Brazilian Version of the Foot Health Status Questionnaire (FHSQ-Br): Cross-Cultural Adaptation and Evaluation of Measurement Properties

OBJECTIVE: To conduct a cross-cultural adaptation of the Foot Health Status Questionnaire into Brazilian-Portuguese and to assess its measurement properties. INTRODUCTION: This instrument is an outcome measure with 10 domains with scores ranging from 0-100, worst to best, respectively. The translated instrument will improve the examinations and foot care of rheumatoid arthritis patients. METHODS: The questions were translated, back-translated, evaluated by a multidisciplinary committee and pre-tested (n = 40 rheumatoid arthritis subjects). The new version was submitted to a field test (n = 65) to evaluate measurement properties such as test-retest reliability, internal consistency and construct validity. The Health Assessment Questionnaire, Numeric Rating Scale for foot pain and Sharp/van der Heijde scores for foot X-rays were used to test the construct validity. RESULTS: The cross-cultural adaptation was completed with minor wording adaptations from the original instrument. The evaluation of measurement properties showed high reliability with low variation coefficients between interviews. The a-Cronbach coefficients varied from 0.468 to 0.855, while correlation to the Health Assessment Questionnaire and Numeric Rating Scale was statistically significant for five out of eight domains. DISCUSSION: Intra- and inter-observer correlations showed high reliability. Internal consistency coefficients were high for all domains, revealing higher values for less subjective domains. As for construct validity, each domain revealed correlations with a specific group of parameters according to what the domains intended to measure. CONCLUSION: The FHSQ was cross-culturally adapted, generating a reliable, consistent, and valid instrument that is useful for evaluating foot health in patients with rheumatoid arthritis

General principles for treatment of early rheumatoid arthritis

Os principais objetivos do tratamento de um paciente com artrite reumatóide (AR) são: reduzir a dor, o edema articular e os sintomas constitucionais, como a fadiga, melhorar a função articular, interromper a progressão do dano ósseo-cartilaginoso, prevenir incapacidades e reduzir a morbimortalidade. Nos últimos anos, o conceito terapêutico da AR inicial (primeiros 12 meses de sintomas da doença) sofreu grandes mudanças. Três aspectos, em particular, passaram a ser base do novo paradigma de tratamento: a precocidade do diagnóstico, o início imediato das drogas modificadoras do curso da doença (DMARD) e o controle rigoroso da atividade inflamatória. Nesse artigo, os autores fazem uma revisão dos princípios gerais do manejo de pacientes com diagnóstico de AR inicial.The main goals of the treatment of a patient with RA are: to reduce pain, joint swelling and constitutional symptoms such as fatigue, to improve joint function, stop progression of bone-cartilage damage , prevent disabilities and reduce morbidity and mortality. In recent years, the therapeutic concept of early RA (first 12 months of symptoms) has undergone major changes. Three aspects in particular have become the basis of the new treatment paradigm: early diagnosis, immediate beginning of Disease Modifying Antirheumatic Drugs therapy (DMARD) and strict control of the inflammatory activity. In this article, the authors review the general principles of management of patients with early RA

Prospective evaluation of the quality of life in a cohort of patients with early rheumatoid arthritis

INTRODUÇÃO: Poucos estudos avaliaram, de forma prospectiva, os instrumentos de aferição de qualidade de vida, tanto genéricos quanto específicos, em pacientes com artrite reumatoide (AR) inicial. OBJETIVO: O objetivo deste trabalho foi caracterizar uma população de pacientes com AR inicial (menos de 12 meses de sintomas da doença no momento do diagnóstico) acompanhada prospectivamente quanto ao padrão de respostas aos questionários de qualidade de vida Health Assessment Questionnaire (HAQ) e o Medical Outcomes Study SF-36 Health Survey (SF - 36). PACIENTES E MÉTODOS: Foram avaliados 40 pacientes com diagnóstico de AR inicial no momento do diagnóstico, acompanhados prospectivamente por três anos, em uso de esquema terapêutico padronizado. Registrados os dados demográficos e clínicos e aplicados os questionários HAQ e SF-36 na avaliação inicial e aos 3, 6, 12, 18, 24 e 36 meses de acompanhamento. Comparações feitas pelo teste t de Student, t pareado e Wilcoxon (nível de significância de 5%). RESULTADOS: A idade média foi de 45 anos e predominou o sexo feminino (90%). A média do escore do HAQ inicial foi 1,89, com declínio progressivo até 0,77 no terceiro ano (P < 0,0001). A maioria dos elementos do SF-36 apresentaram significativa melhora durante os três anos de seguimento, com exceção de estado geral e vitalidade. CONCLUSÃO: Nessa população de pacientes com AR inicial no momento do diagnóstico, observou-se alterações importantes impacto na qualidade de vida no momento do diagnóstico, conforme avaliado pelos questionários HAQ e SF-36. O tratamento precoce da AR parece se associar à melhora da qualidade de vida relacionada com a saúde relatada pelo paciente.INTRODUCTION: Few studies have prospectively assessed the tools used to measure quality of life, both generic and specific, in patients with early rheumatoid arthritis (RA). OBJECTIVE: The objective of this study was to characterize a population of patients with early RA (less than 12 months after symptom onset at the time of the diagnosis) prospectively followed for the pattern of responses to questionnaires addressing quality of life, the Health Assessment Questionnaire (HAQ) and Medical Outcomes Study SF-36 Health Survey (SF-36). PATIENTS AND METHODS: Forty patients with early RA at the time of diagnosis, treated with a standard treatment regimen, were prospectively followed for 3 years. Demographic and clinical data were recorded, and HAQ and SF-36 questionnaires were applied at baseline and after 3, 6, 12, 18, 24, and 36 months. Paired Student t test and Wilcoxon test were used for comparisons (significance level of 5%). RESULTS: The mean age was 45 years, with a prevalence of the female gender (90%). The average score of the initial HAQ was 1.89, with a progressive decline to 0.77 in the third year (P < 0.0001). Most domains of the SF-36 questionnaire presented significant improvement during the three years of follow-up, except for general health and vitality. CONCLUSION: In this population of patients with early RA at the time of diagnosis, the results showed significant impact on quality of life at the time of diagnosis, as measured by HAQ and SF-36 questionnaires. The early treatment of RA seems to be associated with improved health-related quality of life reported by patients

Immunogenicity and Reactogenicity of 2009 Influenza A (H1N1) Inactivated Monovalent Non-Adjuvanted Vaccine in Elderly and Immunocompromised Patients

Background\ud \ud Immunosuppressed individuals present serious morbidity and mortality from influenza, therefore it is important to understand the safety and immunogenicity of influenza vaccination among them.\ud Methods\ud \ud This multicenter cohort study evaluated the immunogenicity and reactogenicity of an inactivated, monovalent, non-adjuvanted pandemic (H1N1) 2009 vaccine among the elderly, HIV-infected, rheumatoid arthritis (RA), cancer, kidney transplant, and juvenile idiopathic arthritis (JIA) patients. Participants were included during routine clinical visits, and vaccinated according to conventional influenza vaccination schedules. Antibody response was measured by the hemagglutination-inhibition assay, before and 21 days after vaccination.\ud Results\ud \ud 319 patients with cancer, 260 with RA, 256 HIV-infected, 149 elderly individuals, 85 kidney transplant recipients, and 83 with JIA were included.\ud \ud The proportions of seroprotection, seroconversion, and the geometric mean titer ratios postvaccination were, respectively: 37.6%, 31.8%, and 3.2 among kidney transplant recipients, 61.5%, 53.1%, and 7.5 among RA patients, 63.1%, 55.7%, and 5.7 among the elderly, 59.0%, 54.7%, and 5.9 among HIV-infected patients, 52.4%, 49.2%, and 5.3 among cancer patients, 85.5%, 78.3%, and 16.5 among JIA patients. The vaccine was well tolerated, with no reported severe adverse events.\ud Conclusions\ud \ud The vaccine was safe among all groups, with an acceptable immunogenicity among the elderly and JIA patients, however new vaccination strategies should be explored to improve the immune response of immunocompromised adult patients. (ClinicalTrials.gov, NCT01218685)Fundação Butantan funded the study, and employed several of the authors. The funder had a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript

Brazilian recommendations on the safety and effectiveness of the yellow fever vaccination in patients with chronic immune-mediated inflammatory diseases

Background: In Brazil, we are facing an alarming epidemic scenario of Yellow fever (YF), which is reaching the most populous areas of the country in unvaccinated people. Vaccination is the only effective tool to prevent YF. In special situations, such as patients with chronic immune-mediated inflammatory diseases (CIMID), undergoing immunosuppressive therapy, as a higher risk of severe adverse events may occur, assessment of the risk-benefit ratio of the yellow fever vaccine (YFV) should be performed on an individual level. Main body of the abstract: Faced with the scarcity of specific orientation on YFV for this special group of patients, the Brazilian Rheumatology Society (BRS) endorsed a project aiming the development of individualized YFV recommendations for patients with CIMID, guided by questions addressed by both medical professionals and patients, followed an internationally validated methodology (GIN-McMaster Guideline Development). Firstly, a systematic review was carried out and an expert panel formed to take part of the decision process, comprising BRS clinical practitioners, as well as individuals from the Brazilian Dermatology Society (BDS), Brazilian Inflammatory Bowel Diseases Study Group (GEDIIB), and specialists on infectious diseases and vaccination (from Tropical Medicine, Infectious Diseases and Immunizations National Societies); in addition, two representatives of patient groups were included as members of the panel. When the quality of the evidence was low or there was a lack of evidence to determine the recommendations, the decisions were based on the expert opinion panel and a Delphi approach was performed. A recommendation was accepted upon achieving ≥80% agreement among the panel, including the patient representatives. As a result, eight recommendations were developed regarding the safety of YFV in patients with CIMID, considering the immunosuppression degree conferred by the treatment used. It was not possible to establish recommendations on the effectiveness of YFV in these patients as there is no consistent evidence to support these recommendations. Conclusion: This paper approaches a real need, assessed by clinicians and patient care groups, to address specific questions on the management of YFV in patients with CIMID living or traveling to YF endemic areas, involving specialists from many areas together with patients, and might have global applicability, contributing to and supporting vaccination practices. We recommended a shared decision-making approach on taking or not the YFV

Comportamento distinto dos sorotipos do fator reumatoide em avaliação seriada de pacientes com artrite reumatoide inicial

Introdução: O fator reumatoide (FR), apesar de suas limitações, ainda é o marcador sorológico mais utilizado para diagnóstico da artrite reumatoide (AR) inicial. Há controvérsias sobre sensibilidade, especificidade, correlação com prognóstico radiológico e variação ao longo do tempo dos títulos dos sorotipos IgG, IgM e IgA. Objetivo: Avaliar o comportamento dos diferentes sorotipos de FR (IgG, IgM e IgA), em avaliações seriadas, e sua correlaçãocom a ocorrência de erosões radiográficas. Pacientes e métodos: Foram avaliados 40 pacientes com o diagnóstico de AR inicial (menos de 12 meses de sintomas) durante três anos de acompanhamento. A titulação dos sorotipos de FR foi feita por ELISA, na avaliação inicial, e seriadamente ao longo de 36 meses. Aplicou-se um modelo de regressão de efeitos mistos, considerando-se como desfecho a ocorrência de erosões radiográficas (radiografia de mãos e punhos, pés e tornozelos anuais). Resultados: Na avaliação inicial, 30%, 42,5% e 50% dos pacientes foram positivos para FR IgG, IgA e IgM, respectivamente. Os títulos de FR IgA e FR IgM foram maiores nos pacientes que apresentaram erosões radiográficas durante o acompanhamento (10-220 UI/dL contra 0 a 10 UI/dL nos pacientes sem erosões, P < 0,05). Os títulos de FR IgM e IgG não variaram ao longo dos três anos de acompanhamento. Por outro lado, em relação aos títulos de FR IgA houve uma tendência linear positiva ascendente significativa (P = 0,0013) apenas no grupo que apresentou erosões radiográficas. Conclusão: 1) Pesquisa dos sorotipos FR IgA e FR IgG não aumenta a frequência de positividade do FR e, portanto, não contribui para o diagnóstico de AR; 2) a estabilidade observada do FR IgM ao longo do tempo não justifica solicitações repetidas do FR durante a evolução da AR; 3) títulos mais altos de FR IgA e FR IgM são observados nos pacientes mais graves, com erosões radiográficas; 4) FR IgA apresenta um comportamento claramente distinto nos pacientes que apresentam ou não erosões radiográficas, o que pode ter implicações na fisiopatogenia e na avaliação prognóstica da doença

Effect of aquatic respiratory exercise-based program in patients with fibromyalgia

Objective: This study assessed the effects of an aquatic respiratory exercise-based program in patients with fibromyalgia (FMS). Methods: Forty women, aged between 20 and 60 years, were randomly assigned into two groups of 20 patients: the aquatic respiratory exercise-based program (ARG) and the control group (CTL). The ARG group performed the exercise program for 1 h, four times a week, for 4 weeks which included: (i) warming-Lip; (ii) respiratory exercises, consisting of five different breathing patterns, along With upper, lower limbs and trunk movements (45 min); and (iii) relaxation exercises. Both groups were included in supervised recreational activities of 1 h, once a week, for 4 weeks. Questionnaires were applied before and after intervention to assess quality of life and functional capacity (SF-36, Fibromyalgia Impact Questionnaire [FIQ]), anxiety (Hamilton Anxiety Scale [HAS]), and quality of sleep (Pittsburg Sleep Quality Index [PSQI]). Number of tender points and pain (Visual Analogue Scale [VAS]) were also evaluated. Results: At baseline there was no difference between the two groups, including number of tender points and questionnaire responses. After intervention, the ARG group, compared with the CTL group, showed improvement in SF-36 scores (physical functioning P = 0.001, bodily pain 1) = 0.001, vitality P = 0.009, social functioning P = 0.001, emotional role P = 0.001), in FIQ (total score P = 0.049, work missed P = 0.036, fatigue P = 0.013, morning tiredness P = 0.007) plus in VAS-pain (P = 0.029), VAS-dyspnea (P = 0.04), anxiety (HAS P = 0.005) and quality of sleep (PSQI P = 0.004). Conclusions: The short-term aquatic respiratory exercise-based program improved pain, quality of life, functional capacity, anxiety and quality of sleep in patients with FMS and may be a relevant addition to the treatment of these patients

Early rheumatoid arthritis : concepts

A generalização do conceito de artrite reumatoide - AR inicial e da existência de uma janela de oportunidade terapêutica - período de tempo no qual a instituição de terapia adequada para a doença determinaria melhora clínica - firmaram a noção de que diagnóstico e tratamento precoces modificam o curso da doença. Atualmente, almeja-se avaliar um paciente com sintomas articulares na primeira oportunidade possível e a definição da fase inicial da AR compreende as primeiras semanas ou meses de sintomas (em geral, menos de 12 meses), destacando-se como período crítico as primeiras 12 semanas de manifestações como a AR muito inicial ou muito precoce. Embora todos os pacientes necessitem de avaliação e tratamento precoces, há razões específicas pelas quais é necessário o pronto envolvimento do especialista na avaliação de pacientes com diagnóstico de AR precoce, uma vez que a inflamação que caracteriza a doença deve ser suprimida o mais rápido possível. Não diagnosticar ou não tratar de forma adequada um paciente com AR em fase bem inicial da doença aumenta o risco de evolução com inflamação persistente e dano articular progressivo. Por outro lado, tratar agressivamente pacientes com artrite leve, que provavelmente não progredirão para formas erosivas é igualmente danoso - expõe o paciente a riscos sem benefício comprovado e representa o oposto do tratamento precoce efetivo. Portanto, dentro do conceito atual de janela de oportunidade, é essencial fazer o diagnóstico precoce da AR e estabelecer o mais rapidamente possível quais pacientes evoluirão para formas mais graves, e, portanto, necessitarão de terapia mais agressiva.Generalization of the concept of early rheumatoid arthritis -RA and existence of a window of therapeutic opportunity, the period when appropriate therapy for this disease would determine clinical improvement, led to the concept that early diagnosis and treatment can change the disease's course. Currently, the goal is to evaluate patients with joint symptoms at the earliest opportunity. Definition of the initial phase of RA includes the first few weeks or months of symptoms (usually less than 12 months), and the first 12 weeks of symptoms of very early or initial RA are considered to be the critical period. Although all patients require early assessment and treatment, there are specific reasons for the involvement of a specialist soon in the evaluation of patients with early RA, since the inflammation that characterizes the disease should be treated as soon as possible. Failure to diagnose or treat a patient with RA at the very early stage of the disease increases the risk of progression to persistent joint inflammation and damage. On the other hand, aggressively treating patients with mild arthritis, which probably will not evolve to erosive forms is equally damaging. It exposes patients to risk without proven benefits and represents the opposite of effective early treatment. Therefore, within the current concept of a window of opportunity, early diagnosis of RA is essential and to establish, as soon as possible those patients who will progress to more severe forms, and therefore require more aggressive therapy

Early rheumatoid arthritis: concepts

A generalização do conceito de artrite reumatoide - AR inicial e da existência de uma janela de oportunidade terapêutica - período de tempo no qual a instituição de terapia adequada para a doença determinaria melhora clínica - firmaram a noção de que diagnóstico e tratamento precoces modificam o curso da doença. Atualmente, almeja-se avaliar um paciente com sintomas articulares na primeira oportunidade possível e a definição da fase inicial da AR compreende as primeiras semanas ou meses de sintomas (em geral, menos de 12 meses), destacando-se como período crítico as primeiras 12 semanas de manifestações como a AR muito inicial ou muito precoce. Embora todos os pacientes necessitem de avaliação e tratamento precoces, há razões específicas pelas quais é necessário o pronto envolvimento do especialista na avaliação de pacientes com diagnóstico de AR precoce, uma vez que a inflamação que caracteriza a doença deve ser suprimida o mais rápido possível. Não diagnosticar ou não tratar de forma adequada um paciente com AR em fase bem inicial da doença aumenta o risco de evolução com inflamação persistente e dano articular progressivo. Por outro lado, tratar agressivamente pacientes com artrite leve, que provavelmente não progredirão para formas erosivas é igualmente danoso - expõe o paciente a riscos sem benefício comprovado e representa o oposto do tratamento precoce efetivo. Portanto, dentro do conceito atual de janela de oportunidade, é essencial fazer o diagnóstico precoce da AR e estabelecer o mais rapidamente possível quais pacientes evoluirão para formas mais graves, e, portanto, necessitarão de terapia mais agressiva.Generalization of the concept of early rheumatoid arthritis -RA and existence of a window of therapeutic opportunity, the period when appropriate therapy for this disease would determine clinical improvement, led to the concept that early diagnosis and treatment can change the disease's course. Currently, the goal is to evaluate patients with joint symptoms at the earliest opportunity. Definition of the initial phase of RA includes the first few weeks or months of symptoms (usually less than 12 months), and the first 12 weeks of symptoms of very early or initial RA are considered to be the critical period. Although all patients require early assessment and treatment, there are specific reasons for the involvement of a specialist soon in the evaluation of patients with early RA, since the inflammation that characterizes the disease should be treated as soon as possible. Failure to diagnose or treat a patient with RA at the very early stage of the disease increases the risk of progression to persistent joint inflammation and damage. On the other hand, aggressively treating patients with mild arthritis, which probably will not evolve to erosive forms is equally damaging. It exposes patients to risk without proven benefits and represents the opposite of effective early treatment. Therefore, within the current concept of a window of opportunity, early diagnosis of RA is essential and to establish, as soon as possible those patients who will progress to more severe forms, and therefore require more aggressive therapy