rheumatic drugs, 942 synthetic DMARDs combined with anti-tumor necrosis factor (etanercept, infliximab, adalimumab) and 195 synthetic DMARDs combined with other biologics (abatacept, rituximab and tocilizumab). The occurrence of tuberculosis and the drug exposure time were assessed, and screening for tuberculosis was performed. STATISTICAL ANALYSIS: Unpaired t-test and Fisher's two-tailed test; p<0.05. RESULTS: The exposure times were 981 patient-years in the controls, 1744 patient-years in the anti-TNF group (adalimumab=676, infliximab=547 and etanercept=521 patient-years) and 336 patient-years in the other biologics group. The incidence rates of tuberculosis were 1.01/1000 patient-years in the controls and 2.87 patient-years among anti-TNF users (adalimumab=4.43/1000 patient-years; etanercept=1.92/1000 patient-years and infliximab=1.82/1000 patient-years). No cases of tuberculosis occurred in the other biologics group. The mean drug exposure time until the occurrence of tuberculosis was 27(11) months for the anti-TNF group. CONCLUSIONS: The incidence of tuberculosis was higher among users of synthetic DMARDs and anti-TNF than among users of synthetic DMARDs and synthetic DMARDs and non-anti-TNF biologics and also occurred later, suggesting infection during treatment and no screening failure.

Ultrasound of ankles in the diagnosis of complications of chikungunya fever / Ultrassonografia do tornozelo no diagnóstico das complicações da febre chikungunya

Abstract Objective: To describe the main ultrasound findings of chikungunya fever in the ankle. Materials and Methods: This was a cross-sectional observational study involving 52 patients referred to the Hospital Universitário Pedro Ernesto and presenting with clinical and biochemical evidence of chikungunya fever. The examinations were performed by a radiologist with more than 20 years of experience in ultrasound. Results: The predominant gender was female (in 88.5%), and the mean age was 58.4 years. The majority (61.5%) of the patients came from the northern part of the city of Rio de Janeiro, and 46.2% were using corticosteroids to treat inflammatory symptoms. The most common alterations observed by ultrasound were joint effusion (in 69.2%), tenosynovitis (in 59.6%), cellulitis (in 46.2%), Kager's fat pad thickening (in 29.9%), myositis (of the soleus or flexor hallucis longus muscle) (in 17.3%), retrocalcaneal bursitis (in 5.8%), tendon ruptures (in 3.8%), and increased vascular flow on power Doppler (in 3.8%). Conclusion: Signs of synovitis and tenosynovitis were the main ultrasound findings in a predominantly female population with a mean age of 58.4 years. Further studies are needed in order to define the role of ultrasound in the follow-up of such patients.

Resumo Objetivo: Descrever os principais achados ultrassonográficos da febre chikungunya no tornozelo. Materiais e Métodos: Estudo transversal e observacional com 52 pacientes encaminhados ao Hospital Universitário Pedro Ernesto com quadros clínico e laboratorial compatíveis com febre chikungunya. Os exames foram realizados por um radiologista com mais de 20 anos de experiência no método. Resultados: Houve predomínio do sexo feminino (88,5%) e média de idade dos pacientes de 58,4 anos. A maioria dos doentes (61,5%) era proveniente da zona norte da cidade do Rio de Janeiro e fazia uso de esteroides (46,2%) para o tratamento dos sintomas inflamatórios. As alterações ultrassonográficas mais comuns foram: derrame articular (69,2%), tenossinovites (59,6%), celulite (46,2%), espessamento da gordura de Kager (29,9%), miosite (sóleo e/ou flexor longo do hálux) (17,3%), bursite retrocalcânea (5,8%), roturas tendíneas (3,8%) e hiperfluxo vascular pelo Doppler de amplitude (3,8%). Conclusão: Predominaram os sinais ultrassonográficos de sinovite e tenossinovite numa população majoritariamente do sexo feminino e com idade média de 58,4 anos. Sugere-se a realização de outros estudos para definição do papel da ultrassonografia no acompanhamento desses doentes.

Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas - BiobadaBrasil) / Incidência de tuberculose em pacientes com artrite reumatoide em uso de bloqueadores do TNF no Brasil: dados do Registro Brasileiro de Monitoração de Terapias Biológicas BiobadaBrasil

Abstract Objectives To assess the incidence of tuberculosis and to screen for latent tuberculosis infection among Brazilians with rheumatoid arthritis using biologics in clinical practice. Patients and methods This cohort study used data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoração de Terapias Biológicas - BiobadaBrasil), from 01/2009 to 05/2013, encompassing 1552 treatments, including 415 with only synthetic disease-modifying anti-rheumatic drugs, 942 synthetic DMARDs combined with anti-tumor necrosis factor (etanercept, infliximab, adalimumab) and 195 synthetic DMARDs combined with other biologics (abatacept, rituximab and tocilizumab). The occurrence of tuberculosis and the drug exposure time were assessed, and screening for tuberculosis was performed. Statistical analysis: Unpaired t-test and Fisher's two-tailed test; p < 0.05. Results The exposure times were 981 patient-years in the controls, 1744 patient-years in the anti-TNF group (adalimumab = 676, infliximab = 547 and etanercept = 521 patient-years) and 336 patient-years in the other biologics group. The incidence rates of tuberculosis were 1.01/1000 patient-years in the controls and 2.87 patient-years among anti-TNF users (adalimumab = 4.43/1000 patient-years; etanercept = 1.92/1000 patient-years and infliximab = 1.82/1000 patient-years). No cases of tuberculosis occurred in the other biologics group. The mean drug exposure time until the occurrence of tuberculosis was 27(11) months for the anti-TNF group. Conclusions The incidence of tuberculosis was higher among users of synthetic DMARDs and anti-TNF than among users of synthetic DMARDs and synthetic DMARDs and non-anti-TNF biologics and also occurred later, suggesting infection during treatment and no screening failure.

Resumo Objetivos Avaliar incidência de tuberculose e triagem para tuberculose latente em brasileiros com artrite reumatoide em uso de agentes biológicos na prática clinica. Pacientes e métodos Estudo de coorte com dados do Registro Brasileiro de Monitoração de Terapias Biológicas (BiobadaBrasil), de 01/2009 a 05/2013, abrangeu 1.552 tratamentos, 415 somente com drogas modificadoras do curso da doença (MMCDs) sintéticas, 942 MMCDs sintéticas em associação com anti-TNF (etanercepte, infliximabe, adalimumabe) e 195 MMCDs sintéticas em associação com outros biológicos (abatacepte, rituximabe e tocilizumabe). Avaliaram-se ocorrência de tuberculose, tempo de exposição às drogas e triagem para TB. Análise estatística: teste t não pareado e teste de Fisher bicaudal; p < 0,05. Resultados O tempo de exposição dos controles foi de 981 pacientes-ano, do grupo de anti-TNF foi de 1.744 pacientes-ano (adalimumabe = 676, infliximabe = 547 e etanercepte = 521 pacientes-ano) e o de outros biológicos de 336 pacientes-ano. A incidência de TB foi de 1,01/1.000 pacientes-ano nos controles e de 2,87 pacientes-ano nos usuários de anti-TNF (adalimumabe = 4,43/1.000 pacientes-ano; etanercepte = 1,92/1.000 pacientes-ano e infliximabe = 1,82/1.000 pacientes-ano). Não houve casos de tuberculose no grupo de outros biológicos. O tempo médio de exposição até a ocorrência de tuberculose foi de 27(11) meses para o grupo anti-TNF. Conclusões A incidência de tuberculose foi maior nos usuários de MMCDs sintéticas e anti-TNF do que nos usuários de MMCDs sintéticas e de MMCDs sintéticas e biológicos não anti-TNF, e também mais tardia, sugerindo infecção durante o tratamento, e não falha na triagem.

Shared decision making in Brazil: history and current discussion.

There is no SDM in clinical practice in Brazil. The first steps have been taken towards research and tool development recently. Likewise, our society is starting to get involved with decision making in health care. This paper aims to offer an overview of the Brazilian health system history, its values, and its influence on SDM. The participative social control concept is introduced as a result of the movement against the dictatorship era. In addition, the influence of social changes on the Medical Ethical Code is delineated. SDM state of the art in Brazil is also discussed and the challenges to implement it on clinical practice are described. Regardless the challenges, it is possible to make a positive assessment of SDM in Brazil.

Apoios de decisão: instrumento de auxílio à medicina baseada em preferências. Uma revisão conceitual / Decision aids: an instrument to eliciting patient preference. Current concepts

A necessidade da incorporação das preferências dos pacientes nas tomadas de decisão é uma realidade da assistência médica contemporânea, que caracteriza a medicina baseada em preferências. Os apoios de decisão são instrumentos que surgem como mecanismos de auxílio ao médico a expor riscos e benefícios de uma determinada tomada de decisão, sendo um mecanismo facilitador para a decisão compartilhada. Na literatura médica, particularmente em reumatologia, nota-se um emergente interesse pelo estudo das preferências dos pacientes nos ensaios clínicos. Este artigo de revisão tem por objetivo conceituar e caracterizar os apoios de decisão e suas implicações na pesquisa e prática clínicas, bem como ressaltar os princípios metodológicos necessários para a sua utilização e desenvolvimento.

Patient preferences in decision making is one reality of the medical assistance, which characterizes the value based medicine. The decision aids are instruments that appear as support mechanisms for the doctor to exercise this model of decision making. In medical literature, particularly in rheumatology, an emergent interest on patient's preference study is noticed in clinical trials. The aim of this article is to appraise and to characterize the decision aids and its implications in the practical research and clinics, as well as standing out the necessary methodology principles for its use and development.

Revisões sistemáticas e metanálises na reumatologia / Systematic review and meta-analyses rheumatology

O conhecimento científico tem crescido exponencialmente, fazendo com que os médicos e tomadores de decisão estejam inundados de informações, necessitando integrá-las de modo consistente. A fim de otimizar as tomadas de decisão, os estudos de revisão, caracterizados como revisão sistemática e metanálise, estabelecem tais consistências e avaliam se seus resultados podem ser extrapolados para a população em geral ou a um paciente em particular. Este artigo propõe a revisão de conceitos gerais envolvendo tais estudos, enfatizando suas propriedades metodológicas para usá-las na prática clínica.

Avaliação do perfil sociodemográfico, clínico-laboratorial e terapêutico dos pacientes com artrite reumatóide que participaram de projetos de pesquisa na Escola Paulista de Medicina, nos últimos 25 anos / Evaluation of the sociodemographic, clinical-laboratorial and therapeutic profile of rheumatoid arthritis patients who participated of research projects in the Escola Paulista de Medicina in the last 25 years

OBJETIVO: descrever o perfil sociodemográfico, clínico-laboratorial e terapêutico dos pacientes com artrite reumatóide (AR) do ambulatório de reumatologia da Escola Paulista de Medicina (EPM-UNIFESP) que participaram de teses de pós-graduação no período de 25 anos, compreendido entre 1979 e 2004. PACIENTES E MÉTODOS: teses que avaliaram pacientes com AR da EPM. Exclusão: teses que incluíram pacientes de outras instituições ou com outras doencas. Classificação dos estudos: conforme o período de conclusão - I (1979-1984); II (1985-1989); III (1990-1994); IV (1995-1999); V (2000-2004) - e tipo de estudo (pesquisa básica; reabilitação; radiologia; qualidade de vida; epidemiologia e economia de saúde). RESULTADOS: Foram selecionadas 26 de 65 teses. Houve um predomínio de pesquisa básica (7 teses) nos três primeiros períodos, seguidos por reabilitação (6 teses) e de qualidade de vida (5 teses). Demografia: média de idade de 52 anos, predomínio do sexo feminino e raça branca. A escolaridade, avaliada em 5 estudos (qualidade de vida e economia de saúde), apresentou nível médio e superior de ensino nos últimos períodos. A classificação funcional (CF) foi pesquisada em 11 estudos, com maior prevalência da CF II. Tratamento: predomínio do uso de antiinflamatórios não-esteroidais (AINEs) e corticóides nos períodos I a III e, nos períodos III e V, de drogas modificadoras de atividade de doença (DMARDs), especialmente de metotrexato (MTX). CONCLUSÕES: observou-se alteração no nível de escolaridade e predomínio dos estudos de pesquisa básica, reabilitação e qualidade de vida. Houve preferência inicial pelos AINEs e, atualmente, pelos DMARDs.