Incidence of Infectious Adverse Events in Patients With Rheumatoid Arthritis and Spondyloarthritis on Biologic Drugs-Data From the Brazilian Registry for Biologics Monitoring.

BACKGROUND: The safety profile of biologic drugs might present substantial regional differences. Since 2009, the Brazilian Society of Rheumatology has maintained BIOBADABRASIL (Brazilian Registry for Biologic Drugs), a registry for monitoring of biologic therapies in rheumatic diseases. OBJECTIVES: The aim of this study was to verify the incidence rate (IR) of serious infections in rheumatoid arthritis (RA) and spondyloarthritis (SpA) patients on biologic drugs. METHODS: BIOBADABRASIL prospectively included patients with rheumatic diseases who started the first biologic drug or a synthetic disease-modifying antirheumatic drug as a parallel control group. This study focuses on serious infectious adverse events (SIAEs) in RA and SpA patients on biologic drugs compared with controls, from January 2009 to June 2015. Time of exposure was set from initiation of the drug to the date of last administration or censorship. Serious infectious adverse events IR was calculated per 1000 patient/years with 95% confidence interval (CI). RESULTS: A total of 1698 patients (RA, 1121; SpA, 577) were included, 7119 patient/years. Serious infectious adverse events were more common among patients on tumor necrosis factor inhibitors (TNFi's) than controls (adjusted IR ratio, 2.96 [95% CI, 2.01-4.36]; p < 0.001). Subsequent TNFi was associated with a higher SIAEs incidence when compared with first TNFI (adjusted IR ratio, 1.55 [95% CI, 1.15-2.08]; p = 0.004). Serious infectious adverse events were associated with age and corticosteroids intake. Serious infectious adverse events were more frequent in the respiratory tract in all subgroups. CONCLUSIONS: In BIOBADABRASIL, biologic drugs, especially the subsequent TNFi, were associated with a higher risk of serious infections compared with synthetic DMARDs. Corticosteroid intake and age represented risk factors for SIAEs. Constant monitoring is required to follow the safety profile of drugs in the clinical setting of rheumatic conditions in Brazil.

Development of a Brazilian Portuguese adapted version of the Gap-Kalamazoo communication skills assessment form.

OBJECTIVE: The goal of this study was to translate, adapt and validate the items of the Gap-Kalamazoo Communication Skills Assessment Form for use in the Brazilian cultural setting. METHODS: The Gap-Kalamazoo Communication Skills Assessment Form was translated into Portuguese by two independent bilingual Brazilian translators and was reconciled by a third bilingual healthcare professional. The translated text was then assessed for content using a modified Delphi technique and adjusted as needed to assure content validity. A total of nine phrases in the completed tool were adjusted. The final tool was then used to assess videotaped simulations as a means of validation.  Response process was assessed using exploratory factor analysis and internal structure was assessed via Cronbach's Alpha (internal consistency) and Intraclass Correlation (test-retest reliability and inter-rater reliability). RESULTS: One hundred and four (104) videotaped communication skills simulations were assessed by 38 subjects (6 staff physicians, 4 faculty physicians, 8 resident physicians, 4 professional actors with experience in simulation, and 16 other allied healthcare professionals). Measures of Internal consistency (Cronbach's alpha = 0.818) and test-retest reliability (intra-class correlation coefficient = 0.942) were high.  Exploratory factor analysis confirmed the uni-dimensionality of the instrument. CONCLUSIONS: Our results support the validity and reliability of the Brazilian Gap-Kalamazoo Communication Skills Assessment Form when used among Brazilian medical residents.  The Brazilian version of Gap-Kalamazoo Communication Skills Assessment Form was found to be adequate both in the linguistic and technical aspects.  The use of this instrument in Brazilian medical education can enhance the assessment of physician-patient-team relationships on an ongoing basis.

Functional Outcome of School Children With History of Global Developmental Delay.

This study aimed to investigate the functional and developmental outcomes in school age children diagnosed with global developmental delay before 2 years old and to verify the association between their final diagnosis and environmental and biological factors. Forty-five Brazilian children (26 boys), mean age 95.84 (7.72) months, who attended regular school and were diagnosed with global developmental delay before they were 2 years old had their functions evaluated. Children with global developmental delay were diagnosed with several conditions at school age. Students with greater chances of receiving a diagnosis were those whose mothers were younger at the time their children were born (OR = 1.47, CI = 1.04-2.09, P = .03), who had impaired motor performance, specially balance (OR = 1.33, CI = 1.01-1.75, P = .04), and who needed help during cognitive and behavioral tasks at school (OR = 1.08, CI = 1.00-1.17, P = .048). Interdisciplinary evaluation contributed to defining the specific diagnosis and to identifying the necessity of specialized support.

Effectiveness of an educational intervention on the suitability of indications for cesarean delivery in a Brazilian teaching hospital.

OBJECTIVE: To evaluate the effectiveness of an intervention to adjust the indications for caesarean delivery in a Brazilian teaching hospital in accordance with a specific protocol. METHODS: The present before-and-after study was carried out in three stages. In stages 1 and 3, data were obtained for 160 cesarean deliveries that occurred between May 20 and July 10 in 2011 and 2012, respectively. For stage 2, the protocol was implemented for 12 months. The deliveries in stages 1 and 3 were classified as high or low risk, and as consistent or inconsistent clinical cases on the basis of the protocol. RESULTS: A total of 160 (61.1%; 95% confidence interval [CI] 55.2-67.0) of 262 deliveries in stage 1 were by cesarean, compared with 160 (71.4%; 95% CI 65.5-77.3) of 224 in stage 3 (P=0.67). In stage 1, 125 (78.1%; 95% CI 71.7-84.5) showed indications consistent with the protocol, compared with 136 (85.0%; 95% CI 79.5-90.5) in stage 3 (P=0.11). Among the low-risk cesarean deliveries, 27 (51.9%; 95% CI 38.3-65.5) of 52 were consistent with the protocol in stage 1, compared with 49 (72.1%; 95% CI 61.4-86.1) of 68 in stage 3 (P=0.02). CONCLUSION: The proposed intervention improved the suitability of indications for cesarean delivery among low-risk pregnancies only.

Cross-cultural validation of the Patient-Practitioner Orientation Scale (PPOS).

OBJECTIVES: Translate, adapt and validate the Patient-Practitioner Orientation Scale (PPOS) for use in Brazil. METHODS: The PPOS was translated to Portuguese using a modified Delphi technique. The final version was applied to 360 participants. Reliability (test-retest and internal consistency) and construct validity (explanatory and confirmatory factor analysis) were assessed. RESULTS: Only two items did not reach pre-established criteria agreement in Delphi technique. In pre-testing, seven items were modified. Internal consistency (Cronbach's alpha=0.605) and test-retest reliability (intraclass correlation coefficient=0.670) were adequate. In explanatory factor analysis, one item did not achieve a loading factor, one item was considered factorially complex and two items were inconsistent with a priori factors. Confirmatory factor analysis provided an acceptable adjustment for the observed variables (χ(2)/df=2.33; GFI=0.91; AGFI=0.89; CFI=0.84; NFI=0.75; NNFI=0.81; RMSEA=0.062 (p=0.016) and SRMR=0.065). CONCLUSIONS: The Brazilian version PPOS (B-PPOS) showed acceptable validity and adequate reliability. PRACTICE IMPLICATIONS: The use of the B-PPOS in national and cross-cultural studies may contribute to the evaluation and monitoring of the attitudes of doctors, medical students and patients toward their professional relationships in research and practice.

Brazilian version of the Jefferson Scale of Empathy: psychometric properties and factor analysis.

BACKGROUND: Empathy is a central characteristic of medical professionalism and has recently gained attention in medical education research. The Jefferson Scale of Empathy is the most commonly used measure of empathy worldwide, and to date it has been translated in 39 languages. This study aimed to adapt the Jefferson Scale of Empathy to the Brazilian culture and to test its reliability and validity among Brazilian medical students. METHODS: The Portuguese version of the Jefferson Scale of Empathy was adapted to Brazil using back-translation techniques. This version was pretested among 39 fifth-year medical students in September 2010. During the final fifth- and sixth-year Objective Structured Clinical Examination (October 2011), 319 students were invited to respond to the scale anonymously. Cronbach's alpha, exploratory factor analysis, item-total correlation, and gender comparisons were performed to check the reliability and validity of the scale. RESULTS: The student response rate was 93.7% (299 students). Cronbach's coefficient for the scale was 0.84. A principal component analysis confirmed the construct validity of the scale for three main factors: Compassionate Care (first factor), Ability to Stand in the Patient's Shoes (second factor), and Perspective Taking (third factor). Gender comparisons did not reveal differences in the scores between female and male students. CONCLUSIONS: The adapted Brazilian version of the Jefferson Scale of Empathy proved to be a valid, reliable instrument for use in national and cross-cultural studies in medical education.

Health-related quality of life of medical students.

OBJECTIVES: Mental problems such as stress, anxiety and depression have been described among medical students and are associated with poor academic and professional performance. It has been speculated that these problems impair students' quality of life (QoL). The authors aimed to assess the health-related QoL (HRQL) of medical students throughout their 6 years of training at a school with a traditional curriculum. METHODS: Of a total of 490 students attending our institution's medical school, 38 were surveyed in February 2006 (incoming Year 1 group, surveyed when students were in the second week of Year 1 classes) and 352 were surveyed in February 2007 (students in Years 1-6). Students self-reported their HRQL and depressive symptoms using the Short-Form Health Survey (SF-36) and the Beck Depression Inventory (BDI). Comparisons were performed according to year in training, presence of depressive symptoms, gender, living arrangements and correlations with family income. RESULTS: The students' ages ranged from 18 to 31 years (median 22.3 years). Students in Years 2, 3, 4 and 6 had lower scores for mental and physical dimensions of HRQL compared with the incoming Year 1 group (P < 0.01), with the largest difference observed for Year 3 students. Students with depressive symptoms had lower scores in all domains of the SF-36 (P < 0.01). Female students had lower HRQL scores than males (P < 0.01). No differences were observed for students living with versus without family and no correlation with family income was found. CONCLUSIONS: Major impairments in HRQL were observed among Year 3 students, students with depressive symptoms and women. Medical schools should institute efforts to ensure that students' HRQL and emotional support are maintained, particularly during critical phases of medical training.

Cross-sectional survey of hantavirus infection, Brazil.

A cross-sectional serosurvey was conducted to assess the proportion of persons exposed to hantaviruses in a virus-endemic area of the state of Minas Gerais, Brazil. Findings of this study suggested the presence of > or =1 hantaviruses circulating in this region causing hantavirus pulmonary syndrome, mild disease, or asymptomatic infection.

Quality of life in children and adolescents with allergic rhinitis.

UNLABELLED: Allergic rhinitis (AR) remains a significant pediatric health problem because of the burden of uncontrolled symptoms on daily activities and on general well being. AIM: to assess the impact of AR on health-related quality of life (HRQL) of children and adolescents using a generic instrument, the Child Health Questionnaire (CHQ - PF50). METHODS: Between January and November 2004, parents or caregivers of 23 children and adolescents with AR without comorbidities and with positive prick tests for at least one air allergen were invited to participate of a cross-sectional study and asked to answer the self-administered CHQ-PF50. The scores were compared to those of healthy children and adolescents. RESULTS: Patient scores were lower (p<0.05) than healthy subsets in both the physical and psychosocial summaries and in most of the CHQ-PF50 scales (p<0,05), except for the 'change in health' scale. The size effect was higher in the physical score compared to the psychosocial summary score. CONCLUSIONS: allergic rhinitis has a global negative impact on the HRQL of children and adolescents, with major repercussions in physical function; AR also negatively affects family relations.

Quality of life in children and adolescents with allergic rhinitis / Qualidade de vida em crianças e adolescentes com rinite alérgica

Allergic rhinitis (AR) remains a significant pediatric health problem because of the burden of uncontrolled symptoms on daily activities and on general well being. AIM: to assess the impact of AR on health-related quality of life (HRQL) of children and adolescents using a generic instrument, the Child Health Questionnaire (CHQ - PF50). METHODS: Between January and November 2004, parents or caregivers of 23 children and adolescents with AR without comorbidities and with positive prick tests for at least one air allergen were invited to participate of a cross-sectional study and asked to answer the self-administered CHQ-PF50. The scores were compared to those of healthy children and adolescents. RESULTS: Patient scores were lower (p<0.05) than healthy subsets in both the physical and psychosocial summaries and in most of the CHQ-PF50 scales (p<0,05), except for the "change in health" scale. The size effect was higher in the physical score compared to the psychosocial summary score. CONCLUSIONS: allergic rhinitis has a global negative impact on the HRQL of children and adolescents, with major repercussions in physical function; AR also negatively affects family relations.

A rinite alérgica (RA) representa importante problema de saúde pública, compromete as atividades diárias e pode repercutir no bem estar dos pacientes. OBJETIVO: Avaliar o impacto da RA na qualidade de vida relacionada à saúde (QVRS) de crianças e adolescentes por meio do questionário genérico Child Health Questionnaire (CHQ-PF50). CASUÍSTICA E MÉTODOS: Entre janeiro e novembro de 2004 pais ou responsáveis de 23 crianças e adolescentes com RA sem comorbidades e teste cutâneo de hipersensibilidade imediata positivo para pelo menos um aeroalérgeno foram convidados a participar de um estudo transversal e solicitados a responder o CHQ-PF50. Os escores obtidos foram comparados com os de crianças e adolescentes saudáveis. RESULTADOS: Os escores obtidos pelos pacientes foram menores (p<0,05) que os do grupo controle nos sumários físico e psicossocial e na maioria das escalas, com exceção na escala "alteração na saúde". O tamanho do efeito foi maior no escore sumário físico que no psicossocial. CONCLUSÕES: A RA causa impacto negativo global na QVRS de crianças e adolescentes com maior repercussão na função física, e afeta negativamente a dinâmica familiar.

Psychometric properties of the Child Health Assessment Questionnaire (CHAQ) applied to children and adolescents with cerebral palsy.

BACKGROUND: Cerebral palsy (CP) patients have motor limitations that can affect functionality and abilities for activities of daily living (ADL). Health related quality of life and health status instruments validated to be applied to these patients do not directly approach the concepts of functionality or ADL. The Child Health Assessment Questionnaire (CHAQ) seems to be a good instrument to approach this dimension, but it was never used for CP patients. The purpose of the study was to verify the psychometric properties of CHAQ applied to children and adolescents with CP. METHODS: Parents or guardians of children and adolescents with CP, aged 5 to 18 years, answered the CHAQ. A healthy group of 314 children and adolescents was recruited during the validation of the CHAQ Brazilian-version. Data quality, reliability and validity were studied. The motor function was evaluated by the Gross Motor Function Measure (GMFM). RESULTS: Ninety-six parents/guardians answered the questionnaire. The age of the patients ranged from 5 to 17.9 years (average: 9.3). The rate of missing data was low (<9.3%). The floor effect was observed in two domains, being higher only in the visual analogue scales (< or = 35.5%). The ceiling effect was significant in all domains and particularly high in patients with quadriplegia (81.8 to 90.9%) and extrapyramidal (45.4 to 91.0%). The Cronbach alpha coefficient ranged from 0.85 to 0.95. The validity was appropriate: for the discriminant validity the correlation of the disability index with the visual analogue scales was not significant; for the convergent validity CHAQ disability index had a strong correlation with the GMFM (0.77); for the divergent validity there was no correlation between GMFM and the pain and overall evaluation scales; for the criterion validity GMFM as well as CHAQ detected differences in the scores among the clinical type of CP (p < 0.01); for the construct validity, the patients' disability index score (mean:2.16; SD:0.72) was higher than the healthy group (mean:0.12; SD:0.23)(p < 0.01). CONCLUSION: CHAQ reliability and validity were adequate to this population. However, further studies are necessary to verify the influence of the ceiling effect on the responsiveness of the instrument.

Psychometric properties of the initial Brazilian version of the CHQ-PF50 applied to the caregivers of children and adolescents with cerebral palsy.

GOALS: To evaluate the psychometric properties of the initial Brazilian version of the Child Health Questionnaire(CHQ-PF50) in children and adolescents with cerebral palsy(CP). METHODS: The caregivers of 5- to 18-year-old children and adolescents with CP answered the self-administered CHQ-PF50 questionnaire. Data quality, reliability and validity were studied. The Gross Motor Function Measure was used to assess physical function. RESULTS: Ninety-six caregivers answered the questionnaire. Patient age ranged from 5 to 17.9 years (mean: 9.3 years). Missing data rate was low. Floor effect occurred in 3 scales and was substantial for quadriplegia group (63.6-77.3%). Ceiling effect occurred in 9 scales. Reliability was adequate for all scales except for the general health perception scale (Cronbach alpha coefficient = 0.24). The validity was adequate in general, but the role/social limitations-emotional behavioral scale was not satisfactory for discriminant and divergent validity. CONCLUSION: The initial Brazilian version of the CHQ-PF50 showed, in general, adequate psychometric properties for application in patients with CP. Although floor and ceiling effects are expected in heterogeneous group as a limitation inherent to generic assessment instruments, they must be carefully considered in further studies. The general health perception and role/social limitations-emotional behavioral scale must be further reviewed for this population.