OBJECTIVE: We evaluated the incidence of and the main risk factors associated with cutaneous adverse events in patients with chronic inflammatory arthritis following anti-TNF-α therapy. METHODS: A total of 257 patients with active arthritis who were taking TNF-α blockers, including 158 patients with rheumatoid arthritis, 87 with ankylosing spondylitis and 12 with psoriatic arthritis, were enrolled in a 5-year prospective analysis. Patients with overlapping or other rheumatic diseases were excluded. Anthropometric, socioeconomic, demographic and clinical data were evaluated, including the Disease Activity Score-28, Bath Ankylosing Spondylitis Disease Activity Index and Psoriasis Area Severity Index. Skin conditions were evaluated by two dermatology experts, and in doubtful cases, skin lesion biopsies were performed. Associations between adverse cutaneous events and clinical, demographic and epidemiological variables were determined using the chi-square test, and logistic regression analyses were performed to identify risk factors. The significance level was set at p<0.05. RESULTS: After 60 months of follow-up, 71 adverse events (73.85/1000 patient-years) were observed, of which allergic and immune-mediated phenomena were the most frequent events, followed by infectious conditions involving bacterial (47.1%), parasitic (23.5%), fungal (20.6%) and viral (8.8%) agents. CONCLUSION: The skin is significantly affected by adverse reactions resulting from the use of TNF-α blockers, and the main risk factors for cutaneous events were advanced age, female sex, a diagnosis of rheumatoid arthritis, disease activity and the use of infliximab.

To review all specific questionnaires regarding quality of life in osteoporosis and to describe their distinctive indications, we searched Medline, the Scientific Electronic Library Online database, and the Latin-American and Caribbean Health Sciences Literature database. Nine specific questionnaires related to osteoporosis quality of life were found: 1) the Women's Health Questionnaire, 2) Osteoporosis Quality of Life Questionnaire, 3) Osteoporosis Assessment Questionnaire, 4) Osteoporosis Functional Disability Questionnaire, 5) Quality of Life Questionnaire of the European Foundation for Osteoporosis, 6) Osteoporosis-Targeted Quality of Life Questionnaire, 7) Japanese Osteoporosis Quality of Life Questionnaire, 8) the 16-item Assessment of Health-Related Quality of Life in Osteoporosis, and 9) the Quality of Life Questionnaire in Osteoporosis (QUALIOST TM). The Quality of Life Questionnaire of the European Foundation for Osteoporosis is the osteoporosis-specific questionnaire most commonly used in the literature. The Quality of Life Questionnaire of the European Foundation for Osteoporosis and the Osteoporosis Quality of Life Questionnaire are targeted more toward fracture assessment, and the Osteoporosis Functional Disability Questionnaire can be used for longitudinal studies involving exercise. In the present study, the authors summarize all of the specific questionnaires for osteoporosis and demonstrate that these questionnaires should be selected based on the objectives to be evaluated. Osteoporosis-specific quality of life questionnaires should be validated in the language of the country of origin before being used.

OBJETIVOS: Avaliar a resposta clínica após a estratégia de troca entre agentes antifator de necrose tumoral alfa (anti-TNF-alfa) em pacientes com artrite reumatoide (AR). PACIENTES E MÉTODOS: Foram incluídos 99 pacientes com diagnóstico de AR (American College of Rheumatology, 1987), em uso de terapia anti-TNF-alfa, para avaliação da resposta terapêutica após 24 semanas. A estratégia de troca foi feita se, após 12 a 24 semanas, houvesse relato de evento adverso sério (T: toxicidade) ou se não ocorresse redução maior que 0,6 do índice de atividade da doença (DAS28) inicial (RI: resposta inadequada). Nesse último caso, o paciente foi considerado como falência primária (FP). Falência secundária (FS) foi definida se houvesse perda de resposta após melhora inicial. Remissão (DAS28 < 2,6), baixa atividade de doença (2,61 < 3,2) e melhora funcional [aumento > 0,2 do questionário de avaliação da saúde (HAQ) inicial] foram avaliadas por análise de regressão linear. P < 0,05 foi considerado significante. RESULTADOS: A estratégia de troca foi realizada em 39 (39,4%) pacientes, especialmente por FP (24,3%), FS (35,1%) e T (40,5%). A taxa de retenção ao primeiro agente foi de 60,1%, e o tempo médio para a troca foi de 14,2 ± 10,9 meses. Após a troca, houve tendência à queda do DAS28 (4,7 ± 1,4; P = 0,08), mas não do HAQ (1,2 ± 0,77; P = 0,11). Cerca de 43% deles alcançaram boa/moderada resposta EULAR. O principal determinante da troca foi o DAS28 inicial mais elevado, independente de idade, tempo de doença e capacidade funcional. CONCLUSÃO: A estratégia de troca entre agentes anti-TNF-alfa é válida para o controle da atividade de doença, embora com baixa probabilidade de remissão e sem melhora significativa da capacidade funcional

OBJECTIVES: To assess clinical response after switching between anti-tumor necrosis factor-alpha (anti-TNF-alpha) agents in patients with rheumatoid arthritis (RA). PATIENTS AND METHODS: This study included 99 patients diagnosed with RA American College of Rheumatology, 1987), on anti-TNF-alpha therapy, to assess the therapeutic response after 24 weeks. Switching was performed if, after 12 to 24 weeks, a severe adverse event was reported (toxicity: T) or if no reduction greater than 0.6 in the initial Disease Activity Score 28 (DAS28) occurred (inadequate response: IR). In case of IR, the patient was considered as primary failure (PF). Secondary failure (SF) was defined as loss of response after initial improvement. Remission (DAS28 < 2.6), low disease activity (between 2.61 and 3.2), and functional improvement [increase in the initial Health Assessment Questionnaire (HAQ) > 0.2] were assessed by use of linear regression analysis. The significance level adopted was P < 0.05. RESULTS: Switching was performed in 39 (39.4%) patients, especially due to PF (24.3%), SF (35.1%) and T (40.5%). The retention rate of the first agent was 60.1%, and the mean time for switching was 14.2 ± 10.9 months. After switching, a tendency towards a decrease in DAS28 was observed (4.7 ± 1.4; P = 0.08), but not in the HAQ (1.2 ± 0.77; P = 0.11). Around 43% of the patients achieved good/moderate EULAR response. The major determinant of switching was a higher initial DAS28, independent of age, duration of disease, and functional capacity. CONCLUSION: Switching between anti-TNF-alpha agents is a valid strategy to control disease activity, despite the low likelihood of remission and no significant improvement in functional capacity

OBJECTIVES: 1) To characterize the impact of multiple myeloma on the quality of life of patients treated in two public institutions in São Paulo State, Brazil, using a generic Short Form 36 Health Survey and a questionnaire specific for oncologic patients (QLQ-C30) upon diagnosis, after the clinical treatment, and at day +100 after autologous stem cell transplantation; 2) to evaluate whether autologous stem cell transplantation can improve the quality of life of our economically challenged population aside from providing a clinical benefit and disease control. METHODS: We evaluated 49 patients with multiple myeloma (a total of 70 interviews) using the two questionnaires. The scores upon diagnosis, post-treatment/pre-autologous stem cell transplantation, and at D+100 were compared using ANOVA (a comparison of the three groups), post hoc tests (two-by-two comparisons of the three groups), and paired t-tests (the same case at two different times). RESULTS: Of the included patients, 87.8% had a family budget under US $600 (economic class C, D, or E) per month. The generic Short Form 36 Health Survey questionnaire demonstrated that physical function, role-physical, and bodily pain indices were statistically different across all three groups, favoring the D+100 autologous stem cell transplantation group (ANOVA). The questionnaire specific for oncologic patients, the QLQ-C30 questionnaire, confirmed what had been demonstrated by the Short Form 36 Health Survey with respect to physical function and bodily pain, with improvements in role functioning, fatigue, and lack of appetite and constipation, favoring the D+100 autologous stem cell transplant group (ANOVA). The post hoc tests and paired t-tests confirmed a better outcome after autologous stem cell transplantation CONCLUSION: The questionnaire specific for cancer patients seems to be more informative than the generic Short Form 36 Health Survey questionnaire and reflects the real benefit of autologous stem cell transplantation in the quality of life of multiple myeloma patients in two public Brazilian institutions that provide assistance for economically challenged patients.

INTRODUÇÃO/OBJETIVOS: O BRAZOS (The Brazilian Osteoporosis Study) é um estudo epidemiológico, de base populacional, realizado em amostra representativa de mulheres e homens brasileiros, de idade superior a 40 anos, com o objetivo de identificar os principais fatores clínicos de risco associados com fratura por baixo impacto. Nesse artigo são apresentados os principais resultados do estudo, de acordo com cada região do país. PACIENTES E MÉTODOS: Um total de 2.420 indivíduos, provenientes das cinco regiões do país e de todas as classes socioeconômicas foram incluídos no estudo. Foram avaliados dados antropométricos, bem como aspectos relacionados aos hábitos de vida, fraturas, ingestão alimentar, atividade física, quedas e qualidade de vida por meio de entrevista individual e quantitativa. Fratura por baixo impacto foi definida como aquela decorrente de queda da própria altura ou menos. Valor de P < 0,05 foi considerado como estatisticamente significante. RESULTADOS: Não houve diferença estatisticamente significativa da prevalência de fratura nas cinco regiões do Brasil, de acordo com o sexo ou classe social. No entanto, nas mulheres, houve maior ocorrência de fraturas na região metropolitana do que nos municípios do interior dos estados e tendência a maior frequência de fraturas em homens da região nordeste. Não foi verificada diferença estatisticamente significativa de fraturas se os homens eram provenientes das capitais ou do interior dos estados. CONCLUSÕES: De acordo com os nossos resultados, não foi observada diferença significativa da prevalência de fraturas por baixo impacto nem da frequência ou relevância de fatores de risco entre as cinco regiões do Brasil.

OBJECTIVES: The BRAZOS (The Brazilian Osteoporosis Study) study is the first epidemiological and population-based study carried out in a representative sample of Brazilian men and women, 40 years or older, with the objective of identifying the prevalence and main clinical risk factors (CRF) associated with low-impact fractures. This report shows the main results according to each region of the country. PATIENTS AND METHODS: A total of 2,420 subjects (70% women) from 150 different cities in five geographic regions in Brazil, and from all different socio-economical classes were included in this study. Anthropometrical data, as well life style, previous fractures, nutritional status, physical activity, falls, and quality of life were evaluated by a quantitative individual survey. Low-impact fracture was defined as that resulting from a fall no greater than standing height of an individual. A P < 0.05 was considered significant. RESULTS: Statistically significant differences in the prevalence of fractures among the five Brazilian regions according to gender or social class were not observed. However, in women, a higher incidence of fractures was observed in metropolitan areas than in rural areas, and a tendency for a higher frequency of fractures was observed in men from Northeastern states. Statistically significant differences among men from metropolitan areas or rural areas were not observed. CONCLUSIONS: Significant differences in the prevalence of low-impact fractures among the five different regions of Brazil were not observed, as well as its frequency or relevance of risk factors.

OBJETIVOS: Avaliar a confiabilidade e a validade da versão brasileira do questionário genérico Pediatric Quality of Life InventoryTM (PedsQL TM 4.0) e mensurar a qualidade de vida de crianças e adolescentes saudáveis e de pacientes com doenças reumáticas. MÉTODOS: No processo de validação, seguimos a metodologia proposta pelos idealizadores da versão original em inglês do questionário PedsQL TM 4.0. O instrumento foi administrado por entrevista em dois grupos: 240 crianças e adolescentes aparentemente saudáveis de São Paulo (SP) e 105 pacientes com doenças reumáticas crônicas, pareados por idade, e aos respectivos pais ou responsáveis. O questionário foi aplicado nos cuidadores e nas crianças separadamente e no mesmo dia. RESULTADOS: Os valores do teste alfa de Cronbach situaram-se entre 0,6 e 0,9 para todas as dimensões, demonstrando uma consistência interna adequada. Os pacientes com doenças reumáticas apresentaram uma redução significativa na qualidade de vida quando comparados com as crianças saudáveis (p < 0,0001). A validade construída da versão brasileira do PedsQL TM 4.0 também foi comprovada. Observamos altos níveis de correlação entre os relatos dos cuidadores e dos pacientes na dimensão física (r = 0,77, p < 0,001) e escolar (r = 0,73, p < 0,001). A correlação foi mais baixa nas dimensões emocional e social (r = 0,40 e 0,59, respectivamente, p < 0,001). CONCLUSÕES: O questionário mostrou ser confiável, válido e de fácil e rápida aplicação. A qualidade de vida dos pacientes com doenças reumáticas foi mais baixa, o que reforça a necessidade de uma abordagem ampla aos pacientes com doenças crônicas, focada nos aspectos psicossociais.

OBJECTIVES: To evaluate the reliability and validity of the Brazilian version of the Pediatric Quality of Life InventoryTM (PedsQL TM 4.0) Generic Core Scales and measure the quality of life of healthy children and adolescents and patients with rheumatic diseases. METHODS: We followed the translation methodology proposed by the developer of the original English version of the PedsQL TM 4.0. The instrument was administered by interviews in two groups: 240 apparently healthy children and adolescents from São Paulo (SP, Brazil) and 105 patients with chronic rheumatic diseases, matched by age, as well as to their respective parents or caregivers. The parent proxy-report was administered to the children's parents or caregivers separately on the same day. RESULTS: Cronbach's alpha values were between 0.6 and 0.9 for all dimensions, demonstrating adequate internal consistency. Patients with rheumatic diseases reported significantly lower PedsQL TM scores on all dimensions when compared to the healthy control group (p < 0.0001). Construct validity of the Brazilian Portuguese version of the PedsQL TM 4.0 was also confirmed. Parent proxy-report of patients with rheumatic diseases highly correlated with child self-report for physical functioning (r = 0.77, p < 0.001) and school functioning (r = 0.73, p < 0.001). Lower correlations were observed for emotional and social functioning (r = 0.40 and 0.59, respectively, p < 0.001). CONCLUSIONS: The tool demonstrated reliability, validity and the administration was fast and easy. Quality of life of patients with rheumatic diseases was significantly lower than the healthy control group, supporting the necessity of a comprehensive approach to rheumatic disease management, focused on the psychosocial dimensions.

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.